RESTful Lookup — Test-Drive (2007 – 2026)

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{
  "NDC": [
    {
      "NDCCode": "59088-206-07",
      "PackageDescription": "85 g in 1 TUBE (59088-206-07) ",
      "NDC11Code": "59088-0206-07",
      "ProductNDC": "59088-206",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fungizyl Ac",
      "NonProprietaryName": "Dimethyl Sulfoxide 2%, Miconazole Nitrate 2%",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20241204",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Puretek Corporation",
      "SubstanceName": "DIMETHYL SULFOXIDE; MICONAZOLE NITRATE",
      "StrengthNumber": "20; 20",
      "StrengthUnit": "mg/g; mg/g",
      "Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2025-04-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20241204",
      "SamplePackage": "N",
      "IndicationAndUsage": "Fungizyl AC is indicated for the treatment of fungal infections of the skin, including athlete's foot, jock itch, and ringworm. It also helps with superficial skin infections caused by Candida species. Dimethyl Sulfoxide (DMSO) enhances the penetration of Miconazole Nitrate through the skin, improving antifungal effectiveness.",
      "Description": "Fungizyl AC is a topical antifungal formulation that combines Dimethyl Sulfoxide (DMSO) and Miconazole Nitrate with a mixture of emollients and essential oils. The formulation is designed to provide effective antifungal activity while also soothing and moisturizing the skin. Each gram of Fungizyl AC contains 20 mg of Dimethyl Sulfoxide and 20 mg of Miconazole Nitrate in a vehicle with Aleurites Moluccana (Kukui) Seed Oil, Aqua (Purified Water), Butylene Glycol, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Seed Oil, Cety Alcohol, Cetyl Phosphate, Chlorphenesin, Dimethicone, Dimethicone Crosspolymer, Disodium EDTA, DL-Alpha-Tocopheryl Acetate, GenRx® Complex (Proprietary Blend), Glycerin, Glyceryl Stearate, PEG-100 Stearate, Pentylene Glycol, Phenoxyethanol, Sodium Hydroxide, and Stearyl Alcohol."
    },
    {
      "NDCCode": "31260-206-07",
      "PackageDescription": "1000 kg in 1 SUPERSACK (31260-206-07) ",
      "NDC11Code": "31260-0206-07",
      "ProductNDC": "31260-206",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Aluminum Zirconium Trichlorohydrex Gly",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20060101",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Gulbrandsen Technologies India Private Limited",
      "SubstanceName": "ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY",
      "StrengthNumber": "1",
      "StrengthUnit": "kg/kg",
      "Status": "Deprecated",
      "LastUpdate": "2014-02-04",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "01-JAN-06"
    },
    {
      "NDCCode": "45334-206-07",
      "PackageDescription": "7.4 mL in 1 TUBE (45334-206-07) ",
      "NDC11Code": "45334-0206-07",
      "ProductNDC": "45334-206",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Vanicream",
      "NonProprietaryName": "Pyrithione Zinc",
      "DosageFormName": "SHAMPOO",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20220103",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M032",
      "LabelerName": "Pharmaceutical Specialties, Inc.",
      "SubstanceName": "PYRITHIONE ZINC",
      "StrengthNumber": "2",
      "StrengthUnit": "g/100mL",
      "Status": "Active",
      "LastUpdate": "2024-12-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220103",
      "SamplePackage": "Y",
      "IndicationAndUsage": "Uses. Controls and reduces the symptoms of dandruff and seborrheic dermatitis."
    },
    {
      "NDCCode": "51167-106-02",
      "PackageDescription": "4 BLISTER PACK in 1 CARTON (51167-106-02)  / 1 KIT in 1 BLISTER PACK *  14 TABLET, FILM COATED in 1 BLISTER PACK (51167-206-14)  *  7 TABLET, FILM COATED in 1 BLISTER PACK (51167-306-07) ",
      "NDC11Code": "51167-0106-02",
      "ProductNDC": "51167-106",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Trikafta",
      "NonProprietaryName": "Elexacaftor, Tezacaftor, And Ivacaftor",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20210608",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA212273",
      "LabelerName": "Vertex Pharmaceuticals Incorporated",
      "Status": "Active",
      "LastUpdate": "2026-06-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20210608",
      "SamplePackage": "N",
      "IndicationAndUsage": "TRIKAFTA is indicated for the treatment of cystic fibrosis (CF) in adult and pediatric patients aged 2 years and older who have a clinical diagnosis of CF and who have at least one variant in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is either responsive based on clinical and/or in vitro data (see Table 6) or results in production of CFTR protein [see Clinical Pharmacology (12.1)]. If the patient's genotype is unknown, an FDA-cleared CF genetic test should be used to confirm the presence of at least one variant in the CFTR gene that is either responsive based on clinical and/or in vitro data or results in production of CFTR protein.",
      "Description": "TRIKAFTA is a co-package of elexacaftor, tezacaftor and ivacaftor fixed-dose combination tablets or granules and ivacaftor tablets or granules. Both tablets and granules are for oral administration. The elexacaftor, tezacaftor and ivacaftor fixed-dose combination tablets are available as: orange, oblong-shaped, film-coated tablet containing 100 mg of elexacaftor, 50 mg of tezacaftor, 75 mg of ivacaftor, or light orange, oblong-shaped, film-coated tablet containing 50 mg of elexacaftor, 25 mg of tezacaftor, 37.5 mg of ivacaftor. The fixed-dose combination tablet contains the following inactive ingredients: croscarmellose sodium, hypromellose, hypromellose acetate succinate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. The tablet film coat contains hydroxypropyl cellulose, hypromellose, iron oxide red, iron oxide yellow, talc, and titanium dioxide. The ivacaftor tablet is available as a light blue, oblong-shaped, film-coated tablet containing 150 mg or 75 mg of ivacaftor and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose acetate succinate, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. The tablet film coat contains carnauba wax, FD&C Blue #2, PEG 3350, polyvinyl alcohol, talc, and titanium dioxide. The printing ink contains ammonium hydroxide, iron oxide black, propylene glycol, and shellac. The elexacaftor, tezacaftor and ivacaftor fixed-dose combination oral granules are white to off-white, sweetened, unflavored granules approximately 2 mm in diameter enclosed in unit-dose packets. Each unit-dose packet contains 100 mg of elexacaftor, 50 mg of tezacaftor, 75 mg of ivacaftor or 80 mg of elexacaftor, 40 mg of tezacaftor, 60 mg of ivacaftor and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, hypromellose acetate succinate, lactose monohydrate, magnesium stearate, mannitol, sodium lauryl sulfate, and sucralose. The ivacaftor oral granules are white to off-white, sweetened, unflavored granules approximately 2 mm in diameter enclosed in unit-dose packets. Each unit-dose packet contains 75 mg or 59.5 mg of ivacaftor and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose acetate succinate, lactose monohydrate, magnesium stearate, mannitol, sodium lauryl sulfate, and sucralose. The active ingredients of TRIKAFTA are described below."
    },
    {
      "NDCCode": "55910-206-07",
      "PackageDescription": "1 BLISTER PACK in 1 CARTON (55910-206-07)  / 1 KIT in 1 BLISTER PACK *  6 TABLET, COATED in 1 BLISTER PACK *  4 TABLET, COATED in 1 BLISTER PACK",
      "NDC11Code": "55910-0206-07",
      "ProductNDC": "55910-206",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Mucus Fast Max Day Cold And Flu And Night Cold And Flu",
      "NonProprietaryName": "Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl, Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl, Triprolidine Hcl",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20241223",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part341",
      "LabelerName": "DOLGENCORP, INC.",
      "Status": "Deprecated",
      "LastUpdate": "2026-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20241223",
      "SamplePackage": "N",
      "IndicationAndUsage": "temporarily relieves these common cold and flu symptoms: coughnasal congestionminor aches and painssore throatheadachestuffy nosesinus congestion and pressure. temporarily reduces fever. helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive."
    },
    {
      "NDCCode": "58602-206-07",
      "PackageDescription": "1 BOTTLE in 1 CARTON (58602-206-07)  > 30 mL in 1 BOTTLE",
      "NDC11Code": "58602-0206-07",
      "ProductNDC": "58602-206",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Aurophen Infants Pain And Fever",
      "NonProprietaryName": "Acetaminophen",
      "DosageFormName": "SUSPENSION",
      "RouteName": "ORAL",
      "StartMarketingDate": "20150430",
      "EndMarketingDate": "20220722",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part343",
      "LabelerName": "Aurohealth LLC",
      "SubstanceName": "ACETAMINOPHEN",
      "StrengthNumber": "160",
      "StrengthUnit": "mg/5mL",
      "Status": "Deprecated",
      "LastUpdate": "2022-07-26",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20150430",
      "EndMarketingDatePackage": "20220722",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "63402-206-28",
      "PackageDescription": "4 BLISTER PACK in 1 CARTON (63402-206-28)  / 7 TABLET in 1 BLISTER PACK (63402-206-07) ",
      "NDC11Code": "63402-0206-28",
      "ProductNDC": "63402-206",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Aptiom",
      "NonProprietaryName": "Eslicarbazepine Acetate",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20140407",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA022416",
      "LabelerName": "Sumitomo Pharma America, Inc.",
      "SubstanceName": "ESLICARBAZEPINE ACETATE",
      "StrengthNumber": "600",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2023-12-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20140407",
      "SamplePackage": "N",
      "IndicationAndUsage": "APTIOM is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.",
      "Description": "The chemical name of APTIOM (eslicarbazepine acetate) is (S)-10-Acetoxy-10,11-dihydro-5H-dibenz[b,f]azepine-5-carboxamide. APTIOM is a dibenz[b,f]azepine-5-carboxamide derivative. Its molecular formula is C17H16N2O3 and its molecular weight is 296.32. The chemical structure is:. APTIOM is a white to off-white, odorless crystalline solid. It is insoluble in hexane, very slightly soluble in aqueous solvents and soluble in organic solvents such as acetone, acetonitrile, and methanol. Each APTIOM tablet contains 200 mg, 400 mg, 600 mg or 800 mg of eslicarbazepine acetate and the following inactive ingredients: croscarmellose sodium, magnesium stearate, and povidone."
    },
    {
      "NDCCode": "71919-206-07",
      "PackageDescription": "15 mL in 1 VIAL, GLASS (71919-206-07) ",
      "NDC11Code": "71919-0206-07",
      "ProductNDC": "71919-206",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Citrus Vulgaris",
      "NonProprietaryName": "Citrus Aurantium Fruit Rind",
      "DosageFormName": "LIQUID",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100322",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Washington Homeopathic Products",
      "SubstanceName": "CITRUS AURANTIUM FRUIT RIND",
      "StrengthNumber": "30",
      "StrengthUnit": "[hp_C]/mL",
      "Status": "Deprecated",
      "LastUpdate": "2022-03-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20100322",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "87063-206-07",
      "PackageDescription": "7 TABLET in 1 BOTTLE (87063-206-07) ",
      "NDC11Code": "87063-0206-07",
      "ProductNDC": "87063-206",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Fluconazole",
      "NonProprietaryName": "Fluconazole",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20081007",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077731",
      "LabelerName": "ASCLEMED USA INC.",
      "SubstanceName": "FLUCONAZOLE",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-05-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260513",
      "SamplePackage": "N",
      "IndicationAndUsage": "Fluconazole tablets are indicated for the treatment of: 1 Vaginal candidiasis (vaginal yeast infections due to Candida). , 2 Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candidainfections including candidemia, disseminated candidiasis, and pneumonia. , 3 Cryptococcal meningitis. Before prescribing fluconazole tablets for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIESsection. Studies comparing fluconazole tablets to amphotericin B in non-HIV infected patients have not been conducted. .",
      "Description": "Fluconazole, the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration. Fluconazole is designated chemically as 2,4-difluoro-α,α 1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an empirical formula of C 13H 12F 2N 6O and molecular weight of 306.3. The structural formula is:. Fluconazole USP is a white crystalline solid which is slightly soluble in water and saline. Fluconazole tablets USP contain 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole USP and the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, povidone, croscarmellose sodium, FD&C Red No. 40 aluminum lake dye, and magnesium stearate. Meets USP Dissolution Test 2."
    },
    {
      "NDCCode": "59088-083-00",
      "PackageDescription": "1 KIT in 1 PACKAGE (59088-083-00)  *  9 BLISTER PACK in 1 CARTON (55111-292-09)  / 9 TABLET in 1 BLISTER PACK *  85 g in 1 BOTTLE, WITH APPLICATOR (59088-283-07) ",
      "NDC11Code": "59088-0083-00",
      "ProductNDC": "59088-083",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Migranow",
      "NonProprietaryName": "Sumatriptan Succinate, Camphor, Menthol",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20160418",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "PureTek Corporation",
      "Status": "Active",
      "LastUpdate": "2024-12-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20160418",
      "SamplePackage": "N",
      "IndicationAndUsage": "Sumatriptan tablets are indicated for the acute treatment of migraine attacks with or without aura in adults. Sumatriptan tablets are not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine (see CONTRAINDICATIONS). Safety and effectiveness of sumatriptan tablets have not been established for cluster headache, which is present in an older, predominantly male population.",
      "Description": "Sumatriptan tablets USP contain sumatriptan (as the succinate), a selective 5-hydroxytryptamine 1 receptor subtype agonist. Sumatriptan succinate USP is chemically designated as 3-[2- (dimethylamino) ethyl]-N-methyl-indole-5-methanesulfonamide succinate (1:1), and it has the following structure:. The molecular formula is C 14H 21N 3O 2SC 4H 6O 4, representing a molecular weight of 413.5. Sumatriptan succinate USP is a white to off-white powder that is readily soluble in water and in saline. Each sumatriptan tablet USP for oral administration contains 35, 70, or 140 mg of sumatriptan succinate USP equivalent to 25, 50, or 100 mg of sumatriptan, respectively. Each tablet also contains the inactive ingredients croscarmellose sodium, lactose anhydrous, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, talc, titanium dioxide and triacetin."
    },
    {
      "NDCCode": "59088-202-07",
      "PackageDescription": "85 g in 1 TUBE (59088-202-07) ",
      "NDC11Code": "59088-0202-07",
      "ProductNDC": "59088-202",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Menticam",
      "NonProprietaryName": "Camphor,menthol, Methyl Salicylate",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20231026",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M017",
      "LabelerName": "PureTek Corporation",
      "SubstanceName": "CAMPHOR (SYNTHETIC); MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE",
      "StrengthNumber": "4; 7.5; 10",
      "StrengthUnit": "g/85g; g/85g; g/85g",
      "Status": "Active",
      "LastUpdate": "2024-10-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20231026",
      "SamplePackage": "N",
      "IndicationAndUsage": "For the temporary relief of minor aches and pains of muscles and joints associated with: 1 simple bachache, 2 arthritis, 3 strains, 4 bruises, 5 sprains."
    },
    {
      "NDCCode": "59088-203-07",
      "PackageDescription": "100 g in 1 TUBE (59088-203-07) ",
      "NDC11Code": "59088-0203-07",
      "ProductNDC": "59088-203",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Menticam",
      "NonProprietaryName": "Camphor, Menthol, Methyl Salicylate",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20231026",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M017",
      "LabelerName": "PureTek Corporation",
      "SubstanceName": "MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE; CAMPHOR (SYNTHETIC)",
      "StrengthNumber": "10; 30; 4",
      "StrengthUnit": "g/100g; g/100g; g/100g",
      "Status": "Active",
      "LastUpdate": "2024-10-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20231026",
      "SamplePackage": "N",
      "IndicationAndUsage": "For the temporary relief of minor aches and pains of muscles and joints associated with: 1 simple bachache, 2 arthritis, 3 strains, 4 bruises, 5 sprains."
    },
    {
      "NDCCode": "59088-204-07",
      "PackageDescription": "85 g in 1 TUBE (59088-204-07) ",
      "NDC11Code": "59088-0204-07",
      "ProductNDC": "59088-204",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lidotral 5% Gel",
      "NonProprietaryName": "Lidocaine Hcl",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20240725",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Puretek Corporation",
      "SubstanceName": "LIDOCAINE HYDROCHLORIDE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
      "Status": "Active",
      "LastUpdate": "2024-07-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240725",
      "SamplePackage": "N",
      "IndicationAndUsage": "For the temporary relief of pain.",
      "Description": "Lidotral® 5% Gel contains 50 mg of Lidocaine HCI per gram in a mild acidic vehicle with Aqua (Purified Water), Aloe Barbadensis (Aloe Vera) Leaf Juice, Caprylyl Glycol, Carbomer, Chlorphenesin, Cucumis Sativus (Cucumber) Fruit Extract, Dimethicone, Glycerin, Phenoxyethanol, Propanediol, Propylene Glycol, Sodium Hydroxide. Lidocaine HCl is chemically designated as acetamide, 2-(diethylamino)-N-(2,6 dimethylphenyl), and has the following structure."
    },
    {
      "NDCCode": "59088-207-07",
      "PackageDescription": "85 g in 1 TUBE (59088-207-07) ",
      "NDC11Code": "59088-0207-07",
      "ProductNDC": "59088-207",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Lasolex Ag",
      "NonProprietaryName": "Miconazole Nitrate",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20251203",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M005",
      "LabelerName": "Puretek Corporation",
      "SubstanceName": "MICONAZOLE NITRATE",
      "StrengthNumber": "2",
      "StrengthUnit": "g/100g",
      "Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
      "Status": "Active",
      "LastUpdate": "2026-01-02",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20251203",
      "SamplePackage": "N",
      "IndicationAndUsage": "For the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis). For relief of itching, scaling, cracking, burning, redness, soreness, irritation, discomfort."
    },
    {
      "NDCCode": "59088-212-07",
      "PackageDescription": "85 g in 1 TUBE (59088-212-07) ",
      "NDC11Code": "59088-0212-07",
      "ProductNDC": "59088-212",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Exemax Cream",
      "NonProprietaryName": "Dimethicone, Allantoin",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20250702",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M016",
      "LabelerName": "PureTek Corporation",
      "SubstanceName": "ALLANTOIN; DIMETHICONE",
      "StrengthNumber": "2; 5",
      "StrengthUnit": "g/100g; g/100g",
      "Pharm_Classes": "Skin Barrier Activity [PE]",
      "Status": "Active",
      "LastUpdate": "2025-07-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250702",
      "SamplePackage": "N",
      "IndicationAndUsage": "● temporarily protects and helps relieve chapped or cracked skin ● helps protect from the drying effects of wind and cold weather.",
      "Description": "Drug Facts."
    },
    {
      "NDCCode": "59088-221-07",
      "PackageDescription": "85 g in 1 TUBE (59088-221-07) ",
      "NDC11Code": "59088-0221-07",
      "ProductNDC": "59088-221",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Lidoease 2%",
      "NonProprietaryName": "Lidocaine Hcl 2%",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20250806",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M017",
      "LabelerName": "PureTek Corporation",
      "SubstanceName": "LIDOCAINE HYDROCHLORIDE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
      "Status": "Active",
      "LastUpdate": "2026-04-17",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20250806",
      "SamplePackage": "N",
      "IndicationAndUsage": "For the temporarily relief of pain and itching associated with: ■ minor burns ■ sunburn ■ minor cuts ■ scrapes ■ insect bites ■ minor skin irritations."
    },
    {
      "NDCCode": "59088-239-07",
      "PackageDescription": "85 g in 1 TUBE (59088-239-07) ",
      "NDC11Code": "59088-0239-07",
      "ProductNDC": "59088-239",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Lasolex Ac",
      "NonProprietaryName": "Miconazole Nitrate 2% Antifungal",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20260603",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M005",
      "LabelerName": "PureTek Corporation",
      "SubstanceName": "MICONAZOLE NITRATE",
      "StrengthNumber": "2",
      "StrengthUnit": "g/100g",
      "Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
      "Status": "Active",
      "LastUpdate": "2026-06-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260603",
      "SamplePackage": "N",
      "IndicationAndUsage": "For the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis). For relief of itching, scaling, cracking, burning, redness, soreness, irritation, discomfort, chafing associated with jock itch, itchy, scaly skin between the toes, or itching, burning feet."
    },
    {
      "NDCCode": "59088-241-07",
      "PackageDescription": "85 g in 1 TUBE (59088-241-07) ",
      "NDC11Code": "59088-0241-07",
      "ProductNDC": "59088-241",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Lidocaine 3%",
      "NonProprietaryName": "Lidocaine Hcl 3%",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20250812",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M017",
      "LabelerName": "PureTek Corporation",
      "SubstanceName": "LIDOCAINE HYDROCHLORIDE",
      "StrengthNumber": "30",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
      "Status": "Active",
      "LastUpdate": "2025-08-14",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250812",
      "SamplePackage": "N",
      "IndicationAndUsage": "For the temporarily relief of pain and itching associated with: minor burns sunburn minor cuts scrapes insect bites minor skin irritations rashes due to poison ivy, poison oak, or poison sumac."
    },
    {
      "NDCCode": "59088-244-07",
      "PackageDescription": "85 g in 1 BOTTLE (59088-244-07) ",
      "NDC11Code": "59088-0244-07",
      "ProductNDC": "59088-244",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Cvs Feminine Intimate Powder",
      "NonProprietaryName": "Miconazole Nitrate",
      "DosageFormName": "POWDER",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20190531",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part333C",
      "LabelerName": "PureTek Corporation",
      "SubstanceName": "MICONAZOLE NITRATE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20190531",
      "SamplePackage": "N",
      "IndicationAndUsage": "for the treatment and relief of external genital itching. relieves itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with external genital itching."
    },
    {
      "NDCCode": "59088-247-07",
      "PackageDescription": "85 g in 1 TUBE (59088-247-07) ",
      "NDC11Code": "59088-0247-07",
      "ProductNDC": "59088-247",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lidocaine 5% Gel",
      "NonProprietaryName": "Lidocaine Hcl 5%",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20250919",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Puretek Corporation",
      "SubstanceName": "LIDOCAINE HYDROCHLORIDE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
      "Status": "Active",
      "LastUpdate": "2025-09-24",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250919",
      "SamplePackage": "N",
      "IndicationAndUsage": "For the temporary relief of pain.",
      "Description": "Lidocaine 5% Gel contains 50 mg of Lidocaine HCI per gram in a mild acidic vehicle with Aqua (Purified Water), Aloe Barbadensis (Aloe Vera) Leaf Juice, Caprylyl Glycol, Carbomer, Chlorphenesin, Cucumis Sativus (Cucumber) Fruit Extract, Dimethicone, Glycerin, Phenoxyethanol, Propanediol, Propylene Glycol, Sodium Hydroxide. Lidocaine HCl is chemically designated as acetamide, 2-(diethylamino)-N-(2,6 dimethylphenyl), and has the following structure."
    },
    {
      "NDCCode": "59088-259-07",
      "PackageDescription": "85 g in 1 BOTTLE, WITH APPLICATOR (59088-259-07) ",
      "NDC11Code": "59088-0259-07",
      "ProductNDC": "59088-259",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Camphor 4% Plus Menthol 10%",
      "NonProprietaryName": "Camphor 4% Plus Menthol 10%",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20250820",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M017",
      "LabelerName": "PureTek Corporation",
      "SubstanceName": "MENTHOL; CAMPHOR (SYNTHETIC)",
      "StrengthNumber": "100; 40",
      "StrengthUnit": "mg/g; mg/g",
      "Status": "Active",
      "LastUpdate": "2025-08-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20250820",
      "SamplePackage": "N",
      "IndicationAndUsage": "for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains, etc."
    },
    {
      "NDCCode": "59088-283-07",
      "PackageDescription": "85 g in 1 BOTTLE, WITH APPLICATOR (59088-283-07) ",
      "NDC11Code": "59088-0283-07",
      "ProductNDC": "59088-283",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Camphotrex",
      "NonProprietaryName": "Camphor, Menthol",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20160412",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M017",
      "LabelerName": "PureTek Corporation",
      "SubstanceName": "CAMPHOR (SYNTHETIC); MENTHOL",
      "StrengthNumber": "4; 10",
      "StrengthUnit": "g/100g; g/100g",
      "Status": "Active",
      "LastUpdate": "2024-07-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20160412",
      "SamplePackage": "N",
      "IndicationAndUsage": "for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains, etc."
    },
    {
      "NDCCode": "59088-307-07",
      "PackageDescription": "85 g in 1 BOTTLE (59088-307-07) ",
      "NDC11Code": "59088-0307-07",
      "ProductNDC": "59088-307",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lidotral 3.88% Roll On",
      "NonProprietaryName": "Lidocaine Hci",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20240228",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "PureTek Corporation",
      "SubstanceName": "LIDOCAINE HYDROCHLORIDE",
      "StrengthNumber": "38.8",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
      "Status": "Active",
      "LastUpdate": "2024-03-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240228",
      "SamplePackage": "N",
      "IndicationAndUsage": "For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritation.",
      "Description": "Lidotral® 3.88% Roll on Gel contains 38.8 mg of Lidocaine HCI per gram in a mild acidic vehicle with Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis (Aloe Vera) Leaf Juice, Aminomethyl Propanol, Aqua (Purified Water), C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Cetearyl Alcohol Ceteth-20 Phosphate, Cyclopentasiloxane Dicetyl Phosphate, Dimethicone, Disodium EDTA, Ethyl Alcohol Ethylhexylglycerin, Glyceryl Stearates, Phenoxyethanol, Steareth-21. Lidocaine HCl is chemically designated as acetamide, 2-(diethylamino)-N-(2,6 dimethylphenyl), and has the following structure:."
    },
    {
      "NDCCode": "59088-317-07",
      "PackageDescription": "85 g in 1 TUBE (59088-317-07) ",
      "NDC11Code": "59088-0317-07",
      "ProductNDC": "59088-317",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lidotral 3.88 Percent Plus Hydrocortisone 1 Percent Cream",
      "NonProprietaryName": "Lidocaine Hcl, Hydrocortisone Acetate",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20240603",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "PureTek Corporation",
      "SubstanceName": "LIDOCAINE HYDROCHLORIDE; HYDROCORTISONE ACETATE",
      "StrengthNumber": "38.8; 10",
      "StrengthUnit": "mg/g; mg/g",
      "Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Local Anesthesia [PE]",
      "Status": "Active",
      "LastUpdate": "2024-06-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240603",
      "SamplePackage": "N",
      "IndicationAndUsage": "For the temporary relief of pain and itching associated with minor burns, sunburns or minor skin irritations or hemorrhoids and itching associated with inflammation, and rashes due to eczema.",
      "Description": "Lidocaine HCl is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), and has the following structure. Hydrocortisone acetate has a chemical name pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β)-, It has the following structural formula."
    },
    {
      "NDCCode": "59088-319-07",
      "PackageDescription": "85 g in 1 TUBE (59088-319-07) ",
      "NDC11Code": "59088-0319-07",
      "ProductNDC": "59088-319",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lidotral 5 Percent And Hydrocortisone 1 Percent With Peptides And Arnica",
      "NonProprietaryName": "Lidocaine Hcl 5 % , Hydrocortisone Acetate 1%",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20240315",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "PureTek Corporation",
      "SubstanceName": "LIDOCAINE HYDROCHLORIDE; HYDROCORTISONE ACETATE",
      "StrengthNumber": "50; 10",
      "StrengthUnit": "mg/g; mg/g",
      "Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Local Anesthesia [PE]",
      "Status": "Active",
      "LastUpdate": "2024-03-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240315",
      "SamplePackage": "N",
      "IndicationAndUsage": "The product is used for the anti-inflammatory and anesthetic relief of redness, pain, itching, and discoloration due to inflammation and skin burns. For the relief of redness, pain, itching, discoloration, inflammation and mild skin burns associated with radiation. For use after radiation treatment, cosmetic procedures, sun exposure, and for inflammatory skin conditions.",
      "Description": "Lidocaine HCl is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), and has the following structure. Hydrocortisone acetate has a chemical name pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β)-, It has the following structural formula. Lidotral 5% + Hydrocortisone 1% Cream with Peptides & Arnica Each gram contains Lidocaine HCl 50 mg, Hydrocortisone Acetate 10 mg. ACTIVE INGREDIENTS: Lidocaine HCl 5% Hydrocortisone Acetate 1%."
    },
    {
      "NDCCode": "59088-321-07",
      "PackageDescription": "85 g in 1 TUBE (59088-321-07) ",
      "NDC11Code": "59088-0321-07",
      "ProductNDC": "59088-321",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Neurozyl",
      "NonProprietaryName": "Lidocaine Hcl 4.12 %",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20240613",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "PureTek Corporation",
      "SubstanceName": "LIDOCAINE HYDROCHLORIDE",
      "StrengthNumber": "41.2",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
      "Status": "Active",
      "LastUpdate": "2024-06-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240613",
      "SamplePackage": "N",
      "IndicationAndUsage": "Neurozyl Cream is indicated for the temporary relief of pain.",
      "Description": "Neurozyl Cream contains 41.2 mg of Lidocaine HCI per gram in a mild acidic vehicle with Aloe Barbadensis (Aloe Vera) Leaf Juice, Aqua (Purified Water), Arnica Montana Flower Extract, Bis (tripeptide-1) Copper Acetate, Calcium Acetate, Ceteareth-20, Cetearyl Alcohol, Curcuma Longa (Turmeric) Root Extract, Ethylhexylglycerin, Glycerin, Mineral Oil, Oat Straw (Avena Sativa) Powder, Passiflora Incarnata Fruit Extract, Petrolatum, Phenoxyethanol, Propylene Glycol, Salix Alba (Willow) Bark Extract, Scutellaria Baicalensis (Chinese Skullcap) Root Extract, Sodium Phosphate. Lidocaine HCl is chemically designated as acetamide, 2-(diethylamino)-N-(2,6 dimethylphenyl), and has the following structure:."
    },
    {
      "NDCCode": "59088-326-07",
      "PackageDescription": "85 g in 1 TUBE (59088-326-07) ",
      "NDC11Code": "59088-0326-07",
      "ProductNDC": "59088-326",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Scartrate Cream",
      "NonProprietaryName": "Dimethicone, Allantoin",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20240718",
      "EndMarketingDate": "20260228",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Puretek Corporation",
      "SubstanceName": "ALLANTOIN; DIMETHICONE",
      "StrengthNumber": "22.5; 50",
      "StrengthUnit": "mg/g; mg/g",
      "Pharm_Classes": "Skin Barrier Activity [PE]",
      "Status": "Deprecated",
      "LastUpdate": "2026-03-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20240718",
      "EndMarketingDatePackage": "20260228",
      "SamplePackage": "N",
      "IndicationAndUsage": "Scartrate Cream is indicated for temporary protection and relief of chapped or cracked skin, it also effectively reduces the overall appearance of scars.",
      "Description": "Scartrate Cream contains 50 mg of Dimethicone and 22.5 mg of Allantoin per gram in a vehicle consisting of Aleurites Moluccana (Kukui) Seed Oil, Aloe Barbadensis Leaf (Aloe Vera) Juice, Aqua (Purified Water), Butylene Glycol, Carthamus Tinctorius (Safflower) Oil, Cetyl Alcohol, Dimethicone Crosspolymer, Disodium EDTA, DL-alpha Tocopheryl Acetate, GenRx® Complex (proprietary blend), Glycerin, Glyceryl Stearate, PEG-100 Stearate, Phenoxyethanol, sh-Polypeptide-121, Sodium Hydroxide, Stearic Acid, and Fragrance."
    },
    {
      "NDCCode": "59088-327-07",
      "PackageDescription": "85 g in 1 BOTTLE, WITH APPLICATOR (59088-327-07) ",
      "NDC11Code": "59088-0327-07",
      "ProductNDC": "59088-327",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Lidotral 5 Percent Roll On Gel",
      "NonProprietaryName": "Lidocaine Hydrochloride",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20240802",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "Puretek Corporation",
      "SubstanceName": "LIDOCAINE HYDROCHLORIDE",
      "StrengthNumber": "50",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
      "Status": "Active",
      "LastUpdate": "2024-08-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20240802",
      "SamplePackage": "N",
      "IndicationAndUsage": "For the temporary relief of pain.",
      "Description": "Lidotral® 5% Roll on Gel contains 50 mg of Lidocaine HCI per gram in a mild acidic vehicle with Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis (Aloe Vera) Leaf Juice, Aminomethyl Propanol, Aqua (Purified Water), Arnica Montana (Arnica) Flower Extract, Benzyl Alcohol, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Cetearyl Alcohol, Ceteth-20 Phosphate, Cyclopentasiloxane, Dicetyl Phosphate, Dimethicone, Disodium EDTA, Ethyl Alcohol, Glycerin, Glyceryl Stearate, Steareth-21. Lidocaine HCl is chemically designated as acetamide, 2-(diethylamino)-N-(2,6 dimethylphenyl), and has the following structure."
    },
    {
      "NDCCode": "59088-329-07",
      "PackageDescription": "85 g in 1 BOTTLE (59088-329-07) ",
      "NDC11Code": "59088-0329-07",
      "ProductNDC": "59088-329",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Penetral Roll-on",
      "NonProprietaryName": "Capsaicin 0.025%",
      "DosageFormName": "GEL",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20260714",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M017",
      "LabelerName": "PureTek Corporation",
      "SubstanceName": "CAPSICUM OLEORESIN",
      "StrengthNumber": ".25",
      "StrengthUnit": "mg/g",
      "Status": "Active",
      "LastUpdate": "2026-07-16",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260714",
      "SamplePackage": "N",
      "IndicationAndUsage": "For the temporary relief of minor aches and pains of muscles and joints associated with: ■ simple backache ■ arthritis ■ strains ■ bruises, and sprains. ■ Provides warming pain relief."
    },
    {
      "NDCCode": "59088-371-07",
      "PackageDescription": "1 TUBE in 1 CARTON (59088-371-07)  > 85 g in 1 TUBE",
      "NDC11Code": "59088-0371-07",
      "ProductNDC": "59088-371",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Dermacinrx Lidotral",
      "NonProprietaryName": "Lidocaine Hydrochloride",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20151203",
      "MarketingCategoryName": "UNAPPROVED DRUG OTHER",
      "LabelerName": "PureTek Corporation",
      "SubstanceName": "LIDOCAINE HYDROCHLORIDE",
      "StrengthNumber": "38.8",
      "StrengthUnit": "mg/g",
      "Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
      "Status": "Active",
      "LastUpdate": "2019-02-06",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20151203",
      "SamplePackage": "N",
      "IndicationAndUsage": "For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritation.",
      "Description": "Lidotral (Lidocaine HCl) 3.88% Cream contains Lidocaine HCl 3.88% in a mild acidic vehicle. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), and has the following structure. Ingredients: Each gram of Lidotral 3.88% Cream contains Lidocaine HCl USP 38.8 mg. Inactive Ingredients include: Calcium Acetate, Ceteareth 20, Cetearyl Alcohol, Glycerin, Methylparaben, Mineral Oil, Petrolatum, Propylene Glycol, Propylparaben, Purified Water, Sodium Phosphate Monobasic."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"59088-206-07","ProprietaryName":"Fungizyl Ac","NonProprietaryName":"Dimethyl Sulfoxide 2%, Miconazole Nitrate 2%"},{"NDCCode":"31260-206-07","NonProprietaryName":"Aluminum Zirconium Trichlorohydrex Gly"},{"NDCCode":"45334-206-07","ProprietaryName":"Vanicream","NonProprietaryName":"Pyrithione Zinc"},{"NDCCode":"51167-106-02","ProprietaryName":"Trikafta","NonProprietaryName":"Elexacaftor, Tezacaftor, And Ivacaftor"},{"NDCCode":"55910-206-07","ProprietaryName":"Mucus Fast Max Day Cold And Flu And Night Cold And Flu","NonProprietaryName":"Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl, Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl, Triprolidine Hcl"},{"NDCCode":"58602-206-07","ProprietaryName":"Aurophen Infants Pain And Fever","NonProprietaryName":"Acetaminophen"},{"NDCCode":"63402-206-28","ProprietaryName":"Aptiom","NonProprietaryName":"Eslicarbazepine Acetate"},{"NDCCode":"71919-206-07","ProprietaryName":"Citrus Vulgaris","NonProprietaryName":"Citrus Aurantium Fruit Rind"},{"NDCCode":"87063-206-07","ProprietaryName":"Fluconazole","NonProprietaryName":"Fluconazole"},{"NDCCode":"59088-083-00","ProprietaryName":"Migranow","NonProprietaryName":"Sumatriptan Succinate, Camphor, Menthol"},{"NDCCode":"59088-202-07","ProprietaryName":"Menticam","NonProprietaryName":"Camphor,menthol, Methyl Salicylate"},{"NDCCode":"59088-203-07","ProprietaryName":"Menticam","NonProprietaryName":"Camphor, Menthol, Methyl Salicylate"},{"NDCCode":"59088-204-07","ProprietaryName":"Lidotral 5% Gel","NonProprietaryName":"Lidocaine Hcl"},{"NDCCode":"59088-207-07","ProprietaryName":"Lasolex Ag","NonProprietaryName":"Miconazole Nitrate"},{"NDCCode":"59088-212-07","ProprietaryName":"Exemax Cream","NonProprietaryName":"Dimethicone, Allantoin"},{"NDCCode":"59088-221-07","ProprietaryName":"Lidoease 2%","NonProprietaryName":"Lidocaine Hcl 2%"},{"NDCCode":"59088-239-07","ProprietaryName":"Lasolex Ac","NonProprietaryName":"Miconazole Nitrate 2% Antifungal"},{"NDCCode":"59088-241-07","ProprietaryName":"Lidocaine 3%","NonProprietaryName":"Lidocaine Hcl 3%"},{"NDCCode":"59088-244-07","ProprietaryName":"Cvs Feminine Intimate Powder","NonProprietaryName":"Miconazole Nitrate"},{"NDCCode":"59088-247-07","ProprietaryName":"Lidocaine 5% Gel","NonProprietaryName":"Lidocaine Hcl 5%"},{"NDCCode":"59088-259-07","ProprietaryName":"Camphor 4% Plus Menthol 10%","NonProprietaryName":"Camphor 4% Plus Menthol 10%"},{"NDCCode":"59088-283-07","ProprietaryName":"Camphotrex","NonProprietaryName":"Camphor, Menthol"},{"NDCCode":"59088-307-07","ProprietaryName":"Lidotral 3.88% Roll On","NonProprietaryName":"Lidocaine Hci"},{"NDCCode":"59088-317-07","ProprietaryName":"Lidotral 3.88 Percent Plus Hydrocortisone 1 Percent Cream","NonProprietaryName":"Lidocaine Hcl, Hydrocortisone Acetate"},{"NDCCode":"59088-319-07","ProprietaryName":"Lidotral 5 Percent And Hydrocortisone 1 Percent With Peptides And Arnica","NonProprietaryName":"Lidocaine Hcl 5 % , Hydrocortisone Acetate 1%"},{"NDCCode":"59088-321-07","ProprietaryName":"Neurozyl","NonProprietaryName":"Lidocaine Hcl 4.12 %"},{"NDCCode":"59088-326-07","ProprietaryName":"Scartrate Cream","NonProprietaryName":"Dimethicone, Allantoin"},{"NDCCode":"59088-327-07","ProprietaryName":"Lidotral 5 Percent Roll On Gel","NonProprietaryName":"Lidocaine Hydrochloride"},{"NDCCode":"59088-329-07","ProprietaryName":"Penetral Roll-on","NonProprietaryName":"Capsaicin 0.025%"},{"NDCCode":"59088-371-07","ProprietaryName":"Dermacinrx Lidotral","NonProprietaryName":"Lidocaine Hydrochloride"}]}
                    

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<NDCList>
  <NDC>
    <NDCCode>59088-206-07</NDCCode>
    <PackageDescription>85 g in 1 TUBE (59088-206-07) </PackageDescription>
    <NDC11Code>59088-0206-07</NDC11Code>
    <ProductNDC>59088-206</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fungizyl Ac</ProprietaryName>
    <NonProprietaryName>Dimethyl Sulfoxide 2%, Miconazole Nitrate 2%</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20241204</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Puretek Corporation</LabelerName>
    <SubstanceName>DIMETHYL SULFOXIDE; MICONAZOLE NITRATE</SubstanceName>
    <StrengthNumber>20; 20</StrengthNumber>
    <StrengthUnit>mg/g; mg/g</StrengthUnit>
    <Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-04-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241204</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fungizyl AC is indicated for the treatment of fungal infections of the skin, including athlete's foot, jock itch, and ringworm. It also helps with superficial skin infections caused by Candida species. Dimethyl Sulfoxide (DMSO) enhances the penetration of Miconazole Nitrate through the skin, improving antifungal effectiveness.</IndicationAndUsage>
    <Description>Fungizyl AC is a topical antifungal formulation that combines Dimethyl Sulfoxide (DMSO) and Miconazole Nitrate with a mixture of emollients and essential oils. The formulation is designed to provide effective antifungal activity while also soothing and moisturizing the skin. Each gram of Fungizyl AC contains 20 mg of Dimethyl Sulfoxide and 20 mg of Miconazole Nitrate in a vehicle with Aleurites Moluccana (Kukui) Seed Oil, Aqua (Purified Water), Butylene Glycol, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Seed Oil, Cety Alcohol, Cetyl Phosphate, Chlorphenesin, Dimethicone, Dimethicone Crosspolymer, Disodium EDTA, DL-Alpha-Tocopheryl Acetate, GenRx® Complex (Proprietary Blend), Glycerin, Glyceryl Stearate, PEG-100 Stearate, Pentylene Glycol, Phenoxyethanol, Sodium Hydroxide, and Stearyl Alcohol.</Description>
  </NDC>
  <NDC>
    <NDCCode>31260-206-07</NDCCode>
    <PackageDescription>1000 kg in 1 SUPERSACK (31260-206-07) </PackageDescription>
    <NDC11Code>31260-0206-07</NDC11Code>
    <ProductNDC>31260-206</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Aluminum Zirconium Trichlorohydrex Gly</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20060101</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Gulbrandsen Technologies India Private Limited</LabelerName>
    <SubstanceName>ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>kg/kg</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2014-02-04</LastUpdate>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>01-JAN-06</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>45334-206-07</NDCCode>
    <PackageDescription>7.4 mL in 1 TUBE (45334-206-07) </PackageDescription>
    <NDC11Code>45334-0206-07</NDC11Code>
    <ProductNDC>45334-206</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Vanicream</ProprietaryName>
    <NonProprietaryName>Pyrithione Zinc</NonProprietaryName>
    <DosageFormName>SHAMPOO</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20220103</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M032</ApplicationNumber>
    <LabelerName>Pharmaceutical Specialties, Inc.</LabelerName>
    <SubstanceName>PYRITHIONE ZINC</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>g/100mL</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-12-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220103</StartMarketingDatePackage>
    <SamplePackage>Y</SamplePackage>
    <IndicationAndUsage>Uses. Controls and reduces the symptoms of dandruff and seborrheic dermatitis.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>51167-106-02</NDCCode>
    <PackageDescription>4 BLISTER PACK in 1 CARTON (51167-106-02)  / 1 KIT in 1 BLISTER PACK *  14 TABLET, FILM COATED in 1 BLISTER PACK (51167-206-14)  *  7 TABLET, FILM COATED in 1 BLISTER PACK (51167-306-07) </PackageDescription>
    <NDC11Code>51167-0106-02</NDC11Code>
    <ProductNDC>51167-106</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Trikafta</ProprietaryName>
    <NonProprietaryName>Elexacaftor, Tezacaftor, And Ivacaftor</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20210608</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA212273</ApplicationNumber>
    <LabelerName>Vertex Pharmaceuticals Incorporated</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2026-06-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210608</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>TRIKAFTA is indicated for the treatment of cystic fibrosis (CF) in adult and pediatric patients aged 2 years and older who have a clinical diagnosis of CF and who have at least one variant in the cystic fibrosis transmembrane conductance regulator (CFTR) gene that is either responsive based on clinical and/or in vitro data (see Table 6) or results in production of CFTR protein [see Clinical Pharmacology (12.1)]. If the patient's genotype is unknown, an FDA-cleared CF genetic test should be used to confirm the presence of at least one variant in the CFTR gene that is either responsive based on clinical and/or in vitro data or results in production of CFTR protein.</IndicationAndUsage>
    <Description>TRIKAFTA is a co-package of elexacaftor, tezacaftor and ivacaftor fixed-dose combination tablets or granules and ivacaftor tablets or granules. Both tablets and granules are for oral administration. The elexacaftor, tezacaftor and ivacaftor fixed-dose combination tablets are available as: orange, oblong-shaped, film-coated tablet containing 100 mg of elexacaftor, 50 mg of tezacaftor, 75 mg of ivacaftor, or light orange, oblong-shaped, film-coated tablet containing 50 mg of elexacaftor, 25 mg of tezacaftor, 37.5 mg of ivacaftor. The fixed-dose combination tablet contains the following inactive ingredients: croscarmellose sodium, hypromellose, hypromellose acetate succinate, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. The tablet film coat contains hydroxypropyl cellulose, hypromellose, iron oxide red, iron oxide yellow, talc, and titanium dioxide. The ivacaftor tablet is available as a light blue, oblong-shaped, film-coated tablet containing 150 mg or 75 mg of ivacaftor and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose acetate succinate, lactose monohydrate, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. The tablet film coat contains carnauba wax, FD&amp;C Blue #2, PEG 3350, polyvinyl alcohol, talc, and titanium dioxide. The printing ink contains ammonium hydroxide, iron oxide black, propylene glycol, and shellac. The elexacaftor, tezacaftor and ivacaftor fixed-dose combination oral granules are white to off-white, sweetened, unflavored granules approximately 2 mm in diameter enclosed in unit-dose packets. Each unit-dose packet contains 100 mg of elexacaftor, 50 mg of tezacaftor, 75 mg of ivacaftor or 80 mg of elexacaftor, 40 mg of tezacaftor, 60 mg of ivacaftor and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, hypromellose acetate succinate, lactose monohydrate, magnesium stearate, mannitol, sodium lauryl sulfate, and sucralose. The ivacaftor oral granules are white to off-white, sweetened, unflavored granules approximately 2 mm in diameter enclosed in unit-dose packets. Each unit-dose packet contains 75 mg or 59.5 mg of ivacaftor and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose acetate succinate, lactose monohydrate, magnesium stearate, mannitol, sodium lauryl sulfate, and sucralose. The active ingredients of TRIKAFTA are described below.</Description>
  </NDC>
  <NDC>
    <NDCCode>55910-206-07</NDCCode>
    <PackageDescription>1 BLISTER PACK in 1 CARTON (55910-206-07)  / 1 KIT in 1 BLISTER PACK *  6 TABLET, COATED in 1 BLISTER PACK *  4 TABLET, COATED in 1 BLISTER PACK</PackageDescription>
    <NDC11Code>55910-0206-07</NDC11Code>
    <ProductNDC>55910-206</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Mucus Fast Max Day Cold And Flu And Night Cold And Flu</ProprietaryName>
    <NonProprietaryName>Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl, Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl, Triprolidine Hcl</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20241223</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part341</ApplicationNumber>
    <LabelerName>DOLGENCORP, INC.</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2026-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20241223</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>temporarily relieves these common cold and flu symptoms: coughnasal congestionminor aches and painssore throatheadachestuffy nosesinus congestion and pressure. temporarily reduces fever. helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>58602-206-07</NDCCode>
    <PackageDescription>1 BOTTLE in 1 CARTON (58602-206-07)  &gt; 30 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>58602-0206-07</NDC11Code>
    <ProductNDC>58602-206</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Aurophen Infants Pain And Fever</ProprietaryName>
    <NonProprietaryName>Acetaminophen</NonProprietaryName>
    <DosageFormName>SUSPENSION</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20150430</StartMarketingDate>
    <EndMarketingDate>20220722</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part343</ApplicationNumber>
    <LabelerName>Aurohealth LLC</LabelerName>
    <SubstanceName>ACETAMINOPHEN</SubstanceName>
    <StrengthNumber>160</StrengthNumber>
    <StrengthUnit>mg/5mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-07-26</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20150430</StartMarketingDatePackage>
    <EndMarketingDatePackage>20220722</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>63402-206-28</NDCCode>
    <PackageDescription>4 BLISTER PACK in 1 CARTON (63402-206-28)  / 7 TABLET in 1 BLISTER PACK (63402-206-07) </PackageDescription>
    <NDC11Code>63402-0206-28</NDC11Code>
    <ProductNDC>63402-206</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Aptiom</ProprietaryName>
    <NonProprietaryName>Eslicarbazepine Acetate</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20140407</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA022416</ApplicationNumber>
    <LabelerName>Sumitomo Pharma America, Inc.</LabelerName>
    <SubstanceName>ESLICARBAZEPINE ACETATE</SubstanceName>
    <StrengthNumber>600</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2023-12-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20140407</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>APTIOM is indicated for the treatment of partial-onset seizures in patients 4 years of age and older.</IndicationAndUsage>
    <Description>The chemical name of APTIOM (eslicarbazepine acetate) is (S)-10-Acetoxy-10,11-dihydro-5H-dibenz[b,f]azepine-5-carboxamide. APTIOM is a dibenz[b,f]azepine-5-carboxamide derivative. Its molecular formula is C17H16N2O3 and its molecular weight is 296.32. The chemical structure is:. APTIOM is a white to off-white, odorless crystalline solid. It is insoluble in hexane, very slightly soluble in aqueous solvents and soluble in organic solvents such as acetone, acetonitrile, and methanol. Each APTIOM tablet contains 200 mg, 400 mg, 600 mg or 800 mg of eslicarbazepine acetate and the following inactive ingredients: croscarmellose sodium, magnesium stearate, and povidone.</Description>
  </NDC>
  <NDC>
    <NDCCode>71919-206-07</NDCCode>
    <PackageDescription>15 mL in 1 VIAL, GLASS (71919-206-07) </PackageDescription>
    <NDC11Code>71919-0206-07</NDC11Code>
    <ProductNDC>71919-206</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Citrus Vulgaris</ProprietaryName>
    <NonProprietaryName>Citrus Aurantium Fruit Rind</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100322</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Washington Homeopathic Products</LabelerName>
    <SubstanceName>CITRUS AURANTIUM FRUIT RIND</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>[hp_C]/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-03-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20100322</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>87063-206-07</NDCCode>
    <PackageDescription>7 TABLET in 1 BOTTLE (87063-206-07) </PackageDescription>
    <NDC11Code>87063-0206-07</NDC11Code>
    <ProductNDC>87063-206</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Fluconazole</ProprietaryName>
    <NonProprietaryName>Fluconazole</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20081007</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077731</ApplicationNumber>
    <LabelerName>ASCLEMED USA INC.</LabelerName>
    <SubstanceName>FLUCONAZOLE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Azole Antifungal [EPC], Azoles [CS], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-05-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260513</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Fluconazole tablets are indicated for the treatment of: 1 Vaginal candidiasis (vaginal yeast infections due to Candida). , 2 Oropharyngeal and esophageal candidiasis. In open noncomparative studies of relatively small numbers of patients, fluconazole tablets were also effective for the treatment of Candida urinary tract infections, peritonitis, and systemic Candidainfections including candidemia, disseminated candidiasis, and pneumonia. , 3 Cryptococcal meningitis. Before prescribing fluconazole tablets for AIDS patients with cryptococcal meningitis, please see CLINICAL STUDIESsection. Studies comparing fluconazole tablets to amphotericin B in non-HIV infected patients have not been conducted. .</IndicationAndUsage>
    <Description>Fluconazole, the first of a new subclass of synthetic triazole antifungal agents, is available as tablets for oral administration. Fluconazole is designated chemically as 2,4-difluoro-α,α 1-bis(1H-1,2,4-triazol-1-ylmethyl) benzyl alcohol with an empirical formula of C 13H 12F 2N 6O and molecular weight of 306.3. The structural formula is:. Fluconazole USP is a white crystalline solid which is slightly soluble in water and saline. Fluconazole tablets USP contain 50 mg, 100 mg, 150 mg, or 200 mg of fluconazole USP and the following inactive ingredients: microcrystalline cellulose, dibasic calcium phosphate anhydrous, povidone, croscarmellose sodium, FD&amp;C Red No. 40 aluminum lake dye, and magnesium stearate. Meets USP Dissolution Test 2.</Description>
  </NDC>
  <NDC>
    <NDCCode>59088-083-00</NDCCode>
    <PackageDescription>1 KIT in 1 PACKAGE (59088-083-00)  *  9 BLISTER PACK in 1 CARTON (55111-292-09)  / 9 TABLET in 1 BLISTER PACK *  85 g in 1 BOTTLE, WITH APPLICATOR (59088-283-07) </PackageDescription>
    <NDC11Code>59088-0083-00</NDC11Code>
    <ProductNDC>59088-083</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Migranow</ProprietaryName>
    <NonProprietaryName>Sumatriptan Succinate, Camphor, Menthol</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20160418</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>PureTek Corporation</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2024-12-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160418</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Sumatriptan tablets are indicated for the acute treatment of migraine attacks with or without aura in adults. Sumatriptan tablets are not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine (see CONTRAINDICATIONS). Safety and effectiveness of sumatriptan tablets have not been established for cluster headache, which is present in an older, predominantly male population.</IndicationAndUsage>
    <Description>Sumatriptan tablets USP contain sumatriptan (as the succinate), a selective 5-hydroxytryptamine 1 receptor subtype agonist. Sumatriptan succinate USP is chemically designated as 3-[2- (dimethylamino) ethyl]-N-methyl-indole-5-methanesulfonamide succinate (1:1), and it has the following structure:. The molecular formula is C 14H 21N 3O 2SC 4H 6O 4, representing a molecular weight of 413.5. Sumatriptan succinate USP is a white to off-white powder that is readily soluble in water and in saline. Each sumatriptan tablet USP for oral administration contains 35, 70, or 140 mg of sumatriptan succinate USP equivalent to 25, 50, or 100 mg of sumatriptan, respectively. Each tablet also contains the inactive ingredients croscarmellose sodium, lactose anhydrous, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, talc, titanium dioxide and triacetin.</Description>
  </NDC>
  <NDC>
    <NDCCode>59088-202-07</NDCCode>
    <PackageDescription>85 g in 1 TUBE (59088-202-07) </PackageDescription>
    <NDC11Code>59088-0202-07</NDC11Code>
    <ProductNDC>59088-202</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Menticam</ProprietaryName>
    <NonProprietaryName>Camphor,menthol, Methyl Salicylate</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20231026</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M017</ApplicationNumber>
    <LabelerName>PureTek Corporation</LabelerName>
    <SubstanceName>CAMPHOR (SYNTHETIC); MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE</SubstanceName>
    <StrengthNumber>4; 7.5; 10</StrengthNumber>
    <StrengthUnit>g/85g; g/85g; g/85g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-10-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231026</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For the temporary relief of minor aches and pains of muscles and joints associated with: 1 simple bachache, 2 arthritis, 3 strains, 4 bruises, 5 sprains.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>59088-203-07</NDCCode>
    <PackageDescription>100 g in 1 TUBE (59088-203-07) </PackageDescription>
    <NDC11Code>59088-0203-07</NDC11Code>
    <ProductNDC>59088-203</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Menticam</ProprietaryName>
    <NonProprietaryName>Camphor, Menthol, Methyl Salicylate</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20231026</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M017</ApplicationNumber>
    <LabelerName>PureTek Corporation</LabelerName>
    <SubstanceName>MENTHOL, UNSPECIFIED FORM; METHYL SALICYLATE; CAMPHOR (SYNTHETIC)</SubstanceName>
    <StrengthNumber>10; 30; 4</StrengthNumber>
    <StrengthUnit>g/100g; g/100g; g/100g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-10-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20231026</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For the temporary relief of minor aches and pains of muscles and joints associated with: 1 simple bachache, 2 arthritis, 3 strains, 4 bruises, 5 sprains.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>59088-204-07</NDCCode>
    <PackageDescription>85 g in 1 TUBE (59088-204-07) </PackageDescription>
    <NDC11Code>59088-0204-07</NDC11Code>
    <ProductNDC>59088-204</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lidotral 5% Gel</ProprietaryName>
    <NonProprietaryName>Lidocaine Hcl</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20240725</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Puretek Corporation</LabelerName>
    <SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-07-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240725</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For the temporary relief of pain.</IndicationAndUsage>
    <Description>Lidotral® 5% Gel contains 50 mg of Lidocaine HCI per gram in a mild acidic vehicle with Aqua (Purified Water), Aloe Barbadensis (Aloe Vera) Leaf Juice, Caprylyl Glycol, Carbomer, Chlorphenesin, Cucumis Sativus (Cucumber) Fruit Extract, Dimethicone, Glycerin, Phenoxyethanol, Propanediol, Propylene Glycol, Sodium Hydroxide. Lidocaine HCl is chemically designated as acetamide, 2-(diethylamino)-N-(2,6 dimethylphenyl), and has the following structure.</Description>
  </NDC>
  <NDC>
    <NDCCode>59088-207-07</NDCCode>
    <PackageDescription>85 g in 1 TUBE (59088-207-07) </PackageDescription>
    <NDC11Code>59088-0207-07</NDC11Code>
    <ProductNDC>59088-207</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lasolex Ag</ProprietaryName>
    <NonProprietaryName>Miconazole Nitrate</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20251203</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M005</ApplicationNumber>
    <LabelerName>Puretek Corporation</LabelerName>
    <SubstanceName>MICONAZOLE NITRATE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-01-02</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251203</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis). For relief of itching, scaling, cracking, burning, redness, soreness, irritation, discomfort.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>59088-212-07</NDCCode>
    <PackageDescription>85 g in 1 TUBE (59088-212-07) </PackageDescription>
    <NDC11Code>59088-0212-07</NDC11Code>
    <ProductNDC>59088-212</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Exemax Cream</ProprietaryName>
    <NonProprietaryName>Dimethicone, Allantoin</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20250702</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M016</ApplicationNumber>
    <LabelerName>PureTek Corporation</LabelerName>
    <SubstanceName>ALLANTOIN; DIMETHICONE</SubstanceName>
    <StrengthNumber>2; 5</StrengthNumber>
    <StrengthUnit>g/100g; g/100g</StrengthUnit>
    <Pharm_Classes>Skin Barrier Activity [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-07-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250702</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>● temporarily protects and helps relieve chapped or cracked skin ● helps protect from the drying effects of wind and cold weather.</IndicationAndUsage>
    <Description>Drug Facts.</Description>
  </NDC>
  <NDC>
    <NDCCode>59088-221-07</NDCCode>
    <PackageDescription>85 g in 1 TUBE (59088-221-07) </PackageDescription>
    <NDC11Code>59088-0221-07</NDC11Code>
    <ProductNDC>59088-221</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lidoease 2%</ProprietaryName>
    <NonProprietaryName>Lidocaine Hcl 2%</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20250806</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M017</ApplicationNumber>
    <LabelerName>PureTek Corporation</LabelerName>
    <SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-04-17</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250806</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For the temporarily relief of pain and itching associated with: ■ minor burns ■ sunburn ■ minor cuts ■ scrapes ■ insect bites ■ minor skin irritations.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>59088-239-07</NDCCode>
    <PackageDescription>85 g in 1 TUBE (59088-239-07) </PackageDescription>
    <NDC11Code>59088-0239-07</NDC11Code>
    <ProductNDC>59088-239</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lasolex Ac</ProprietaryName>
    <NonProprietaryName>Miconazole Nitrate 2% Antifungal</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20260603</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M005</ApplicationNumber>
    <LabelerName>PureTek Corporation</LabelerName>
    <SubstanceName>MICONAZOLE NITRATE</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-06-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260603</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For the treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis). For relief of itching, scaling, cracking, burning, redness, soreness, irritation, discomfort, chafing associated with jock itch, itchy, scaly skin between the toes, or itching, burning feet.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>59088-241-07</NDCCode>
    <PackageDescription>85 g in 1 TUBE (59088-241-07) </PackageDescription>
    <NDC11Code>59088-0241-07</NDC11Code>
    <ProductNDC>59088-241</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lidocaine 3%</ProprietaryName>
    <NonProprietaryName>Lidocaine Hcl 3%</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20250812</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M017</ApplicationNumber>
    <LabelerName>PureTek Corporation</LabelerName>
    <SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>30</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-08-14</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250812</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For the temporarily relief of pain and itching associated with: minor burns sunburn minor cuts scrapes insect bites minor skin irritations rashes due to poison ivy, poison oak, or poison sumac.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>59088-244-07</NDCCode>
    <PackageDescription>85 g in 1 BOTTLE (59088-244-07) </PackageDescription>
    <NDC11Code>59088-0244-07</NDC11Code>
    <ProductNDC>59088-244</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Cvs Feminine Intimate Powder</ProprietaryName>
    <NonProprietaryName>Miconazole Nitrate</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20190531</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part333C</ApplicationNumber>
    <LabelerName>PureTek Corporation</LabelerName>
    <SubstanceName>MICONAZOLE NITRATE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190531</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>for the treatment and relief of external genital itching. relieves itching, scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with external genital itching.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>59088-247-07</NDCCode>
    <PackageDescription>85 g in 1 TUBE (59088-247-07) </PackageDescription>
    <NDC11Code>59088-0247-07</NDC11Code>
    <ProductNDC>59088-247</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lidocaine 5% Gel</ProprietaryName>
    <NonProprietaryName>Lidocaine Hcl 5%</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20250919</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Puretek Corporation</LabelerName>
    <SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-09-24</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250919</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For the temporary relief of pain.</IndicationAndUsage>
    <Description>Lidocaine 5% Gel contains 50 mg of Lidocaine HCI per gram in a mild acidic vehicle with Aqua (Purified Water), Aloe Barbadensis (Aloe Vera) Leaf Juice, Caprylyl Glycol, Carbomer, Chlorphenesin, Cucumis Sativus (Cucumber) Fruit Extract, Dimethicone, Glycerin, Phenoxyethanol, Propanediol, Propylene Glycol, Sodium Hydroxide. Lidocaine HCl is chemically designated as acetamide, 2-(diethylamino)-N-(2,6 dimethylphenyl), and has the following structure.</Description>
  </NDC>
  <NDC>
    <NDCCode>59088-259-07</NDCCode>
    <PackageDescription>85 g in 1 BOTTLE, WITH APPLICATOR (59088-259-07) </PackageDescription>
    <NDC11Code>59088-0259-07</NDC11Code>
    <ProductNDC>59088-259</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Camphor 4% Plus Menthol 10%</ProprietaryName>
    <NonProprietaryName>Camphor 4% Plus Menthol 10%</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20250820</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M017</ApplicationNumber>
    <LabelerName>PureTek Corporation</LabelerName>
    <SubstanceName>MENTHOL; CAMPHOR (SYNTHETIC)</SubstanceName>
    <StrengthNumber>100; 40</StrengthNumber>
    <StrengthUnit>mg/g; mg/g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2025-08-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250820</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains, etc.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>59088-283-07</NDCCode>
    <PackageDescription>85 g in 1 BOTTLE, WITH APPLICATOR (59088-283-07) </PackageDescription>
    <NDC11Code>59088-0283-07</NDC11Code>
    <ProductNDC>59088-283</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Camphotrex</ProprietaryName>
    <NonProprietaryName>Camphor, Menthol</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20160412</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M017</ApplicationNumber>
    <LabelerName>PureTek Corporation</LabelerName>
    <SubstanceName>CAMPHOR (SYNTHETIC); MENTHOL</SubstanceName>
    <StrengthNumber>4; 10</StrengthNumber>
    <StrengthUnit>g/100g; g/100g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-07-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20160412</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains, etc.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>59088-307-07</NDCCode>
    <PackageDescription>85 g in 1 BOTTLE (59088-307-07) </PackageDescription>
    <NDC11Code>59088-0307-07</NDC11Code>
    <ProductNDC>59088-307</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lidotral 3.88% Roll On</ProprietaryName>
    <NonProprietaryName>Lidocaine Hci</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20240228</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>PureTek Corporation</LabelerName>
    <SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>38.8</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-03-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240228</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritation.</IndicationAndUsage>
    <Description>Lidotral® 3.88% Roll on Gel contains 38.8 mg of Lidocaine HCI per gram in a mild acidic vehicle with Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis (Aloe Vera) Leaf Juice, Aminomethyl Propanol, Aqua (Purified Water), C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Cetearyl Alcohol Ceteth-20 Phosphate, Cyclopentasiloxane Dicetyl Phosphate, Dimethicone, Disodium EDTA, Ethyl Alcohol Ethylhexylglycerin, Glyceryl Stearates, Phenoxyethanol, Steareth-21. Lidocaine HCl is chemically designated as acetamide, 2-(diethylamino)-N-(2,6 dimethylphenyl), and has the following structure:.</Description>
  </NDC>
  <NDC>
    <NDCCode>59088-317-07</NDCCode>
    <PackageDescription>85 g in 1 TUBE (59088-317-07) </PackageDescription>
    <NDC11Code>59088-0317-07</NDC11Code>
    <ProductNDC>59088-317</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lidotral 3.88 Percent Plus Hydrocortisone 1 Percent Cream</ProprietaryName>
    <NonProprietaryName>Lidocaine Hcl, Hydrocortisone Acetate</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20240603</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>PureTek Corporation</LabelerName>
    <SubstanceName>LIDOCAINE HYDROCHLORIDE; HYDROCORTISONE ACETATE</SubstanceName>
    <StrengthNumber>38.8; 10</StrengthNumber>
    <StrengthUnit>mg/g; mg/g</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Local Anesthesia [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-06-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240603</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For the temporary relief of pain and itching associated with minor burns, sunburns or minor skin irritations or hemorrhoids and itching associated with inflammation, and rashes due to eczema.</IndicationAndUsage>
    <Description>Lidocaine HCl is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), and has the following structure. Hydrocortisone acetate has a chemical name pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β)-, It has the following structural formula.</Description>
  </NDC>
  <NDC>
    <NDCCode>59088-319-07</NDCCode>
    <PackageDescription>85 g in 1 TUBE (59088-319-07) </PackageDescription>
    <NDC11Code>59088-0319-07</NDC11Code>
    <ProductNDC>59088-319</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lidotral 5 Percent And Hydrocortisone 1 Percent With Peptides And Arnica</ProprietaryName>
    <NonProprietaryName>Lidocaine Hcl 5 % , Hydrocortisone Acetate 1%</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20240315</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>PureTek Corporation</LabelerName>
    <SubstanceName>LIDOCAINE HYDROCHLORIDE; HYDROCORTISONE ACETATE</SubstanceName>
    <StrengthNumber>50; 10</StrengthNumber>
    <StrengthUnit>mg/g; mg/g</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Local Anesthesia [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-03-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240315</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>The product is used for the anti-inflammatory and anesthetic relief of redness, pain, itching, and discoloration due to inflammation and skin burns. For the relief of redness, pain, itching, discoloration, inflammation and mild skin burns associated with radiation. For use after radiation treatment, cosmetic procedures, sun exposure, and for inflammatory skin conditions.</IndicationAndUsage>
    <Description>Lidocaine HCl is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), and has the following structure. Hydrocortisone acetate has a chemical name pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β)-, It has the following structural formula. Lidotral 5% + Hydrocortisone 1% Cream with Peptides &amp; Arnica Each gram contains Lidocaine HCl 50 mg, Hydrocortisone Acetate 10 mg. ACTIVE INGREDIENTS: Lidocaine HCl 5% Hydrocortisone Acetate 1%.</Description>
  </NDC>
  <NDC>
    <NDCCode>59088-321-07</NDCCode>
    <PackageDescription>85 g in 1 TUBE (59088-321-07) </PackageDescription>
    <NDC11Code>59088-0321-07</NDC11Code>
    <ProductNDC>59088-321</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Neurozyl</ProprietaryName>
    <NonProprietaryName>Lidocaine Hcl 4.12 %</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20240613</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>PureTek Corporation</LabelerName>
    <SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>41.2</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-06-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240613</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Neurozyl Cream is indicated for the temporary relief of pain.</IndicationAndUsage>
    <Description>Neurozyl Cream contains 41.2 mg of Lidocaine HCI per gram in a mild acidic vehicle with Aloe Barbadensis (Aloe Vera) Leaf Juice, Aqua (Purified Water), Arnica Montana Flower Extract, Bis (tripeptide-1) Copper Acetate, Calcium Acetate, Ceteareth-20, Cetearyl Alcohol, Curcuma Longa (Turmeric) Root Extract, Ethylhexylglycerin, Glycerin, Mineral Oil, Oat Straw (Avena Sativa) Powder, Passiflora Incarnata Fruit Extract, Petrolatum, Phenoxyethanol, Propylene Glycol, Salix Alba (Willow) Bark Extract, Scutellaria Baicalensis (Chinese Skullcap) Root Extract, Sodium Phosphate. Lidocaine HCl is chemically designated as acetamide, 2-(diethylamino)-N-(2,6 dimethylphenyl), and has the following structure:.</Description>
  </NDC>
  <NDC>
    <NDCCode>59088-326-07</NDCCode>
    <PackageDescription>85 g in 1 TUBE (59088-326-07) </PackageDescription>
    <NDC11Code>59088-0326-07</NDC11Code>
    <ProductNDC>59088-326</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Scartrate Cream</ProprietaryName>
    <NonProprietaryName>Dimethicone, Allantoin</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20240718</StartMarketingDate>
    <EndMarketingDate>20260228</EndMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Puretek Corporation</LabelerName>
    <SubstanceName>ALLANTOIN; DIMETHICONE</SubstanceName>
    <StrengthNumber>22.5; 50</StrengthNumber>
    <StrengthUnit>mg/g; mg/g</StrengthUnit>
    <Pharm_Classes>Skin Barrier Activity [PE]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-03-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20240718</StartMarketingDatePackage>
    <EndMarketingDatePackage>20260228</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Scartrate Cream is indicated for temporary protection and relief of chapped or cracked skin, it also effectively reduces the overall appearance of scars.</IndicationAndUsage>
    <Description>Scartrate Cream contains 50 mg of Dimethicone and 22.5 mg of Allantoin per gram in a vehicle consisting of Aleurites Moluccana (Kukui) Seed Oil, Aloe Barbadensis Leaf (Aloe Vera) Juice, Aqua (Purified Water), Butylene Glycol, Carthamus Tinctorius (Safflower) Oil, Cetyl Alcohol, Dimethicone Crosspolymer, Disodium EDTA, DL-alpha Tocopheryl Acetate, GenRx® Complex (proprietary blend), Glycerin, Glyceryl Stearate, PEG-100 Stearate, Phenoxyethanol, sh-Polypeptide-121, Sodium Hydroxide, Stearic Acid, and Fragrance.</Description>
  </NDC>
  <NDC>
    <NDCCode>59088-327-07</NDCCode>
    <PackageDescription>85 g in 1 BOTTLE, WITH APPLICATOR (59088-327-07) </PackageDescription>
    <NDC11Code>59088-0327-07</NDC11Code>
    <ProductNDC>59088-327</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Lidotral 5 Percent Roll On Gel</ProprietaryName>
    <NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20240802</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>Puretek Corporation</LabelerName>
    <SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>50</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-08-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20240802</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For the temporary relief of pain.</IndicationAndUsage>
    <Description>Lidotral® 5% Roll on Gel contains 50 mg of Lidocaine HCI per gram in a mild acidic vehicle with Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis (Aloe Vera) Leaf Juice, Aminomethyl Propanol, Aqua (Purified Water), Arnica Montana (Arnica) Flower Extract, Benzyl Alcohol, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Cetearyl Alcohol, Ceteth-20 Phosphate, Cyclopentasiloxane, Dicetyl Phosphate, Dimethicone, Disodium EDTA, Ethyl Alcohol, Glycerin, Glyceryl Stearate, Steareth-21. Lidocaine HCl is chemically designated as acetamide, 2-(diethylamino)-N-(2,6 dimethylphenyl), and has the following structure.</Description>
  </NDC>
  <NDC>
    <NDCCode>59088-329-07</NDCCode>
    <PackageDescription>85 g in 1 BOTTLE (59088-329-07) </PackageDescription>
    <NDC11Code>59088-0329-07</NDC11Code>
    <ProductNDC>59088-329</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Penetral Roll-on</ProprietaryName>
    <NonProprietaryName>Capsaicin 0.025%</NonProprietaryName>
    <DosageFormName>GEL</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20260714</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M017</ApplicationNumber>
    <LabelerName>PureTek Corporation</LabelerName>
    <SubstanceName>CAPSICUM OLEORESIN</SubstanceName>
    <StrengthNumber>.25</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-07-16</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260714</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For the temporary relief of minor aches and pains of muscles and joints associated with: ■ simple backache ■ arthritis ■ strains ■ bruises, and sprains. ■ Provides warming pain relief.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>59088-371-07</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (59088-371-07)  &gt; 85 g in 1 TUBE</PackageDescription>
    <NDC11Code>59088-0371-07</NDC11Code>
    <ProductNDC>59088-371</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Dermacinrx Lidotral</ProprietaryName>
    <NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20151203</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
    <LabelerName>PureTek Corporation</LabelerName>
    <SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>38.8</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2019-02-06</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20151203</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritation.</IndicationAndUsage>
    <Description>Lidotral (Lidocaine HCl) 3.88% Cream contains Lidocaine HCl 3.88% in a mild acidic vehicle. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), and has the following structure. Ingredients: Each gram of Lidotral 3.88% Cream contains Lidocaine HCl USP 38.8 mg. Inactive Ingredients include: Calcium Acetate, Ceteareth 20, Cetearyl Alcohol, Glycerin, Methylparaben, Mineral Oil, Petrolatum, Propylene Glycol, Propylparaben, Purified Water, Sodium Phosphate Monobasic.</Description>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>59088-206-07</NDCCode><ProprietaryName>Fungizyl Ac</ProprietaryName><NonProprietaryName>Dimethyl Sulfoxide 2%, Miconazole Nitrate 2%</NonProprietaryName></NDC><NDC><NDCCode>31260-206-07</NDCCode><NonProprietaryName>Aluminum Zirconium Trichlorohydrex Gly</NonProprietaryName></NDC><NDC><NDCCode>45334-206-07</NDCCode><ProprietaryName>Vanicream</ProprietaryName><NonProprietaryName>Pyrithione Zinc</NonProprietaryName></NDC><NDC><NDCCode>51167-106-02</NDCCode><ProprietaryName>Trikafta</ProprietaryName><NonProprietaryName>Elexacaftor, Tezacaftor, And Ivacaftor</NonProprietaryName></NDC><NDC><NDCCode>55910-206-07</NDCCode><ProprietaryName>Mucus Fast Max Day Cold And Flu And Night Cold And Flu</ProprietaryName><NonProprietaryName>Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl, Acetaminophen, Dextromethorphan Hbr, Phenylephrine Hcl, Triprolidine Hcl</NonProprietaryName></NDC><NDC><NDCCode>58602-206-07</NDCCode><ProprietaryName>Aurophen Infants Pain And Fever</ProprietaryName><NonProprietaryName>Acetaminophen</NonProprietaryName></NDC><NDC><NDCCode>63402-206-28</NDCCode><ProprietaryName>Aptiom</ProprietaryName><NonProprietaryName>Eslicarbazepine Acetate</NonProprietaryName></NDC><NDC><NDCCode>71919-206-07</NDCCode><ProprietaryName>Citrus Vulgaris</ProprietaryName><NonProprietaryName>Citrus Aurantium Fruit Rind</NonProprietaryName></NDC><NDC><NDCCode>87063-206-07</NDCCode><ProprietaryName>Fluconazole</ProprietaryName><NonProprietaryName>Fluconazole</NonProprietaryName></NDC><NDC><NDCCode>59088-083-00</NDCCode><ProprietaryName>Migranow</ProprietaryName><NonProprietaryName>Sumatriptan Succinate, Camphor, Menthol</NonProprietaryName></NDC><NDC><NDCCode>59088-202-07</NDCCode><ProprietaryName>Menticam</ProprietaryName><NonProprietaryName>Camphor,menthol, Methyl Salicylate</NonProprietaryName></NDC><NDC><NDCCode>59088-203-07</NDCCode><ProprietaryName>Menticam</ProprietaryName><NonProprietaryName>Camphor, Menthol, Methyl Salicylate</NonProprietaryName></NDC><NDC><NDCCode>59088-204-07</NDCCode><ProprietaryName>Lidotral 5% Gel</ProprietaryName><NonProprietaryName>Lidocaine Hcl</NonProprietaryName></NDC><NDC><NDCCode>59088-207-07</NDCCode><ProprietaryName>Lasolex Ag</ProprietaryName><NonProprietaryName>Miconazole Nitrate</NonProprietaryName></NDC><NDC><NDCCode>59088-212-07</NDCCode><ProprietaryName>Exemax Cream</ProprietaryName><NonProprietaryName>Dimethicone, Allantoin</NonProprietaryName></NDC><NDC><NDCCode>59088-221-07</NDCCode><ProprietaryName>Lidoease 2%</ProprietaryName><NonProprietaryName>Lidocaine Hcl 2%</NonProprietaryName></NDC><NDC><NDCCode>59088-239-07</NDCCode><ProprietaryName>Lasolex Ac</ProprietaryName><NonProprietaryName>Miconazole Nitrate 2% Antifungal</NonProprietaryName></NDC><NDC><NDCCode>59088-241-07</NDCCode><ProprietaryName>Lidocaine 3%</ProprietaryName><NonProprietaryName>Lidocaine Hcl 3%</NonProprietaryName></NDC><NDC><NDCCode>59088-244-07</NDCCode><ProprietaryName>Cvs Feminine Intimate Powder</ProprietaryName><NonProprietaryName>Miconazole Nitrate</NonProprietaryName></NDC><NDC><NDCCode>59088-247-07</NDCCode><ProprietaryName>Lidocaine 5% Gel</ProprietaryName><NonProprietaryName>Lidocaine Hcl 5%</NonProprietaryName></NDC><NDC><NDCCode>59088-259-07</NDCCode><ProprietaryName>Camphor 4% Plus Menthol 10%</ProprietaryName><NonProprietaryName>Camphor 4% Plus Menthol 10%</NonProprietaryName></NDC><NDC><NDCCode>59088-283-07</NDCCode><ProprietaryName>Camphotrex</ProprietaryName><NonProprietaryName>Camphor, Menthol</NonProprietaryName></NDC><NDC><NDCCode>59088-307-07</NDCCode><ProprietaryName>Lidotral 3.88% Roll On</ProprietaryName><NonProprietaryName>Lidocaine Hci</NonProprietaryName></NDC><NDC><NDCCode>59088-317-07</NDCCode><ProprietaryName>Lidotral 3.88 Percent Plus Hydrocortisone 1 Percent Cream</ProprietaryName><NonProprietaryName>Lidocaine Hcl, Hydrocortisone Acetate</NonProprietaryName></NDC><NDC><NDCCode>59088-319-07</NDCCode><ProprietaryName>Lidotral 5 Percent And Hydrocortisone 1 Percent With Peptides And Arnica</ProprietaryName><NonProprietaryName>Lidocaine Hcl 5 % , Hydrocortisone Acetate 1%</NonProprietaryName></NDC><NDC><NDCCode>59088-321-07</NDCCode><ProprietaryName>Neurozyl</ProprietaryName><NonProprietaryName>Lidocaine Hcl 4.12 %</NonProprietaryName></NDC><NDC><NDCCode>59088-326-07</NDCCode><ProprietaryName>Scartrate Cream</ProprietaryName><NonProprietaryName>Dimethicone, Allantoin</NonProprietaryName></NDC><NDC><NDCCode>59088-327-07</NDCCode><ProprietaryName>Lidotral 5 Percent Roll On Gel</ProprietaryName><NonProprietaryName>Lidocaine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>59088-329-07</NDCCode><ProprietaryName>Penetral Roll-on</ProprietaryName><NonProprietaryName>Capsaicin 0.025%</NonProprietaryName></NDC><NDC><NDCCode>59088-371-07</NDCCode><ProprietaryName>Dermacinrx Lidotral</ProprietaryName><NonProprietaryName>Lidocaine Hydrochloride</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",
      "MailingAddressFaxNumber": "425-861-5585",
      "FirstLinePracticeLocationAddress": "16375 NE 85TH ST",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3554",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-7363",
      "PracticeLocationAddressFaxNumber": "425-861-5585",
      "EnumerationDate": "05/04/2006",
      "LastUpdateDate": "12/11/2007",
      "AuthorizedOfficialLastName": "MONTECILLO",
      "AuthorizedOfficialFirstName": "RANIA",
      "AuthorizedOfficialTitle": "OWNER",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-7363",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "801TX",
      "LicenseNumberStateCode1": "WA",
      "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."
    },
    {
      "NPI": "1346319878",
      "EntityType": "Organization",
      "EIN": "N/A",
      "OrgName": "REDMOND EYE CLINIC PLLC",
      "FirstLineMailingAddress": "16150 NE 85TH ST STE 206",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3543",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-3574",
      "MailingAddressFaxNumber": "425-881-0230",
      "FirstLinePracticeLocationAddress": "16150 NE 85TH ST STE 206",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3543",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-3574",
      "PracticeLocationAddressFaxNumber": "425-881-0230",
      "EnumerationDate": "11/07/2006",
      "LastUpdateDate": "07/08/2007",
      "AuthorizedOfficialLastName": "OTTEN",
      "AuthorizedOfficialFirstName": "LARRY",
      "AuthorizedOfficialMiddleName": "C",
      "AuthorizedOfficialTitle": "DR",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-3574",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "OD00001172",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
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      "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",
      "Taxonomy1": "Mental Health Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "10/26/2024",
      "PrimaryTaxonomyCode": "101YM0800X",
      "PrimaryTaxonomy": "Mental Health Counselor"
    },
    {
      "NPI": "1912723131",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "WEIMER",
      "FirstName": "ALAYNA",
      "FirstLineMailingAddress": "2748 NW 19TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-7766",
      "MailingAddressCountryCode": "US",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-499-8292",
      "EnumerationDate": "12/03/2024",
      "LastUpdateDate": "12/03/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "171M00000X",
      "Taxonomy1": "Case Manager/Care Coordinator",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "12/03/2024",
      "PrimaryTaxonomyCode": "171M00000X",
      "PrimaryTaxonomy": "Case Manager/Care Coordinator"
    },
    {
      "NPI": "1790594125",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "WIDDER",
      "FirstName": "JENNIFER",
      "MiddleName": "LYNN",
      "FirstLineMailingAddress": "22350 CALGARY DR",
      "MailingAddressCityName": "BEND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97702-9216",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-749-8895",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1858",
      "EnumerationDate": "12/31/2024",
      "LastUpdateDate": "12/31/2024",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "175T00000X",
      "Taxonomy1": "Peer Specialist",
      "LicenseNumber1": "112910",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "12/31/2024",
      "PrimaryTaxonomyCode": "175T00000X",
      "PrimaryTaxonomy": "Peer Specialist"
    },
    {
      "NPI": "1538965306",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "PARSONS",
      "FirstName": "JEANINE",
      "MiddleName": "JEWELL",
      "FirstLineMailingAddress": "2821 SW 28TH ST",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-8681",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "760-927-4761",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1848",
      "EnumerationDate": "02/21/2025",
      "LastUpdateDate": "02/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "175T00000X",
      "Taxonomy1": "Peer Specialist",
      "LicenseNumber1": "113398",
      "LicenseNumberStateCode1": "OR",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "02/21/2025",
      "PrimaryTaxonomyCode": "175T00000X",
      "PrimaryTaxonomy": "Peer Specialist"
    }
  ]
}
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