{
"NDC": [
{
"NDCCode": "55714-2329-0",
"PackageDescription": "7.08 g in 1 BOTTLE, GLASS (55714-2329-0)",
"NDC11Code": "55714-2329-00",
"ProductNDC": "55714-2329",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Edema - Fluid Retention",
"NonProprietaryName": "Elaps Corallinus, Apis Mel., Arsenicum Alb., Cantharis, Cinchona, Colchicum, Convallaria, Crotalus Horridus, Digitalis, Juniperus Com., Lachesis, Merc. Viv., Naja, Nat. Carb., Nat.sulphuricum, Rhus Toxicodendron, Sambucus Nig., Strophanthus Hispidus, Thuja Occ., Vipera Berus, Echinacea, Lappa, Solidago, Taraxacum, Urtica Ur.",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "MICRURUS CORALLINUS VENOM; APIS MELLIFERA; ARSENIC TRIOXIDE; LYTTA VESICATORIA; CINCHONA OFFICINALIS BARK; COLCHICUM AUTUMNALE BULB; CONVALLARIA MAJALIS; CROTALUS HORRIDUS HORRIDUS VENOM; DIGITALIS; JUNIPERUS COMMUNIS FRUIT; LACHESIS MUTA VENOM; MERCURY; NAJA NAJA VENOM; SODIUM CARBONATE; SODIUM SULFATE; TOXICODENDRON PUBESCENS LEAF; SAMBUCUS NIGRA FLOWERING TOP; STROPHANTHUS HISPIDUS SEED; THUJA OCCIDENTALIS LEAFY TWIG; VIPERA BERUS VENOM; ECHINACEA, UNSPECIFIED; ARCTIUM LAPPA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; TARAXACUM OFFICINALE; URTICA URENS",
"StrengthNumber": "30; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 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; [hp_X]/g; [hp_X]/g; [hp_X]/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-05",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "55154-2329-0",
"PackageDescription": "10 BLISTER PACK in 1 BAG (55154-2329-0) / 1 TABLET in 1 BLISTER PACK",
"NDC11Code": "55154-2329-00",
"ProductNDC": "55154-2329",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lisinopril",
"NonProprietaryName": "Lisinopril",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170307",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077321",
"LabelerName": "Cardinal Health 107, LLC",
"SubstanceName": "LISINOPRIL",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-09-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20170307",
"SamplePackage": "N",
"IndicationAndUsage": "Lisinopril tablet USP is an angiotensin converting enzyme (ACE) inhibitor indicated for: 1 Treatment of hypertension in adults and pediatric patients 6 years of age and older (1.1), 2 Adjunct therapy for heart failure (1.2), 3 Treatment of Acute Myocardial Infarction (1.3).",
"Description": "Lisinopril is an oral long-acting angiotensin converting enzyme (ACE) inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O52H2O and its structural formula is. Lisinopril is a white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril tablets USP are supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Inactive Ingredients. 2.5 mg tablets - colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, mannitol, pre-gelatinized starch and starch (corn). 5 mg, 10 mg, 20 mg and 30 mg tablets – colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, mannitol, red ferric oxide, pre-gelatinized starch and starch (corn). 40 mg tablets - colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, mannitol, yellow ferric oxide, pre-gelatinized starch and starch (corn)."
},
{
"NDCCode": "70518-2329-0",
"PackageDescription": "30 TABLET in 1 BOTTLE, PLASTIC (70518-2329-0) ",
"NDC11Code": "70518-2329-00",
"ProductNDC": "70518-2329",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valacyclovir Hydrochloride",
"NonProprietaryName": "Valacyclovir Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190927",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077478",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "VALACYCLOVIR HYDROCHLORIDE",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT]",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190927",
"SamplePackage": "N"
},
{
"NDCCode": "55714-2329-1",
"PackageDescription": "28.35 g in 1 BOTTLE, GLASS (55714-2329-1)",
"NDC11Code": "55714-2329-01",
"ProductNDC": "55714-2329",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Edema - Fluid Retention",
"NonProprietaryName": "Elaps Corallinus, Apis Mel., Arsenicum Alb., Cantharis, Cinchona, Colchicum, Convallaria, Crotalus Horridus, Digitalis, Juniperus Com., Lachesis, Merc. Viv., Naja, Nat. Carb., Nat.sulphuricum, Rhus Toxicodendron, Sambucus Nig., Strophanthus Hispidus, Thuja Occ., Vipera Berus, Echinacea, Lappa, Solidago, Taraxacum, Urtica Ur.",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "MICRURUS CORALLINUS VENOM; APIS MELLIFERA; ARSENIC TRIOXIDE; LYTTA VESICATORIA; CINCHONA OFFICINALIS BARK; COLCHICUM AUTUMNALE BULB; CONVALLARIA MAJALIS; CROTALUS HORRIDUS HORRIDUS VENOM; DIGITALIS; JUNIPERUS COMMUNIS FRUIT; LACHESIS MUTA VENOM; MERCURY; NAJA NAJA VENOM; SODIUM CARBONATE; SODIUM SULFATE; TOXICODENDRON PUBESCENS LEAF; SAMBUCUS NIGRA FLOWERING TOP; STROPHANTHUS HISPIDUS SEED; THUJA OCCIDENTALIS LEAFY TWIG; VIPERA BERUS VENOM; ECHINACEA, UNSPECIFIED; ARCTIUM LAPPA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; TARAXACUM OFFICINALE; URTICA URENS",
"StrengthNumber": "30; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 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; [hp_X]/g; [hp_X]/g; [hp_X]/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-05",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "55714-2329-2",
"PackageDescription": "56.7 g in 1 BOTTLE, GLASS (55714-2329-2)",
"NDC11Code": "55714-2329-02",
"ProductNDC": "55714-2329",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Edema - Fluid Retention",
"NonProprietaryName": "Elaps Corallinus, Apis Mel., Arsenicum Alb., Cantharis, Cinchona, Colchicum, Convallaria, Crotalus Horridus, Digitalis, Juniperus Com., Lachesis, Merc. Viv., Naja, Nat. Carb., Nat.sulphuricum, Rhus Toxicodendron, Sambucus Nig., Strophanthus Hispidus, Thuja Occ., Vipera Berus, Echinacea, Lappa, Solidago, Taraxacum, Urtica Ur.",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "MICRURUS CORALLINUS VENOM; APIS MELLIFERA; ARSENIC TRIOXIDE; LYTTA VESICATORIA; CINCHONA OFFICINALIS BARK; COLCHICUM AUTUMNALE BULB; CONVALLARIA MAJALIS; CROTALUS HORRIDUS HORRIDUS VENOM; DIGITALIS; JUNIPERUS COMMUNIS FRUIT; LACHESIS MUTA VENOM; MERCURY; NAJA NAJA VENOM; SODIUM CARBONATE; SODIUM SULFATE; TOXICODENDRON PUBESCENS LEAF; SAMBUCUS NIGRA FLOWERING TOP; STROPHANTHUS HISPIDUS SEED; THUJA OCCIDENTALIS LEAFY TWIG; VIPERA BERUS VENOM; ECHINACEA, UNSPECIFIED; ARCTIUM LAPPA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; TARAXACUM OFFICINALE; URTICA URENS",
"StrengthNumber": "30; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 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; [hp_X]/g; [hp_X]/g; [hp_X]/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-05",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "22840-2329-2",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (22840-2329-2) ",
"NDC11Code": "22840-2329-02",
"ProductNDC": "22840-2329",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Firebush Kochia",
"NonProprietaryName": "Kochia Scoparia",
"DosageFormName": "SOLUTION",
"RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19810915",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101833",
"LabelerName": "Greer Laboratories, Inc.",
"SubstanceName": "BASSIA SCOPARIA POLLEN",
"StrengthNumber": "40000",
"StrengthUnit": "[PNU]/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]",
"Status": "Active",
"LastUpdate": "2025-06-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19810915",
"SamplePackage": "N",
"IndicationAndUsage": "Non-Standardized Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergies to one or more of the specific non-standardized allergens., 2 Immunotherapy for the reduction of allergen-induced allergic symptoms confirmed by appropriate positive skin tests or by in vitro testing for allergen-specific IgE antibodies. .",
"Description": "Non-Standardized Allergenic Extracts are sterile solutions used for percutaneous testing, intradermal testing, or subcutaneous immunotherapy. Aqueous extracts contain the soluble extractants of the source material in water for injection, 0.5% sodium chloride, 0.54% sodium bicarbonate, and 0.4% phenol. Glycerinated extracts contain the soluable extractants of the source material in water for injection and 50% glycerin, 0.25% sodium chloride, 0.27% sodium bicarbonate, and 0.2% phenol. The pH of the extracts range from 6 to 9. Certain food extracts (Barley, Oat, Pineapple, Rye, Spinach, and Wheat), labeled “For Diagnostic Use Only”, contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Source materials used in the manufacture of allergenic extracts are collected from natural sources or from laboratory cultures. Non-Standardized Allergenic Extracts appear as clear and colorless to dark brown solutions that should be free of particulate matter. Extracts are labeled either as weight-to-volume based on the weight of the source material to the volume of the extracting fluid, or as PNU/milliliter with one PNU representing 0.00001 mg of protein nitrogen per milliliter."
},
{
"NDCCode": "22840-2329-4",
"PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (22840-2329-4) ",
"NDC11Code": "22840-2329-04",
"ProductNDC": "22840-2329",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Firebush Kochia",
"NonProprietaryName": "Kochia Scoparia",
"DosageFormName": "SOLUTION",
"RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19810915",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101833",
"LabelerName": "Greer Laboratories, Inc.",
"SubstanceName": "BASSIA SCOPARIA POLLEN",
"StrengthNumber": "40000",
"StrengthUnit": "[PNU]/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]",
"Status": "Active",
"LastUpdate": "2025-06-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19810915",
"SamplePackage": "N",
"IndicationAndUsage": "Non-Standardized Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergies to one or more of the specific non-standardized allergens., 2 Immunotherapy for the reduction of allergen-induced allergic symptoms confirmed by appropriate positive skin tests or by in vitro testing for allergen-specific IgE antibodies. .",
"Description": "Non-Standardized Allergenic Extracts are sterile solutions used for percutaneous testing, intradermal testing, or subcutaneous immunotherapy. Aqueous extracts contain the soluble extractants of the source material in water for injection, 0.5% sodium chloride, 0.54% sodium bicarbonate, and 0.4% phenol. Glycerinated extracts contain the soluable extractants of the source material in water for injection and 50% glycerin, 0.25% sodium chloride, 0.27% sodium bicarbonate, and 0.2% phenol. The pH of the extracts range from 6 to 9. Certain food extracts (Barley, Oat, Pineapple, Rye, Spinach, and Wheat), labeled “For Diagnostic Use Only”, contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Source materials used in the manufacture of allergenic extracts are collected from natural sources or from laboratory cultures. Non-Standardized Allergenic Extracts appear as clear and colorless to dark brown solutions that should be free of particulate matter. Extracts are labeled either as weight-to-volume based on the weight of the source material to the volume of the extracting fluid, or as PNU/milliliter with one PNU representing 0.00001 mg of protein nitrogen per milliliter."
},
{
"NDCCode": "36987-2329-1",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (36987-2329-1)",
"NDC11Code": "36987-2329-01",
"ProductNDC": "36987-2329",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Johnson Grass",
"NonProprietaryName": "Johnson Grass",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "SORGHUM HALEPENSE POLLEN",
"StrengthNumber": "10000",
"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": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "36987-2329-2",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (36987-2329-2)",
"NDC11Code": "36987-2329-02",
"ProductNDC": "36987-2329",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Johnson Grass",
"NonProprietaryName": "Johnson Grass",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "SORGHUM HALEPENSE POLLEN",
"StrengthNumber": "10000",
"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": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "36987-2329-3",
"PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (36987-2329-3)",
"NDC11Code": "36987-2329-03",
"ProductNDC": "36987-2329",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Johnson Grass",
"NonProprietaryName": "Johnson Grass",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "SORGHUM HALEPENSE POLLEN",
"StrengthNumber": "10000",
"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": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "36987-2329-4",
"PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (36987-2329-4)",
"NDC11Code": "36987-2329-04",
"ProductNDC": "36987-2329",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Johnson Grass",
"NonProprietaryName": "Johnson Grass",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "SORGHUM HALEPENSE POLLEN",
"StrengthNumber": "10000",
"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": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "63629-2329-1",
"PackageDescription": "60 g in 1 TUBE (63629-2329-1) ",
"NDC11Code": "63629-2329-01",
"ProductNDC": "63629-2329",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clobetasol Propionate",
"NonProprietaryName": "Clobetasol Propionate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180619",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210034",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "CLOBETASOL PROPIONATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-09-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210419",
"SamplePackage": "N",
"IndicationAndUsage": "Clobetasol propionate cream is a super-high potency corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.",
"Description": "Clobetasol Propionate Cream USP, 0.05% contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Chemically, clobetasol propionate is (11ß,16ß)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-pregna-1,4- diene-3,20-dione, and it has the following structural formula. Clobetasol propionate has the molecular formula C25H32CIFO5 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water. Clobetasol propionate cream contains clobetasol propionate 0.5 mg/g in a cream base composed of cetyl alcohol, citric acid monohydrate, glycol stearate, lanolin liquid, methylparaben, PEG-400 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, stearyl alcohol, and white petrolatum. Sodium hydroxide may be used to adjust pH."
},
{
"NDCCode": "67296-2329-8",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (67296-2329-8) / 1 KIT in 1 BLISTER PACK",
"NDC11Code": "67296-2329-08",
"ProductNDC": "67296-2329",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mono-linyah",
"NonProprietaryName": "Norgestimate And Ethinyl Estradiol",
"DosageFormName": "KIT",
"StartMarketingDate": "20120523",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090523",
"LabelerName": "Redpharm Drug",
"Status": "Active",
"LastUpdate": "2026-09-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20120523",
"SamplePackage": "N",
"IndicationAndUsage": "Mono-Linyah is a combination of norgestimate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. ( 1.1).",
"Description": "Mono-Linyah is a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol. Norgestimate is designated as (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime,(17α)(+)-) and ethinyl estradiol is designated as (19-nor-17α-pregna,1,3,5(10)-trien-20-yne-3,17-diol). : 1 Each active blue tablet contains 0.250 mg of norgestimate and 0.035 mg of ethinyl estradiol. Inactive ingredients include: FD&C Blue No. 2 Aluminium Lake, FD&C Blue No. 1 Aluminum lake, FD&C Red No. 40 Aluminum Lake, FD&C Yellow No. 10 Aluminum Lake, titanium dioxide, polyvinyl alcohol, talc, macrogol/PEG 3350 NF, lecithin, lactose monohydrate, magnesium stearate and pregelatinized corn starch., 2 Each white placebo tablet containing only inert ingredients, as follows: titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol, lactose monohydrate, magnesium stearate and pregelatinized corn starch."
},
{
"NDCCode": "71335-2329-1",
"PackageDescription": "7 TABLET, FILM COATED in 1 BOTTLE (71335-2329-1) ",
"NDC11Code": "71335-2329-01",
"ProductNDC": "71335-2329",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Moxifloxacin Hydrochloride",
"NonProprietaryName": "Moxifloxacin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140304",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202632",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "MOXIFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]",
"Status": "Active",
"LastUpdate": "2026-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20241004",
"SamplePackage": "N",
"IndicationAndUsage": "Moxifloxacin tablets are a fluoroquinolone antibacterial indicated for treating infections in adults 18 years of age and older caused by designated susceptible bacteria, in the conditions listed below: : 1 Community Acquired Pneumonia (1.1), 2 Skin and Skin Structure Infections: Uncomplicated (1.2) and Complicated (1.3) , 3 Complicated Intra-Abdominal Infections (1.4) , 4 Plague (1.5), 5 Acute Bacterial Sinusitis (1.6), 6 Acute Bacterial Exacerbation of Chronic Bronchitis (1.7).",
"Description": "Moxifloxacin hydrochloride is a synthetic antibacterial agent for oral administration. Moxifloxacin, a fluoroquinolone, is available as the monohydrochloride salt of 1-cyclopropyl-7-[(S,S)-2,8-diazabicyclo[4.3.0]non-8-yl]-6-fluoro-8-methoxy-1,4-dihydro-4-oxo-3 quinoline carboxylic acid. It is a slightly yellow to yellow powder or crystals, slightly hygroscopic substance with a molecular weight of 437.9. Its molecular formula is C21H24FN3O4*HCl and its chemical structure is as follows."
},
{
"NDCCode": "71335-2329-2",
"PackageDescription": "10 TABLET, FILM COATED in 1 BOTTLE (71335-2329-2) ",
"NDC11Code": "71335-2329-02",
"ProductNDC": "71335-2329",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Moxifloxacin Hydrochloride",
"NonProprietaryName": "Moxifloxacin Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140304",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202632",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "MOXIFLOXACIN HYDROCHLORIDE",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]",
"Status": "Active",
"LastUpdate": "2026-02-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240103",
"SamplePackage": "N",
"IndicationAndUsage": "Moxifloxacin tablets are a fluoroquinolone antibacterial indicated for treating infections in adults 18 years of age and older caused by designated susceptible bacteria, in the conditions listed below: : 1 Community Acquired Pneumonia (1.1), 2 Skin and Skin Structure Infections: Uncomplicated (1.2) and Complicated (1.3) , 3 Complicated Intra-Abdominal Infections (1.4) , 4 Plague (1.5), 5 Acute Bacterial Sinusitis (1.6), 6 Acute Bacterial Exacerbation of Chronic Bronchitis (1.7).",
"Description": "Moxifloxacin hydrochloride is a synthetic antibacterial agent for oral administration. Moxifloxacin, a fluoroquinolone, is available as the monohydrochloride salt of 1-cyclopropyl-7-[(S,S)-2,8-diazabicyclo[4.3.0]non-8-yl]-6-fluoro-8-methoxy-1,4-dihydro-4-oxo-3 quinoline carboxylic acid. It is a slightly yellow to yellow powder or crystals, slightly hygroscopic substance with a molecular weight of 437.9. Its molecular formula is C21H24FN3O4*HCl and its chemical structure is as follows."
},
{
"NDCCode": "72162-2329-2",
"PackageDescription": "1 TUBE in 1 CARTON (72162-2329-2) / 15 g in 1 TUBE",
"NDC11Code": "72162-2329-02",
"ProductNDC": "72162-2329",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Desonide",
"NonProprietaryName": "Desonide",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20060822",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA017426",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "DESONIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-02-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240618",
"SamplePackage": "N",
"IndicationAndUsage": "Desonide Ointment, 0.05% is a low potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. It should not be used for longer than two weeks unless directed by a physician.",
"Description": "Desonide Ointment, 0.05% contains desonide (Pregna-1,4-diene-3,20-dione,11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(11ß,16α)) a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primary synthetic steroids used topically as anti-inflammatory and antipruritic agents. Chemically, desonide, the active ingredient in Desonide Ointment, 0.05% is C24H32O6. It has the following structural formula. The molecular weight of desonide is 416.51. It is a white to off-white powder. The solubility of desonide in distilled water saturated with ether is 184 mg/L. Each gram of Desonide Ointment, 0.05% contains 0.5 milligram of desonide microdispersed in a base of white petrolatum."
},
{
"NDCCode": "80830-2329-2",
"PackageDescription": "10 POUCH in 1 CARTON (80830-2329-2) / 1 BAG in 1 POUCH / 100 mL in 1 BAG",
"NDC11Code": "80830-2329-02",
"ProductNDC": "80830-2329",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tranexamic Acid In Sodium Chloride",
"NonProprietaryName": "Tranexamic Acid",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20231023",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217155",
"LabelerName": "Amneal Pharmaceuticals Private Limited",
"SubstanceName": "TRANEXAMIC ACID",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]",
"Status": "Active",
"LastUpdate": "2025-05-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231023",
"SamplePackage": "N",
"IndicationAndUsage": "Tranexamic acid in 0.7% sodium chloride injection is indicated in patients with hemophilia for short-term use (two to eight days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.",
"Description": "Tranexamic acid, USP is trans-4-(aminomethyl)cyclohexanecarboxylic acid, an antifibrinolytic agent. Tranexamic acid, USP is a white, crystalline powder. The structural formula is. Molecular Formula: C8H15NO2 Molecular Weight: 157.21 g/mol. Tranexamic Acid in 0.7% Sodium Chloride Injection, 1,000 mg per 100 mL (10 mg per mL) is a sterile, clear, colorless, nonpyrogenic injectable solution for intravenous administration. Each IV bag contains: 1,000 mg of tranexamic acid, USP; 700 mg of sodium chloride, USP and water for injection, USP. The aqueous solution has a pH of 6.5 to 8.0."
},
{
"NDCCode": "80830-2329-3",
"PackageDescription": "12 POUCH in 1 CARTON (80830-2329-3) / 1 BAG in 1 POUCH / 100 mL in 1 BAG",
"NDC11Code": "80830-2329-03",
"ProductNDC": "80830-2329",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tranexamic Acid In Sodium Chloride",
"NonProprietaryName": "Tranexamic Acid",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20231023",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217155",
"LabelerName": "Amneal Pharmaceuticals Private Limited",
"SubstanceName": "TRANEXAMIC ACID",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]",
"Status": "Active",
"LastUpdate": "2025-05-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240108",
"SamplePackage": "N",
"IndicationAndUsage": "Tranexamic acid in 0.7% sodium chloride injection is indicated in patients with hemophilia for short-term use (two to eight days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.",
"Description": "Tranexamic acid, USP is trans-4-(aminomethyl)cyclohexanecarboxylic acid, an antifibrinolytic agent. Tranexamic acid, USP is a white, crystalline powder. The structural formula is. Molecular Formula: C8H15NO2 Molecular Weight: 157.21 g/mol. Tranexamic Acid in 0.7% Sodium Chloride Injection, 1,000 mg per 100 mL (10 mg per mL) is a sterile, clear, colorless, nonpyrogenic injectable solution for intravenous administration. Each IV bag contains: 1,000 mg of tranexamic acid, USP; 700 mg of sodium chloride, USP and water for injection, USP. The aqueous solution has a pH of 6.5 to 8.0."
},
{
"NDCCode": "80830-2329-4",
"PackageDescription": "10 POUCH in 1 CARTON (80830-2329-4) / 1 BAG in 1 POUCH (80830-2329-5) / 100 mL in 1 BAG",
"NDC11Code": "80830-2329-04",
"ProductNDC": "80830-2329",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tranexamic Acid In Sodium Chloride",
"NonProprietaryName": "Tranexamic Acid",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20250709",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA217155",
"LabelerName": "Amneal Pharmaceuticals Private Limited",
"SubstanceName": "TRANEXAMIC ACID",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]",
"Status": "Active",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250709",
"SamplePackage": "N",
"IndicationAndUsage": "Tranexamic acid in 0.7% sodium chloride injection is indicated in patients with hemophilia for short-term use (two to eight days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.",
"Description": "Tranexamic acid, USP is trans-4-(aminomethyl)cyclohexanecarboxylic acid, an antifibrinolytic agent. Tranexamic acid, USP is a white, crystalline powder. The structural formula is. Molecular Formula: C8H15NO2 Molecular Weight: 157.21 g/mol. Tranexamic Acid in 0.7% Sodium Chloride Injection, 1,000 mg per 100 mL (10 mg per mL) is a sterile, clear, colorless, nonpyrogenic injectable solution for intravenous administration. Each IV bag contains: 1,000 mg of tranexamic acid, USP; 700 mg of sodium chloride, USP and water for injection, USP. The aqueous solution has a pH of 6.5 to 8.0."
},
{
"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."
}
]
}
{"NDC":[{"NDCCode":"55714-2329-0","ProprietaryName":"Edema - Fluid Retention","NonProprietaryName":"Elaps Corallinus, Apis Mel., Arsenicum Alb., Cantharis, Cinchona, Colchicum, Convallaria, Crotalus Horridus, Digitalis, Juniperus Com., Lachesis, Merc. Viv., Naja, Nat. Carb., Nat.sulphuricum, Rhus Toxicodendron, Sambucus Nig., Strophanthus Hispidus, Thuja Occ., Vipera Berus, Echinacea, Lappa, Solidago, Taraxacum, Urtica Ur."},{"NDCCode":"55154-2329-0","ProprietaryName":"Lisinopril","NonProprietaryName":"Lisinopril"},{"NDCCode":"70518-2329-0","ProprietaryName":"Valacyclovir Hydrochloride","NonProprietaryName":"Valacyclovir Hydrochloride"},{"NDCCode":"55714-2329-1","ProprietaryName":"Edema - Fluid Retention","NonProprietaryName":"Elaps Corallinus, Apis Mel., Arsenicum Alb., Cantharis, Cinchona, Colchicum, Convallaria, Crotalus Horridus, Digitalis, Juniperus Com., Lachesis, Merc. Viv., Naja, Nat. Carb., Nat.sulphuricum, Rhus Toxicodendron, Sambucus Nig., Strophanthus Hispidus, Thuja Occ., Vipera Berus, Echinacea, Lappa, Solidago, Taraxacum, Urtica Ur."},{"NDCCode":"55714-2329-2","ProprietaryName":"Edema - Fluid Retention","NonProprietaryName":"Elaps Corallinus, Apis Mel., Arsenicum Alb., Cantharis, Cinchona, Colchicum, Convallaria, Crotalus Horridus, Digitalis, Juniperus Com., Lachesis, Merc. Viv., Naja, Nat. Carb., Nat.sulphuricum, Rhus Toxicodendron, Sambucus Nig., Strophanthus Hispidus, Thuja Occ., Vipera Berus, Echinacea, Lappa, Solidago, Taraxacum, Urtica Ur."},{"NDCCode":"22840-2329-2","ProprietaryName":"Firebush Kochia","NonProprietaryName":"Kochia Scoparia"},{"NDCCode":"22840-2329-4","ProprietaryName":"Firebush Kochia","NonProprietaryName":"Kochia Scoparia"},{"NDCCode":"36987-2329-1","ProprietaryName":"Johnson Grass","NonProprietaryName":"Johnson Grass"},{"NDCCode":"36987-2329-2","ProprietaryName":"Johnson Grass","NonProprietaryName":"Johnson Grass"},{"NDCCode":"36987-2329-3","ProprietaryName":"Johnson Grass","NonProprietaryName":"Johnson Grass"},{"NDCCode":"36987-2329-4","ProprietaryName":"Johnson Grass","NonProprietaryName":"Johnson Grass"},{"NDCCode":"63629-2329-1","ProprietaryName":"Clobetasol Propionate","NonProprietaryName":"Clobetasol Propionate"},{"NDCCode":"67296-2329-8","ProprietaryName":"Mono-linyah","NonProprietaryName":"Norgestimate And Ethinyl Estradiol"},{"NDCCode":"71335-2329-1","ProprietaryName":"Moxifloxacin Hydrochloride","NonProprietaryName":"Moxifloxacin Hydrochloride"},{"NDCCode":"71335-2329-2","ProprietaryName":"Moxifloxacin Hydrochloride","NonProprietaryName":"Moxifloxacin Hydrochloride"},{"NDCCode":"72162-2329-2","ProprietaryName":"Desonide","NonProprietaryName":"Desonide"},{"NDCCode":"80830-2329-2","ProprietaryName":"Tranexamic Acid In Sodium Chloride","NonProprietaryName":"Tranexamic Acid"},{"NDCCode":"80830-2329-3","ProprietaryName":"Tranexamic Acid In Sodium Chloride","NonProprietaryName":"Tranexamic Acid"},{"NDCCode":"80830-2329-4","ProprietaryName":"Tranexamic Acid In Sodium Chloride","NonProprietaryName":"Tranexamic Acid"},{"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"}]}
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<NDCList>
<NDC>
<NDCCode>55714-2329-0</NDCCode>
<PackageDescription>7.08 g in 1 BOTTLE, GLASS (55714-2329-0)</PackageDescription>
<NDC11Code>55714-2329-00</NDC11Code>
<ProductNDC>55714-2329</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Edema - Fluid Retention</ProprietaryName>
<NonProprietaryName>Elaps Corallinus, Apis Mel., Arsenicum Alb., Cantharis, Cinchona, Colchicum, Convallaria, Crotalus Horridus, Digitalis, Juniperus Com., Lachesis, Merc. Viv., Naja, Nat. Carb., Nat.sulphuricum, Rhus Toxicodendron, Sambucus Nig., Strophanthus Hispidus, Thuja Occ., Vipera Berus, Echinacea, Lappa, Solidago, Taraxacum, Urtica Ur.</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>MICRURUS CORALLINUS VENOM; APIS MELLIFERA; ARSENIC TRIOXIDE; LYTTA VESICATORIA; CINCHONA OFFICINALIS BARK; COLCHICUM AUTUMNALE BULB; CONVALLARIA MAJALIS; CROTALUS HORRIDUS HORRIDUS VENOM; DIGITALIS; JUNIPERUS COMMUNIS FRUIT; LACHESIS MUTA VENOM; MERCURY; NAJA NAJA VENOM; SODIUM CARBONATE; SODIUM SULFATE; TOXICODENDRON PUBESCENS LEAF; SAMBUCUS NIGRA FLOWERING TOP; STROPHANTHUS HISPIDUS SEED; THUJA OCCIDENTALIS LEAFY TWIG; VIPERA BERUS VENOM; ECHINACEA, UNSPECIFIED; ARCTIUM LAPPA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; TARAXACUM OFFICINALE; URTICA URENS</SubstanceName>
<StrengthNumber>30; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 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; [hp_X]/g; [hp_X]/g; [hp_X]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-05</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>55154-2329-0</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 BAG (55154-2329-0) / 1 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>55154-2329-00</NDC11Code>
<ProductNDC>55154-2329</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lisinopril</ProprietaryName>
<NonProprietaryName>Lisinopril</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170307</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077321</ApplicationNumber>
<LabelerName>Cardinal Health 107, LLC</LabelerName>
<SubstanceName>LISINOPRIL</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC], Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170307</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lisinopril tablet USP is an angiotensin converting enzyme (ACE) inhibitor indicated for: 1 Treatment of hypertension in adults and pediatric patients 6 years of age and older (1.1), 2 Adjunct therapy for heart failure (1.2), 3 Treatment of Acute Myocardial Infarction (1.3).</IndicationAndUsage>
<Description>Lisinopril is an oral long-acting angiotensin converting enzyme (ACE) inhibitor. Lisinopril, a synthetic peptide derivative, is chemically described as (S)-1-[N2-(1-carboxy-3-phenylpropyl)-L-lysyl]-L-proline dihydrate. Its empirical formula is C21H31N3O52H2O and its structural formula is. Lisinopril is a white, crystalline powder, with a molecular weight of 441.53. It is soluble in water and sparingly soluble in methanol and practically insoluble in ethanol. Lisinopril tablets USP are supplied as 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg and 40 mg tablets for oral administration. Inactive Ingredients. 2.5 mg tablets - colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, mannitol, pre-gelatinized starch and starch (corn). 5 mg, 10 mg, 20 mg and 30 mg tablets – colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, mannitol, red ferric oxide, pre-gelatinized starch and starch (corn). 40 mg tablets - colloidal silicon dioxide, dibasic calcium phosphate, magnesium stearate, mannitol, yellow ferric oxide, pre-gelatinized starch and starch (corn).</Description>
</NDC>
<NDC>
<NDCCode>70518-2329-0</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE, PLASTIC (70518-2329-0) </PackageDescription>
<NDC11Code>70518-2329-00</NDC11Code>
<ProductNDC>70518-2329</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Valacyclovir Hydrochloride</ProprietaryName>
<NonProprietaryName>Valacyclovir Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190927</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077478</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>VALACYCLOVIR HYDROCHLORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190927</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>55714-2329-1</NDCCode>
<PackageDescription>28.35 g in 1 BOTTLE, GLASS (55714-2329-1)</PackageDescription>
<NDC11Code>55714-2329-01</NDC11Code>
<ProductNDC>55714-2329</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Edema - Fluid Retention</ProprietaryName>
<NonProprietaryName>Elaps Corallinus, Apis Mel., Arsenicum Alb., Cantharis, Cinchona, Colchicum, Convallaria, Crotalus Horridus, Digitalis, Juniperus Com., Lachesis, Merc. Viv., Naja, Nat. Carb., Nat.sulphuricum, Rhus Toxicodendron, Sambucus Nig., Strophanthus Hispidus, Thuja Occ., Vipera Berus, Echinacea, Lappa, Solidago, Taraxacum, Urtica Ur.</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>MICRURUS CORALLINUS VENOM; APIS MELLIFERA; ARSENIC TRIOXIDE; LYTTA VESICATORIA; CINCHONA OFFICINALIS BARK; COLCHICUM AUTUMNALE BULB; CONVALLARIA MAJALIS; CROTALUS HORRIDUS HORRIDUS VENOM; DIGITALIS; JUNIPERUS COMMUNIS FRUIT; LACHESIS MUTA VENOM; MERCURY; NAJA NAJA VENOM; SODIUM CARBONATE; SODIUM SULFATE; TOXICODENDRON PUBESCENS LEAF; SAMBUCUS NIGRA FLOWERING TOP; STROPHANTHUS HISPIDUS SEED; THUJA OCCIDENTALIS LEAFY TWIG; VIPERA BERUS VENOM; ECHINACEA, UNSPECIFIED; ARCTIUM LAPPA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; TARAXACUM OFFICINALE; URTICA URENS</SubstanceName>
<StrengthNumber>30; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 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; [hp_X]/g; [hp_X]/g; [hp_X]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-05</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>55714-2329-2</NDCCode>
<PackageDescription>56.7 g in 1 BOTTLE, GLASS (55714-2329-2)</PackageDescription>
<NDC11Code>55714-2329-02</NDC11Code>
<ProductNDC>55714-2329</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Edema - Fluid Retention</ProprietaryName>
<NonProprietaryName>Elaps Corallinus, Apis Mel., Arsenicum Alb., Cantharis, Cinchona, Colchicum, Convallaria, Crotalus Horridus, Digitalis, Juniperus Com., Lachesis, Merc. Viv., Naja, Nat. Carb., Nat.sulphuricum, Rhus Toxicodendron, Sambucus Nig., Strophanthus Hispidus, Thuja Occ., Vipera Berus, Echinacea, Lappa, Solidago, Taraxacum, Urtica Ur.</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>MICRURUS CORALLINUS VENOM; APIS MELLIFERA; ARSENIC TRIOXIDE; LYTTA VESICATORIA; CINCHONA OFFICINALIS BARK; COLCHICUM AUTUMNALE BULB; CONVALLARIA MAJALIS; CROTALUS HORRIDUS HORRIDUS VENOM; DIGITALIS; JUNIPERUS COMMUNIS FRUIT; LACHESIS MUTA VENOM; MERCURY; NAJA NAJA VENOM; SODIUM CARBONATE; SODIUM SULFATE; TOXICODENDRON PUBESCENS LEAF; SAMBUCUS NIGRA FLOWERING TOP; STROPHANTHUS HISPIDUS SEED; THUJA OCCIDENTALIS LEAFY TWIG; VIPERA BERUS VENOM; ECHINACEA, UNSPECIFIED; ARCTIUM LAPPA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; TARAXACUM OFFICINALE; URTICA URENS</SubstanceName>
<StrengthNumber>30; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 3; 3; 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; [hp_X]/g; [hp_X]/g; [hp_X]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-05</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>22840-2329-2</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (22840-2329-2) </PackageDescription>
<NDC11Code>22840-2329-02</NDC11Code>
<ProductNDC>22840-2329</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Firebush Kochia</ProprietaryName>
<NonProprietaryName>Kochia Scoparia</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19810915</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101833</ApplicationNumber>
<LabelerName>Greer Laboratories, Inc.</LabelerName>
<SubstanceName>BASSIA SCOPARIA POLLEN</SubstanceName>
<StrengthNumber>40000</StrengthNumber>
<StrengthUnit>[PNU]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19810915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Non-Standardized Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergies to one or more of the specific non-standardized allergens., 2 Immunotherapy for the reduction of allergen-induced allergic symptoms confirmed by appropriate positive skin tests or by in vitro testing for allergen-specific IgE antibodies. .</IndicationAndUsage>
<Description>Non-Standardized Allergenic Extracts are sterile solutions used for percutaneous testing, intradermal testing, or subcutaneous immunotherapy. Aqueous extracts contain the soluble extractants of the source material in water for injection, 0.5% sodium chloride, 0.54% sodium bicarbonate, and 0.4% phenol. Glycerinated extracts contain the soluable extractants of the source material in water for injection and 50% glycerin, 0.25% sodium chloride, 0.27% sodium bicarbonate, and 0.2% phenol. The pH of the extracts range from 6 to 9. Certain food extracts (Barley, Oat, Pineapple, Rye, Spinach, and Wheat), labeled “For Diagnostic Use Only”, contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Source materials used in the manufacture of allergenic extracts are collected from natural sources or from laboratory cultures. Non-Standardized Allergenic Extracts appear as clear and colorless to dark brown solutions that should be free of particulate matter. Extracts are labeled either as weight-to-volume based on the weight of the source material to the volume of the extracting fluid, or as PNU/milliliter with one PNU representing 0.00001 mg of protein nitrogen per milliliter.</Description>
</NDC>
<NDC>
<NDCCode>22840-2329-4</NDCCode>
<PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (22840-2329-4) </PackageDescription>
<NDC11Code>22840-2329-04</NDC11Code>
<ProductNDC>22840-2329</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Firebush Kochia</ProprietaryName>
<NonProprietaryName>Kochia Scoparia</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19810915</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101833</ApplicationNumber>
<LabelerName>Greer Laboratories, Inc.</LabelerName>
<SubstanceName>BASSIA SCOPARIA POLLEN</SubstanceName>
<StrengthNumber>40000</StrengthNumber>
<StrengthUnit>[PNU]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19810915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Non-Standardized Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergies to one or more of the specific non-standardized allergens., 2 Immunotherapy for the reduction of allergen-induced allergic symptoms confirmed by appropriate positive skin tests or by in vitro testing for allergen-specific IgE antibodies. .</IndicationAndUsage>
<Description>Non-Standardized Allergenic Extracts are sterile solutions used for percutaneous testing, intradermal testing, or subcutaneous immunotherapy. Aqueous extracts contain the soluble extractants of the source material in water for injection, 0.5% sodium chloride, 0.54% sodium bicarbonate, and 0.4% phenol. Glycerinated extracts contain the soluable extractants of the source material in water for injection and 50% glycerin, 0.25% sodium chloride, 0.27% sodium bicarbonate, and 0.2% phenol. The pH of the extracts range from 6 to 9. Certain food extracts (Barley, Oat, Pineapple, Rye, Spinach, and Wheat), labeled “For Diagnostic Use Only”, contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Source materials used in the manufacture of allergenic extracts are collected from natural sources or from laboratory cultures. Non-Standardized Allergenic Extracts appear as clear and colorless to dark brown solutions that should be free of particulate matter. Extracts are labeled either as weight-to-volume based on the weight of the source material to the volume of the extracting fluid, or as PNU/milliliter with one PNU representing 0.00001 mg of protein nitrogen per milliliter.</Description>
</NDC>
<NDC>
<NDCCode>36987-2329-1</NDCCode>
<PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (36987-2329-1)</PackageDescription>
<NDC11Code>36987-2329-01</NDC11Code>
<ProductNDC>36987-2329</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Johnson Grass</ProprietaryName>
<NonProprietaryName>Johnson Grass</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>SORGHUM HALEPENSE POLLEN</SubstanceName>
<StrengthNumber>10000</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>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>36987-2329-2</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (36987-2329-2)</PackageDescription>
<NDC11Code>36987-2329-02</NDC11Code>
<ProductNDC>36987-2329</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Johnson Grass</ProprietaryName>
<NonProprietaryName>Johnson Grass</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>SORGHUM HALEPENSE POLLEN</SubstanceName>
<StrengthNumber>10000</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>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>36987-2329-3</NDCCode>
<PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (36987-2329-3)</PackageDescription>
<NDC11Code>36987-2329-03</NDC11Code>
<ProductNDC>36987-2329</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Johnson Grass</ProprietaryName>
<NonProprietaryName>Johnson Grass</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>SORGHUM HALEPENSE POLLEN</SubstanceName>
<StrengthNumber>10000</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>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>36987-2329-4</NDCCode>
<PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (36987-2329-4)</PackageDescription>
<NDC11Code>36987-2329-04</NDC11Code>
<ProductNDC>36987-2329</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Johnson Grass</ProprietaryName>
<NonProprietaryName>Johnson Grass</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>SORGHUM HALEPENSE POLLEN</SubstanceName>
<StrengthNumber>10000</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>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>63629-2329-1</NDCCode>
<PackageDescription>60 g in 1 TUBE (63629-2329-1) </PackageDescription>
<NDC11Code>63629-2329-01</NDC11Code>
<ProductNDC>63629-2329</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clobetasol Propionate</ProprietaryName>
<NonProprietaryName>Clobetasol Propionate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180619</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210034</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>CLOBETASOL PROPIONATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210419</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Clobetasol propionate cream is a super-high potency corticosteroid formulation indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Treatment beyond 2 consecutive weeks is not recommended, and the total dosage should not exceed 50 g per week because of the potential for the drug to suppress the hypothalamic-pituitary-adrenal (HPA) axis. Use in pediatric patients under 12 years of age is not recommended. As with other highly active corticosteroids, therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary.</IndicationAndUsage>
<Description>Clobetasol Propionate Cream USP, 0.05% contains the active compound clobetasol propionate, a synthetic corticosteroid, for topical dermatologic use. Clobetasol, an analog of prednisolone, has a high degree of glucocorticoid activity and a slight degree of mineralocorticoid activity. Chemically, clobetasol propionate is (11ß,16ß)-21-chloro-9-fluoro-11-hydroxy-16-methyl-17-(1-oxopropoxy)-pregna-1,4- diene-3,20-dione, and it has the following structural formula. Clobetasol propionate has the molecular formula C25H32CIFO5 and a molecular weight of 467. It is a white to cream-colored crystalline powder insoluble in water. Clobetasol propionate cream contains clobetasol propionate 0.5 mg/g in a cream base composed of cetyl alcohol, citric acid monohydrate, glycol stearate, lanolin liquid, methylparaben, PEG-400 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, stearyl alcohol, and white petrolatum. Sodium hydroxide may be used to adjust pH.</Description>
</NDC>
<NDC>
<NDCCode>67296-2329-8</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (67296-2329-8) / 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>67296-2329-08</NDC11Code>
<ProductNDC>67296-2329</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mono-linyah</ProprietaryName>
<NonProprietaryName>Norgestimate And Ethinyl Estradiol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20120523</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090523</ApplicationNumber>
<LabelerName>Redpharm Drug</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-09-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120523</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Mono-Linyah is a combination of norgestimate, a progestin, and ethinyl estradiol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. ( 1.1).</IndicationAndUsage>
<Description>Mono-Linyah is a combination oral contraceptive containing the progestational compound norgestimate and the estrogenic compound ethinyl estradiol. Norgestimate is designated as (18,19-Dinor-17-pregn-4-en-20-yn-3-one,17-(acetyloxy)-13-ethyl-, oxime,(17α)(+)-) and ethinyl estradiol is designated as (19-nor-17α-pregna,1,3,5(10)-trien-20-yne-3,17-diol). : 1 Each active blue tablet contains 0.250 mg of norgestimate and 0.035 mg of ethinyl estradiol. Inactive ingredients include: FD&C Blue No. 2 Aluminium Lake, FD&C Blue No. 1 Aluminum lake, FD&C Red No. 40 Aluminum Lake, FD&C Yellow No. 10 Aluminum Lake, titanium dioxide, polyvinyl alcohol, talc, macrogol/PEG 3350 NF, lecithin, lactose monohydrate, magnesium stearate and pregelatinized corn starch., 2 Each white placebo tablet containing only inert ingredients, as follows: titanium dioxide, polydextrose, hypromellose, triacetin, macrogol/polyethylene glycol, lactose monohydrate, magnesium stearate and pregelatinized corn starch.</Description>
</NDC>
<NDC>
<NDCCode>71335-2329-1</NDCCode>
<PackageDescription>7 TABLET, FILM COATED in 1 BOTTLE (71335-2329-1) </PackageDescription>
<NDC11Code>71335-2329-01</NDC11Code>
<ProductNDC>71335-2329</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Moxifloxacin Hydrochloride</ProprietaryName>
<NonProprietaryName>Moxifloxacin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140304</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202632</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>MOXIFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241004</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Moxifloxacin tablets are a fluoroquinolone antibacterial indicated for treating infections in adults 18 years of age and older caused by designated susceptible bacteria, in the conditions listed below: : 1 Community Acquired Pneumonia (1.1), 2 Skin and Skin Structure Infections: Uncomplicated (1.2) and Complicated (1.3) , 3 Complicated Intra-Abdominal Infections (1.4) , 4 Plague (1.5), 5 Acute Bacterial Sinusitis (1.6), 6 Acute Bacterial Exacerbation of Chronic Bronchitis (1.7).</IndicationAndUsage>
<Description>Moxifloxacin hydrochloride is a synthetic antibacterial agent for oral administration. Moxifloxacin, a fluoroquinolone, is available as the monohydrochloride salt of 1-cyclopropyl-7-[(S,S)-2,8-diazabicyclo[4.3.0]non-8-yl]-6-fluoro-8-methoxy-1,4-dihydro-4-oxo-3 quinoline carboxylic acid. It is a slightly yellow to yellow powder or crystals, slightly hygroscopic substance with a molecular weight of 437.9. Its molecular formula is C21H24FN3O4*HCl and its chemical structure is as follows.</Description>
</NDC>
<NDC>
<NDCCode>71335-2329-2</NDCCode>
<PackageDescription>10 TABLET, FILM COATED in 1 BOTTLE (71335-2329-2) </PackageDescription>
<NDC11Code>71335-2329-02</NDC11Code>
<ProductNDC>71335-2329</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Moxifloxacin Hydrochloride</ProprietaryName>
<NonProprietaryName>Moxifloxacin Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140304</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202632</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>MOXIFLOXACIN HYDROCHLORIDE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Fluoroquinolone Antibacterial [EPC], Fluoroquinolones [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240103</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Moxifloxacin tablets are a fluoroquinolone antibacterial indicated for treating infections in adults 18 years of age and older caused by designated susceptible bacteria, in the conditions listed below: : 1 Community Acquired Pneumonia (1.1), 2 Skin and Skin Structure Infections: Uncomplicated (1.2) and Complicated (1.3) , 3 Complicated Intra-Abdominal Infections (1.4) , 4 Plague (1.5), 5 Acute Bacterial Sinusitis (1.6), 6 Acute Bacterial Exacerbation of Chronic Bronchitis (1.7).</IndicationAndUsage>
<Description>Moxifloxacin hydrochloride is a synthetic antibacterial agent for oral administration. Moxifloxacin, a fluoroquinolone, is available as the monohydrochloride salt of 1-cyclopropyl-7-[(S,S)-2,8-diazabicyclo[4.3.0]non-8-yl]-6-fluoro-8-methoxy-1,4-dihydro-4-oxo-3 quinoline carboxylic acid. It is a slightly yellow to yellow powder or crystals, slightly hygroscopic substance with a molecular weight of 437.9. Its molecular formula is C21H24FN3O4*HCl and its chemical structure is as follows.</Description>
</NDC>
<NDC>
<NDCCode>72162-2329-2</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (72162-2329-2) / 15 g in 1 TUBE</PackageDescription>
<NDC11Code>72162-2329-02</NDC11Code>
<ProductNDC>72162-2329</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Desonide</ProprietaryName>
<NonProprietaryName>Desonide</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20060822</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA017426</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>DESONIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-02-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240618</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Desonide Ointment, 0.05% is a low potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. It should not be used for longer than two weeks unless directed by a physician.</IndicationAndUsage>
<Description>Desonide Ointment, 0.05% contains desonide (Pregna-1,4-diene-3,20-dione,11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-,(11ß,16α)) a synthetic corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primary synthetic steroids used topically as anti-inflammatory and antipruritic agents. Chemically, desonide, the active ingredient in Desonide Ointment, 0.05% is C24H32O6. It has the following structural formula. The molecular weight of desonide is 416.51. It is a white to off-white powder. The solubility of desonide in distilled water saturated with ether is 184 mg/L. Each gram of Desonide Ointment, 0.05% contains 0.5 milligram of desonide microdispersed in a base of white petrolatum.</Description>
</NDC>
<NDC>
<NDCCode>80830-2329-2</NDCCode>
<PackageDescription>10 POUCH in 1 CARTON (80830-2329-2) / 1 BAG in 1 POUCH / 100 mL in 1 BAG</PackageDescription>
<NDC11Code>80830-2329-02</NDC11Code>
<ProductNDC>80830-2329</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tranexamic Acid In Sodium Chloride</ProprietaryName>
<NonProprietaryName>Tranexamic Acid</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20231023</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217155</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals Private Limited</LabelerName>
<SubstanceName>TRANEXAMIC ACID</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231023</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tranexamic acid in 0.7% sodium chloride injection is indicated in patients with hemophilia for short-term use (two to eight days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.</IndicationAndUsage>
<Description>Tranexamic acid, USP is trans-4-(aminomethyl)cyclohexanecarboxylic acid, an antifibrinolytic agent. Tranexamic acid, USP is a white, crystalline powder. The structural formula is. Molecular Formula: C8H15NO2 Molecular Weight: 157.21 g/mol. Tranexamic Acid in 0.7% Sodium Chloride Injection, 1,000 mg per 100 mL (10 mg per mL) is a sterile, clear, colorless, nonpyrogenic injectable solution for intravenous administration. Each IV bag contains: 1,000 mg of tranexamic acid, USP; 700 mg of sodium chloride, USP and water for injection, USP. The aqueous solution has a pH of 6.5 to 8.0.</Description>
</NDC>
<NDC>
<NDCCode>80830-2329-3</NDCCode>
<PackageDescription>12 POUCH in 1 CARTON (80830-2329-3) / 1 BAG in 1 POUCH / 100 mL in 1 BAG</PackageDescription>
<NDC11Code>80830-2329-03</NDC11Code>
<ProductNDC>80830-2329</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tranexamic Acid In Sodium Chloride</ProprietaryName>
<NonProprietaryName>Tranexamic Acid</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20231023</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217155</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals Private Limited</LabelerName>
<SubstanceName>TRANEXAMIC ACID</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-05-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240108</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tranexamic acid in 0.7% sodium chloride injection is indicated in patients with hemophilia for short-term use (two to eight days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.</IndicationAndUsage>
<Description>Tranexamic acid, USP is trans-4-(aminomethyl)cyclohexanecarboxylic acid, an antifibrinolytic agent. Tranexamic acid, USP is a white, crystalline powder. The structural formula is. Molecular Formula: C8H15NO2 Molecular Weight: 157.21 g/mol. Tranexamic Acid in 0.7% Sodium Chloride Injection, 1,000 mg per 100 mL (10 mg per mL) is a sterile, clear, colorless, nonpyrogenic injectable solution for intravenous administration. Each IV bag contains: 1,000 mg of tranexamic acid, USP; 700 mg of sodium chloride, USP and water for injection, USP. The aqueous solution has a pH of 6.5 to 8.0.</Description>
</NDC>
<NDC>
<NDCCode>80830-2329-4</NDCCode>
<PackageDescription>10 POUCH in 1 CARTON (80830-2329-4) / 1 BAG in 1 POUCH (80830-2329-5) / 100 mL in 1 BAG</PackageDescription>
<NDC11Code>80830-2329-04</NDC11Code>
<ProductNDC>80830-2329</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tranexamic Acid In Sodium Chloride</ProprietaryName>
<NonProprietaryName>Tranexamic Acid</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20250709</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA217155</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals Private Limited</LabelerName>
<SubstanceName>TRANEXAMIC ACID</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Antifibrinolytic Agent [EPC], Decreased Fibrinolysis [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250709</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Tranexamic acid in 0.7% sodium chloride injection is indicated in patients with hemophilia for short-term use (two to eight days) to reduce or prevent hemorrhage and reduce the need for replacement therapy during and following tooth extraction.</IndicationAndUsage>
<Description>Tranexamic acid, USP is trans-4-(aminomethyl)cyclohexanecarboxylic acid, an antifibrinolytic agent. Tranexamic acid, USP is a white, crystalline powder. The structural formula is. Molecular Formula: C8H15NO2 Molecular Weight: 157.21 g/mol. Tranexamic Acid in 0.7% Sodium Chloride Injection, 1,000 mg per 100 mL (10 mg per mL) is a sterile, clear, colorless, nonpyrogenic injectable solution for intravenous administration. Each IV bag contains: 1,000 mg of tranexamic acid, USP; 700 mg of sodium chloride, USP and water for injection, USP. The aqueous solution has a pH of 6.5 to 8.0.</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>
</NDCList>
<NDCList><NDC><NDCCode>55714-2329-0</NDCCode><ProprietaryName>Edema - Fluid Retention</ProprietaryName><NonProprietaryName>Elaps Corallinus, Apis Mel., Arsenicum Alb., Cantharis, Cinchona, Colchicum, Convallaria, Crotalus Horridus, Digitalis, Juniperus Com., Lachesis, Merc. Viv., Naja, Nat. Carb., Nat.sulphuricum, Rhus Toxicodendron, Sambucus Nig., Strophanthus Hispidus, Thuja Occ., Vipera Berus, Echinacea, Lappa, Solidago, Taraxacum, Urtica Ur.</NonProprietaryName></NDC><NDC><NDCCode>55154-2329-0</NDCCode><ProprietaryName>Lisinopril</ProprietaryName><NonProprietaryName>Lisinopril</NonProprietaryName></NDC><NDC><NDCCode>70518-2329-0</NDCCode><ProprietaryName>Valacyclovir Hydrochloride</ProprietaryName><NonProprietaryName>Valacyclovir Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>55714-2329-1</NDCCode><ProprietaryName>Edema - Fluid Retention</ProprietaryName><NonProprietaryName>Elaps Corallinus, Apis Mel., Arsenicum Alb., Cantharis, Cinchona, Colchicum, Convallaria, Crotalus Horridus, Digitalis, Juniperus Com., Lachesis, Merc. Viv., Naja, Nat. Carb., Nat.sulphuricum, Rhus Toxicodendron, Sambucus Nig., Strophanthus Hispidus, Thuja Occ., Vipera Berus, Echinacea, Lappa, Solidago, Taraxacum, Urtica Ur.</NonProprietaryName></NDC><NDC><NDCCode>55714-2329-2</NDCCode><ProprietaryName>Edema - Fluid Retention</ProprietaryName><NonProprietaryName>Elaps Corallinus, Apis Mel., Arsenicum Alb., Cantharis, Cinchona, Colchicum, Convallaria, Crotalus Horridus, Digitalis, Juniperus Com., Lachesis, Merc. Viv., Naja, Nat. Carb., Nat.sulphuricum, Rhus Toxicodendron, Sambucus Nig., Strophanthus Hispidus, Thuja Occ., Vipera Berus, Echinacea, Lappa, Solidago, Taraxacum, Urtica Ur.</NonProprietaryName></NDC><NDC><NDCCode>22840-2329-2</NDCCode><ProprietaryName>Firebush Kochia</ProprietaryName><NonProprietaryName>Kochia Scoparia</NonProprietaryName></NDC><NDC><NDCCode>22840-2329-4</NDCCode><ProprietaryName>Firebush Kochia</ProprietaryName><NonProprietaryName>Kochia Scoparia</NonProprietaryName></NDC><NDC><NDCCode>36987-2329-1</NDCCode><ProprietaryName>Johnson Grass</ProprietaryName><NonProprietaryName>Johnson Grass</NonProprietaryName></NDC><NDC><NDCCode>36987-2329-2</NDCCode><ProprietaryName>Johnson Grass</ProprietaryName><NonProprietaryName>Johnson Grass</NonProprietaryName></NDC><NDC><NDCCode>36987-2329-3</NDCCode><ProprietaryName>Johnson Grass</ProprietaryName><NonProprietaryName>Johnson Grass</NonProprietaryName></NDC><NDC><NDCCode>36987-2329-4</NDCCode><ProprietaryName>Johnson Grass</ProprietaryName><NonProprietaryName>Johnson Grass</NonProprietaryName></NDC><NDC><NDCCode>63629-2329-1</NDCCode><ProprietaryName>Clobetasol Propionate</ProprietaryName><NonProprietaryName>Clobetasol Propionate</NonProprietaryName></NDC><NDC><NDCCode>67296-2329-8</NDCCode><ProprietaryName>Mono-linyah</ProprietaryName><NonProprietaryName>Norgestimate And Ethinyl Estradiol</NonProprietaryName></NDC><NDC><NDCCode>71335-2329-1</NDCCode><ProprietaryName>Moxifloxacin Hydrochloride</ProprietaryName><NonProprietaryName>Moxifloxacin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>71335-2329-2</NDCCode><ProprietaryName>Moxifloxacin Hydrochloride</ProprietaryName><NonProprietaryName>Moxifloxacin Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>72162-2329-2</NDCCode><ProprietaryName>Desonide</ProprietaryName><NonProprietaryName>Desonide</NonProprietaryName></NDC><NDC><NDCCode>80830-2329-2</NDCCode><ProprietaryName>Tranexamic Acid In Sodium Chloride</ProprietaryName><NonProprietaryName>Tranexamic Acid</NonProprietaryName></NDC><NDC><NDCCode>80830-2329-3</NDCCode><ProprietaryName>Tranexamic Acid In Sodium Chloride</ProprietaryName><NonProprietaryName>Tranexamic Acid</NonProprietaryName></NDC><NDC><NDCCode>80830-2329-4</NDCCode><ProprietaryName>Tranexamic Acid In Sodium Chloride</ProprietaryName><NonProprietaryName>Tranexamic Acid</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></NDCList>