{
"NDC": [
{
"NDCCode": "43406-0595-4",
"PackageDescription": "120 mL in 1 BOTTLE, PLASTIC (43406-0595-4) ",
"NDC11Code": "43406-0595-04",
"ProductNDC": "43406-0595",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tiny Tot Cough Syrup",
"NonProprietaryName": "Squilla, Antimonium Tart, Arsenicum Alb, Belladonna, Bryonia, Chamomilla, Cuprum Met, Drosera, Hepar Sulph Calc, Ipecacuanha, Kali Bic, Kali Carb, Phosphorus, Pulsatilla, Spongia",
"DosageFormName": "SYRUP",
"RouteName": "ORAL",
"StartMarketingDate": "20151111",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Natural Creations, Inc",
"SubstanceName": "DRIMIA MARITIMA BULB; ANTIMONY POTASSIUM TARTRATE; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; MATRICARIA CHAMOMILLA WHOLE; COPPER; DROSERA ROTUNDIFOLIA WHOLE; CALCIUM SULFIDE; IPECAC; POTASSIUM DICHROMATE; POTASSIUM CARBONATE; PHOSPHORUS; PULSATILLA VULGARIS WHOLE; SPONGIA OFFICINALIS SKELETON, ROASTED",
"StrengthNumber": "8; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30",
"StrengthUnit": "[hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL",
"Pharm_Classes": "Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Inhibit Ovum Fertilization [PE]",
"Status": "Active",
"LastUpdate": "2025-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151111",
"SamplePackage": "N",
"IndicationAndUsage": "USES: Temporarily relieves cough (dry cough, tickling cough, hacking cough).**."
},
{
"NDCCode": "43406-0664-4",
"PackageDescription": "120 mL in 1 BOTTLE, PLASTIC (43406-0664-4) ",
"NDC11Code": "43406-0664-04",
"ProductNDC": "43406-0664",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cough Syrup",
"NonProprietaryName": "Camphor (natural), Arsenic Trioxide, Bryonia Alba Root, Drosera Rotundifolia, Ipecac, Potassium Carbonate, Phosphorus, Anemone Pulsatilla, Spongia Officinalis Skeleton, Roasted, Drimia Maritima Whole",
"DosageFormName": "SYRUP",
"RouteName": "ORAL",
"StartMarketingDate": "20070507",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Natural Creations, Inc.",
"SubstanceName": "CAMPHOR (NATURAL); ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; DROSERA ROTUNDIFOLIA; IPECAC; POTASSIUM CARBONATE; PHOSPHORUS; ANEMONE PULSATILLA; SPONGIA OFFICINALIS SKELETON, ROASTED; DRIMIA MARITIMA WHOLE",
"StrengthNumber": "30; 30; 30; 30; 30; 30; 30; 30; 30; 30",
"StrengthUnit": "[hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL",
"Status": "Active",
"LastUpdate": "2023-01-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20070507",
"SamplePackage": "N",
"IndicationAndUsage": "USES: Temporarily relieves dry cough, dry barking cough, dry, hacking, painful cough, incessant coughing, dry rattling cough, congestion and tightness of chest, shortness of breath, and/or other symptoms related to coughing.**."
},
{
"NDCCode": "11822-0595-4",
"PackageDescription": "1 BOTTLE in 1 CARTON (11822-0595-4) / 118 mL in 1 BOTTLE",
"NDC11Code": "11822-0595-04",
"ProductNDC": "11822-0595",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Childrens Fever Reducer And Pain Reliever",
"NonProprietaryName": "Acetaminophen",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL",
"StartMarketingDate": "19970923",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Rite Aid Corporation",
"SubstanceName": "ACETAMINOPHEN",
"StrengthNumber": "160",
"StrengthUnit": "mg/5mL",
"Status": "Active",
"LastUpdate": "2024-10-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19970923",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily: 1 reduces fever , 2 relieves minor aches and pains due to:, 3 the common cold, 4 flu, 5 headache, 6 sore throat, 7 toothache."
},
{
"NDCCode": "12658-0595-1",
"PackageDescription": "4 kg in 1 DRUM (12658-0595-1) ",
"NDC11Code": "12658-0595-01",
"ProductNDC": "12658-0595",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Carvedilol Phosphate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20061020",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Pharmaceutical Works POLPHARMA",
"SubstanceName": "CARVEDILOL PHOSPHATE",
"StrengthNumber": "4",
"StrengthUnit": "kg/4kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20-OCT-06"
},
{
"NDCCode": "15631-0595-1",
"PackageDescription": "4 TABLET in 1 BLISTER PACK (15631-0595-1)",
"NDC11Code": "15631-0595-01",
"ProductNDC": "15631-0595",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Guaiacum",
"NonProprietaryName": "Guaiacum",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160107",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
"SubstanceName": "GUAIACUM OFFICINALE RESIN",
"StrengthNumber": "1",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Condition listed above or as directed by the physician."
},
{
"NDCCode": "15631-0595-4",
"PackageDescription": "250 TABLET in 1 CONTAINER (15631-0595-4)",
"NDC11Code": "15631-0595-04",
"ProductNDC": "15631-0595",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Guaiacum",
"NonProprietaryName": "Guaiacum",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160107",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
"SubstanceName": "GUAIACUM OFFICINALE RESIN",
"StrengthNumber": "1",
"StrengthUnit": "[hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Condition listed above or as directed by the physician."
},
{
"NDCCode": "17856-0595-4",
"PackageDescription": "1 CASE in 1 CUP, UNIT-DOSE (17856-0595-4) / 50 CUP in 1 CASE (17856-0595-3) / 30 mL in 1 CUP",
"NDC11Code": "17856-0595-04",
"ProductNDC": "17856-0595",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Citrate And Citric Acid",
"NonProprietaryName": "Sodium Citrate And Citric Acid Monohydrate",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "19690101",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Atlantic Biologicals Corp.",
"SubstanceName": "ANHYDROUS CITRIC ACID; SODIUM CITRATE",
"StrengthNumber": "334; 500",
"StrengthUnit": "mg/5mL; mg/5mL",
"Pharm_Classes": "Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]",
"Status": "Deprecated",
"LastUpdate": "2026-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240418",
"SamplePackage": "N",
"IndicationAndUsage": "Sodium Citrate and Citric Acid Oral Solution USP is an effective alkalinizing agent. It is useful in those conditions where long-term maintenance of an alkaline urine is desirable, and is of value in the alleviation of chronic metabolic acidosis, such as results from chronic renal insufficiency or the syndrome of renal tubular acidosis, especially when the administration of potassium salts is undesirable or contraindicated. This product is also useful for buffering and neutralizing gastric hydrochloric acid quickly and effectively. Sodium Citrate and Citric Acid Oral Solution USP is concentrated, and when administered after meals and before bedtime, allows one to maintain an alkaline urinary pH around the clock, usually without the necessity of a 2 A.M. dose. This product alkalinizes the urine without producing a systemic alkalosis in the recommended dosage. This product is highly palatable, pleasant tasting, and tolerable, even when administered for long periods.",
"Description": "Sodium Citrate and Citric Acid Oral Solution USP is a stable and pleasant-tasting systemic alkalizer containing sodium citrate and citric acid in a sugar-free base. It is a nonparticulate neutralizing buffer. Sodium Citrate and Citric Acid Oral Solution USP contains in each teaspoonful (5 mL). SODIUM CITRATE Dihydrate 500 mg (0.34 Molar) CITRIC ACID Monohydrate 334 mg (0.32 Molar). Each mL contains 1 mEq sodium ion and is equivalent to 1 mEq bicarbonate (HCO3). INACTIVE INGREDIENTS: Flavoring, polyethylene glycol, propylene glycol, purified water, sodium benzoate, and sorbitol solution."
},
{
"NDCCode": "49288-0595-4",
"PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (49288-0595-4)",
"NDC11Code": "49288-0595-04",
"ProductNDC": "49288-0595",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Whole Wheat",
"NonProprietaryName": "Whole Wheat",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19740323",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102223",
"LabelerName": "Antigen Laboratories, Inc.",
"SubstanceName": "WHEAT",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Grain Proteins [EXT]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.",
"Description": "Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label."
},
{
"NDCCode": "71335-0595-4",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (71335-0595-4) ",
"NDC11Code": "71335-0595-04",
"ProductNDC": "71335-0595",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bisoprolol Fumarate And Hydrochlorothiazide",
"NonProprietaryName": "Bisoprolol Fumarate And Hydrochlorothiazide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20101012",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA079106",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "HYDROCHLOROTHIAZIDE; BISOPROLOL FUMARATE",
"StrengthNumber": "6.25; 5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS], beta-Adrenergic Blocker [EPC]",
"Status": "Active",
"LastUpdate": "2024-05-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230719",
"SamplePackage": "N",
"IndicationAndUsage": "Bisoprolol fumarate and hydrochlorothiazide tablets are indicated in the management of hypertension.",
"Description": "Bisoprolol fumarate and hydrochlorothiazide tablets USP are indicated for the treatment of hypertension. It combines two antihypertensive agents in a once–daily dosage: a synthetic beta1-selective (cardioselective) adrenoceptor blocking agent (bisoprolol fumarate) and a benzothiadiazine diuretic (hydrochlorothiazide). Bisoprolol fumarate is chemically described as (±)-1-[4-[[2-(1-methylethoxy)ethoxy]methyl] phenoxy]-3-[(1-methylethyl)amino]-2-propanol(E)-2-butenedioate(2:1)(salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its molecular formula is (C18H31NO4)2C4H4O4 and it has a molecular weight of 766.97. Its structural formula is. Bisoprolol fumarate is a white crystalline powder, approximately equally hydrophilic and lipophilic, and readily soluble in water, methanol, ethanol, and chloroform. Hydrochlorothiazide (HCTZ) is 6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. It is a white, or practically white, practically odorless crystalline powder. It is slightly soluble in water, sparingly soluble in dilute sodium hydroxide solution, freely soluble in n-butylamine and dimethylformamide, sparingly soluble in methanol, and insoluble in ether, chloroform, and dilute mineral acids. Its molecular formula is C7H8ClN3O4S2 and it has a molecular weight of 297.73. Its structural formula is. Each Bisoprolol Fumarate and Hydrochlorothiazide tablet USP 2.5 mg/6.25 mg for oral administration contains. Bisoprolol fumarate USP….. 2.5 mg. Hydrochlorothiazide USP…. 6.25 mg. Each Bisoprolol Fumarate and Hydrochlorothiazide tablet USP 5 mg/6.25 mg for oral administration contains. Bisoprolol fumarate USP….. 5 mg. Hydrochlorothiazide USP…. 6.25 mg. Each Bisoprolol Fumarate and Hydrochlorothiazide tablet USP 10 mg/6.25 mg for oral administration contains. Bisoprolol fumarate USP….. 10 mg. Hydrochlorothiazide USP…. 6.25 mg. Inactive ingredients include pregelatinized starch, dibasic calcium phosphate anhydrous, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, colloidal silicon dioxide, copovidone and titanium dioxide. The 5 mg/6.25 mg tablet also contains red and yellow iron oxide. The 2.5 mg/6.25 mg tablet also contains yellow iron oxide."
},
{
"NDCCode": "80425-0595-4",
"PackageDescription": "120 CAPSULE in 1 BOTTLE (80425-0595-4) ",
"NDC11Code": "80425-0595-04",
"ProductNDC": "80425-0595",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Gabapentin",
"NonProprietaryName": "Gabapentin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20260911",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA214956",
"LabelerName": "Advanced Rx of Tennessee, LLC",
"SubstanceName": "GABAPENTIN",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
"Status": "Active",
"LastUpdate": "2026-09-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260911",
"SamplePackage": "N",
"IndicationAndUsage": "Gabapentin capsules are indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.",
"Description": "The active ingredient in gabapentin capsules is gabapentin, USP which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C 9H 17NO 2and the molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin, USP is a white to off-white crystalline solid with a pK a1of 3.7 and a pK a2of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Each gabapentin capsule contains 100 mg, 300 mg, or 400 mg of gabapentin, USP and the following inactive ingredients: mannitol, pre-gelatinized starch and talc. The 100 mg capsule shell contains titanium dioxide, gelatin and sodium lauryl sulfate. The 300 mg and 400 mg capsule shell contains FD&C Red 40, D&C Yellow 10, titanium dioxide, gelatin and sodium lauryl sulfate. The ink ingredients common for all strengths are shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide and potassium hydroxide."
},
{
"NDCCode": "43406-0610-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (43406-0610-1) ",
"NDC11Code": "43406-0610-01",
"ProductNDC": "43406-0610",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Constipation",
"NonProprietaryName": "Magnesium Carbonate, Magnesium Chloride, Horse Chestnut, Potassium Alum, Aluminum Oxide, Bryonia Alba Root, Strychnos Nux-vomica Seed, Silicon Dioxide",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20170901",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Natural Creations, Inc.",
"SubstanceName": "MAGNESIUM CARBONATE; MAGNESIUM CHLORIDE; HORSE CHESTNUT; POTASSIUM ALUM; ALUMINUM OXIDE; BRYONIA ALBA ROOT; STRYCHNOS NUX-VOMICA SEED; SILICON DIOXIDE",
"StrengthNumber": "4; 4; 12; 12; 12; 12; 12; 12",
"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",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20170901",
"SamplePackage": "N",
"IndicationAndUsage": "USES: Temporarily relieves great straining, large, dry, hard, knotty stools, &/or other symptoms of constipation.**."
},
{
"NDCCode": "43406-0669-2",
"PackageDescription": "60 mL in 1 BOTTLE, SPRAY (43406-0669-2) ",
"NDC11Code": "43406-0669-02",
"ProductNDC": "43406-0669",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Throat",
"NonProprietaryName": "Baptisia, Phytolacca, Hydrastis, Apis Mel, Arg Nit, Belladonna, Hepar Sulph Calc, Kali Bic, Lac Can, Lachesis, Merc Solub",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20180403",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Natural Creations, Inc",
"SubstanceName": "BAPTISIA TINCTORIA WHOLE; PHYTOLACCA AMERICANA ROOT; GOLDENSEAL; APIS MELLIFERA; SILVER NITRATE; ATROPA BELLADONNA; CALCIUM SULFIDE; POTASSIUM DICHROMATE; CANIS LUPUS FAMILIARIS MILK; LACHESIS MUTA VENOM; MERCURIUS SOLUBILIS",
"StrengthNumber": "4; 4; 6; 12; 12; 12; 12; 12; 12; 12; 12",
"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",
"Pharm_Classes": "Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2023-01-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180403",
"SamplePackage": "N",
"IndicationAndUsage": "USES: Temporarily relieves sore, raw, rough-feeling, tickling cough, hoarseness, &/or other symptoms due to a sore throat.**."
},
{
"NDCCode": "43406-0672-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (43406-0672-1) ",
"NDC11Code": "43406-0672-01",
"ProductNDC": "43406-0672",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Candida Hp",
"NonProprietaryName": "Baptisia Tinctoria Root, Echinacea Purpurea, Glycyrrhiza Glabra, Astragalus Nuttallii Leaf, Candida Albicans, Sodium Borate, Oyster Shell Calcium Carbonate, Crude, Wood Creosote, Lycopodium Clavatum Spore, Strychnos Nux-vomica Seed, Phosphoric Acid, Anemone Pulsatilla, Sepia Officinalis Juice, Thuja Occidentalis Leafy Twig, Sodium Phosphate, Dibasic, Heptahydrate, Nitric Acid",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20180101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Natural Creations, Inc.",
"SubstanceName": "BAPTISIA TINCTORIA ROOT; ECHINACEA PURPUREA; GLYCYRRHIZA GLABRA; ASTRAGALUS NUTTALLII LEAF; SODIUM BORATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; WOOD CREOSOTE; LYCOPODIUM CLAVATUM SPORE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; THUJA OCCIDENTALIS LEAFY TWIG; CANDIDA ALBICANS",
"StrengthNumber": "4; 4; 4; 6; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 200",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS]",
"Status": "Active",
"LastUpdate": "2025-11-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180101",
"SamplePackage": "N",
"IndicationAndUsage": "USES: Temporarily relieves symptoms associated with vaginal yeast infection.**."
},
{
"NDCCode": "43406-0678-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (43406-0678-1) ",
"NDC11Code": "43406-0678-01",
"ProductNDC": "43406-0678",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Digestion",
"NonProprietaryName": "Gentiana Lut, Sambucus Nig, Arsenicum Alb, Bismuth Sub, Carbo Veg, Kali Bic, Lycopodium, Nux Vom, Phosphorus, Pulsatilla",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20180502",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Natural Creations, Inc",
"SubstanceName": "GENTIANA LUTEA ROOT; SAMBUCUS NIGRA FLOWERING TOP; ARSENIC TRIOXIDE; BISMUTH SUBNITRATE; ACTIVATED CHARCOAL; POTASSIUM DICHROMATE; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS WHOLE",
"StrengthNumber": "4; 4; 12; 12; 12; 12; 12; 12; 12; 12",
"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",
"Pharm_Classes": "Allergens [CS], Bismuth [CS], Bismuth [EPC], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180502",
"SamplePackage": "N",
"IndicationAndUsage": "USES: Temporarily relieves distention, belching, pressure, flatulence, burning sensation, &/or other symptoms related to weak digestion.**."
},
{
"NDCCode": "43406-0679-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (43406-0679-1) ",
"NDC11Code": "43406-0679-01",
"ProductNDC": "43406-0679",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Vermasode",
"NonProprietaryName": "Artemisia Vulgaris, Chelidonium Majus, Granatum, Spigelia Anthelmia, Ratanhia, Arsenicum Album, Ferrum Metallicum, Calcarea Carbonica, Cina, Gaertner Bacillus, Graphites, Mercurius Dulcis, Natrum Muriaticum, Natrum Phosphoricum, Vermin Nosode",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20180613",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Natural Creations, Inc",
"SubstanceName": "ARTEMISIA VULGARIS ROOT; CHELIDONIUM MAJUS WHOLE; PUNICA GRANATUM ROOT BARK; SPIGELIA ANTHELMIA WHOLE; KRAMERIA LAPPACEA ROOT; ARSENIC TRIOXIDE; IRON; OYSTER SHELL CALCIUM CARBONATE, CRUDE; ARTEMISIA CINA PRE-FLOWERING TOP; SALMONELLA ENTERICA ENTERICA SEROVAR ENTERITIDIS; GRAPHITE; CALOMEL; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE",
"StrengthNumber": "4; 4; 4; 4; 4; 6; 9; 12; 12; 12; 12; 12; 12; 12",
"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",
"Status": "Active",
"LastUpdate": "2025-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180613",
"SamplePackage": "N",
"IndicationAndUsage": "USES: Temporarily relieves symptoms caused by pinworm infestation.**."
},
{
"NDCCode": "43406-0680-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (43406-0680-1) ",
"NDC11Code": "43406-0680-01",
"ProductNDC": "43406-0680",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mood",
"NonProprietaryName": "Aralia Quin, Cimicifuga, Spigelia Anth, Arg Nit, Arsenicum Alb, Aurum Met, Ignatia Amara, Lachesis, Lycopodium, Nat Mur, Phosphoricum Ac, Platinum Met, Pulsatilla, Sepia, Thuja Occ",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20180613",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Natural Creations, Inc",
"SubstanceName": "AMERICAN GINSENG; BLACK COHOSH; SPIGELIA ANTHELMIA WHOLE; SILVER NITRATE; ARSENIC TRIOXIDE; GOLD; STRYCHNOS IGNATII SEED; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; PHOSPHORIC ACID; PLATINUM; PULSATILLA VULGARIS WHOLE; SEPIA OFFICINALIS JUICE; THUJA OCCIDENTALIS LEAFY TWIG",
"StrengthNumber": "4; 4; 4; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12",
"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",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180613",
"SamplePackage": "N",
"IndicationAndUsage": "USES: Temporarily relieves feelings of minor moodiness and melancholy.**."
},
{
"NDCCode": "43406-0686-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (43406-0686-1) ",
"NDC11Code": "43406-0686-01",
"ProductNDC": "43406-0686",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Panacode",
"NonProprietaryName": "Syzygium, Hydrastis, Adrenalinum, Pancreatinum, Pituitarum Posterium, Bovista, Insulin, Lycopersicum, Phosphoricum Ac, Phosphorus, Tarentula Hispana, Terebinthina, Uranium Nitricum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20200211",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Natural Creations, Inc",
"SubstanceName": "SYZYGIUM CUMINI SEED; GOLDENSEAL; EPINEPHRINE; PANCRELIPASE; SUS SCROFA PITUITARY GLAND, POSTERIOR; LYCOPERDON UTRIFORME FRUITING BODY; INSULIN PORK; SOLANUM LYCOPERSICUM WHOLE; PHOSPHORIC ACID; PHOSPHORUS; LYCOSA TARANTULA; TURPENTINE OIL; URANYL NITRATE HEXAHYDRATE",
"StrengthNumber": "4; 6; 9; 9; 9; 12; 12; 12; 12; 12; 12; 12; 12",
"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",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Catecholamine [EPC], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200211",
"SamplePackage": "N",
"IndicationAndUsage": "USES: Helps promote a healthy digestive tract.**."
},
{
"NDCCode": "43406-0688-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (43406-0688-1) ",
"NDC11Code": "43406-0688-01",
"ProductNDC": "43406-0688",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cold",
"NonProprietaryName": "Baptisia Tinctoria, Echinacea Angustifolia, Eupatorium Perfoliatum, Lomatium Dissectum, Pueraria Lobata, Trifolium Pratense, Phytolacca Decandra, Allium Cepa, Arsenicum Iodatum, Baryta Carbonica, Bromium, Calcarea Carbonica, Kali Muriaticum, Lachesis Mutus, Mercurius Solubilis, Silicea",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20190207",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Natural Creations, Inc",
"SubstanceName": "BAPTISIA TINCTORIA WHOLE; ECHINACEA ANGUSTIFOLIA WHOLE; EUPATORIUM PERFOLIATUM FLOWERING TOP; LOMATIUM DISSECTUM ROOT; PUERARIA MONTANA VAR. LOBATA WHOLE; TRIFOLIUM PRATENSE FLOWER; PHYTOLACCA AMERICANA ROOT; ONION; ARSENIC TRIIODIDE; BARIUM CARBONATE; BROMINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM CHLORIDE; LACHESIS MUTA VENOM; MERCURIUS SOLUBILIS; SILICON DIOXIDE",
"StrengthNumber": "4; 4; 4; 4; 4; 4; 6; 12; 12; 12; 12; 12; 12; 12; 12; 12",
"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",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Non-Standardized Food Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Vegetable Proteins [CS]",
"Status": "Active",
"LastUpdate": "2025-11-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190207",
"SamplePackage": "N",
"IndicationAndUsage": "USES: Temporarily relieves symptoms associated with the common cold.**."
},
{
"NDCCode": "43406-0690-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (43406-0690-1) ",
"NDC11Code": "43406-0690-01",
"ProductNDC": "43406-0690",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Gastrozen",
"NonProprietaryName": "Coffea Tosta, Glycyrrhiza, Phytolacca, Taraxacum, Hydrastis, Arsenicum Alb, Gelsemium, Merc Solub, Nitricum Ac, Nux Vom, Petroleum, Phosphoricum Ac, Phosphorus, Bromium, Cadmium Sulphuricum, Cinchona, Conium, Hydrogen, Iodium, Lachesis, Pulsatilla, Silicea, Sulphuricum Ac",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20180613",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Natural Creations, Inc",
"SubstanceName": "COFFEA ARABICA SEED, ROASTED; GLYCYRRHIZA GLABRA; PHYTOLACCA AMERICANA ROOT; TARAXACUM OFFICINALE; GOLDENSEAL; ARSENIC TRIOXIDE; GELSEMIUM SEMPERVIRENS ROOT; MERCURIUS SOLUBILIS; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; KEROSENE; PHOSPHORIC ACID; PHOSPHORUS; BROMINE; CADMIUM SULFATE; CINCHONA OFFICINALIS BARK; CONIUM MACULATUM FLOWERING TOP; HYDROGEN; IODINE; LACHESIS MUTA VENOM; PULSATILLA VULGARIS WHOLE; SILICON DIOXIDE; SULFURIC ACID",
"StrengthNumber": "4; 4; 4; 4; 6; 12; 12; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30; 30; 30; 30; 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_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS]",
"Status": "Active",
"LastUpdate": "2023-01-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180613",
"SamplePackage": "N",
"IndicationAndUsage": "USES: Temporarily relieves minor abdominal cramps and bloating.**."
},
{
"NDCCode": "43406-0691-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (43406-0691-1) ",
"NDC11Code": "43406-0691-01",
"ProductNDC": "43406-0691",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hives",
"NonProprietaryName": "Echinacea Ang, Apis Mel, Arsenicum Alb, Carbolicum Ac, Ledum, Rhus Tox, Sulphur, Urtica Urens",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20180613",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Natural Creations, Inc",
"SubstanceName": "ECHINACEA ANGUSTIFOLIA WHOLE; APIS MELLIFERA; ARSENIC TRIOXIDE; PHENOL; RHODODENDRON TOMENTOSUM LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF; SULFUR; URTICA URENS WHOLE",
"StrengthNumber": "4; 12; 12; 12; 12; 12; 12; 12",
"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",
"Pharm_Classes": "Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180613",
"SamplePackage": "N",
"IndicationAndUsage": "USES: Temporarily relieves itching, burning, rosy or red skin.**."
},
{
"NDCCode": "43406-0693-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (43406-0693-1) ",
"NDC11Code": "43406-0693-01",
"ProductNDC": "43406-0693",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nasal Decongestant",
"NonProprietaryName": "Camellia Sinensis, Ephedra Vulgaris, Belladonna, Arsenicum Album, Cinnabaris, Kali Bichromicum, Pulsatilla, Sepia, Calcarea Carbonica, Mercurius Solubilis, Sulphur",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20180613",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Natural Creations, Inc",
"SubstanceName": "CAMELLIA SINENSIS WHOLE; EPHEDRA DISTACHYA FLOWERING TWIG; ATROPA BELLADONNA; ARSENIC TRIOXIDE; MERCURIC SULFIDE; POTASSIUM DICHROMATE; PULSATILLA VULGARIS WHOLE; SEPIA OFFICINALIS JUICE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; MERCURIUS SOLUBILIS; SULFUR",
"StrengthNumber": "4; 4; 4; 12; 12; 12; 12; 12; 30; 30; 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",
"Status": "Active",
"LastUpdate": "2023-01-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20180613",
"SamplePackage": "N",
"IndicationAndUsage": "USES: Temporary relief of nasal congestion.**."
},
{
"NDCCode": "43406-0707-5",
"PackageDescription": "56.7 g in 1 TUBE (43406-0707-5) ",
"NDC11Code": "43406-0707-05",
"ProductNDC": "43406-0707",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Injure Gel",
"NonProprietaryName": "Arnica Montana, Calendula Officinalis, Hypericum Perf, Symphytum Off, Bellis Per, Ledum Palustre, Sulphuricum Ac, Calc Fluor, Ferrum Phos, Rhus Tox, Nat Sulphuricum",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190821",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Natural Creations, Inc",
"SubstanceName": "CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; BELLIS PERENNIS WHOLE; RHODODENDRON TOMENTOSUM LEAFY TWIG; SULFURIC ACID; CALCIUM FLUORIDE; FERROSOFERRIC PHOSPHATE; TOXICODENDRON PUBESCENS LEAF; ARNICA MONTANA WHOLE; HYPERICUM PERFORATUM WHOLE; SODIUM SULFATE",
"StrengthNumber": "4; 6; 12; 12; 12; 30; 30; 30; 30; 30; 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_C]/g; [hp_C]/g; [hp_C]/g",
"Status": "Active",
"LastUpdate": "2023-01-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190821",
"SamplePackage": "N",
"IndicationAndUsage": "USES: Temporarily relieves soreness and bruised feelings.**."
},
{
"NDCCode": "43406-0709-5",
"PackageDescription": "56.7 g in 1 TUBE, WITH APPLICATOR (43406-0709-5) ",
"NDC11Code": "43406-0709-05",
"ProductNDC": "43406-0709",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hemorrhoid Gel",
"NonProprietaryName": "Achillea Millefolium, Aesculus Hippocastanum, Hamamelis Virginiana, Ruscus Aculeatus, Aloe Socotrina, Paeonia Officinalis, Ignatia Amara, Nitricum Acidum, Nux Vomica, Phosphorus, Podophyllum Peitatum, Pulsatilla, Ratanhia, Chelidonium Majus, Sulphur",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190912",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Natural Creations, Inc",
"SubstanceName": "ACHILLEA MILLEFOLIUM WHOLE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; RUSCUS ACULEATUS WHOLE; ALOE; PAEONIA OFFICINALIS ROOT; STRYCHNOS IGNATII SEED; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PODOPHYLLUM; PULSATILLA VULGARIS WHOLE; KRAMERIA LAPPACEA ROOT; HORSE CHESTNUT; CHELIDONIUM MAJUS WHOLE; SULFUR",
"StrengthNumber": "4; 4; 4; 6; 6; 12; 12; 12; 12; 12; 12; 30; 30; 30; 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_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]",
"Status": "Active",
"LastUpdate": "2023-01-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190912",
"SamplePackage": "N",
"IndicationAndUsage": "USES: Temporarily relieves bleeding, painful, burning &/or stinging hemorrhoids & hemorrhoid related symptoms.**."
},
{
"NDCCode": "43406-0715-2",
"PackageDescription": "60 mL in 1 BOTTLE, DROPPER (43406-0715-2) ",
"NDC11Code": "43406-0715-02",
"ProductNDC": "43406-0715",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hydrate 1",
"NonProprietaryName": "Berberisaqui,betavulgaris,boldo,carduusmarianus,chelidoniummajus,eleutherococcus Senticosus,hordeumvulgare,irisversicolor,rosmarinusofficinalis,taraxacumofficinale,xanthoxylumfraxineum,ulmusfulva,glycyrrhizaglabra,gettysburgaqua,wildbadaqua,carlsbadaqua,atp,natrummuriaticum,oxygen,silicea,wiesbadenaqua,hydrogen",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20210602",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Natural Creations, Inc",
"SubstanceName": "BERBERIS AQUIFOLIUM ROOT BARK; BETA VULGARIS WHOLE; PEUMUS BOLDUS LEAF; MILK THISTLE; CHELIDONIUM MAJUS WHOLE; ELEUTHEROCOCCUS SENTICOSUS WHOLE; HORDEUM VULGARE WHOLE; IRIS VERSICOLOR ROOT; SALVIA ROSMARINUS FLOWERING TOP; TARAXACUM OFFICINALE; ULMUS RUBRA BARK; ZANTHOXYLUM AMERICANUM BARK; GLYCYRRHIZA GLABRA; ADENOSINE TRIPHOSPHATE; HYDROGEN; SODIUM CHLORIDE; OXYGEN; SILICON DIOXIDE",
"StrengthNumber": "4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 6; 4; 12; 30; 34; 30; 30; 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_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]",
"Status": "Active",
"LastUpdate": "2025-12-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210602",
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"IndicationAndUsage": "USES: To help maintain a healthy level of hydration in the body.**."
},
{
"NDCCode": "0597-0595-20",
"PackageDescription": "2 KIT in 1 CARTON (0597-0595-20) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY (0597-0590-26) / .8 mL in 1 SYRINGE * 2 PACKET in 1 TRAY / 1 mL in 1 PACKET",
"NDC11Code": "00597-0595-20",
"ProductNDC": "0597-0595",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Adalimumab-adbm",
"NonProprietaryName": "Adalimumab-adbm",
"DosageFormName": "KIT",
"StartMarketingDate": "20231001",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA761058",
"LabelerName": "Boehringer Ingelheim Pharmaceuticals, Inc.",
"Status": "Active",
"LastUpdate": "2025-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231001",
"SamplePackage": "N",
"IndicationAndUsage": "Adalimumab-adbm is a tumor necrosis factor (TNF) blocker indicated for: 1 Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1), 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2), 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3), 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adult patients. (1.6)Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers., 7 Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. (1.7), 8 Treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. (1.9).",
"Description": "Adalimumab-adbm is a tumor necrosis factor blocker. Adalimumab-adbm is a recombinant human IgG1 monoclonal antibody produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. Adalimumab-adbm injection is supplied as a sterile, preservative-free solution of adalimumab-adbm for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (Adalimumab-adbm Pen) or as a single-dose, 1 mL prefilled glass syringe. Enclosed within the pen is a single-dose, 1 mL prefilled glass syringe. The solution of Adalimumab-adbm is clear to slightly opalescent and colorless to slightly yellow, with a pH of about 5.5. Each 40 mg/0.4 mL prefilled syringe or prefilled pen delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of Adalimumab-adbm contains adalimumab-adbm (40 mg), glacial acetic acid (0.03 mg), polysorbate 80 (0.2 mg), sodium acetate trihydrate (0.47 mg), trehalose dihydrate (30.3 mg), and Water for Injection, USP. Each 40 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of Adalimumab-adbm contains adalimumab-adbm (40 mg), glacial acetic acid (0.13 mg), polysorbate 80 (0.8 mg), sodium acetate trihydrate (2.4 mg), trehalose dihydrate (65.0 mg), and Water for Injection, USP. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of Adalimumab-adbm contains adalimumab-adbm (20 mg), glacial acetic acid (0.06 mg), polysorbate 80 (0.4 mg), sodium acetate trihydrate (1.21 mg), trehalose dihydrate (32.5 mg), and Water for Injection, USP. Each 10 mg/0.2 mL prefilled syringe delivers 0.2 mL (10 mg) of drug product. Each 0.2 mL of Adalimumab-adbm contains adalimumab-adbm (10 mg), glacial acetic acid (0.03 mg), polysorbate 80 (0.2 mg), sodium acetate trihydrate (0.61 mg), trehalose dihydrate (16.3 mg), and Water for Injection, USP."
},
{
"NDCCode": "0832-0595-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (0832-0595-30) ",
"NDC11Code": "00832-0595-30",
"ProductNDC": "0832-0595",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Exemestane",
"NonProprietaryName": "Exemestane",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170727",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209208",
"LabelerName": "Upsher-Smith Laboratories, Inc.",
"SubstanceName": "EXEMESTANE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aromatase Inhibitor [EPC], Aromatase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-03-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170727",
"SamplePackage": "N",
"IndicationAndUsage": "Exemestane tablets are an aromatase inhibitor indicated for: 1 adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer who have received two to three years of tamoxifen and are switched to exemestane for completion of a total of five consecutive years of adjuvant hormonal therapy ( 14.1). , 2 treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy ( 14.2). .",
"Description": "Exemestane tablets, USP for oral administration contain 25 mg of exemestane, an irreversible, steroidal aromatase inactivator. Exemestane, USP is chemically described as 6-methylenandrosta-1,4-diene-3,17-dione. Its molecular formula is C 20H 24O 2and its structural formula is as follows:. The active ingredient is a white to slightly yellow crystalline powder with a molecular weight of 296.41. Exemestane is freely soluble in N, N-dimethylformamide, soluble in methanol, and practically insoluble in water. Each exemestane tablet contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate and titanium dioxide. FDA approved dissolution test specifications differs from USP."
},
{
"NDCCode": "13537-595-12",
"PackageDescription": "1 TUBE in 1 BOX (13537-595-12) > 4 g in 1 TUBE (13537-595-11)",
"NDC11Code": "13537-0595-12",
"ProductNDC": "13537-595",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Esika Hydracolor 2 In 1 Spf 25",
"ProprietaryNameSuffix": "(rosa Encanto) - Pink",
"NonProprietaryName": "Octinoxate And Oxybenzone",
"DosageFormName": "LIPSTICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20151123",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation LTD",
"SubstanceName": "OCTINOXATE; OXYBENZONE",
"StrengthNumber": ".0664; .0151",
"StrengthUnit": "g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "14141-595-01",
"PackageDescription": "1 CASE in 1 BOX (14141-595-01) / 10 g in 1 CASE",
"NDC11Code": "14141-0595-01",
"ProductNDC": "14141-595",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Esika Colorfix Polvos 32h Polvo Compacto Facial De Alta Cobertura Fps 15 220-c",
"NonProprietaryName": "Octinoxate, Titanium Dioxide, Zinc Oxide",
"DosageFormName": "POWDER",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260803",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "BEL STAR S.A.",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "30; 62.4; 49",
"StrengthUnit": "mg/g; mg/g; mg/g",
"Status": "Active",
"LastUpdate": "2026-08-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260803",
"SamplePackage": "N",
"IndicationAndUsage": "Ayuda a prevenir quemaduras solares."
},
{
"NDCCode": "21130-595-40",
"PackageDescription": "355 mL in 1 BOTTLE (21130-595-40) ",
"NDC11Code": "21130-0595-40",
"ProductNDC": "21130-595",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Signature Care Nighttime Severe Cold And Flu Relief",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20200710",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Safeway",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "650; 20; 12.5; 10",
"StrengthUnit": "mg/30mL; mg/30mL; mg/30mL; mg/30mL",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-11-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20200710",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves common cold/flu symptoms: 1 sinus congestion and pressure, 2 nasal congestion, 3 minor aches and pains, 4 headache, 5 runny nose and sneezing, 6 sore throat, 7 cough to help you sleep, 8 fever, 9 cough due to minor throat and bronchial irritation, 10 reduces swelling of nasal passages, 11 promotes nasal and/or sinus drainage, 12 temporarily restores freer breathing through the nose."
},
{
"NDCCode": "21695-595-05",
"PackageDescription": "5 mL in 1 BOTTLE, PLASTIC (21695-595-05)",
"NDC11Code": "21695-0595-05",
"ProductNDC": "21695-595",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Neomycin And Polymyxin B Sulfates And Dexamethasone",
"NonProprietaryName": "Neomycin Sulfate, Polymyxin B Sulfate And Dexamethasone",
"DosageFormName": "SUSPENSION",
"RouteName": "OPHTHALMIC",
"StartMarketingDate": "19861117",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA062721",
"LabelerName": "Rebel Distributors Corp",
"SubstanceName": "NEOMYCIN SULFATE; POLYMYXIN B SULFATE; DEXAMETHASONE",
"StrengthNumber": "3.5; 10000; 1",
"StrengthUnit": "mg/mL; mg/mL; mg/mL",
"Pharm_Classes": "Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS],Polymyxin-class Antibacterial [EPC],Polymyxins [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists. Ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroids use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns; or penetration of foreign bodies. The use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye. The particular anti-infective drug in this product is active against the following common bacterial eye pathogens: Staphylococcus aureus, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter species, Neisseria species, and Pseudomonas aeruginosa. This product does not provide adequate coverage against: Serratia marcescens and streptococci, including Streptococcus pneumoniae.",
"Description": "Neomycin and polymyxin B sulfates and dexamethasone ophthalmic suspension is a multiple dose anti-infective steroid combination in sterile suspension form for topical application. The chemical structure for the active ingredient, dexamethasone, is. Established Name. dexamethasone. Chemical Name. pregna-1, 4-diene-3, 20-dione, 9-fluoro-11,17, 21-trihydroxy-16-methyl-, (11β, 16α)-. The other active ingredients are neomycin sulfate and polymyxin B sulfate. Each mL contains: Actives: neomycin sulfate equivalent to neomycin 3.5 mg, polymyxin B sulfate 10,000 units, dexamethasone 0.1%. Preservative: benzalkonium chloride 0.004%. Vehicle: hypromellose 2910 0.5%. Inactives: sodium chloride, polysorbate 20, hydrochloric acid and/or sodium hydroxide (to adjust pH), purified water."
}
]
}
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Astragalus Nuttallii Leaf, Candida Albicans, Sodium Borate, Oyster Shell Calcium Carbonate, Crude, Wood Creosote, Lycopodium Clavatum Spore, Strychnos Nux-vomica Seed, Phosphoric Acid, Anemone Pulsatilla, Sepia Officinalis Juice, Thuja Occidentalis Leafy Twig, Sodium Phosphate, Dibasic, Heptahydrate, Nitric Acid"},{"NDCCode":"43406-0678-1","ProprietaryName":"Digestion","NonProprietaryName":"Gentiana Lut, Sambucus Nig, Arsenicum Alb, Bismuth Sub, Carbo Veg, Kali Bic, Lycopodium, Nux Vom, Phosphorus, Pulsatilla"},{"NDCCode":"43406-0679-1","ProprietaryName":"Vermasode","NonProprietaryName":"Artemisia Vulgaris, Chelidonium Majus, Granatum, Spigelia Anthelmia, Ratanhia, Arsenicum Album, Ferrum Metallicum, Calcarea Carbonica, Cina, Gaertner Bacillus, Graphites, Mercurius Dulcis, Natrum Muriaticum, Natrum Phosphoricum, Vermin Nosode"},{"NDCCode":"43406-0680-1","ProprietaryName":"Mood","NonProprietaryName":"Aralia Quin, Cimicifuga, Spigelia Anth, Arg Nit, Arsenicum Alb, Aurum Met, Ignatia Amara, Lachesis, Lycopodium, Nat Mur, Phosphoricum Ac, Platinum Met, Pulsatilla, Sepia, Thuja Occ"},{"NDCCode":"43406-0686-1","ProprietaryName":"Panacode","NonProprietaryName":"Syzygium, Hydrastis, Adrenalinum, Pancreatinum, Pituitarum Posterium, Bovista, Insulin, Lycopersicum, Phosphoricum Ac, Phosphorus, Tarentula Hispana, Terebinthina, Uranium Nitricum"},{"NDCCode":"43406-0688-1","ProprietaryName":"Cold","NonProprietaryName":"Baptisia Tinctoria, Echinacea Angustifolia, Eupatorium Perfoliatum, Lomatium Dissectum, Pueraria Lobata, Trifolium Pratense, Phytolacca Decandra, Allium Cepa, Arsenicum Iodatum, Baryta Carbonica, Bromium, Calcarea Carbonica, Kali Muriaticum, Lachesis Mutus, Mercurius Solubilis, Silicea"},{"NDCCode":"43406-0690-1","ProprietaryName":"Gastrozen","NonProprietaryName":"Coffea Tosta, Glycyrrhiza, Phytolacca, Taraxacum, Hydrastis, Arsenicum Alb, Gelsemium, Merc Solub, Nitricum Ac, Nux Vom, Petroleum, Phosphoricum Ac, Phosphorus, Bromium, Cadmium Sulphuricum, Cinchona, Conium, Hydrogen, Iodium, Lachesis, Pulsatilla, Silicea, Sulphuricum Ac"},{"NDCCode":"43406-0691-1","ProprietaryName":"Hives","NonProprietaryName":"Echinacea Ang, Apis Mel, Arsenicum Alb, Carbolicum Ac, Ledum, Rhus Tox, Sulphur, Urtica Urens"},{"NDCCode":"43406-0693-1","ProprietaryName":"Nasal Decongestant","NonProprietaryName":"Camellia Sinensis, Ephedra Vulgaris, Belladonna, Arsenicum Album, Cinnabaris, Kali Bichromicum, Pulsatilla, Sepia, Calcarea Carbonica, Mercurius Solubilis, Sulphur"},{"NDCCode":"43406-0707-5","ProprietaryName":"Injure Gel","NonProprietaryName":"Arnica Montana, Calendula Officinalis, Hypericum Perf, Symphytum Off, Bellis Per, Ledum Palustre, Sulphuricum Ac, Calc Fluor, Ferrum Phos, Rhus Tox, Nat Sulphuricum"},{"NDCCode":"43406-0709-5","ProprietaryName":"Hemorrhoid Gel","NonProprietaryName":"Achillea Millefolium, Aesculus Hippocastanum, Hamamelis Virginiana, Ruscus Aculeatus, Aloe Socotrina, Paeonia Officinalis, Ignatia Amara, Nitricum Acidum, Nux Vomica, Phosphorus, Podophyllum Peitatum, Pulsatilla, Ratanhia, Chelidonium Majus, Sulphur"},{"NDCCode":"43406-0715-2","ProprietaryName":"Hydrate 1","NonProprietaryName":"Berberisaqui,betavulgaris,boldo,carduusmarianus,chelidoniummajus,eleutherococcus Senticosus,hordeumvulgare,irisversicolor,rosmarinusofficinalis,taraxacumofficinale,xanthoxylumfraxineum,ulmusfulva,glycyrrhizaglabra,gettysburgaqua,wildbadaqua,carlsbadaqua,atp,natrummuriaticum,oxygen,silicea,wiesbadenaqua,hydrogen"},{"NDCCode":"0597-0595-20","ProprietaryName":"Adalimumab-adbm","NonProprietaryName":"Adalimumab-adbm"},{"NDCCode":"0832-0595-30","ProprietaryName":"Exemestane","NonProprietaryName":"Exemestane"},{"NDCCode":"13537-595-12","ProprietaryName":"Esika Hydracolor 2 In 1 Spf 25","NonProprietaryName":"Octinoxate And Oxybenzone"},{"NDCCode":"14141-595-01","ProprietaryName":"Esika Colorfix Polvos 32h Polvo Compacto Facial De Alta Cobertura Fps 15 220-c","NonProprietaryName":"Octinoxate, Titanium Dioxide, Zinc 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<NDCList>
<NDC>
<NDCCode>43406-0595-4</NDCCode>
<PackageDescription>120 mL in 1 BOTTLE, PLASTIC (43406-0595-4) </PackageDescription>
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<ProductNDC>43406-0595</ProductNDC>
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<NonProprietaryName>Squilla, Antimonium Tart, Arsenicum Alb, Belladonna, Bryonia, Chamomilla, Cuprum Met, Drosera, Hepar Sulph Calc, Ipecacuanha, Kali Bic, Kali Carb, Phosphorus, Pulsatilla, Spongia</NonProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20151111</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Natural Creations, Inc</LabelerName>
<SubstanceName>DRIMIA MARITIMA BULB; ANTIMONY POTASSIUM TARTRATE; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; MATRICARIA CHAMOMILLA WHOLE; COPPER; DROSERA ROTUNDIFOLIA WHOLE; CALCIUM SULFIDE; IPECAC; POTASSIUM DICHROMATE; POTASSIUM CARBONATE; PHOSPHORUS; PULSATILLA VULGARIS WHOLE; SPONGIA OFFICINALIS SKELETON, ROASTED</SubstanceName>
<StrengthNumber>8; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
<Pharm_Classes>Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Inhibit Ovum Fertilization [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151111</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: Temporarily relieves cough (dry cough, tickling cough, hacking cough).**.</IndicationAndUsage>
</NDC>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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<NonProprietaryName>Camphor (natural), Arsenic Trioxide, Bryonia Alba Root, Drosera Rotundifolia, Ipecac, Potassium Carbonate, Phosphorus, Anemone Pulsatilla, Spongia Officinalis Skeleton, Roasted, Drimia Maritima Whole</NonProprietaryName>
<DosageFormName>SYRUP</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20070507</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Natural Creations, Inc.</LabelerName>
<SubstanceName>CAMPHOR (NATURAL); ARSENIC TRIOXIDE; BRYONIA ALBA ROOT; DROSERA ROTUNDIFOLIA; IPECAC; POTASSIUM CARBONATE; PHOSPHORUS; ANEMONE PULSATILLA; SPONGIA OFFICINALIS SKELETON, ROASTED; DRIMIA MARITIMA WHOLE</SubstanceName>
<StrengthNumber>30; 30; 30; 30; 30; 30; 30; 30; 30; 30</StrengthNumber>
<StrengthUnit>[hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-01-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20070507</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: Temporarily relieves dry cough, dry barking cough, dry, hacking, painful cough, incessant coughing, dry rattling cough, congestion and tightness of chest, shortness of breath, and/or other symptoms related to coughing.**.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>11822-0595-4</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (11822-0595-4) / 118 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>11822-0595-04</NDC11Code>
<ProductNDC>11822-0595</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Childrens Fever Reducer And Pain Reliever</ProprietaryName>
<NonProprietaryName>Acetaminophen</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19970923</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>Rite Aid Corporation</LabelerName>
<SubstanceName>ACETAMINOPHEN</SubstanceName>
<StrengthNumber>160</StrengthNumber>
<StrengthUnit>mg/5mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-10-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19970923</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily: 1 reduces fever , 2 relieves minor aches and pains due to:, 3 the common cold, 4 flu, 5 headache, 6 sore throat, 7 toothache.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>12658-0595-1</NDCCode>
<PackageDescription>4 kg in 1 DRUM (12658-0595-1) </PackageDescription>
<NDC11Code>12658-0595-01</NDC11Code>
<ProductNDC>12658-0595</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Carvedilol Phosphate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20061020</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Pharmaceutical Works POLPHARMA</LabelerName>
<SubstanceName>CARVEDILOL PHOSPHATE</SubstanceName>
<StrengthNumber>4</StrengthNumber>
<StrengthUnit>kg/4kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20-OCT-06</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>15631-0595-1</NDCCode>
<PackageDescription>4 TABLET in 1 BLISTER PACK (15631-0595-1)</PackageDescription>
<NDC11Code>15631-0595-01</NDC11Code>
<ProductNDC>15631-0595</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Guaiacum</ProprietaryName>
<NonProprietaryName>Guaiacum</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160107</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
<SubstanceName>GUAIACUM OFFICINALE RESIN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>15631-0595-4</NDCCode>
<PackageDescription>250 TABLET in 1 CONTAINER (15631-0595-4)</PackageDescription>
<NDC11Code>15631-0595-04</NDC11Code>
<ProductNDC>15631-0595</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Guaiacum</ProprietaryName>
<NonProprietaryName>Guaiacum</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160107</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
<SubstanceName>GUAIACUM OFFICINALE RESIN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>17856-0595-4</NDCCode>
<PackageDescription>1 CASE in 1 CUP, UNIT-DOSE (17856-0595-4) / 50 CUP in 1 CASE (17856-0595-3) / 30 mL in 1 CUP</PackageDescription>
<NDC11Code>17856-0595-04</NDC11Code>
<ProductNDC>17856-0595</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Citrate And Citric Acid</ProprietaryName>
<NonProprietaryName>Sodium Citrate And Citric Acid Monohydrate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19690101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Atlantic Biologicals Corp.</LabelerName>
<SubstanceName>ANHYDROUS CITRIC ACID; SODIUM CITRATE</SubstanceName>
<StrengthNumber>334; 500</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA], Acidifying Activity [MoA], Anti-coagulant [EPC], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Decreased Coagulation Factor Activity [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240418</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sodium Citrate and Citric Acid Oral Solution USP is an effective alkalinizing agent. It is useful in those conditions where long-term maintenance of an alkaline urine is desirable, and is of value in the alleviation of chronic metabolic acidosis, such as results from chronic renal insufficiency or the syndrome of renal tubular acidosis, especially when the administration of potassium salts is undesirable or contraindicated. This product is also useful for buffering and neutralizing gastric hydrochloric acid quickly and effectively. Sodium Citrate and Citric Acid Oral Solution USP is concentrated, and when administered after meals and before bedtime, allows one to maintain an alkaline urinary pH around the clock, usually without the necessity of a 2 A.M. dose. This product alkalinizes the urine without producing a systemic alkalosis in the recommended dosage. This product is highly palatable, pleasant tasting, and tolerable, even when administered for long periods.</IndicationAndUsage>
<Description>Sodium Citrate and Citric Acid Oral Solution USP is a stable and pleasant-tasting systemic alkalizer containing sodium citrate and citric acid in a sugar-free base. It is a nonparticulate neutralizing buffer. Sodium Citrate and Citric Acid Oral Solution USP contains in each teaspoonful (5 mL). SODIUM CITRATE Dihydrate 500 mg (0.34 Molar) CITRIC ACID Monohydrate 334 mg (0.32 Molar). Each mL contains 1 mEq sodium ion and is equivalent to 1 mEq bicarbonate (HCO3). INACTIVE INGREDIENTS: Flavoring, polyethylene glycol, propylene glycol, purified water, sodium benzoate, and sorbitol solution.</Description>
</NDC>
<NDC>
<NDCCode>49288-0595-4</NDCCode>
<PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (49288-0595-4)</PackageDescription>
<NDC11Code>49288-0595-04</NDC11Code>
<ProductNDC>49288-0595</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Whole Wheat</ProprietaryName>
<NonProprietaryName>Whole Wheat</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19740323</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102223</ApplicationNumber>
<LabelerName>Antigen Laboratories, Inc.</LabelerName>
<SubstanceName>WHEAT</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Food Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Grain Proteins [EXT]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extract is used for diagnostic testing and for the treatment (immunotherapy) of patients whose histories indicate that upon natural exposure to the allergen, they experience allergic symptoms. Confirmation is determined by skin testing. Diagnostic use of allergenic extracts usually begins with direct skin testing. This product is not intended for treatment of patients who do not manifest immediate hypersensitivity reactions to the allergenic extract following skin testing.</IndicationAndUsage>
<Description>Antigen Laboratories’ allergenic extracts are manufactured from source material listed on the vial label. Lower concentrations (e.g. 1:50, 1:33, etc.) may be prepared either by dilution from a more concentrated stock or by direct extraction. The extract is a sterile solution containing extractables of source materials obtained from biological collecting and/or processing firms and Antigen Laboratories. All source materials are inspected by Antigen Laboratories’ technical personnel in accordance with 21 CFR 680.1 (b) (1). The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. FOR ALLERGENIC EXTRACTS CONTAINING 50% V/V GLYCERINE AS PRESERVATIVE AND STABILIZER. INACTIVE INGREDIENTS. Sodium chloride…………………………………………………………….0.95%. Sodium bicarbonate………………………………………………………..0.24%. Glycerine…………………………………………………………………50% (v/v). Water for Injection…………………………………………………q.s. to volume. Active allergens are described by common and scientific name on the stock concentrate container label or on last page of this circular. Food allergenic extracts may be manufactured on a weight/volume (w/v) or volume/volume (v/v) basis. Food extracts made from dried raw material are extracted at 2-10% (1:50-1:10 w/v ratio) in extracting fluid containing 50% glycerine. Slurries of juicy fruits or vegetables (prepared with a minimum amount of water for injection) are combined with an equal volume of glycerine for a ration of 1:1 volume/volume (v/v). Sodium chloride and sodium bicarbonate are added to the slurry and glycerine mixture. Fresh egg white extract is prepared by adding one part raw egg white to nine parts of extracting fluid (1:9 v/v). Antigen E is considered the most important allergen of Short Ragweed pollen and is used for the standardization of Short Ragweed allergenic extracts. Stock mixtures containing Short Ragweed are analyzed for Antigen E content by radial immunodiffusion using Center for Biologics Evaluation and Research (CBER) references and anti-serum. Antigen E content expressed as units of Antigen E per milliliter (U/ml) is printed on container label.</Description>
</NDC>
<NDC>
<NDCCode>71335-0595-4</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (71335-0595-4) </PackageDescription>
<NDC11Code>71335-0595-04</NDC11Code>
<ProductNDC>71335-0595</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bisoprolol Fumarate And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Bisoprolol Fumarate And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20101012</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA079106</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>HYDROCHLOROTHIAZIDE; BISOPROLOL FUMARATE</SubstanceName>
<StrengthNumber>6.25; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS], beta-Adrenergic Blocker [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-05-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230719</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Bisoprolol fumarate and hydrochlorothiazide tablets are indicated in the management of hypertension.</IndicationAndUsage>
<Description>Bisoprolol fumarate and hydrochlorothiazide tablets USP are indicated for the treatment of hypertension. It combines two antihypertensive agents in a once–daily dosage: a synthetic beta1-selective (cardioselective) adrenoceptor blocking agent (bisoprolol fumarate) and a benzothiadiazine diuretic (hydrochlorothiazide). Bisoprolol fumarate is chemically described as (±)-1-[4-[[2-(1-methylethoxy)ethoxy]methyl] phenoxy]-3-[(1-methylethyl)amino]-2-propanol(E)-2-butenedioate(2:1)(salt). It possesses an asymmetric carbon atom in its structure and is provided as a racemic mixture. The S(-) enantiomer is responsible for most of the beta-blocking activity. Its molecular formula is (C18H31NO4)2C4H4O4 and it has a molecular weight of 766.97. Its structural formula is. Bisoprolol fumarate is a white crystalline powder, approximately equally hydrophilic and lipophilic, and readily soluble in water, methanol, ethanol, and chloroform. Hydrochlorothiazide (HCTZ) is 6-Chloro-3,4-dihydro-2H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. It is a white, or practically white, practically odorless crystalline powder. It is slightly soluble in water, sparingly soluble in dilute sodium hydroxide solution, freely soluble in n-butylamine and dimethylformamide, sparingly soluble in methanol, and insoluble in ether, chloroform, and dilute mineral acids. Its molecular formula is C7H8ClN3O4S2 and it has a molecular weight of 297.73. Its structural formula is. Each Bisoprolol Fumarate and Hydrochlorothiazide tablet USP 2.5 mg/6.25 mg for oral administration contains. Bisoprolol fumarate USP….. 2.5 mg. Hydrochlorothiazide USP…. 6.25 mg. Each Bisoprolol Fumarate and Hydrochlorothiazide tablet USP 5 mg/6.25 mg for oral administration contains. Bisoprolol fumarate USP….. 5 mg. Hydrochlorothiazide USP…. 6.25 mg. Each Bisoprolol Fumarate and Hydrochlorothiazide tablet USP 10 mg/6.25 mg for oral administration contains. Bisoprolol fumarate USP….. 10 mg. Hydrochlorothiazide USP…. 6.25 mg. Inactive ingredients include pregelatinized starch, dibasic calcium phosphate anhydrous, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, colloidal silicon dioxide, copovidone and titanium dioxide. The 5 mg/6.25 mg tablet also contains red and yellow iron oxide. The 2.5 mg/6.25 mg tablet also contains yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>80425-0595-4</NDCCode>
<PackageDescription>120 CAPSULE in 1 BOTTLE (80425-0595-4) </PackageDescription>
<NDC11Code>80425-0595-04</NDC11Code>
<ProductNDC>80425-0595</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Gabapentin</ProprietaryName>
<NonProprietaryName>Gabapentin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260911</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA214956</ApplicationNumber>
<LabelerName>Advanced Rx of Tennessee, LLC</LabelerName>
<SubstanceName>GABAPENTIN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260911</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Gabapentin capsules are indicated for: 1 Management of postherpetic neuralgia in adults, 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy.</IndicationAndUsage>
<Description>The active ingredient in gabapentin capsules is gabapentin, USP which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C 9H 17NO 2and the molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin, USP is a white to off-white crystalline solid with a pK a1of 3.7 and a pK a2of 10.7. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient (n-octanol/0.05M phosphate buffer) at pH 7.4 is –1.25. Each gabapentin capsule contains 100 mg, 300 mg, or 400 mg of gabapentin, USP and the following inactive ingredients: mannitol, pre-gelatinized starch and talc. The 100 mg capsule shell contains titanium dioxide, gelatin and sodium lauryl sulfate. The 300 mg and 400 mg capsule shell contains FD&C Red 40, D&C Yellow 10, titanium dioxide, gelatin and sodium lauryl sulfate. The ink ingredients common for all strengths are shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide and potassium hydroxide.</Description>
</NDC>
<NDC>
<NDCCode>43406-0610-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (43406-0610-1) </PackageDescription>
<NDC11Code>43406-0610-01</NDC11Code>
<ProductNDC>43406-0610</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Constipation</ProprietaryName>
<NonProprietaryName>Magnesium Carbonate, Magnesium Chloride, Horse Chestnut, Potassium Alum, Aluminum Oxide, Bryonia Alba Root, Strychnos Nux-vomica Seed, Silicon Dioxide</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170901</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Natural Creations, Inc.</LabelerName>
<SubstanceName>MAGNESIUM CARBONATE; MAGNESIUM CHLORIDE; HORSE CHESTNUT; POTASSIUM ALUM; ALUMINUM OXIDE; BRYONIA ALBA ROOT; STRYCHNOS NUX-VOMICA SEED; SILICON DIOXIDE</SubstanceName>
<StrengthNumber>4; 4; 12; 12; 12; 12; 12; 12</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</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170901</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: Temporarily relieves great straining, large, dry, hard, knotty stools, &/or other symptoms of constipation.**.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43406-0669-2</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE, SPRAY (43406-0669-2) </PackageDescription>
<NDC11Code>43406-0669-02</NDC11Code>
<ProductNDC>43406-0669</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Throat</ProprietaryName>
<NonProprietaryName>Baptisia, Phytolacca, Hydrastis, Apis Mel, Arg Nit, Belladonna, Hepar Sulph Calc, Kali Bic, Lac Can, Lachesis, Merc Solub</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180403</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Natural Creations, Inc</LabelerName>
<SubstanceName>BAPTISIA TINCTORIA WHOLE; PHYTOLACCA AMERICANA ROOT; GOLDENSEAL; APIS MELLIFERA; SILVER NITRATE; ATROPA BELLADONNA; CALCIUM SULFIDE; POTASSIUM DICHROMATE; CANIS LUPUS FAMILIARIS MILK; LACHESIS MUTA VENOM; MERCURIUS SOLUBILIS</SubstanceName>
<StrengthNumber>4; 4; 6; 12; 12; 12; 12; 12; 12; 12; 12</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</StrengthUnit>
<Pharm_Classes>Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180403</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: Temporarily relieves sore, raw, rough-feeling, tickling cough, hoarseness, &/or other symptoms due to a sore throat.**.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43406-0672-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (43406-0672-1) </PackageDescription>
<NDC11Code>43406-0672-01</NDC11Code>
<ProductNDC>43406-0672</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Candida Hp</ProprietaryName>
<NonProprietaryName>Baptisia Tinctoria Root, Echinacea Purpurea, Glycyrrhiza Glabra, Astragalus Nuttallii Leaf, Candida Albicans, Sodium Borate, Oyster Shell Calcium Carbonate, Crude, Wood Creosote, Lycopodium Clavatum Spore, Strychnos Nux-vomica Seed, Phosphoric Acid, Anemone Pulsatilla, Sepia Officinalis Juice, Thuja Occidentalis Leafy Twig, Sodium Phosphate, Dibasic, Heptahydrate, Nitric Acid</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Natural Creations, Inc.</LabelerName>
<SubstanceName>BAPTISIA TINCTORIA ROOT; ECHINACEA PURPUREA; GLYCYRRHIZA GLABRA; ASTRAGALUS NUTTALLII LEAF; SODIUM BORATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; WOOD CREOSOTE; LYCOPODIUM CLAVATUM SPORE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; THUJA OCCIDENTALIS LEAFY TWIG; CANDIDA ALBICANS</SubstanceName>
<StrengthNumber>4; 4; 4; 6; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 200</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: Temporarily relieves symptoms associated with vaginal yeast infection.**.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43406-0678-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (43406-0678-1) </PackageDescription>
<NDC11Code>43406-0678-01</NDC11Code>
<ProductNDC>43406-0678</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Digestion</ProprietaryName>
<NonProprietaryName>Gentiana Lut, Sambucus Nig, Arsenicum Alb, Bismuth Sub, Carbo Veg, Kali Bic, Lycopodium, Nux Vom, Phosphorus, Pulsatilla</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180502</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Natural Creations, Inc</LabelerName>
<SubstanceName>GENTIANA LUTEA ROOT; SAMBUCUS NIGRA FLOWERING TOP; ARSENIC TRIOXIDE; BISMUTH SUBNITRATE; ACTIVATED CHARCOAL; POTASSIUM DICHROMATE; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS WHOLE</SubstanceName>
<StrengthNumber>4; 4; 12; 12; 12; 12; 12; 12; 12; 12</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</StrengthUnit>
<Pharm_Classes>Allergens [CS], Bismuth [CS], Bismuth [EPC], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180502</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: Temporarily relieves distention, belching, pressure, flatulence, burning sensation, &/or other symptoms related to weak digestion.**.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43406-0679-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (43406-0679-1) </PackageDescription>
<NDC11Code>43406-0679-01</NDC11Code>
<ProductNDC>43406-0679</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Vermasode</ProprietaryName>
<NonProprietaryName>Artemisia Vulgaris, Chelidonium Majus, Granatum, Spigelia Anthelmia, Ratanhia, Arsenicum Album, Ferrum Metallicum, Calcarea Carbonica, Cina, Gaertner Bacillus, Graphites, Mercurius Dulcis, Natrum Muriaticum, Natrum Phosphoricum, Vermin Nosode</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180613</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Natural Creations, Inc</LabelerName>
<SubstanceName>ARTEMISIA VULGARIS ROOT; CHELIDONIUM MAJUS WHOLE; PUNICA GRANATUM ROOT BARK; SPIGELIA ANTHELMIA WHOLE; KRAMERIA LAPPACEA ROOT; ARSENIC TRIOXIDE; IRON; OYSTER SHELL CALCIUM CARBONATE, CRUDE; ARTEMISIA CINA PRE-FLOWERING TOP; SALMONELLA ENTERICA ENTERICA SEROVAR ENTERITIDIS; GRAPHITE; CALOMEL; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE</SubstanceName>
<StrengthNumber>4; 4; 4; 4; 4; 6; 9; 12; 12; 12; 12; 12; 12; 12</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</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180613</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: Temporarily relieves symptoms caused by pinworm infestation.**.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43406-0680-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (43406-0680-1) </PackageDescription>
<NDC11Code>43406-0680-01</NDC11Code>
<ProductNDC>43406-0680</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mood</ProprietaryName>
<NonProprietaryName>Aralia Quin, Cimicifuga, Spigelia Anth, Arg Nit, Arsenicum Alb, Aurum Met, Ignatia Amara, Lachesis, Lycopodium, Nat Mur, Phosphoricum Ac, Platinum Met, Pulsatilla, Sepia, Thuja Occ</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180613</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Natural Creations, Inc</LabelerName>
<SubstanceName>AMERICAN GINSENG; BLACK COHOSH; SPIGELIA ANTHELMIA WHOLE; SILVER NITRATE; ARSENIC TRIOXIDE; GOLD; STRYCHNOS IGNATII SEED; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; PHOSPHORIC ACID; PLATINUM; PULSATILLA VULGARIS WHOLE; SEPIA OFFICINALIS JUICE; THUJA OCCIDENTALIS LEAFY TWIG</SubstanceName>
<StrengthNumber>4; 4; 4; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12</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</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180613</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: Temporarily relieves feelings of minor moodiness and melancholy.**.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43406-0686-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (43406-0686-1) </PackageDescription>
<NDC11Code>43406-0686-01</NDC11Code>
<ProductNDC>43406-0686</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Panacode</ProprietaryName>
<NonProprietaryName>Syzygium, Hydrastis, Adrenalinum, Pancreatinum, Pituitarum Posterium, Bovista, Insulin, Lycopersicum, Phosphoricum Ac, Phosphorus, Tarentula Hispana, Terebinthina, Uranium Nitricum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200211</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Natural Creations, Inc</LabelerName>
<SubstanceName>SYZYGIUM CUMINI SEED; GOLDENSEAL; EPINEPHRINE; PANCRELIPASE; SUS SCROFA PITUITARY GLAND, POSTERIOR; LYCOPERDON UTRIFORME FRUITING BODY; INSULIN PORK; SOLANUM LYCOPERSICUM WHOLE; PHOSPHORIC ACID; PHOSPHORUS; LYCOSA TARANTULA; TURPENTINE OIL; URANYL NITRATE HEXAHYDRATE</SubstanceName>
<StrengthNumber>4; 6; 9; 9; 9; 12; 12; 12; 12; 12; 12; 12; 12</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</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Catecholamine [EPC], Catecholamines [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200211</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: Helps promote a healthy digestive tract.**.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43406-0688-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (43406-0688-1) </PackageDescription>
<NDC11Code>43406-0688-01</NDC11Code>
<ProductNDC>43406-0688</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cold</ProprietaryName>
<NonProprietaryName>Baptisia Tinctoria, Echinacea Angustifolia, Eupatorium Perfoliatum, Lomatium Dissectum, Pueraria Lobata, Trifolium Pratense, Phytolacca Decandra, Allium Cepa, Arsenicum Iodatum, Baryta Carbonica, Bromium, Calcarea Carbonica, Kali Muriaticum, Lachesis Mutus, Mercurius Solubilis, Silicea</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190207</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Natural Creations, Inc</LabelerName>
<SubstanceName>BAPTISIA TINCTORIA WHOLE; ECHINACEA ANGUSTIFOLIA WHOLE; EUPATORIUM PERFOLIATUM FLOWERING TOP; LOMATIUM DISSECTUM ROOT; PUERARIA MONTANA VAR. LOBATA WHOLE; TRIFOLIUM PRATENSE FLOWER; PHYTOLACCA AMERICANA ROOT; ONION; ARSENIC TRIIODIDE; BARIUM CARBONATE; BROMINE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; POTASSIUM CHLORIDE; LACHESIS MUTA VENOM; MERCURIUS SOLUBILIS; SILICON DIOXIDE</SubstanceName>
<StrengthNumber>4; 4; 4; 4; 4; 4; 6; 12; 12; 12; 12; 12; 12; 12; 12; 12</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</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Non-Standardized Food Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190207</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: Temporarily relieves symptoms associated with the common cold.**.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43406-0690-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (43406-0690-1) </PackageDescription>
<NDC11Code>43406-0690-01</NDC11Code>
<ProductNDC>43406-0690</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Gastrozen</ProprietaryName>
<NonProprietaryName>Coffea Tosta, Glycyrrhiza, Phytolacca, Taraxacum, Hydrastis, Arsenicum Alb, Gelsemium, Merc Solub, Nitricum Ac, Nux Vom, Petroleum, Phosphoricum Ac, Phosphorus, Bromium, Cadmium Sulphuricum, Cinchona, Conium, Hydrogen, Iodium, Lachesis, Pulsatilla, Silicea, Sulphuricum Ac</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180613</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Natural Creations, Inc</LabelerName>
<SubstanceName>COFFEA ARABICA SEED, ROASTED; GLYCYRRHIZA GLABRA; PHYTOLACCA AMERICANA ROOT; TARAXACUM OFFICINALE; GOLDENSEAL; ARSENIC TRIOXIDE; GELSEMIUM SEMPERVIRENS ROOT; MERCURIUS SOLUBILIS; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; KEROSENE; PHOSPHORIC ACID; PHOSPHORUS; BROMINE; CADMIUM SULFATE; CINCHONA OFFICINALIS BARK; CONIUM MACULATUM FLOWERING TOP; HYDROGEN; IODINE; LACHESIS MUTA VENOM; PULSATILLA VULGARIS WHOLE; SILICON DIOXIDE; SULFURIC ACID</SubstanceName>
<StrengthNumber>4; 4; 4; 4; 6; 12; 12; 12; 12; 12; 12; 12; 12; 30; 30; 30; 30; 30; 30; 30; 30; 30; 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_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180613</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: Temporarily relieves minor abdominal cramps and bloating.**.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43406-0691-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (43406-0691-1) </PackageDescription>
<NDC11Code>43406-0691-01</NDC11Code>
<ProductNDC>43406-0691</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hives</ProprietaryName>
<NonProprietaryName>Echinacea Ang, Apis Mel, Arsenicum Alb, Carbolicum Ac, Ledum, Rhus Tox, Sulphur, Urtica Urens</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180613</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Natural Creations, Inc</LabelerName>
<SubstanceName>ECHINACEA ANGUSTIFOLIA WHOLE; APIS MELLIFERA; ARSENIC TRIOXIDE; PHENOL; RHODODENDRON TOMENTOSUM LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF; SULFUR; URTICA URENS WHOLE</SubstanceName>
<StrengthNumber>4; 12; 12; 12; 12; 12; 12; 12</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</StrengthUnit>
<Pharm_Classes>Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180613</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: Temporarily relieves itching, burning, rosy or red skin.**.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43406-0693-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (43406-0693-1) </PackageDescription>
<NDC11Code>43406-0693-01</NDC11Code>
<ProductNDC>43406-0693</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nasal Decongestant</ProprietaryName>
<NonProprietaryName>Camellia Sinensis, Ephedra Vulgaris, Belladonna, Arsenicum Album, Cinnabaris, Kali Bichromicum, Pulsatilla, Sepia, Calcarea Carbonica, Mercurius Solubilis, Sulphur</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180613</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Natural Creations, Inc</LabelerName>
<SubstanceName>CAMELLIA SINENSIS WHOLE; EPHEDRA DISTACHYA FLOWERING TWIG; ATROPA BELLADONNA; ARSENIC TRIOXIDE; MERCURIC SULFIDE; POTASSIUM DICHROMATE; PULSATILLA VULGARIS WHOLE; SEPIA OFFICINALIS JUICE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; MERCURIUS SOLUBILIS; SULFUR</SubstanceName>
<StrengthNumber>4; 4; 4; 12; 12; 12; 12; 12; 30; 30; 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</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-01-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180613</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: Temporary relief of nasal congestion.**.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43406-0707-5</NDCCode>
<PackageDescription>56.7 g in 1 TUBE (43406-0707-5) </PackageDescription>
<NDC11Code>43406-0707-05</NDC11Code>
<ProductNDC>43406-0707</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Injure Gel</ProprietaryName>
<NonProprietaryName>Arnica Montana, Calendula Officinalis, Hypericum Perf, Symphytum Off, Bellis Per, Ledum Palustre, Sulphuricum Ac, Calc Fluor, Ferrum Phos, Rhus Tox, Nat Sulphuricum</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190821</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Natural Creations, Inc</LabelerName>
<SubstanceName>CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; BELLIS PERENNIS WHOLE; RHODODENDRON TOMENTOSUM LEAFY TWIG; SULFURIC ACID; CALCIUM FLUORIDE; FERROSOFERRIC PHOSPHATE; TOXICODENDRON PUBESCENS LEAF; ARNICA MONTANA WHOLE; HYPERICUM PERFORATUM WHOLE; SODIUM SULFATE</SubstanceName>
<StrengthNumber>4; 6; 12; 12; 12; 30; 30; 30; 30; 30; 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_C]/g; [hp_C]/g; [hp_C]/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-01-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190821</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: Temporarily relieves soreness and bruised feelings.**.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43406-0709-5</NDCCode>
<PackageDescription>56.7 g in 1 TUBE, WITH APPLICATOR (43406-0709-5) </PackageDescription>
<NDC11Code>43406-0709-05</NDC11Code>
<ProductNDC>43406-0709</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hemorrhoid Gel</ProprietaryName>
<NonProprietaryName>Achillea Millefolium, Aesculus Hippocastanum, Hamamelis Virginiana, Ruscus Aculeatus, Aloe Socotrina, Paeonia Officinalis, Ignatia Amara, Nitricum Acidum, Nux Vomica, Phosphorus, Podophyllum Peitatum, Pulsatilla, Ratanhia, Chelidonium Majus, Sulphur</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190912</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Natural Creations, Inc</LabelerName>
<SubstanceName>ACHILLEA MILLEFOLIUM WHOLE; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; RUSCUS ACULEATUS WHOLE; ALOE; PAEONIA OFFICINALIS ROOT; STRYCHNOS IGNATII SEED; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PODOPHYLLUM; PULSATILLA VULGARIS WHOLE; KRAMERIA LAPPACEA ROOT; HORSE CHESTNUT; CHELIDONIUM MAJUS WHOLE; SULFUR</SubstanceName>
<StrengthNumber>4; 4; 4; 6; 6; 12; 12; 12; 12; 12; 12; 30; 30; 30; 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_C]/g; [hp_C]/g; [hp_C]/g; [hp_C]/g</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190912</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: Temporarily relieves bleeding, painful, burning &/or stinging hemorrhoids & hemorrhoid related symptoms.**.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43406-0715-2</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE, DROPPER (43406-0715-2) </PackageDescription>
<NDC11Code>43406-0715-02</NDC11Code>
<ProductNDC>43406-0715</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hydrate 1</ProprietaryName>
<NonProprietaryName>Berberisaqui,betavulgaris,boldo,carduusmarianus,chelidoniummajus,eleutherococcus Senticosus,hordeumvulgare,irisversicolor,rosmarinusofficinalis,taraxacumofficinale,xanthoxylumfraxineum,ulmusfulva,glycyrrhizaglabra,gettysburgaqua,wildbadaqua,carlsbadaqua,atp,natrummuriaticum,oxygen,silicea,wiesbadenaqua,hydrogen</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20210602</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Natural Creations, Inc</LabelerName>
<SubstanceName>BERBERIS AQUIFOLIUM ROOT BARK; BETA VULGARIS WHOLE; PEUMUS BOLDUS LEAF; MILK THISTLE; CHELIDONIUM MAJUS WHOLE; ELEUTHEROCOCCUS SENTICOSUS WHOLE; HORDEUM VULGARE WHOLE; IRIS VERSICOLOR ROOT; SALVIA ROSMARINUS FLOWERING TOP; TARAXACUM OFFICINALE; ULMUS RUBRA BARK; ZANTHOXYLUM AMERICANUM BARK; GLYCYRRHIZA GLABRA; ADENOSINE TRIPHOSPHATE; HYDROGEN; SODIUM CHLORIDE; OXYGEN; SILICON DIOXIDE</SubstanceName>
<StrengthNumber>4; 4; 4; 4; 4; 4; 4; 4; 4; 4; 6; 4; 12; 30; 34; 30; 30; 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_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210602</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: To help maintain a healthy level of hydration in the body.**.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0597-0595-20</NDCCode>
<PackageDescription>2 KIT in 1 CARTON (0597-0595-20) / 1 KIT in 1 KIT * 1 SYRINGE in 1 TRAY (0597-0590-26) / .8 mL in 1 SYRINGE * 2 PACKET in 1 TRAY / 1 mL in 1 PACKET</PackageDescription>
<NDC11Code>00597-0595-20</NDC11Code>
<ProductNDC>0597-0595</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Adalimumab-adbm</ProprietaryName>
<NonProprietaryName>Adalimumab-adbm</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20231001</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA761058</ApplicationNumber>
<LabelerName>Boehringer Ingelheim Pharmaceuticals, Inc.</LabelerName>
<Status>Active</Status>
<LastUpdate>2025-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adalimumab-adbm is a tumor necrosis factor (TNF) blocker indicated for: 1 Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. (1.1), 2 Reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. (1.2), 3 Reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. (1.3), 4 Reducing signs and symptoms in adult patients with active ankylosing spondylitis. (1.4), 5 Treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. (1.5), 6 Treatment of moderately to severely active ulcerative colitis in adult patients. (1.6)Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers., 7 Treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. (1.7), 8 Treatment of moderate to severe hidradenitis suppurativa in patients 12 years of age and older. (1.8), 9 Treatment of non-infectious intermediate, posterior, and panuveitis in adults and pediatric patients 2 years of age and older. (1.9).</IndicationAndUsage>
<Description>Adalimumab-adbm is a tumor necrosis factor blocker. Adalimumab-adbm is a recombinant human IgG1 monoclonal antibody produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary (CHO)) expression system and is purified by a process that includes specific viral inactivation and removal steps. It consists of 1330 amino acids and has a molecular weight of approximately 148 kilodaltons. Adalimumab-adbm injection is supplied as a sterile, preservative-free solution of adalimumab-adbm for subcutaneous administration. The drug product is supplied as either a single-dose, prefilled pen (Adalimumab-adbm Pen) or as a single-dose, 1 mL prefilled glass syringe. Enclosed within the pen is a single-dose, 1 mL prefilled glass syringe. The solution of Adalimumab-adbm is clear to slightly opalescent and colorless to slightly yellow, with a pH of about 5.5. Each 40 mg/0.4 mL prefilled syringe or prefilled pen delivers 0.4 mL (40 mg) of drug product. Each 0.4 mL of Adalimumab-adbm contains adalimumab-adbm (40 mg), glacial acetic acid (0.03 mg), polysorbate 80 (0.2 mg), sodium acetate trihydrate (0.47 mg), trehalose dihydrate (30.3 mg), and Water for Injection, USP. Each 40 mg/0.8 mL prefilled syringe or prefilled pen delivers 0.8 mL (40 mg) of drug product. Each 0.8 mL of Adalimumab-adbm contains adalimumab-adbm (40 mg), glacial acetic acid (0.13 mg), polysorbate 80 (0.8 mg), sodium acetate trihydrate (2.4 mg), trehalose dihydrate (65.0 mg), and Water for Injection, USP. Each 20 mg/0.4 mL prefilled syringe delivers 0.4 mL (20 mg) of drug product. Each 0.4 mL of Adalimumab-adbm contains adalimumab-adbm (20 mg), glacial acetic acid (0.06 mg), polysorbate 80 (0.4 mg), sodium acetate trihydrate (1.21 mg), trehalose dihydrate (32.5 mg), and Water for Injection, USP. Each 10 mg/0.2 mL prefilled syringe delivers 0.2 mL (10 mg) of drug product. Each 0.2 mL of Adalimumab-adbm contains adalimumab-adbm (10 mg), glacial acetic acid (0.03 mg), polysorbate 80 (0.2 mg), sodium acetate trihydrate (0.61 mg), trehalose dihydrate (16.3 mg), and Water for Injection, USP.</Description>
</NDC>
<NDC>
<NDCCode>0832-0595-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (0832-0595-30) </PackageDescription>
<NDC11Code>00832-0595-30</NDC11Code>
<ProductNDC>0832-0595</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Exemestane</ProprietaryName>
<NonProprietaryName>Exemestane</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170727</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209208</ApplicationNumber>
<LabelerName>Upsher-Smith Laboratories, Inc.</LabelerName>
<SubstanceName>EXEMESTANE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aromatase Inhibitor [EPC], Aromatase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-03-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170727</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Exemestane tablets are an aromatase inhibitor indicated for: 1 adjuvant treatment of postmenopausal women with estrogen-receptor positive early breast cancer who have received two to three years of tamoxifen and are switched to exemestane for completion of a total of five consecutive years of adjuvant hormonal therapy ( 14.1). , 2 treatment of advanced breast cancer in postmenopausal women whose disease has progressed following tamoxifen therapy ( 14.2). .</IndicationAndUsage>
<Description>Exemestane tablets, USP for oral administration contain 25 mg of exemestane, an irreversible, steroidal aromatase inactivator. Exemestane, USP is chemically described as 6-methylenandrosta-1,4-diene-3,17-dione. Its molecular formula is C 20H 24O 2and its structural formula is as follows:. The active ingredient is a white to slightly yellow crystalline powder with a molecular weight of 296.41. Exemestane is freely soluble in N, N-dimethylformamide, soluble in methanol, and practically insoluble in water. Each exemestane tablet contains the following inactive ingredients: colloidal silicon dioxide, crospovidone, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol, polysorbate 80, sodium starch glycolate and titanium dioxide. FDA approved dissolution test specifications differs from USP.</Description>
</NDC>
<NDC>
<NDCCode>13537-595-12</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (13537-595-12) > 4 g in 1 TUBE (13537-595-11)</PackageDescription>
<NDC11Code>13537-0595-12</NDC11Code>
<ProductNDC>13537-595</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Esika Hydracolor 2 In 1 Spf 25</ProprietaryName>
<ProprietaryNameSuffix>(rosa Encanto) - Pink</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Oxybenzone</NonProprietaryName>
<DosageFormName>LIPSTICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20151123</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura Corporation LTD</LabelerName>
<SubstanceName>OCTINOXATE; OXYBENZONE</SubstanceName>
<StrengthNumber>.0664; .0151</StrengthNumber>
<StrengthUnit>g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>14141-595-01</NDCCode>
<PackageDescription>1 CASE in 1 BOX (14141-595-01) / 10 g in 1 CASE</PackageDescription>
<NDC11Code>14141-0595-01</NDC11Code>
<ProductNDC>14141-595</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Esika Colorfix Polvos 32h Polvo Compacto Facial De Alta Cobertura Fps 15 220-c</ProprietaryName>
<NonProprietaryName>Octinoxate, Titanium Dioxide, Zinc Oxide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260803</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>BEL STAR S.A.</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>30; 62.4; 49</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-08-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260803</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ayuda a prevenir quemaduras solares.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>21130-595-40</NDCCode>
<PackageDescription>355 mL in 1 BOTTLE (21130-595-40) </PackageDescription>
<NDC11Code>21130-0595-40</NDC11Code>
<ProductNDC>21130-595</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Signature Care Nighttime Severe Cold And Flu Relief</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate, Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200710</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Safeway</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>650; 20; 12.5; 10</StrengthNumber>
<StrengthUnit>mg/30mL; mg/30mL; mg/30mL; mg/30mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-11-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200710</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves common cold/flu symptoms: 1 sinus congestion and pressure, 2 nasal congestion, 3 minor aches and pains, 4 headache, 5 runny nose and sneezing, 6 sore throat, 7 cough to help you sleep, 8 fever, 9 cough due to minor throat and bronchial irritation, 10 reduces swelling of nasal passages, 11 promotes nasal and/or sinus drainage, 12 temporarily restores freer breathing through the nose.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>21695-595-05</NDCCode>
<PackageDescription>5 mL in 1 BOTTLE, PLASTIC (21695-595-05)</PackageDescription>
<NDC11Code>21695-0595-05</NDC11Code>
<ProductNDC>21695-595</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Neomycin And Polymyxin B Sulfates And Dexamethasone</ProprietaryName>
<NonProprietaryName>Neomycin Sulfate, Polymyxin B Sulfate And Dexamethasone</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>OPHTHALMIC</RouteName>
<StartMarketingDate>19861117</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA062721</ApplicationNumber>
<LabelerName>Rebel Distributors Corp</LabelerName>
<SubstanceName>NEOMYCIN SULFATE; POLYMYXIN B SULFATE; DEXAMETHASONE</SubstanceName>
<StrengthNumber>3.5; 10000; 1</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Aminoglycoside Antibacterial [EPC],Aminoglycosides [CS],Polymyxin-class Antibacterial [EPC],Polymyxins [CS],Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial ocular infection exists. Ocular corticosteroids are indicated in inflammatory conditions of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe where the inherent risk of corticosteroids use in certain infective conjunctivitides is accepted to obtain a diminution in edema and inflammation. They are also indicated in chronic anterior uveitis and corneal injury from chemical, radiation or thermal burns; or penetration of foreign bodies. The use of a combination drug with an anti-infective component is indicated where the risk of infection is high or where there is an expectation that potentially dangerous numbers of bacteria will be present in the eye. The particular anti-infective drug in this product is active against the following common bacterial eye pathogens: Staphylococcus aureus, Escherichia coli, Haemophilus influenzae, Klebsiella/Enterobacter species, Neisseria species, and Pseudomonas aeruginosa. This product does not provide adequate coverage against: Serratia marcescens and streptococci, including Streptococcus pneumoniae.</IndicationAndUsage>
<Description>Neomycin and polymyxin B sulfates and dexamethasone ophthalmic suspension is a multiple dose anti-infective steroid combination in sterile suspension form for topical application. The chemical structure for the active ingredient, dexamethasone, is. Established Name. dexamethasone. Chemical Name. pregna-1, 4-diene-3, 20-dione, 9-fluoro-11,17, 21-trihydroxy-16-methyl-, (11β, 16α)-. The other active ingredients are neomycin sulfate and polymyxin B sulfate. Each mL contains: Actives: neomycin sulfate equivalent to neomycin 3.5 mg, polymyxin B sulfate 10,000 units, dexamethasone 0.1%. Preservative: benzalkonium chloride 0.004%. Vehicle: hypromellose 2910 0.5%. Inactives: sodium chloride, polysorbate 20, hydrochloric acid and/or sodium hydroxide (to adjust pH), purified water.</Description>
</NDC>
</NDCList>