RESTful Lookup — Test-Drive (2007 – 2026)

Query complete (29 ms elapsed)

{
  "NDC": [
    {
      "NDCCode": "54136-350-15",
      "PackageDescription": "15 g in 1 TUBE (54136-350-15) ",
      "NDC11Code": "54136-0350-15",
      "ProductNDC": "54136-350",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Invisible Sunscreen Stick Spf 50",
      "NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene",
      "DosageFormName": "STICK",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20240201",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Better Planet Brands LLC",
      "SubstanceName": "HOMOSALATE; OCTOCRYLENE; AVOBENZONE; OCTISALATE",
      "StrengthNumber": "15; 7.5; 3; 5",
      "StrengthUnit": "g/100g; g/100g; g/100g; g/100g",
      "Status": "Active",
      "LastUpdate": "2025-12-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240201",
      "SamplePackage": "N",
      "IndicationAndUsage": " helps prevent sunburn."
    },
    {
      "NDCCode": "54136-118-91",
      "PackageDescription": "1 TUBE in 1 CARTON (54136-118-91)  / 15 g in 1 TUBE",
      "NDC11Code": "54136-0118-91",
      "ProductNDC": "54136-118",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Incredibly Clear Acne Spot",
      "NonProprietaryName": "Salicylic Acid",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200514",
      "EndMarketingDate": "20251031",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M006",
      "LabelerName": "Better Planet Brands LLC",
      "SubstanceName": "SALICYLIC ACID",
      "StrengthNumber": "2",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2025-11-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20200514",
      "EndMarketingDatePackage": "20251031",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses. * For the treatment of acne."
    },
    {
      "NDCCode": "54136-153-44",
      "PackageDescription": "1 TUBE in 1 CARTON (54136-153-44)  / 52 g in 1 TUBE",
      "NDC11Code": "54136-0153-44",
      "ProductNDC": "54136-153",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Radically Rejuvenating Day Cream",
      "NonProprietaryName": "Zinc Oxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200409",
      "EndMarketingDate": "20251130",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Better Planet Brands LLC",
      "SubstanceName": "ZINC OXIDE",
      "StrengthNumber": "15.5",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2025-12-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20200409",
      "EndMarketingDatePackage": "20251130",
      "SamplePackage": "N",
      "IndicationAndUsage": "* Help prevent sunburn * if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
    },
    {
      "NDCCode": "54136-946-19",
      "PackageDescription": "1 TUBE in 1 CARTON (54136-946-19)  / 52 g in 1 TUBE",
      "NDC11Code": "54136-0946-19",
      "ProductNDC": "54136-946",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Seriously Soothing Face Cream",
      "NonProprietaryName": "Zinc Oxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200422",
      "EndMarketingDate": "20251231",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Better Planet Brands LLC",
      "SubstanceName": "ZINC OXIDE",
      "StrengthNumber": "15.5",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20200422",
      "EndMarketingDatePackage": "20251231",
      "SamplePackage": "N",
      "IndicationAndUsage": "* Help prevent sunburn * if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
    },
    {
      "NDCCode": "50268-350-15",
      "PackageDescription": "50 BLISTER PACK in 1 BOX (50268-350-15)  / 1 TABLET in 1 BLISTER PACK (50268-350-11) ",
      "NDC11Code": "50268-0350-15",
      "ProductNDC": "50268-350",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Gemfibrozil",
      "NonProprietaryName": "Gemfibrozil",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20140710",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077836",
      "LabelerName": "AvPAK",
      "SubstanceName": "GEMFIBROZIL",
      "StrengthNumber": "600",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "PPAR alpha [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-11-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20140710",
      "SamplePackage": "N",
      "IndicationAndUsage": "Gemfibrozil Tablets, USP are indicated as adjunctive therapy to diet for. 1. Treatment of adult patients with very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. Patients who present such risk typically have serum triglycerides over 2,000 mg/dL and have elevations of VLDL-cholesterol as well as fasting chylomicrons (Type V hyperlipidemia). Subjects who consistently have total serum or plasma triglycerides below 1,000 mg/dL are unlikely to present a risk of pancreatitis. Gemfibrozil therapy may be considered for those subjects with triglyceride elevations between 1,000 and 2,000 mg/dL who have a history of pancreatitis or of recurrent abdominal pain typical of pancreatitis. It is recognized that some Type IV patients with triglycerides under 1,000 mg/dL may, through dietary or alcoholic indiscretion, convert to a Type V pattern with massive triglyceride elevations accompanying fasting chylomicronemia, but the influence of gemfibrozil therapy on the risk of pancreatitis in such situations has not been adequately studied. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV, and V hyperlipoproteinemia. 2. Reducing the risk of developing coronary heart disease only in Type IIb patients without history of or symptoms of existing coronary heart disease who have had an inadequate response to weight loss, dietary therapy, exercise, and other pharmacologic agents (such as bile acid sequestrants and nicotinic acid, known to reduce LDL- and raise HDL-cholesterol) and who have the following triad of lipid abnormalities: low HDL-cholesterol levels in addition to elevated LDL-cholesterol and elevated triglycerides (see WARNINGS, PRECAUTIONS, and CLINICAL PHARMACOLOGY). The National Cholesterol Education Program has defined a serum HDL-cholesterol value that is consistently below 35 mg/dL as constituting an independent risk factor for coronary heart disease. Patients with significantly elevated triglycerides should be closely observed when treated with gemfibrozil. In some patients with high triglyceride levels, treatment with gemfibrozil is associated with a significant increase in LDL-cholesterol. BECAUSE OF POTENTIAL TOXICITY SUCH AS MALIGNANCY, GALLBLADDER DISEASE, ABDOMINAL PAIN LEADING TO APPENDECTOMY AND OTHER ABDOMINAL SURGERIES, AN INCREASED INCIDENCE IN NON-CORONARY MORTALITY, AND THE 44% RELATIVE INCREASE DURING THE TRIAL PERIOD IN AGE-ADJUSTED ALL-CAUSE MORTALITY SEEN WITH THE CHEMICALLY AND PHARMACOLOGICALLY RELATED DRUG, CLOFIBRATE, THE POTENTIAL BENEFIT OF GEMFIBROZIL IN TREATING TYPE IIA PATIENTS WITH ELEVATIONS OF LDL-CHOLESTEROL ONLY IS NOT LIKELY TO OUTWEIGH THE RISKS. GEMFIBROZIL IS ALSO NOT INDICATED FOR THE TREATMENT OF PATIENTS WITH LOW HDL-CHOLESTEROL AS THEIR ONLY LIPID ABNORMALITY. In a subgroup analysis of patients in the Helsinki Heart Study with above-median HDL-cholesterol values at baseline (greater than 46.4 mg/dL), the incidence of serious coronary events was similar for gemfibrozil and placebo subgroups (see Table I). The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcohol intake may be important factors in hypertriglyceridemia and should be managed prior to any drug therapy. Physical exercise can be an important ancillary measure, and has been associated with rises in HDL-cholesterol. Diseases contributory to hyperlipidemia such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy is sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of estrogen therapy may obviate the need for specific drug therapy of hypertriglyceridemia. The use of drugs should be considered only when reasonable attempts have been made to obtain satisfactory results with nondrug methods. If the decision is made to use drugs, the patient should be instructed that this does not reduce the importance of adhering to diet.",
      "Description": "Gemfibrozil, USP is a lipid regulating agent. It is available as tablets for oral administration. Each tablet contains 600 mg gemfibrozil. Each tablet also contains the following inactive ingredients: colloidal silicon dioxide, NF; croscarmellose sodium, NF; calcium stearate, NF; microcrystalline cellulose, NF; methylcellulose, USP and opadry white. The chemical name is 5-(2,5-dimethylphenoxy)-2,2-dimethylpentanoic acid, with the following structural formula. The empirical formula is C 15H 22O 3 and the molecular weight is 250.35; the solubility in water and acid is 0.0019% and in dilute base it is greater than 1%. The melting point is 58° to 61°C. Gemfibrozil is a white solid which is stable under ordinary conditions."
    },
    {
      "NDCCode": "57237-350-15",
      "PackageDescription": "1 TUBE in 1 CARTON (57237-350-15)  / 15 g in 1 TUBE",
      "NDC11Code": "57237-0350-15",
      "ProductNDC": "57237-350",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Micoclear",
      "NonProprietaryName": "Clotrimazole Antifungal",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20251106",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M005",
      "LabelerName": "Rising Pharma Holdings, Inc.",
      "SubstanceName": "CLOTRIMAZOLE",
      "StrengthNumber": "10",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
      "Status": "Active",
      "LastUpdate": "2025-11-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20251106",
      "SamplePackage": "N",
      "IndicationAndUsage": "cures most athlete's foot, jock itch and ringworm. relieves itching, burning, cracking, scaling, discomfort and chafing associated with jock itch."
    },
    {
      "NDCCode": "57483-350-15",
      "PackageDescription": "2 BOTTLE, DROPPER in 1 CARTON (57483-350-15)  / 15 mL in 1 BOTTLE, DROPPER",
      "NDC11Code": "57483-0350-15",
      "ProductNDC": "57483-350",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Nasova Ear Drying Drops",
      "NonProprietaryName": "Isopropyl Alcohol 95%",
      "DosageFormName": "SOLUTION/ DROPS",
      "RouteName": "AURICULAR (OTIC)",
      "StartMarketingDate": "20211102",
      "EndMarketingDate": "20241031",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M",
      "LabelerName": "Innovus Pharmaceuticals, Inc.",
      "SubstanceName": "ISOPROPYL ALCOHOL",
      "StrengthNumber": "950",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-11-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20211102",
      "EndMarketingDatePackage": "20241031",
      "SamplePackage": "N",
      "IndicationAndUsage": "Dries water in the ears and relieves water-clogged ears."
    },
    {
      "NDCCode": "61748-350-15",
      "PackageDescription": "1 TUBE in 1 CARTON (61748-350-15)  > 15 g in 1 TUBE",
      "NDC11Code": "61748-0350-15",
      "ProductNDC": "61748-350",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Diflorasone Diacetate",
      "NonProprietaryName": "Diflorasone Diacetate",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20160308",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA206572",
      "LabelerName": "VersaPharm Incorporated",
      "SubstanceName": "DIFLORASONE DIACETATE",
      "StrengthNumber": ".5",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231"
    },
    {
      "NDCCode": "65753-350-15",
      "PackageDescription": "25 POUCH in 1 CONTAINER (65753-350-15)  / 1.1 mL in 1 POUCH",
      "NDC11Code": "65753-0350-15",
      "ProductNDC": "65753-350",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Stingx",
      "NonProprietaryName": "Benzocaine",
      "DosageFormName": "SWAB",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20191125",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M017",
      "LabelerName": "CoreTex Products Inc",
      "SubstanceName": "BENZOCAINE",
      "StrengthNumber": "6",
      "StrengthUnit": "g/100mL",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]",
      "Status": "Active",
      "LastUpdate": "2023-10-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20191125",
      "SamplePackage": "N",
      "IndicationAndUsage": "For temporary pain relief from insect bites and stings."
    },
    {
      "NDCCode": "66184-455-01",
      "PackageDescription": "9.9 g in 1 CARTRIDGE (66184-455-01)",
      "NDC11Code": "66184-0455-01",
      "ProductNDC": "66184-455",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Ck One Waterfresh Face Makeup Spf 15",
      "ProprietaryNameSuffix": "350 Beige",
      "NonProprietaryName": "Titanium Dioxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20120123",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Coty US LLC",
      "SubstanceName": "TITANIUM DIOXIDE; OCTINOXATE",
      "StrengthNumber": "4.95; 2.4",
      "StrengthUnit": "mL/9.9g; mL/9.9g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "66184-455-02",
      "PackageDescription": "9.9 g in 1 BOX (66184-455-02)",
      "NDC11Code": "66184-0455-02",
      "ProductNDC": "66184-455",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Ck One Waterfresh Face Makeup Spf 15",
      "ProprietaryNameSuffix": "350 Beige",
      "NonProprietaryName": "Titanium Dioxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20120123",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Coty US LLC",
      "SubstanceName": "TITANIUM DIOXIDE; OCTINOXATE",
      "StrengthNumber": "4.95; 2.4",
      "StrengthUnit": "mL/9.9g; mL/9.9g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "68001-350-68",
      "PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (68001-350-68)  > 15 mL in 1 VIAL, MULTI-DOSE",
      "NDC11Code": "68001-0350-68",
      "ProductNDC": "68001-350",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Gemcitabine",
      "NonProprietaryName": "Gemcitabine",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20180525",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA209604",
      "LabelerName": "BluePoint Laboratories",
      "SubstanceName": "GEMCITABINE HYDROCHLORIDE",
      "StrengthNumber": "100",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2023-09-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20180525",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "69691-350-15",
      "PackageDescription": "100 g in 1 BOX (69691-350-15)",
      "NDC11Code": "69691-0350-15",
      "ProductNDC": "69691-350",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Preginot",
      "NonProprietaryName": "Allantoin-lidocaine",
      "DosageFormName": "PATCH",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20150401",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Pharmaco Technology LLC",
      "SubstanceName": "ALLANTOIN; LIDOCAINE; PETROLATUM",
      "StrengthNumber": "2; 4; 30",
      "StrengthUnit": "g/100g; g/100g; g/100g",
      "Pharm_Classes": "Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2015-05-01"
    },
    {
      "NDCCode": "71919-350-07",
      "PackageDescription": "15 mL in 1 VIAL, GLASS (71919-350-07) ",
      "NDC11Code": "71919-0350-07",
      "ProductNDC": "71919-350",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hydrocyanicum Acidum",
      "NonProprietaryName": "Hydrogen Cyanide",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20160610",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Washington Homeopathic Products",
      "SubstanceName": "HYDROGEN CYANIDE",
      "StrengthNumber": "30",
      "StrengthUnit": "[hp_C]/mL",
      "Status": "Deprecated",
      "LastUpdate": "2022-03-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20160610",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "73928-007-15",
      "PackageDescription": "350 mL in 1 BOTTLE, PLASTIC (73928-007-15) ",
      "NDC11Code": "73928-0007-15",
      "ProductNDC": "73928-007",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Anthem Hand Sanitizer",
      "NonProprietaryName": "Alcohol",
      "DosageFormName": "SOLUTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20200727",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M003",
      "LabelerName": "KINGKEY MBC LIFE TECHNOLOGY GROUP CO., LTD",
      "SubstanceName": "ALCOHOL",
      "StrengthNumber": "75",
      "StrengthUnit": "mL/100mL",
      "Status": "Active",
      "LastUpdate": "2025-10-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20200727",
      "SamplePackage": "N",
      "IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
    },
    {
      "NDCCode": "75936-350-03",
      "PackageDescription": "15 mL in 1 TUBE (75936-350-03) ",
      "NDC11Code": "75936-0350-03",
      "ProductNDC": "75936-350",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Glow Screen Body Broad Spectrum Sunscreen Spf 40",
      "NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20210120",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "Supergoop, LLC",
      "SubstanceName": "HOMOSALATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE",
      "StrengthNumber": "7; 5; 10; 3",
      "StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL",
      "Status": "Active",
      "LastUpdate": "2026-01-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20210120",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "76168-350-15",
      "PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (76168-350-15)  > 15 mL in 1 BOTTLE, DROPPER",
      "NDC11Code": "76168-0350-15",
      "ProductNDC": "76168-350",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Lubricant Drops",
      "NonProprietaryName": "Carboxymethylcellulose Sodium",
      "DosageFormName": "SOLUTION/ DROPS",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20220405",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part349",
      "LabelerName": "Velocity Pharma LLC",
      "SubstanceName": "CARBOXYMETHYLCELLULOSE SODIUM",
      "StrengthNumber": "5",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20231231",
      "StartMarketingDatePackage": "20220405",
      "SamplePackage": "N",
      "IndicationAndUsage": "For the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun. . May be used as a protectant against further irritation."
    },
    {
      "NDCCode": "84515-350-01",
      "PackageDescription": "15 g in 1 BOX (84515-350-01) ",
      "NDC11Code": "84515-0350-01",
      "ProductNDC": "84515-350",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Collagen Cream",
      "NonProprietaryName": "Collagen Cream",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20241014",
      "EndMarketingDate": "20311031",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M016",
      "LabelerName": "Yiwu Xinqian E Commerce Co Ltd",
      "SubstanceName": "NIACINAMIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2024-12-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20241014",
      "EndMarketingDatePackage": "20311031",
      "SamplePackage": "N",
      "IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
    },
    {
      "NDCCode": "84756-350-02",
      "PackageDescription": "15 mL in 1 BOTTLE (84756-350-02) ",
      "NDC11Code": "84756-0350-02",
      "ProductNDC": "84756-350",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Vitamin C Brightening Eye Cream",
      "NonProprietaryName": "Vitamin C Brightening Eye Cream",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20241119",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M016",
      "LabelerName": "Yiwu Ziqiu Import Export Co Ltd",
      "SubstanceName": "NIACINAMIDE",
      "StrengthNumber": "5",
      "StrengthUnit": "g/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-12-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20241119",
      "SamplePackage": "N",
      "IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
    },
    {
      "NDCCode": "0023-9177-15",
      "PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (0023-9177-15)  / 15 mL in 1 BOTTLE, DROPPER",
      "NDC11Code": "00023-9177-15",
      "ProductNDC": "0023-9177",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Alphagan P",
      "NonProprietaryName": "Brimonidine Tartrate",
      "DosageFormName": "SOLUTION/ DROPS",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20010710",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021262",
      "LabelerName": "Allergan, Inc.",
      "SubstanceName": "BRIMONIDINE TARTRATE",
      "StrengthNumber": "1.5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-07-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20010710",
      "SamplePackage": "N",
      "IndicationAndUsage": "ALPHAGAN  P (brimonidine tartrate ophthalmic solution) 0.1% or 0.15% is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.",
      "Description": "ALPHAGAN P (brimonidine tartrate ophthalmic solution) 0.1% or 0.15%, sterile, is a relatively selective alpha-2 adrenergic receptor agonist for topical ophthalmic use. The structural formula of brimonidine tartrate is. 5-Bromo-6-(2-imidazolidinylideneamino) quinoxaline L-tartrate; MW= 442.24. In solution, ALPHAGAN P (brimonidine tartrate ophthalmic solution) has a clear, greenish-yellow color. It has an osmolality of 250-350 mOsmol/kg and a pH of 7.4-8.0 (0.1%) or 6.9-7.4 (0.15%). Brimonidine tartrate appears as an off-white to pale-yellow powder and is soluble in both water (0.6 mg/mL) and in the product vehicle (1.4 mg/mL) at pH 7.7. Each mL of ALPHAGAN P contains the active ingredient brimonidine tartrate 0.1% (1 mg/mL) or 0.15% (1.5 mg/mL) with the inactive ingredients sodium carboxymethylcellulose; sodium borate; boric acid; sodium chloride; potassium chloride; calcium chloride; magnesium chloride; PURITE® 0.005% (0.05 mg/mL) as a preservative; purified water; and hydrochloric acid and/or sodium hydroxide to adjust pH."
    },
    {
      "NDCCode": "0023-9321-15",
      "PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (0023-9321-15)  / 15 mL in 1 BOTTLE, DROPPER",
      "NDC11Code": "00023-9321-15",
      "ProductNDC": "0023-9321",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Alphagan P",
      "NonProprietaryName": "Brimonidine Tartrate",
      "DosageFormName": "SOLUTION/ DROPS",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20060125",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA021770",
      "LabelerName": "Allergan, Inc.",
      "SubstanceName": "BRIMONIDINE TARTRATE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-07-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20060125",
      "SamplePackage": "N",
      "IndicationAndUsage": "ALPHAGAN  P (brimonidine tartrate ophthalmic solution) 0.1% or 0.15% is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.",
      "Description": "ALPHAGAN P (brimonidine tartrate ophthalmic solution) 0.1% or 0.15%, sterile, is a relatively selective alpha-2 adrenergic receptor agonist for topical ophthalmic use. The structural formula of brimonidine tartrate is. 5-Bromo-6-(2-imidazolidinylideneamino) quinoxaline L-tartrate; MW= 442.24. In solution, ALPHAGAN P (brimonidine tartrate ophthalmic solution) has a clear, greenish-yellow color. It has an osmolality of 250-350 mOsmol/kg and a pH of 7.4-8.0 (0.1%) or 6.9-7.4 (0.15%). Brimonidine tartrate appears as an off-white to pale-yellow powder and is soluble in both water (0.6 mg/mL) and in the product vehicle (1.4 mg/mL) at pH 7.7. Each mL of ALPHAGAN P contains the active ingredient brimonidine tartrate 0.1% (1 mg/mL) or 0.15% (1.5 mg/mL) with the inactive ingredients sodium carboxymethylcellulose; sodium borate; boric acid; sodium chloride; potassium chloride; calcium chloride; magnesium chloride; PURITE® 0.005% (0.05 mg/mL) as a preservative; purified water; and hydrochloric acid and/or sodium hydroxide to adjust pH."
    },
    {
      "NDCCode": "0121-0727-16",
      "PackageDescription": "473 mL in 1 BOTTLE (0121-0727-16) ",
      "NDC11Code": "00121-0727-16",
      "ProductNDC": "0121-0727",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ranitidine",
      "NonProprietaryName": "Ranitidine",
      "DosageFormName": "SYRUP",
      "RouteName": "ORAL",
      "StartMarketingDate": "20101101",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077405",
      "LabelerName": "Pharmaceutical Associates, Inc.",
      "SubstanceName": "RANITIDINE",
      "StrengthNumber": "15",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2022-01-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20101101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Ranitidine Syrup (Ranitidine Oral Solution USP) is indicated in: 1 Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Studies available to date have not assessed the safety of ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks., 2 Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. No placebo-controlled comparative studies have been carried out for periods of longer than 1 year., 3 The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis)., 4 Short-term treatment of active, benign gastric ulcer. Most patients heal within 6 weeks and the usefulness of further treatment has not been demonstrated. Studies available to date have not assessed the safety of ranitidine in uncomplicated, benign gastric ulcer for periods of more than 6 weeks., 5 Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers. Placebo-controlled studies have been carried out for 1 year., 6 Treatment of GERD. Symptomatic relief commonly occurs within 24 hours after starting therapy with ranitidine 150 mg twice daily., 7 Treatment of endoscopically diagnosed erosive esophagitis. Symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with ranitidine 150 mg 4 times daily., 8 Maintenance of healing of erosive esophagitis. Placebo-controlled trials have been carried out for 48 weeks.",
      "Description": "The active ingredient in Ranitidine Syrup (Ranitidine Oral Solution USP) is ranitidine hydrochloride (HCl) USP, a histamine H 2-receptor antagonist. Chemically, it is N[2-[[[5-[(dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-N' -methyl-2-nitro-1,1-ethenediamine, HCl. It has the following structure:. The empirical formula is C 13H 22N 4O 3SHCl, representing a molecular weight of 350.87. Ranitidine HCl is a white to pale yellow, granular substance that is soluble in water. It has a slightly bitter taste and sulfurlike odor. Each 1 mL of Ranitidine Syrup (Ranitidine Oral Solution USP) contains 16.8 mg of ranitidine HCl equivalent to 15 mg of ranitidine. Ranitidine Syrup (Ranitidine Oral Solution USP) also contains the inactive ingredients dibasic sodium phosphate, hydroxyethylcellulose, methylparaben, purified water, sodium chloride, sodium saccharin, spearmint flavor, sucrose and may contain monobasic sodium phosphate."
    },
    {
      "NDCCode": "0121-4727-10",
      "PackageDescription": "4 TRAY in 1 CASE (0121-4727-10)  > 10 CUP, UNIT-DOSE in 1 TRAY > 10 mL in 1 CUP, UNIT-DOSE",
      "NDC11Code": "00121-4727-10",
      "ProductNDC": "0121-4727",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ranitidine",
      "NonProprietaryName": "Ranitidine",
      "DosageFormName": "SYRUP",
      "RouteName": "ORAL",
      "StartMarketingDate": "20101101",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077405",
      "LabelerName": "Pharmaceutical Associates, Inc.",
      "SubstanceName": "RANITIDINE",
      "StrengthNumber": "15",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2022-01-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20101101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Ranitidine Syrup (Ranitidine Oral Solution USP) is indicated in: 1 Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Studies available to date have not assessed the safety of ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks., 2 Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. No placebo-controlled comparative studies have been carried out for periods of longer than 1 year., 3 The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis)., 4 Short-term treatment of active, benign gastric ulcer. Most patients heal within 6 weeks and the usefulness of further treatment has not been demonstrated. Studies available to date have not assessed the safety of ranitidine in uncomplicated, benign gastric ulcer for periods of more than 6 weeks., 5 Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers. Placebo-controlled studies have been carried out for 1 year., 6 Treatment of GERD. Symptomatic relief commonly occurs within 24 hours after starting therapy with ranitidine 150 mg twice daily., 7 Treatment of endoscopically diagnosed erosive esophagitis. Symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with ranitidine 150 mg 4 times daily., 8 Maintenance of healing of erosive esophagitis. Placebo-controlled trials have been carried out for 48 weeks.",
      "Description": "The active ingredient in Ranitidine Syrup (Ranitidine Oral Solution USP) is ranitidine hydrochloride (HCl) USP, a histamine H 2-receptor antagonist. Chemically, it is N[2-[[[5-[(dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-N' -methyl-2-nitro-1,1-ethenediamine, HCl. It has the following structure:. The empirical formula is C 13H 22N 4O 3SHCl, representing a molecular weight of 350.87. Ranitidine HCl is a white to pale yellow, granular substance that is soluble in water. It has a slightly bitter taste and sulfurlike odor. Each 1 mL of Ranitidine Syrup (Ranitidine Oral Solution USP) contains 16.8 mg of ranitidine HCl equivalent to 15 mg of ranitidine. Ranitidine Syrup (Ranitidine Oral Solution USP) also contains the inactive ingredients dibasic sodium phosphate, hydroxyethylcellulose, methylparaben, purified water, sodium chloride, sodium saccharin, spearmint flavor, sucrose and may contain monobasic sodium phosphate."
    },
    {
      "NDCCode": "0264-7865-00",
      "PackageDescription": "12 CONTAINER in 1 CASE (0264-7865-00)  / 1000 mL in 1 CONTAINER",
      "NDC11Code": "00264-7865-00",
      "ProductNDC": "0264-7865",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Potassium Chloride In Sodium Chloride",
      "NonProprietaryName": "Sodium Chloride And Potassium Chloride",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "19890929",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA019708",
      "LabelerName": "B. Braun Medical Inc.",
      "SubstanceName": "SODIUM CHLORIDE; POTASSIUM CHLORIDE",
      "StrengthNumber": ".9; .15",
      "StrengthUnit": "g/100mL; g/100mL",
      "Pharm_Classes": "Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-02-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "19890929",
      "SamplePackage": "N",
      "IndicationAndUsage": "Potassium Chloride in 0.9% Sodium Chloride Injection is indicated for use in adults and pediatric patients as a source of electrolytes and water for hydration.",
      "Description": "Each 100 mL of 20 mEq Potassium Chloride in 0.9% Sodium Chloride Injection (20 mEq K+/L) contains: Sodium Chloride USP 0.9 g Potassium Chloride USP 0.15 g; Water for Injection USP qs. pH may be adjusted with Hydrochloric Acid NF. pH: 5.6 (3.5–6.5)              Calculated Osmolarity: 350 mOsmol/L. Concentration of Electrolytes (mEq/L): Sodium 154             Potassium 20             Chloride 174. Potassium Chloride in 0.9% Sodium Chloride Injection is sterile, nonpyrogenic, hypertonic and contains no bacteriostatic or antimicrobial agents. This product is intended for intravenous administration. The formulas of the active ingredients are. Not made with natural rubber latex, PVC or DEHP. The plastic container is made from a multilayered film specifically developed for parenteral drugs. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. Addition of medication should be accomplished using complete aseptic technique. The closure system has two ports; the one for the administration set has a tamper evident plastic protector and the other is a medication addition site. Refer to the Directions for Use of the container."
    },
    {
      "NDCCode": "0407-1414-72",
      "PackageDescription": "10 BOTTLE, PLASTIC in 1 BOX (0407-1414-72)  / 500 mL in 1 BOTTLE, PLASTIC",
      "NDC11Code": "00407-1414-72",
      "ProductNDC": "0407-1414",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Omnipaque",
      "NonProprietaryName": "Iohexol",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20161221",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA020608",
      "LabelerName": "GE Healthcare",
      "SubstanceName": "IOHEXOL",
      "StrengthNumber": "350",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-04-15",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20161221",
      "SamplePackage": "N",
      "IndicationAndUsage": "OMNIPAQUE is a radiographic contrast agent indicated for intrathecal, intra-arterial, intravenous, oral, rectal, intraarticular, and body cavity imaging procedures in adults and pediatric patients. (1).",
      "Description": "Iohexol is a nonionic radiographic contrast agent available as: 1 OMNIPAQUE (iohexol) injection for intrathecal, intra-arterial, intravenous, oral, rectal, intraarticular, and body cavity use, 2 OMNIPAQUE (iohexol) oral solution for oral use."
    },
    {
      "NDCCode": "0832-1435-15",
      "PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (0832-1435-15)  / 15 mL in 1 BOTTLE, DROPPER",
      "NDC11Code": "00832-1435-15",
      "ProductNDC": "0832-1435",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Brimonidine Tartrate",
      "NonProprietaryName": "Brimonidine Tartrate",
      "DosageFormName": "SOLUTION/ DROPS",
      "RouteName": "OPHTHALMIC",
      "StartMarketingDate": "20250730",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA217599",
      "LabelerName": "Upsher-Smith Laboratories, LLC",
      "SubstanceName": "BRIMONIDINE TARTRATE",
      "StrengthNumber": "1",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2026-09-11",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260908",
      "SamplePackage": "N",
      "IndicationAndUsage": "Brimonidine tartrate ophthalmic solution 0.1% is an alpha-adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.",
      "Description": "Brimonidine tartrate ophthalmic solution 0.1%, sterile, is a relatively selective alpha-2 adrenergic receptor agonist (for ophthalmic use). The structural formula of brimonidine tartrate is. 5-bromo-6-(2-imidazolidinylideneamino) quinoxaline L-tartrate; MW= 442.24. In a brimonidine tartrate ophthalmic solution has a clear, greenish-yellow color. It has an osmolality of 250 to 350 mOsmol/kg and a pH of 7.4 to 8.0 (0.1%). Brimonidine tartrate appears as an off-white to pale-yellow powder and is soluble in both water (0.6 mg/mL) and in the product vehicle (1.4 mg/mL) at pH 7.7. Each mL of brimonidine tartrate ophthalmic solution contains the active ingredient brimonidine tartrate 0.1% (1 mg/mL) with the inactive ingredients: sodium carboxymethylcellulose, sodium borate, boric acid, sodium chloride, potassium chloride, calcium chloride, magnesium chloride, stabilized oxychloro complex 0.005% (0.05 mg/mL) as a preservative, purified water, hydrochloric acid and/or sodium hydroxide to adjust pH."
    },
    {
      "NDCCode": "11026-2780-4",
      "PackageDescription": "1 BOTTLE in 1 CARTON (11026-2780-4)  > 118 mL in 1 BOTTLE",
      "NDC11Code": "11026-2780-04",
      "ProductNDC": "11026-2780",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Broncotron Ped",
      "NonProprietaryName": "Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20121215",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part341",
      "LabelerName": "Seyer Pharmatec, Inc.",
      "SubstanceName": "DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "15; 350; 10",
      "StrengthUnit": "mg/5mL; mg/5mL; mg/5mL",
      "Status": "Deprecated",
      "LastUpdate": "2021-10-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20121215",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "11527-325-33",
      "PackageDescription": "1 TUBE in 1 CARTON (11527-325-33)  / 15 g in 1 TUBE",
      "NDC11Code": "11527-0325-33",
      "ProductNDC": "11527-325",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Theriac Advanced Healing",
      "NonProprietaryName": "Lanolin",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20210301",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M016",
      "LabelerName": "Sheffield Pharmaceuticals LLC",
      "SubstanceName": "LANOLIN",
      "StrengthNumber": "350.8",
      "StrengthUnit": "mg/g",
      "Status": "Active",
      "LastUpdate": "2023-10-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20210301",
      "SamplePackage": "N",
      "IndicationAndUsage": "Temporarily Protects Minor: 1 cuts , 2 scrapes, 3 burns."
    },
    {
      "NDCCode": "12634-437-85",
      "PackageDescription": "15 TABLET in 1 BOTTLE (12634-437-85)",
      "NDC11Code": "12634-0437-85",
      "ProductNDC": "12634-437",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Carisoprodol",
      "NonProprietaryName": "Carisoprodol",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "19911017",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA089346",
      "LabelerName": "Apotheca Inc.",
      "SubstanceName": "CARISOPRODOL",
      "StrengthNumber": "350",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]",
      "DEASchedule": "CIV",
      "Status": "Deprecated",
      "LastUpdate": "2019-07-30",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Carisoprodol tablets are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. Carisoprodol tablets should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration [ see  Dosage and Administration (2)].",
      "Description": "Carisoprodol tablets USP are available as 350 mg round, white tablets. Carisoprodol is a white, crystalline powder, having a mild, characteristic odor and a bitter taste. It is slightly soluble in water; freely soluble in alcohol, in chloroform, and in acetone; and its solubility is practically independent of pH. Carisoprodol is present as a racemic mixture. Chemically, carisoprodol is N-isopropyl-2-methyl-2-propyl-1,3-propanediol dicarbamate and the molecular formula is C 12H 24N 2O 4, with a molecular weight of 260.33. The structural formula is:. Other ingredients in the carisoprodol tablets include corn starch, lactose, magnesium stearate, povidone, sodium lauryl sulfate, sodium starch glycolate, and stearic acid."
    },
    {
      "NDCCode": "13811-050-30",
      "PackageDescription": "30 CAPSULE in 1 BOTTLE (13811-050-30)",
      "NDC11Code": "13811-0050-30",
      "ProductNDC": "13811-050",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ultimatecare",
      "ProprietaryNameSuffix": "One Nf",
      "NonProprietaryName": "Omega-3 Fatty Acids, Doconexent, Icosapent, Linolenic Acid, Calcium Ascorbate, Calcium Threonate, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, F",
      "DosageFormName": "CAPSULE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20091204",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "TRIGEN Laboratories, Inc.",
      "SubstanceName": "OMEGA-3 FATTY ACIDS; DOCONEXENT; ICOSAPENT; LINOLENIC ACID; CALCIUM ASCORBATE; CALCIUM THREONATE; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; BIOTIN; CALCIUM; IRON; FERROUS ASPARTO GLYCINATE; IODINE; MAGNESIUM OXIDE; ZINC OXIDE; DOCUSATE SODIUM",
      "StrengthNumber": "500; 350; 100; 50; 24; 1; 800; 15; 1.5; 10; 50; 1; 300; 100; 20; 7; 150; 50; 5; 50",
      "StrengthUnit": "mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1",
      "Pharm_Classes": "Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Fatty Acids, Omega-3 [Chemical/Ingredient],Omega-3 Fatty Acid [EPC]",
      "Status": "Deprecated",
      "LastUpdate": "2017-09-19"
    }
  ]
}
                    

{"NDC":[{"NDCCode":"54136-350-15","ProprietaryName":"Invisible Sunscreen Stick Spf 50","NonProprietaryName":"Avobenzone, Homosalate, Octisalate, Octocrylene"},{"NDCCode":"54136-118-91","ProprietaryName":"Incredibly Clear Acne Spot","NonProprietaryName":"Salicylic Acid"},{"NDCCode":"54136-153-44","ProprietaryName":"Radically Rejuvenating Day Cream","NonProprietaryName":"Zinc Oxide"},{"NDCCode":"54136-946-19","ProprietaryName":"Seriously Soothing Face Cream","NonProprietaryName":"Zinc Oxide"},{"NDCCode":"50268-350-15","ProprietaryName":"Gemfibrozil","NonProprietaryName":"Gemfibrozil"},{"NDCCode":"57237-350-15","ProprietaryName":"Micoclear","NonProprietaryName":"Clotrimazole Antifungal"},{"NDCCode":"57483-350-15","ProprietaryName":"Nasova Ear Drying Drops","NonProprietaryName":"Isopropyl Alcohol 95%"},{"NDCCode":"61748-350-15","ProprietaryName":"Diflorasone Diacetate","NonProprietaryName":"Diflorasone Diacetate"},{"NDCCode":"65753-350-15","ProprietaryName":"Stingx","NonProprietaryName":"Benzocaine"},{"NDCCode":"66184-455-01","ProprietaryName":"Ck One Waterfresh Face Makeup Spf 15","NonProprietaryName":"Titanium Dioxide"},{"NDCCode":"66184-455-02","ProprietaryName":"Ck One Waterfresh Face Makeup Spf 15","NonProprietaryName":"Titanium Dioxide"},{"NDCCode":"68001-350-68","ProprietaryName":"Gemcitabine","NonProprietaryName":"Gemcitabine"},{"NDCCode":"69691-350-15","ProprietaryName":"Preginot","NonProprietaryName":"Allantoin-lidocaine"},{"NDCCode":"71919-350-07","ProprietaryName":"Hydrocyanicum Acidum","NonProprietaryName":"Hydrogen Cyanide"},{"NDCCode":"73928-007-15","ProprietaryName":"Anthem Hand Sanitizer","NonProprietaryName":"Alcohol"},{"NDCCode":"75936-350-03","ProprietaryName":"Glow Screen Body Broad Spectrum Sunscreen Spf 40","NonProprietaryName":"Avobenzone, Homosalate, Octisalate, Octocrylene"},{"NDCCode":"76168-350-15","ProprietaryName":"Lubricant Drops","NonProprietaryName":"Carboxymethylcellulose Sodium"},{"NDCCode":"84515-350-01","ProprietaryName":"Collagen Cream","NonProprietaryName":"Collagen Cream"},{"NDCCode":"84756-350-02","ProprietaryName":"Vitamin C Brightening Eye Cream","NonProprietaryName":"Vitamin C Brightening Eye Cream"},{"NDCCode":"0023-9177-15","ProprietaryName":"Alphagan P","NonProprietaryName":"Brimonidine Tartrate"},{"NDCCode":"0023-9321-15","ProprietaryName":"Alphagan P","NonProprietaryName":"Brimonidine Tartrate"},{"NDCCode":"0121-0727-16","ProprietaryName":"Ranitidine","NonProprietaryName":"Ranitidine"},{"NDCCode":"0121-4727-10","ProprietaryName":"Ranitidine","NonProprietaryName":"Ranitidine"},{"NDCCode":"0264-7865-00","ProprietaryName":"Potassium Chloride In Sodium Chloride","NonProprietaryName":"Sodium Chloride And Potassium Chloride"},{"NDCCode":"0407-1414-72","ProprietaryName":"Omnipaque","NonProprietaryName":"Iohexol"},{"NDCCode":"0832-1435-15","ProprietaryName":"Brimonidine Tartrate","NonProprietaryName":"Brimonidine Tartrate"},{"NDCCode":"11026-2780-4","ProprietaryName":"Broncotron Ped","NonProprietaryName":"Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl"},{"NDCCode":"11527-325-33","ProprietaryName":"Theriac Advanced Healing","NonProprietaryName":"Lanolin"},{"NDCCode":"12634-437-85","ProprietaryName":"Carisoprodol","NonProprietaryName":"Carisoprodol"},{"NDCCode":"13811-050-30","ProprietaryName":"Ultimatecare","NonProprietaryName":"Omega-3 Fatty Acids, Doconexent, Icosapent, Linolenic Acid, Calcium Ascorbate, Calcium Threonate, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, F"}]}
                    

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<NDCList>
  <NDC>
    <NDCCode>54136-350-15</NDCCode>
    <PackageDescription>15 g in 1 TUBE (54136-350-15) </PackageDescription>
    <NDC11Code>54136-0350-15</NDC11Code>
    <ProductNDC>54136-350</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Invisible Sunscreen Stick Spf 50</ProprietaryName>
    <NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene</NonProprietaryName>
    <DosageFormName>STICK</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20240201</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Better Planet Brands LLC</LabelerName>
    <SubstanceName>HOMOSALATE; OCTOCRYLENE; AVOBENZONE; OCTISALATE</SubstanceName>
    <StrengthNumber>15; 7.5; 3; 5</StrengthNumber>
    <StrengthUnit>g/100g; g/100g; g/100g; g/100g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-12-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240201</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage> helps prevent sunburn.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>54136-118-91</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (54136-118-91)  / 15 g in 1 TUBE</PackageDescription>
    <NDC11Code>54136-0118-91</NDC11Code>
    <ProductNDC>54136-118</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Incredibly Clear Acne Spot</ProprietaryName>
    <NonProprietaryName>Salicylic Acid</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200514</StartMarketingDate>
    <EndMarketingDate>20251031</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M006</ApplicationNumber>
    <LabelerName>Better Planet Brands LLC</LabelerName>
    <SubstanceName>SALICYLIC ACID</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-11-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20200514</StartMarketingDatePackage>
    <EndMarketingDatePackage>20251031</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses. * For the treatment of acne.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>54136-153-44</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (54136-153-44)  / 52 g in 1 TUBE</PackageDescription>
    <NDC11Code>54136-0153-44</NDC11Code>
    <ProductNDC>54136-153</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Radically Rejuvenating Day Cream</ProprietaryName>
    <NonProprietaryName>Zinc Oxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200409</StartMarketingDate>
    <EndMarketingDate>20251130</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Better Planet Brands LLC</LabelerName>
    <SubstanceName>ZINC OXIDE</SubstanceName>
    <StrengthNumber>15.5</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-12-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20200409</StartMarketingDatePackage>
    <EndMarketingDatePackage>20251130</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>* Help prevent sunburn * if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>54136-946-19</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (54136-946-19)  / 52 g in 1 TUBE</PackageDescription>
    <NDC11Code>54136-0946-19</NDC11Code>
    <ProductNDC>54136-946</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Seriously Soothing Face Cream</ProprietaryName>
    <NonProprietaryName>Zinc Oxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200422</StartMarketingDate>
    <EndMarketingDate>20251231</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Better Planet Brands LLC</LabelerName>
    <SubstanceName>ZINC OXIDE</SubstanceName>
    <StrengthNumber>15.5</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20200422</StartMarketingDatePackage>
    <EndMarketingDatePackage>20251231</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>* Help prevent sunburn * if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>50268-350-15</NDCCode>
    <PackageDescription>50 BLISTER PACK in 1 BOX (50268-350-15)  / 1 TABLET in 1 BLISTER PACK (50268-350-11) </PackageDescription>
    <NDC11Code>50268-0350-15</NDC11Code>
    <ProductNDC>50268-350</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Gemfibrozil</ProprietaryName>
    <NonProprietaryName>Gemfibrozil</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140710</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077836</ApplicationNumber>
    <LabelerName>AvPAK</LabelerName>
    <SubstanceName>GEMFIBROZIL</SubstanceName>
    <StrengthNumber>600</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>PPAR alpha [CS], Peroxisome Proliferator Receptor alpha Agonist [EPC], Peroxisome Proliferator-activated Receptor alpha Agonists [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20140710</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Gemfibrozil Tablets, USP are indicated as adjunctive therapy to diet for. 1. Treatment of adult patients with very high elevations of serum triglyceride levels (Types IV and V hyperlipidemia) who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them. Patients who present such risk typically have serum triglycerides over 2,000 mg/dL and have elevations of VLDL-cholesterol as well as fasting chylomicrons (Type V hyperlipidemia). Subjects who consistently have total serum or plasma triglycerides below 1,000 mg/dL are unlikely to present a risk of pancreatitis. Gemfibrozil therapy may be considered for those subjects with triglyceride elevations between 1,000 and 2,000 mg/dL who have a history of pancreatitis or of recurrent abdominal pain typical of pancreatitis. It is recognized that some Type IV patients with triglycerides under 1,000 mg/dL may, through dietary or alcoholic indiscretion, convert to a Type V pattern with massive triglyceride elevations accompanying fasting chylomicronemia, but the influence of gemfibrozil therapy on the risk of pancreatitis in such situations has not been adequately studied. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV, and V hyperlipoproteinemia. 2. Reducing the risk of developing coronary heart disease only in Type IIb patients without history of or symptoms of existing coronary heart disease who have had an inadequate response to weight loss, dietary therapy, exercise, and other pharmacologic agents (such as bile acid sequestrants and nicotinic acid, known to reduce LDL- and raise HDL-cholesterol) and who have the following triad of lipid abnormalities: low HDL-cholesterol levels in addition to elevated LDL-cholesterol and elevated triglycerides (see WARNINGS, PRECAUTIONS, and CLINICAL PHARMACOLOGY). The National Cholesterol Education Program has defined a serum HDL-cholesterol value that is consistently below 35 mg/dL as constituting an independent risk factor for coronary heart disease. Patients with significantly elevated triglycerides should be closely observed when treated with gemfibrozil. In some patients with high triglyceride levels, treatment with gemfibrozil is associated with a significant increase in LDL-cholesterol. BECAUSE OF POTENTIAL TOXICITY SUCH AS MALIGNANCY, GALLBLADDER DISEASE, ABDOMINAL PAIN LEADING TO APPENDECTOMY AND OTHER ABDOMINAL SURGERIES, AN INCREASED INCIDENCE IN NON-CORONARY MORTALITY, AND THE 44% RELATIVE INCREASE DURING THE TRIAL PERIOD IN AGE-ADJUSTED ALL-CAUSE MORTALITY SEEN WITH THE CHEMICALLY AND PHARMACOLOGICALLY RELATED DRUG, CLOFIBRATE, THE POTENTIAL BENEFIT OF GEMFIBROZIL IN TREATING TYPE IIA PATIENTS WITH ELEVATIONS OF LDL-CHOLESTEROL ONLY IS NOT LIKELY TO OUTWEIGH THE RISKS. GEMFIBROZIL IS ALSO NOT INDICATED FOR THE TREATMENT OF PATIENTS WITH LOW HDL-CHOLESTEROL AS THEIR ONLY LIPID ABNORMALITY. In a subgroup analysis of patients in the Helsinki Heart Study with above-median HDL-cholesterol values at baseline (greater than 46.4 mg/dL), the incidence of serious coronary events was similar for gemfibrozil and placebo subgroups (see Table I). The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcohol intake may be important factors in hypertriglyceridemia and should be managed prior to any drug therapy. Physical exercise can be an important ancillary measure, and has been associated with rises in HDL-cholesterol. Diseases contributory to hyperlipidemia such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy is sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of estrogen therapy may obviate the need for specific drug therapy of hypertriglyceridemia. The use of drugs should be considered only when reasonable attempts have been made to obtain satisfactory results with nondrug methods. If the decision is made to use drugs, the patient should be instructed that this does not reduce the importance of adhering to diet.</IndicationAndUsage>
    <Description>Gemfibrozil, USP is a lipid regulating agent. It is available as tablets for oral administration. Each tablet contains 600 mg gemfibrozil. Each tablet also contains the following inactive ingredients: colloidal silicon dioxide, NF; croscarmellose sodium, NF; calcium stearate, NF; microcrystalline cellulose, NF; methylcellulose, USP and opadry white. The chemical name is 5-(2,5-dimethylphenoxy)-2,2-dimethylpentanoic acid, with the following structural formula. The empirical formula is C 15H 22O 3 and the molecular weight is 250.35; the solubility in water and acid is 0.0019% and in dilute base it is greater than 1%. The melting point is 58° to 61°C. Gemfibrozil is a white solid which is stable under ordinary conditions.</Description>
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  <NDC>
    <NDCCode>57237-350-15</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (57237-350-15)  / 15 g in 1 TUBE</PackageDescription>
    <NDC11Code>57237-0350-15</NDC11Code>
    <ProductNDC>57237-350</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Micoclear</ProprietaryName>
    <NonProprietaryName>Clotrimazole Antifungal</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20251106</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M005</ApplicationNumber>
    <LabelerName>Rising Pharma Holdings, Inc.</LabelerName>
    <SubstanceName>CLOTRIMAZOLE</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251106</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>cures most athlete's foot, jock itch and ringworm. relieves itching, burning, cracking, scaling, discomfort and chafing associated with jock itch.</IndicationAndUsage>
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  <NDC>
    <NDCCode>57483-350-15</NDCCode>
    <PackageDescription>2 BOTTLE, DROPPER in 1 CARTON (57483-350-15)  / 15 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>57483-0350-15</NDC11Code>
    <ProductNDC>57483-350</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Nasova Ear Drying Drops</ProprietaryName>
    <NonProprietaryName>Isopropyl Alcohol 95%</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>AURICULAR (OTIC)</RouteName>
    <StartMarketingDate>20211102</StartMarketingDate>
    <EndMarketingDate>20241031</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M</ApplicationNumber>
    <LabelerName>Innovus Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
    <StrengthNumber>950</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-11-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20211102</StartMarketingDatePackage>
    <EndMarketingDatePackage>20241031</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Dries water in the ears and relieves water-clogged ears.</IndicationAndUsage>
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  <NDC>
    <NDCCode>61748-350-15</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (61748-350-15)  &gt; 15 g in 1 TUBE</PackageDescription>
    <NDC11Code>61748-0350-15</NDC11Code>
    <ProductNDC>61748-350</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Diflorasone Diacetate</ProprietaryName>
    <NonProprietaryName>Diflorasone Diacetate</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20160308</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA206572</ApplicationNumber>
    <LabelerName>VersaPharm Incorporated</LabelerName>
    <SubstanceName>DIFLORASONE DIACETATE</SubstanceName>
    <StrengthNumber>.5</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>65753-350-15</NDCCode>
    <PackageDescription>25 POUCH in 1 CONTAINER (65753-350-15)  / 1.1 mL in 1 POUCH</PackageDescription>
    <NDC11Code>65753-0350-15</NDC11Code>
    <ProductNDC>65753-350</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Stingx</ProprietaryName>
    <NonProprietaryName>Benzocaine</NonProprietaryName>
    <DosageFormName>SWAB</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20191125</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M017</ApplicationNumber>
    <LabelerName>CoreTex Products Inc</LabelerName>
    <SubstanceName>BENZOCAINE</SubstanceName>
    <StrengthNumber>6</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-10-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20191125</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For temporary pain relief from insect bites and stings.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>66184-455-01</NDCCode>
    <PackageDescription>9.9 g in 1 CARTRIDGE (66184-455-01)</PackageDescription>
    <NDC11Code>66184-0455-01</NDC11Code>
    <ProductNDC>66184-455</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ck One Waterfresh Face Makeup Spf 15</ProprietaryName>
    <ProprietaryNameSuffix>350 Beige</ProprietaryNameSuffix>
    <NonProprietaryName>Titanium Dioxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20120123</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Coty US LLC</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE; OCTINOXATE</SubstanceName>
    <StrengthNumber>4.95; 2.4</StrengthNumber>
    <StrengthUnit>mL/9.9g; mL/9.9g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>66184-455-02</NDCCode>
    <PackageDescription>9.9 g in 1 BOX (66184-455-02)</PackageDescription>
    <NDC11Code>66184-0455-02</NDC11Code>
    <ProductNDC>66184-455</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Ck One Waterfresh Face Makeup Spf 15</ProprietaryName>
    <ProprietaryNameSuffix>350 Beige</ProprietaryNameSuffix>
    <NonProprietaryName>Titanium Dioxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20120123</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Coty US LLC</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE; OCTINOXATE</SubstanceName>
    <StrengthNumber>4.95; 2.4</StrengthNumber>
    <StrengthUnit>mL/9.9g; mL/9.9g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>68001-350-68</NDCCode>
    <PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (68001-350-68)  &gt; 15 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
    <NDC11Code>68001-0350-68</NDC11Code>
    <ProductNDC>68001-350</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Gemcitabine</ProprietaryName>
    <NonProprietaryName>Gemcitabine</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20180525</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA209604</ApplicationNumber>
    <LabelerName>BluePoint Laboratories</LabelerName>
    <SubstanceName>GEMCITABINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>100</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-09-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180525</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>69691-350-15</NDCCode>
    <PackageDescription>100 g in 1 BOX (69691-350-15)</PackageDescription>
    <NDC11Code>69691-0350-15</NDC11Code>
    <ProductNDC>69691-350</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Preginot</ProprietaryName>
    <NonProprietaryName>Allantoin-lidocaine</NonProprietaryName>
    <DosageFormName>PATCH</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20150401</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Pharmaco Technology LLC</LabelerName>
    <SubstanceName>ALLANTOIN; LIDOCAINE; PETROLATUM</SubstanceName>
    <StrengthNumber>2; 4; 30</StrengthNumber>
    <StrengthUnit>g/100g; g/100g; g/100g</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC],Amides [Chemical/Ingredient],Antiarrhythmic [EPC],Local Anesthesia [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2015-05-01</LastUpdate>
  </NDC>
  <NDC>
    <NDCCode>71919-350-07</NDCCode>
    <PackageDescription>15 mL in 1 VIAL, GLASS (71919-350-07) </PackageDescription>
    <NDC11Code>71919-0350-07</NDC11Code>
    <ProductNDC>71919-350</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hydrocyanicum Acidum</ProprietaryName>
    <NonProprietaryName>Hydrogen Cyanide</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20160610</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Washington Homeopathic Products</LabelerName>
    <SubstanceName>HYDROGEN CYANIDE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>[hp_C]/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-03-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160610</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>73928-007-15</NDCCode>
    <PackageDescription>350 mL in 1 BOTTLE, PLASTIC (73928-007-15) </PackageDescription>
    <NDC11Code>73928-0007-15</NDC11Code>
    <ProductNDC>73928-007</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Anthem Hand Sanitizer</ProprietaryName>
    <NonProprietaryName>Alcohol</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20200727</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M003</ApplicationNumber>
    <LabelerName>KINGKEY MBC LIFE TECHNOLOGY GROUP CO., LTD</LabelerName>
    <SubstanceName>ALCOHOL</SubstanceName>
    <StrengthNumber>75</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-10-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20200727</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>75936-350-03</NDCCode>
    <PackageDescription>15 mL in 1 TUBE (75936-350-03) </PackageDescription>
    <NDC11Code>75936-0350-03</NDC11Code>
    <ProductNDC>75936-350</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Glow Screen Body Broad Spectrum Sunscreen Spf 40</ProprietaryName>
    <NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20210120</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>Supergoop, LLC</LabelerName>
    <SubstanceName>HOMOSALATE; OCTISALATE; OCTOCRYLENE; AVOBENZONE</SubstanceName>
    <StrengthNumber>7; 5; 10; 3</StrengthNumber>
    <StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-01-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210120</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>76168-350-15</NDCCode>
    <PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (76168-350-15)  &gt; 15 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>76168-0350-15</NDC11Code>
    <ProductNDC>76168-350</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lubricant Drops</ProprietaryName>
    <NonProprietaryName>Carboxymethylcellulose Sodium</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20220405</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part349</ApplicationNumber>
    <LabelerName>Velocity Pharma LLC</LabelerName>
    <SubstanceName>CARBOXYMETHYLCELLULOSE SODIUM</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220405</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For the temporary relief of burning, irritation, and discomfort due to dryness of the eye or exposure to wind or sun. . May be used as a protectant against further irritation.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>84515-350-01</NDCCode>
    <PackageDescription>15 g in 1 BOX (84515-350-01) </PackageDescription>
    <NDC11Code>84515-0350-01</NDC11Code>
    <ProductNDC>84515-350</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Collagen Cream</ProprietaryName>
    <NonProprietaryName>Collagen Cream</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20241014</StartMarketingDate>
    <EndMarketingDate>20311031</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M016</ApplicationNumber>
    <LabelerName>Yiwu Xinqian E Commerce Co Ltd</LabelerName>
    <SubstanceName>NIACINAMIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-12-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20241014</StartMarketingDatePackage>
    <EndMarketingDatePackage>20311031</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>84756-350-02</NDCCode>
    <PackageDescription>15 mL in 1 BOTTLE (84756-350-02) </PackageDescription>
    <NDC11Code>84756-0350-02</NDC11Code>
    <ProductNDC>84756-350</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Vitamin C Brightening Eye Cream</ProprietaryName>
    <NonProprietaryName>Vitamin C Brightening Eye Cream</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20241119</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M016</ApplicationNumber>
    <LabelerName>Yiwu Ziqiu Import Export Co Ltd</LabelerName>
    <SubstanceName>NIACINAMIDE</SubstanceName>
    <StrengthNumber>5</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-12-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241119</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>0023-9177-15</NDCCode>
    <PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (0023-9177-15)  / 15 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>00023-9177-15</NDC11Code>
    <ProductNDC>0023-9177</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Alphagan P</ProprietaryName>
    <NonProprietaryName>Brimonidine Tartrate</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20010710</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021262</ApplicationNumber>
    <LabelerName>Allergan, Inc.</LabelerName>
    <SubstanceName>BRIMONIDINE TARTRATE</SubstanceName>
    <StrengthNumber>1.5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20010710</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ALPHAGAN  P (brimonidine tartrate ophthalmic solution) 0.1% or 0.15% is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.</IndicationAndUsage>
    <Description>ALPHAGAN P (brimonidine tartrate ophthalmic solution) 0.1% or 0.15%, sterile, is a relatively selective alpha-2 adrenergic receptor agonist for topical ophthalmic use. The structural formula of brimonidine tartrate is. 5-Bromo-6-(2-imidazolidinylideneamino) quinoxaline L-tartrate; MW= 442.24. In solution, ALPHAGAN P (brimonidine tartrate ophthalmic solution) has a clear, greenish-yellow color. It has an osmolality of 250-350 mOsmol/kg and a pH of 7.4-8.0 (0.1%) or 6.9-7.4 (0.15%). Brimonidine tartrate appears as an off-white to pale-yellow powder and is soluble in both water (0.6 mg/mL) and in the product vehicle (1.4 mg/mL) at pH 7.7. Each mL of ALPHAGAN P contains the active ingredient brimonidine tartrate 0.1% (1 mg/mL) or 0.15% (1.5 mg/mL) with the inactive ingredients sodium carboxymethylcellulose; sodium borate; boric acid; sodium chloride; potassium chloride; calcium chloride; magnesium chloride; PURITE® 0.005% (0.05 mg/mL) as a preservative; purified water; and hydrochloric acid and/or sodium hydroxide to adjust pH.</Description>
  </NDC>
  <NDC>
    <NDCCode>0023-9321-15</NDCCode>
    <PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (0023-9321-15)  / 15 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>00023-9321-15</NDC11Code>
    <ProductNDC>0023-9321</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Alphagan P</ProprietaryName>
    <NonProprietaryName>Brimonidine Tartrate</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20060125</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA021770</ApplicationNumber>
    <LabelerName>Allergan, Inc.</LabelerName>
    <SubstanceName>BRIMONIDINE TARTRATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20060125</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>ALPHAGAN  P (brimonidine tartrate ophthalmic solution) 0.1% or 0.15% is indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.</IndicationAndUsage>
    <Description>ALPHAGAN P (brimonidine tartrate ophthalmic solution) 0.1% or 0.15%, sterile, is a relatively selective alpha-2 adrenergic receptor agonist for topical ophthalmic use. The structural formula of brimonidine tartrate is. 5-Bromo-6-(2-imidazolidinylideneamino) quinoxaline L-tartrate; MW= 442.24. In solution, ALPHAGAN P (brimonidine tartrate ophthalmic solution) has a clear, greenish-yellow color. It has an osmolality of 250-350 mOsmol/kg and a pH of 7.4-8.0 (0.1%) or 6.9-7.4 (0.15%). Brimonidine tartrate appears as an off-white to pale-yellow powder and is soluble in both water (0.6 mg/mL) and in the product vehicle (1.4 mg/mL) at pH 7.7. Each mL of ALPHAGAN P contains the active ingredient brimonidine tartrate 0.1% (1 mg/mL) or 0.15% (1.5 mg/mL) with the inactive ingredients sodium carboxymethylcellulose; sodium borate; boric acid; sodium chloride; potassium chloride; calcium chloride; magnesium chloride; PURITE® 0.005% (0.05 mg/mL) as a preservative; purified water; and hydrochloric acid and/or sodium hydroxide to adjust pH.</Description>
  </NDC>
  <NDC>
    <NDCCode>0121-0727-16</NDCCode>
    <PackageDescription>473 mL in 1 BOTTLE (0121-0727-16) </PackageDescription>
    <NDC11Code>00121-0727-16</NDC11Code>
    <ProductNDC>0121-0727</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ranitidine</ProprietaryName>
    <NonProprietaryName>Ranitidine</NonProprietaryName>
    <DosageFormName>SYRUP</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20101101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077405</ApplicationNumber>
    <LabelerName>Pharmaceutical Associates, Inc.</LabelerName>
    <SubstanceName>RANITIDINE</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-01-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20101101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ranitidine Syrup (Ranitidine Oral Solution USP) is indicated in: 1 Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Studies available to date have not assessed the safety of ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks., 2 Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. No placebo-controlled comparative studies have been carried out for periods of longer than 1 year., 3 The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis)., 4 Short-term treatment of active, benign gastric ulcer. Most patients heal within 6 weeks and the usefulness of further treatment has not been demonstrated. Studies available to date have not assessed the safety of ranitidine in uncomplicated, benign gastric ulcer for periods of more than 6 weeks., 5 Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers. Placebo-controlled studies have been carried out for 1 year., 6 Treatment of GERD. Symptomatic relief commonly occurs within 24 hours after starting therapy with ranitidine 150 mg twice daily., 7 Treatment of endoscopically diagnosed erosive esophagitis. Symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with ranitidine 150 mg 4 times daily., 8 Maintenance of healing of erosive esophagitis. Placebo-controlled trials have been carried out for 48 weeks.</IndicationAndUsage>
    <Description>The active ingredient in Ranitidine Syrup (Ranitidine Oral Solution USP) is ranitidine hydrochloride (HCl) USP, a histamine H 2-receptor antagonist. Chemically, it is N[2-[[[5-[(dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-N' -methyl-2-nitro-1,1-ethenediamine, HCl. It has the following structure:. The empirical formula is C 13H 22N 4O 3SHCl, representing a molecular weight of 350.87. Ranitidine HCl is a white to pale yellow, granular substance that is soluble in water. It has a slightly bitter taste and sulfurlike odor. Each 1 mL of Ranitidine Syrup (Ranitidine Oral Solution USP) contains 16.8 mg of ranitidine HCl equivalent to 15 mg of ranitidine. Ranitidine Syrup (Ranitidine Oral Solution USP) also contains the inactive ingredients dibasic sodium phosphate, hydroxyethylcellulose, methylparaben, purified water, sodium chloride, sodium saccharin, spearmint flavor, sucrose and may contain monobasic sodium phosphate.</Description>
  </NDC>
  <NDC>
    <NDCCode>0121-4727-10</NDCCode>
    <PackageDescription>4 TRAY in 1 CASE (0121-4727-10)  &gt; 10 CUP, UNIT-DOSE in 1 TRAY &gt; 10 mL in 1 CUP, UNIT-DOSE</PackageDescription>
    <NDC11Code>00121-4727-10</NDC11Code>
    <ProductNDC>0121-4727</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ranitidine</ProprietaryName>
    <NonProprietaryName>Ranitidine</NonProprietaryName>
    <DosageFormName>SYRUP</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20101101</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077405</ApplicationNumber>
    <LabelerName>Pharmaceutical Associates, Inc.</LabelerName>
    <SubstanceName>RANITIDINE</SubstanceName>
    <StrengthNumber>15</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2022-01-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20101101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ranitidine Syrup (Ranitidine Oral Solution USP) is indicated in: 1 Short-term treatment of active duodenal ulcer. Most patients heal within 4 weeks. Studies available to date have not assessed the safety of ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks., 2 Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. No placebo-controlled comparative studies have been carried out for periods of longer than 1 year., 3 The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis)., 4 Short-term treatment of active, benign gastric ulcer. Most patients heal within 6 weeks and the usefulness of further treatment has not been demonstrated. Studies available to date have not assessed the safety of ranitidine in uncomplicated, benign gastric ulcer for periods of more than 6 weeks., 5 Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers. Placebo-controlled studies have been carried out for 1 year., 6 Treatment of GERD. Symptomatic relief commonly occurs within 24 hours after starting therapy with ranitidine 150 mg twice daily., 7 Treatment of endoscopically diagnosed erosive esophagitis. Symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with ranitidine 150 mg 4 times daily., 8 Maintenance of healing of erosive esophagitis. Placebo-controlled trials have been carried out for 48 weeks.</IndicationAndUsage>
    <Description>The active ingredient in Ranitidine Syrup (Ranitidine Oral Solution USP) is ranitidine hydrochloride (HCl) USP, a histamine H 2-receptor antagonist. Chemically, it is N[2-[[[5-[(dimethylamino)methyl]-2-furanyl]methyl]thio]ethyl]-N' -methyl-2-nitro-1,1-ethenediamine, HCl. It has the following structure:. The empirical formula is C 13H 22N 4O 3SHCl, representing a molecular weight of 350.87. Ranitidine HCl is a white to pale yellow, granular substance that is soluble in water. It has a slightly bitter taste and sulfurlike odor. Each 1 mL of Ranitidine Syrup (Ranitidine Oral Solution USP) contains 16.8 mg of ranitidine HCl equivalent to 15 mg of ranitidine. Ranitidine Syrup (Ranitidine Oral Solution USP) also contains the inactive ingredients dibasic sodium phosphate, hydroxyethylcellulose, methylparaben, purified water, sodium chloride, sodium saccharin, spearmint flavor, sucrose and may contain monobasic sodium phosphate.</Description>
  </NDC>
  <NDC>
    <NDCCode>0264-7865-00</NDCCode>
    <PackageDescription>12 CONTAINER in 1 CASE (0264-7865-00)  / 1000 mL in 1 CONTAINER</PackageDescription>
    <NDC11Code>00264-7865-00</NDC11Code>
    <ProductNDC>0264-7865</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Potassium Chloride In Sodium Chloride</ProprietaryName>
    <NonProprietaryName>Sodium Chloride And Potassium Chloride</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>19890929</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA019708</ApplicationNumber>
    <LabelerName>B. Braun Medical Inc.</LabelerName>
    <SubstanceName>SODIUM CHLORIDE; POTASSIUM CHLORIDE</SubstanceName>
    <StrengthNumber>.9; .15</StrengthNumber>
    <StrengthUnit>g/100mL; g/100mL</StrengthUnit>
    <Pharm_Classes>Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-02-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19890929</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Potassium Chloride in 0.9% Sodium Chloride Injection is indicated for use in adults and pediatric patients as a source of electrolytes and water for hydration.</IndicationAndUsage>
    <Description>Each 100 mL of 20 mEq Potassium Chloride in 0.9% Sodium Chloride Injection (20 mEq K+/L) contains: Sodium Chloride USP 0.9 g Potassium Chloride USP 0.15 g; Water for Injection USP qs. pH may be adjusted with Hydrochloric Acid NF. pH: 5.6 (3.5–6.5)              Calculated Osmolarity: 350 mOsmol/L. Concentration of Electrolytes (mEq/L): Sodium 154             Potassium 20             Chloride 174. Potassium Chloride in 0.9% Sodium Chloride Injection is sterile, nonpyrogenic, hypertonic and contains no bacteriostatic or antimicrobial agents. This product is intended for intravenous administration. The formulas of the active ingredients are. Not made with natural rubber latex, PVC or DEHP. The plastic container is made from a multilayered film specifically developed for parenteral drugs. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. Addition of medication should be accomplished using complete aseptic technique. The closure system has two ports; the one for the administration set has a tamper evident plastic protector and the other is a medication addition site. Refer to the Directions for Use of the container.</Description>
  </NDC>
  <NDC>
    <NDCCode>0407-1414-72</NDCCode>
    <PackageDescription>10 BOTTLE, PLASTIC in 1 BOX (0407-1414-72)  / 500 mL in 1 BOTTLE, PLASTIC</PackageDescription>
    <NDC11Code>00407-1414-72</NDC11Code>
    <ProductNDC>0407-1414</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Omnipaque</ProprietaryName>
    <NonProprietaryName>Iohexol</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20161221</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA020608</ApplicationNumber>
    <LabelerName>GE Healthcare</LabelerName>
    <SubstanceName>IOHEXOL</SubstanceName>
    <StrengthNumber>350</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-15</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20161221</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>OMNIPAQUE is a radiographic contrast agent indicated for intrathecal, intra-arterial, intravenous, oral, rectal, intraarticular, and body cavity imaging procedures in adults and pediatric patients. (1).</IndicationAndUsage>
    <Description>Iohexol is a nonionic radiographic contrast agent available as: 1 OMNIPAQUE (iohexol) injection for intrathecal, intra-arterial, intravenous, oral, rectal, intraarticular, and body cavity use, 2 OMNIPAQUE (iohexol) oral solution for oral use.</Description>
  </NDC>
  <NDC>
    <NDCCode>0832-1435-15</NDCCode>
    <PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (0832-1435-15)  / 15 mL in 1 BOTTLE, DROPPER</PackageDescription>
    <NDC11Code>00832-1435-15</NDC11Code>
    <ProductNDC>0832-1435</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Brimonidine Tartrate</ProprietaryName>
    <NonProprietaryName>Brimonidine Tartrate</NonProprietaryName>
    <DosageFormName>SOLUTION/ DROPS</DosageFormName>
    <RouteName>OPHTHALMIC</RouteName>
    <StartMarketingDate>20250730</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA217599</ApplicationNumber>
    <LabelerName>Upsher-Smith Laboratories, LLC</LabelerName>
    <SubstanceName>BRIMONIDINE TARTRATE</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-09-11</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260908</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Brimonidine tartrate ophthalmic solution 0.1% is an alpha-adrenergic receptor agonist indicated for the reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.</IndicationAndUsage>
    <Description>Brimonidine tartrate ophthalmic solution 0.1%, sterile, is a relatively selective alpha-2 adrenergic receptor agonist (for ophthalmic use). The structural formula of brimonidine tartrate is. 5-bromo-6-(2-imidazolidinylideneamino) quinoxaline L-tartrate; MW= 442.24. In a brimonidine tartrate ophthalmic solution has a clear, greenish-yellow color. It has an osmolality of 250 to 350 mOsmol/kg and a pH of 7.4 to 8.0 (0.1%). Brimonidine tartrate appears as an off-white to pale-yellow powder and is soluble in both water (0.6 mg/mL) and in the product vehicle (1.4 mg/mL) at pH 7.7. Each mL of brimonidine tartrate ophthalmic solution contains the active ingredient brimonidine tartrate 0.1% (1 mg/mL) with the inactive ingredients: sodium carboxymethylcellulose, sodium borate, boric acid, sodium chloride, potassium chloride, calcium chloride, magnesium chloride, stabilized oxychloro complex 0.005% (0.05 mg/mL) as a preservative, purified water, hydrochloric acid and/or sodium hydroxide to adjust pH.</Description>
  </NDC>
  <NDC>
    <NDCCode>11026-2780-4</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (11026-2780-4)  &gt; 118 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>11026-2780-04</NDC11Code>
    <ProductNDC>11026-2780</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Broncotron Ped</ProprietaryName>
    <NonProprietaryName>Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20121215</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part341</ApplicationNumber>
    <LabelerName>Seyer Pharmatec, Inc.</LabelerName>
    <SubstanceName>DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>15; 350; 10</StrengthNumber>
    <StrengthUnit>mg/5mL; mg/5mL; mg/5mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2021-10-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20121215</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>11527-325-33</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (11527-325-33)  / 15 g in 1 TUBE</PackageDescription>
    <NDC11Code>11527-0325-33</NDC11Code>
    <ProductNDC>11527-325</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Theriac Advanced Healing</ProprietaryName>
    <NonProprietaryName>Lanolin</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20210301</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M016</ApplicationNumber>
    <LabelerName>Sheffield Pharmaceuticals LLC</LabelerName>
    <SubstanceName>LANOLIN</SubstanceName>
    <StrengthNumber>350.8</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2023-10-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210301</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Temporarily Protects Minor: 1 cuts , 2 scrapes, 3 burns.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>12634-437-85</NDCCode>
    <PackageDescription>15 TABLET in 1 BOTTLE (12634-437-85)</PackageDescription>
    <NDC11Code>12634-0437-85</NDC11Code>
    <ProductNDC>12634-437</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Carisoprodol</ProprietaryName>
    <NonProprietaryName>Carisoprodol</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>19911017</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA089346</ApplicationNumber>
    <LabelerName>Apotheca Inc.</LabelerName>
    <SubstanceName>CARISOPRODOL</SubstanceName>
    <StrengthNumber>350</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Centrally-mediated Muscle Relaxation [PE],Muscle Relaxant [EPC]</Pharm_Classes>
    <DEASchedule>CIV</DEASchedule>
    <Status>Deprecated</Status>
    <LastUpdate>2019-07-30</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Carisoprodol tablets are indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. Carisoprodol tablets should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration [ see  Dosage and Administration (2)].</IndicationAndUsage>
    <Description>Carisoprodol tablets USP are available as 350 mg round, white tablets. Carisoprodol is a white, crystalline powder, having a mild, characteristic odor and a bitter taste. It is slightly soluble in water; freely soluble in alcohol, in chloroform, and in acetone; and its solubility is practically independent of pH. Carisoprodol is present as a racemic mixture. Chemically, carisoprodol is N-isopropyl-2-methyl-2-propyl-1,3-propanediol dicarbamate and the molecular formula is C 12H 24N 2O 4, with a molecular weight of 260.33. The structural formula is:. Other ingredients in the carisoprodol tablets include corn starch, lactose, magnesium stearate, povidone, sodium lauryl sulfate, sodium starch glycolate, and stearic acid.</Description>
  </NDC>
  <NDC>
    <NDCCode>13811-050-30</NDCCode>
    <PackageDescription>30 CAPSULE in 1 BOTTLE (13811-050-30)</PackageDescription>
    <NDC11Code>13811-0050-30</NDC11Code>
    <ProductNDC>13811-050</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ultimatecare</ProprietaryName>
    <ProprietaryNameSuffix>One Nf</ProprietaryNameSuffix>
    <NonProprietaryName>Omega-3 Fatty Acids, Doconexent, Icosapent, Linolenic Acid, Calcium Ascorbate, Calcium Threonate, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, F</NonProprietaryName>
    <DosageFormName>CAPSULE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20091204</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>TRIGEN Laboratories, Inc.</LabelerName>
    <SubstanceName>OMEGA-3 FATTY ACIDS; DOCONEXENT; ICOSAPENT; LINOLENIC ACID; CALCIUM ASCORBATE; CALCIUM THREONATE; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; BIOTIN; CALCIUM; IRON; FERROUS ASPARTO GLYCINATE; IODINE; MAGNESIUM OXIDE; ZINC OXIDE; DOCUSATE SODIUM</SubstanceName>
    <StrengthNumber>500; 350; 100; 50; 24; 1; 800; 15; 1.5; 10; 50; 1; 300; 100; 20; 7; 150; 50; 5; 50</StrengthNumber>
    <StrengthUnit>mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1</StrengthUnit>
    <Pharm_Classes>Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Blood Coagulation Factor [EPC],Increased Coagulation Factor Activity [PE],Calcium [Chemical/Ingredient],Cations, Divalent [Chemical/Ingredient],Fatty Acids, Omega-3 [Chemical/Ingredient],Omega-3 Fatty Acid [EPC]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2017-09-19</LastUpdate>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>54136-350-15</NDCCode><ProprietaryName>Invisible Sunscreen Stick Spf 50</ProprietaryName><NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene</NonProprietaryName></NDC><NDC><NDCCode>54136-118-91</NDCCode><ProprietaryName>Incredibly Clear Acne Spot</ProprietaryName><NonProprietaryName>Salicylic Acid</NonProprietaryName></NDC><NDC><NDCCode>54136-153-44</NDCCode><ProprietaryName>Radically Rejuvenating Day Cream</ProprietaryName><NonProprietaryName>Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>54136-946-19</NDCCode><ProprietaryName>Seriously Soothing Face Cream</ProprietaryName><NonProprietaryName>Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>50268-350-15</NDCCode><ProprietaryName>Gemfibrozil</ProprietaryName><NonProprietaryName>Gemfibrozil</NonProprietaryName></NDC><NDC><NDCCode>57237-350-15</NDCCode><ProprietaryName>Micoclear</ProprietaryName><NonProprietaryName>Clotrimazole Antifungal</NonProprietaryName></NDC><NDC><NDCCode>57483-350-15</NDCCode><ProprietaryName>Nasova Ear Drying Drops</ProprietaryName><NonProprietaryName>Isopropyl Alcohol 95%</NonProprietaryName></NDC><NDC><NDCCode>61748-350-15</NDCCode><ProprietaryName>Diflorasone Diacetate</ProprietaryName><NonProprietaryName>Diflorasone Diacetate</NonProprietaryName></NDC><NDC><NDCCode>65753-350-15</NDCCode><ProprietaryName>Stingx</ProprietaryName><NonProprietaryName>Benzocaine</NonProprietaryName></NDC><NDC><NDCCode>66184-455-01</NDCCode><ProprietaryName>Ck One Waterfresh Face Makeup Spf 15</ProprietaryName><NonProprietaryName>Titanium Dioxide</NonProprietaryName></NDC><NDC><NDCCode>66184-455-02</NDCCode><ProprietaryName>Ck One Waterfresh Face Makeup Spf 15</ProprietaryName><NonProprietaryName>Titanium Dioxide</NonProprietaryName></NDC><NDC><NDCCode>68001-350-68</NDCCode><ProprietaryName>Gemcitabine</ProprietaryName><NonProprietaryName>Gemcitabine</NonProprietaryName></NDC><NDC><NDCCode>69691-350-15</NDCCode><ProprietaryName>Preginot</ProprietaryName><NonProprietaryName>Allantoin-lidocaine</NonProprietaryName></NDC><NDC><NDCCode>71919-350-07</NDCCode><ProprietaryName>Hydrocyanicum Acidum</ProprietaryName><NonProprietaryName>Hydrogen Cyanide</NonProprietaryName></NDC><NDC><NDCCode>73928-007-15</NDCCode><ProprietaryName>Anthem Hand Sanitizer</ProprietaryName><NonProprietaryName>Alcohol</NonProprietaryName></NDC><NDC><NDCCode>75936-350-03</NDCCode><ProprietaryName>Glow Screen Body Broad Spectrum Sunscreen Spf 40</ProprietaryName><NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene</NonProprietaryName></NDC><NDC><NDCCode>76168-350-15</NDCCode><ProprietaryName>Lubricant Drops</ProprietaryName><NonProprietaryName>Carboxymethylcellulose Sodium</NonProprietaryName></NDC><NDC><NDCCode>84515-350-01</NDCCode><ProprietaryName>Collagen Cream</ProprietaryName><NonProprietaryName>Collagen Cream</NonProprietaryName></NDC><NDC><NDCCode>84756-350-02</NDCCode><ProprietaryName>Vitamin C Brightening Eye Cream</ProprietaryName><NonProprietaryName>Vitamin C Brightening Eye Cream</NonProprietaryName></NDC><NDC><NDCCode>0023-9177-15</NDCCode><ProprietaryName>Alphagan P</ProprietaryName><NonProprietaryName>Brimonidine Tartrate</NonProprietaryName></NDC><NDC><NDCCode>0023-9321-15</NDCCode><ProprietaryName>Alphagan P</ProprietaryName><NonProprietaryName>Brimonidine Tartrate</NonProprietaryName></NDC><NDC><NDCCode>0121-0727-16</NDCCode><ProprietaryName>Ranitidine</ProprietaryName><NonProprietaryName>Ranitidine</NonProprietaryName></NDC><NDC><NDCCode>0121-4727-10</NDCCode><ProprietaryName>Ranitidine</ProprietaryName><NonProprietaryName>Ranitidine</NonProprietaryName></NDC><NDC><NDCCode>0264-7865-00</NDCCode><ProprietaryName>Potassium Chloride In Sodium Chloride</ProprietaryName><NonProprietaryName>Sodium Chloride And Potassium Chloride</NonProprietaryName></NDC><NDC><NDCCode>0407-1414-72</NDCCode><ProprietaryName>Omnipaque</ProprietaryName><NonProprietaryName>Iohexol</NonProprietaryName></NDC><NDC><NDCCode>0832-1435-15</NDCCode><ProprietaryName>Brimonidine Tartrate</ProprietaryName><NonProprietaryName>Brimonidine Tartrate</NonProprietaryName></NDC><NDC><NDCCode>11026-2780-4</NDCCode><ProprietaryName>Broncotron Ped</ProprietaryName><NonProprietaryName>Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl</NonProprietaryName></NDC><NDC><NDCCode>11527-325-33</NDCCode><ProprietaryName>Theriac Advanced Healing</ProprietaryName><NonProprietaryName>Lanolin</NonProprietaryName></NDC><NDC><NDCCode>12634-437-85</NDCCode><ProprietaryName>Carisoprodol</ProprietaryName><NonProprietaryName>Carisoprodol</NonProprietaryName></NDC><NDC><NDCCode>13811-050-30</NDCCode><ProprietaryName>Ultimatecare</ProprietaryName><NonProprietaryName>Omega-3 Fatty Acids, Doconexent, Icosapent, Linolenic Acid, Calcium Ascorbate, Calcium Threonate, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, F</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();
    }
}
            
        

            
{
  "NPI": [
    {
      "NPI": "1295783033",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "REDMOND EYE DOCTORS, PLLC",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3554",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-7363",
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      "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",
      "MailingAddressPostalCode": "97709-1397",
      "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": "10/28/2024",
      "LastUpdateDate": "10/28/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YM0800X",
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}
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