{
"NDC": [
{
"NDCCode": "57955-1511-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-1511-2)",
"NDC11Code": "57955-1511-02",
"ProductNDC": "57955-1511",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hyperactive",
"NonProprietaryName": "Adrenalinum, Allium Sativum, Anethum Graveolens, Arsenicum Album, Arsenicum Iodatum, Asafoetida, Belladonna, Cereus Bonplandii, Chamomilla, Coffea Cruda, Erodium, Impatiens Glandulifera, Flos, Iodium, Mandragora Officinarum, Solidago Virgaurea, Thyroidinum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20121106",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "EPINEPHRINE; GARLIC; DILL; ARSENIC TRIOXIDE; ARSENIC TRIIODIDE; ASAFETIDA; ATROPA BELLADONNA; HARRISIA POMANENSIS STEM; MATRICARIA RECUTITA; ARABICA COFFEE BEAN; ERODIUM CICUTARIUM; IMPATIENS GLANDULIFERA FLOWER; IODINE; MANDRAGORA OFFICINARUM ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; THYROID, UNSPECIFIED",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses a natural aid for: hyperactivity, excitability, impulsiveness, restlessness."
},
{
"NDCCode": "22840-1511-2",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (22840-1511-2) ",
"NDC11Code": "22840-1511-02",
"ProductNDC": "22840-1511",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Mustard",
"NonProprietaryName": "Brassica Spp.",
"DosageFormName": "SOLUTION",
"RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19810915",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101833",
"LabelerName": "Greer Laboratories, Inc.",
"SubstanceName": "BRASSICA RAPA POLLEN",
"StrengthNumber": ".1",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]",
"Status": "Active",
"LastUpdate": "2025-06-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19810915",
"SamplePackage": "N",
"IndicationAndUsage": "Non-Standardized Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergies to one or more of the specific non-standardized allergens., 2 Immunotherapy for the reduction of allergen-induced allergic symptoms confirmed by appropriate positive skin tests or by in vitro testing for allergen-specific IgE antibodies. .",
"Description": "Non-Standardized Allergenic Extracts are sterile solutions used for percutaneous testing, intradermal testing, or subcutaneous immunotherapy. Aqueous extracts contain the soluble extractants of the source material in water for injection, 0.5% sodium chloride, 0.54% sodium bicarbonate, and 0.4% phenol. Glycerinated extracts contain the soluable extractants of the source material in water for injection and 50% glycerin, 0.25% sodium chloride, 0.27% sodium bicarbonate, and 0.2% phenol. The pH of the extracts range from 6 to 9. Certain food extracts (Barley, Oat, Pineapple, Rye, Spinach, and Wheat), labeled “For Diagnostic Use Only”, contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Source materials used in the manufacture of allergenic extracts are collected from natural sources or from laboratory cultures. Non-Standardized Allergenic Extracts appear as clear and colorless to dark brown solutions that should be free of particulate matter. Extracts are labeled either as weight-to-volume based on the weight of the source material to the volume of the extracting fluid, or as PNU/milliliter with one PNU representing 0.00001 mg of protein nitrogen per milliliter."
},
{
"NDCCode": "36987-1511-2",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (36987-1511-2)",
"NDC11Code": "36987-1511-02",
"ProductNDC": "36987-1511",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Spinach",
"NonProprietaryName": "Spinach",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "SPINACH",
"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],Vegetable Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "37662-1511-2",
"PackageDescription": "500 PELLET in 1 VIAL, GLASS (37662-1511-2) ",
"NDC11Code": "37662-1511-02",
"ProductNDC": "37662-1511",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Linum Usitatissimum",
"NonProprietaryName": "Linum Usitatissimum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220913",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "FLAX SEED",
"StrengthNumber": "1",
"StrengthUnit": "[hp_M]/1",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]",
"Status": "Active",
"LastUpdate": "2022-09-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220913",
"SamplePackage": "N"
},
{
"NDCCode": "50090-1511-2",
"PackageDescription": "21 CAPSULE in 1 BOTTLE (50090-1511-2) ",
"NDC11Code": "50090-1511-02",
"ProductNDC": "50090-1511",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20051109",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065271",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Active",
"LastUpdate": "2025-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20141210",
"SamplePackage": "N",
"IndicationAndUsage": "Adults and Pediatric Patients. Adult Patients only. Triple therapy for Helicobacter pylori (H. pylori) with clarithromycin and lansoprazole:. Amoxicillin capsules in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. Dual therapy for H. pylori with lansoprazole: Amoxicillin capsules, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. (See the clarithromycin package insert, MICROBIOLOGY.) Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. Usage. To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin capsules and other antibacterial drugs, amoxicillin capsules should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Amoxicillin capsules, USP are a semisynthetic antibacterial (amoxicillin), an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2S,5R,6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as: The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.45. Each capsule of amoxicillin with blue cap and pink body, contains 250 mg or 500 mg amoxicillin USP as the trihydrate. The body of the 250 mg capsule is imprinted with ‘A44’ in black ink. The body of the 500 mg capsule is imprinted with ‘A45’ in black ink. Inactive ingredients: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, and titanium dioxide. Meets USP Dissolution Test 2."
},
{
"NDCCode": "51552-1511-2",
"PackageDescription": "5 g in 1 CONTAINER (51552-1511-2) ",
"NDC11Code": "51552-1511-02",
"ProductNDC": "51552-1511",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Nicotinamide Adenine Dinucleotide (nad)",
"DosageFormName": "POWDER",
"StartMarketingDate": "20160915",
"EndMarketingDate": "20240525",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Fagron Inc",
"SubstanceName": "NADIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"StartMarketingDatePackage": "15-SEP-16",
"EndMarketingDatePackage": "03-FEB-24"
},
{
"NDCCode": "55714-1511-2",
"PackageDescription": "59.14 mL in 1 BOTTLE, GLASS (55714-1511-2)",
"NDC11Code": "55714-1511-02",
"ProductNDC": "55714-1511",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Diarrhea",
"NonProprietaryName": "Aconitum Nap., Arg. Nit., Arsenicum Alb., Baptisia, Bryonia, Carbo Veg., Chamomilla, Cinchona, Collinsonia, Colocynthis, Elaterium, Gelsemium, Ipecac., Iris Versicolor, Lycopodium, Mag. Carb., Phosphorus, Podoph. Pelt., Rheum, Sulphur, Tabacum, Vaccinium, Aesculus Hipp. Juglans Regia, Valeriana",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Newton Laboratories, Inc.",
"SubstanceName": "ACONITUM NAPELLUS; SILVER NITRATE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; ACTIVATED CHARCOAL; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; COLLINSONIA CANADENSIS ROOT; CITRULLUS COLOCYNTHIS FRUIT PULP; ECBALLIUM ELATERIUM FRUIT; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; IRIS VERSICOLOR ROOT; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CARBONATE; PHOSPHORUS; PODOPHYLLUM; RHEUM OFFICINALE WHOLE; SULFUR; TOBACCO LEAF; BILBERRY; HORSE CHESTNUT; JUGLANS REGIA WHOLE; VALERIAN",
"StrengthNumber": "15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"IndicationAndUsage": "Diarrhea Formulated for associated symptoms such as loose or watery stools, cramping, gas, nausea, irritation and fatigue."
},
{
"NDCCode": "71335-1511-2",
"PackageDescription": "12 TABLET in 1 BOTTLE (71335-1511-2) ",
"NDC11Code": "71335-1511-02",
"ProductNDC": "71335-1511",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluconazole",
"NonProprietaryName": "Fluconazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20040729",
"EndMarketingDate": "20220630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076077",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "FLUCONAZOLE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20211228",
"EndMarketingDatePackage": "20220630",
"SamplePackage": "N"
},
{
"NDCCode": "71335-1511-7",
"PackageDescription": "2 TABLET in 1 BOTTLE (71335-1511-7) ",
"NDC11Code": "71335-1511-07",
"ProductNDC": "71335-1511",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fluconazole",
"NonProprietaryName": "Fluconazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20040729",
"EndMarketingDate": "20220630",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076077",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "FLUCONAZOLE",
"StrengthNumber": "200",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200601",
"EndMarketingDatePackage": "20220630",
"SamplePackage": "N"
},
{
"NDCCode": "0409-1511-98",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 TRAY (0409-1511-98) / 20 mL in 1 VIAL, SINGLE-DOSE (0409-1511-97) ",
"NDC11Code": "00409-1511-98",
"ProductNDC": "0409-1511",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Propofol",
"NonProprietaryName": "Propofol",
"DosageFormName": "INJECTION, EMULSION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20260817",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077908",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "PROPOFOL",
"StrengthNumber": "10",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "General Anesthesia [PE], General Anesthetic [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260817",
"SamplePackage": "N",
"IndicationAndUsage": "Propofol injectable emulsion is an intravenous general anesthetic and sedation drug indicated for: : 1 Induction of General Anesthesia for Patients Greater than or Equal to 3 Years of Age , 2 Maintenance of General Anesthesia for Patients Greater than or Equal to 2 Months of Age , 3 Initiation and Maintenance of Monitored Anesthesia Care (MAC) Sedation in Adult Patients , 4 Sedation for Adult Patients in Combination with Regional Anesthesia , 5 Intensive Care Unit (ICU) Sedation of Intubated, Mechanically Ventilated Adult Patients .",
"Description": "Propofol Injectable Emulsion, USP is an anesthetic available as a sterile, nonpyrogenic white to slight off-white homogeneous emulsion for intravenous administration. The structural formula is. Chemical name: 2,6-diisopropylphenol. Molecular formula: C12H18O. Molecular weight: 178.28. Propofol, USP is slightly soluble in water. The pKa is 11. The octanol/water partition coefficient for propofol is 6761:1 at a pH of 6 to 8.5. Each mL of propofol injectable emulsion, USP contains 10 mg of propofol, 100 mg of soybean oil (100 mg/mL), 22.5 mg of glycerol (22.5 mg/mL), 12 mg of egg lecithin (12 mg/mL), 1.5 mg of benzyl alcohol (1.5 mg/mL), 0.7 mg of sodium benzoate (0.7 mg/mL), and sodium hydroxide to adjust pH, in water for injection. Propofol Injectable Emulsion, USP is isotonic and has a pH of 6 to 8.5."
},
{
"NDCCode": "22840-1511-4",
"PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (22840-1511-4) ",
"NDC11Code": "22840-1511-04",
"ProductNDC": "22840-1511",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Mustard",
"NonProprietaryName": "Brassica Spp.",
"DosageFormName": "SOLUTION",
"RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19810915",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101833",
"LabelerName": "Greer Laboratories, Inc.",
"SubstanceName": "BRASSICA RAPA POLLEN",
"StrengthNumber": ".1",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]",
"Status": "Active",
"LastUpdate": "2025-06-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19810915",
"SamplePackage": "N",
"IndicationAndUsage": "Non-Standardized Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergies to one or more of the specific non-standardized allergens., 2 Immunotherapy for the reduction of allergen-induced allergic symptoms confirmed by appropriate positive skin tests or by in vitro testing for allergen-specific IgE antibodies. .",
"Description": "Non-Standardized Allergenic Extracts are sterile solutions used for percutaneous testing, intradermal testing, or subcutaneous immunotherapy. Aqueous extracts contain the soluble extractants of the source material in water for injection, 0.5% sodium chloride, 0.54% sodium bicarbonate, and 0.4% phenol. Glycerinated extracts contain the soluable extractants of the source material in water for injection and 50% glycerin, 0.25% sodium chloride, 0.27% sodium bicarbonate, and 0.2% phenol. The pH of the extracts range from 6 to 9. Certain food extracts (Barley, Oat, Pineapple, Rye, Spinach, and Wheat), labeled “For Diagnostic Use Only”, contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Source materials used in the manufacture of allergenic extracts are collected from natural sources or from laboratory cultures. Non-Standardized Allergenic Extracts appear as clear and colorless to dark brown solutions that should be free of particulate matter. Extracts are labeled either as weight-to-volume based on the weight of the source material to the volume of the extracting fluid, or as PNU/milliliter with one PNU representing 0.00001 mg of protein nitrogen per milliliter."
},
{
"NDCCode": "50090-1511-0",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (50090-1511-0) ",
"NDC11Code": "50090-1511-00",
"ProductNDC": "50090-1511",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20051109",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065271",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Active",
"LastUpdate": "2025-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20141210",
"SamplePackage": "N",
"IndicationAndUsage": "Adults and Pediatric Patients. Adult Patients only. Triple therapy for Helicobacter pylori (H. pylori) with clarithromycin and lansoprazole:. Amoxicillin capsules in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. Dual therapy for H. pylori with lansoprazole: Amoxicillin capsules, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. (See the clarithromycin package insert, MICROBIOLOGY.) Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. Usage. To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin capsules and other antibacterial drugs, amoxicillin capsules should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Amoxicillin capsules, USP are a semisynthetic antibacterial (amoxicillin), an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2S,5R,6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as: The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.45. Each capsule of amoxicillin with blue cap and pink body, contains 250 mg or 500 mg amoxicillin USP as the trihydrate. The body of the 250 mg capsule is imprinted with ‘A44’ in black ink. The body of the 500 mg capsule is imprinted with ‘A45’ in black ink. Inactive ingredients: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, and titanium dioxide. Meets USP Dissolution Test 2."
},
{
"NDCCode": "50090-1511-1",
"PackageDescription": "40 CAPSULE in 1 BOTTLE (50090-1511-1) ",
"NDC11Code": "50090-1511-01",
"ProductNDC": "50090-1511",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20051109",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065271",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Active",
"LastUpdate": "2025-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20141210",
"SamplePackage": "N",
"IndicationAndUsage": "Adults and Pediatric Patients. Adult Patients only. Triple therapy for Helicobacter pylori (H. pylori) with clarithromycin and lansoprazole:. Amoxicillin capsules in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. Dual therapy for H. pylori with lansoprazole: Amoxicillin capsules, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. (See the clarithromycin package insert, MICROBIOLOGY.) Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. Usage. To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin capsules and other antibacterial drugs, amoxicillin capsules should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Amoxicillin capsules, USP are a semisynthetic antibacterial (amoxicillin), an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2S,5R,6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as: The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.45. Each capsule of amoxicillin with blue cap and pink body, contains 250 mg or 500 mg amoxicillin USP as the trihydrate. The body of the 250 mg capsule is imprinted with ‘A44’ in black ink. The body of the 500 mg capsule is imprinted with ‘A45’ in black ink. Inactive ingredients: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, and titanium dioxide. Meets USP Dissolution Test 2."
},
{
"NDCCode": "50090-1511-5",
"PackageDescription": "15 CAPSULE in 1 BOTTLE (50090-1511-5) ",
"NDC11Code": "50090-1511-05",
"ProductNDC": "50090-1511",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20051109",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065271",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Active",
"LastUpdate": "2025-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210326",
"SamplePackage": "N",
"IndicationAndUsage": "Adults and Pediatric Patients. Adult Patients only. Triple therapy for Helicobacter pylori (H. pylori) with clarithromycin and lansoprazole:. Amoxicillin capsules in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. Dual therapy for H. pylori with lansoprazole: Amoxicillin capsules, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. (See the clarithromycin package insert, MICROBIOLOGY.) Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. Usage. To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin capsules and other antibacterial drugs, amoxicillin capsules should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Amoxicillin capsules, USP are a semisynthetic antibacterial (amoxicillin), an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2S,5R,6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as: The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.45. Each capsule of amoxicillin with blue cap and pink body, contains 250 mg or 500 mg amoxicillin USP as the trihydrate. The body of the 250 mg capsule is imprinted with ‘A44’ in black ink. The body of the 500 mg capsule is imprinted with ‘A45’ in black ink. Inactive ingredients: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, and titanium dioxide. Meets USP Dissolution Test 2."
},
{
"NDCCode": "50090-1511-7",
"PackageDescription": "10 CAPSULE in 1 BOTTLE (50090-1511-7) ",
"NDC11Code": "50090-1511-07",
"ProductNDC": "50090-1511",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20051109",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065271",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Active",
"LastUpdate": "2025-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210326",
"SamplePackage": "N",
"IndicationAndUsage": "Adults and Pediatric Patients. Adult Patients only. Triple therapy for Helicobacter pylori (H. pylori) with clarithromycin and lansoprazole:. Amoxicillin capsules in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. Dual therapy for H. pylori with lansoprazole: Amoxicillin capsules, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. (See the clarithromycin package insert, MICROBIOLOGY.) Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. Usage. To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin capsules and other antibacterial drugs, amoxicillin capsules should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Amoxicillin capsules, USP are a semisynthetic antibacterial (amoxicillin), an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2S,5R,6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as: The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.45. Each capsule of amoxicillin with blue cap and pink body, contains 250 mg or 500 mg amoxicillin USP as the trihydrate. The body of the 250 mg capsule is imprinted with ‘A44’ in black ink. The body of the 500 mg capsule is imprinted with ‘A45’ in black ink. Inactive ingredients: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, and titanium dioxide. Meets USP Dissolution Test 2."
},
{
"NDCCode": "50090-1511-8",
"PackageDescription": "9 CAPSULE in 1 BOTTLE (50090-1511-8) ",
"NDC11Code": "50090-1511-08",
"ProductNDC": "50090-1511",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Amoxicillin",
"NonProprietaryName": "Amoxicillin",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20051109",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA065271",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "AMOXICILLIN",
"StrengthNumber": "500",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Penicillin-class Antibacterial [EPC], Penicillins [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20141210",
"SamplePackage": "N",
"IndicationAndUsage": "Adults and Pediatric Patients. Adult Patients only. Triple therapy for Helicobacter pylori (H. pylori) with clarithromycin and lansoprazole:. Amoxicillin capsules in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. Dual therapy for H. pylori with lansoprazole: Amoxicillin capsules, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. (See the clarithromycin package insert, MICROBIOLOGY.) Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. Usage. To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin capsules and other antibacterial drugs, amoxicillin capsules should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.",
"Description": "Amoxicillin capsules, USP are a semisynthetic antibacterial (amoxicillin), an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2S,5R,6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as: The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.45. Each capsule of amoxicillin with blue cap and pink body, contains 250 mg or 500 mg amoxicillin USP as the trihydrate. The body of the 250 mg capsule is imprinted with ‘A44’ in black ink. The body of the 500 mg capsule is imprinted with ‘A45’ in black ink. Inactive ingredients: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, and titanium dioxide. Meets USP Dissolution Test 2."
},
{
"NDCCode": "57955-0001-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0001-2)",
"NDC11Code": "57955-0001-02",
"ProductNDC": "57955-0001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Eating Disorders",
"NonProprietaryName": "Antimonium Crudum, Cinchona Officinalis, Ferrum Metallicum, Hyoscyamus Niger, Ignatia Amara, Natrum Muriaticum, Nux Vomica, Phosphoricum Acidum, Pulsatilla, Staphysagria, Thuja Occidentalis, Veratrum Album",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20140417",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc",
"SubstanceName": "ANTIMONY TRISULFIDE; CINCHONA OFFICINALIS BARK; IRON; HYOSCYAMUS NIGER; STRYCHNOS IGNATII SEED; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PULSATILLA VULGARIS; DELPHINIUM STAPHISAGRIA SEED; THUJA OCCIDENTALIS LEAFY TWIG; VERATRUM ALBUM ROOT",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for a natural aid for relief of: nausea, vomiting, loss of appetite, digestive tract disturbances and emotional sensitivity that may be associated with eating disorders."
},
{
"NDCCode": "57955-0002-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0002-2)",
"NDC11Code": "57955-0002-02",
"ProductNDC": "57955-0002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Birth Ease",
"NonProprietaryName": "Aletris Farinosa, Apis Mellifica, Arnica Montana, Belladonna, Caulophyllum Thalictroides, Chamomilla, Cimicifuga Racemosa, Ferrum Metallicum, Kali Carbonicum, Sabina, Secale Cornutum, Viburnum Opulus",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20140417",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "ALETRIS FARINOSA ROOT; APIS MELLIFERA; ARNICA MONTANA; ATROPA BELLADONNA; CAULOPHYLLUM THALICTROIDES ROOT; MATRICARIA RECUTITA; BLACK COHOSH; IRON; POTASSIUM CARBONATE; JUNIPERUS SABINA LEAFY TWIG; CLAVICEPS PURPUREA SCLEROTIUM; VIBURNUM OPULUS BARK",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of: Muscular pains, stinging pain, tenderness over abdomen, vaginal dryness and heat, tender nipples, spasmodic labor pains, restlessness, extreme backache."
},
{
"NDCCode": "57955-0003-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0003-2)",
"NDC11Code": "57955-0003-02",
"ProductNDC": "57955-0003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Breast Cyst And Discomforts",
"NonProprietaryName": "Aconitum Napellus, Bellis Perennis, Bromium, Bryonia, Chamomilla, Conium Maculatum, Iodium, Phellandrium Aquaticum, Phytolacca Decandra, Scrophularia Nodosa, Silicea",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20140417",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "ACONITUM NAPELLUS; BELLIS PERENNIS; BROMINE; BRYONIA ALBA ROOT; MATRICARIA RECUTITA; CONIUM MACULATUM FLOWERING TOP; IODINE; OENANTHE AQUATICA FRUIT; PHYTOLACCA AMERICANA ROOT; SCROPHULARIA NODOSA; SILICON DIOXIDE",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of symptoms: inflammation, tenderness, lumpiness, hardness, soreness, cracked or irritated nipples from nursing, shrinking breasts following nursing."
},
{
"NDCCode": "57955-0004-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0004-2)",
"NDC11Code": "57955-0004-02",
"ProductNDC": "57955-0004",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Menstrual Cramps And Irregularities",
"NonProprietaryName": "Cactus Grandiflorus, Caulophyllum Thalictroides, Chamomilla, Cimicifuga Racemosa, Colocynthis, Ipecacuanha, Magnesia Phosphorica, Sepia, Viburnum Opulus, Xanthoxylum Fraxineum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150219",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "SELENICEREUS GRANDIFLORUS STEM; CAULOPHYLLUM THALICTROIDES ROOT; MATRICARIA RECUTITA; BLACK COHOSH; CITRULLUS COLOCYNTHIS FRUIT PULP; IPECAC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SEPIA OFFICINALIS JUICE; VIBURNUM OPULUS BARK; ZANTHOXYLUM AMERICANUM BARK",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of symptoms: cramps, aches and pains, Abdominal bloating, heavy or gushing menstruation, backache, menstrual headache, irregular periods, lack of menstrual flow."
},
{
"NDCCode": "57955-0005-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0005-2)",
"NDC11Code": "57955-0005-02",
"ProductNDC": "57955-0005",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ferticare",
"NonProprietaryName": "Agnus Castus, Apis Mellifica, Aurum Metallicum, Borax, Conium Maculatum, Ferrum Metallicum, Iodium, Lilium Tigrinum, Lycopodium Clavatum, Natrum Muriatcum, Palladium Metallicum, Sepia",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20140417",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "CHASTE TREE; APIS MELLIFERA; GOLD; SODIUM BORATE; CONIUM MACULATUM FLOWERING TOP; IRON; IODINE; LILIUM LANCIFOLIUM WHOLE FLOWERING; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; PALLADIUM; SEPIA OFFICINALIS JUICE",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of symptoms: vaginal dryness, vaginal discharge, sensitive vagina, itching of female genitals associated with sexual activities, irregular cycles and discomforts during intercourse."
},
{
"NDCCode": "57955-0008-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0008-2)",
"NDC11Code": "57955-0008-02",
"ProductNDC": "57955-0008",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Morning Sickness",
"NonProprietaryName": "Aletris Farinosa, Amygdalus Persica, Colchicum Autumnale, Cucurbita Pepo, Semen, Ferrum Metallicum, Ipecacuanha, Lycopodium Clavatum, Nux Vomica, Phosphorus, Pulsatilla, Tabacum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20121106",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "ALETRIS FARINOSA ROOT; PRUNUS PERSICA FLOWER; COLCHICUM AUTUMNALE BULB; PUMPKIN SEED; IRON; IPECAC; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; TOBACCO LEAF",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of: morning sickness, nausea, vomiting, belching, excess saliva, sinking feeling in stomach, tiredness, weakness, sensitivity to noise, and emotional sensitivity."
},
{
"NDCCode": "57955-0010-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0010-2)",
"NDC11Code": "57955-0010-02",
"ProductNDC": "57955-0010",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Male Strengthener",
"NonProprietaryName": "Agnus Castus, Arnica Montana, Baryta Carbonica, Caladium Seguinum, Kali Bromatum, Lycopodium Clavatum, Nuphar Luteum, Nux Vomica, Onosmodium Virginianum, Phosphoricum Acidum, Picnicum Acidum, Selenium Metallicum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20140421",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "CHASTE TREE; ARNICA MONTANA; BARIUM CARBONATE; DIEFFENBACHIA SEGUINE; POTASSIUM BROMIDE; LYCOPODIUM CLAVATUM SPORE; NUPHAR LUTEUM ROOT; STRYCHNOS NUX-VOMICA SEED; ONOSMODIUM VIRGINIANUM WHOLE; PHOSPHORIC ACID; PICRIC ACID; SELENIUM",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of: diminished or absent sexual desire, premature emission, weakness or pain of sexual organs, and tiredness ."
},
{
"NDCCode": "57955-0011-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0011-2)",
"NDC11Code": "57955-0011-02",
"ProductNDC": "57955-0011",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Prostate Strengthener",
"NonProprietaryName": "Baryta Carbonica, Chimaphila Umbellata, Clematis Erecta, Conium Maculatum, Digitalis Purpurea, Phosphoricum Acidum, Sabal Serrulata, Selenium Metallicum, Staphysagria, Thuja Occidentalis, Zincum Metallicum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20140331",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "BARIUM CARBONATE; CHIMAPHILA UMBELLATA; CLEMATIS RECTA FLOWERING TOP; CONIUM MACULATUM FLOWERING TOP; DIGITALIS; PHOSPHORIC ACID; SAW PALMETTO; SELENIUM; DELPHINIUM STAPHISAGRIA SEED; THUJA OCCIDENTALIS LEAFY TWIG; ZINC",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of prostate symptoms: : 1 scanty urination, 2 dribbling, 3 burning and irritation, 4 premature impotence."
},
{
"NDCCode": "57955-0012-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0012-2)",
"NDC11Code": "57955-0012-02",
"ProductNDC": "57955-0012",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bed Wetting Prevention",
"NonProprietaryName": "Belladonna, Bellis Perennis, Benzoicum Acidum, Causticum, Equisetum Hyemale, Lycopodium Clavatum, Phosphorus, Plantago Major, Rhus Aromatica, Sepia",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20150831",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "ATROPA BELLADONNA; BELLIS PERENNIS; BENZOIC ACID; CAUSTICUM; EQUISETUM HYEMALE; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; PLANTAGO MAJOR; RHUS AROMATICA ROOT BARK; SEPIA OFFICINALIS JUICE",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of: involuntary urination during sleep, urinary disturbances, restless sleep.."
},
{
"NDCCode": "57955-0015-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0015-2)",
"NDC11Code": "57955-0015-02",
"ProductNDC": "57955-0015",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Attention And Learning Enhancement",
"NonProprietaryName": "Baryta Carbonica, Calcarea Carbonica, Ignatia Amara, Lycopodium Clavatum, Magnesia Carbonica, Natrum Carbonicum, Natrum Muriaticum, Thuja Occidentalis",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20140528",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "BARIUM CARBONATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CARBONATE; SODIUM CARBONATE; SODIUM CHLORIDE; THUJA OCCIDENTALIS LEAFY TWIG",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2018-02-18",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "57955-0016-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0016-2)",
"NDC11Code": "57955-0016-02",
"ProductNDC": "57955-0016",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Paraclenz",
"NonProprietaryName": "Calcarea Carbonica, Chenopodium Anthelminticum, Cina, Croton Tiglium, Filix Mas, Gambogia, Granatum, Lycopodium Clavatum, Mercurius Corrosivus, Natrum Phosphoricum, Santoninum, Senna, Spigelia Anthelmia, Stannum Metallicum, Tanacetum Vulgare, Teucrium Marum, Zingeber Officinale",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20111118",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "OYSTER SHELL CALCIUM CARBONATE, CRUDE; DYSPHANIA AMBROSIOIDES; ARTEMISIA CINA PRE-FLOWERING TOP; CROTON TIGLIUM SEED; DRYOPTERIS FILIX-MAS ROOT; GAMBOGE; PUNICA GRANATUM ROOT BARK; LYCOPODIUM CLAVATUM SPORE; MERCURIC CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SANTONIN; SENNA LEAF; SPIGELIA ANTHELMIA; TIN; TANACETUM VULGARE TOP; TEUCRIUM MARUM; GINGER",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for symptoms associated with parasites and worms: intestinal irritation, appetite swings, bad breath, constipation, itching nose or anus, angry or irritable moods."
},
{
"NDCCode": "57955-0017-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0017-2)",
"NDC11Code": "57955-0017-02",
"ProductNDC": "57955-0017",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tonsilcure",
"NonProprietaryName": "Ammonium Muriaticum, Baryta Carbonica, Belladonna, Calcarea Phosphorica, Ferrum Phosphoricum, Guaiacum, Kali Muriaticum, Lycopodium Clavatum, Mercurius Solubilis, Phytolacca Decandra, Silicea",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20121022",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "AMMONIUM CHLORIDE; BARIUM CARBONATE; ATROPA BELLADONNA; TRIBASIC CALCIUM PHOSPHATE; FERROSOFERRIC PHOSPHATE; GUAIACUM OFFICINALE RESIN; POTASSIUM CHLORIDE; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; PHYTOLACCA AMERICANA ROOT; SILICON DIOXIDE",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of: sore throat, inflammation, swollen glands, difficulty swallowing, associated fever, redness and burning, sensation of a lump in throat, congestion, mucous."
},
{
"NDCCode": "57955-0018-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0018-2)",
"NDC11Code": "57955-0018-02",
"ProductNDC": "57955-0018",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Teething",
"NonProprietaryName": "Agaricus Muscarius, Belladonna, Calcarea Carbonica, Calcarea Phosphorica, Chamomilla, Ferrum Phosphoricum, Kreosotum, Zincum Metallicum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20121022",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "AMANITA MUSCARIA FRUITING BODY; ATROPA BELLADONNA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; MATRICARIA RECUTITA; FERROSOFERRIC PHOSPHATE; WOOD CREOSOTE; ZINC",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of: teething pain, swelling gums, delayed teething, low grade fever, restlessness, heavy salivation, irritability, desire to be held constantly."
},
{
"NDCCode": "57955-0019-2",
"PackageDescription": "59 mL in 1 BOTTLE, SPRAY (57955-0019-2)",
"NDC11Code": "57955-0019-02",
"ProductNDC": "57955-0019",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Constipation Relief",
"NonProprietaryName": "Alumina, Bellis Perennis, Causticum, Collinsonia Canadensis, Hydrastis Canadensis, Lac Defloratum, Natrum Muriaticum, Nux Vomica, Plumbum Metallicum, Sepia",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20160627",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "King Bio Inc.",
"SubstanceName": "ALUMINUM OXIDE; BELLIS PERENNIS; CAUSTICUM; COLLINSONIA CANADENSIS ROOT; GOLDENSEAL; SKIM MILK; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; LEAD; SEPIA OFFICINALIS JUICE",
"StrengthNumber": "10; 10; 10; 10; 10; 10; 10; 10; 10; 10",
"StrengthUnit": "[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Uses for temporary relief of symptoms of constipation: irregularity, hard, dry stools, great straining, rumbling and bloated bowels, mucus in stools, associated headache."
}
]
}
{"NDC":[{"NDCCode":"57955-1511-2","ProprietaryName":"Hyperactive","NonProprietaryName":"Adrenalinum, Allium Sativum, Anethum Graveolens, Arsenicum Album, Arsenicum Iodatum, Asafoetida, Belladonna, Cereus Bonplandii, Chamomilla, Coffea Cruda, Erodium, Impatiens Glandulifera, Flos, Iodium, Mandragora Officinarum, Solidago Virgaurea, Thyroidinum"},{"NDCCode":"22840-1511-2","ProprietaryName":"Mustard","NonProprietaryName":"Brassica Spp."},{"NDCCode":"36987-1511-2","ProprietaryName":"Spinach","NonProprietaryName":"Spinach"},{"NDCCode":"37662-1511-2","ProprietaryName":"Linum Usitatissimum","NonProprietaryName":"Linum Usitatissimum"},{"NDCCode":"50090-1511-2","ProprietaryName":"Amoxicillin","NonProprietaryName":"Amoxicillin"},{"NDCCode":"51552-1511-2","NonProprietaryName":"Nicotinamide Adenine Dinucleotide (nad)"},{"NDCCode":"55714-1511-2","ProprietaryName":"Diarrhea","NonProprietaryName":"Aconitum Nap., Arg. Nit., Arsenicum Alb., Baptisia, Bryonia, Carbo Veg., Chamomilla, Cinchona, Collinsonia, Colocynthis, Elaterium, Gelsemium, Ipecac., Iris Versicolor, Lycopodium, Mag. Carb., Phosphorus, Podoph. Pelt., Rheum, Sulphur, Tabacum, Vaccinium, Aesculus Hipp. Juglans Regia, Valeriana"},{"NDCCode":"71335-1511-2","ProprietaryName":"Fluconazole","NonProprietaryName":"Fluconazole"},{"NDCCode":"71335-1511-7","ProprietaryName":"Fluconazole","NonProprietaryName":"Fluconazole"},{"NDCCode":"0409-1511-98","ProprietaryName":"Propofol","NonProprietaryName":"Propofol"},{"NDCCode":"22840-1511-4","ProprietaryName":"Mustard","NonProprietaryName":"Brassica Spp."},{"NDCCode":"50090-1511-0","ProprietaryName":"Amoxicillin","NonProprietaryName":"Amoxicillin"},{"NDCCode":"50090-1511-1","ProprietaryName":"Amoxicillin","NonProprietaryName":"Amoxicillin"},{"NDCCode":"50090-1511-5","ProprietaryName":"Amoxicillin","NonProprietaryName":"Amoxicillin"},{"NDCCode":"50090-1511-7","ProprietaryName":"Amoxicillin","NonProprietaryName":"Amoxicillin"},{"NDCCode":"50090-1511-8","ProprietaryName":"Amoxicillin","NonProprietaryName":"Amoxicillin"},{"NDCCode":"57955-0001-2","ProprietaryName":"Eating Disorders","NonProprietaryName":"Antimonium Crudum, Cinchona Officinalis, Ferrum Metallicum, Hyoscyamus Niger, Ignatia Amara, Natrum Muriaticum, Nux Vomica, Phosphoricum Acidum, Pulsatilla, Staphysagria, Thuja Occidentalis, Veratrum Album"},{"NDCCode":"57955-0002-2","ProprietaryName":"Birth Ease","NonProprietaryName":"Aletris Farinosa, Apis Mellifica, Arnica Montana, Belladonna, Caulophyllum Thalictroides, Chamomilla, Cimicifuga Racemosa, Ferrum Metallicum, Kali Carbonicum, Sabina, Secale Cornutum, Viburnum Opulus"},{"NDCCode":"57955-0003-2","ProprietaryName":"Breast Cyst And Discomforts","NonProprietaryName":"Aconitum Napellus, Bellis Perennis, Bromium, Bryonia, Chamomilla, Conium Maculatum, Iodium, Phellandrium Aquaticum, Phytolacca Decandra, Scrophularia Nodosa, Silicea"},{"NDCCode":"57955-0004-2","ProprietaryName":"Menstrual Cramps And Irregularities","NonProprietaryName":"Cactus Grandiflorus, Caulophyllum Thalictroides, Chamomilla, Cimicifuga Racemosa, Colocynthis, Ipecacuanha, Magnesia Phosphorica, Sepia, Viburnum Opulus, Xanthoxylum Fraxineum"},{"NDCCode":"57955-0005-2","ProprietaryName":"Ferticare","NonProprietaryName":"Agnus Castus, Apis Mellifica, Aurum Metallicum, Borax, Conium Maculatum, Ferrum Metallicum, Iodium, Lilium Tigrinum, Lycopodium Clavatum, Natrum Muriatcum, Palladium Metallicum, Sepia"},{"NDCCode":"57955-0008-2","ProprietaryName":"Morning Sickness","NonProprietaryName":"Aletris Farinosa, Amygdalus Persica, Colchicum Autumnale, Cucurbita Pepo, Semen, Ferrum Metallicum, Ipecacuanha, Lycopodium Clavatum, Nux Vomica, Phosphorus, Pulsatilla, Tabacum"},{"NDCCode":"57955-0010-2","ProprietaryName":"Male Strengthener","NonProprietaryName":"Agnus Castus, Arnica Montana, Baryta Carbonica, Caladium Seguinum, Kali Bromatum, Lycopodium Clavatum, Nuphar Luteum, Nux Vomica, Onosmodium Virginianum, Phosphoricum Acidum, Picnicum Acidum, Selenium Metallicum"},{"NDCCode":"57955-0011-2","ProprietaryName":"Prostate Strengthener","NonProprietaryName":"Baryta Carbonica, Chimaphila Umbellata, Clematis Erecta, Conium Maculatum, Digitalis Purpurea, Phosphoricum Acidum, Sabal Serrulata, Selenium Metallicum, Staphysagria, Thuja Occidentalis, Zincum Metallicum"},{"NDCCode":"57955-0012-2","ProprietaryName":"Bed Wetting Prevention","NonProprietaryName":"Belladonna, Bellis Perennis, Benzoicum Acidum, Causticum, Equisetum Hyemale, Lycopodium Clavatum, Phosphorus, Plantago Major, Rhus Aromatica, Sepia"},{"NDCCode":"57955-0015-2","ProprietaryName":"Attention And Learning Enhancement","NonProprietaryName":"Baryta Carbonica, Calcarea Carbonica, Ignatia Amara, Lycopodium Clavatum, Magnesia Carbonica, Natrum Carbonicum, Natrum Muriaticum, Thuja Occidentalis"},{"NDCCode":"57955-0016-2","ProprietaryName":"Paraclenz","NonProprietaryName":"Calcarea Carbonica, Chenopodium Anthelminticum, Cina, Croton Tiglium, Filix Mas, Gambogia, Granatum, Lycopodium Clavatum, Mercurius Corrosivus, Natrum Phosphoricum, Santoninum, Senna, Spigelia Anthelmia, Stannum Metallicum, Tanacetum Vulgare, Teucrium Marum, Zingeber Officinale"},{"NDCCode":"57955-0017-2","ProprietaryName":"Tonsilcure","NonProprietaryName":"Ammonium Muriaticum, Baryta Carbonica, Belladonna, Calcarea Phosphorica, Ferrum Phosphoricum, Guaiacum, Kali Muriaticum, Lycopodium Clavatum, Mercurius Solubilis, Phytolacca Decandra, Silicea"},{"NDCCode":"57955-0018-2","ProprietaryName":"Teething","NonProprietaryName":"Agaricus Muscarius, Belladonna, Calcarea Carbonica, Calcarea Phosphorica, Chamomilla, Ferrum Phosphoricum, Kreosotum, Zincum Metallicum"},{"NDCCode":"57955-0019-2","ProprietaryName":"Constipation Relief","NonProprietaryName":"Alumina, Bellis Perennis, Causticum, Collinsonia Canadensis, Hydrastis Canadensis, Lac Defloratum, Natrum Muriaticum, Nux Vomica, Plumbum Metallicum, Sepia"}]}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>57955-1511-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-1511-2)</PackageDescription>
<NDC11Code>57955-1511-02</NDC11Code>
<ProductNDC>57955-1511</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hyperactive</ProprietaryName>
<NonProprietaryName>Adrenalinum, Allium Sativum, Anethum Graveolens, Arsenicum Album, Arsenicum Iodatum, Asafoetida, Belladonna, Cereus Bonplandii, Chamomilla, Coffea Cruda, Erodium, Impatiens Glandulifera, Flos, Iodium, Mandragora Officinarum, Solidago Virgaurea, Thyroidinum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121106</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>EPINEPHRINE; GARLIC; DILL; ARSENIC TRIOXIDE; ARSENIC TRIIODIDE; ASAFETIDA; ATROPA BELLADONNA; HARRISIA POMANENSIS STEM; MATRICARIA RECUTITA; ARABICA COFFEE BEAN; ERODIUM CICUTARIUM; IMPATIENS GLANDULIFERA FLOWER; IODINE; MANDRAGORA OFFICINARUM ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; THYROID, UNSPECIFIED</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses a natural aid for: hyperactivity, excitability, impulsiveness, restlessness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>22840-1511-2</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (22840-1511-2) </PackageDescription>
<NDC11Code>22840-1511-02</NDC11Code>
<ProductNDC>22840-1511</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Mustard</ProprietaryName>
<NonProprietaryName>Brassica Spp.</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19810915</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101833</ApplicationNumber>
<LabelerName>Greer Laboratories, Inc.</LabelerName>
<SubstanceName>BRASSICA RAPA POLLEN</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19810915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Non-Standardized Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergies to one or more of the specific non-standardized allergens., 2 Immunotherapy for the reduction of allergen-induced allergic symptoms confirmed by appropriate positive skin tests or by in vitro testing for allergen-specific IgE antibodies. .</IndicationAndUsage>
<Description>Non-Standardized Allergenic Extracts are sterile solutions used for percutaneous testing, intradermal testing, or subcutaneous immunotherapy. Aqueous extracts contain the soluble extractants of the source material in water for injection, 0.5% sodium chloride, 0.54% sodium bicarbonate, and 0.4% phenol. Glycerinated extracts contain the soluable extractants of the source material in water for injection and 50% glycerin, 0.25% sodium chloride, 0.27% sodium bicarbonate, and 0.2% phenol. The pH of the extracts range from 6 to 9. Certain food extracts (Barley, Oat, Pineapple, Rye, Spinach, and Wheat), labeled “For Diagnostic Use Only”, contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Source materials used in the manufacture of allergenic extracts are collected from natural sources or from laboratory cultures. Non-Standardized Allergenic Extracts appear as clear and colorless to dark brown solutions that should be free of particulate matter. Extracts are labeled either as weight-to-volume based on the weight of the source material to the volume of the extracting fluid, or as PNU/milliliter with one PNU representing 0.00001 mg of protein nitrogen per milliliter.</Description>
</NDC>
<NDC>
<NDCCode>36987-1511-2</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (36987-1511-2)</PackageDescription>
<NDC11Code>36987-1511-02</NDC11Code>
<ProductNDC>36987-1511</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Spinach</ProprietaryName>
<NonProprietaryName>Spinach</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>SPINACH</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],Vegetable Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>37662-1511-2</NDCCode>
<PackageDescription>500 PELLET in 1 VIAL, GLASS (37662-1511-2) </PackageDescription>
<NDC11Code>37662-1511-02</NDC11Code>
<ProductNDC>37662-1511</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Linum Usitatissimum</ProprietaryName>
<NonProprietaryName>Linum Usitatissimum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220913</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>FLAX SEED</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_M]/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2022-09-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220913</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50090-1511-2</NDCCode>
<PackageDescription>21 CAPSULE in 1 BOTTLE (50090-1511-2) </PackageDescription>
<NDC11Code>50090-1511-02</NDC11Code>
<ProductNDC>50090-1511</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin</ProprietaryName>
<NonProprietaryName>Amoxicillin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20051109</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065271</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adults and Pediatric Patients. Adult Patients only. Triple therapy for Helicobacter pylori (H. pylori) with clarithromycin and lansoprazole:. Amoxicillin capsules in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. Dual therapy for H. pylori with lansoprazole: Amoxicillin capsules, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. (See the clarithromycin package insert, MICROBIOLOGY.) Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. Usage. To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin capsules and other antibacterial drugs, amoxicillin capsules should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Amoxicillin capsules, USP are a semisynthetic antibacterial (amoxicillin), an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2S,5R,6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as: The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.45. Each capsule of amoxicillin with blue cap and pink body, contains 250 mg or 500 mg amoxicillin USP as the trihydrate. The body of the 250 mg capsule is imprinted with ‘A44’ in black ink. The body of the 500 mg capsule is imprinted with ‘A45’ in black ink. Inactive ingredients: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, and titanium dioxide. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>51552-1511-2</NDCCode>
<PackageDescription>5 g in 1 CONTAINER (51552-1511-2) </PackageDescription>
<NDC11Code>51552-1511-02</NDC11Code>
<ProductNDC>51552-1511</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Nicotinamide Adenine Dinucleotide (nad)</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20160915</StartMarketingDate>
<EndMarketingDate>20240525</EndMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Fagron Inc</LabelerName>
<SubstanceName>NADIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<StartMarketingDatePackage>15-SEP-16</StartMarketingDatePackage>
<EndMarketingDatePackage>03-FEB-24</EndMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>55714-1511-2</NDCCode>
<PackageDescription>59.14 mL in 1 BOTTLE, GLASS (55714-1511-2)</PackageDescription>
<NDC11Code>55714-1511-02</NDC11Code>
<ProductNDC>55714-1511</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Diarrhea</ProprietaryName>
<NonProprietaryName>Aconitum Nap., Arg. Nit., Arsenicum Alb., Baptisia, Bryonia, Carbo Veg., Chamomilla, Cinchona, Collinsonia, Colocynthis, Elaterium, Gelsemium, Ipecac., Iris Versicolor, Lycopodium, Mag. Carb., Phosphorus, Podoph. Pelt., Rheum, Sulphur, Tabacum, Vaccinium, Aesculus Hipp. Juglans Regia, Valeriana</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Newton Laboratories, Inc.</LabelerName>
<SubstanceName>ACONITUM NAPELLUS; SILVER NITRATE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA; BRYONIA ALBA ROOT; ACTIVATED CHARCOAL; MATRICARIA RECUTITA; CINCHONA OFFICINALIS BARK; COLLINSONIA CANADENSIS ROOT; CITRULLUS COLOCYNTHIS FRUIT PULP; ECBALLIUM ELATERIUM FRUIT; GELSEMIUM SEMPERVIRENS ROOT; IPECAC; IRIS VERSICOLOR ROOT; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CARBONATE; PHOSPHORUS; PODOPHYLLUM; RHEUM OFFICINALE WHOLE; SULFUR; TOBACCO LEAF; BILBERRY; HORSE CHESTNUT; JUGLANS REGIA WHOLE; VALERIAN</SubstanceName>
<StrengthNumber>15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 3; 3; 3</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Diarrhea Formulated for associated symptoms such as loose or watery stools, cramping, gas, nausea, irritation and fatigue.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>71335-1511-2</NDCCode>
<PackageDescription>12 TABLET in 1 BOTTLE (71335-1511-2) </PackageDescription>
<NDC11Code>71335-1511-02</NDC11Code>
<ProductNDC>71335-1511</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluconazole</ProprietaryName>
<NonProprietaryName>Fluconazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040729</StartMarketingDate>
<EndMarketingDate>20220630</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076077</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>FLUCONAZOLE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20211228</StartMarketingDatePackage>
<EndMarketingDatePackage>20220630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71335-1511-7</NDCCode>
<PackageDescription>2 TABLET in 1 BOTTLE (71335-1511-7) </PackageDescription>
<NDC11Code>71335-1511-07</NDC11Code>
<ProductNDC>71335-1511</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Fluconazole</ProprietaryName>
<NonProprietaryName>Fluconazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20040729</StartMarketingDate>
<EndMarketingDate>20220630</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076077</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>FLUCONAZOLE</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200601</StartMarketingDatePackage>
<EndMarketingDatePackage>20220630</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0409-1511-98</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 TRAY (0409-1511-98) / 20 mL in 1 VIAL, SINGLE-DOSE (0409-1511-97) </PackageDescription>
<NDC11Code>00409-1511-98</NDC11Code>
<ProductNDC>0409-1511</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Propofol</ProprietaryName>
<NonProprietaryName>Propofol</NonProprietaryName>
<DosageFormName>INJECTION, EMULSION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20260817</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077908</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>PROPOFOL</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>General Anesthesia [PE], General Anesthetic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260817</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Propofol injectable emulsion is an intravenous general anesthetic and sedation drug indicated for: : 1 Induction of General Anesthesia for Patients Greater than or Equal to 3 Years of Age , 2 Maintenance of General Anesthesia for Patients Greater than or Equal to 2 Months of Age , 3 Initiation and Maintenance of Monitored Anesthesia Care (MAC) Sedation in Adult Patients , 4 Sedation for Adult Patients in Combination with Regional Anesthesia , 5 Intensive Care Unit (ICU) Sedation of Intubated, Mechanically Ventilated Adult Patients .</IndicationAndUsage>
<Description>Propofol Injectable Emulsion, USP is an anesthetic available as a sterile, nonpyrogenic white to slight off-white homogeneous emulsion for intravenous administration. The structural formula is. Chemical name: 2,6-diisopropylphenol. Molecular formula: C12H18O. Molecular weight: 178.28. Propofol, USP is slightly soluble in water. The pKa is 11. The octanol/water partition coefficient for propofol is 6761:1 at a pH of 6 to 8.5. Each mL of propofol injectable emulsion, USP contains 10 mg of propofol, 100 mg of soybean oil (100 mg/mL), 22.5 mg of glycerol (22.5 mg/mL), 12 mg of egg lecithin (12 mg/mL), 1.5 mg of benzyl alcohol (1.5 mg/mL), 0.7 mg of sodium benzoate (0.7 mg/mL), and sodium hydroxide to adjust pH, in water for injection. Propofol Injectable Emulsion, USP is isotonic and has a pH of 6 to 8.5.</Description>
</NDC>
<NDC>
<NDCCode>22840-1511-4</NDCCode>
<PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (22840-1511-4) </PackageDescription>
<NDC11Code>22840-1511-04</NDC11Code>
<ProductNDC>22840-1511</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Mustard</ProprietaryName>
<NonProprietaryName>Brassica Spp.</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19810915</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101833</ApplicationNumber>
<LabelerName>Greer Laboratories, Inc.</LabelerName>
<SubstanceName>BRASSICA RAPA POLLEN</SubstanceName>
<StrengthNumber>.1</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19810915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Non-Standardized Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergies to one or more of the specific non-standardized allergens., 2 Immunotherapy for the reduction of allergen-induced allergic symptoms confirmed by appropriate positive skin tests or by in vitro testing for allergen-specific IgE antibodies. .</IndicationAndUsage>
<Description>Non-Standardized Allergenic Extracts are sterile solutions used for percutaneous testing, intradermal testing, or subcutaneous immunotherapy. Aqueous extracts contain the soluble extractants of the source material in water for injection, 0.5% sodium chloride, 0.54% sodium bicarbonate, and 0.4% phenol. Glycerinated extracts contain the soluable extractants of the source material in water for injection and 50% glycerin, 0.25% sodium chloride, 0.27% sodium bicarbonate, and 0.2% phenol. The pH of the extracts range from 6 to 9. Certain food extracts (Barley, Oat, Pineapple, Rye, Spinach, and Wheat), labeled “For Diagnostic Use Only”, contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Source materials used in the manufacture of allergenic extracts are collected from natural sources or from laboratory cultures. Non-Standardized Allergenic Extracts appear as clear and colorless to dark brown solutions that should be free of particulate matter. Extracts are labeled either as weight-to-volume based on the weight of the source material to the volume of the extracting fluid, or as PNU/milliliter with one PNU representing 0.00001 mg of protein nitrogen per milliliter.</Description>
</NDC>
<NDC>
<NDCCode>50090-1511-0</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (50090-1511-0) </PackageDescription>
<NDC11Code>50090-1511-00</NDC11Code>
<ProductNDC>50090-1511</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin</ProprietaryName>
<NonProprietaryName>Amoxicillin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20051109</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065271</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adults and Pediatric Patients. Adult Patients only. Triple therapy for Helicobacter pylori (H. pylori) with clarithromycin and lansoprazole:. Amoxicillin capsules in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. Dual therapy for H. pylori with lansoprazole: Amoxicillin capsules, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. (See the clarithromycin package insert, MICROBIOLOGY.) Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. Usage. To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin capsules and other antibacterial drugs, amoxicillin capsules should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Amoxicillin capsules, USP are a semisynthetic antibacterial (amoxicillin), an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2S,5R,6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as: The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.45. Each capsule of amoxicillin with blue cap and pink body, contains 250 mg or 500 mg amoxicillin USP as the trihydrate. The body of the 250 mg capsule is imprinted with ‘A44’ in black ink. The body of the 500 mg capsule is imprinted with ‘A45’ in black ink. Inactive ingredients: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, and titanium dioxide. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>50090-1511-1</NDCCode>
<PackageDescription>40 CAPSULE in 1 BOTTLE (50090-1511-1) </PackageDescription>
<NDC11Code>50090-1511-01</NDC11Code>
<ProductNDC>50090-1511</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin</ProprietaryName>
<NonProprietaryName>Amoxicillin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20051109</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065271</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adults and Pediatric Patients. Adult Patients only. Triple therapy for Helicobacter pylori (H. pylori) with clarithromycin and lansoprazole:. Amoxicillin capsules in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. Dual therapy for H. pylori with lansoprazole: Amoxicillin capsules, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. (See the clarithromycin package insert, MICROBIOLOGY.) Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. Usage. To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin capsules and other antibacterial drugs, amoxicillin capsules should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Amoxicillin capsules, USP are a semisynthetic antibacterial (amoxicillin), an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2S,5R,6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as: The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.45. Each capsule of amoxicillin with blue cap and pink body, contains 250 mg or 500 mg amoxicillin USP as the trihydrate. The body of the 250 mg capsule is imprinted with ‘A44’ in black ink. The body of the 500 mg capsule is imprinted with ‘A45’ in black ink. Inactive ingredients: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, and titanium dioxide. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>50090-1511-5</NDCCode>
<PackageDescription>15 CAPSULE in 1 BOTTLE (50090-1511-5) </PackageDescription>
<NDC11Code>50090-1511-05</NDC11Code>
<ProductNDC>50090-1511</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin</ProprietaryName>
<NonProprietaryName>Amoxicillin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20051109</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065271</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210326</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adults and Pediatric Patients. Adult Patients only. Triple therapy for Helicobacter pylori (H. pylori) with clarithromycin and lansoprazole:. Amoxicillin capsules in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. Dual therapy for H. pylori with lansoprazole: Amoxicillin capsules, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. (See the clarithromycin package insert, MICROBIOLOGY.) Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. Usage. To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin capsules and other antibacterial drugs, amoxicillin capsules should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Amoxicillin capsules, USP are a semisynthetic antibacterial (amoxicillin), an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2S,5R,6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as: The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.45. Each capsule of amoxicillin with blue cap and pink body, contains 250 mg or 500 mg amoxicillin USP as the trihydrate. The body of the 250 mg capsule is imprinted with ‘A44’ in black ink. The body of the 500 mg capsule is imprinted with ‘A45’ in black ink. Inactive ingredients: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, and titanium dioxide. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>50090-1511-7</NDCCode>
<PackageDescription>10 CAPSULE in 1 BOTTLE (50090-1511-7) </PackageDescription>
<NDC11Code>50090-1511-07</NDC11Code>
<ProductNDC>50090-1511</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin</ProprietaryName>
<NonProprietaryName>Amoxicillin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20051109</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065271</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-04-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210326</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adults and Pediatric Patients. Adult Patients only. Triple therapy for Helicobacter pylori (H. pylori) with clarithromycin and lansoprazole:. Amoxicillin capsules in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. Dual therapy for H. pylori with lansoprazole: Amoxicillin capsules, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. (See the clarithromycin package insert, MICROBIOLOGY.) Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. Usage. To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin capsules and other antibacterial drugs, amoxicillin capsules should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Amoxicillin capsules, USP are a semisynthetic antibacterial (amoxicillin), an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2S,5R,6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as: The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.45. Each capsule of amoxicillin with blue cap and pink body, contains 250 mg or 500 mg amoxicillin USP as the trihydrate. The body of the 250 mg capsule is imprinted with ‘A44’ in black ink. The body of the 500 mg capsule is imprinted with ‘A45’ in black ink. Inactive ingredients: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, and titanium dioxide. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>50090-1511-8</NDCCode>
<PackageDescription>9 CAPSULE in 1 BOTTLE (50090-1511-8) </PackageDescription>
<NDC11Code>50090-1511-08</NDC11Code>
<ProductNDC>50090-1511</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Amoxicillin</ProprietaryName>
<NonProprietaryName>Amoxicillin</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20051109</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA065271</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>AMOXICILLIN</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Penicillin-class Antibacterial [EPC], Penicillins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-04-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20141210</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Adults and Pediatric Patients. Adult Patients only. Triple therapy for Helicobacter pylori (H. pylori) with clarithromycin and lansoprazole:. Amoxicillin capsules in combination with clarithromycin plus lansoprazole as triple therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) to eradicate H. pylori. Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. Dual therapy for H. pylori with lansoprazole: Amoxicillin capsules, in combination with lansoprazole delayed-release capsules as dual therapy, is indicated for the treatment of patients with H. pylori infection and duodenal ulcer disease (active or 1-year history of a duodenal ulcer) who are either allergic or intolerant to clarithromycin or in whom resistance to clarithromycin is known or suspected. (See the clarithromycin package insert, MICROBIOLOGY.) Eradication of H. pylori has been shown to reduce the risk of duodenal ulcer recurrence. Usage. To reduce the development of drug-resistant bacteria and maintain the effectiveness of amoxicillin capsules and other antibacterial drugs, amoxicillin capsules should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.</IndicationAndUsage>
<Description>Amoxicillin capsules, USP are a semisynthetic antibacterial (amoxicillin), an analog of ampicillin, with a broad spectrum of bactericidal activity against many Gram-positive and Gram-negative microorganisms. Chemically, it is (2S,5R,6R)-6-[(R)-(-)-2-amino-2-(p-hydroxyphenyl)acetamido]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid trihydrate. It may be represented structurally as: The amoxicillin molecular formula is C16H19N3O5S3H2O, and the molecular weight is 419.45. Each capsule of amoxicillin with blue cap and pink body, contains 250 mg or 500 mg amoxicillin USP as the trihydrate. The body of the 250 mg capsule is imprinted with ‘A44’ in black ink. The body of the 500 mg capsule is imprinted with ‘A45’ in black ink. Inactive ingredients: D&C Red No. 28, FD&C Blue No. 1, FD&C Red No. 40, gelatin, magnesium stearate, microcrystalline cellulose, sodium lauryl sulfate, and titanium dioxide. Meets USP Dissolution Test 2.</Description>
</NDC>
<NDC>
<NDCCode>57955-0001-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0001-2)</PackageDescription>
<NDC11Code>57955-0001-02</NDC11Code>
<ProductNDC>57955-0001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Eating Disorders</ProprietaryName>
<NonProprietaryName>Antimonium Crudum, Cinchona Officinalis, Ferrum Metallicum, Hyoscyamus Niger, Ignatia Amara, Natrum Muriaticum, Nux Vomica, Phosphoricum Acidum, Pulsatilla, Staphysagria, Thuja Occidentalis, Veratrum Album</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140417</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc</LabelerName>
<SubstanceName>ANTIMONY TRISULFIDE; CINCHONA OFFICINALIS BARK; IRON; HYOSCYAMUS NIGER; STRYCHNOS IGNATII SEED; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PULSATILLA VULGARIS; DELPHINIUM STAPHISAGRIA SEED; THUJA OCCIDENTALIS LEAFY TWIG; VERATRUM ALBUM ROOT</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for a natural aid for relief of: nausea, vomiting, loss of appetite, digestive tract disturbances and emotional sensitivity that may be associated with eating disorders.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0002-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0002-2)</PackageDescription>
<NDC11Code>57955-0002-02</NDC11Code>
<ProductNDC>57955-0002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Birth Ease</ProprietaryName>
<NonProprietaryName>Aletris Farinosa, Apis Mellifica, Arnica Montana, Belladonna, Caulophyllum Thalictroides, Chamomilla, Cimicifuga Racemosa, Ferrum Metallicum, Kali Carbonicum, Sabina, Secale Cornutum, Viburnum Opulus</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140417</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>ALETRIS FARINOSA ROOT; APIS MELLIFERA; ARNICA MONTANA; ATROPA BELLADONNA; CAULOPHYLLUM THALICTROIDES ROOT; MATRICARIA RECUTITA; BLACK COHOSH; IRON; POTASSIUM CARBONATE; JUNIPERUS SABINA LEAFY TWIG; CLAVICEPS PURPUREA SCLEROTIUM; VIBURNUM OPULUS BARK</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of: Muscular pains, stinging pain, tenderness over abdomen, vaginal dryness and heat, tender nipples, spasmodic labor pains, restlessness, extreme backache.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0003-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0003-2)</PackageDescription>
<NDC11Code>57955-0003-02</NDC11Code>
<ProductNDC>57955-0003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Breast Cyst And Discomforts</ProprietaryName>
<NonProprietaryName>Aconitum Napellus, Bellis Perennis, Bromium, Bryonia, Chamomilla, Conium Maculatum, Iodium, Phellandrium Aquaticum, Phytolacca Decandra, Scrophularia Nodosa, Silicea</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140417</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>ACONITUM NAPELLUS; BELLIS PERENNIS; BROMINE; BRYONIA ALBA ROOT; MATRICARIA RECUTITA; CONIUM MACULATUM FLOWERING TOP; IODINE; OENANTHE AQUATICA FRUIT; PHYTOLACCA AMERICANA ROOT; SCROPHULARIA NODOSA; SILICON DIOXIDE</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of symptoms: inflammation, tenderness, lumpiness, hardness, soreness, cracked or irritated nipples from nursing, shrinking breasts following nursing.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0004-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0004-2)</PackageDescription>
<NDC11Code>57955-0004-02</NDC11Code>
<ProductNDC>57955-0004</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Menstrual Cramps And Irregularities</ProprietaryName>
<NonProprietaryName>Cactus Grandiflorus, Caulophyllum Thalictroides, Chamomilla, Cimicifuga Racemosa, Colocynthis, Ipecacuanha, Magnesia Phosphorica, Sepia, Viburnum Opulus, Xanthoxylum Fraxineum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150219</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>SELENICEREUS GRANDIFLORUS STEM; CAULOPHYLLUM THALICTROIDES ROOT; MATRICARIA RECUTITA; BLACK COHOSH; CITRULLUS COLOCYNTHIS FRUIT PULP; IPECAC; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SEPIA OFFICINALIS JUICE; VIBURNUM OPULUS BARK; ZANTHOXYLUM AMERICANUM BARK</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of symptoms: cramps, aches and pains, Abdominal bloating, heavy or gushing menstruation, backache, menstrual headache, irregular periods, lack of menstrual flow.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0005-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0005-2)</PackageDescription>
<NDC11Code>57955-0005-02</NDC11Code>
<ProductNDC>57955-0005</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ferticare</ProprietaryName>
<NonProprietaryName>Agnus Castus, Apis Mellifica, Aurum Metallicum, Borax, Conium Maculatum, Ferrum Metallicum, Iodium, Lilium Tigrinum, Lycopodium Clavatum, Natrum Muriatcum, Palladium Metallicum, Sepia</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140417</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>CHASTE TREE; APIS MELLIFERA; GOLD; SODIUM BORATE; CONIUM MACULATUM FLOWERING TOP; IRON; IODINE; LILIUM LANCIFOLIUM WHOLE FLOWERING; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; PALLADIUM; SEPIA OFFICINALIS JUICE</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of symptoms: vaginal dryness, vaginal discharge, sensitive vagina, itching of female genitals associated with sexual activities, irregular cycles and discomforts during intercourse.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0008-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0008-2)</PackageDescription>
<NDC11Code>57955-0008-02</NDC11Code>
<ProductNDC>57955-0008</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Morning Sickness</ProprietaryName>
<NonProprietaryName>Aletris Farinosa, Amygdalus Persica, Colchicum Autumnale, Cucurbita Pepo, Semen, Ferrum Metallicum, Ipecacuanha, Lycopodium Clavatum, Nux Vomica, Phosphorus, Pulsatilla, Tabacum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121106</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>ALETRIS FARINOSA ROOT; PRUNUS PERSICA FLOWER; COLCHICUM AUTUMNALE BULB; PUMPKIN SEED; IRON; IPECAC; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS; TOBACCO LEAF</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of: morning sickness, nausea, vomiting, belching, excess saliva, sinking feeling in stomach, tiredness, weakness, sensitivity to noise, and emotional sensitivity.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0010-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0010-2)</PackageDescription>
<NDC11Code>57955-0010-02</NDC11Code>
<ProductNDC>57955-0010</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Male Strengthener</ProprietaryName>
<NonProprietaryName>Agnus Castus, Arnica Montana, Baryta Carbonica, Caladium Seguinum, Kali Bromatum, Lycopodium Clavatum, Nuphar Luteum, Nux Vomica, Onosmodium Virginianum, Phosphoricum Acidum, Picnicum Acidum, Selenium Metallicum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140421</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>CHASTE TREE; ARNICA MONTANA; BARIUM CARBONATE; DIEFFENBACHIA SEGUINE; POTASSIUM BROMIDE; LYCOPODIUM CLAVATUM SPORE; NUPHAR LUTEUM ROOT; STRYCHNOS NUX-VOMICA SEED; ONOSMODIUM VIRGINIANUM WHOLE; PHOSPHORIC ACID; PICRIC ACID; SELENIUM</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of: diminished or absent sexual desire, premature emission, weakness or pain of sexual organs, and tiredness .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0011-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0011-2)</PackageDescription>
<NDC11Code>57955-0011-02</NDC11Code>
<ProductNDC>57955-0011</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Prostate Strengthener</ProprietaryName>
<NonProprietaryName>Baryta Carbonica, Chimaphila Umbellata, Clematis Erecta, Conium Maculatum, Digitalis Purpurea, Phosphoricum Acidum, Sabal Serrulata, Selenium Metallicum, Staphysagria, Thuja Occidentalis, Zincum Metallicum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140331</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>BARIUM CARBONATE; CHIMAPHILA UMBELLATA; CLEMATIS RECTA FLOWERING TOP; CONIUM MACULATUM FLOWERING TOP; DIGITALIS; PHOSPHORIC ACID; SAW PALMETTO; SELENIUM; DELPHINIUM STAPHISAGRIA SEED; THUJA OCCIDENTALIS LEAFY TWIG; ZINC</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of prostate symptoms: : 1 scanty urination, 2 dribbling, 3 burning and irritation, 4 premature impotence.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0012-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0012-2)</PackageDescription>
<NDC11Code>57955-0012-02</NDC11Code>
<ProductNDC>57955-0012</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bed Wetting Prevention</ProprietaryName>
<NonProprietaryName>Belladonna, Bellis Perennis, Benzoicum Acidum, Causticum, Equisetum Hyemale, Lycopodium Clavatum, Phosphorus, Plantago Major, Rhus Aromatica, Sepia</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150831</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>ATROPA BELLADONNA; BELLIS PERENNIS; BENZOIC ACID; CAUSTICUM; EQUISETUM HYEMALE; LYCOPODIUM CLAVATUM SPORE; PHOSPHORUS; PLANTAGO MAJOR; RHUS AROMATICA ROOT BARK; SEPIA OFFICINALIS JUICE</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of: involuntary urination during sleep, urinary disturbances, restless sleep..</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0015-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0015-2)</PackageDescription>
<NDC11Code>57955-0015-02</NDC11Code>
<ProductNDC>57955-0015</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Attention And Learning Enhancement</ProprietaryName>
<NonProprietaryName>Baryta Carbonica, Calcarea Carbonica, Ignatia Amara, Lycopodium Clavatum, Magnesia Carbonica, Natrum Carbonicum, Natrum Muriaticum, Thuja Occidentalis</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140528</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>BARIUM CARBONATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; STRYCHNOS IGNATII SEED; LYCOPODIUM CLAVATUM SPORE; MAGNESIUM CARBONATE; SODIUM CARBONATE; SODIUM CHLORIDE; THUJA OCCIDENTALIS LEAFY TWIG</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-02-18</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>57955-0016-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0016-2)</PackageDescription>
<NDC11Code>57955-0016-02</NDC11Code>
<ProductNDC>57955-0016</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Paraclenz</ProprietaryName>
<NonProprietaryName>Calcarea Carbonica, Chenopodium Anthelminticum, Cina, Croton Tiglium, Filix Mas, Gambogia, Granatum, Lycopodium Clavatum, Mercurius Corrosivus, Natrum Phosphoricum, Santoninum, Senna, Spigelia Anthelmia, Stannum Metallicum, Tanacetum Vulgare, Teucrium Marum, Zingeber Officinale</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20111118</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>OYSTER SHELL CALCIUM CARBONATE, CRUDE; DYSPHANIA AMBROSIOIDES; ARTEMISIA CINA PRE-FLOWERING TOP; CROTON TIGLIUM SEED; DRYOPTERIS FILIX-MAS ROOT; GAMBOGE; PUNICA GRANATUM ROOT BARK; LYCOPODIUM CLAVATUM SPORE; MERCURIC CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SANTONIN; SENNA LEAF; SPIGELIA ANTHELMIA; TIN; TANACETUM VULGARE TOP; TEUCRIUM MARUM; GINGER</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for symptoms associated with parasites and worms: intestinal irritation, appetite swings, bad breath, constipation, itching nose or anus, angry or irritable moods.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0017-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0017-2)</PackageDescription>
<NDC11Code>57955-0017-02</NDC11Code>
<ProductNDC>57955-0017</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tonsilcure</ProprietaryName>
<NonProprietaryName>Ammonium Muriaticum, Baryta Carbonica, Belladonna, Calcarea Phosphorica, Ferrum Phosphoricum, Guaiacum, Kali Muriaticum, Lycopodium Clavatum, Mercurius Solubilis, Phytolacca Decandra, Silicea</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121022</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>AMMONIUM CHLORIDE; BARIUM CARBONATE; ATROPA BELLADONNA; TRIBASIC CALCIUM PHOSPHATE; FERROSOFERRIC PHOSPHATE; GUAIACUM OFFICINALE RESIN; POTASSIUM CHLORIDE; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; PHYTOLACCA AMERICANA ROOT; SILICON DIOXIDE</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of: sore throat, inflammation, swollen glands, difficulty swallowing, associated fever, redness and burning, sensation of a lump in throat, congestion, mucous.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0018-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0018-2)</PackageDescription>
<NDC11Code>57955-0018-02</NDC11Code>
<ProductNDC>57955-0018</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Teething</ProprietaryName>
<NonProprietaryName>Agaricus Muscarius, Belladonna, Calcarea Carbonica, Calcarea Phosphorica, Chamomilla, Ferrum Phosphoricum, Kreosotum, Zincum Metallicum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121022</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>AMANITA MUSCARIA FRUITING BODY; ATROPA BELLADONNA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TRIBASIC CALCIUM PHOSPHATE; MATRICARIA RECUTITA; FERROSOFERRIC PHOSPHATE; WOOD CREOSOTE; ZINC</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of: teething pain, swelling gums, delayed teething, low grade fever, restlessness, heavy salivation, irritability, desire to be held constantly.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57955-0019-2</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, SPRAY (57955-0019-2)</PackageDescription>
<NDC11Code>57955-0019-02</NDC11Code>
<ProductNDC>57955-0019</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Constipation Relief</ProprietaryName>
<NonProprietaryName>Alumina, Bellis Perennis, Causticum, Collinsonia Canadensis, Hydrastis Canadensis, Lac Defloratum, Natrum Muriaticum, Nux Vomica, Plumbum Metallicum, Sepia</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160627</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>King Bio Inc.</LabelerName>
<SubstanceName>ALUMINUM OXIDE; BELLIS PERENNIS; CAUSTICUM; COLLINSONIA CANADENSIS ROOT; GOLDENSEAL; SKIM MILK; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; LEAD; SEPIA OFFICINALIS JUICE</SubstanceName>
<StrengthNumber>10; 10; 10; 10; 10; 10; 10; 10; 10; 10</StrengthNumber>
<StrengthUnit>[hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses for temporary relief of symptoms of constipation: irregularity, hard, dry stools, great straining, rumbling and bloated bowels, mucus in stools, associated headache.</IndicationAndUsage>
</NDC>
</NDCList>