RESTful Lookup — Test-Drive (2007 – 2026)

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{
  "NDC": [
    {
      "NDCCode": "43742-1538-1",
      "PackageDescription": "30 mL in 1 BOTTLE, DROPPER (43742-1538-1) ",
      "NDC11Code": "43742-1538-01",
      "ProductNDC": "43742-1538",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Skin Infections",
      "NonProprietaryName": "Echinacea (angustifolia), Phytolacca Decandra, Hepar Sulphuris Calcareum, Mercurius Solubilis, Mezereum, Ailanthus Glandulosus, Arsenicum Album, Lachesis Mutus, Herpes Simplex I And Ii Nosode, Herpes Zoster Nosode",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20190822",
      "EndMarketingDate": "20281110",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Deseret Biologials, Inc.",
      "SubstanceName": "ECHINACEA ANGUSTIFOLIA; PHYTOLACCA AMERICANA ROOT; CALCIUM SULFIDE; MERCURIUS SOLUBILIS; DAPHNE MEZEREUM BARK; AILANTHUS ALTISSIMA FLOWERING TWIG; ARSENIC TRIOXIDE; LACHESIS MUTA VENOM; HUMAN HERPESVIRUS 1; HUMAN HERPESVIRUS 2; HUMAN HERPESVIRUS 3",
      "StrengthNumber": "3; 4; 8; 8; 9; 10; 12; 12; 15; 15; 15",
      "StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
      "Status": "Active",
      "LastUpdate": "2024-02-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20190822",
      "EndMarketingDatePackage": "20281110",
      "SamplePackage": "N",
      "IndicationAndUsage": "For temporary relief of symptoms related to skin infections including inflammation, rash, fever and swelling.**. **These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration."
    },
    {
      "NDCCode": "10477-1538-1",
      "PackageDescription": "50 g in 1 JAR (10477-1538-1)",
      "NDC11Code": "10477-1538-01",
      "ProductNDC": "10477-1538",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Mineral Sunscreen Spf 20",
      "NonProprietaryName": "Octinoxate, Octisalate, Zinc Oxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20050906",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Goodier Cosmetics, LP",
      "SubstanceName": "OCTINOXATE; OCTISALATE; ZINC OXIDE",
      "StrengthNumber": "3; 2; 5",
      "StrengthUnit": "g/100g; g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2014-12-05"
    },
    {
      "NDCCode": "10477-1538-2",
      "PackageDescription": "1 JAR in 1 CARTON (10477-1538-2)  > 48 g in 1 JAR",
      "NDC11Code": "10477-1538-02",
      "ProductNDC": "10477-1538",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Mineral Sunscreen Spf 20",
      "NonProprietaryName": "Octinoxate, Octisalate, Zinc Oxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20050906",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Goodier Cosmetics, LP",
      "SubstanceName": "OCTINOXATE; OCTISALATE; ZINC OXIDE",
      "StrengthNumber": "3; 2; 5",
      "StrengthUnit": "g/100g; g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2014-12-05"
    },
    {
      "NDCCode": "10477-1538-3",
      "PackageDescription": "7 g in 1 JAR (10477-1538-3)",
      "NDC11Code": "10477-1538-03",
      "ProductNDC": "10477-1538",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Mineral Sunscreen Spf 20",
      "NonProprietaryName": "Octinoxate, Octisalate, Zinc Oxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20050906",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Goodier Cosmetics, LP",
      "SubstanceName": "OCTINOXATE; OCTISALATE; ZINC OXIDE",
      "StrengthNumber": "3; 2; 5",
      "StrengthUnit": "g/100g; g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2014-12-05"
    },
    {
      "NDCCode": "10742-1538-1",
      "PackageDescription": "1 TUBE in 1 BLISTER PACK (10742-1538-1)  > 2 g in 1 TUBE",
      "NDC11Code": "10742-1538-01",
      "ProductNDC": "10742-1538",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Softlips Chocolate Bunny",
      "NonProprietaryName": "Dimethicone, Octinoxate, Octisalate, Oxybenzone",
      "DosageFormName": "STICK",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20130215",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "The Mentholatum Company",
      "SubstanceName": "DIMETHICONE; OCTINOXATE; OCTISALATE; OXYBENZONE",
      "StrengthNumber": "20; 75; 30; 30",
      "StrengthUnit": "mg/g; mg/g; mg/g; mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2016-12-02"
    },
    {
      "NDCCode": "22840-1538-1",
      "PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (22840-1538-1) ",
      "NDC11Code": "22840-1538-01",
      "ProductNDC": "22840-1538",
      "ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Silk Worm",
      "NonProprietaryName": "Bombyx Mori",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19810915",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101833",
      "LabelerName": "Greer Laboratories, Inc.",
      "SubstanceName": "BOMBYX MORI FIBER",
      "StrengthNumber": ".001",
      "StrengthUnit": "g/mL",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Insect Proteins [CS], Non-Standardized Insect Allergenic Extract [EPC], Silk [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": "36987-1538-1",
      "PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (36987-1538-1)",
      "NDC11Code": "36987-1538-01",
      "ProductNDC": "36987-1538",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Coconut",
      "NonProprietaryName": "Coconut",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19720829",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102192",
      "LabelerName": "Nelco Laboratories, Inc.",
      "SubstanceName": "COCONUT",
      "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],Fruit Proteins [EXT]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
      "Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
    },
    {
      "NDCCode": "36987-1538-2",
      "PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (36987-1538-2)",
      "NDC11Code": "36987-1538-02",
      "ProductNDC": "36987-1538",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Coconut",
      "NonProprietaryName": "Coconut",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19720829",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102192",
      "LabelerName": "Nelco Laboratories, Inc.",
      "SubstanceName": "COCONUT",
      "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],Fruit Proteins [EXT]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
      "Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
    },
    {
      "NDCCode": "36987-1538-3",
      "PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (36987-1538-3)",
      "NDC11Code": "36987-1538-03",
      "ProductNDC": "36987-1538",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Coconut",
      "NonProprietaryName": "Coconut",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19720829",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102192",
      "LabelerName": "Nelco Laboratories, Inc.",
      "SubstanceName": "COCONUT",
      "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],Fruit Proteins [EXT]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
      "Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
    },
    {
      "NDCCode": "36987-1538-4",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (36987-1538-4)",
      "NDC11Code": "36987-1538-04",
      "ProductNDC": "36987-1538",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Coconut",
      "NonProprietaryName": "Coconut",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19720829",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102192",
      "LabelerName": "Nelco Laboratories, Inc.",
      "SubstanceName": "COCONUT",
      "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],Fruit Proteins [EXT]",
      "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": "37662-1538-1",
      "PackageDescription": "200 PELLET in 1 VIAL, GLASS (37662-1538-1) ",
      "NDC11Code": "37662-1538-01",
      "ProductNDC": "37662-1538",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Manganum Oxydatum Nigrum",
      "NonProprietaryName": "Manganum Oxydatum Nigrum",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220921",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Hahnemann Laboratories, INC.",
      "SubstanceName": "MANGANESE DIOXIDE",
      "StrengthNumber": "12",
      "StrengthUnit": "[hp_C]/1",
      "Status": "Active",
      "LastUpdate": "2022-09-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220921",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "37662-1538-2",
      "PackageDescription": "1200 PELLET in 1 BOTTLE, GLASS (37662-1538-2) ",
      "NDC11Code": "37662-1538-02",
      "ProductNDC": "37662-1538",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Manganum Oxydatum Nigrum",
      "NonProprietaryName": "Manganum Oxydatum Nigrum",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220921",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Hahnemann Laboratories, INC.",
      "SubstanceName": "MANGANESE DIOXIDE",
      "StrengthNumber": "12",
      "StrengthUnit": "[hp_C]/1",
      "Status": "Active",
      "LastUpdate": "2022-09-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220921",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "37662-1538-3",
      "PackageDescription": "4000 PELLET in 1 BOTTLE, GLASS (37662-1538-3) ",
      "NDC11Code": "37662-1538-03",
      "ProductNDC": "37662-1538",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Manganum Oxydatum Nigrum",
      "NonProprietaryName": "Manganum Oxydatum Nigrum",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220921",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Hahnemann Laboratories, INC.",
      "SubstanceName": "MANGANESE DIOXIDE",
      "StrengthNumber": "12",
      "StrengthUnit": "[hp_C]/1",
      "Status": "Active",
      "LastUpdate": "2022-09-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220921",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "38779-0242-0",
      "PackageDescription": "1538.5 g in 1 PAIL (38779-0242-0) ",
      "NDC11Code": "38779-0242-00",
      "ProductNDC": "38779-0242",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Nystatin",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20150716",
      "MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
      "LabelerName": "Medisca Inc.",
      "SubstanceName": "NYSTATIN",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Unfinished",
      "LastUpdate": "2026-01-21",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "16-JUL-15"
    },
    {
      "NDCCode": "41226-500-52",
      "PackageDescription": "1538 mL in 1 BOTTLE, PLASTIC (41226-500-52) ",
      "NDC11Code": "41226-0500-52",
      "ProductNDC": "41226-500",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Kroger Antibacterial",
      "NonProprietaryName": "Benzalkonium Chloride",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20240205",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "505G(a)(3)",
      "LabelerName": "Kroger Company",
      "SubstanceName": "BENZALKONIUM CHLORIDE",
      "StrengthNumber": "130",
      "StrengthUnit": "mg/100mL",
      "Status": "Active",
      "LastUpdate": "2026-05-07",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20240205",
      "SamplePackage": "N",
      "IndicationAndUsage": "Helps decrease bacteria on hands."
    },
    {
      "NDCCode": "50090-1538-0",
      "PackageDescription": "355 mL in 1 BOTTLE (50090-1538-0) ",
      "NDC11Code": "50090-1538-00",
      "ProductNDC": "50090-1538",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Mintox",
      "NonProprietaryName": "Aluminum Hydroxide, Magnesium Hydroxide, Dimethicone",
      "DosageFormName": "SUSPENSION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20110201",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part331",
      "LabelerName": "A-S Medication Solutions",
      "SubstanceName": "ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE",
      "StrengthNumber": "200; 20; 200",
      "StrengthUnit": "mg/5mL; mg/5mL; mg/5mL",
      "Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Skin Barrier Activity [PE], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20141216",
      "SamplePackage": "N",
      "IndicationAndUsage": "relieves. : 1 heartburn, 2 sour stomach, 3 acid indigestion, 4 symptoms referred to as gas."
    },
    {
      "NDCCode": "51552-1538-2",
      "PackageDescription": "1 g in 1 CONTAINER (51552-1538-2) ",
      "NDC11Code": "51552-1538-02",
      "ProductNDC": "51552-1538",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Imiquimod",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20180103",
      "EndMarketingDate": "20270531",
      "MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
      "LabelerName": "Fagron Inc",
      "SubstanceName": "IMIQUIMOD",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Unfinished",
      "LastUpdate": "2023-12-01",
      "StartMarketingDatePackage": "03-JAN-18",
      "EndMarketingDatePackage": "31-JAN-27"
    },
    {
      "NDCCode": "51552-1538-3",
      "PackageDescription": "10 g in 1 CONTAINER (51552-1538-3) ",
      "NDC11Code": "51552-1538-03",
      "ProductNDC": "51552-1538",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Imiquimod",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20180103",
      "EndMarketingDate": "20270531",
      "MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
      "LabelerName": "Fagron Inc",
      "SubstanceName": "IMIQUIMOD",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Unfinished",
      "LastUpdate": "2023-12-01",
      "StartMarketingDatePackage": "03-JAN-18",
      "EndMarketingDatePackage": "31-JAN-27"
    },
    {
      "NDCCode": "51552-1538-4",
      "PackageDescription": "25 g in 1 CONTAINER (51552-1538-4) ",
      "NDC11Code": "51552-1538-04",
      "ProductNDC": "51552-1538",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Imiquimod",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20180103",
      "EndMarketingDate": "20270531",
      "MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
      "LabelerName": "Fagron Inc",
      "SubstanceName": "IMIQUIMOD",
      "StrengthNumber": "1",
      "StrengthUnit": "g/g",
      "Status": "Unfinished",
      "LastUpdate": "2023-12-01",
      "StartMarketingDatePackage": "03-JAN-18",
      "EndMarketingDatePackage": "31-MAY-27"
    },
    {
      "NDCCode": "51662-1538-1",
      "PackageDescription": "30 mL in 1 VIAL, SINGLE-DOSE (51662-1538-1) ",
      "NDC11Code": "51662-1538-01",
      "ProductNDC": "51662-1538",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lidocaine Hcl",
      "NonProprietaryName": "Lidocaine Hcl",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL",
      "StartMarketingDate": "20210503",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA088329",
      "LabelerName": "HF Acquisition Co LLC, DBA HealthFirst",
      "SubstanceName": "LIDOCAINE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
      "Status": "Active",
      "LastUpdate": "2024-02-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210503",
      "SamplePackage": "N",
      "IndicationAndUsage": "Lidocaine Hydrochloride Injection, USP is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed.",
      "Description": "Lidocaine Hydrochloride Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride in water for injection for parenteral administration in various concentrations with characteristics as follows. Multiple-dose vials contain 0.1% of methylparaben added as preservative. May contain sodium hydroxide and/or hydrochloric acid for pH adjustment. The pH is 6.5 (5.0 to 7.0). See HOW SUPPLIED section for various sizes and strengths. Lidocaine is a local anesthetic of the amide type. Lidocaine Hydrochloride, USP is chemically designated 2-(diethylamino)-N-(2,6-dimethylphenyl)-acetamide monohydrochloride monohydrate, a white powder freely soluble in water. The molecular weight is 288.82. It has the following structural formula. The semi-rigid vial used for the plastic vials is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The container requires no vapor barrier to maintain the proper drug concentration."
    },
    {
      "NDCCode": "51662-1538-3",
      "PackageDescription": "25 POUCH in 1 CASE (51662-1538-3)  / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1538-2)  / 30 mL in 1 VIAL, SINGLE-DOSE",
      "NDC11Code": "51662-1538-03",
      "ProductNDC": "51662-1538",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lidocaine Hcl",
      "NonProprietaryName": "Lidocaine Hcl",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL",
      "StartMarketingDate": "20210503",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA088329",
      "LabelerName": "HF Acquisition Co LLC, DBA HealthFirst",
      "SubstanceName": "LIDOCAINE HYDROCHLORIDE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
      "Status": "Active",
      "LastUpdate": "2024-02-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230109",
      "SamplePackage": "N",
      "IndicationAndUsage": "Lidocaine Hydrochloride Injection, USP is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed.",
      "Description": "Lidocaine Hydrochloride Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride in water for injection for parenteral administration in various concentrations with characteristics as follows. Multiple-dose vials contain 0.1% of methylparaben added as preservative. May contain sodium hydroxide and/or hydrochloric acid for pH adjustment. The pH is 6.5 (5.0 to 7.0). See HOW SUPPLIED section for various sizes and strengths. Lidocaine is a local anesthetic of the amide type. Lidocaine Hydrochloride, USP is chemically designated 2-(diethylamino)-N-(2,6-dimethylphenyl)-acetamide monohydrochloride monohydrate, a white powder freely soluble in water. The molecular weight is 288.82. It has the following structural formula. The semi-rigid vial used for the plastic vials is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The container requires no vapor barrier to maintain the proper drug concentration."
    },
    {
      "NDCCode": "53002-1538-0",
      "PackageDescription": "100 TABLET in 1 BOTTLE (53002-1538-0) ",
      "NDC11Code": "53002-1538-00",
      "ProductNDC": "53002-1538",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Gabapentin",
      "NonProprietaryName": "Gabapentin",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160204",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA205101",
      "LabelerName": "RPK Pharmaceuticals, Inc.",
      "SubstanceName": "GABAPENTIN",
      "StrengthNumber": "600",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20221231",
      "SamplePackage": "N",
      "IndicationAndUsage": "Gabapentin is indicated for: : 1 Management of postherpetic neuralgia in adults , 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy .",
      "Description": "The active ingredient in gabapentin capsules and tablets, USP is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C 9H 17NO 2 and the molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin, USP is a white to off-white crystalline solid with a pK a1 of 4.72±0.10 and a pK a2 of 10.27±0.29. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient is -1.083±0.235 at 25°C temperature. Each gabapentin capsule contains 100 mg, 300 mg or 400 mg of gabapentin, USP and the following inactive ingredients: pregelatinized starch (maize), and talc. The 100 mg capsule shell contains gelatin, sodium lauryl sulfate (SLS) and titanium dioxide. The 300 mg capsule shell contains gelatin, titanium dioxide, FD&C Red 40, D&C Yellow 10, and sodium lauryl sulfate (SLS). The 400 mg capsule shell contains gelatin, titanium dioxide, sodium lauryl sulfate (SLS), D&C Yellow 10, and FD&C Red 40. The imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, and potassium hydroxide. Each gabapentin tablet contains 600 mg or 800 mg of gabapentin, USP and the following inactive ingredients: poloxamer 407, mannitol, magnesium stearate, hydroxypropyl cellulose, talc, copovidone, crospovidone, colloidal silicon dioxide and coating agent contains hypromellose, titanium dioxide, polyethylene glycol and talc."
    },
    {
      "NDCCode": "53002-1538-3",
      "PackageDescription": "30 TABLET in 1 BOTTLE (53002-1538-3) ",
      "NDC11Code": "53002-1538-03",
      "ProductNDC": "53002-1538",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Gabapentin",
      "NonProprietaryName": "Gabapentin",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160204",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA205101",
      "LabelerName": "RPK Pharmaceuticals, Inc.",
      "SubstanceName": "GABAPENTIN",
      "StrengthNumber": "600",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20221231",
      "SamplePackage": "N",
      "IndicationAndUsage": "Gabapentin is indicated for: : 1 Management of postherpetic neuralgia in adults , 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy .",
      "Description": "The active ingredient in gabapentin capsules and tablets, USP is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C 9H 17NO 2 and the molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin, USP is a white to off-white crystalline solid with a pK a1 of 4.72±0.10 and a pK a2 of 10.27±0.29. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient is -1.083±0.235 at 25°C temperature. Each gabapentin capsule contains 100 mg, 300 mg or 400 mg of gabapentin, USP and the following inactive ingredients: pregelatinized starch (maize), and talc. The 100 mg capsule shell contains gelatin, sodium lauryl sulfate (SLS) and titanium dioxide. The 300 mg capsule shell contains gelatin, titanium dioxide, FD&C Red 40, D&C Yellow 10, and sodium lauryl sulfate (SLS). The 400 mg capsule shell contains gelatin, titanium dioxide, sodium lauryl sulfate (SLS), D&C Yellow 10, and FD&C Red 40. The imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, and potassium hydroxide. Each gabapentin tablet contains 600 mg or 800 mg of gabapentin, USP and the following inactive ingredients: poloxamer 407, mannitol, magnesium stearate, hydroxypropyl cellulose, talc, copovidone, crospovidone, colloidal silicon dioxide and coating agent contains hypromellose, titanium dioxide, polyethylene glycol and talc."
    },
    {
      "NDCCode": "54340-245-03",
      "PackageDescription": "1538 mL in 1 BOTTLE, DISPENSING (54340-245-03)",
      "NDC11Code": "54340-0245-03",
      "ProductNDC": "54340-245",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Dial Antibacterial Hand Wash",
      "NonProprietaryName": "Dial White Tea And Vitamin E Antibacterial Hand Soap With Moisturizer",
      "DosageFormName": "SOLUTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20150105",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "The Dial Corporation, A Henkel Company",
      "SubstanceName": "BENZETHONIUM CHLORIDE",
      "StrengthNumber": ".1",
      "StrengthUnit": "g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "For handwashing to decrease bacteria on the skin."
    },
    {
      "NDCCode": "54868-1538-1",
      "PackageDescription": "100 TABLET in 1 BOTTLE (54868-1538-1)",
      "NDC11Code": "54868-1538-01",
      "ProductNDC": "54868-1538",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Nitrostat",
      "NonProprietaryName": "Nitroglycerin",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19940922",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021134",
      "LabelerName": "Physicians Total Care, Inc.",
      "SubstanceName": "NITROGLYCERIN",
      "StrengthNumber": ".3",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2018-07-24",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Nitroglycerin is indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.",
      "Description": "Nitrostat is a stabilized sublingual compressed nitroglycerin tablet that contains 0.3 mg (1/200 grain), 0.4 mg (1/150 grain), or 0.6 mg (1/100 grain) nitroglycerin; as well as lactose monohydrate, NF; glyceryl monostearate, NF; pregelatinized starch, NF; calcium stearate, NF powder; and silicon dioxide, colloidal, NF. Nitroglycerin, an organic nitrate, is a vasodilating agent. The chemical name for nitroglycerin is 1, 2, 3 propanetriol trinitrate and the chemical structure is. Molecular weight: 227.09."
    },
    {
      "NDCCode": "55714-1538-1",
      "PackageDescription": "30 mL in 1 BOTTLE, GLASS (55714-1538-1) ",
      "NDC11Code": "55714-1538-01",
      "ProductNDC": "55714-1538",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hypercalm-mental Focus",
      "NonProprietaryName": "Chamomilla, Echinacea, Hypericum Perforatum, Passiflora Incarnata, Aconitum Napellus, Adrenalinum, Argentum Nit., Arsenicum Album, Baptisia Tinctoria, Chamomilla, Coffea Cruda, Cypripedium Pubescens, Digitalis Purpurea, Gelsemium Sempervirens, Humulus Lupulus, Hyoscyamus Niger, Ignatia Amara, Impatiens Glandulifera Flos, Iodium, Lachesis Mutus, Lycopodium Clavatum, Natrum Muriaticum, Nux Vomica, Scutellaria Lateriflora, Staphysagria, Stramonium, Theridion, Veratrum Viride",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20230601",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Newton Laboratories, Inc.",
      "SubstanceName": "ECHINACEA, UNSPECIFIED; GELSEMIUM SEMPERVIRENS ROOT; PASSIFLORA INCARNATA FLOWERING TOP; ACONITUM NAPELLUS; EPINEPHRINE; SILVER NITRATE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; MATRICARIA CHAMOMILLA; ARABICA COFFEE BEAN; CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT; DIGITALIS; HYOSCYAMUS NIGER; STRYCHNOS IGNATII SEED; IMPATIENS GLANDULIFERA FLOWER; IODINE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; SCUTELLARIA LATERIFLORA WHOLE; DELPHINIUM STAPHISAGRIA SEED; DATURA STRAMONIUM; THERIDION CURASSAVICUM; VERATRUM VIRIDE ROOT; HOPS; HYPERICUM PERFORATUM",
      "StrengthNumber": "6; 15; 6; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 6",
      "StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
      "Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Allergens [CS], Allergens [CS], Allergens [CS], Catecholamine [EPC], Catecholamines [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Plant Proteins [CS], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS], Seed Storage Proteins [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-07-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20230601",
      "SamplePackage": "N",
      "IndicationAndUsage": "Formulated for associated symptoms such as impulsiveness, lack of focus, irritability and emotional or disruptive behavior."
    },
    {
      "NDCCode": "63083-1538-1",
      "PackageDescription": "29.5 mL in 1 BOTTLE, DROPPER (63083-1538-1) ",
      "NDC11Code": "63083-1538-01",
      "ProductNDC": "63083-1538",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Progesterone",
      "ProprietaryNameSuffix": "1538",
      "NonProprietaryName": "Progesterone",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "19840815",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Professional Complementary Health Formulas",
      "SubstanceName": "PROGESTERONE",
      "StrengthNumber": "9",
      "StrengthUnit": "[hp_X]/29.5mL",
      "Pharm_Classes": "Progesterone [CS], Progesterone [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-01-09",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19850815",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "64942-1538-1",
      "PackageDescription": "76 g in 1 CONTAINER (64942-1538-1) ",
      "NDC11Code": "64942-1538-01",
      "ProductNDC": "64942-1538",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Axe",
      "ProprietaryNameSuffix": "Essence Antiperspirant And Deodorant",
      "NonProprietaryName": "Aluminum Zirconium Tetrachlorohydrex Gly",
      "DosageFormName": "STICK",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20170926",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part350",
      "LabelerName": "Conopco Inc. d/b/a/ Unilever",
      "SubstanceName": "ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY",
      "StrengthNumber": "18.2",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20170926",
      "SamplePackage": "N",
      "IndicationAndUsage": " reduces underarm wetness.  24 Hour Protection.",
      "Description": "Axe Essence Antiperspirant and Deodorant."
    },
    {
      "NDCCode": "64942-1538-2",
      "PackageDescription": "2 CONTAINER in 1 PACKAGE (64942-1538-2)  > 76 g in 1 CONTAINER (64942-1538-1) ",
      "NDC11Code": "64942-1538-02",
      "ProductNDC": "64942-1538",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Axe",
      "ProprietaryNameSuffix": "Essence Antiperspirant And Deodorant",
      "NonProprietaryName": "Aluminum Zirconium Tetrachlorohydrex Gly",
      "DosageFormName": "STICK",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20170926",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part350",
      "LabelerName": "Conopco Inc. d/b/a/ Unilever",
      "SubstanceName": "ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY",
      "StrengthNumber": "18.2",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20170926",
      "SamplePackage": "N",
      "IndicationAndUsage": " reduces underarm wetness.  24 Hour Protection.",
      "Description": "Axe Essence Antiperspirant and Deodorant."
    },
    {
      "NDCCode": "67046-1538-3",
      "PackageDescription": "30 CAPSULE in 1 BLISTER PACK (67046-1538-3) ",
      "NDC11Code": "67046-1538-03",
      "ProductNDC": "67046-1538",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fenofibrate",
      "NonProprietaryName": "Fenofibrate",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20250325",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA209504",
      "LabelerName": "Coupler LLC",
      "SubstanceName": "FENOFIBRATE",
      "StrengthNumber": "67",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-04-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250325",
      "SamplePackage": "N",
      "IndicationAndUsage": "Fenofibrate capsules are indicated as adjunctive therapy to diet for the reduction of LDL-C, total-C, Triglycerides and apo B in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb). Lipid altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate (see National Cholesterol Education Program [NCEP] Treatment Guidelines, below).",
      "Description": "Fenofibrate Capsules USP (Micronized) are lipid regulating agent available as capsules for oral administration. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C 20H 21O 4Cl and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79 to 82°C. Fenofibrate USP is a white solid which is stable under ordinary conditions. Each 67 mg Fenofibrate Capsule (Micronized) contain the following inactive ingredients: colloidal silicone dioxide, croscarmellose sodium, crospovidone, lactose monohydrate, magnesium stearate, povidone, pregelatinized starch, sodium lauryl sulfate, talc, FD&C Blue 1, FD&C Red 33, D&C Yellow 10, titanium dioxide and gelatin. Imprinting ink contains shellac, potassium hydroxide, propylene glycol and black iron oxide. Each 134 mg Fenofibrate Capsule (Micronized) contain the following inactive ingredients: colloidal silicone dioxide, croscarmellose sodium, crospovidone, lactose monohydrate, magnesium stearate, povidone, pregelatinized starch, sodium lauryl sulfate, talc, FD&C Blue 1, D&C Red 3, titanium dioxide and gelatin. Imprinting ink contains shellac, potassium hydroxide and propylene glycol. Each 200 mg Fenofibrate Capsule (Micronized) contain the following inactive ingredients: colloidal silicone dioxide, croscarmellose sodium, crospovidone, lactose monohydrate, magnesium stearate, povidone, pregelatinized starch, sodium lauryl sulfate, talc, iron oxide red, iron oxide yellow, titanium dioxide and gelatin. Imprinting ink contains shellac, potassium hydroxide, propylene glycol and black iron oxide."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"43742-1538-1","ProprietaryName":"Skin Infections","NonProprietaryName":"Echinacea (angustifolia), Phytolacca Decandra, Hepar Sulphuris Calcareum, Mercurius Solubilis, Mezereum, Ailanthus Glandulosus, Arsenicum Album, Lachesis Mutus, Herpes Simplex I And Ii Nosode, Herpes Zoster Nosode"},{"NDCCode":"10477-1538-1","ProprietaryName":"Mineral Sunscreen Spf 20","NonProprietaryName":"Octinoxate, Octisalate, Zinc Oxide"},{"NDCCode":"10477-1538-2","ProprietaryName":"Mineral Sunscreen Spf 20","NonProprietaryName":"Octinoxate, Octisalate, Zinc Oxide"},{"NDCCode":"10477-1538-3","ProprietaryName":"Mineral Sunscreen Spf 20","NonProprietaryName":"Octinoxate, Octisalate, Zinc Oxide"},{"NDCCode":"10742-1538-1","ProprietaryName":"Softlips Chocolate Bunny","NonProprietaryName":"Dimethicone, Octinoxate, Octisalate, Oxybenzone"},{"NDCCode":"22840-1538-1","ProprietaryName":"Silk Worm","NonProprietaryName":"Bombyx Mori"},{"NDCCode":"36987-1538-1","ProprietaryName":"Coconut","NonProprietaryName":"Coconut"},{"NDCCode":"36987-1538-2","ProprietaryName":"Coconut","NonProprietaryName":"Coconut"},{"NDCCode":"36987-1538-3","ProprietaryName":"Coconut","NonProprietaryName":"Coconut"},{"NDCCode":"36987-1538-4","ProprietaryName":"Coconut","NonProprietaryName":"Coconut"},{"NDCCode":"37662-1538-1","ProprietaryName":"Manganum Oxydatum Nigrum","NonProprietaryName":"Manganum Oxydatum Nigrum"},{"NDCCode":"37662-1538-2","ProprietaryName":"Manganum Oxydatum Nigrum","NonProprietaryName":"Manganum Oxydatum Nigrum"},{"NDCCode":"37662-1538-3","ProprietaryName":"Manganum Oxydatum Nigrum","NonProprietaryName":"Manganum Oxydatum Nigrum"},{"NDCCode":"38779-0242-0","NonProprietaryName":"Nystatin"},{"NDCCode":"41226-500-52","ProprietaryName":"Kroger Antibacterial","NonProprietaryName":"Benzalkonium Chloride"},{"NDCCode":"50090-1538-0","ProprietaryName":"Mintox","NonProprietaryName":"Aluminum Hydroxide, Magnesium Hydroxide, Dimethicone"},{"NDCCode":"51552-1538-2","NonProprietaryName":"Imiquimod"},{"NDCCode":"51552-1538-3","NonProprietaryName":"Imiquimod"},{"NDCCode":"51552-1538-4","NonProprietaryName":"Imiquimod"},{"NDCCode":"51662-1538-1","ProprietaryName":"Lidocaine Hcl","NonProprietaryName":"Lidocaine Hcl"},{"NDCCode":"51662-1538-3","ProprietaryName":"Lidocaine Hcl","NonProprietaryName":"Lidocaine Hcl"},{"NDCCode":"53002-1538-0","ProprietaryName":"Gabapentin","NonProprietaryName":"Gabapentin"},{"NDCCode":"53002-1538-3","ProprietaryName":"Gabapentin","NonProprietaryName":"Gabapentin"},{"NDCCode":"54340-245-03","ProprietaryName":"Dial Antibacterial Hand Wash","NonProprietaryName":"Dial White Tea And Vitamin E Antibacterial Hand Soap With Moisturizer"},{"NDCCode":"54868-1538-1","ProprietaryName":"Nitrostat","NonProprietaryName":"Nitroglycerin"},{"NDCCode":"55714-1538-1","ProprietaryName":"Hypercalm-mental Focus","NonProprietaryName":"Chamomilla, Echinacea, Hypericum Perforatum, Passiflora Incarnata, Aconitum Napellus, Adrenalinum, Argentum Nit., Arsenicum Album, Baptisia Tinctoria, Chamomilla, Coffea Cruda, Cypripedium Pubescens, Digitalis Purpurea, Gelsemium Sempervirens, Humulus Lupulus, Hyoscyamus Niger, Ignatia Amara, Impatiens Glandulifera Flos, Iodium, Lachesis Mutus, Lycopodium Clavatum, Natrum Muriaticum, Nux Vomica, Scutellaria Lateriflora, Staphysagria, Stramonium, Theridion, Veratrum Viride"},{"NDCCode":"63083-1538-1","ProprietaryName":"Progesterone","NonProprietaryName":"Progesterone"},{"NDCCode":"64942-1538-1","ProprietaryName":"Axe","NonProprietaryName":"Aluminum Zirconium Tetrachlorohydrex Gly"},{"NDCCode":"64942-1538-2","ProprietaryName":"Axe","NonProprietaryName":"Aluminum Zirconium Tetrachlorohydrex Gly"},{"NDCCode":"67046-1538-3","ProprietaryName":"Fenofibrate","NonProprietaryName":"Fenofibrate"}]}
                    

<?xml version="1.0" encoding="utf-8"?>
<NDCList>
  <NDC>
    <NDCCode>43742-1538-1</NDCCode>
    <PackageDescription>30 mL in 1 BOTTLE, DROPPER (43742-1538-1) </PackageDescription>
    <NDC11Code>43742-1538-01</NDC11Code>
    <ProductNDC>43742-1538</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Skin Infections</ProprietaryName>
    <NonProprietaryName>Echinacea (angustifolia), Phytolacca Decandra, Hepar Sulphuris Calcareum, Mercurius Solubilis, Mezereum, Ailanthus Glandulosus, Arsenicum Album, Lachesis Mutus, Herpes Simplex I And Ii Nosode, Herpes Zoster Nosode</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20190822</StartMarketingDate>
    <EndMarketingDate>20281110</EndMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Deseret Biologials, Inc.</LabelerName>
    <SubstanceName>ECHINACEA ANGUSTIFOLIA; PHYTOLACCA AMERICANA ROOT; CALCIUM SULFIDE; MERCURIUS SOLUBILIS; DAPHNE MEZEREUM BARK; AILANTHUS ALTISSIMA FLOWERING TWIG; ARSENIC TRIOXIDE; LACHESIS MUTA VENOM; HUMAN HERPESVIRUS 1; HUMAN HERPESVIRUS 2; HUMAN HERPESVIRUS 3</SubstanceName>
    <StrengthNumber>3; 4; 8; 8; 9; 10; 12; 12; 15; 15; 15</StrengthNumber>
    <StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-02-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20190822</StartMarketingDatePackage>
    <EndMarketingDatePackage>20281110</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For temporary relief of symptoms related to skin infections including inflammation, rash, fever and swelling.**. **These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>10477-1538-1</NDCCode>
    <PackageDescription>50 g in 1 JAR (10477-1538-1)</PackageDescription>
    <NDC11Code>10477-1538-01</NDC11Code>
    <ProductNDC>10477-1538</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Mineral Sunscreen Spf 20</ProprietaryName>
    <NonProprietaryName>Octinoxate, Octisalate, Zinc Oxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20050906</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Goodier Cosmetics, LP</LabelerName>
    <SubstanceName>OCTINOXATE; OCTISALATE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>3; 2; 5</StrengthNumber>
    <StrengthUnit>g/100g; g/100g; g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-12-05</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>10477-1538-2</NDCCode>
    <PackageDescription>1 JAR in 1 CARTON (10477-1538-2)  &gt; 48 g in 1 JAR</PackageDescription>
    <NDC11Code>10477-1538-02</NDC11Code>
    <ProductNDC>10477-1538</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Mineral Sunscreen Spf 20</ProprietaryName>
    <NonProprietaryName>Octinoxate, Octisalate, Zinc Oxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20050906</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Goodier Cosmetics, LP</LabelerName>
    <SubstanceName>OCTINOXATE; OCTISALATE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>3; 2; 5</StrengthNumber>
    <StrengthUnit>g/100g; g/100g; g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-12-05</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>10477-1538-3</NDCCode>
    <PackageDescription>7 g in 1 JAR (10477-1538-3)</PackageDescription>
    <NDC11Code>10477-1538-03</NDC11Code>
    <ProductNDC>10477-1538</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Mineral Sunscreen Spf 20</ProprietaryName>
    <NonProprietaryName>Octinoxate, Octisalate, Zinc Oxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20050906</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Goodier Cosmetics, LP</LabelerName>
    <SubstanceName>OCTINOXATE; OCTISALATE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>3; 2; 5</StrengthNumber>
    <StrengthUnit>g/100g; g/100g; g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-12-05</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>10742-1538-1</NDCCode>
    <PackageDescription>1 TUBE in 1 BLISTER PACK (10742-1538-1)  &gt; 2 g in 1 TUBE</PackageDescription>
    <NDC11Code>10742-1538-01</NDC11Code>
    <ProductNDC>10742-1538</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Softlips Chocolate Bunny</ProprietaryName>
    <NonProprietaryName>Dimethicone, Octinoxate, Octisalate, Oxybenzone</NonProprietaryName>
    <DosageFormName>STICK</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20130215</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>The Mentholatum Company</LabelerName>
    <SubstanceName>DIMETHICONE; OCTINOXATE; OCTISALATE; OXYBENZONE</SubstanceName>
    <StrengthNumber>20; 75; 30; 30</StrengthNumber>
    <StrengthUnit>mg/g; mg/g; mg/g; mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2016-12-02</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>22840-1538-1</NDCCode>
    <PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (22840-1538-1) </PackageDescription>
    <NDC11Code>22840-1538-01</NDC11Code>
    <ProductNDC>22840-1538</ProductNDC>
    <ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
    <ProprietaryName>Silk Worm</ProprietaryName>
    <NonProprietaryName>Bombyx Mori</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19810915</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA101833</ApplicationNumber>
    <LabelerName>Greer Laboratories, Inc.</LabelerName>
    <SubstanceName>BOMBYX MORI FIBER</SubstanceName>
    <StrengthNumber>.001</StrengthNumber>
    <StrengthUnit>g/mL</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Insect Proteins [CS], Non-Standardized Insect Allergenic Extract [EPC], Silk [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>36987-1538-1</NDCCode>
    <PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (36987-1538-1)</PackageDescription>
    <NDC11Code>36987-1538-01</NDC11Code>
    <ProductNDC>36987-1538</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Coconut</ProprietaryName>
    <NonProprietaryName>Coconut</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19720829</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA102192</ApplicationNumber>
    <LabelerName>Nelco Laboratories, Inc.</LabelerName>
    <SubstanceName>COCONUT</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],Fruit Proteins [EXT]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
    <Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
  </NDC>
  <NDC>
    <NDCCode>36987-1538-2</NDCCode>
    <PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (36987-1538-2)</PackageDescription>
    <NDC11Code>36987-1538-02</NDC11Code>
    <ProductNDC>36987-1538</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Coconut</ProprietaryName>
    <NonProprietaryName>Coconut</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19720829</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA102192</ApplicationNumber>
    <LabelerName>Nelco Laboratories, Inc.</LabelerName>
    <SubstanceName>COCONUT</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],Fruit Proteins [EXT]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
    <Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
  </NDC>
  <NDC>
    <NDCCode>36987-1538-3</NDCCode>
    <PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (36987-1538-3)</PackageDescription>
    <NDC11Code>36987-1538-03</NDC11Code>
    <ProductNDC>36987-1538</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Coconut</ProprietaryName>
    <NonProprietaryName>Coconut</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19720829</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA102192</ApplicationNumber>
    <LabelerName>Nelco Laboratories, Inc.</LabelerName>
    <SubstanceName>COCONUT</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],Fruit Proteins [EXT]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
    <Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
  </NDC>
  <NDC>
    <NDCCode>36987-1538-4</NDCCode>
    <PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (36987-1538-4)</PackageDescription>
    <NDC11Code>36987-1538-04</NDC11Code>
    <ProductNDC>36987-1538</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Coconut</ProprietaryName>
    <NonProprietaryName>Coconut</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19720829</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA102192</ApplicationNumber>
    <LabelerName>Nelco Laboratories, Inc.</LabelerName>
    <SubstanceName>COCONUT</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],Fruit Proteins [EXT]</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>37662-1538-1</NDCCode>
    <PackageDescription>200 PELLET in 1 VIAL, GLASS (37662-1538-1) </PackageDescription>
    <NDC11Code>37662-1538-01</NDC11Code>
    <ProductNDC>37662-1538</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Manganum Oxydatum Nigrum</ProprietaryName>
    <NonProprietaryName>Manganum Oxydatum Nigrum</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220921</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Hahnemann Laboratories, INC.</LabelerName>
    <SubstanceName>MANGANESE DIOXIDE</SubstanceName>
    <StrengthNumber>12</StrengthNumber>
    <StrengthUnit>[hp_C]/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2022-09-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220921</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>37662-1538-2</NDCCode>
    <PackageDescription>1200 PELLET in 1 BOTTLE, GLASS (37662-1538-2) </PackageDescription>
    <NDC11Code>37662-1538-02</NDC11Code>
    <ProductNDC>37662-1538</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Manganum Oxydatum Nigrum</ProprietaryName>
    <NonProprietaryName>Manganum Oxydatum Nigrum</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220921</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Hahnemann Laboratories, INC.</LabelerName>
    <SubstanceName>MANGANESE DIOXIDE</SubstanceName>
    <StrengthNumber>12</StrengthNumber>
    <StrengthUnit>[hp_C]/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2022-09-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220921</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>37662-1538-3</NDCCode>
    <PackageDescription>4000 PELLET in 1 BOTTLE, GLASS (37662-1538-3) </PackageDescription>
    <NDC11Code>37662-1538-03</NDC11Code>
    <ProductNDC>37662-1538</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Manganum Oxydatum Nigrum</ProprietaryName>
    <NonProprietaryName>Manganum Oxydatum Nigrum</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220921</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Hahnemann Laboratories, INC.</LabelerName>
    <SubstanceName>MANGANESE DIOXIDE</SubstanceName>
    <StrengthNumber>12</StrengthNumber>
    <StrengthUnit>[hp_C]/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2022-09-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220921</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>38779-0242-0</NDCCode>
    <PackageDescription>1538.5 g in 1 PAIL (38779-0242-0) </PackageDescription>
    <NDC11Code>38779-0242-00</NDC11Code>
    <ProductNDC>38779-0242</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Nystatin</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20150716</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
    <LabelerName>Medisca Inc.</LabelerName>
    <SubstanceName>NYSTATIN</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2026-01-21</LastUpdate>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>16-JUL-15</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>41226-500-52</NDCCode>
    <PackageDescription>1538 mL in 1 BOTTLE, PLASTIC (41226-500-52) </PackageDescription>
    <NDC11Code>41226-0500-52</NDC11Code>
    <ProductNDC>41226-500</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Kroger Antibacterial</ProprietaryName>
    <NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20240205</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>505G(a)(3)</ApplicationNumber>
    <LabelerName>Kroger Company</LabelerName>
    <SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>130</StrengthNumber>
    <StrengthUnit>mg/100mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-05-07</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240205</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Helps decrease bacteria on hands.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>50090-1538-0</NDCCode>
    <PackageDescription>355 mL in 1 BOTTLE (50090-1538-0) </PackageDescription>
    <NDC11Code>50090-1538-00</NDC11Code>
    <ProductNDC>50090-1538</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Mintox</ProprietaryName>
    <NonProprietaryName>Aluminum Hydroxide, Magnesium Hydroxide, Dimethicone</NonProprietaryName>
    <DosageFormName>SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20110201</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part331</ApplicationNumber>
    <LabelerName>A-S Medication Solutions</LabelerName>
    <SubstanceName>ALUMINUM HYDROXIDE; DIMETHICONE; MAGNESIUM HYDROXIDE</SubstanceName>
    <StrengthNumber>200; 20; 200</StrengthNumber>
    <StrengthUnit>mg/5mL; mg/5mL; mg/5mL</StrengthUnit>
    <Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Skin Barrier Activity [PE], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20141216</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>relieves. : 1 heartburn, 2 sour stomach, 3 acid indigestion, 4 symptoms referred to as gas.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>51552-1538-2</NDCCode>
    <PackageDescription>1 g in 1 CONTAINER (51552-1538-2) </PackageDescription>
    <NDC11Code>51552-1538-02</NDC11Code>
    <ProductNDC>51552-1538</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Imiquimod</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20180103</StartMarketingDate>
    <EndMarketingDate>20270531</EndMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
    <LabelerName>Fagron Inc</LabelerName>
    <SubstanceName>IMIQUIMOD</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2023-12-01</LastUpdate>
    <StartMarketingDatePackage>03-JAN-18</StartMarketingDatePackage>
    <EndMarketingDatePackage>31-JAN-27</EndMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>51552-1538-3</NDCCode>
    <PackageDescription>10 g in 1 CONTAINER (51552-1538-3) </PackageDescription>
    <NDC11Code>51552-1538-03</NDC11Code>
    <ProductNDC>51552-1538</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Imiquimod</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20180103</StartMarketingDate>
    <EndMarketingDate>20270531</EndMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
    <LabelerName>Fagron Inc</LabelerName>
    <SubstanceName>IMIQUIMOD</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2023-12-01</LastUpdate>
    <StartMarketingDatePackage>03-JAN-18</StartMarketingDatePackage>
    <EndMarketingDatePackage>31-JAN-27</EndMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>51552-1538-4</NDCCode>
    <PackageDescription>25 g in 1 CONTAINER (51552-1538-4) </PackageDescription>
    <NDC11Code>51552-1538-04</NDC11Code>
    <ProductNDC>51552-1538</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Imiquimod</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20180103</StartMarketingDate>
    <EndMarketingDate>20270531</EndMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
    <LabelerName>Fagron Inc</LabelerName>
    <SubstanceName>IMIQUIMOD</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>g/g</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2023-12-01</LastUpdate>
    <StartMarketingDatePackage>03-JAN-18</StartMarketingDatePackage>
    <EndMarketingDatePackage>31-MAY-27</EndMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>51662-1538-1</NDCCode>
    <PackageDescription>30 mL in 1 VIAL, SINGLE-DOSE (51662-1538-1) </PackageDescription>
    <NDC11Code>51662-1538-01</NDC11Code>
    <ProductNDC>51662-1538</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lidocaine Hcl</ProprietaryName>
    <NonProprietaryName>Lidocaine Hcl</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL</RouteName>
    <StartMarketingDate>20210503</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA088329</ApplicationNumber>
    <LabelerName>HF Acquisition Co LLC, DBA HealthFirst</LabelerName>
    <SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-02-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210503</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lidocaine Hydrochloride Injection, USP is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed.</IndicationAndUsage>
    <Description>Lidocaine Hydrochloride Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride in water for injection for parenteral administration in various concentrations with characteristics as follows. Multiple-dose vials contain 0.1% of methylparaben added as preservative. May contain sodium hydroxide and/or hydrochloric acid for pH adjustment. The pH is 6.5 (5.0 to 7.0). See HOW SUPPLIED section for various sizes and strengths. Lidocaine is a local anesthetic of the amide type. Lidocaine Hydrochloride, USP is chemically designated 2-(diethylamino)-N-(2,6-dimethylphenyl)-acetamide monohydrochloride monohydrate, a white powder freely soluble in water. The molecular weight is 288.82. It has the following structural formula. The semi-rigid vial used for the plastic vials is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The container requires no vapor barrier to maintain the proper drug concentration.</Description>
  </NDC>
  <NDC>
    <NDCCode>51662-1538-3</NDCCode>
    <PackageDescription>25 POUCH in 1 CASE (51662-1538-3)  / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1538-2)  / 30 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
    <NDC11Code>51662-1538-03</NDC11Code>
    <ProductNDC>51662-1538</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lidocaine Hcl</ProprietaryName>
    <NonProprietaryName>Lidocaine Hcl</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>EPIDURAL; INFILTRATION; INTRACAUDAL; PERINEURAL</RouteName>
    <StartMarketingDate>20210503</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA088329</ApplicationNumber>
    <LabelerName>HF Acquisition Co LLC, DBA HealthFirst</LabelerName>
    <SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-02-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230109</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Lidocaine Hydrochloride Injection, USP is indicated for production of local or regional anesthesia by infiltration techniques such as percutaneous injection and intravenous regional anesthesia by peripheral nerve block techniques such as brachial plexus and intercostal and by central neural techniques such as lumbar and caudal epidural blocks, when the accepted procedures for these techniques as described in standard textbooks are observed.</IndicationAndUsage>
    <Description>Lidocaine Hydrochloride Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride in water for injection for parenteral administration in various concentrations with characteristics as follows. Multiple-dose vials contain 0.1% of methylparaben added as preservative. May contain sodium hydroxide and/or hydrochloric acid for pH adjustment. The pH is 6.5 (5.0 to 7.0). See HOW SUPPLIED section for various sizes and strengths. Lidocaine is a local anesthetic of the amide type. Lidocaine Hydrochloride, USP is chemically designated 2-(diethylamino)-N-(2,6-dimethylphenyl)-acetamide monohydrochloride monohydrate, a white powder freely soluble in water. The molecular weight is 288.82. It has the following structural formula. The semi-rigid vial used for the plastic vials is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The container requires no vapor barrier to maintain the proper drug concentration.</Description>
  </NDC>
  <NDC>
    <NDCCode>53002-1538-0</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (53002-1538-0) </PackageDescription>
    <NDC11Code>53002-1538-00</NDC11Code>
    <ProductNDC>53002-1538</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Gabapentin</ProprietaryName>
    <NonProprietaryName>Gabapentin</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160204</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA205101</ApplicationNumber>
    <LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>GABAPENTIN</SubstanceName>
    <StrengthNumber>600</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221231</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Gabapentin is indicated for: : 1 Management of postherpetic neuralgia in adults , 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy .</IndicationAndUsage>
    <Description>The active ingredient in gabapentin capsules and tablets, USP is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C 9H 17NO 2 and the molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin, USP is a white to off-white crystalline solid with a pK a1 of 4.72±0.10 and a pK a2 of 10.27±0.29. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient is -1.083±0.235 at 25°C temperature. Each gabapentin capsule contains 100 mg, 300 mg or 400 mg of gabapentin, USP and the following inactive ingredients: pregelatinized starch (maize), and talc. The 100 mg capsule shell contains gelatin, sodium lauryl sulfate (SLS) and titanium dioxide. The 300 mg capsule shell contains gelatin, titanium dioxide, FD&amp;C Red 40, D&amp;C Yellow 10, and sodium lauryl sulfate (SLS). The 400 mg capsule shell contains gelatin, titanium dioxide, sodium lauryl sulfate (SLS), D&amp;C Yellow 10, and FD&amp;C Red 40. The imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, and potassium hydroxide. Each gabapentin tablet contains 600 mg or 800 mg of gabapentin, USP and the following inactive ingredients: poloxamer 407, mannitol, magnesium stearate, hydroxypropyl cellulose, talc, copovidone, crospovidone, colloidal silicon dioxide and coating agent contains hypromellose, titanium dioxide, polyethylene glycol and talc.</Description>
  </NDC>
  <NDC>
    <NDCCode>53002-1538-3</NDCCode>
    <PackageDescription>30 TABLET in 1 BOTTLE (53002-1538-3) </PackageDescription>
    <NDC11Code>53002-1538-03</NDC11Code>
    <ProductNDC>53002-1538</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Gabapentin</ProprietaryName>
    <NonProprietaryName>Gabapentin</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160204</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA205101</ApplicationNumber>
    <LabelerName>RPK Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>GABAPENTIN</SubstanceName>
    <StrengthNumber>600</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20221231</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Gabapentin is indicated for: : 1 Management of postherpetic neuralgia in adults , 2 Adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy .</IndicationAndUsage>
    <Description>The active ingredient in gabapentin capsules and tablets, USP is gabapentin, which has the chemical name 1-(aminomethyl)cyclohexaneacetic acid. The molecular formula of gabapentin is C 9H 17NO 2 and the molecular weight is 171.24. The structural formula of gabapentin is:. Gabapentin, USP is a white to off-white crystalline solid with a pK a1 of 4.72±0.10 and a pK a2 of 10.27±0.29. It is freely soluble in water and both basic and acidic aqueous solutions. The log of the partition coefficient is -1.083±0.235 at 25°C temperature. Each gabapentin capsule contains 100 mg, 300 mg or 400 mg of gabapentin, USP and the following inactive ingredients: pregelatinized starch (maize), and talc. The 100 mg capsule shell contains gelatin, sodium lauryl sulfate (SLS) and titanium dioxide. The 300 mg capsule shell contains gelatin, titanium dioxide, FD&amp;C Red 40, D&amp;C Yellow 10, and sodium lauryl sulfate (SLS). The 400 mg capsule shell contains gelatin, titanium dioxide, sodium lauryl sulfate (SLS), D&amp;C Yellow 10, and FD&amp;C Red 40. The imprinting ink contains shellac, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, strong ammonia solution, black iron oxide, and potassium hydroxide. Each gabapentin tablet contains 600 mg or 800 mg of gabapentin, USP and the following inactive ingredients: poloxamer 407, mannitol, magnesium stearate, hydroxypropyl cellulose, talc, copovidone, crospovidone, colloidal silicon dioxide and coating agent contains hypromellose, titanium dioxide, polyethylene glycol and talc.</Description>
  </NDC>
  <NDC>
    <NDCCode>54340-245-03</NDCCode>
    <PackageDescription>1538 mL in 1 BOTTLE, DISPENSING (54340-245-03)</PackageDescription>
    <NDC11Code>54340-0245-03</NDC11Code>
    <ProductNDC>54340-245</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Dial Antibacterial Hand Wash</ProprietaryName>
    <NonProprietaryName>Dial White Tea And Vitamin E Antibacterial Hand Soap With Moisturizer</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20150105</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>The Dial Corporation, A Henkel Company</LabelerName>
    <SubstanceName>BENZETHONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>.1</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>For handwashing to decrease bacteria on the skin.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>54868-1538-1</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE (54868-1538-1)</PackageDescription>
    <NDC11Code>54868-1538-01</NDC11Code>
    <ProductNDC>54868-1538</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Nitrostat</ProprietaryName>
    <NonProprietaryName>Nitroglycerin</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19940922</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021134</ApplicationNumber>
    <LabelerName>Physicians Total Care, Inc.</LabelerName>
    <SubstanceName>NITROGLYCERIN</SubstanceName>
    <StrengthNumber>.3</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2018-07-24</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Nitroglycerin is indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.</IndicationAndUsage>
    <Description>Nitrostat is a stabilized sublingual compressed nitroglycerin tablet that contains 0.3 mg (1/200 grain), 0.4 mg (1/150 grain), or 0.6 mg (1/100 grain) nitroglycerin; as well as lactose monohydrate, NF; glyceryl monostearate, NF; pregelatinized starch, NF; calcium stearate, NF powder; and silicon dioxide, colloidal, NF. Nitroglycerin, an organic nitrate, is a vasodilating agent. The chemical name for nitroglycerin is 1, 2, 3 propanetriol trinitrate and the chemical structure is. Molecular weight: 227.09.</Description>
  </NDC>
  <NDC>
    <NDCCode>55714-1538-1</NDCCode>
    <PackageDescription>30 mL in 1 BOTTLE, GLASS (55714-1538-1) </PackageDescription>
    <NDC11Code>55714-1538-01</NDC11Code>
    <ProductNDC>55714-1538</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hypercalm-mental Focus</ProprietaryName>
    <NonProprietaryName>Chamomilla, Echinacea, Hypericum Perforatum, Passiflora Incarnata, Aconitum Napellus, Adrenalinum, Argentum Nit., Arsenicum Album, Baptisia Tinctoria, Chamomilla, Coffea Cruda, Cypripedium Pubescens, Digitalis Purpurea, Gelsemium Sempervirens, Humulus Lupulus, Hyoscyamus Niger, Ignatia Amara, Impatiens Glandulifera Flos, Iodium, Lachesis Mutus, Lycopodium Clavatum, Natrum Muriaticum, Nux Vomica, Scutellaria Lateriflora, Staphysagria, Stramonium, Theridion, Veratrum Viride</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20230601</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Newton Laboratories, Inc.</LabelerName>
    <SubstanceName>ECHINACEA, UNSPECIFIED; GELSEMIUM SEMPERVIRENS ROOT; PASSIFLORA INCARNATA FLOWERING TOP; ACONITUM NAPELLUS; EPINEPHRINE; SILVER NITRATE; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; MATRICARIA CHAMOMILLA; ARABICA COFFEE BEAN; CYPRIPEDIUM PARVIFLORUM VAR. PUBESCENS ROOT; DIGITALIS; HYOSCYAMUS NIGER; STRYCHNOS IGNATII SEED; IMPATIENS GLANDULIFERA FLOWER; IODINE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; SCUTELLARIA LATERIFLORA WHOLE; DELPHINIUM STAPHISAGRIA SEED; DATURA STRAMONIUM; THERIDION CURASSAVICUM; VERATRUM VIRIDE ROOT; HOPS; HYPERICUM PERFORATUM</SubstanceName>
    <StrengthNumber>6; 15; 6; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 6</StrengthNumber>
    <StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Allergens [CS], Allergens [CS], Allergens [CS], Catecholamine [EPC], Catecholamines [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Plant Proteins [CS], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS], Seed Storage Proteins [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-07-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20230601</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Formulated for associated symptoms such as impulsiveness, lack of focus, irritability and emotional or disruptive behavior.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>63083-1538-1</NDCCode>
    <PackageDescription>29.5 mL in 1 BOTTLE, DROPPER (63083-1538-1) </PackageDescription>
    <NDC11Code>63083-1538-01</NDC11Code>
    <ProductNDC>63083-1538</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Progesterone</ProprietaryName>
    <ProprietaryNameSuffix>1538</ProprietaryNameSuffix>
    <NonProprietaryName>Progesterone</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19840815</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Professional Complementary Health Formulas</LabelerName>
    <SubstanceName>PROGESTERONE</SubstanceName>
    <StrengthNumber>9</StrengthNumber>
    <StrengthUnit>[hp_X]/29.5mL</StrengthUnit>
    <Pharm_Classes>Progesterone [CS], Progesterone [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-09</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19850815</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>64942-1538-1</NDCCode>
    <PackageDescription>76 g in 1 CONTAINER (64942-1538-1) </PackageDescription>
    <NDC11Code>64942-1538-01</NDC11Code>
    <ProductNDC>64942-1538</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Axe</ProprietaryName>
    <ProprietaryNameSuffix>Essence Antiperspirant And Deodorant</ProprietaryNameSuffix>
    <NonProprietaryName>Aluminum Zirconium Tetrachlorohydrex Gly</NonProprietaryName>
    <DosageFormName>STICK</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20170926</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part350</ApplicationNumber>
    <LabelerName>Conopco Inc. d/b/a/ Unilever</LabelerName>
    <SubstanceName>ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY</SubstanceName>
    <StrengthNumber>18.2</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170926</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage> reduces underarm wetness.  24 Hour Protection.</IndicationAndUsage>
    <Description>Axe Essence Antiperspirant and Deodorant.</Description>
  </NDC>
  <NDC>
    <NDCCode>64942-1538-2</NDCCode>
    <PackageDescription>2 CONTAINER in 1 PACKAGE (64942-1538-2)  &gt; 76 g in 1 CONTAINER (64942-1538-1) </PackageDescription>
    <NDC11Code>64942-1538-02</NDC11Code>
    <ProductNDC>64942-1538</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Axe</ProprietaryName>
    <ProprietaryNameSuffix>Essence Antiperspirant And Deodorant</ProprietaryNameSuffix>
    <NonProprietaryName>Aluminum Zirconium Tetrachlorohydrex Gly</NonProprietaryName>
    <DosageFormName>STICK</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20170926</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part350</ApplicationNumber>
    <LabelerName>Conopco Inc. d/b/a/ Unilever</LabelerName>
    <SubstanceName>ALUMINUM ZIRCONIUM TETRACHLOROHYDREX GLY</SubstanceName>
    <StrengthNumber>18.2</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170926</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage> reduces underarm wetness.  24 Hour Protection.</IndicationAndUsage>
    <Description>Axe Essence Antiperspirant and Deodorant.</Description>
  </NDC>
  <NDC>
    <NDCCode>67046-1538-3</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BLISTER PACK (67046-1538-3) </PackageDescription>
    <NDC11Code>67046-1538-03</NDC11Code>
    <ProductNDC>67046-1538</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fenofibrate</ProprietaryName>
    <NonProprietaryName>Fenofibrate</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20250325</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA209504</ApplicationNumber>
    <LabelerName>Coupler LLC</LabelerName>
    <SubstanceName>FENOFIBRATE</SubstanceName>
    <StrengthNumber>67</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Peroxisome Proliferator Receptor alpha Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-04-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250325</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fenofibrate capsules are indicated as adjunctive therapy to diet for the reduction of LDL-C, total-C, Triglycerides and apo B in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb). Lipid altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate (see National Cholesterol Education Program [NCEP] Treatment Guidelines, below).</IndicationAndUsage>
    <Description>Fenofibrate Capsules USP (Micronized) are lipid regulating agent available as capsules for oral administration. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C 20H 21O 4Cl and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79 to 82°C. Fenofibrate USP is a white solid which is stable under ordinary conditions. Each 67 mg Fenofibrate Capsule (Micronized) contain the following inactive ingredients: colloidal silicone dioxide, croscarmellose sodium, crospovidone, lactose monohydrate, magnesium stearate, povidone, pregelatinized starch, sodium lauryl sulfate, talc, FD&amp;C Blue 1, FD&amp;C Red 33, D&amp;C Yellow 10, titanium dioxide and gelatin. Imprinting ink contains shellac, potassium hydroxide, propylene glycol and black iron oxide. Each 134 mg Fenofibrate Capsule (Micronized) contain the following inactive ingredients: colloidal silicone dioxide, croscarmellose sodium, crospovidone, lactose monohydrate, magnesium stearate, povidone, pregelatinized starch, sodium lauryl sulfate, talc, FD&amp;C Blue 1, D&amp;C Red 3, titanium dioxide and gelatin. Imprinting ink contains shellac, potassium hydroxide and propylene glycol. Each 200 mg Fenofibrate Capsule (Micronized) contain the following inactive ingredients: colloidal silicone dioxide, croscarmellose sodium, crospovidone, lactose monohydrate, magnesium stearate, povidone, pregelatinized starch, sodium lauryl sulfate, talc, iron oxide red, iron oxide yellow, titanium dioxide and gelatin. Imprinting ink contains shellac, potassium hydroxide, propylene glycol and black iron oxide.</Description>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>43742-1538-1</NDCCode><ProprietaryName>Skin Infections</ProprietaryName><NonProprietaryName>Echinacea (angustifolia), Phytolacca Decandra, Hepar Sulphuris Calcareum, Mercurius Solubilis, Mezereum, Ailanthus Glandulosus, Arsenicum Album, Lachesis Mutus, Herpes Simplex I And Ii Nosode, Herpes Zoster Nosode</NonProprietaryName></NDC><NDC><NDCCode>10477-1538-1</NDCCode><ProprietaryName>Mineral Sunscreen Spf 20</ProprietaryName><NonProprietaryName>Octinoxate, Octisalate, Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>10477-1538-2</NDCCode><ProprietaryName>Mineral Sunscreen Spf 20</ProprietaryName><NonProprietaryName>Octinoxate, Octisalate, Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>10477-1538-3</NDCCode><ProprietaryName>Mineral Sunscreen Spf 20</ProprietaryName><NonProprietaryName>Octinoxate, Octisalate, Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>10742-1538-1</NDCCode><ProprietaryName>Softlips Chocolate Bunny</ProprietaryName><NonProprietaryName>Dimethicone, Octinoxate, Octisalate, Oxybenzone</NonProprietaryName></NDC><NDC><NDCCode>22840-1538-1</NDCCode><ProprietaryName>Silk Worm</ProprietaryName><NonProprietaryName>Bombyx Mori</NonProprietaryName></NDC><NDC><NDCCode>36987-1538-1</NDCCode><ProprietaryName>Coconut</ProprietaryName><NonProprietaryName>Coconut</NonProprietaryName></NDC><NDC><NDCCode>36987-1538-2</NDCCode><ProprietaryName>Coconut</ProprietaryName><NonProprietaryName>Coconut</NonProprietaryName></NDC><NDC><NDCCode>36987-1538-3</NDCCode><ProprietaryName>Coconut</ProprietaryName><NonProprietaryName>Coconut</NonProprietaryName></NDC><NDC><NDCCode>36987-1538-4</NDCCode><ProprietaryName>Coconut</ProprietaryName><NonProprietaryName>Coconut</NonProprietaryName></NDC><NDC><NDCCode>37662-1538-1</NDCCode><ProprietaryName>Manganum Oxydatum Nigrum</ProprietaryName><NonProprietaryName>Manganum Oxydatum Nigrum</NonProprietaryName></NDC><NDC><NDCCode>37662-1538-2</NDCCode><ProprietaryName>Manganum Oxydatum Nigrum</ProprietaryName><NonProprietaryName>Manganum Oxydatum Nigrum</NonProprietaryName></NDC><NDC><NDCCode>37662-1538-3</NDCCode><ProprietaryName>Manganum Oxydatum Nigrum</ProprietaryName><NonProprietaryName>Manganum Oxydatum Nigrum</NonProprietaryName></NDC><NDC><NDCCode>38779-0242-0</NDCCode><NonProprietaryName>Nystatin</NonProprietaryName></NDC><NDC><NDCCode>41226-500-52</NDCCode><ProprietaryName>Kroger Antibacterial</ProprietaryName><NonProprietaryName>Benzalkonium Chloride</NonProprietaryName></NDC><NDC><NDCCode>50090-1538-0</NDCCode><ProprietaryName>Mintox</ProprietaryName><NonProprietaryName>Aluminum Hydroxide, Magnesium Hydroxide, Dimethicone</NonProprietaryName></NDC><NDC><NDCCode>51552-1538-2</NDCCode><NonProprietaryName>Imiquimod</NonProprietaryName></NDC><NDC><NDCCode>51552-1538-3</NDCCode><NonProprietaryName>Imiquimod</NonProprietaryName></NDC><NDC><NDCCode>51552-1538-4</NDCCode><NonProprietaryName>Imiquimod</NonProprietaryName></NDC><NDC><NDCCode>51662-1538-1</NDCCode><ProprietaryName>Lidocaine Hcl</ProprietaryName><NonProprietaryName>Lidocaine Hcl</NonProprietaryName></NDC><NDC><NDCCode>51662-1538-3</NDCCode><ProprietaryName>Lidocaine Hcl</ProprietaryName><NonProprietaryName>Lidocaine Hcl</NonProprietaryName></NDC><NDC><NDCCode>53002-1538-0</NDCCode><ProprietaryName>Gabapentin</ProprietaryName><NonProprietaryName>Gabapentin</NonProprietaryName></NDC><NDC><NDCCode>53002-1538-3</NDCCode><ProprietaryName>Gabapentin</ProprietaryName><NonProprietaryName>Gabapentin</NonProprietaryName></NDC><NDC><NDCCode>54340-245-03</NDCCode><ProprietaryName>Dial Antibacterial Hand Wash</ProprietaryName><NonProprietaryName>Dial White Tea And Vitamin E Antibacterial Hand Soap With Moisturizer</NonProprietaryName></NDC><NDC><NDCCode>54868-1538-1</NDCCode><ProprietaryName>Nitrostat</ProprietaryName><NonProprietaryName>Nitroglycerin</NonProprietaryName></NDC><NDC><NDCCode>55714-1538-1</NDCCode><ProprietaryName>Hypercalm-mental Focus</ProprietaryName><NonProprietaryName>Chamomilla, Echinacea, Hypericum Perforatum, Passiflora Incarnata, Aconitum Napellus, Adrenalinum, Argentum Nit., Arsenicum Album, Baptisia Tinctoria, Chamomilla, Coffea Cruda, Cypripedium Pubescens, Digitalis Purpurea, Gelsemium Sempervirens, Humulus Lupulus, Hyoscyamus Niger, Ignatia Amara, Impatiens Glandulifera Flos, Iodium, Lachesis Mutus, Lycopodium Clavatum, Natrum Muriaticum, Nux Vomica, Scutellaria Lateriflora, Staphysagria, Stramonium, Theridion, Veratrum Viride</NonProprietaryName></NDC><NDC><NDCCode>63083-1538-1</NDCCode><ProprietaryName>Progesterone</ProprietaryName><NonProprietaryName>Progesterone</NonProprietaryName></NDC><NDC><NDCCode>64942-1538-1</NDCCode><ProprietaryName>Axe</ProprietaryName><NonProprietaryName>Aluminum Zirconium Tetrachlorohydrex Gly</NonProprietaryName></NDC><NDC><NDCCode>64942-1538-2</NDCCode><ProprietaryName>Axe</ProprietaryName><NonProprietaryName>Aluminum Zirconium Tetrachlorohydrex Gly</NonProprietaryName></NDC><NDC><NDCCode>67046-1538-3</NDCCode><ProprietaryName>Fenofibrate</ProprietaryName><NonProprietaryName>Fenofibrate</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

This document is intended for developers who want to write applications that can interact with the DataLabs REST API. With DataLabs Web Services, you can create a customized services for your own website or application. You can use the REST API to retrieve DataLabs Web Services results programmatically.

Important: The REST API requires the use of an API key, which you can get from the DataLabs MyAccount Console.

Working With DataLabs REST API

You can retrieve results for a particular operation (search, getcode, etc) by sending an HTTP GET request to its URI.
For instance, the URI for a “search” request has the following format:

https://www.datalabs.health/api/{domain}/{operation}?q={query}&rt={result type}&token={token}

If the request succeeds, the server responds with a 200 OK HTTP status code and the response data.

Four parameters are required with each “search” request:

• Use the domain parameter to specify required data domain.
• Use the operation parameter to specify “format_check” operation.
• Use the q (query) parameter to specify your query.
• Use the token (API key) query parameter to identify your application.

Optional parameter:

• Use the rt (result type) parameter to specify required result type (json/xml/min.json/min.xml).

All other query parameters (if any) are optional.

Full list of API parameters:

• Use the domain parameter to specify required data domain.
• Use the operation parameter to specify “format_check” operation.
• Use the q (query) parameter to specify your query.
• Use the token (API key) query parameter to identify your application.
• Use the tin (tin number) parameter to specify your query about tin number.
• Use the tinname (tin name) parameter to specify your query about tin name.
• Use the zipcode (zip code) parameter to specify your query about zip code.
• Use the radius (radius) parameter to specify your query about radius.
• Use the fromdate (fromdate) parameter to specify your query about from date.
• Use the todate (todate) parameter to specify your query about to date.

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

• check_status — this method allows to get current code status.
• getcode — this method allows retrieval of full infrormation regarding one item based on the provided key.
• getcodes — this method allows retrieval of full infrormation regarding number of items based on the provided keys (q=1285636522,1730198755,1427145176,1487730636).
• search — allows retrieval of set of items based on the free-form lookup query.
• search_and_keywords — returns not only free-form lookup results but also keywords relevant to the original query.

Plus there are three NPI-specific operations:

• validate — allows to determine whether provider's information is valid based on data in the CMS database.
• paginate_with_predicates — provides server side data pagination using sorting and ordering criteria.
• search_with_predicates — this method is a "blend" of free text search and traditional prdeicate-based data selection.
• zipradius — allows to get npis by zipcode & radius.
• npideactivated — allows to get deactivated npis between two dates.

REST Search Examples

Query Parameter Reference

The query parameters you can use with the DataLabs REST API are summarized in the following table.
All parameter values need to be URL encoded.

Use Case #1 - I Need to Find Healthcare Provider (Doctor or Orgranization) Having Just Partial Information

So, you have to find healthcare provider having just partial information. For instance all you have is "EYE doctor RANIA in REDMOND". Strictly speaking, it is necessary to perform a search with minimum information and the maximum level of relevance of the result.

Coding example below demonstrates simplest implementation in C# language. By default DataLabs full text search API returns 30 results and, as you may see below, the first result in the list is "REDMOND EYE DOCTORS, PLLC" where dr. Rania Montecillo specified an owner.

Feel free to use and modify this code to find doctors you may know. If you provide more or less meaningfull information you will be pleasantly surprised to see them in the search results.

            
//--------------------------------------------------------------------------------------
// Fulltext search on NPI registry. Perform "search" operation to get most relevant results.
//--------------------------------------------------------------------------------------
using System;
using System.Net.Http;
using System.Threading.Tasks;

public class Program
{
    private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

    static async Task Main(string[] args)
    {
        string endPoint = $"https://www.datalabs.health/api/npi/search?q=EYE%20RANIA%20REDMOND&token={token}";
        using HttpClient client = new HttpClient();
        string response = await client.GetStringAsync(endPoint);

        Console.WriteLine(response);

        Console.WriteLine("Done. Press any key to exit ...");
        Console.ReadKey();
    }
}
            
        

            
{
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      "TaxonomyCode1": "207RI0200X",
      "Taxonomy1": "Infectious Disease",
      "LicenseNumber1": "39215",
      "LicenseNumberStateCode1": "KY",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "207RI0200X",
      "Taxonomy2": "Infectious Disease",
      "LicenseNumber2": "25MA07672000",
      "LicenseNumberStateCode2": "NJ",
      "PrimaryTaxonomySwitch2": "Y"
    },
    {
      "NPI": "1184645301",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "BAIK",
      "FirstName": "RANIA",
      "Credential": "D.O.",
      "FirstLineMailingAddress": "602 ROUTE 169",
      "SecondLineMailingAddress": "PO BOX 865",
      "MailingAddressCityName": "WOODSTOCK",
      "MailingAddressStateName": "CT",
      "MailingAddressPostalCode": "06281-2225",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "860-821-3406",
      "MailingAddressFaxNumber": "860-821-3407",
      "FirstLinePracticeLocationAddress": "602 ROUTE 169",
      "PracticeLocationAddressCityName": "WOODSTOCK",
      "PracticeLocationAddressStateName": "CT",
      "PracticeLocationAddressPostalCode": "06281-2225",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "860-821-3406",
      "PracticeLocationAddressFaxNumber": "860-821-3407",
      "EnumerationDate": "07/22/2006",
      "LastUpdateDate": "01/14/2016",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207Q00000X",
      "Taxonomy1": "Family Medicine",
      "LicenseNumber1": "000260",
      "LicenseNumberStateCode1": "CT",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1265443618",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "LOUTFI",
      "FirstName": "RANIA",
      "MiddleName": "H",
      "Credential": "MD",
      "FirstLineMailingAddress": "1 COOPER PLZ",
      "SecondLineMailingAddress": "THE COOPER HOSPITALIST TEAM",
      "MailingAddressCityName": "CAMDEN",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08103-1461",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "856-342-3150",
      "MailingAddressFaxNumber": "856-968-8418",
      "FirstLinePracticeLocationAddress": "1 COOPER PLZ",
      "SecondLinePracticeLocationAddress": "THE COOPER HOSPITALIST TEAM",
      "PracticeLocationAddressCityName": "CAMDEN",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

Use Case #2 - I Need to Find Detailed Healthcare Provider Information Using Known NPI Number

This is very common scenario. You need to get full replica of NPI record. Again, it simple. Just use code provided below. API response may contain single NPI record, or empty list in case NPI does not exist in the CMS National Plan and Provider Enumeration System (NPPES) Registry.

                
    //--------------------------------------------------------------------------------------
    // Perform "getcode" operation to get healthcare provider information using NPI number.
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/getcode?q=1285636522&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

                
    {
      "NPI": [
        {
          "NPI": "1285636522",
          "EntityType": "Organization",
          "EIN": "N/A",
          "IsOrgSubpart": "N",
          "OrgName": "MEDSTAR GEORGETOWN MEDICAL CENTER, INC",
          "FirstLineMailingAddress": "PO BOX 418283",
          "MailingAddressCityName": "BOSTON",
          "MailingAddressStateName": "MA",
          "MailingAddressPostalCode": "02241-8283",
          "MailingAddressCountryCode": "US",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "888-896-1400",
          "EnumerationDate": "06/01/2005",
          "LastUpdateDate": "11/25/2011",
          "AuthorizedOfficialLastName": "SCHNEIDER",
          "AuthorizedOfficialFirstName": "STEPHANIE",
          "AuthorizedOfficialTitle": "VP",
          "AuthorizedOfficialTelephoneNumber": "703-558-1403",
          "TaxonomyCode1": "207R00000X",
          "Taxonomy1": "Internal Medicine",
          "LicenseNumber1": "=========",
          "LicenseNumberStateCode1": "DC",
          "PrimaryTaxonomySwitch1": "Y",
          "OtherIdentifier1": "W677",
          "OtherIdentifierType1": "OTHER",
          "OtherIdentifierState1": "DC",
          "OtherIdentifierIssuer1": "BLUE SHIELD ADULT PCP GRP",
          "OtherIdentifier2": "027174100",
          "OtherIdentifierType2": "MEDICAID",
          "OtherIdentifierState2": "DC",
          "OtherIdentifier3": "097005100",
          "OtherIdentifierType3": "MEDICAID",
          "OtherIdentifierState3": "MD",
          "OtherIdentifier4": "442AGE",
          "OtherIdentifierType4": "OTHER",
          "OtherIdentifierState4": "MD",
          "OtherIdentifierIssuer4": "BLUE SHIELD PEDS PCP GRP#",
          "OtherIdentifier5": "6572",
          "OtherIdentifierType5": "OTHER",
          "OtherIdentifierState5": "DC",
          "OtherIdentifierIssuer5": "BLUE SHIELD GROUP NUMBER",
          "OtherIdentifier6": "W675",
          "OtherIdentifierType6": "OTHER",
          "OtherIdentifierState6": "DC",
          "OtherIdentifierIssuer6": "BLUE SHIELD PEDS PCP GRP#",
          "HealthcareProviderTaxonomyGroup1": "193200000X MULTI-SPECIALTY GROUP",
          "HealthcareProviderTaxonomyGroupDescription1": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization."
        }
      ]
    }
    Done. Press any key to exit ...
                
            

Use Case #3 - I Need to Get Multiple Healthcare Providers Using List of NPI Numbers

You may need to perform bulk search for performance optimization. The "getcodes" operation allows you to decrease number of round trips in orders of magnitude. For instance you can get information about hundred NPI in one REST call, instead of sending NPI numbers one-by-one.

                
    //--------------------------------------------------------------------------------------
    // Perform "getcodes" operation to get multiple healthcare providers using list of NPIs. 
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/getcodes?q=1285636522,1730198755,1427145176&rt=minjson&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

                
    {
      "NPI": [
        {
          "NPI": "1285636522",
          "OrgName": "MEDSTAR GEORGETOWN MEDICAL CENTER, INC",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "888-896-1400"
        },
        {
          "NPI": "1730198755",
          "OrgName": "MEDSTAR GEORGETOWN MEDICAL CENTER",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "888-896-1400"
        },
        {
          "NPI": "1427145176",
          "OrgName": "MEDSTAR - GEORGETOWN MEDICAL CENTER, INC.",
          "OtherOrgName": "GEORGETOWN UNIVERSITY HOSPITAL",
          "OtherOrgNameTypeCode": "3",
          "FirstLinePracticeLocationAddress": "3800 RESERVOIR RD., NW",
          "PracticeLocationAddressCityName": "WASHINGTON",
          "PracticeLocationAddressStateName": "DC",
          "PracticeLocationAddressPostalCode": "20007-2113",
          "PracticeLocationAddressCountryCode": "US",
          "PracticeLocationAddressTelephoneNumber": "202-444-3000",
          "PracticeLocationAddressFaxNumber": "202-444-3095"
        }
      ]
    }
    Done. Press any key to exit ...
                
            

Use Case #4 - I Need to Check NPI Number Status

Again, very common scenario. You just need to check NPI number status. It is simple. Take a look at the code below. Expected result contains requested NPI number, status, and short status description.

                
    //--------------------------------------------------------------------------------------
    // Perform "check_status" operation to get NPI Number status (active, deactivated, etc).
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/check_status?q=1285636522&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

                
    {
      "Code": "1285636522",
      "Status": "Active",
      "Message": "\"1285636522\" NPI Number does exist and has \"active\" status"
    }
                
    Done. Press any key to exit ...
                
            

Use Case #5 - I need to retrieve a list of healthcare providers based on specified search parameters.

The system allows users to retrieve a list of healthcare providers by filtering on specified fields (e.g., organization name, state, city, ZIP code, etc.). The example below demonstrates how to retrieve all providers with a specified city, state, and ZIP code.

                
    //--------------------------------------------------------------------------------------
    // Perform "search_with_predicates" operation to get multiple healthcare providers using specified city, state, and ZIP code. 
    //--------------------------------------------------------------------------------------
    using System;
    using System.Net.Http;
    using System.Threading.Tasks;

    public class Program
    {
        private const string token = "3932f3b0-cfab-11dc-95ff-0800200c9a663932f3b0-cfab-11dc-95ff-0800200c9a66";

        static async Task Main(string[] args)
        {
            string endPoint = $"https://www.datalabs.health/api/npi/search_with_predicates?q=&qf=City:true:REDMOND&qf=State:true:OR&qf=Zip:true:97756-9069&rt=json&token={token}";
            using HttpClient client = new HttpClient();
            string response = await client.GetStringAsync(endPoint);

            Console.WriteLine(response);

            Console.WriteLine("Done. Press any key to exit ...");
            Console.ReadKey();
        }
    }
                
            

                
{
  "NPI": [
    {
      "NPI": "1083349906",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "STAFFORD",
      "FirstName": "KADY",
      "NamePrefix": "MS.",
      "Credential": "LPC",
      "FirstLineMailingAddress": "13574 SW HIGHWAY 126",
      "MailingAddressCityName": "POWELL BUTTE",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97753-1541",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-480-6360",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-203-0307",
      "EnumerationDate": "07/24/2022",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YP2500X",
      "Taxonomy1": "Professional Counselor",
      "LicenseNumber1": "LPC6225",
      "LicenseNumberStateCode1": "ID",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C9084",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1215724679",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "SCHAY",
      "FirstName": "ANGELICA",
      "MiddleName": "NICOLE",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1841",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1841",
      "EnumerationDate": "04/21/2025",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101Y00000X",
      "Taxonomy1": "Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101Y00000X",
      "PrimaryTaxonomy": "Counselor"
    },
    {
      "NPI": "1013556505",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "IVENS",
      "FirstName": "KRYSTA",
      "FirstLineMailingAddress": "743 NW QUINCE AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-1250",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "360-526-1448",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "971-217-6150",
      "EnumerationDate": "12/31/2019",
      "LastUpdateDate": "02/15/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C7963",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "02/15/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1497336275",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "ARANT",
      "FirstName": "ERIN",
      "MiddleName": "HENNESSEY",
      "FirstLineMailingAddress": "4639 SW 37TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-6776",
      "MailingAddressCountryCode": "US",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "04/14/2021",
      "LastUpdateDate": "04/14/2021",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "225X00000X",
      "Taxonomy1": "Occupational Therapist",
      "LicenseNumber1": "390047",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/14/2021",
      "PrimaryTaxonomyCode": "225X00000X",
      "PrimaryTaxonomy": "Occupational Therapist"
    },
    {
      "NPI": "1174191407",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "GRIMALT",
      "FirstName": "EUGENIA",
      "MiddleName": "N",
      "Credential": "PT",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1848",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "06/14/2021",
      "LastUpdateDate": "06/14/2021",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "2251P0200X",
      "Taxonomy1": "Pediatric Physical Therapist",
      "LicenseNumber1": "63979",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization.",
      "CertificationDate": "06/14/2021",
      "PrimaryTaxonomyCode": "2251P0200X",
      "PrimaryTaxonomy": "Pediatric Physical Therapist"
    },
    {
      "NPI": "1912604117",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "PAINTER",
      "FirstName": "JENNIFER",
      "FirstLineMailingAddress": "20080 DOANNA WAY UNIT 3",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97702-2931",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "209-743-9813",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "02/08/2023",
      "LastUpdateDate": "02/08/2023",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "02/08/2023",
      "PrimaryTaxonomyCode": "101YM0800X",
      "PrimaryTaxonomy": "Mental Health Counselor"
    },
    {
      "NPI": "1396434700",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "GROVE",
      "FirstName": "JENNIFER",
      "MiddleName": "RHEA",
      "FirstLineMailingAddress": "303 NW BROADWAY ST",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97703-2658",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "801-573-6047",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "801-573-6047",
      "EnumerationDate": "05/02/2023",
      "LastUpdateDate": "05/02/2023",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "1041C0700X",
      "Taxonomy1": "Clinical Social Worker",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "05/02/2023",
      "PrimaryTaxonomyCode": "1041C0700X",
      "PrimaryTaxonomy": "Clinical Social Worker"
    },
    {
      "NPI": "1407698970",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "REDDEN",
      "FirstName": "SHANNON",
      "Credential": "CHW",
      "OtherLastName": "MCDOUGALL",
      "OtherFirstName": "SHANNON",
      "OtherLastNameTypeCode": "1",
      "FirstLineMailingAddress": "2312 NE 5TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-8488",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-460-2192",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "PracticeLocationAddressFaxNumber": "541-550-7956",
      "EnumerationDate": "06/06/2024",
      "LastUpdateDate": "06/06/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "172V00000X",
      "Taxonomy1": "Community Health Worker",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "06/06/2024",
      "PrimaryTaxonomyCode": "172V00000X",
      "PrimaryTaxonomy": "Community Health Worker"
    },
    {
      "NPI": "1942022256",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "JACQUOT",
      "FirstName": "SHAYLA",
      "FirstLineMailingAddress": "PO BOX 1397",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
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}
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