{
"NDC": [
{
"NDCCode": "55714-2364-0",
"PackageDescription": ".5 mL in 1 BOTTLE, GLASS (55714-2364-0)",
"NDC11Code": "55714-2364-00",
"ProductNDC": "55714-2364",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Vitality",
"NonProprietaryName": "Adrenalinum, Aloe, Arsenicum Alb., Baptisia, Berber. Aqui., Berber. Vulg., Bryonia, Chelidonium Majus, Crotalus Horridus, Digitalis, Ferrum Metallicum, Glonoinum, Glycyrrhiza Glabra , Hydrocotyle, Iodium, Iris Versicolor, Lachesis, Lycopodium, Nat. Mur., Nux Vom., Rhus Toxicodendron, Ruta, Thuja Occ., Thyroidinum, Echinacea, Lappa, Solidago, Taraxacum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "EPINEPHRINE; ALOE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; MAHONIA AQUIFOLIUM ROOT BARK; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; CROTALUS HORRIDUS HORRIDUS VENOM; DIGITALIS; IRON; NITROGLYCERIN; GLYCYRRHIZA GLABRA; CENTELLA ASIATICA; IODINE; IRIS VERSICOLOR ROOT; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG; THYROID, UNSPECIFIED; ECHINACEA, UNSPECIFIED; ARCTIUM LAPPA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; TARAXACUM OFFICINALE",
"StrengthNumber": "15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3; 3",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Vitality Formulated for symptoms associated with low energy, mild stress and weakness."
},
{
"NDCCode": "55714-2364-1",
"PackageDescription": "29.57 mL in 1 BOTTLE, GLASS (55714-2364-1)",
"NDC11Code": "55714-2364-01",
"ProductNDC": "55714-2364",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Vitality",
"NonProprietaryName": "Adrenalinum, Aloe, Arsenicum Alb., Baptisia, Berber. Aqui., Berber. Vulg., Bryonia, Chelidonium Majus, Crotalus Horridus, Digitalis, Ferrum Metallicum, Glonoinum, Glycyrrhiza Glabra , Hydrocotyle, Iodium, Iris Versicolor, Lachesis, Lycopodium, Nat. Mur., Nux Vom., Rhus Toxicodendron, Ruta, Thuja Occ., Thyroidinum, Echinacea, Lappa, Solidago, Taraxacum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "EPINEPHRINE; ALOE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; MAHONIA AQUIFOLIUM ROOT BARK; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; CROTALUS HORRIDUS HORRIDUS VENOM; DIGITALIS; IRON; NITROGLYCERIN; GLYCYRRHIZA GLABRA; CENTELLA ASIATICA; IODINE; IRIS VERSICOLOR ROOT; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG; THYROID, UNSPECIFIED; ECHINACEA, UNSPECIFIED; ARCTIUM LAPPA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; TARAXACUM OFFICINALE",
"StrengthNumber": "15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3; 3",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Vitality Formulated for symptoms associated with low energy, mild stress and weakness."
},
{
"NDCCode": "55714-2364-2",
"PackageDescription": "59.14 mL in 1 BOTTLE, GLASS (55714-2364-2)",
"NDC11Code": "55714-2364-02",
"ProductNDC": "55714-2364",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Vitality",
"NonProprietaryName": "Adrenalinum, Aloe, Arsenicum Alb., Baptisia, Berber. Aqui., Berber. Vulg., Bryonia, Chelidonium Majus, Crotalus Horridus, Digitalis, Ferrum Metallicum, Glonoinum, Glycyrrhiza Glabra , Hydrocotyle, Iodium, Iris Versicolor, Lachesis, Lycopodium, Nat. Mur., Nux Vom., Rhus Toxicodendron, Ruta, Thuja Occ., Thyroidinum, Echinacea, Lappa, Solidago, Taraxacum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "EPINEPHRINE; ALOE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; MAHONIA AQUIFOLIUM ROOT BARK; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; CROTALUS HORRIDUS HORRIDUS VENOM; DIGITALIS; IRON; NITROGLYCERIN; GLYCYRRHIZA GLABRA; CENTELLA ASIATICA; IODINE; IRIS VERSICOLOR ROOT; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG; THYROID, UNSPECIFIED; ECHINACEA, UNSPECIFIED; ARCTIUM LAPPA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; TARAXACUM OFFICINALE",
"StrengthNumber": "15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3; 3",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Vitality Formulated for symptoms associated with low energy, mild stress and weakness."
},
{
"NDCCode": "15631-2364-0",
"PackageDescription": "1 TABLET in 1 BLISTER PACK (15631-2364-0)",
"NDC11Code": "15631-2364-00",
"ProductNDC": "15631-2364",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bio-combination 9",
"NonProprietaryName": "Ferrum Phosphoricum, Kali Muriaticum, Kali Phosphoricum, Magnesia Phosphorica",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160411",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
"SubstanceName": "FERROSOFERRIC PHOSPHATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE",
"StrengthNumber": "12; 6; 3; 6",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Condition listed above or as directed by the physician."
},
{
"NDCCode": "50090-2364-0",
"PackageDescription": "12 BOTTLE, DROPPER in 1 CARTON (50090-2364-0) > 2 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "50090-2364-00",
"ProductNDC": "50090-2364",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tetracaine Hydrochloride",
"NonProprietaryName": "Tetracaine Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "19690328",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208135",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "TETRACAINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2018-01-10",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "70518-2364-0",
"PackageDescription": "90 CAPSULE in 1 BOTTLE, PLASTIC (70518-2364-0) ",
"NDC11Code": "70518-2364-00",
"ProductNDC": "70518-2364",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pregabalin",
"NonProprietaryName": "Pregabalin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20191016",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209743",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"DEASchedule": "CV",
"Status": "Deprecated",
"LastUpdate": "2024-09-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20191016",
"SamplePackage": "N",
"IndicationAndUsage": "Pregabalin capsules are indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older , 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.",
"Description": "Pregabalin is described chemically as ( S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin is a white to off-white, crystalline solid with a pK a1of 4.2 and a pK a2of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with pregelatinized starch and talc. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and white capsule shells contain sodium lauryl sulfate. Each capsule shell is imprinted with black pharmaceutical ink which contains: butyl alcohol, dehydrated alcohol, ferrosoferric oxide, isopropyl alcohol, propylene glycol, potassium hydroxide, purified water, strong ammonia solution and shellac."
},
{
"NDCCode": "36987-2364-1",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (36987-2364-1)",
"NDC11Code": "36987-2364-01",
"ProductNDC": "36987-2364",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Standardized Redtop Grass Pollen",
"NonProprietaryName": "Standardized Redtop Grass Pollen",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19980210",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "AGROSTIS GIGANTEA POLLEN",
"StrengthNumber": "10000",
"StrengthUnit": "[BAU]/mL",
"Pharm_Classes": "Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Standardized Pollen Extract is intended for use in the diagnosis and therapy of pollen allergic patients as established by allergy history and skin test reactivity. Standardized Grass Pollen extracts labeled in BAU/mL are not interchangeable with Grass Pollen extracts labeled in AU/mL or with non-standardized Grass Pollen extracts. The 10,000 BAU/mL dose form is indicated for percutaneous testing. If negative, 100,000 BAU/mL dose form can be used for percutaneous testing. For immunotherapy, availability of 10,000 and 100,000 BAU/mL dosages facilitates safe switching. (See Dosage & Administration). The use of standardized grass pollen extracts is indicated for hyposensitization treatment and may be used as part of the over-all management of the allergic patient. Treatment of grass sensitive patients consists of using specific standardized grass products of up to and including doses of 100,000 BAU/mL (up to 10,000 BAU/mL for Bermuda grass) or stock mixtures of standardized grass products. Stock mixtures of standardized grass extracts are particularly useful in hyposensitization treatment when multiple allergies to grasses are diagnosed. For previously untreated patients, the 10,000 BAU/mL concentrates can be used to formulate dosages. If tolerated, the concentrates can be inceased to 100,000 BAU/mL dose formulation.",
"Description": "Standardized Grass Pollen Extracts include: Orchard (Dactylis glomerata), Perennial Rye (Lolium perenne), Timothy (Phleum pratense), Redtop (Agrostis alba), Kentucky (June) Bluegrass (Poa pratensis), Bermuda (Cynodon dactylon), Meadow Fescue (Festuca elatior), Sweet Vernal (Anthoxanthum odoratum). The standardized grass pollen extract is prepared by extracting raw pollen material at a ratio of either 1:5 w/v, 1:6.66 w/v or 1:10 w/v in Cocas fluid containing 0.5% NaCl, 0.275% NaHCO3, WFI and 0.4% phenol as preservative. Following extraction, a calculated amount of glycerin is added to make a 50%(v/v) glycerinated solution. Standardized Grass Pollen extracts have potency designations of 10,000 BAU/mL and 100,000 BAU/mL except Bermuda Grass (10,000 BAU/mL only). Extracts with a potency of 10,000 BAU/mL are diluted from the 100,000 BAU/mL lots with Glycerol Saline 50%(v/v). The Glycerol Saline 50%(v/v) solution consists of Glycerin and Salts and Buffered Diluent whose ingredients are 0.5% NaCl, 0.08% Na2HPO4, 0.036% KH2PO4, WFI and 0.4% phenol as a preservative. All extracts are aseptically filled in sterile containers. Standardized pollen extracts are intended for administration by prick-puncture or intradermal routes when used for diagnostic purposes and administered subcutaneously when used for immunotherapy injection. Standardized grass pollen extracts labeled in BAU/mL are not interchangeable with grass pollen extracts labeled in AU/mL or with non-standardized grass pollen extracts. The Bioequivalent Allergy Unit (BAU), the potency unit used for all Standardized Pollen Extracts, replaces the previous unitage for these products. Bioequivalent Allergy Units were assigned to the FDA, Center for Biologics Evaluation and Research (CBER) reference extracts, based on quantitative intradermal skin test results. BAU's are intended to assure that the labeled unitage of different allergenic extracts will correspond to the expected clinical response in sensitive patients. References labeled 10,000 BAU/mL can be diluted one half million fold to produce an intradermal sum of erythema diameter response of 50mm in highly puncture reactive subjects. 100,000 BAU/mL can be diluted 1:5 million fold to yield the same intradermal response.(2) The assignment of BAU/mL to standardized grass pollen extracts, is accomplished by an ELISA assay comparing the extract to the CBER reference. Previously, the potency / concentration of grass mixtures was designated based on the manufacturing strength, e.g. 1:10 w/v or 1:20 w/v, or in PNU's/mL. For grass mixtures containing standardized extracts, the potency will reflect the contribution of each individual component in the mixture, i.e., the actual potency of each component will be listed on a per mL basis. In addition, because the individual components may be cross-reactive, an additional caution statement, \"due to cross reactivity, total potency may be 100,000 BAU/mL,\" will be added to the label."
},
{
"NDCCode": "36987-2364-2",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (36987-2364-2)",
"NDC11Code": "36987-2364-02",
"ProductNDC": "36987-2364",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Standardized Redtop Grass Pollen",
"NonProprietaryName": "Standardized Redtop Grass Pollen",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19980210",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "AGROSTIS GIGANTEA POLLEN",
"StrengthNumber": "10000",
"StrengthUnit": "[BAU]/mL",
"Pharm_Classes": "Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Standardized Pollen Extract is intended for use in the diagnosis and therapy of pollen allergic patients as established by allergy history and skin test reactivity. Standardized Grass Pollen extracts labeled in BAU/mL are not interchangeable with Grass Pollen extracts labeled in AU/mL or with non-standardized Grass Pollen extracts. The 10,000 BAU/mL dose form is indicated for percutaneous testing. If negative, 100,000 BAU/mL dose form can be used for percutaneous testing. For immunotherapy, availability of 10,000 and 100,000 BAU/mL dosages facilitates safe switching. (See Dosage & Administration). The use of standardized grass pollen extracts is indicated for hyposensitization treatment and may be used as part of the over-all management of the allergic patient. Treatment of grass sensitive patients consists of using specific standardized grass products of up to and including doses of 100,000 BAU/mL (up to 10,000 BAU/mL for Bermuda grass) or stock mixtures of standardized grass products. Stock mixtures of standardized grass extracts are particularly useful in hyposensitization treatment when multiple allergies to grasses are diagnosed. For previously untreated patients, the 10,000 BAU/mL concentrates can be used to formulate dosages. If tolerated, the concentrates can be inceased to 100,000 BAU/mL dose formulation.",
"Description": "Standardized Grass Pollen Extracts include: Orchard (Dactylis glomerata), Perennial Rye (Lolium perenne), Timothy (Phleum pratense), Redtop (Agrostis alba), Kentucky (June) Bluegrass (Poa pratensis), Bermuda (Cynodon dactylon), Meadow Fescue (Festuca elatior), Sweet Vernal (Anthoxanthum odoratum). The standardized grass pollen extract is prepared by extracting raw pollen material at a ratio of either 1:5 w/v, 1:6.66 w/v or 1:10 w/v in Cocas fluid containing 0.5% NaCl, 0.275% NaHCO3, WFI and 0.4% phenol as preservative. Following extraction, a calculated amount of glycerin is added to make a 50%(v/v) glycerinated solution. Standardized Grass Pollen extracts have potency designations of 10,000 BAU/mL and 100,000 BAU/mL except Bermuda Grass (10,000 BAU/mL only). Extracts with a potency of 10,000 BAU/mL are diluted from the 100,000 BAU/mL lots with Glycerol Saline 50%(v/v). The Glycerol Saline 50%(v/v) solution consists of Glycerin and Salts and Buffered Diluent whose ingredients are 0.5% NaCl, 0.08% Na2HPO4, 0.036% KH2PO4, WFI and 0.4% phenol as a preservative. All extracts are aseptically filled in sterile containers. Standardized pollen extracts are intended for administration by prick-puncture or intradermal routes when used for diagnostic purposes and administered subcutaneously when used for immunotherapy injection. Standardized grass pollen extracts labeled in BAU/mL are not interchangeable with grass pollen extracts labeled in AU/mL or with non-standardized grass pollen extracts. The Bioequivalent Allergy Unit (BAU), the potency unit used for all Standardized Pollen Extracts, replaces the previous unitage for these products. Bioequivalent Allergy Units were assigned to the FDA, Center for Biologics Evaluation and Research (CBER) reference extracts, based on quantitative intradermal skin test results. BAU's are intended to assure that the labeled unitage of different allergenic extracts will correspond to the expected clinical response in sensitive patients. References labeled 10,000 BAU/mL can be diluted one half million fold to produce an intradermal sum of erythema diameter response of 50mm in highly puncture reactive subjects. 100,000 BAU/mL can be diluted 1:5 million fold to yield the same intradermal response.(2) The assignment of BAU/mL to standardized grass pollen extracts, is accomplished by an ELISA assay comparing the extract to the CBER reference. Previously, the potency / concentration of grass mixtures was designated based on the manufacturing strength, e.g. 1:10 w/v or 1:20 w/v, or in PNU's/mL. For grass mixtures containing standardized extracts, the potency will reflect the contribution of each individual component in the mixture, i.e., the actual potency of each component will be listed on a per mL basis. In addition, because the individual components may be cross-reactive, an additional caution statement, \"due to cross reactivity, total potency may be 100,000 BAU/mL,\" will be added to the label."
},
{
"NDCCode": "36987-2364-3",
"PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (36987-2364-3)",
"NDC11Code": "36987-2364-03",
"ProductNDC": "36987-2364",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Standardized Redtop Grass Pollen",
"NonProprietaryName": "Standardized Redtop Grass Pollen",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19980210",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "AGROSTIS GIGANTEA POLLEN",
"StrengthNumber": "10000",
"StrengthUnit": "[BAU]/mL",
"Pharm_Classes": "Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Standardized Pollen Extract is intended for use in the diagnosis and therapy of pollen allergic patients as established by allergy history and skin test reactivity. Standardized Grass Pollen extracts labeled in BAU/mL are not interchangeable with Grass Pollen extracts labeled in AU/mL or with non-standardized Grass Pollen extracts. The 10,000 BAU/mL dose form is indicated for percutaneous testing. If negative, 100,000 BAU/mL dose form can be used for percutaneous testing. For immunotherapy, availability of 10,000 and 100,000 BAU/mL dosages facilitates safe switching. (See Dosage & Administration). The use of standardized grass pollen extracts is indicated for hyposensitization treatment and may be used as part of the over-all management of the allergic patient. Treatment of grass sensitive patients consists of using specific standardized grass products of up to and including doses of 100,000 BAU/mL (up to 10,000 BAU/mL for Bermuda grass) or stock mixtures of standardized grass products. Stock mixtures of standardized grass extracts are particularly useful in hyposensitization treatment when multiple allergies to grasses are diagnosed. For previously untreated patients, the 10,000 BAU/mL concentrates can be used to formulate dosages. If tolerated, the concentrates can be inceased to 100,000 BAU/mL dose formulation.",
"Description": "Standardized Grass Pollen Extracts include: Orchard (Dactylis glomerata), Perennial Rye (Lolium perenne), Timothy (Phleum pratense), Redtop (Agrostis alba), Kentucky (June) Bluegrass (Poa pratensis), Bermuda (Cynodon dactylon), Meadow Fescue (Festuca elatior), Sweet Vernal (Anthoxanthum odoratum). The standardized grass pollen extract is prepared by extracting raw pollen material at a ratio of either 1:5 w/v, 1:6.66 w/v or 1:10 w/v in Cocas fluid containing 0.5% NaCl, 0.275% NaHCO3, WFI and 0.4% phenol as preservative. Following extraction, a calculated amount of glycerin is added to make a 50%(v/v) glycerinated solution. Standardized Grass Pollen extracts have potency designations of 10,000 BAU/mL and 100,000 BAU/mL except Bermuda Grass (10,000 BAU/mL only). Extracts with a potency of 10,000 BAU/mL are diluted from the 100,000 BAU/mL lots with Glycerol Saline 50%(v/v). The Glycerol Saline 50%(v/v) solution consists of Glycerin and Salts and Buffered Diluent whose ingredients are 0.5% NaCl, 0.08% Na2HPO4, 0.036% KH2PO4, WFI and 0.4% phenol as a preservative. All extracts are aseptically filled in sterile containers. Standardized pollen extracts are intended for administration by prick-puncture or intradermal routes when used for diagnostic purposes and administered subcutaneously when used for immunotherapy injection. Standardized grass pollen extracts labeled in BAU/mL are not interchangeable with grass pollen extracts labeled in AU/mL or with non-standardized grass pollen extracts. The Bioequivalent Allergy Unit (BAU), the potency unit used for all Standardized Pollen Extracts, replaces the previous unitage for these products. Bioequivalent Allergy Units were assigned to the FDA, Center for Biologics Evaluation and Research (CBER) reference extracts, based on quantitative intradermal skin test results. BAU's are intended to assure that the labeled unitage of different allergenic extracts will correspond to the expected clinical response in sensitive patients. References labeled 10,000 BAU/mL can be diluted one half million fold to produce an intradermal sum of erythema diameter response of 50mm in highly puncture reactive subjects. 100,000 BAU/mL can be diluted 1:5 million fold to yield the same intradermal response.(2) The assignment of BAU/mL to standardized grass pollen extracts, is accomplished by an ELISA assay comparing the extract to the CBER reference. Previously, the potency / concentration of grass mixtures was designated based on the manufacturing strength, e.g. 1:10 w/v or 1:20 w/v, or in PNU's/mL. For grass mixtures containing standardized extracts, the potency will reflect the contribution of each individual component in the mixture, i.e., the actual potency of each component will be listed on a per mL basis. In addition, because the individual components may be cross-reactive, an additional caution statement, \"due to cross reactivity, total potency may be 100,000 BAU/mL,\" will be added to the label."
},
{
"NDCCode": "36987-2364-4",
"PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (36987-2364-4)",
"NDC11Code": "36987-2364-04",
"ProductNDC": "36987-2364",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Standardized Redtop Grass Pollen",
"NonProprietaryName": "Standardized Redtop Grass Pollen",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19980210",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "AGROSTIS GIGANTEA POLLEN",
"StrengthNumber": "10000",
"StrengthUnit": "[BAU]/mL",
"Pharm_Classes": "Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Standardized Pollen Extract is intended for use in the diagnosis and therapy of pollen allergic patients as established by allergy history and skin test reactivity. Standardized Grass Pollen extracts labeled in BAU/mL are not interchangeable with Grass Pollen extracts labeled in AU/mL or with non-standardized Grass Pollen extracts. The 10,000 BAU/mL dose form is indicated for percutaneous testing. If negative, 100,000 BAU/mL dose form can be used for percutaneous testing. For immunotherapy, availability of 10,000 and 100,000 BAU/mL dosages facilitates safe switching. (See Dosage & Administration). The use of standardized grass pollen extracts is indicated for hyposensitization treatment and may be used as part of the over-all management of the allergic patient. Treatment of grass sensitive patients consists of using specific standardized grass products of up to and including doses of 100,000 BAU/mL (up to 10,000 BAU/mL for Bermuda grass) or stock mixtures of standardized grass products. Stock mixtures of standardized grass extracts are particularly useful in hyposensitization treatment when multiple allergies to grasses are diagnosed. For previously untreated patients, the 10,000 BAU/mL concentrates can be used to formulate dosages. If tolerated, the concentrates can be inceased to 100,000 BAU/mL dose formulation.",
"Description": "Standardized Grass Pollen Extracts include: Orchard (Dactylis glomerata), Perennial Rye (Lolium perenne), Timothy (Phleum pratense), Redtop (Agrostis alba), Kentucky (June) Bluegrass (Poa pratensis), Bermuda (Cynodon dactylon), Meadow Fescue (Festuca elatior), Sweet Vernal (Anthoxanthum odoratum). The standardized grass pollen extract is prepared by extracting raw pollen material at a ratio of either 1:5 w/v, 1:6.66 w/v or 1:10 w/v in Cocas fluid containing 0.5% NaCl, 0.275% NaHCO3, WFI and 0.4% phenol as preservative. Following extraction, a calculated amount of glycerin is added to make a 50%(v/v) glycerinated solution. Standardized Grass Pollen extracts have potency designations of 10,000 BAU/mL and 100,000 BAU/mL except Bermuda Grass (10,000 BAU/mL only). Extracts with a potency of 10,000 BAU/mL are diluted from the 100,000 BAU/mL lots with Glycerol Saline 50%(v/v). The Glycerol Saline 50%(v/v) solution consists of Glycerin and Salts and Buffered Diluent whose ingredients are 0.5% NaCl, 0.08% Na2HPO4, 0.036% KH2PO4, WFI and 0.4% phenol as a preservative. All extracts are aseptically filled in sterile containers. Standardized pollen extracts are intended for administration by prick-puncture or intradermal routes when used for diagnostic purposes and administered subcutaneously when used for immunotherapy injection. Standardized grass pollen extracts labeled in BAU/mL are not interchangeable with grass pollen extracts labeled in AU/mL or with non-standardized grass pollen extracts. The Bioequivalent Allergy Unit (BAU), the potency unit used for all Standardized Pollen Extracts, replaces the previous unitage for these products. Bioequivalent Allergy Units were assigned to the FDA, Center for Biologics Evaluation and Research (CBER) reference extracts, based on quantitative intradermal skin test results. BAU's are intended to assure that the labeled unitage of different allergenic extracts will correspond to the expected clinical response in sensitive patients. References labeled 10,000 BAU/mL can be diluted one half million fold to produce an intradermal sum of erythema diameter response of 50mm in highly puncture reactive subjects. 100,000 BAU/mL can be diluted 1:5 million fold to yield the same intradermal response.(2) The assignment of BAU/mL to standardized grass pollen extracts, is accomplished by an ELISA assay comparing the extract to the CBER reference. Previously, the potency / concentration of grass mixtures was designated based on the manufacturing strength, e.g. 1:10 w/v or 1:20 w/v, or in PNU's/mL. For grass mixtures containing standardized extracts, the potency will reflect the contribution of each individual component in the mixture, i.e., the actual potency of each component will be listed on a per mL basis. In addition, because the individual components may be cross-reactive, an additional caution statement, \"due to cross reactivity, total potency may be 100,000 BAU/mL,\" will be added to the label."
},
{
"NDCCode": "50090-2364-1",
"PackageDescription": "4 mL in 1 BOTTLE, DROPPER (50090-2364-1) ",
"NDC11Code": "50090-2364-01",
"ProductNDC": "50090-2364",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tetracaine Hydrochloride",
"NonProprietaryName": "Tetracaine Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "20161102",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA208135",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "TETRACAINE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Ester Local Anesthetic [EPC], Esters [CS], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2025-02-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190923",
"SamplePackage": "N",
"IndicationAndUsage": "Tetracaine Hydrochloride Ophthalmic Solution 0.5% is indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic.",
"Description": "Tetracaine hydrochloride is chemically designated as benzoic acid, 4-(butylamino)-,2-(dimethylamino) ethyl ester, monohydrochloride. Its chemical formula is C15H24N2O2 HCl and it is represented by the chemical structure. Tetracaine hydrochloride is a fine, white, crystalline, odorless powder and has a molecular weight of 300.82. Tetracaine Hydrochloride Ophthalmic Solution 0.5% has a pH of 3.7 to 5.5. Active ingredient: tetracaine hydrochloride 0.5% w/v (equivalent to 0.44% w/v tetracaine). Inactive ingredients: sodium chloride, sodium acetate trihydrate, acetic acid (to adjust pH approximately 4.5), Water for Injection, USP."
},
{
"NDCCode": "55154-2364-5",
"PackageDescription": "5 VIAL in 1 BAG (55154-2364-5) / 2 mL in 1 VIAL",
"NDC11Code": "55154-2364-05",
"ProductNDC": "55154-2364",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Furosemide",
"NonProprietaryName": "Furosemide",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20100713",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA018667",
"LabelerName": "Cardinal Health 107, LLC",
"SubstanceName": "FUROSEMIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20100713",
"SamplePackage": "N",
"IndicationAndUsage": "FUROSEMIDE INJECTION is a loop diuretic indicated for: 1 The treatment of edema associated with heart failure, cirrhosis of the liver, and renal disease (1.1), 2 Acute pulmonary edema as adjunctive therapy (1.2).",
"Description": "Furosemide Injection contains furosemide as the active pharmaceutical ingredient. Furosemide is a loop diuretic which is an anthranilic acid derivative. Furosemide chemical name is 4-chloro-N-furfuryl-5-sulfamoylanthranilic acid. Furosemide is a white to slightly-yellow crystalline powder. It is practically insoluble in water, sparingly soluble in alcohol, freely soluble in dilute alkali solutions and insoluble in dilute acids. The structural formula is as follows. Furosemide Injection, USP 10 mg/mL is a sterile, non-pyrogenic solution, available in single-dose vials for intravenous and intramuscular injection. Each mL of Furosemide Injection contains: 10 mg of Furosemide, 7.5 mg of Sodium Chloride for isotonicity, 1.34 mg of Sodium Hydroxide, Hydrochloric Acid and Sodium Hydroxide as pH adjusters, in Water for Injection. Furosemide Injection solution pH is between 8.0 and 9.3. It contains no preservative."
},
{
"NDCCode": "65044-2364-5",
"PackageDescription": "5 mL in 1 VIAL (65044-2364-5) ",
"NDC11Code": "65044-2364-05",
"ProductNDC": "65044-2364",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Pollens - Weeds And Garden Plants, Russian Thistle Salsola Kali",
"NonProprietaryName": "Russian Thistle Salsola Kali",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL",
"StartMarketingDate": "19410419",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103888",
"LabelerName": "Jubilant HollisterStier LLC",
"SubstanceName": "SALSOLA KALI POLLEN",
"StrengthNumber": "500",
"StrengthUnit": "[PNU]/mL",
"Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "19410419",
"SamplePackage": "N",
"IndicationAndUsage": "Certain diagnostics carry labeling which states Allergenic Extract for Diagnostic Use Only. Data to support the therapeutic use of products labeled with this statement have not been established.15. In addition to a carefully taken history, the use of intradermal testing extracts is an accepted method in the diagnosis of allergenic conditions.1, 2, 3 When scratch, prick or puncture reactions are small, or if the patient gives a history of allergic symptoms to a substance but scratch, prick or puncture tests are inconclusive, intradermal tests may be indicated. However, ANTIGENS PRODUCING LARGE 3 TO 4+ SCRATCH, PRICK OR PUNCTURE TESTS SHOULD NOT BE TESTED INTRADERMALLY. Extracts of all allergens do not produce equivalent results in intradermal testing. The intensity of the skin reaction produced will be determined by two factors: the degree of sensitivity of the patient and the nature of the antigenic extract applied. In general, pollen extracts produce whealing reactions, whereas other inhalants produce erythematous reactions with wheals less often. Skin tests to foods seldom produce whealing reactions except for infrequent instances of severe sensitivity to fish, nuts or spices, and rarely other foods.",
"Description": "Extracts for intradermal testing are supplied in sterile multi-dose vials containing, in addition to the extract allergens and antigens, 0.5% sodium chloride, 0.275% sodium bicarbonate, up to 2% glycerin, 2.5% glycerin for AP products, and, as preservative, 0.4% phenol. The strength of these extracts may be expressed in terms of:. 1. Weight to Volume (w/v) 2. Protein Nitrogen Units/mL (PNU/mL)3. Allergy Units/mL (AU/mL)4. Bioequivalent Allergy Units/mL (BAU/mL)5. Concentrate: 1 Weight to volume (w/v). For regular extracts this describes the extraction ratio, i.e., the amount of crude allergen added to the extracting fluid. A 1:10 extract, therefore, indicates that the solution contains the extracted material from one gram of raw material added to each 10 mL of extracting fluid. The amount and composition of extracted material will vary with the kind of antigen, the extracting fluid, duration of extraction, pH, temperature, and other variables. In contrast to this, AP (acetone precipitated) extracts, if present, are prepared by reconstituting dry allergenically active concentrates produced by a precipitation process from extracts of raw materials. For those AP extracts labeled on a weight per volume (w/v) basis, the strength designation indicates the dry weight of finished (acetone) precipitate per volume of reconstituting fluid. For example, 1:50 (w/v) means that each gram of dry precipitate obtained from the original extract is reconstituted in 50 mL of solution., 2 Protein Nitrogen Units per mL (PNU/mL). One protein nitrogen unit represents 0.00001 mg phosphotungstic acid-precipitable protein nitrogen dissolved in one mL of antigen extract. The PNU content of extracts of the same antigen may vary according to the method of measuring the PNU. Thus, PNU contents of extracts from different manufacturers are not comparable unless the PNU method is known to be the same and reproducible from lot to lot. Also, the amount of protein nitrogen extracted from an antigen is influenced by the same variables as the weight to volume extract. Allergenic materials make up a variable proportion of the total protein of an extract., 3 Allergy Units per mL (AU/mL). The potency of standardized AP and regular extracts labeled in Allergy Units (AU)/mL is determined by in vitro comparison to the reference standard established by the Center for Biologics Evaluation and Research (CBER) of the Food and Drug Administration., 4 Bioequivalent Allergy Units per mL(BAU/mL). When originally licensed, the Reference Preparations for standardized extracts were arbitrarily assigned 100,000 Allergy Units (AU)/mL. Subsequently, quantitative skin testing by the ID50EAL method14 was used to determine that some Reference Preparations should be assigned 10,000 AU/mL, and others 100,000 AU/mL. To avoid possible confusion about this change in the method of allergy unit assignment, the nomenclature changed for standardized extracts whose allergy units are assigned based on quantitative skin testing, and are labeled in Bioequivalent Allergy Units (BAU)/mL. References labeled 10,000 BAU/mL can be diluted one to a half million fold, and references labeled 100,000 BAU/mL can be diluted one to 5 million fold and produce a sum of erythema diameter of 50 mm when Intradermal testing highly reactive subjects., 5 Concentrate. Concentrate label terminology applies to allergenic extract mixtures, where the individual allergens being combined vary in strength or the designation of strength."
},
{
"NDCCode": "68071-2364-8",
"PackageDescription": "80 mL in 1 BOTTLE (68071-2364-8) ",
"NDC11Code": "68071-2364-08",
"ProductNDC": "68071-2364",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "POWDER, FOR SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "20060619",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065322",
"LabelerName": "NuCare Pharmaceuticals,Inc.",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "250",
"StrengthUnit": "mg/5mL",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Active",
"LastUpdate": "2026-02-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210311",
"SamplePackage": "N",
"IndicationAndUsage": "To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin and other antibacterial drugs, Amoxicillin for Oral Suspension should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Amoxicillin for Oral Suspension is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of the designated bacteria in the conditions listed below.",
"Description": "Formulations of Amoxicillin for Oral Suspension, USP contain Amoxicillin, a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2 S,5 R,6 R)-6-[( R)-(-)-2-amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-zabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as:. The Amoxicillin molecular formula is C 16H 19N 3O 5S3H 2O, and the molecular weight is 419.45. Amoxicillin for Oral Suspension, USP: Each 5 mL of reconstituted suspension contains 125 mg, 200 mg, 250 mg or 400 mg Amoxicillin as the trihydrate. Each 5 mL of the 125 mg, 200 mg, 250 mg and 400 mg reconstituted suspension contains 0.1898 mEq (4.3635 mg) of sodium. Inactive ingredients: colloidal silicon dioxide, hypromellose, sodium benzoate, sucrose, trisodium citrate dihydrate, tutti frutti flavor and xanthan gum."
},
{
"NDCCode": "70518-2364-1",
"PackageDescription": "60 CAPSULE in 1 BOTTLE, PLASTIC (70518-2364-1) ",
"NDC11Code": "70518-2364-01",
"ProductNDC": "70518-2364",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pregabalin",
"NonProprietaryName": "Pregabalin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20191016",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209743",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "PREGABALIN",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"DEASchedule": "CV",
"Status": "Deprecated",
"LastUpdate": "2024-09-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20210715",
"SamplePackage": "N",
"IndicationAndUsage": "Pregabalin capsules are indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older , 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.",
"Description": "Pregabalin is described chemically as ( S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin is a white to off-white, crystalline solid with a pK a1of 4.2 and a pK a2of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with pregelatinized starch and talc. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and white capsule shells contain sodium lauryl sulfate. Each capsule shell is imprinted with black pharmaceutical ink which contains: butyl alcohol, dehydrated alcohol, ferrosoferric oxide, isopropyl alcohol, propylene glycol, potassium hydroxide, purified water, strong ammonia solution and shellac."
},
{
"NDCCode": "80830-2364-8",
"PackageDescription": "20 VIAL in 1 CARTON (80830-2364-8) / 50 mL in 1 VIAL (80830-2364-1) ",
"NDC11Code": "80830-2364-08",
"ProductNDC": "80830-2364",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propofol",
"NonProprietaryName": "Propofol",
"DosageFormName": "INJECTION, EMULSION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20240816",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217525",
"LabelerName": "Amneal Pharmaceuticals Private Limited",
"SubstanceName": "PROPOFOL",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "General Anesthesia [PE], General Anesthetic [EPC]",
"Status": "Active",
"LastUpdate": "2025-05-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240816",
"SamplePackage": "N",
"IndicationAndUsage": "Propofol injectable emulsion is an intravenous general anesthetic and sedation drug indicated for.",
"Description": "Propofol injectable emulsion USP, 10 mg per mL is an anesthetic available as a sterile, nonpyrogenic, white, homogeneous emulsion for intravenous administration. The structural formula of propofol, USP is. Chemical name: 2,6 diisopropylphenol. Molecular formula: C12H18O. Molecular weight: 178.28 g/mol. Propofol, USP is a clear, colorless to slightly yellowish liquid. It is very soluble in methanol and in ethanol, slightly soluble in cyclohexane and in isopropyl alcohol and very slightly soluble in water. The pKa is 11. The octanol/water partition coefficient for propofol is 6761:1 at a pH of 6.0 to 8.5. Each mL of propofol injectable emulsion, USP contains 10 mg propofol, USP; soybean oil, 100 mg; glycerol, 22.5 mg; egg phospholipids, 12 mg; disodium edetate anhydrous, 0.05 mg and sodium hydroxide to adjust pH, in water for injection. Propofol injectable emulsion, USP is isotonic and has a pH of 7.00 to 8.50."
},
{
"NDCCode": "55714-1102-0",
"PackageDescription": ".5 mL in 1 BOTTLE, GLASS (55714-1102-0)",
"NDC11Code": "55714-1102-00",
"ProductNDC": "55714-1102",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sick Stopper",
"NonProprietaryName": "Anthracinum, Influenza A Virus, Influenza B Virus, Pyrogenium, Bufo Rana, Aconitum Nap., Agaricus Musc., Aralia Quinquefolia, Baptisia, Bryonia, Chelidonium Majus, Eupatorium Perf., Hepar Sulph. Calc., Lachesis, Lycopodium, Nux Vom., Rhus Toxicodendron, Sanguinaria, Sulphur, Thuja Occ., Echinacea",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; INFLUENZA A VIRUS; RANCID BEEF; BUFO BUFO CUTANEOUS GLAND; ACONITUM NAPELLUS; AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; AMERICAN GINSENG; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; EUPATORIUM PERFOLIATUM FLOWERING TOP; CALCIUM SULFIDE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; SANGUINARIA CANADENSIS ROOT; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; ECHINACEA, UNSPECIFIED; INFLUENZA B VIRUS",
"StrengthNumber": "30; 30; 30; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 30",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Sick Stopper Formulated for symptoms associated with colds and infections. Begin at the onset of symptoms."
},
{
"NDCCode": "55714-1103-0",
"PackageDescription": ".5 mL in 1 BOTTLE, GLASS (55714-1103-0)",
"NDC11Code": "55714-1103-00",
"ProductNDC": "55714-1103",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Swimmers Support",
"NonProprietaryName": "Antimon. Tart., Arnica, Bellis, Bryonia, Calc. Carb., Capsicum, Chelidonium Majus, Cuprum Met., Digitalis, Drosera, Lachesis, Lacticum Acidum, Ledum, Mag. Carb., Mang. Acet., Nux Vom., Phytolacca, Rhus Toxicodendron, Ruta, Sarcolacticum Ac., Sulphuricum Ac., Verbascum, Vipera Berus",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "ANTIMONY POTASSIUM TARTRATE; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CAPSICUM; CHELIDONIUM MAJUS; COPPER; DIGITALIS; DROSERA ROTUNDIFOLIA FLOWERING TOP; LACHESIS MUTA VENOM; LACTIC ACID, DL-; LEDUM PALUSTRE TWIG; MAGNESIUM CARBONATE; MANGANESE ACETATE TETRAHYDRATE; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; LACTIC ACID, L-; SULFURIC ACID; VERBASCUM THAPSUS; VIPERA BERUS VENOM",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Swimmers Support Formulated for symptoms associated with swimming and exposure to pool chemicals such as cramping, dry skin, fatigue and muscle soreness."
},
{
"NDCCode": "55714-1104-0",
"PackageDescription": ".5 mL in 1 BOTTLE, GLASS (55714-1104-0)",
"NDC11Code": "55714-1104-00",
"ProductNDC": "55714-1104",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hangover Help",
"NonProprietaryName": "Agaricus Musc., Arsenicum Alb., Bismuthum Metallicum, Bryonia, Capsicum, Carbo Veg., Glonoinum, Ipecac., Iris Versicolor, Laurocerasus, Lycopodium, Mezereum, Nux Vom., Pulsatilla, Ranunc. Bulb. , Theridion, Veratrum Alb., Zinc. Met., Zingiber, Chamomilla, Passiflora, Valeriana",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; ARSENIC TRIOXIDE; BISMUTH; BRYONIA ALBA ROOT; CAPSICUM; ACTIVATED CHARCOAL; NITROGLYCERIN; IPECAC; IRIS VERSICOLOR ROOT; PRUNUS LAUROCERASUS LEAF; LYCOPODIUM CLAVATUM SPORE; DAPHNE MEZEREUM BARK; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS; RANUNCULUS BULBOSUS; THERIDION CURASSAVICUM; VERATRUM ALBUM ROOT; ZINC; GINGER; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP; VALERIAN",
"StrengthNumber": "15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Hangover Help Formulated for symptoms associated with intoxication including nausea, dizziness, discomfort and headache."
},
{
"NDCCode": "55714-1105-0",
"PackageDescription": "7.08 g in 1 BOTTLE, GLASS (55714-1105-0)",
"NDC11Code": "55714-1105-00",
"ProductNDC": "55714-1105",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Prime Plus",
"NonProprietaryName": "Agnus, Allium Sativum, Ambra, Angelica Sinensis Radix, Aralia Quinquefolia, Arnica, Arsenicum Alb., Avena, Baptisia, Baryta Carb., Bryonia, Cantharis, Lachesis, Lycopodium, Nux Vom., Phosphoricum Ac., Pulsatilla, Ruta, Sabal, Selenium, Zinc. Met., Ginkgo",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "CHASTE TREE; GARLIC; AMBERGRIS; ANGELICA SINENSIS ROOT; AMERICAN GINSENG; ARNICA MONTANA; ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; BAPTISIA TINCTORIA ROOT; BARIUM CARBONATE; BRYONIA ALBA ROOT; LYTTA VESICATORIA; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PULSATILLA VULGARIS; RUTA GRAVEOLENS FLOWERING TOP; SAW PALMETTO; SELENIUM; ZINC; GINKGO",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3",
"StrengthUnit": "[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Prime+ Formulated for symptoms associated with aging such as impaired memory, loss of vitality, general weakness and dry, wrinkled skin."
},
{
"NDCCode": "55714-1106-0",
"PackageDescription": ".5 mL in 1 BOTTLE, GLASS (55714-1106-0)",
"NDC11Code": "55714-1106-00",
"ProductNDC": "55714-1106",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Panic Button",
"NonProprietaryName": "Aconitum Nap., Apis Mel., Arnica, Arsenicum Alb., Belladonna, Bellis, Bryonia, Calendula, Chamomilla, Cistus Canadensis, Ferrum Phosphoricum, Histaminum Hydrochloricum, Hypericum, Ignatia, Mezereum, Ornithogalum, Passiflora, Phosphorus, Prunus Spin., Rhus Toxicodendron, Sarcolacticum Ac., Sulphur, Veratrum Alb., Valeriana.",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "ACONITUM NAPELLUS; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; HELIANTHEMUM CANADENSE; FERROSOFERRIC PHOSPHATE; HISTAMINE DIHYDROCHLORIDE; HYPERICUM PERFORATUM; STRYCHNOS IGNATII SEED; DAPHNE MEZEREUM BARK; ORNITHOGALUM UMBELLATUM; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; PRUNUS SPINOSA FLOWER BUD; TOXICODENDRON PUBESCENS LEAF; LACTIC ACID, L-; SULFUR; VERATRUM ALBUM ROOT; VALERIAN",
"StrengthNumber": "15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-14",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "55714-1107-0",
"PackageDescription": ".5 mL in 1 BOTTLE, GLASS (55714-1107-0)",
"NDC11Code": "55714-1107-00",
"ProductNDC": "55714-1107",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sports Injury",
"NonProprietaryName": "Apis Mel., Arnica, Bellis, Bryonia, Calendula, Chamomilla, Cinchona, Gelsemium, Hamamelis, Hypericum, Lacticum Acidum, Ledum, Phosphorus, Rhus Toxicodendron, Ruta, Sarcolacticum Ac., Staphysag., Symphytum, Echinacea, Hydrastis",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "APIS MELLIFERA; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; GELSEMIUM SEMPERVIRENS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; LACTIC ACID, DL-; LEDUM PALUSTRE TWIG; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; LACTIC ACID, L-; DELPHINIUM STAPHISAGRIA SEED; COMFREY ROOT; ECHINACEA, UNSPECIFIED; GOLDENSEAL",
"StrengthNumber": "15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2017-10-13"
},
{
"NDCCode": "55714-1108-0",
"PackageDescription": "15 mL in 1 BOTTLE, GLASS (55714-1108-0)",
"NDC11Code": "55714-1108-00",
"ProductNDC": "55714-1108",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sports Recovery",
"NonProprietaryName": "Apis Mel., Arnica, Bellis, Bryonia, Calendula, Chamomilla, Cinchona, Gelsemium, Hamamelis, Hypericum, Lacticum Acidum, Ledum, Phosphorus, Rhus Toxicodendron, Ruta, Sarcolacticum Ac., Staphysag., Symphytum, Echinacea, Hydrastis",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20160725",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "APIS MELLIFERA; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; GELSEMIUM SEMPERVIRENS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; LACTIC ACID, DL-; LEDUM PALUSTRE TWIG; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; LACTIC ACID, L-; DELPHINIUM STAPHISAGRIA SEED; COMFREY ROOT; ECHINACEA, UNSPECIFIED; GOLDENSEAL",
"StrengthNumber": "15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Sports Recovery Formulated for workout recovery and for symptoms associated with injury, overexertion and emotional distress."
},
{
"NDCCode": "55714-1110-0",
"PackageDescription": ".5 mL in 1 BOTTLE, GLASS (55714-1110-0)",
"NDC11Code": "55714-1110-00",
"ProductNDC": "55714-1110",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Jet Lag",
"NonProprietaryName": "Alumina, Aralia Quinquefolia, Arg. Nit., Arnica, Arsenicum Alb., Baptisia, Bryonia, Cantharis, Chelidonium Majus, Conium, Gelsemium, Iodium, Kali Carb., Kali Iod., Lycopodium, Lycopus Virginicus, Nat. Mur., Nux Vom., Phosphorus, Phytolacca, Pulsatilla, Rhus Toxicodendron, Sabal, Thyroidinum, Echinacea",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "ALUMINUM OXIDE; AMERICAN GINSENG; SILVER NITRATE; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CHELIDONIUM MAJUS; CONIUM MACULATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; IODINE; POTASSIUM CARBONATE; POTASSIUM IODIDE; LYCOPODIUM CLAVATUM SPORE; LYCOPUS VIRGINICUS; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SAW PALMETTO; THYROID, UNSPECIFIED; ECHINACEA, UNSPECIFIED",
"StrengthNumber": "15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_M]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Jet Lag Formulated for symptoms associated with travel such as fatigue, insomnia, headaches and digestive discomfort."
},
{
"NDCCode": "55714-1112-0",
"PackageDescription": "7.08 g in 1 BOTTLE, GLASS (55714-1112-0)",
"NDC11Code": "55714-1112-00",
"ProductNDC": "55714-1112",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Swimmers Support",
"NonProprietaryName": "Antimon. Tart., Arnica, Bellis, Bryonia, Calc. Carb., Capsicum, Chelidonium Majus, Cuprum Met., Digitalis, Drosera, Lachesis, Lacticum Acidum, Ledum, Mag. Carb., Mang. Acet., Nux Vom., Phytolacca, Rhus Toxicodendron, Ruta, Sarcolacticum Ac., Sulphuricum Ac., Verbascum, Vipera Berus",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "ANTIMONY POTASSIUM TARTRATE; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CAPSICUM; CHELIDONIUM MAJUS; COPPER; DIGITALIS; DROSERA ROTUNDIFOLIA FLOWERING TOP; LACHESIS MUTA VENOM; LACTIC ACID, DL-; LEDUM PALUSTRE TWIG; MAGNESIUM CARBONATE; MANGANESE ACETATE TETRAHYDRATE; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; LACTIC ACID, L-; SULFURIC ACID; VERBASCUM THAPSUS; VIPERA BERUS VENOM",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Swimmers Support Formulated for symptoms associated with swimming and exposure to pool chemicals such as cramping, dry skin, fatigue and muscle soreness."
},
{
"NDCCode": "55714-1113-0",
"PackageDescription": "7.08 g in 1 BOTTLE, GLASS (55714-1113-0)",
"NDC11Code": "55714-1113-00",
"ProductNDC": "55714-1113",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hangover Help",
"NonProprietaryName": "Agaricus Musc., Arsenicum Alb., Bismuthum Metallicum, Bryonia, Capsicum, Carbo Veg., Glonoinum, Ipecac., Iris Versicolor, Laurocerasus, Lycopodium, Mezereum, Nux Vom., Pulsatilla, Ranunc. Bulb. , Theridion, Veratrum Alb., Zinc. Met., Zingiber, Chamomilla, Passiflora, Valeriana",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; ARSENIC TRIOXIDE; BISMUTH; BRYONIA ALBA ROOT; CAPSICUM; ACTIVATED CHARCOAL; NITROGLYCERIN; IPECAC; IRIS VERSICOLOR ROOT; PRUNUS LAUROCERASUS LEAF; LYCOPODIUM CLAVATUM SPORE; DAPHNE MEZEREUM BARK; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS; RANUNCULUS BULBOSUS; THERIDION CURASSAVICUM; VERATRUM ALBUM ROOT; ZINC; GINGER; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP; VALERIAN",
"StrengthNumber": "15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3",
"StrengthUnit": "[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Hangover Help Formulated for symptoms associated with intoxication including nausea, dizziness, discomfort and headache."
},
{
"NDCCode": "55714-1114-0",
"PackageDescription": "7.08 g in 1 BOTTLE, GLASS (55714-1114-0)",
"NDC11Code": "55714-1114-00",
"ProductNDC": "55714-1114",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sick Stopper",
"NonProprietaryName": "Anthracinum, Influenza A Virus, Influenza B Virus, Pyrogenium, Bufo Rana, Aconitum Nap., Agaricus Musc., Aralia Quinquefolia, Baptisia, Bryonia, Chelidonium Majus, Eupatorium Perf., Hepar Sulph. Calc., Lachesis, Lycopodium, Nux Vom., Rhus Toxicodendron, Sanguinaria, Sulphur, Thuja Occ., Echinacea",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; INFLUENZA A VIRUS; RANCID BEEF; BUFO BUFO CUTANEOUS GLAND; ACONITUM NAPELLUS; AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; AMERICAN GINSENG; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; EUPATORIUM PERFOLIATUM FLOWERING TOP; CALCIUM SULFIDE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; SANGUINARIA CANADENSIS ROOT; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; ECHINACEA, UNSPECIFIED; INFLUENZA B VIRUS",
"StrengthNumber": "30; 30; 30; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 30",
"StrengthUnit": "[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Sick Stopper Formulated for symptoms associated with colds and infections. Begin at the onset of symptoms."
},
{
"NDCCode": "55714-1115-0",
"PackageDescription": "7.08 g in 1 BOTTLE, GLASS (55714-1115-0)",
"NDC11Code": "55714-1115-00",
"ProductNDC": "55714-1115",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Panic Button",
"NonProprietaryName": "Aconitum Nap., Apis Mel., Arnica, Arsenicum Alb., Belladonna, Bellis, Bryonia, Calendula, Chamomilla, Cistus Canadensis, Ferrum Phosphoricum, Histaminum Hydrochloricum, Hypericum, Ignatia, Mezereum, Ornithogalum, Passiflora, Phosphorus, Prunus Spin., Rhus Toxicodendron, Sarcolacticum Ac., Sulphur, Veratrum Alb., Valeriana",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "ACONITUM NAPELLUS; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; HELIANTHEMUM CANADENSE; FERROSOFERRIC PHOSPHATE; HISTAMINE DIHYDROCHLORIDE; HYPERICUM PERFORATUM; STRYCHNOS IGNATII SEED; DAPHNE MEZEREUM BARK; ORNITHOGALUM UMBELLATUM; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; PRUNUS SPINOSA FLOWER BUD; TOXICODENDRON PUBESCENS LEAF; LACTIC ACID, L-; SULFUR; VERATRUM ALBUM ROOT; VALERIAN",
"StrengthNumber": "15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3",
"StrengthUnit": "[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-14",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "55714-1116-0",
"PackageDescription": "7.08 g in 1 BOTTLE, GLASS (55714-1116-0)",
"NDC11Code": "55714-1116-00",
"ProductNDC": "55714-1116",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sports Injury",
"NonProprietaryName": "Apis Mel., Arnica, Bellis, Bryonia, Calendula, Chamomilla, Cinchona, Gelsemium, Hamamelis, Hypericum, Lacticum Acidum, Ledum, Phosphorus, Rhus Toxicodendron, Ruta, Sarcolacticum Ac., Staphysag., Symphytum, Echinacea, Hydrastis",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "APIS MELLIFERA; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; GELSEMIUM SEMPERVIRENS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; LACTIC ACID, DL-; LEDUM PALUSTRE TWIG; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; LACTIC ACID, L-; DELPHINIUM STAPHISAGRIA SEED; COMFREY ROOT; ECHINACEA, UNSPECIFIED; GOLDENSEAL",
"StrengthNumber": "15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3",
"StrengthUnit": "[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g",
"Status": "Deprecated",
"LastUpdate": "2017-10-13"
},
{
"NDCCode": "55714-1118-0",
"PackageDescription": "7.08 g in 1 BOTTLE, GLASS (55714-1118-0)",
"NDC11Code": "55714-1118-00",
"ProductNDC": "55714-1118",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Jet Lag",
"NonProprietaryName": "Alumina, Aralia Quinquefolia, Arg. Nit., Arnica, Arsenicum Alb., Baptisia, Bryonia, Cantharis, Chelidonium Majus, Conium, Gelsemium, Iodium, Kali Carb., Kali Iod., Lycopodium, Lycopus Virginicus, Nat. Mur., Nux Vom., Phosphorus, Phytolacca, Pulsatilla, Rhus Toxicodendron, Sabal, Thyroidinum, Echinacea",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "ALUMINUM OXIDE; AMERICAN GINSENG; SILVER NITRATE; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CHELIDONIUM MAJUS; CONIUM MACULATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; IODINE; POTASSIUM CARBONATE; POTASSIUM IODIDE; LYCOPODIUM CLAVATUM SPORE; LYCOPUS VIRGINICUS; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SAW PALMETTO; THYROID, UNSPECIFIED; ECHINACEA, UNSPECIFIED",
"StrengthNumber": "15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3",
"StrengthUnit": "[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_M]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Jet Lag Formulated for symptoms associated with travel such as fatigue, insomnia, headaches and digestive discomfort."
}
]
}
{"NDC":[{"NDCCode":"55714-2364-0","ProprietaryName":"Vitality","NonProprietaryName":"Adrenalinum, Aloe, Arsenicum Alb., Baptisia, Berber. Aqui., Berber. Vulg., Bryonia, Chelidonium Majus, Crotalus Horridus, Digitalis, Ferrum Metallicum, Glonoinum, Glycyrrhiza Glabra , Hydrocotyle, Iodium, Iris Versicolor, Lachesis, Lycopodium, Nat. Mur., Nux Vom., Rhus Toxicodendron, Ruta, Thuja Occ., Thyroidinum, Echinacea, Lappa, Solidago, Taraxacum"},{"NDCCode":"55714-2364-1","ProprietaryName":"Vitality","NonProprietaryName":"Adrenalinum, Aloe, Arsenicum Alb., Baptisia, Berber. Aqui., Berber. Vulg., Bryonia, Chelidonium Majus, Crotalus Horridus, Digitalis, Ferrum Metallicum, Glonoinum, Glycyrrhiza Glabra , Hydrocotyle, Iodium, Iris Versicolor, Lachesis, Lycopodium, Nat. Mur., Nux Vom., Rhus Toxicodendron, Ruta, Thuja Occ., Thyroidinum, Echinacea, Lappa, Solidago, Taraxacum"},{"NDCCode":"55714-2364-2","ProprietaryName":"Vitality","NonProprietaryName":"Adrenalinum, Aloe, Arsenicum Alb., Baptisia, Berber. Aqui., Berber. Vulg., Bryonia, Chelidonium Majus, Crotalus Horridus, Digitalis, Ferrum Metallicum, Glonoinum, Glycyrrhiza Glabra , Hydrocotyle, Iodium, Iris Versicolor, Lachesis, Lycopodium, Nat. Mur., Nux Vom., Rhus Toxicodendron, Ruta, Thuja Occ., Thyroidinum, Echinacea, Lappa, Solidago, Taraxacum"},{"NDCCode":"15631-2364-0","ProprietaryName":"Bio-combination 9","NonProprietaryName":"Ferrum Phosphoricum, Kali Muriaticum, Kali Phosphoricum, Magnesia Phosphorica"},{"NDCCode":"50090-2364-0","ProprietaryName":"Tetracaine Hydrochloride","NonProprietaryName":"Tetracaine Hydrochloride"},{"NDCCode":"70518-2364-0","ProprietaryName":"Pregabalin","NonProprietaryName":"Pregabalin"},{"NDCCode":"36987-2364-1","ProprietaryName":"Standardized Redtop Grass Pollen","NonProprietaryName":"Standardized Redtop Grass Pollen"},{"NDCCode":"36987-2364-2","ProprietaryName":"Standardized Redtop Grass Pollen","NonProprietaryName":"Standardized Redtop Grass Pollen"},{"NDCCode":"36987-2364-3","ProprietaryName":"Standardized Redtop Grass Pollen","NonProprietaryName":"Standardized Redtop Grass Pollen"},{"NDCCode":"36987-2364-4","ProprietaryName":"Standardized Redtop Grass Pollen","NonProprietaryName":"Standardized Redtop Grass Pollen"},{"NDCCode":"50090-2364-1","ProprietaryName":"Tetracaine Hydrochloride","NonProprietaryName":"Tetracaine Hydrochloride"},{"NDCCode":"55154-2364-5","ProprietaryName":"Furosemide","NonProprietaryName":"Furosemide"},{"NDCCode":"65044-2364-5","ProprietaryName":"Pollens - Weeds And Garden Plants, Russian Thistle Salsola Kali","NonProprietaryName":"Russian Thistle Salsola Kali"},{"NDCCode":"68071-2364-8","ProprietaryName":"Amoxicillin","NonProprietaryName":"Amoxicillin"},{"NDCCode":"70518-2364-1","ProprietaryName":"Pregabalin","NonProprietaryName":"Pregabalin"},{"NDCCode":"80830-2364-8","ProprietaryName":"Propofol","NonProprietaryName":"Propofol"},{"NDCCode":"55714-1102-0","ProprietaryName":"Sick Stopper","NonProprietaryName":"Anthracinum, Influenza A Virus, Influenza B Virus, Pyrogenium, Bufo Rana, Aconitum Nap., Agaricus Musc., Aralia Quinquefolia, Baptisia, Bryonia, Chelidonium Majus, Eupatorium Perf., Hepar Sulph. Calc., Lachesis, Lycopodium, Nux Vom., Rhus Toxicodendron, Sanguinaria, Sulphur, Thuja Occ., Echinacea"},{"NDCCode":"55714-1103-0","ProprietaryName":"Swimmers Support","NonProprietaryName":"Antimon. Tart., Arnica, Bellis, Bryonia, Calc. Carb., Capsicum, Chelidonium Majus, Cuprum Met., Digitalis, Drosera, Lachesis, Lacticum Acidum, Ledum, Mag. Carb., Mang. Acet., Nux Vom., Phytolacca, Rhus Toxicodendron, Ruta, Sarcolacticum Ac., Sulphuricum Ac., Verbascum, Vipera Berus"},{"NDCCode":"55714-1104-0","ProprietaryName":"Hangover Help","NonProprietaryName":"Agaricus Musc., Arsenicum Alb., Bismuthum Metallicum, Bryonia, Capsicum, Carbo Veg., Glonoinum, Ipecac., Iris Versicolor, Laurocerasus, Lycopodium, Mezereum, Nux Vom., Pulsatilla, Ranunc. Bulb. , Theridion, Veratrum Alb., Zinc. Met., Zingiber, Chamomilla, Passiflora, Valeriana"},{"NDCCode":"55714-1105-0","ProprietaryName":"Prime Plus","NonProprietaryName":"Agnus, Allium Sativum, Ambra, Angelica Sinensis Radix, Aralia Quinquefolia, Arnica, Arsenicum Alb., Avena, Baptisia, Baryta Carb., Bryonia, Cantharis, Lachesis, Lycopodium, Nux Vom., Phosphoricum Ac., Pulsatilla, Ruta, Sabal, Selenium, Zinc. Met., Ginkgo"},{"NDCCode":"55714-1106-0","ProprietaryName":"Panic Button","NonProprietaryName":"Aconitum Nap., Apis Mel., Arnica, Arsenicum Alb., Belladonna, Bellis, Bryonia, Calendula, Chamomilla, Cistus Canadensis, Ferrum Phosphoricum, Histaminum Hydrochloricum, Hypericum, Ignatia, Mezereum, Ornithogalum, Passiflora, Phosphorus, Prunus Spin., Rhus Toxicodendron, Sarcolacticum Ac., Sulphur, Veratrum Alb., Valeriana."},{"NDCCode":"55714-1107-0","ProprietaryName":"Sports Injury","NonProprietaryName":"Apis Mel., Arnica, Bellis, Bryonia, Calendula, Chamomilla, Cinchona, Gelsemium, Hamamelis, Hypericum, Lacticum Acidum, Ledum, Phosphorus, Rhus Toxicodendron, Ruta, Sarcolacticum Ac., Staphysag., Symphytum, Echinacea, Hydrastis"},{"NDCCode":"55714-1108-0","ProprietaryName":"Sports Recovery","NonProprietaryName":"Apis Mel., Arnica, Bellis, Bryonia, Calendula, Chamomilla, Cinchona, Gelsemium, Hamamelis, Hypericum, Lacticum Acidum, Ledum, Phosphorus, Rhus Toxicodendron, Ruta, Sarcolacticum Ac., Staphysag., Symphytum, Echinacea, Hydrastis"},{"NDCCode":"55714-1110-0","ProprietaryName":"Jet Lag","NonProprietaryName":"Alumina, Aralia Quinquefolia, Arg. Nit., Arnica, Arsenicum Alb., Baptisia, Bryonia, Cantharis, Chelidonium Majus, Conium, Gelsemium, Iodium, Kali Carb., Kali Iod., Lycopodium, Lycopus Virginicus, Nat. Mur., Nux Vom., Phosphorus, Phytolacca, Pulsatilla, Rhus Toxicodendron, Sabal, Thyroidinum, Echinacea"},{"NDCCode":"55714-1112-0","ProprietaryName":"Swimmers Support","NonProprietaryName":"Antimon. Tart., Arnica, Bellis, Bryonia, Calc. Carb., Capsicum, Chelidonium Majus, Cuprum Met., Digitalis, Drosera, Lachesis, Lacticum Acidum, Ledum, Mag. Carb., Mang. Acet., Nux Vom., Phytolacca, Rhus Toxicodendron, Ruta, Sarcolacticum Ac., Sulphuricum Ac., Verbascum, Vipera Berus"},{"NDCCode":"55714-1113-0","ProprietaryName":"Hangover Help","NonProprietaryName":"Agaricus Musc., Arsenicum Alb., Bismuthum Metallicum, Bryonia, Capsicum, Carbo Veg., Glonoinum, Ipecac., Iris Versicolor, Laurocerasus, Lycopodium, Mezereum, Nux Vom., Pulsatilla, Ranunc. Bulb. , Theridion, Veratrum Alb., Zinc. Met., Zingiber, Chamomilla, Passiflora, Valeriana"},{"NDCCode":"55714-1114-0","ProprietaryName":"Sick Stopper","NonProprietaryName":"Anthracinum, Influenza A Virus, Influenza B Virus, Pyrogenium, Bufo Rana, Aconitum Nap., Agaricus Musc., Aralia Quinquefolia, Baptisia, Bryonia, Chelidonium Majus, Eupatorium Perf., Hepar Sulph. Calc., Lachesis, Lycopodium, Nux Vom., Rhus Toxicodendron, Sanguinaria, Sulphur, Thuja Occ., Echinacea"},{"NDCCode":"55714-1115-0","ProprietaryName":"Panic Button","NonProprietaryName":"Aconitum Nap., Apis Mel., Arnica, Arsenicum Alb., Belladonna, Bellis, Bryonia, Calendula, Chamomilla, Cistus Canadensis, Ferrum Phosphoricum, Histaminum Hydrochloricum, Hypericum, Ignatia, Mezereum, Ornithogalum, Passiflora, Phosphorus, Prunus Spin., Rhus Toxicodendron, Sarcolacticum Ac., Sulphur, Veratrum Alb., Valeriana"},{"NDCCode":"55714-1116-0","ProprietaryName":"Sports Injury","NonProprietaryName":"Apis Mel., Arnica, Bellis, Bryonia, Calendula, Chamomilla, Cinchona, Gelsemium, Hamamelis, Hypericum, Lacticum Acidum, Ledum, Phosphorus, Rhus Toxicodendron, Ruta, Sarcolacticum Ac., Staphysag., Symphytum, Echinacea, Hydrastis"},{"NDCCode":"55714-1118-0","ProprietaryName":"Jet Lag","NonProprietaryName":"Alumina, Aralia Quinquefolia, Arg. Nit., Arnica, Arsenicum Alb., Baptisia, Bryonia, Cantharis, Chelidonium Majus, Conium, Gelsemium, Iodium, Kali Carb., Kali Iod., Lycopodium, Lycopus Virginicus, Nat. Mur., Nux Vom., Phosphorus, Phytolacca, Pulsatilla, Rhus Toxicodendron, Sabal, Thyroidinum, Echinacea"}]}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>55714-2364-0</NDCCode>
<PackageDescription>.5 mL in 1 BOTTLE, GLASS (55714-2364-0)</PackageDescription>
<NDC11Code>55714-2364-00</NDC11Code>
<ProductNDC>55714-2364</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Vitality</ProprietaryName>
<NonProprietaryName>Adrenalinum, Aloe, Arsenicum Alb., Baptisia, Berber. Aqui., Berber. Vulg., Bryonia, Chelidonium Majus, Crotalus Horridus, Digitalis, Ferrum Metallicum, Glonoinum, Glycyrrhiza Glabra , Hydrocotyle, Iodium, Iris Versicolor, Lachesis, Lycopodium, Nat. Mur., Nux Vom., Rhus Toxicodendron, Ruta, Thuja Occ., Thyroidinum, Echinacea, Lappa, Solidago, Taraxacum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>EPINEPHRINE; ALOE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; MAHONIA AQUIFOLIUM ROOT BARK; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; CROTALUS HORRIDUS HORRIDUS VENOM; DIGITALIS; IRON; NITROGLYCERIN; GLYCYRRHIZA GLABRA; CENTELLA ASIATICA; IODINE; IRIS VERSICOLOR ROOT; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG; THYROID, UNSPECIFIED; ECHINACEA, UNSPECIFIED; ARCTIUM LAPPA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; TARAXACUM OFFICINALE</SubstanceName>
<StrengthNumber>15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3; 3</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Vitality Formulated for symptoms associated with low energy, mild stress and weakness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55714-2364-1</NDCCode>
<PackageDescription>29.57 mL in 1 BOTTLE, GLASS (55714-2364-1)</PackageDescription>
<NDC11Code>55714-2364-01</NDC11Code>
<ProductNDC>55714-2364</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Vitality</ProprietaryName>
<NonProprietaryName>Adrenalinum, Aloe, Arsenicum Alb., Baptisia, Berber. Aqui., Berber. Vulg., Bryonia, Chelidonium Majus, Crotalus Horridus, Digitalis, Ferrum Metallicum, Glonoinum, Glycyrrhiza Glabra , Hydrocotyle, Iodium, Iris Versicolor, Lachesis, Lycopodium, Nat. Mur., Nux Vom., Rhus Toxicodendron, Ruta, Thuja Occ., Thyroidinum, Echinacea, Lappa, Solidago, Taraxacum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>EPINEPHRINE; ALOE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; MAHONIA AQUIFOLIUM ROOT BARK; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; CROTALUS HORRIDUS HORRIDUS VENOM; DIGITALIS; IRON; NITROGLYCERIN; GLYCYRRHIZA GLABRA; CENTELLA ASIATICA; IODINE; IRIS VERSICOLOR ROOT; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG; THYROID, UNSPECIFIED; ECHINACEA, UNSPECIFIED; ARCTIUM LAPPA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; TARAXACUM OFFICINALE</SubstanceName>
<StrengthNumber>15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3; 3</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Vitality Formulated for symptoms associated with low energy, mild stress and weakness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55714-2364-2</NDCCode>
<PackageDescription>59.14 mL in 1 BOTTLE, GLASS (55714-2364-2)</PackageDescription>
<NDC11Code>55714-2364-02</NDC11Code>
<ProductNDC>55714-2364</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Vitality</ProprietaryName>
<NonProprietaryName>Adrenalinum, Aloe, Arsenicum Alb., Baptisia, Berber. Aqui., Berber. Vulg., Bryonia, Chelidonium Majus, Crotalus Horridus, Digitalis, Ferrum Metallicum, Glonoinum, Glycyrrhiza Glabra , Hydrocotyle, Iodium, Iris Versicolor, Lachesis, Lycopodium, Nat. Mur., Nux Vom., Rhus Toxicodendron, Ruta, Thuja Occ., Thyroidinum, Echinacea, Lappa, Solidago, Taraxacum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>EPINEPHRINE; ALOE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; MAHONIA AQUIFOLIUM ROOT BARK; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; CROTALUS HORRIDUS HORRIDUS VENOM; DIGITALIS; IRON; NITROGLYCERIN; GLYCYRRHIZA GLABRA; CENTELLA ASIATICA; IODINE; IRIS VERSICOLOR ROOT; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; THUJA OCCIDENTALIS LEAFY TWIG; THYROID, UNSPECIFIED; ECHINACEA, UNSPECIFIED; ARCTIUM LAPPA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; TARAXACUM OFFICINALE</SubstanceName>
<StrengthNumber>15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3; 3</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Vitality Formulated for symptoms associated with low energy, mild stress and weakness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>15631-2364-0</NDCCode>
<PackageDescription>1 TABLET in 1 BLISTER PACK (15631-2364-0)</PackageDescription>
<NDC11Code>15631-2364-00</NDC11Code>
<ProductNDC>15631-2364</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bio-combination 9</ProprietaryName>
<NonProprietaryName>Ferrum Phosphoricum, Kali Muriaticum, Kali Phosphoricum, Magnesia Phosphorica</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160411</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
<SubstanceName>FERROSOFERRIC PHOSPHATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE</SubstanceName>
<StrengthNumber>12; 6; 3; 6</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>50090-2364-0</NDCCode>
<PackageDescription>12 BOTTLE, DROPPER in 1 CARTON (50090-2364-0) > 2 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>50090-2364-00</NDC11Code>
<ProductNDC>50090-2364</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tetracaine Hydrochloride</ProprietaryName>
<NonProprietaryName>Tetracaine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>19690328</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208135</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>TETRACAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Ester Local Anesthetic [EPC],Esters [Chemical/Ingredient],Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-01-10</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>70518-2364-0</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE, PLASTIC (70518-2364-0) </PackageDescription>
<NDC11Code>70518-2364-00</NDC11Code>
<ProductNDC>70518-2364</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pregabalin</ProprietaryName>
<NonProprietaryName>Pregabalin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191016</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209743</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2024-09-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191016</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pregabalin capsules are indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older , 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
<Description>Pregabalin is described chemically as ( S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin is a white to off-white, crystalline solid with a pK a1of 4.2 and a pK a2of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with pregelatinized starch and talc. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and white capsule shells contain sodium lauryl sulfate. Each capsule shell is imprinted with black pharmaceutical ink which contains: butyl alcohol, dehydrated alcohol, ferrosoferric oxide, isopropyl alcohol, propylene glycol, potassium hydroxide, purified water, strong ammonia solution and shellac.</Description>
</NDC>
<NDC>
<NDCCode>36987-2364-1</NDCCode>
<PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (36987-2364-1)</PackageDescription>
<NDC11Code>36987-2364-01</NDC11Code>
<ProductNDC>36987-2364</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Standardized Redtop Grass Pollen</ProprietaryName>
<NonProprietaryName>Standardized Redtop Grass Pollen</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19980210</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>AGROSTIS GIGANTEA POLLEN</SubstanceName>
<StrengthNumber>10000</StrengthNumber>
<StrengthUnit>[BAU]/mL</StrengthUnit>
<Pharm_Classes>Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Standardized Pollen Extract is intended for use in the diagnosis and therapy of pollen allergic patients as established by allergy history and skin test reactivity. Standardized Grass Pollen extracts labeled in BAU/mL are not interchangeable with Grass Pollen extracts labeled in AU/mL or with non-standardized Grass Pollen extracts. The 10,000 BAU/mL dose form is indicated for percutaneous testing. If negative, 100,000 BAU/mL dose form can be used for percutaneous testing. For immunotherapy, availability of 10,000 and 100,000 BAU/mL dosages facilitates safe switching. (See Dosage & Administration). The use of standardized grass pollen extracts is indicated for hyposensitization treatment and may be used as part of the over-all management of the allergic patient. Treatment of grass sensitive patients consists of using specific standardized grass products of up to and including doses of 100,000 BAU/mL (up to 10,000 BAU/mL for Bermuda grass) or stock mixtures of standardized grass products. Stock mixtures of standardized grass extracts are particularly useful in hyposensitization treatment when multiple allergies to grasses are diagnosed. For previously untreated patients, the 10,000 BAU/mL concentrates can be used to formulate dosages. If tolerated, the concentrates can be inceased to 100,000 BAU/mL dose formulation.</IndicationAndUsage>
<Description>Standardized Grass Pollen Extracts include: Orchard (Dactylis glomerata), Perennial Rye (Lolium perenne), Timothy (Phleum pratense), Redtop (Agrostis alba), Kentucky (June) Bluegrass (Poa pratensis), Bermuda (Cynodon dactylon), Meadow Fescue (Festuca elatior), Sweet Vernal (Anthoxanthum odoratum). The standardized grass pollen extract is prepared by extracting raw pollen material at a ratio of either 1:5 w/v, 1:6.66 w/v or 1:10 w/v in Cocas fluid containing 0.5% NaCl, 0.275% NaHCO3, WFI and 0.4% phenol as preservative. Following extraction, a calculated amount of glycerin is added to make a 50%(v/v) glycerinated solution. Standardized Grass Pollen extracts have potency designations of 10,000 BAU/mL and 100,000 BAU/mL except Bermuda Grass (10,000 BAU/mL only). Extracts with a potency of 10,000 BAU/mL are diluted from the 100,000 BAU/mL lots with Glycerol Saline 50%(v/v). The Glycerol Saline 50%(v/v) solution consists of Glycerin and Salts and Buffered Diluent whose ingredients are 0.5% NaCl, 0.08% Na2HPO4, 0.036% KH2PO4, WFI and 0.4% phenol as a preservative. All extracts are aseptically filled in sterile containers. Standardized pollen extracts are intended for administration by prick-puncture or intradermal routes when used for diagnostic purposes and administered subcutaneously when used for immunotherapy injection. Standardized grass pollen extracts labeled in BAU/mL are not interchangeable with grass pollen extracts labeled in AU/mL or with non-standardized grass pollen extracts. The Bioequivalent Allergy Unit (BAU), the potency unit used for all Standardized Pollen Extracts, replaces the previous unitage for these products. Bioequivalent Allergy Units were assigned to the FDA, Center for Biologics Evaluation and Research (CBER) reference extracts, based on quantitative intradermal skin test results. BAU's are intended to assure that the labeled unitage of different allergenic extracts will correspond to the expected clinical response in sensitive patients. References labeled 10,000 BAU/mL can be diluted one half million fold to produce an intradermal sum of erythema diameter response of 50mm in highly puncture reactive subjects. 100,000 BAU/mL can be diluted 1:5 million fold to yield the same intradermal response.(2) The assignment of BAU/mL to standardized grass pollen extracts, is accomplished by an ELISA assay comparing the extract to the CBER reference. Previously, the potency / concentration of grass mixtures was designated based on the manufacturing strength, e.g. 1:10 w/v or 1:20 w/v, or in PNU's/mL. For grass mixtures containing standardized extracts, the potency will reflect the contribution of each individual component in the mixture, i.e., the actual potency of each component will be listed on a per mL basis. In addition, because the individual components may be cross-reactive, an additional caution statement, "due to cross reactivity, total potency may be 100,000 BAU/mL," will be added to the label.</Description>
</NDC>
<NDC>
<NDCCode>36987-2364-2</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (36987-2364-2)</PackageDescription>
<NDC11Code>36987-2364-02</NDC11Code>
<ProductNDC>36987-2364</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Standardized Redtop Grass Pollen</ProprietaryName>
<NonProprietaryName>Standardized Redtop Grass Pollen</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19980210</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>AGROSTIS GIGANTEA POLLEN</SubstanceName>
<StrengthNumber>10000</StrengthNumber>
<StrengthUnit>[BAU]/mL</StrengthUnit>
<Pharm_Classes>Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Standardized Pollen Extract is intended for use in the diagnosis and therapy of pollen allergic patients as established by allergy history and skin test reactivity. Standardized Grass Pollen extracts labeled in BAU/mL are not interchangeable with Grass Pollen extracts labeled in AU/mL or with non-standardized Grass Pollen extracts. The 10,000 BAU/mL dose form is indicated for percutaneous testing. If negative, 100,000 BAU/mL dose form can be used for percutaneous testing. For immunotherapy, availability of 10,000 and 100,000 BAU/mL dosages facilitates safe switching. (See Dosage & Administration). The use of standardized grass pollen extracts is indicated for hyposensitization treatment and may be used as part of the over-all management of the allergic patient. Treatment of grass sensitive patients consists of using specific standardized grass products of up to and including doses of 100,000 BAU/mL (up to 10,000 BAU/mL for Bermuda grass) or stock mixtures of standardized grass products. Stock mixtures of standardized grass extracts are particularly useful in hyposensitization treatment when multiple allergies to grasses are diagnosed. For previously untreated patients, the 10,000 BAU/mL concentrates can be used to formulate dosages. If tolerated, the concentrates can be inceased to 100,000 BAU/mL dose formulation.</IndicationAndUsage>
<Description>Standardized Grass Pollen Extracts include: Orchard (Dactylis glomerata), Perennial Rye (Lolium perenne), Timothy (Phleum pratense), Redtop (Agrostis alba), Kentucky (June) Bluegrass (Poa pratensis), Bermuda (Cynodon dactylon), Meadow Fescue (Festuca elatior), Sweet Vernal (Anthoxanthum odoratum). The standardized grass pollen extract is prepared by extracting raw pollen material at a ratio of either 1:5 w/v, 1:6.66 w/v or 1:10 w/v in Cocas fluid containing 0.5% NaCl, 0.275% NaHCO3, WFI and 0.4% phenol as preservative. Following extraction, a calculated amount of glycerin is added to make a 50%(v/v) glycerinated solution. Standardized Grass Pollen extracts have potency designations of 10,000 BAU/mL and 100,000 BAU/mL except Bermuda Grass (10,000 BAU/mL only). Extracts with a potency of 10,000 BAU/mL are diluted from the 100,000 BAU/mL lots with Glycerol Saline 50%(v/v). The Glycerol Saline 50%(v/v) solution consists of Glycerin and Salts and Buffered Diluent whose ingredients are 0.5% NaCl, 0.08% Na2HPO4, 0.036% KH2PO4, WFI and 0.4% phenol as a preservative. All extracts are aseptically filled in sterile containers. Standardized pollen extracts are intended for administration by prick-puncture or intradermal routes when used for diagnostic purposes and administered subcutaneously when used for immunotherapy injection. Standardized grass pollen extracts labeled in BAU/mL are not interchangeable with grass pollen extracts labeled in AU/mL or with non-standardized grass pollen extracts. The Bioequivalent Allergy Unit (BAU), the potency unit used for all Standardized Pollen Extracts, replaces the previous unitage for these products. Bioequivalent Allergy Units were assigned to the FDA, Center for Biologics Evaluation and Research (CBER) reference extracts, based on quantitative intradermal skin test results. BAU's are intended to assure that the labeled unitage of different allergenic extracts will correspond to the expected clinical response in sensitive patients. References labeled 10,000 BAU/mL can be diluted one half million fold to produce an intradermal sum of erythema diameter response of 50mm in highly puncture reactive subjects. 100,000 BAU/mL can be diluted 1:5 million fold to yield the same intradermal response.(2) The assignment of BAU/mL to standardized grass pollen extracts, is accomplished by an ELISA assay comparing the extract to the CBER reference. Previously, the potency / concentration of grass mixtures was designated based on the manufacturing strength, e.g. 1:10 w/v or 1:20 w/v, or in PNU's/mL. For grass mixtures containing standardized extracts, the potency will reflect the contribution of each individual component in the mixture, i.e., the actual potency of each component will be listed on a per mL basis. In addition, because the individual components may be cross-reactive, an additional caution statement, "due to cross reactivity, total potency may be 100,000 BAU/mL," will be added to the label.</Description>
</NDC>
<NDC>
<NDCCode>36987-2364-3</NDCCode>
<PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (36987-2364-3)</PackageDescription>
<NDC11Code>36987-2364-03</NDC11Code>
<ProductNDC>36987-2364</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Standardized Redtop Grass Pollen</ProprietaryName>
<NonProprietaryName>Standardized Redtop Grass Pollen</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19980210</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>AGROSTIS GIGANTEA POLLEN</SubstanceName>
<StrengthNumber>10000</StrengthNumber>
<StrengthUnit>[BAU]/mL</StrengthUnit>
<Pharm_Classes>Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Standardized Pollen Extract is intended for use in the diagnosis and therapy of pollen allergic patients as established by allergy history and skin test reactivity. Standardized Grass Pollen extracts labeled in BAU/mL are not interchangeable with Grass Pollen extracts labeled in AU/mL or with non-standardized Grass Pollen extracts. The 10,000 BAU/mL dose form is indicated for percutaneous testing. If negative, 100,000 BAU/mL dose form can be used for percutaneous testing. For immunotherapy, availability of 10,000 and 100,000 BAU/mL dosages facilitates safe switching. (See Dosage & Administration). The use of standardized grass pollen extracts is indicated for hyposensitization treatment and may be used as part of the over-all management of the allergic patient. Treatment of grass sensitive patients consists of using specific standardized grass products of up to and including doses of 100,000 BAU/mL (up to 10,000 BAU/mL for Bermuda grass) or stock mixtures of standardized grass products. Stock mixtures of standardized grass extracts are particularly useful in hyposensitization treatment when multiple allergies to grasses are diagnosed. For previously untreated patients, the 10,000 BAU/mL concentrates can be used to formulate dosages. If tolerated, the concentrates can be inceased to 100,000 BAU/mL dose formulation.</IndicationAndUsage>
<Description>Standardized Grass Pollen Extracts include: Orchard (Dactylis glomerata), Perennial Rye (Lolium perenne), Timothy (Phleum pratense), Redtop (Agrostis alba), Kentucky (June) Bluegrass (Poa pratensis), Bermuda (Cynodon dactylon), Meadow Fescue (Festuca elatior), Sweet Vernal (Anthoxanthum odoratum). The standardized grass pollen extract is prepared by extracting raw pollen material at a ratio of either 1:5 w/v, 1:6.66 w/v or 1:10 w/v in Cocas fluid containing 0.5% NaCl, 0.275% NaHCO3, WFI and 0.4% phenol as preservative. Following extraction, a calculated amount of glycerin is added to make a 50%(v/v) glycerinated solution. Standardized Grass Pollen extracts have potency designations of 10,000 BAU/mL and 100,000 BAU/mL except Bermuda Grass (10,000 BAU/mL only). Extracts with a potency of 10,000 BAU/mL are diluted from the 100,000 BAU/mL lots with Glycerol Saline 50%(v/v). The Glycerol Saline 50%(v/v) solution consists of Glycerin and Salts and Buffered Diluent whose ingredients are 0.5% NaCl, 0.08% Na2HPO4, 0.036% KH2PO4, WFI and 0.4% phenol as a preservative. All extracts are aseptically filled in sterile containers. Standardized pollen extracts are intended for administration by prick-puncture or intradermal routes when used for diagnostic purposes and administered subcutaneously when used for immunotherapy injection. Standardized grass pollen extracts labeled in BAU/mL are not interchangeable with grass pollen extracts labeled in AU/mL or with non-standardized grass pollen extracts. The Bioequivalent Allergy Unit (BAU), the potency unit used for all Standardized Pollen Extracts, replaces the previous unitage for these products. Bioequivalent Allergy Units were assigned to the FDA, Center for Biologics Evaluation and Research (CBER) reference extracts, based on quantitative intradermal skin test results. BAU's are intended to assure that the labeled unitage of different allergenic extracts will correspond to the expected clinical response in sensitive patients. References labeled 10,000 BAU/mL can be diluted one half million fold to produce an intradermal sum of erythema diameter response of 50mm in highly puncture reactive subjects. 100,000 BAU/mL can be diluted 1:5 million fold to yield the same intradermal response.(2) The assignment of BAU/mL to standardized grass pollen extracts, is accomplished by an ELISA assay comparing the extract to the CBER reference. Previously, the potency / concentration of grass mixtures was designated based on the manufacturing strength, e.g. 1:10 w/v or 1:20 w/v, or in PNU's/mL. For grass mixtures containing standardized extracts, the potency will reflect the contribution of each individual component in the mixture, i.e., the actual potency of each component will be listed on a per mL basis. In addition, because the individual components may be cross-reactive, an additional caution statement, "due to cross reactivity, total potency may be 100,000 BAU/mL," will be added to the label.</Description>
</NDC>
<NDC>
<NDCCode>36987-2364-4</NDCCode>
<PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (36987-2364-4)</PackageDescription>
<NDC11Code>36987-2364-04</NDC11Code>
<ProductNDC>36987-2364</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Standardized Redtop Grass Pollen</ProprietaryName>
<NonProprietaryName>Standardized Redtop Grass Pollen</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19980210</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>AGROSTIS GIGANTEA POLLEN</SubstanceName>
<StrengthNumber>10000</StrengthNumber>
<StrengthUnit>[BAU]/mL</StrengthUnit>
<Pharm_Classes>Standardized Pollen Allergenic Extract [EPC],Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Standardized Pollen Extract is intended for use in the diagnosis and therapy of pollen allergic patients as established by allergy history and skin test reactivity. Standardized Grass Pollen extracts labeled in BAU/mL are not interchangeable with Grass Pollen extracts labeled in AU/mL or with non-standardized Grass Pollen extracts. The 10,000 BAU/mL dose form is indicated for percutaneous testing. If negative, 100,000 BAU/mL dose form can be used for percutaneous testing. For immunotherapy, availability of 10,000 and 100,000 BAU/mL dosages facilitates safe switching. (See Dosage & Administration). The use of standardized grass pollen extracts is indicated for hyposensitization treatment and may be used as part of the over-all management of the allergic patient. Treatment of grass sensitive patients consists of using specific standardized grass products of up to and including doses of 100,000 BAU/mL (up to 10,000 BAU/mL for Bermuda grass) or stock mixtures of standardized grass products. Stock mixtures of standardized grass extracts are particularly useful in hyposensitization treatment when multiple allergies to grasses are diagnosed. For previously untreated patients, the 10,000 BAU/mL concentrates can be used to formulate dosages. If tolerated, the concentrates can be inceased to 100,000 BAU/mL dose formulation.</IndicationAndUsage>
<Description>Standardized Grass Pollen Extracts include: Orchard (Dactylis glomerata), Perennial Rye (Lolium perenne), Timothy (Phleum pratense), Redtop (Agrostis alba), Kentucky (June) Bluegrass (Poa pratensis), Bermuda (Cynodon dactylon), Meadow Fescue (Festuca elatior), Sweet Vernal (Anthoxanthum odoratum). The standardized grass pollen extract is prepared by extracting raw pollen material at a ratio of either 1:5 w/v, 1:6.66 w/v or 1:10 w/v in Cocas fluid containing 0.5% NaCl, 0.275% NaHCO3, WFI and 0.4% phenol as preservative. Following extraction, a calculated amount of glycerin is added to make a 50%(v/v) glycerinated solution. Standardized Grass Pollen extracts have potency designations of 10,000 BAU/mL and 100,000 BAU/mL except Bermuda Grass (10,000 BAU/mL only). Extracts with a potency of 10,000 BAU/mL are diluted from the 100,000 BAU/mL lots with Glycerol Saline 50%(v/v). The Glycerol Saline 50%(v/v) solution consists of Glycerin and Salts and Buffered Diluent whose ingredients are 0.5% NaCl, 0.08% Na2HPO4, 0.036% KH2PO4, WFI and 0.4% phenol as a preservative. All extracts are aseptically filled in sterile containers. Standardized pollen extracts are intended for administration by prick-puncture or intradermal routes when used for diagnostic purposes and administered subcutaneously when used for immunotherapy injection. Standardized grass pollen extracts labeled in BAU/mL are not interchangeable with grass pollen extracts labeled in AU/mL or with non-standardized grass pollen extracts. The Bioequivalent Allergy Unit (BAU), the potency unit used for all Standardized Pollen Extracts, replaces the previous unitage for these products. Bioequivalent Allergy Units were assigned to the FDA, Center for Biologics Evaluation and Research (CBER) reference extracts, based on quantitative intradermal skin test results. BAU's are intended to assure that the labeled unitage of different allergenic extracts will correspond to the expected clinical response in sensitive patients. References labeled 10,000 BAU/mL can be diluted one half million fold to produce an intradermal sum of erythema diameter response of 50mm in highly puncture reactive subjects. 100,000 BAU/mL can be diluted 1:5 million fold to yield the same intradermal response.(2) The assignment of BAU/mL to standardized grass pollen extracts, is accomplished by an ELISA assay comparing the extract to the CBER reference. Previously, the potency / concentration of grass mixtures was designated based on the manufacturing strength, e.g. 1:10 w/v or 1:20 w/v, or in PNU's/mL. For grass mixtures containing standardized extracts, the potency will reflect the contribution of each individual component in the mixture, i.e., the actual potency of each component will be listed on a per mL basis. In addition, because the individual components may be cross-reactive, an additional caution statement, "due to cross reactivity, total potency may be 100,000 BAU/mL," will be added to the label.</Description>
</NDC>
<NDC>
<NDCCode>50090-2364-1</NDCCode>
<PackageDescription>4 mL in 1 BOTTLE, DROPPER (50090-2364-1) </PackageDescription>
<NDC11Code>50090-2364-01</NDC11Code>
<ProductNDC>50090-2364</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tetracaine Hydrochloride</ProprietaryName>
<NonProprietaryName>Tetracaine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>20161102</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA208135</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>TETRACAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Ester Local Anesthetic [EPC], Esters [CS], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190923</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tetracaine Hydrochloride Ophthalmic Solution 0.5% is indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic.</IndicationAndUsage>
<Description>Tetracaine hydrochloride is chemically designated as benzoic acid, 4-(butylamino)-,2-(dimethylamino) ethyl ester, monohydrochloride. Its chemical formula is C15H24N2O2 HCl and it is represented by the chemical structure. Tetracaine hydrochloride is a fine, white, crystalline, odorless powder and has a molecular weight of 300.82. Tetracaine Hydrochloride Ophthalmic Solution 0.5% has a pH of 3.7 to 5.5. Active ingredient: tetracaine hydrochloride 0.5% w/v (equivalent to 0.44% w/v tetracaine). Inactive ingredients: sodium chloride, sodium acetate trihydrate, acetic acid (to adjust pH approximately 4.5), Water for Injection, USP.</Description>
</NDC>
<NDC>
<NDCCode>55154-2364-5</NDCCode>
<PackageDescription>5 VIAL in 1 BAG (55154-2364-5) / 2 mL in 1 VIAL</PackageDescription>
<NDC11Code>55154-2364-05</NDC11Code>
<ProductNDC>55154-2364</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Furosemide</ProprietaryName>
<NonProprietaryName>Furosemide</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20100713</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA018667</ApplicationNumber>
<LabelerName>Cardinal Health 107, LLC</LabelerName>
<SubstanceName>FUROSEMIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Increased Diuresis at Loop of Henle [PE], Loop Diuretic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100713</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>FUROSEMIDE INJECTION is a loop diuretic indicated for: 1 The treatment of edema associated with heart failure, cirrhosis of the liver, and renal disease (1.1), 2 Acute pulmonary edema as adjunctive therapy (1.2).</IndicationAndUsage>
<Description>Furosemide Injection contains furosemide as the active pharmaceutical ingredient. Furosemide is a loop diuretic which is an anthranilic acid derivative. Furosemide chemical name is 4-chloro-N-furfuryl-5-sulfamoylanthranilic acid. Furosemide is a white to slightly-yellow crystalline powder. It is practically insoluble in water, sparingly soluble in alcohol, freely soluble in dilute alkali solutions and insoluble in dilute acids. The structural formula is as follows. Furosemide Injection, USP 10 mg/mL is a sterile, non-pyrogenic solution, available in single-dose vials for intravenous and intramuscular injection. Each mL of Furosemide Injection contains: 10 mg of Furosemide, 7.5 mg of Sodium Chloride for isotonicity, 1.34 mg of Sodium Hydroxide, Hydrochloric Acid and Sodium Hydroxide as pH adjusters, in Water for Injection. Furosemide Injection solution pH is between 8.0 and 9.3. It contains no preservative.</Description>
</NDC>
<NDC>
<NDCCode>65044-2364-5</NDCCode>
<PackageDescription>5 mL in 1 VIAL (65044-2364-5) </PackageDescription>
<NDC11Code>65044-2364-05</NDC11Code>
<ProductNDC>65044-2364</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Pollens - Weeds And Garden Plants, Russian Thistle Salsola Kali</ProprietaryName>
<NonProprietaryName>Russian Thistle Salsola Kali</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL</RouteName>
<StartMarketingDate>19410419</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103888</ApplicationNumber>
<LabelerName>Jubilant HollisterStier LLC</LabelerName>
<SubstanceName>SALSOLA KALI POLLEN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>[PNU]/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19410419</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Certain diagnostics carry labeling which states Allergenic Extract for Diagnostic Use Only. Data to support the therapeutic use of products labeled with this statement have not been established.15. In addition to a carefully taken history, the use of intradermal testing extracts is an accepted method in the diagnosis of allergenic conditions.1, 2, 3 When scratch, prick or puncture reactions are small, or if the patient gives a history of allergic symptoms to a substance but scratch, prick or puncture tests are inconclusive, intradermal tests may be indicated. However, ANTIGENS PRODUCING LARGE 3 TO 4+ SCRATCH, PRICK OR PUNCTURE TESTS SHOULD NOT BE TESTED INTRADERMALLY. Extracts of all allergens do not produce equivalent results in intradermal testing. The intensity of the skin reaction produced will be determined by two factors: the degree of sensitivity of the patient and the nature of the antigenic extract applied. In general, pollen extracts produce whealing reactions, whereas other inhalants produce erythematous reactions with wheals less often. Skin tests to foods seldom produce whealing reactions except for infrequent instances of severe sensitivity to fish, nuts or spices, and rarely other foods.</IndicationAndUsage>
<Description>Extracts for intradermal testing are supplied in sterile multi-dose vials containing, in addition to the extract allergens and antigens, 0.5% sodium chloride, 0.275% sodium bicarbonate, up to 2% glycerin, 2.5% glycerin for AP products, and, as preservative, 0.4% phenol. The strength of these extracts may be expressed in terms of:. 1. Weight to Volume (w/v) 2. Protein Nitrogen Units/mL (PNU/mL)3. Allergy Units/mL (AU/mL)4. Bioequivalent Allergy Units/mL (BAU/mL)5. Concentrate: 1 Weight to volume (w/v). For regular extracts this describes the extraction ratio, i.e., the amount of crude allergen added to the extracting fluid. A 1:10 extract, therefore, indicates that the solution contains the extracted material from one gram of raw material added to each 10 mL of extracting fluid. The amount and composition of extracted material will vary with the kind of antigen, the extracting fluid, duration of extraction, pH, temperature, and other variables. In contrast to this, AP (acetone precipitated) extracts, if present, are prepared by reconstituting dry allergenically active concentrates produced by a precipitation process from extracts of raw materials. For those AP extracts labeled on a weight per volume (w/v) basis, the strength designation indicates the dry weight of finished (acetone) precipitate per volume of reconstituting fluid. For example, 1:50 (w/v) means that each gram of dry precipitate obtained from the original extract is reconstituted in 50 mL of solution., 2 Protein Nitrogen Units per mL (PNU/mL). One protein nitrogen unit represents 0.00001 mg phosphotungstic acid-precipitable protein nitrogen dissolved in one mL of antigen extract. The PNU content of extracts of the same antigen may vary according to the method of measuring the PNU. Thus, PNU contents of extracts from different manufacturers are not comparable unless the PNU method is known to be the same and reproducible from lot to lot. Also, the amount of protein nitrogen extracted from an antigen is influenced by the same variables as the weight to volume extract. Allergenic materials make up a variable proportion of the total protein of an extract., 3 Allergy Units per mL (AU/mL). The potency of standardized AP and regular extracts labeled in Allergy Units (AU)/mL is determined by in vitro comparison to the reference standard established by the Center for Biologics Evaluation and Research (CBER) of the Food and Drug Administration., 4 Bioequivalent Allergy Units per mL(BAU/mL). When originally licensed, the Reference Preparations for standardized extracts were arbitrarily assigned 100,000 Allergy Units (AU)/mL. Subsequently, quantitative skin testing by the ID50EAL method14 was used to determine that some Reference Preparations should be assigned 10,000 AU/mL, and others 100,000 AU/mL. To avoid possible confusion about this change in the method of allergy unit assignment, the nomenclature changed for standardized extracts whose allergy units are assigned based on quantitative skin testing, and are labeled in Bioequivalent Allergy Units (BAU)/mL. References labeled 10,000 BAU/mL can be diluted one to a half million fold, and references labeled 100,000 BAU/mL can be diluted one to 5 million fold and produce a sum of erythema diameter of 50 mm when Intradermal testing highly reactive subjects., 5 Concentrate. Concentrate label terminology applies to allergenic extract mixtures, where the individual allergens being combined vary in strength or the designation of strength.</Description>
</NDC>
<NDC>
<NDCCode>68071-2364-8</NDCCode>
<PackageDescription>80 mL in 1 BOTTLE (68071-2364-8) </PackageDescription>
<NDC11Code>68071-2364-08</NDC11Code>
<ProductNDC>68071-2364</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin</ProprietaryName>
<NonProprietaryName>Amoxicillin</NonProprietaryName>
<DosageFormName>POWDER, FOR SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20060619</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065322</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210311</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To reduce the development of drug-resistant bacteria and maintain the effectiveness of Amoxicillin and other antibacterial drugs, Amoxicillin for Oral Suspension should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Amoxicillin for Oral Suspension is indicated in the treatment of infections due to susceptible (ONLY β-lactamase–negative) isolates of the designated bacteria in the conditions listed below.</IndicationAndUsage>
<Description>Formulations of Amoxicillin for Oral Suspension, USP contain Amoxicillin, a semisynthetic antibiotic, an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2 S,5 R,6 R)-6-[( R)-(-)-2-amino-2-( p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-zabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as:. The Amoxicillin molecular formula is C 16H 19N 3O 5S3H 2O, and the molecular weight is 419.45. Amoxicillin for Oral Suspension, USP: Each 5 mL of reconstituted suspension contains 125 mg, 200 mg, 250 mg or 400 mg Amoxicillin as the trihydrate. Each 5 mL of the 125 mg, 200 mg, 250 mg and 400 mg reconstituted suspension contains 0.1898 mEq (4.3635 mg) of sodium. Inactive ingredients: colloidal silicon dioxide, hypromellose, sodium benzoate, sucrose, trisodium citrate dihydrate, tutti frutti flavor and xanthan gum.</Description>
</NDC>
<NDC>
<NDCCode>70518-2364-1</NDCCode>
<PackageDescription>60 CAPSULE in 1 BOTTLE, PLASTIC (70518-2364-1) </PackageDescription>
<NDC11Code>70518-2364-01</NDC11Code>
<ProductNDC>70518-2364</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pregabalin</ProprietaryName>
<NonProprietaryName>Pregabalin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20191016</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209743</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>PREGABALIN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2024-09-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210715</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Pregabalin capsules are indicated for: 1 Management of neuropathic pain associated with diabetic peripheral neuropathy, 2 Management of postherpetic neuralgia, 3 Adjunctive therapy for the treatment of partial-onset seizures in patients 1 month of age and older , 4 Management of fibromyalgia, 5 Management of neuropathic pain associated with spinal cord injury.</IndicationAndUsage>
<Description>Pregabalin is described chemically as ( S)-3-(aminomethyl)-5-methylhexanoic acid. The molecular formula is C 8H 17NO 2and the molecular weight is 159.23. The chemical structure of pregabalin is:. Pregabalin is a white to off-white, crystalline solid with a pK a1of 4.2 and a pK a2of 10.6. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is – 1.35. Pregabalin Capsules are administered orally and are supplied as imprinted hard-shell capsules containing 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, and 300 mg of pregabalin, along with pregelatinized starch and talc. The capsule shells contain gelatin and titanium dioxide. In addition, the orange capsule shells contain red iron oxide and white capsule shells contain sodium lauryl sulfate. Each capsule shell is imprinted with black pharmaceutical ink which contains: butyl alcohol, dehydrated alcohol, ferrosoferric oxide, isopropyl alcohol, propylene glycol, potassium hydroxide, purified water, strong ammonia solution and shellac.</Description>
</NDC>
<NDC>
<NDCCode>80830-2364-8</NDCCode>
<PackageDescription>20 VIAL in 1 CARTON (80830-2364-8) / 50 mL in 1 VIAL (80830-2364-1) </PackageDescription>
<NDC11Code>80830-2364-08</NDC11Code>
<ProductNDC>80830-2364</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propofol</ProprietaryName>
<NonProprietaryName>Propofol</NonProprietaryName>
<DosageFormName>INJECTION, EMULSION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20240816</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217525</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals Private Limited</LabelerName>
<SubstanceName>PROPOFOL</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>General Anesthesia [PE], General Anesthetic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240816</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Propofol injectable emulsion is an intravenous general anesthetic and sedation drug indicated for.</IndicationAndUsage>
<Description>Propofol injectable emulsion USP, 10 mg per mL is an anesthetic available as a sterile, nonpyrogenic, white, homogeneous emulsion for intravenous administration. The structural formula of propofol, USP is. Chemical name: 2,6 diisopropylphenol. Molecular formula: C12H18O. Molecular weight: 178.28 g/mol. Propofol, USP is a clear, colorless to slightly yellowish liquid. It is very soluble in methanol and in ethanol, slightly soluble in cyclohexane and in isopropyl alcohol and very slightly soluble in water. The pKa is 11. The octanol/water partition coefficient for propofol is 6761:1 at a pH of 6.0 to 8.5. Each mL of propofol injectable emulsion, USP contains 10 mg propofol, USP; soybean oil, 100 mg; glycerol, 22.5 mg; egg phospholipids, 12 mg; disodium edetate anhydrous, 0.05 mg and sodium hydroxide to adjust pH, in water for injection. Propofol injectable emulsion, USP is isotonic and has a pH of 7.00 to 8.50.</Description>
</NDC>
<NDC>
<NDCCode>55714-1102-0</NDCCode>
<PackageDescription>.5 mL in 1 BOTTLE, GLASS (55714-1102-0)</PackageDescription>
<NDC11Code>55714-1102-00</NDC11Code>
<ProductNDC>55714-1102</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sick Stopper</ProprietaryName>
<NonProprietaryName>Anthracinum, Influenza A Virus, Influenza B Virus, Pyrogenium, Bufo Rana, Aconitum Nap., Agaricus Musc., Aralia Quinquefolia, Baptisia, Bryonia, Chelidonium Majus, Eupatorium Perf., Hepar Sulph. Calc., Lachesis, Lycopodium, Nux Vom., Rhus Toxicodendron, Sanguinaria, Sulphur, Thuja Occ., Echinacea</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; INFLUENZA A VIRUS; RANCID BEEF; BUFO BUFO CUTANEOUS GLAND; ACONITUM NAPELLUS; AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; AMERICAN GINSENG; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; EUPATORIUM PERFOLIATUM FLOWERING TOP; CALCIUM SULFIDE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; SANGUINARIA CANADENSIS ROOT; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; ECHINACEA, UNSPECIFIED; INFLUENZA B VIRUS</SubstanceName>
<StrengthNumber>30; 30; 30; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 30</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Sick Stopper Formulated for symptoms associated with colds and infections. Begin at the onset of symptoms.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55714-1103-0</NDCCode>
<PackageDescription>.5 mL in 1 BOTTLE, GLASS (55714-1103-0)</PackageDescription>
<NDC11Code>55714-1103-00</NDC11Code>
<ProductNDC>55714-1103</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Swimmers Support</ProprietaryName>
<NonProprietaryName>Antimon. Tart., Arnica, Bellis, Bryonia, Calc. Carb., Capsicum, Chelidonium Majus, Cuprum Met., Digitalis, Drosera, Lachesis, Lacticum Acidum, Ledum, Mag. Carb., Mang. Acet., Nux Vom., Phytolacca, Rhus Toxicodendron, Ruta, Sarcolacticum Ac., Sulphuricum Ac., Verbascum, Vipera Berus</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>ANTIMONY POTASSIUM TARTRATE; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CAPSICUM; CHELIDONIUM MAJUS; COPPER; DIGITALIS; DROSERA ROTUNDIFOLIA FLOWERING TOP; LACHESIS MUTA VENOM; LACTIC ACID, DL-; LEDUM PALUSTRE TWIG; MAGNESIUM CARBONATE; MANGANESE ACETATE TETRAHYDRATE; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; LACTIC ACID, L-; SULFURIC ACID; VERBASCUM THAPSUS; VIPERA BERUS VENOM</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Swimmers Support Formulated for symptoms associated with swimming and exposure to pool chemicals such as cramping, dry skin, fatigue and muscle soreness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55714-1104-0</NDCCode>
<PackageDescription>.5 mL in 1 BOTTLE, GLASS (55714-1104-0)</PackageDescription>
<NDC11Code>55714-1104-00</NDC11Code>
<ProductNDC>55714-1104</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hangover Help</ProprietaryName>
<NonProprietaryName>Agaricus Musc., Arsenicum Alb., Bismuthum Metallicum, Bryonia, Capsicum, Carbo Veg., Glonoinum, Ipecac., Iris Versicolor, Laurocerasus, Lycopodium, Mezereum, Nux Vom., Pulsatilla, Ranunc. Bulb. , Theridion, Veratrum Alb., Zinc. Met., Zingiber, Chamomilla, Passiflora, Valeriana</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; ARSENIC TRIOXIDE; BISMUTH; BRYONIA ALBA ROOT; CAPSICUM; ACTIVATED CHARCOAL; NITROGLYCERIN; IPECAC; IRIS VERSICOLOR ROOT; PRUNUS LAUROCERASUS LEAF; LYCOPODIUM CLAVATUM SPORE; DAPHNE MEZEREUM BARK; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS; RANUNCULUS BULBOSUS; THERIDION CURASSAVICUM; VERATRUM ALBUM ROOT; ZINC; GINGER; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP; VALERIAN</SubstanceName>
<StrengthNumber>15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Hangover Help Formulated for symptoms associated with intoxication including nausea, dizziness, discomfort and headache.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55714-1105-0</NDCCode>
<PackageDescription>7.08 g in 1 BOTTLE, GLASS (55714-1105-0)</PackageDescription>
<NDC11Code>55714-1105-00</NDC11Code>
<ProductNDC>55714-1105</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Prime Plus</ProprietaryName>
<NonProprietaryName>Agnus, Allium Sativum, Ambra, Angelica Sinensis Radix, Aralia Quinquefolia, Arnica, Arsenicum Alb., Avena, Baptisia, Baryta Carb., Bryonia, Cantharis, Lachesis, Lycopodium, Nux Vom., Phosphoricum Ac., Pulsatilla, Ruta, Sabal, Selenium, Zinc. Met., Ginkgo</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>CHASTE TREE; GARLIC; AMBERGRIS; ANGELICA SINENSIS ROOT; AMERICAN GINSENG; ARNICA MONTANA; ARSENIC TRIOXIDE; AVENA SATIVA FLOWERING TOP; BAPTISIA TINCTORIA ROOT; BARIUM CARBONATE; BRYONIA ALBA ROOT; LYTTA VESICATORIA; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PULSATILLA VULGARIS; RUTA GRAVEOLENS FLOWERING TOP; SAW PALMETTO; SELENIUM; ZINC; GINKGO</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3</StrengthNumber>
<StrengthUnit>[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Prime+ Formulated for symptoms associated with aging such as impaired memory, loss of vitality, general weakness and dry, wrinkled skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55714-1106-0</NDCCode>
<PackageDescription>.5 mL in 1 BOTTLE, GLASS (55714-1106-0)</PackageDescription>
<NDC11Code>55714-1106-00</NDC11Code>
<ProductNDC>55714-1106</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Panic Button</ProprietaryName>
<NonProprietaryName>Aconitum Nap., Apis Mel., Arnica, Arsenicum Alb., Belladonna, Bellis, Bryonia, Calendula, Chamomilla, Cistus Canadensis, Ferrum Phosphoricum, Histaminum Hydrochloricum, Hypericum, Ignatia, Mezereum, Ornithogalum, Passiflora, Phosphorus, Prunus Spin., Rhus Toxicodendron, Sarcolacticum Ac., Sulphur, Veratrum Alb., Valeriana.</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>ACONITUM NAPELLUS; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; HELIANTHEMUM CANADENSE; FERROSOFERRIC PHOSPHATE; HISTAMINE DIHYDROCHLORIDE; HYPERICUM PERFORATUM; STRYCHNOS IGNATII SEED; DAPHNE MEZEREUM BARK; ORNITHOGALUM UMBELLATUM; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; PRUNUS SPINOSA FLOWER BUD; TOXICODENDRON PUBESCENS LEAF; LACTIC ACID, L-; SULFUR; VERATRUM ALBUM ROOT; VALERIAN</SubstanceName>
<StrengthNumber>15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-14</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>55714-1107-0</NDCCode>
<PackageDescription>.5 mL in 1 BOTTLE, GLASS (55714-1107-0)</PackageDescription>
<NDC11Code>55714-1107-00</NDC11Code>
<ProductNDC>55714-1107</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sports Injury</ProprietaryName>
<NonProprietaryName>Apis Mel., Arnica, Bellis, Bryonia, Calendula, Chamomilla, Cinchona, Gelsemium, Hamamelis, Hypericum, Lacticum Acidum, Ledum, Phosphorus, Rhus Toxicodendron, Ruta, Sarcolacticum Ac., Staphysag., Symphytum, Echinacea, Hydrastis</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>APIS MELLIFERA; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; GELSEMIUM SEMPERVIRENS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; LACTIC ACID, DL-; LEDUM PALUSTRE TWIG; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; LACTIC ACID, L-; DELPHINIUM STAPHISAGRIA SEED; COMFREY ROOT; ECHINACEA, UNSPECIFIED; GOLDENSEAL</SubstanceName>
<StrengthNumber>15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-10-13</LastUpdate>
</NDC>
<NDC>
<NDCCode>55714-1108-0</NDCCode>
<PackageDescription>15 mL in 1 BOTTLE, GLASS (55714-1108-0)</PackageDescription>
<NDC11Code>55714-1108-00</NDC11Code>
<ProductNDC>55714-1108</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sports Recovery</ProprietaryName>
<NonProprietaryName>Apis Mel., Arnica, Bellis, Bryonia, Calendula, Chamomilla, Cinchona, Gelsemium, Hamamelis, Hypericum, Lacticum Acidum, Ledum, Phosphorus, Rhus Toxicodendron, Ruta, Sarcolacticum Ac., Staphysag., Symphytum, Echinacea, Hydrastis</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160725</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>APIS MELLIFERA; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; GELSEMIUM SEMPERVIRENS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; LACTIC ACID, DL-; LEDUM PALUSTRE TWIG; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; LACTIC ACID, L-; DELPHINIUM STAPHISAGRIA SEED; COMFREY ROOT; ECHINACEA, UNSPECIFIED; GOLDENSEAL</SubstanceName>
<StrengthNumber>15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Sports Recovery Formulated for workout recovery and for symptoms associated with injury, overexertion and emotional distress.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55714-1110-0</NDCCode>
<PackageDescription>.5 mL in 1 BOTTLE, GLASS (55714-1110-0)</PackageDescription>
<NDC11Code>55714-1110-00</NDC11Code>
<ProductNDC>55714-1110</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Jet Lag</ProprietaryName>
<NonProprietaryName>Alumina, Aralia Quinquefolia, Arg. Nit., Arnica, Arsenicum Alb., Baptisia, Bryonia, Cantharis, Chelidonium Majus, Conium, Gelsemium, Iodium, Kali Carb., Kali Iod., Lycopodium, Lycopus Virginicus, Nat. Mur., Nux Vom., Phosphorus, Phytolacca, Pulsatilla, Rhus Toxicodendron, Sabal, Thyroidinum, Echinacea</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>ALUMINUM OXIDE; AMERICAN GINSENG; SILVER NITRATE; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CHELIDONIUM MAJUS; CONIUM MACULATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; IODINE; POTASSIUM CARBONATE; POTASSIUM IODIDE; LYCOPODIUM CLAVATUM SPORE; LYCOPUS VIRGINICUS; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SAW PALMETTO; THYROID, UNSPECIFIED; ECHINACEA, UNSPECIFIED</SubstanceName>
<StrengthNumber>15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_M]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Jet Lag Formulated for symptoms associated with travel such as fatigue, insomnia, headaches and digestive discomfort.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55714-1112-0</NDCCode>
<PackageDescription>7.08 g in 1 BOTTLE, GLASS (55714-1112-0)</PackageDescription>
<NDC11Code>55714-1112-00</NDC11Code>
<ProductNDC>55714-1112</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Swimmers Support</ProprietaryName>
<NonProprietaryName>Antimon. Tart., Arnica, Bellis, Bryonia, Calc. Carb., Capsicum, Chelidonium Majus, Cuprum Met., Digitalis, Drosera, Lachesis, Lacticum Acidum, Ledum, Mag. Carb., Mang. Acet., Nux Vom., Phytolacca, Rhus Toxicodendron, Ruta, Sarcolacticum Ac., Sulphuricum Ac., Verbascum, Vipera Berus</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>ANTIMONY POTASSIUM TARTRATE; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CAPSICUM; CHELIDONIUM MAJUS; COPPER; DIGITALIS; DROSERA ROTUNDIFOLIA FLOWERING TOP; LACHESIS MUTA VENOM; LACTIC ACID, DL-; LEDUM PALUSTRE TWIG; MAGNESIUM CARBONATE; MANGANESE ACETATE TETRAHYDRATE; STRYCHNOS NUX-VOMICA SEED; PHYTOLACCA AMERICANA ROOT; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; LACTIC ACID, L-; SULFURIC ACID; VERBASCUM THAPSUS; VIPERA BERUS VENOM</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Swimmers Support Formulated for symptoms associated with swimming and exposure to pool chemicals such as cramping, dry skin, fatigue and muscle soreness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55714-1113-0</NDCCode>
<PackageDescription>7.08 g in 1 BOTTLE, GLASS (55714-1113-0)</PackageDescription>
<NDC11Code>55714-1113-00</NDC11Code>
<ProductNDC>55714-1113</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hangover Help</ProprietaryName>
<NonProprietaryName>Agaricus Musc., Arsenicum Alb., Bismuthum Metallicum, Bryonia, Capsicum, Carbo Veg., Glonoinum, Ipecac., Iris Versicolor, Laurocerasus, Lycopodium, Mezereum, Nux Vom., Pulsatilla, Ranunc. Bulb. , Theridion, Veratrum Alb., Zinc. Met., Zingiber, Chamomilla, Passiflora, Valeriana</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; ARSENIC TRIOXIDE; BISMUTH; BRYONIA ALBA ROOT; CAPSICUM; ACTIVATED CHARCOAL; NITROGLYCERIN; IPECAC; IRIS VERSICOLOR ROOT; PRUNUS LAUROCERASUS LEAF; LYCOPODIUM CLAVATUM SPORE; DAPHNE MEZEREUM BARK; STRYCHNOS NUX-VOMICA SEED; PULSATILLA VULGARIS; RANUNCULUS BULBOSUS; THERIDION CURASSAVICUM; VERATRUM ALBUM ROOT; ZINC; GINGER; MATRICARIA RECUTITA; PASSIFLORA INCARNATA FLOWERING TOP; VALERIAN</SubstanceName>
<StrengthNumber>15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3</StrengthNumber>
<StrengthUnit>[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Hangover Help Formulated for symptoms associated with intoxication including nausea, dizziness, discomfort and headache.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55714-1114-0</NDCCode>
<PackageDescription>7.08 g in 1 BOTTLE, GLASS (55714-1114-0)</PackageDescription>
<NDC11Code>55714-1114-00</NDC11Code>
<ProductNDC>55714-1114</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sick Stopper</ProprietaryName>
<NonProprietaryName>Anthracinum, Influenza A Virus, Influenza B Virus, Pyrogenium, Bufo Rana, Aconitum Nap., Agaricus Musc., Aralia Quinquefolia, Baptisia, Bryonia, Chelidonium Majus, Eupatorium Perf., Hepar Sulph. Calc., Lachesis, Lycopodium, Nux Vom., Rhus Toxicodendron, Sanguinaria, Sulphur, Thuja Occ., Echinacea</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; INFLUENZA A VIRUS; RANCID BEEF; BUFO BUFO CUTANEOUS GLAND; ACONITUM NAPELLUS; AMANITA MUSCARIA VAR. MUSCARIA FRUITING BODY; AMERICAN GINSENG; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; CHELIDONIUM MAJUS; EUPATORIUM PERFOLIATUM FLOWERING TOP; CALCIUM SULFIDE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; TOXICODENDRON PUBESCENS LEAF; SANGUINARIA CANADENSIS ROOT; SULFUR; THUJA OCCIDENTALIS LEAFY TWIG; ECHINACEA, UNSPECIFIED; INFLUENZA B VIRUS</SubstanceName>
<StrengthNumber>30; 30; 30; 15; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 30</StrengthNumber>
<StrengthUnit>[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Sick Stopper Formulated for symptoms associated with colds and infections. Begin at the onset of symptoms.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55714-1115-0</NDCCode>
<PackageDescription>7.08 g in 1 BOTTLE, GLASS (55714-1115-0)</PackageDescription>
<NDC11Code>55714-1115-00</NDC11Code>
<ProductNDC>55714-1115</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Panic Button</ProprietaryName>
<NonProprietaryName>Aconitum Nap., Apis Mel., Arnica, Arsenicum Alb., Belladonna, Bellis, Bryonia, Calendula, Chamomilla, Cistus Canadensis, Ferrum Phosphoricum, Histaminum Hydrochloricum, Hypericum, Ignatia, Mezereum, Ornithogalum, Passiflora, Phosphorus, Prunus Spin., Rhus Toxicodendron, Sarcolacticum Ac., Sulphur, Veratrum Alb., Valeriana</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>ACONITUM NAPELLUS; APIS MELLIFERA; ARNICA MONTANA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; HELIANTHEMUM CANADENSE; FERROSOFERRIC PHOSPHATE; HISTAMINE DIHYDROCHLORIDE; HYPERICUM PERFORATUM; STRYCHNOS IGNATII SEED; DAPHNE MEZEREUM BARK; ORNITHOGALUM UMBELLATUM; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORUS; PRUNUS SPINOSA FLOWER BUD; TOXICODENDRON PUBESCENS LEAF; LACTIC ACID, L-; SULFUR; VERATRUM ALBUM ROOT; VALERIAN</SubstanceName>
<StrengthNumber>15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3</StrengthNumber>
<StrengthUnit>[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-14</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>55714-1116-0</NDCCode>
<PackageDescription>7.08 g in 1 BOTTLE, GLASS (55714-1116-0)</PackageDescription>
<NDC11Code>55714-1116-00</NDC11Code>
<ProductNDC>55714-1116</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sports Injury</ProprietaryName>
<NonProprietaryName>Apis Mel., Arnica, Bellis, Bryonia, Calendula, Chamomilla, Cinchona, Gelsemium, Hamamelis, Hypericum, Lacticum Acidum, Ledum, Phosphorus, Rhus Toxicodendron, Ruta, Sarcolacticum Ac., Staphysag., Symphytum, Echinacea, Hydrastis</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>APIS MELLIFERA; ARNICA MONTANA; BELLIS PERENNIS; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; GELSEMIUM SEMPERVIRENS ROOT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; LACTIC ACID, DL-; LEDUM PALUSTRE TWIG; PHOSPHORUS; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP; LACTIC ACID, L-; DELPHINIUM STAPHISAGRIA SEED; COMFREY ROOT; ECHINACEA, UNSPECIFIED; GOLDENSEAL</SubstanceName>
<StrengthNumber>15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3</StrengthNumber>
<StrengthUnit>[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-10-13</LastUpdate>
</NDC>
<NDC>
<NDCCode>55714-1118-0</NDCCode>
<PackageDescription>7.08 g in 1 BOTTLE, GLASS (55714-1118-0)</PackageDescription>
<NDC11Code>55714-1118-00</NDC11Code>
<ProductNDC>55714-1118</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Jet Lag</ProprietaryName>
<NonProprietaryName>Alumina, Aralia Quinquefolia, Arg. Nit., Arnica, Arsenicum Alb., Baptisia, Bryonia, Cantharis, Chelidonium Majus, Conium, Gelsemium, Iodium, Kali Carb., Kali Iod., Lycopodium, Lycopus Virginicus, Nat. Mur., Nux Vom., Phosphorus, Phytolacca, Pulsatilla, Rhus Toxicodendron, Sabal, Thyroidinum, Echinacea</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>ALUMINUM OXIDE; AMERICAN GINSENG; SILVER NITRATE; ARNICA MONTANA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; LYTTA VESICATORIA; CHELIDONIUM MAJUS; CONIUM MACULATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; IODINE; POTASSIUM CARBONATE; POTASSIUM IODIDE; LYCOPODIUM CLAVATUM SPORE; LYCOPUS VIRGINICUS; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; TOXICODENDRON PUBESCENS LEAF; SAW PALMETTO; THYROID, UNSPECIFIED; ECHINACEA, UNSPECIFIED</SubstanceName>
<StrengthNumber>15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3</StrengthNumber>
<StrengthUnit>[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_M]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Jet Lag Formulated for symptoms associated with travel such as fatigue, insomnia, headaches and digestive discomfort.</IndicationAndUsage>
</NDC>
</NDCList>
<NDCList><NDC><NDCCode>55714-2364-0</NDCCode><ProprietaryName>Vitality</ProprietaryName><NonProprietaryName>Adrenalinum, Aloe, Arsenicum Alb., Baptisia, Berber. Aqui., Berber. Vulg., Bryonia, Chelidonium Majus, Crotalus Horridus, Digitalis, Ferrum Metallicum, Glonoinum, Glycyrrhiza Glabra , Hydrocotyle, Iodium, Iris Versicolor, Lachesis, Lycopodium, Nat. Mur., Nux Vom., Rhus Toxicodendron, Ruta, Thuja Occ., Thyroidinum, Echinacea, Lappa, Solidago, Taraxacum</NonProprietaryName></NDC><NDC><NDCCode>55714-2364-1</NDCCode><ProprietaryName>Vitality</ProprietaryName><NonProprietaryName>Adrenalinum, Aloe, Arsenicum Alb., Baptisia, Berber. Aqui., Berber. Vulg., Bryonia, Chelidonium Majus, Crotalus Horridus, Digitalis, Ferrum Metallicum, Glonoinum, Glycyrrhiza Glabra , Hydrocotyle, Iodium, Iris Versicolor, Lachesis, Lycopodium, Nat. Mur., Nux Vom., Rhus Toxicodendron, Ruta, Thuja Occ., Thyroidinum, Echinacea, Lappa, Solidago, Taraxacum</NonProprietaryName></NDC><NDC><NDCCode>55714-2364-2</NDCCode><ProprietaryName>Vitality</ProprietaryName><NonProprietaryName>Adrenalinum, Aloe, Arsenicum Alb., Baptisia, Berber. Aqui., Berber. Vulg., Bryonia, Chelidonium Majus, Crotalus Horridus, Digitalis, Ferrum Metallicum, Glonoinum, Glycyrrhiza Glabra , Hydrocotyle, Iodium, Iris Versicolor, Lachesis, Lycopodium, Nat. Mur., Nux Vom., Rhus Toxicodendron, Ruta, Thuja Occ., Thyroidinum, Echinacea, Lappa, Solidago, Taraxacum</NonProprietaryName></NDC><NDC><NDCCode>15631-2364-0</NDCCode><ProprietaryName>Bio-combination 9</ProprietaryName><NonProprietaryName>Ferrum Phosphoricum, Kali Muriaticum, Kali Phosphoricum, Magnesia Phosphorica</NonProprietaryName></NDC><NDC><NDCCode>50090-2364-0</NDCCode><ProprietaryName>Tetracaine Hydrochloride</ProprietaryName><NonProprietaryName>Tetracaine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>70518-2364-0</NDCCode><ProprietaryName>Pregabalin</ProprietaryName><NonProprietaryName>Pregabalin</NonProprietaryName></NDC><NDC><NDCCode>36987-2364-1</NDCCode><ProprietaryName>Standardized Redtop Grass Pollen</ProprietaryName><NonProprietaryName>Standardized Redtop Grass Pollen</NonProprietaryName></NDC><NDC><NDCCode>36987-2364-2</NDCCode><ProprietaryName>Standardized Redtop Grass Pollen</ProprietaryName><NonProprietaryName>Standardized Redtop Grass Pollen</NonProprietaryName></NDC><NDC><NDCCode>36987-2364-3</NDCCode><ProprietaryName>Standardized Redtop Grass Pollen</ProprietaryName><NonProprietaryName>Standardized Redtop Grass Pollen</NonProprietaryName></NDC><NDC><NDCCode>36987-2364-4</NDCCode><ProprietaryName>Standardized Redtop Grass Pollen</ProprietaryName><NonProprietaryName>Standardized Redtop Grass Pollen</NonProprietaryName></NDC><NDC><NDCCode>50090-2364-1</NDCCode><ProprietaryName>Tetracaine Hydrochloride</ProprietaryName><NonProprietaryName>Tetracaine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>55154-2364-5</NDCCode><ProprietaryName>Furosemide</ProprietaryName><NonProprietaryName>Furosemide</NonProprietaryName></NDC><NDC><NDCCode>65044-2364-5</NDCCode><ProprietaryName>Pollens - Weeds And Garden Plants, Russian Thistle Salsola Kali</ProprietaryName><NonProprietaryName>Russian Thistle Salsola Kali</NonProprietaryName></NDC><NDC><NDCCode>68071-2364-8</NDCCode><ProprietaryName>Amoxicillin</ProprietaryName><NonProprietaryName>Amoxicillin</NonProprietaryName></NDC><NDC><NDCCode>70518-2364-1</NDCCode><ProprietaryName>Pregabalin</ProprietaryName><NonProprietaryName>Pregabalin</NonProprietaryName></NDC><NDC><NDCCode>80830-2364-8</NDCCode><ProprietaryName>Propofol</ProprietaryName><NonProprietaryName>Propofol</NonProprietaryName></NDC><NDC><NDCCode>55714-1102-0</NDCCode><ProprietaryName>Sick Stopper</ProprietaryName><NonProprietaryName>Anthracinum, Influenza A Virus, Influenza B Virus, Pyrogenium, Bufo Rana, Aconitum Nap., Agaricus Musc., Aralia Quinquefolia, Baptisia, Bryonia, Chelidonium Majus, Eupatorium Perf., Hepar Sulph. Calc., Lachesis, Lycopodium, Nux Vom., Rhus Toxicodendron, Sanguinaria, Sulphur, Thuja Occ., Echinacea</NonProprietaryName></NDC><NDC><NDCCode>55714-1103-0</NDCCode><ProprietaryName>Swimmers Support</ProprietaryName><NonProprietaryName>Antimon. Tart., Arnica, Bellis, Bryonia, Calc. Carb., Capsicum, Chelidonium Majus, Cuprum Met., Digitalis, Drosera, Lachesis, Lacticum Acidum, Ledum, Mag. Carb., Mang. Acet., Nux Vom., Phytolacca, Rhus Toxicodendron, Ruta, Sarcolacticum Ac., Sulphuricum Ac., Verbascum, Vipera Berus</NonProprietaryName></NDC><NDC><NDCCode>55714-1104-0</NDCCode><ProprietaryName>Hangover Help</ProprietaryName><NonProprietaryName>Agaricus Musc., Arsenicum Alb., Bismuthum Metallicum, Bryonia, Capsicum, Carbo Veg., Glonoinum, Ipecac., Iris Versicolor, Laurocerasus, Lycopodium, Mezereum, Nux Vom., Pulsatilla, Ranunc. Bulb. , Theridion, Veratrum Alb., Zinc. Met., Zingiber, Chamomilla, Passiflora, Valeriana</NonProprietaryName></NDC><NDC><NDCCode>55714-1105-0</NDCCode><ProprietaryName>Prime Plus</ProprietaryName><NonProprietaryName>Agnus, Allium Sativum, Ambra, Angelica Sinensis Radix, Aralia Quinquefolia, Arnica, Arsenicum Alb., Avena, Baptisia, Baryta Carb., Bryonia, Cantharis, Lachesis, Lycopodium, Nux Vom., Phosphoricum Ac., Pulsatilla, Ruta, Sabal, Selenium, Zinc. Met., Ginkgo</NonProprietaryName></NDC><NDC><NDCCode>55714-1106-0</NDCCode><ProprietaryName>Panic Button</ProprietaryName><NonProprietaryName>Aconitum Nap., Apis Mel., Arnica, Arsenicum Alb., Belladonna, Bellis, Bryonia, Calendula, Chamomilla, Cistus Canadensis, Ferrum Phosphoricum, Histaminum Hydrochloricum, Hypericum, Ignatia, Mezereum, Ornithogalum, Passiflora, Phosphorus, Prunus Spin., Rhus Toxicodendron, Sarcolacticum Ac., Sulphur, Veratrum Alb., Valeriana.</NonProprietaryName></NDC><NDC><NDCCode>55714-1107-0</NDCCode><ProprietaryName>Sports Injury</ProprietaryName><NonProprietaryName>Apis Mel., Arnica, Bellis, Bryonia, Calendula, Chamomilla, Cinchona, Gelsemium, Hamamelis, Hypericum, Lacticum Acidum, Ledum, Phosphorus, Rhus Toxicodendron, Ruta, Sarcolacticum Ac., Staphysag., Symphytum, Echinacea, Hydrastis</NonProprietaryName></NDC><NDC><NDCCode>55714-1108-0</NDCCode><ProprietaryName>Sports Recovery</ProprietaryName><NonProprietaryName>Apis Mel., Arnica, Bellis, Bryonia, Calendula, Chamomilla, Cinchona, Gelsemium, Hamamelis, Hypericum, Lacticum Acidum, Ledum, Phosphorus, Rhus Toxicodendron, Ruta, Sarcolacticum Ac., Staphysag., Symphytum, Echinacea, Hydrastis</NonProprietaryName></NDC><NDC><NDCCode>55714-1110-0</NDCCode><ProprietaryName>Jet Lag</ProprietaryName><NonProprietaryName>Alumina, Aralia Quinquefolia, Arg. Nit., Arnica, Arsenicum Alb., Baptisia, Bryonia, Cantharis, Chelidonium Majus, Conium, Gelsemium, Iodium, Kali Carb., Kali Iod., Lycopodium, Lycopus Virginicus, Nat. Mur., Nux Vom., Phosphorus, Phytolacca, Pulsatilla, Rhus Toxicodendron, Sabal, Thyroidinum, Echinacea</NonProprietaryName></NDC><NDC><NDCCode>55714-1112-0</NDCCode><ProprietaryName>Swimmers Support</ProprietaryName><NonProprietaryName>Antimon. Tart., Arnica, Bellis, Bryonia, Calc. Carb., Capsicum, Chelidonium Majus, Cuprum Met., Digitalis, Drosera, Lachesis, Lacticum Acidum, Ledum, Mag. Carb., Mang. Acet., Nux Vom., Phytolacca, Rhus Toxicodendron, Ruta, Sarcolacticum Ac., Sulphuricum Ac., Verbascum, Vipera Berus</NonProprietaryName></NDC><NDC><NDCCode>55714-1113-0</NDCCode><ProprietaryName>Hangover Help</ProprietaryName><NonProprietaryName>Agaricus Musc., Arsenicum Alb., Bismuthum Metallicum, Bryonia, Capsicum, Carbo Veg., Glonoinum, Ipecac., Iris Versicolor, Laurocerasus, Lycopodium, Mezereum, Nux Vom., Pulsatilla, Ranunc. Bulb. , Theridion, Veratrum Alb., Zinc. Met., Zingiber, Chamomilla, Passiflora, Valeriana</NonProprietaryName></NDC><NDC><NDCCode>55714-1114-0</NDCCode><ProprietaryName>Sick Stopper</ProprietaryName><NonProprietaryName>Anthracinum, Influenza A Virus, Influenza B Virus, Pyrogenium, Bufo Rana, Aconitum Nap., Agaricus Musc., Aralia Quinquefolia, Baptisia, Bryonia, Chelidonium Majus, Eupatorium Perf., Hepar Sulph. Calc., Lachesis, Lycopodium, Nux Vom., Rhus Toxicodendron, Sanguinaria, Sulphur, Thuja Occ., Echinacea</NonProprietaryName></NDC><NDC><NDCCode>55714-1115-0</NDCCode><ProprietaryName>Panic Button</ProprietaryName><NonProprietaryName>Aconitum Nap., Apis Mel., Arnica, Arsenicum Alb., Belladonna, Bellis, Bryonia, Calendula, Chamomilla, Cistus Canadensis, Ferrum Phosphoricum, Histaminum Hydrochloricum, Hypericum, Ignatia, Mezereum, Ornithogalum, Passiflora, Phosphorus, Prunus Spin., Rhus Toxicodendron, Sarcolacticum Ac., Sulphur, Veratrum Alb., Valeriana</NonProprietaryName></NDC><NDC><NDCCode>55714-1116-0</NDCCode><ProprietaryName>Sports Injury</ProprietaryName><NonProprietaryName>Apis Mel., Arnica, Bellis, Bryonia, Calendula, Chamomilla, Cinchona, Gelsemium, Hamamelis, Hypericum, Lacticum Acidum, Ledum, Phosphorus, Rhus Toxicodendron, Ruta, Sarcolacticum Ac., Staphysag., Symphytum, Echinacea, Hydrastis</NonProprietaryName></NDC><NDC><NDCCode>55714-1118-0</NDCCode><ProprietaryName>Jet Lag</ProprietaryName><NonProprietaryName>Alumina, Aralia Quinquefolia, Arg. Nit., Arnica, Arsenicum Alb., Baptisia, Bryonia, Cantharis, Chelidonium Majus, Conium, Gelsemium, Iodium, Kali Carb., Kali Iod., Lycopodium, Lycopus Virginicus, Nat. Mur., Nux Vom., Phosphorus, Phytolacca, Pulsatilla, Rhus Toxicodendron, Sabal, Thyroidinum, Echinacea</NonProprietaryName></NDC></NDCList>