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RESTful Lookup — Test-Drive (2007 – 2026)

How to Find 55312-007-57 NDC Data Using DataLabs API

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{
  "NDC": [
    {
      "NDCCode": "55312-007-57",
      "PackageDescription": "290 g in 1 BOTTLE, PLASTIC (55312-007-57)",
      "NDC11Code": "55312-0007-57",
      "ProductNDC": "55312-007",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Western Family Baby Broad Spectrum Sunscreen",
      "ProprietaryNameSuffix": "Spf 50",
      "NonProprietaryName": "Avobenzone,homosalate, Octocrylene, Octisalate, Oxybenzone",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20140702",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "WESTERN FAMILY FOODS, INC.",
      "SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
      "StrengthNumber": "3; 13; 5; 7; 4",
      "StrengthUnit": "g/100g; g/100g; g/100g; g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures( see directions) , decreases the risk of skin cancer and early skin aging caused by the sun."
    },
    {
      "NDCCode": "55312-006-57",
      "PackageDescription": "295 g in 1 BOTTLE, PLASTIC (55312-006-57)",
      "NDC11Code": "55312-0006-57",
      "ProductNDC": "55312-006",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Western Family Broad Spectrum Sunscreenspf 50",
      "ProprietaryNameSuffix": "Spf 50",
      "NonProprietaryName": "Avobenzone Homosalate Octisalate Octocrylene Oxybenzone",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20140702",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "WESTERN FAMILY FOODS, INC.",
      "SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
      "StrengthNumber": "3; 13; 5; 7; 4",
      "StrengthUnit": "g/100g; g/100g; g/100g; g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decrease the risk of skin cancer and early skin aging caused by the sun."
    },
    {
      "NDCCode": "55312-017-57",
      "PackageDescription": "290 g in 1 BOTTLE, PLASTIC (55312-017-57)",
      "NDC11Code": "55312-0017-57",
      "ProductNDC": "55312-017",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Western Family",
      "ProprietaryNameSuffix": "Spf 15",
      "NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20140707",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "WESTERN FAMILY FOODS, INC.",
      "SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
      "StrengthNumber": "2; 10; 5; 5",
      "StrengthUnit": "g/100g; g/100g; g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decrease the risk of skin cancer and early skin aging caused by the sun."
    },
    {
      "NDCCode": "55312-034-02",
      "PackageDescription": "1 TUBE in 1 CARTON (55312-034-02)  > 57 g in 1 TUBE",
      "NDC11Code": "55312-0034-02",
      "ProductNDC": "55312-034",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Western Family Hemorrhoidal",
      "NonProprietaryName": "Mineral Oil, Petrolatum, Phenylephrine Hcl",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20120731",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part346",
      "LabelerName": "WESTERN FAMILY FOOD, INC.",
      "SubstanceName": "MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "140; 719; 2.5",
      "StrengthUnit": "mg/g; mg/g; mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Directions: 1 children under 12 years of age: ask a doctor , 2 adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe , 3 gently dry by patting or blotting with a tissue or a soft cloth before applying , 4 when first opening tube, remove foil seal , 5 for intrarectal use: remove protective cover form applicator and attach to tube , 6 lubricate applicator well, then gently insert applicator into the rectum , 7 thoroughly clean applicator and replace protective cover after each use , 8 apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement , 9 also apply ointment to external area."
    },
    {
      "NDCCode": "55312-035-57",
      "PackageDescription": "1 TUBE in 1 CARTON (55312-035-57)  > 57 g in 1 TUBE",
      "NDC11Code": "55312-0035-57",
      "ProductNDC": "55312-035",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Western Family Hemorrhoidal",
      "NonProprietaryName": "Mineral Oil",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20130630",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part346",
      "LabelerName": "Western Family Food, Inc.",
      "SubstanceName": "MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE",
      "StrengthNumber": "140; 749; 2.5",
      "StrengthUnit": "mg/100g; mg/100g; mg/100g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Directions: 1 children under 12 years of age: ask a doctor, 2 adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe, 3 gently dry by patting or blotting with a tissue or a soft cloth before applying, 4 when first opening tube, remove foil seal, 5 for intrarectal use: remove protective cover from applicator and attach to tube, 6 lubricate applicator well, then gently insert applicator into the rectum, 7 thoroughly clean applicator and replace protective cover after each use, 8 apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement, 9 also apply ointment to external area."
    },
    {
      "NDCCode": "55312-173-24",
      "PackageDescription": "1 KIT in 1 CARTON (55312-173-24)  *  1 BOTTLE in 1 CARTON (55312-866-26)  > 118 mL in 1 BOTTLE *  57 g in 1 BOTTLE",
      "NDC11Code": "55312-0173-24",
      "ProductNDC": "55312-173",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Lice",
      "NonProprietaryName": "Piperonyl Butoxide, Pyrethrum Extract",
      "DosageFormName": "KIT",
      "StartMarketingDate": "20071029",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part358G",
      "LabelerName": "Western Family Foods Inc",
      "Status": "Deprecated",
      "LastUpdate": "2018-05-04",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "10095-007-01",
      "PackageDescription": "57 g in 1 PACKAGE (10095-007-01)",
      "NDC11Code": "10095-0007-01",
      "ProductNDC": "10095-007",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sulfur",
      "NonProprietaryName": "Sulfur",
      "DosageFormName": "OINTMENT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20150505",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part333D",
      "LabelerName": "World Perfumes, Inc",
      "SubstanceName": "SULFUR",
      "StrengthNumber": "10",
      "StrengthUnit": "g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Sulfur 10% Ointment."
    },
    {
      "NDCCode": "41701-007-39",
      "PackageDescription": "1 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (41701-007-39)  / 57 g in 1 BOTTLE, PLASTIC (41701-007-38) ",
      "NDC11Code": "41701-0007-39",
      "ProductNDC": "41701-007",
      "ProductTypeName": "BULK INGREDIENT",
      "NonProprietaryName": "Desmopressin",
      "DosageFormName": "POWDER",
      "StartMarketingDate": "20110318",
      "MarketingCategoryName": "BULK INGREDIENT",
      "LabelerName": "Piramal Pharma Limited",
      "SubstanceName": "DESMOPRESSIN",
      "StrengthNumber": "57",
      "StrengthUnit": "g/57g",
      "Status": "Unfinished",
      "LastUpdate": "2024-02-10",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "18-MAR-11"
    },
    {
      "NDCCode": "42913-007-00",
      "PackageDescription": "57 g in 1 APPLICATOR (42913-007-00) ",
      "NDC11Code": "42913-0007-00",
      "ProductNDC": "42913-007",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Xtreme Power Stick Ignition",
      "NonProprietaryName": "Aluminum Sesquichlorohydrate",
      "DosageFormName": "STICK",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20141114",
      "EndMarketingDate": "20221222",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part350",
      "LabelerName": "A.P. Deauville, LLC",
      "SubstanceName": "ALUMINUM SESQUICHLOROHYDRATE",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2022-12-23",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20141114",
      "EndMarketingDatePackage": "20221222",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "49252-007-57",
      "PackageDescription": "100 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (49252-007-57) ",
      "NDC11Code": "49252-0007-57",
      "ProductNDC": "49252-007",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Duloxetine",
      "NonProprietaryName": "Duloxetine",
      "DosageFormName": "CAPSULE, DELAYED RELEASE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20151205",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA202336",
      "LabelerName": "Inventia Healthcare Limited.",
      "SubstanceName": "DULOXETINE HYDROCHLORIDE",
      "StrengthNumber": "20",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-09-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20151205",
      "SamplePackage": "N",
      "IndicationAndUsage": "Duloxetine is indicated for the treatment of: 1 Major depressive disorder in adults, 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older, 3 Diabetic peripheral neuropathic pain in adults, 4 Fibromyalgia in adults and pediatric patients 13 years of age and older, 5 Chronic musculoskeletal pain in adults.",
      "Description": "Duloxetine delayed-release capsules USP is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (+)-( S)-N-methyl-γ-(1-naphthyloxy)- 2-thiophenepropylamine hydrochloride. The empirical formula is C 18H 19NOS·HCl, which corresponds to a molecular weight of 333.88. The structural formula is:. Duloxetine hydrochloride is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 20, 30, or 60 mg of duloxetine (equivalent to 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride USP, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include gelatin, hypromellose, hypromellose phthalate, sucrose, sugar spheres, talc, titanium dioxide and triethyl citrate. The 20 mg capsules also contain FD & C Blue 2 and Iron Oxide Yellow and 60 mg capsules contain FD & C Blue 2. The 20 mg, 30 mg and 60 mg capsules are imprinted with black and grey ink which contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution. Grey ink also contains titanium dioxide."
    },
    {
      "NDCCode": "71564-007-02",
      "PackageDescription": "57 g in 1 TUBE (71564-007-02) ",
      "NDC11Code": "71564-0007-02",
      "ProductNDC": "71564-007",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Okeeffes Working Hands Eczema Relief",
      "ProprietaryNameSuffix": "Cream",
      "NonProprietaryName": "Colloidal Oatmeal",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20220221",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M016",
      "LabelerName": "The Gorilla Glue Company/O'Keeffe's Company",
      "SubstanceName": "OATMEAL",
      "StrengthNumber": "2",
      "StrengthUnit": "g/100g",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2025-12-05",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20220221",
      "SamplePackage": "N",
      "IndicationAndUsage": "Uses. temporarily protects and helps relieve minor skin irritation and itching due to: 1 rashes, 2 eczema."
    },
    {
      "NDCCode": "80948-007-57",
      "PackageDescription": "8 BOTTLE in 1 PACKAGE (80948-007-57)  / 350 mL in 1 BOTTLE",
      "NDC11Code": "80948-0007-57",
      "ProductNDC": "80948-007",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Puroma Foaming Hand Alcohol Free Fragrance Free",
      "NonProprietaryName": "Benzalkonium Chloride",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20210310",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M003",
      "LabelerName": "ZENITH MICRO CONTROL",
      "SubstanceName": "BENZALKONIUM CHLORIDE",
      "StrengthNumber": "130",
      "StrengthUnit": "mg/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20210310",
      "SamplePackage": "N",
      "IndicationAndUsage": "Helps eliminate bacteria on hands."
    },
    {
      "NDCCode": "85162-007-02",
      "PackageDescription": "4 BOX in 1 CARTON (85162-007-02)  / 50 POUCH in 1 BOX / 57 g in 1 POUCH",
      "NDC11Code": "85162-0007-02",
      "ProductNDC": "85162-007",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Amerfresh Toothpowder",
      "NonProprietaryName": "Sodium Fluoride",
      "DosageFormName": "POWDER",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20250813",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M021",
      "LabelerName": "Yangzhou ONE & ONLY Personal Care Products Co., LTD",
      "SubstanceName": "SODIUM FLUORIDE",
      "StrengthNumber": ".1",
      "StrengthUnit": "g/100g",
      "Status": "Active",
      "LastUpdate": "2026-03-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20250813",
      "SamplePackage": "N",
      "IndicationAndUsage": "aids in the prevention of dental cavities."
    },
    {
      "NDCCode": "85398-018-01",
      "PackageDescription": "1 KIT in 1 CARTON (85398-018-01)  *  57 g in 1 TUBE (85398-017-02)  *  116 g in 1 CARTON (85398-007-02) ",
      "NDC11Code": "85398-0018-01",
      "ProductNDC": "85398-018",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Hermon Athletes Foot Tolnaftate 1% Kit",
      "NonProprietaryName": "Tolnaftate 1% Kit",
      "DosageFormName": "KIT",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20251031",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M005",
      "LabelerName": "Beautivity LLC",
      "Status": "Active",
      "LastUpdate": "2026-07-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20251031",
      "SamplePackage": "N",
      "IndicationAndUsage": "Directions (Cream): 1 adults and children 12 years and over, 2 use the tip of thecap to break the seal and open the tube, 3 wash the affedted skin with soap and water and dry completely before applying, 4 for athlete's foot wear well-fitting, ventilated shoes. Change shoes and socks at least once daily., 5 between the ttoes only: apply twice a day (morning and night) for 1 week or as directed by a doctor, 6 on the bottom or sides ofthe foot: apply twice a day (morning and night) for 2 weeks or as directed by a doctor, 7 for jock itch and ringworm: apply oncea day (morning or night) for 1 week or as directed by a doctor, 8 wash hands after each use, 9 children under 12 years: ask a doctor, 10 wash affected area and dry thoroughly, 11 apply a thin layer over affected area twice daily (morning and night), 12 supervise children in the use of this product, 13 use daily for2 weeks."
    },
    {
      "NDCCode": "16729-007-10",
      "PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (16729-007-10) ",
      "NDC11Code": "16729-0007-10",
      "ProductNDC": "16729-007",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Simvastatin",
      "NonProprietaryName": "Simvastatin",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20080226",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078155",
      "LabelerName": "Accord Healthcare, Inc.",
      "SubstanceName": "SIMVASTATIN",
      "StrengthNumber": "80",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-11-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20080226",
      "SamplePackage": "N",
      "IndicationAndUsage": "Simvastatin tablet is indicated:  To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events.  As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C):       o In adults with primary hyperlipidemia.       o In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).  As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH).  As an adjunct to diet for the treatment of adults with:       o Primary dysbetalipoproteinemia.       o Hypertriglyceridemia.",
      "Description": "Simvastatin is a prodrug of 3-hydoroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S *,4S *),-8aβ]]. The empirical formula of simvastatin is C 25H 38O 5and its molecular weight is 418.57. Its structural formula is:. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets USP for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: microcrystalline cellulose, hydroxypropyl cellulose, hypromellose E5, croscarmellose sodium, ferric oxide red, lactose monohydrate, magnesium stearate, maize starch, talc, titanium dioxide, butylated hydroxyanisole, ascorbic acid, citric acid monohydrate, and triethyl citrate."
    },
    {
      "NDCCode": "16729-007-15",
      "PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (16729-007-15) ",
      "NDC11Code": "16729-0007-15",
      "ProductNDC": "16729-007",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Simvastatin",
      "NonProprietaryName": "Simvastatin",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20080226",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078155",
      "LabelerName": "Accord Healthcare, Inc.",
      "SubstanceName": "SIMVASTATIN",
      "StrengthNumber": "80",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-11-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20080226",
      "SamplePackage": "N",
      "IndicationAndUsage": "Simvastatin tablet is indicated:  To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events.  As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C):       o In adults with primary hyperlipidemia.       o In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).  As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH).  As an adjunct to diet for the treatment of adults with:       o Primary dysbetalipoproteinemia.       o Hypertriglyceridemia.",
      "Description": "Simvastatin is a prodrug of 3-hydoroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S *,4S *),-8aβ]]. The empirical formula of simvastatin is C 25H 38O 5and its molecular weight is 418.57. Its structural formula is:. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets USP for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: microcrystalline cellulose, hydroxypropyl cellulose, hypromellose E5, croscarmellose sodium, ferric oxide red, lactose monohydrate, magnesium stearate, maize starch, talc, titanium dioxide, butylated hydroxyanisole, ascorbic acid, citric acid monohydrate, and triethyl citrate."
    },
    {
      "NDCCode": "16729-007-17",
      "PackageDescription": "1000 TABLET, FILM COATED in 1 BOTTLE (16729-007-17) ",
      "NDC11Code": "16729-0007-17",
      "ProductNDC": "16729-007",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Simvastatin",
      "NonProprietaryName": "Simvastatin",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20080226",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078155",
      "LabelerName": "Accord Healthcare, Inc.",
      "SubstanceName": "SIMVASTATIN",
      "StrengthNumber": "80",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2025-11-18",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20080226",
      "SamplePackage": "N",
      "IndicationAndUsage": "Simvastatin tablet is indicated:  To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events.  As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C):       o In adults with primary hyperlipidemia.       o In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).  As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH).  As an adjunct to diet for the treatment of adults with:       o Primary dysbetalipoproteinemia.       o Hypertriglyceridemia.",
      "Description": "Simvastatin is a prodrug of 3-hydoroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S *,4S *),-8aβ]]. The empirical formula of simvastatin is C 25H 38O 5and its molecular weight is 418.57. Its structural formula is:. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets USP for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: microcrystalline cellulose, hydroxypropyl cellulose, hypromellose E5, croscarmellose sodium, ferric oxide red, lactose monohydrate, magnesium stearate, maize starch, talc, titanium dioxide, butylated hydroxyanisole, ascorbic acid, citric acid monohydrate, and triethyl citrate."
    },
    {
      "NDCCode": "25682-007-01",
      "PackageDescription": "1 VIAL, GLASS in 1 CARTON (25682-007-01)  / 10 mL in 1 VIAL, GLASS",
      "NDC11Code": "25682-0007-01",
      "ProductNDC": "25682-007",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Kanuma",
      "NonProprietaryName": "Sebelipase Alfa",
      "DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20151208",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA125561",
      "LabelerName": "Alexion Pharmaceuticals, Inc.",
      "SubstanceName": "SEBELIPASE ALFA",
      "StrengthNumber": "2",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Hydrolytic Lysosomal Cholesteryl Ester-specific Enzyme [EPC], Hydrolytic Lysosomal Triacylglycerol-specific Enzyme [EPC], Sterol Esterase [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2026-08-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20151208",
      "SamplePackage": "N",
      "IndicationAndUsage": "KANUMA® is indicated for the treatment of patients with a diagnosis of Lysosomal Acid Lipase (LAL) deficiency.",
      "Description": "Sebelipase alfa is a recombinant human lysosomal acid lipase (rhLAL) that is a lysosomal glycoprotein enzyme produced by recombinant DNA technology in the egg white of eggs laid by genetically engineered chickens. Purified sebelipase alfa is a monomeric glycoprotein containing 6 N-linked glycosylation sites and has a molecular mass of approximately 55 kDa. The amino acid sequence for sebelipase alfa is the same as the amino acid sequence for human LAL. The specific activity of sebelipase alfa is 195 to 345 units/mg. One unit is the amount of enzyme activity that catalyzes the hydrolysis of 1 micromole of the synthetic substrate 4-methylumbelliferyl oleate per minute at 37°C under specified assay conditions. KANUMA (sebelipase alfa) injection is supplied as a sterile, preservative-free, non-pyrogenic clear to slightly opalescent, colorless to slightly colored aqueous solution in single-dose vials for intravenous infusion. Each vial contains sebelipase alfa 20 mg/10 mL. Each mL of solution contains sebelipase alfa (2 mg), citric acid monohydrate (1.57 mg), Human Serum Albumin (10 mg), and trisodium citrate dihydrate (13.7 mg) at pH 5.9."
    },
    {
      "NDCCode": "43353-007-45",
      "PackageDescription": "45 TABLET, FILM COATED in 1 BOTTLE (43353-007-45) ",
      "NDC11Code": "43353-0007-45",
      "ProductNDC": "43353-007",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Simvastatin",
      "NonProprietaryName": "Simvastatin",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20061220",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077691",
      "LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
      "SubstanceName": "SIMVASTATIN",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20180518",
      "SamplePackage": "N",
      "IndicationAndUsage": "Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with coronary heart disease (CHD) or at high risk of CHD, simvastatin tablets can be started simultaneously with diet.",
      "Description": "Simvastatin is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β (2S*,4S*),-8aβ]]. The molecular formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is. Simvastatin USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets USP for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin USP and the following inactive ingredients: ascorbic acid, lactose monohydrate, microcrystalline cellulose, pregelatinized starch (maize), hydroxypropyl cellulose, hypromellose, titanium dioxide, talc, citric acid monohydrate, isopropyl alcohol, magnesium stearate and butylated hydroxyanisole. Simvastatin 5 mg also contains ferric oxide yellow, simvastatin 10 mg and simvastatin 20 mg also contains ferric oxide red and ferric oxide yellow, simvastatin 40 mg and simvastatin 80 mg also contains ferric oxide red."
    },
    {
      "NDCCode": "43353-007-60",
      "PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (43353-007-60) ",
      "NDC11Code": "43353-0007-60",
      "ProductNDC": "43353-007",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Simvastatin",
      "NonProprietaryName": "Simvastatin",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20061220",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA077691",
      "LabelerName": "Aphena Pharma Solutions - Tennessee, LLC",
      "SubstanceName": "SIMVASTATIN",
      "StrengthNumber": "40",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20180518",
      "SamplePackage": "N",
      "IndicationAndUsage": "Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with coronary heart disease (CHD) or at high risk of CHD, simvastatin tablets can be started simultaneously with diet.",
      "Description": "Simvastatin is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β (2S*,4S*),-8aβ]]. The molecular formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is. Simvastatin USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets USP for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin USP and the following inactive ingredients: ascorbic acid, lactose monohydrate, microcrystalline cellulose, pregelatinized starch (maize), hydroxypropyl cellulose, hypromellose, titanium dioxide, talc, citric acid monohydrate, isopropyl alcohol, magnesium stearate and butylated hydroxyanisole. Simvastatin 5 mg also contains ferric oxide yellow, simvastatin 10 mg and simvastatin 20 mg also contains ferric oxide red and ferric oxide yellow, simvastatin 40 mg and simvastatin 80 mg also contains ferric oxide red."
    },
    {
      "NDCCode": "65008-007-06",
      "PackageDescription": "170 g in 1 TUBE (65008-007-06) ",
      "NDC11Code": "65008-0007-06",
      "ProductNDC": "65008-007",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sunsorb Reef Safe Spf50",
      "NonProprietaryName": "Homosalate, Zinc Oxide, Octocrylene",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20190715",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "QS Key West Aloe, LLC",
      "SubstanceName": "HOMOSALATE; ZINC OXIDE; OCTOCRYLENE",
      "StrengthNumber": "100; 57; 50",
      "StrengthUnit": "mg/g; mg/g; mg/g",
      "Pharm_Classes": "Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]",
      "Status": "Active",
      "LastUpdate": "2025-11-13",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20190715",
      "SamplePackage": "N",
      "IndicationAndUsage": "- Helps prevent sunburn. - If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
    },
    {
      "NDCCode": "65278-007-15",
      "PackageDescription": "1 TUBE in 1 CARTON (65278-007-15)  > 50 mL in 1 TUBE",
      "NDC11Code": "65278-0007-15",
      "ProductNDC": "65278-007",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Peter Thomas Roth Cc",
      "ProprietaryNameSuffix": "Light To Medium",
      "NonProprietaryName": "Titanium Dioxide And Zinc Oxide",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20130222",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "June Jacobs Laboratories LLC",
      "SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
      "StrengthNumber": "102.6; 57.6",
      "StrengthUnit": "mg/mL; mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
    },
    {
      "NDCCode": "65278-007-16",
      "PackageDescription": "15 mL in 1 TUBE (65278-007-16)",
      "NDC11Code": "65278-0007-16",
      "ProductNDC": "65278-007",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Peter Thomas Roth Cc",
      "ProprietaryNameSuffix": "Light To Medium",
      "NonProprietaryName": "Titanium Dioxide And Zinc Oxide",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20130222",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "June Jacobs Laboratories LLC",
      "SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
      "StrengthNumber": "102.6; 57.6",
      "StrengthUnit": "mg/mL; mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
    },
    {
      "NDCCode": "55312-000-56",
      "PackageDescription": "226 g in 1 BOTTLE, PLASTIC (55312-000-56)",
      "NDC11Code": "55312-0000-56",
      "ProductNDC": "55312-000",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Western Family Broad Spectrum Sunscreen",
      "ProprietaryNameSuffix": "Spf 70",
      "NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20140303",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "WESTERN FAMILY FOODS, INC.",
      "SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
      "StrengthNumber": "3; 15; 5; 10; 6",
      "StrengthUnit": "g/100g; g/100g; g/100g; g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20191231",
      "IndicationAndUsage": "helps prevent sunburn. if used as directed with other sun protection measures( see directions) , decreases the risk of skin cancer and early skin aging caused by the sun."
    },
    {
      "NDCCode": "55312-001-10",
      "PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (55312-001-10) ",
      "NDC11Code": "55312-0001-10",
      "ProductNDC": "55312-001",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Stool Softener Plus Stimulant Laxative",
      "NonProprietaryName": "Docusate Sodium And Sennosides",
      "DosageFormName": "TABLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20100701",
      "EndMarketingDate": "20191231",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part334",
      "LabelerName": "Western Family Foods, Inc.",
      "SubstanceName": "DOCUSATE SODIUM; SENNOSIDES",
      "StrengthNumber": "50; 8.6",
      "StrengthUnit": "mg/1; mg/1",
      "Status": "Deprecated",
      "LastUpdate": "2020-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "StartMarketingDatePackage": "20100701",
      "EndMarketingDatePackage": "20191231",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "55312-002-01",
      "PackageDescription": "100 PACKET in 1 CARTON (55312-002-01)  > .6 mL in 1 PACKET",
      "NDC11Code": "55312-0002-01",
      "ProductNDC": "55312-002",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Western Family Alcohol Swabs",
      "NonProprietaryName": "Isopropyl Alcohol",
      "DosageFormName": "LIQUID",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20120114",
      "EndMarketingDate": "20180310",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part333A",
      "LabelerName": "Western Family Foods, Inc.",
      "SubstanceName": "ISOPROPYL ALCOHOL",
      "StrengthNumber": "70",
      "StrengthUnit": "mL/100mL",
      "Status": "Deprecated",
      "LastUpdate": "2018-03-14",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20181231"
    },
    {
      "NDCCode": "55312-003-01",
      "PackageDescription": "181.4 g in 1 TUBE (55312-003-01)",
      "NDC11Code": "55312-0003-01",
      "ProductNDC": "55312-003",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Western Family Complete Whitening",
      "NonProprietaryName": "Sodium Fluoride",
      "DosageFormName": "PASTE, DENTIFRICE",
      "RouteName": "DENTAL",
      "StartMarketingDate": "20081124",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part355",
      "LabelerName": "Western Family Foods, Inc",
      "SubstanceName": "SODIUM FLUORIDE",
      "StrengthNumber": "2.43",
      "StrengthUnit": "mg/g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Helps protect against cavities."
    },
    {
      "NDCCode": "55312-004-44",
      "PackageDescription": "532 mL in 1 BOTTLE, PLASTIC (55312-004-44) ",
      "NDC11Code": "55312-0004-44",
      "ProductNDC": "55312-004",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Anti Cavity Rinse",
      "NonProprietaryName": "Sodium Fluoride",
      "DosageFormName": "RINSE",
      "RouteName": "ORAL",
      "StartMarketingDate": "20090512",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part355",
      "LabelerName": "Western Family Foods, Inc",
      "SubstanceName": "SODIUM FLUORIDE",
      "StrengthNumber": ".2",
      "StrengthUnit": "mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2020-09-25",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20201231",
      "StartMarketingDatePackage": "20090512",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "55312-005-22",
      "PackageDescription": "85 g in 1 BOTTLE, PLASTIC (55312-005-22)",
      "NDC11Code": "55312-0005-22",
      "ProductNDC": "55312-005",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Western Family Sport Sunscreen",
      "ProprietaryNameSuffix": "Spf 30",
      "NonProprietaryName": "Avobenzone Homosalate Octisalate Octocrylene Oxybenzone",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20140702",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "WESTERN FAMILY FOODS, INC.",
      "SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
      "StrengthNumber": "2; 10; 5; 4; 5",
      "StrengthUnit": "g/100g; g/100g; g/100g; g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decrease the risk of skin cancer and early skin aging caused by the sun."
    },
    {
      "NDCCode": "55312-005-56",
      "PackageDescription": "226 g in 1 BOTTLE, PLASTIC (55312-005-56)",
      "NDC11Code": "55312-0005-56",
      "ProductNDC": "55312-005",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Western Family Sport Sunscreen",
      "ProprietaryNameSuffix": "Spf 30",
      "NonProprietaryName": "Avobenzone Homosalate Octisalate Octocrylene Oxybenzone",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20140702",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "WESTERN FAMILY FOODS, INC.",
      "SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
      "StrengthNumber": "2; 10; 5; 4; 5",
      "StrengthUnit": "g/100g; g/100g; g/100g; g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20181231",
      "IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decrease the risk of skin cancer and early skin aging caused by the sun."
    }
  ]
}
                    
{"NDC":[{"NDCCode":"55312-007-57","ProprietaryName":"Western Family Baby Broad Spectrum Sunscreen","NonProprietaryName":"Avobenzone,homosalate, Octocrylene, Octisalate, Oxybenzone"},{"NDCCode":"55312-006-57","ProprietaryName":"Western Family Broad Spectrum Sunscreenspf 50","NonProprietaryName":"Avobenzone Homosalate Octisalate Octocrylene Oxybenzone"},{"NDCCode":"55312-017-57","ProprietaryName":"Western Family","NonProprietaryName":"Avobenzone, Homosalate, Octisalate, Octocrylene"},{"NDCCode":"55312-034-02","ProprietaryName":"Western Family Hemorrhoidal","NonProprietaryName":"Mineral Oil, Petrolatum, Phenylephrine Hcl"},{"NDCCode":"55312-035-57","ProprietaryName":"Western Family Hemorrhoidal","NonProprietaryName":"Mineral Oil"},{"NDCCode":"55312-173-24","ProprietaryName":"Lice","NonProprietaryName":"Piperonyl Butoxide, Pyrethrum Extract"},{"NDCCode":"10095-007-01","ProprietaryName":"Sulfur","NonProprietaryName":"Sulfur"},{"NDCCode":"41701-007-39","NonProprietaryName":"Desmopressin"},{"NDCCode":"42913-007-00","ProprietaryName":"Xtreme Power Stick Ignition","NonProprietaryName":"Aluminum Sesquichlorohydrate"},{"NDCCode":"49252-007-57","ProprietaryName":"Duloxetine","NonProprietaryName":"Duloxetine"},{"NDCCode":"71564-007-02","ProprietaryName":"Okeeffes Working Hands Eczema Relief","NonProprietaryName":"Colloidal Oatmeal"},{"NDCCode":"80948-007-57","ProprietaryName":"Puroma Foaming Hand Alcohol Free Fragrance Free","NonProprietaryName":"Benzalkonium Chloride"},{"NDCCode":"85162-007-02","ProprietaryName":"Amerfresh Toothpowder","NonProprietaryName":"Sodium Fluoride"},{"NDCCode":"85398-018-01","ProprietaryName":"Hermon Athletes Foot Tolnaftate 1% Kit","NonProprietaryName":"Tolnaftate 1% Kit"},{"NDCCode":"16729-007-10","ProprietaryName":"Simvastatin","NonProprietaryName":"Simvastatin"},{"NDCCode":"16729-007-15","ProprietaryName":"Simvastatin","NonProprietaryName":"Simvastatin"},{"NDCCode":"16729-007-17","ProprietaryName":"Simvastatin","NonProprietaryName":"Simvastatin"},{"NDCCode":"25682-007-01","ProprietaryName":"Kanuma","NonProprietaryName":"Sebelipase Alfa"},{"NDCCode":"43353-007-45","ProprietaryName":"Simvastatin","NonProprietaryName":"Simvastatin"},{"NDCCode":"43353-007-60","ProprietaryName":"Simvastatin","NonProprietaryName":"Simvastatin"},{"NDCCode":"65008-007-06","ProprietaryName":"Sunsorb Reef Safe Spf50","NonProprietaryName":"Homosalate, Zinc Oxide, Octocrylene"},{"NDCCode":"65278-007-15","ProprietaryName":"Peter Thomas Roth Cc","NonProprietaryName":"Titanium Dioxide And Zinc Oxide"},{"NDCCode":"65278-007-16","ProprietaryName":"Peter Thomas Roth Cc","NonProprietaryName":"Titanium Dioxide And Zinc Oxide"},{"NDCCode":"55312-000-56","ProprietaryName":"Western Family Broad Spectrum Sunscreen","NonProprietaryName":"Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone"},{"NDCCode":"55312-001-10","ProprietaryName":"Stool Softener Plus Stimulant Laxative","NonProprietaryName":"Docusate Sodium And Sennosides"},{"NDCCode":"55312-002-01","ProprietaryName":"Western Family Alcohol Swabs","NonProprietaryName":"Isopropyl Alcohol"},{"NDCCode":"55312-003-01","ProprietaryName":"Western Family Complete Whitening","NonProprietaryName":"Sodium Fluoride"},{"NDCCode":"55312-004-44","ProprietaryName":"Anti Cavity Rinse","NonProprietaryName":"Sodium Fluoride"},{"NDCCode":"55312-005-22","ProprietaryName":"Western Family Sport Sunscreen","NonProprietaryName":"Avobenzone Homosalate Octisalate Octocrylene Oxybenzone"},{"NDCCode":"55312-005-56","ProprietaryName":"Western Family Sport Sunscreen","NonProprietaryName":"Avobenzone Homosalate Octisalate Octocrylene Oxybenzone"}]}
                    
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
  <NDC>
    <NDCCode>55312-007-57</NDCCode>
    <PackageDescription>290 g in 1 BOTTLE, PLASTIC (55312-007-57)</PackageDescription>
    <NDC11Code>55312-0007-57</NDC11Code>
    <ProductNDC>55312-007</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Western Family Baby Broad Spectrum Sunscreen</ProprietaryName>
    <ProprietaryNameSuffix>Spf 50</ProprietaryNameSuffix>
    <NonProprietaryName>Avobenzone,homosalate, Octocrylene, Octisalate, Oxybenzone</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20140702</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>WESTERN FAMILY FOODS, INC.</LabelerName>
    <SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
    <StrengthNumber>3; 13; 5; 7; 4</StrengthNumber>
    <StrengthUnit>g/100g; g/100g; g/100g; g/100g; g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures( see directions) , decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>55312-006-57</NDCCode>
    <PackageDescription>295 g in 1 BOTTLE, PLASTIC (55312-006-57)</PackageDescription>
    <NDC11Code>55312-0006-57</NDC11Code>
    <ProductNDC>55312-006</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Western Family Broad Spectrum Sunscreenspf 50</ProprietaryName>
    <ProprietaryNameSuffix>Spf 50</ProprietaryNameSuffix>
    <NonProprietaryName>Avobenzone Homosalate Octisalate Octocrylene Oxybenzone</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20140702</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>WESTERN FAMILY FOODS, INC.</LabelerName>
    <SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
    <StrengthNumber>3; 13; 5; 7; 4</StrengthNumber>
    <StrengthUnit>g/100g; g/100g; g/100g; g/100g; g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decrease the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>55312-017-57</NDCCode>
    <PackageDescription>290 g in 1 BOTTLE, PLASTIC (55312-017-57)</PackageDescription>
    <NDC11Code>55312-0017-57</NDC11Code>
    <ProductNDC>55312-017</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Western Family</ProprietaryName>
    <ProprietaryNameSuffix>Spf 15</ProprietaryNameSuffix>
    <NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20140707</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>WESTERN FAMILY FOODS, INC.</LabelerName>
    <SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
    <StrengthNumber>2; 10; 5; 5</StrengthNumber>
    <StrengthUnit>g/100g; g/100g; g/100g; g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decrease the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>55312-034-02</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (55312-034-02)  &gt; 57 g in 1 TUBE</PackageDescription>
    <NDC11Code>55312-0034-02</NDC11Code>
    <ProductNDC>55312-034</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Western Family Hemorrhoidal</ProprietaryName>
    <NonProprietaryName>Mineral Oil, Petrolatum, Phenylephrine Hcl</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20120731</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part346</ApplicationNumber>
    <LabelerName>WESTERN FAMILY FOOD, INC.</LabelerName>
    <SubstanceName>MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>140; 719; 2.5</StrengthNumber>
    <StrengthUnit>mg/g; mg/g; mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Directions: 1 children under 12 years of age: ask a doctor , 2 adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe , 3 gently dry by patting or blotting with a tissue or a soft cloth before applying , 4 when first opening tube, remove foil seal , 5 for intrarectal use: remove protective cover form applicator and attach to tube , 6 lubricate applicator well, then gently insert applicator into the rectum , 7 thoroughly clean applicator and replace protective cover after each use , 8 apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement , 9 also apply ointment to external area.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>55312-035-57</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (55312-035-57)  &gt; 57 g in 1 TUBE</PackageDescription>
    <NDC11Code>55312-0035-57</NDC11Code>
    <ProductNDC>55312-035</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Western Family Hemorrhoidal</ProprietaryName>
    <NonProprietaryName>Mineral Oil</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20130630</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part346</ApplicationNumber>
    <LabelerName>Western Family Food, Inc.</LabelerName>
    <SubstanceName>MINERAL OIL; PETROLATUM; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>140; 749; 2.5</StrengthNumber>
    <StrengthUnit>mg/100g; mg/100g; mg/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Directions: 1 children under 12 years of age: ask a doctor, 2 adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe, 3 gently dry by patting or blotting with a tissue or a soft cloth before applying, 4 when first opening tube, remove foil seal, 5 for intrarectal use: remove protective cover from applicator and attach to tube, 6 lubricate applicator well, then gently insert applicator into the rectum, 7 thoroughly clean applicator and replace protective cover after each use, 8 apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement, 9 also apply ointment to external area.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>55312-173-24</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (55312-173-24)  *  1 BOTTLE in 1 CARTON (55312-866-26)  &gt; 118 mL in 1 BOTTLE *  57 g in 1 BOTTLE</PackageDescription>
    <NDC11Code>55312-0173-24</NDC11Code>
    <ProductNDC>55312-173</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Lice</ProprietaryName>
    <NonProprietaryName>Piperonyl Butoxide, Pyrethrum Extract</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <StartMarketingDate>20071029</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part358G</ApplicationNumber>
    <LabelerName>Western Family Foods Inc</LabelerName>
    <Status>Deprecated</Status>
    <LastUpdate>2018-05-04</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>10095-007-01</NDCCode>
    <PackageDescription>57 g in 1 PACKAGE (10095-007-01)</PackageDescription>
    <NDC11Code>10095-0007-01</NDC11Code>
    <ProductNDC>10095-007</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sulfur</ProprietaryName>
    <NonProprietaryName>Sulfur</NonProprietaryName>
    <DosageFormName>OINTMENT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20150505</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part333D</ApplicationNumber>
    <LabelerName>World Perfumes, Inc</LabelerName>
    <SubstanceName>SULFUR</SubstanceName>
    <StrengthNumber>10</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Sulfur 10% Ointment.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>41701-007-39</NDCCode>
    <PackageDescription>1 BOTTLE, PLASTIC in 1 BOTTLE, PLASTIC (41701-007-39)  / 57 g in 1 BOTTLE, PLASTIC (41701-007-38) </PackageDescription>
    <NDC11Code>41701-0007-39</NDC11Code>
    <ProductNDC>41701-007</ProductNDC>
    <ProductTypeName>BULK INGREDIENT</ProductTypeName>
    <NonProprietaryName>Desmopressin</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <StartMarketingDate>20110318</StartMarketingDate>
    <MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
    <LabelerName>Piramal Pharma Limited</LabelerName>
    <SubstanceName>DESMOPRESSIN</SubstanceName>
    <StrengthNumber>57</StrengthNumber>
    <StrengthUnit>g/57g</StrengthUnit>
    <Status>Unfinished</Status>
    <LastUpdate>2024-02-10</LastUpdate>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>18-MAR-11</StartMarketingDatePackage>
  </NDC>
  <NDC>
    <NDCCode>42913-007-00</NDCCode>
    <PackageDescription>57 g in 1 APPLICATOR (42913-007-00) </PackageDescription>
    <NDC11Code>42913-0007-00</NDC11Code>
    <ProductNDC>42913-007</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Xtreme Power Stick Ignition</ProprietaryName>
    <NonProprietaryName>Aluminum Sesquichlorohydrate</NonProprietaryName>
    <DosageFormName>STICK</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20141114</StartMarketingDate>
    <EndMarketingDate>20221222</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part350</ApplicationNumber>
    <LabelerName>A.P. Deauville, LLC</LabelerName>
    <SubstanceName>ALUMINUM SESQUICHLOROHYDRATE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-12-23</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20141114</StartMarketingDatePackage>
    <EndMarketingDatePackage>20221222</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>49252-007-57</NDCCode>
    <PackageDescription>100 CAPSULE, DELAYED RELEASE in 1 BLISTER PACK (49252-007-57) </PackageDescription>
    <NDC11Code>49252-0007-57</NDC11Code>
    <ProductNDC>49252-007</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Duloxetine</ProprietaryName>
    <NonProprietaryName>Duloxetine</NonProprietaryName>
    <DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20151205</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA202336</ApplicationNumber>
    <LabelerName>Inventia Healthcare Limited.</LabelerName>
    <SubstanceName>DULOXETINE HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>20</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Norepinephrine Uptake Inhibitors [MoA], Serotonin Uptake Inhibitors [MoA], Serotonin and Norepinephrine Reuptake Inhibitor [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-09-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20151205</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Duloxetine is indicated for the treatment of: 1 Major depressive disorder in adults, 2 Generalized anxiety disorder in adults and pediatric patients 7 years of age and older, 3 Diabetic peripheral neuropathic pain in adults, 4 Fibromyalgia in adults and pediatric patients 13 years of age and older, 5 Chronic musculoskeletal pain in adults.</IndicationAndUsage>
    <Description>Duloxetine delayed-release capsules USP is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Its chemical designation is (+)-( S)-N-methyl-γ-(1-naphthyloxy)- 2-thiophenepropylamine hydrochloride. The empirical formula is C 18H 19NOS·HCl, which corresponds to a molecular weight of 333.88. The structural formula is:. Duloxetine hydrochloride is a white to slightly brownish white solid, which is slightly soluble in water. Each capsule contains enteric-coated pellets of 20, 30, or 60 mg of duloxetine (equivalent to 22.4, 33.7, or 67.3 mg of duloxetine hydrochloride USP, respectively). These enteric-coated pellets are designed to prevent degradation of the drug in the acidic environment of the stomach. Inactive ingredients include gelatin, hypromellose, hypromellose phthalate, sucrose, sugar spheres, talc, titanium dioxide and triethyl citrate. The 20 mg capsules also contain FD &amp; C Blue 2 and Iron Oxide Yellow and 60 mg capsules contain FD &amp; C Blue 2. The 20 mg, 30 mg and 60 mg capsules are imprinted with black and grey ink which contains black iron oxide, butyl alcohol, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, purified water, shellac and strong ammonia solution. Grey ink also contains titanium dioxide.</Description>
  </NDC>
  <NDC>
    <NDCCode>71564-007-02</NDCCode>
    <PackageDescription>57 g in 1 TUBE (71564-007-02) </PackageDescription>
    <NDC11Code>71564-0007-02</NDC11Code>
    <ProductNDC>71564-007</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Okeeffes Working Hands Eczema Relief</ProprietaryName>
    <ProprietaryNameSuffix>Cream</ProprietaryNameSuffix>
    <NonProprietaryName>Colloidal Oatmeal</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20220221</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M016</ApplicationNumber>
    <LabelerName>The Gorilla Glue Company/O'Keeffe's Company</LabelerName>
    <SubstanceName>OATMEAL</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-12-05</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220221</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Uses. temporarily protects and helps relieve minor skin irritation and itching due to: 1 rashes, 2 eczema.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>80948-007-57</NDCCode>
    <PackageDescription>8 BOTTLE in 1 PACKAGE (80948-007-57)  / 350 mL in 1 BOTTLE</PackageDescription>
    <NDC11Code>80948-0007-57</NDC11Code>
    <ProductNDC>80948-007</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Puroma Foaming Hand Alcohol Free Fragrance Free</ProprietaryName>
    <NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20210310</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M003</ApplicationNumber>
    <LabelerName>ZENITH MICRO CONTROL</LabelerName>
    <SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
    <StrengthNumber>130</StrengthNumber>
    <StrengthUnit>mg/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210310</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Helps eliminate bacteria on hands.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>85162-007-02</NDCCode>
    <PackageDescription>4 BOX in 1 CARTON (85162-007-02)  / 50 POUCH in 1 BOX / 57 g in 1 POUCH</PackageDescription>
    <NDC11Code>85162-0007-02</NDC11Code>
    <ProductNDC>85162-007</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Amerfresh Toothpowder</ProprietaryName>
    <NonProprietaryName>Sodium Fluoride</NonProprietaryName>
    <DosageFormName>POWDER</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20250813</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M021</ApplicationNumber>
    <LabelerName>Yangzhou ONE &amp; ONLY Personal Care Products Co., LTD</LabelerName>
    <SubstanceName>SODIUM FLUORIDE</SubstanceName>
    <StrengthNumber>.1</StrengthNumber>
    <StrengthUnit>g/100g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2026-03-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20250813</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>aids in the prevention of dental cavities.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>85398-018-01</NDCCode>
    <PackageDescription>1 KIT in 1 CARTON (85398-018-01)  *  57 g in 1 TUBE (85398-017-02)  *  116 g in 1 CARTON (85398-007-02) </PackageDescription>
    <NDC11Code>85398-0018-01</NDC11Code>
    <ProductNDC>85398-018</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Hermon Athletes Foot Tolnaftate 1% Kit</ProprietaryName>
    <NonProprietaryName>Tolnaftate 1% Kit</NonProprietaryName>
    <DosageFormName>KIT</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20251031</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M005</ApplicationNumber>
    <LabelerName>Beautivity LLC</LabelerName>
    <Status>Active</Status>
    <LastUpdate>2026-07-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20251031</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Directions (Cream): 1 adults and children 12 years and over, 2 use the tip of thecap to break the seal and open the tube, 3 wash the affedted skin with soap and water and dry completely before applying, 4 for athlete's foot wear well-fitting, ventilated shoes. Change shoes and socks at least once daily., 5 between the ttoes only: apply twice a day (morning and night) for 1 week or as directed by a doctor, 6 on the bottom or sides ofthe foot: apply twice a day (morning and night) for 2 weeks or as directed by a doctor, 7 for jock itch and ringworm: apply oncea day (morning or night) for 1 week or as directed by a doctor, 8 wash hands after each use, 9 children under 12 years: ask a doctor, 10 wash affected area and dry thoroughly, 11 apply a thin layer over affected area twice daily (morning and night), 12 supervise children in the use of this product, 13 use daily for2 weeks.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>16729-007-10</NDCCode>
    <PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (16729-007-10) </PackageDescription>
    <NDC11Code>16729-0007-10</NDC11Code>
    <ProductNDC>16729-007</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Simvastatin</ProprietaryName>
    <NonProprietaryName>Simvastatin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20080226</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078155</ApplicationNumber>
    <LabelerName>Accord Healthcare, Inc.</LabelerName>
    <SubstanceName>SIMVASTATIN</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20080226</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Simvastatin tablet is indicated:  To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events.  As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C):       o In adults with primary hyperlipidemia.       o In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).  As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH).  As an adjunct to diet for the treatment of adults with:       o Primary dysbetalipoproteinemia.       o Hypertriglyceridemia.</IndicationAndUsage>
    <Description>Simvastatin is a prodrug of 3-hydoroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S *,4S *),-8aβ]]. The empirical formula of simvastatin is C 25H 38O 5and its molecular weight is 418.57. Its structural formula is:. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets USP for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: microcrystalline cellulose, hydroxypropyl cellulose, hypromellose E5, croscarmellose sodium, ferric oxide red, lactose monohydrate, magnesium stearate, maize starch, talc, titanium dioxide, butylated hydroxyanisole, ascorbic acid, citric acid monohydrate, and triethyl citrate.</Description>
  </NDC>
  <NDC>
    <NDCCode>16729-007-15</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (16729-007-15) </PackageDescription>
    <NDC11Code>16729-0007-15</NDC11Code>
    <ProductNDC>16729-007</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Simvastatin</ProprietaryName>
    <NonProprietaryName>Simvastatin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20080226</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078155</ApplicationNumber>
    <LabelerName>Accord Healthcare, Inc.</LabelerName>
    <SubstanceName>SIMVASTATIN</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20080226</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Simvastatin tablet is indicated:  To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events.  As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C):       o In adults with primary hyperlipidemia.       o In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).  As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH).  As an adjunct to diet for the treatment of adults with:       o Primary dysbetalipoproteinemia.       o Hypertriglyceridemia.</IndicationAndUsage>
    <Description>Simvastatin is a prodrug of 3-hydoroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S *,4S *),-8aβ]]. The empirical formula of simvastatin is C 25H 38O 5and its molecular weight is 418.57. Its structural formula is:. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets USP for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: microcrystalline cellulose, hydroxypropyl cellulose, hypromellose E5, croscarmellose sodium, ferric oxide red, lactose monohydrate, magnesium stearate, maize starch, talc, titanium dioxide, butylated hydroxyanisole, ascorbic acid, citric acid monohydrate, and triethyl citrate.</Description>
  </NDC>
  <NDC>
    <NDCCode>16729-007-17</NDCCode>
    <PackageDescription>1000 TABLET, FILM COATED in 1 BOTTLE (16729-007-17) </PackageDescription>
    <NDC11Code>16729-0007-17</NDC11Code>
    <ProductNDC>16729-007</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Simvastatin</ProprietaryName>
    <NonProprietaryName>Simvastatin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20080226</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078155</ApplicationNumber>
    <LabelerName>Accord Healthcare, Inc.</LabelerName>
    <SubstanceName>SIMVASTATIN</SubstanceName>
    <StrengthNumber>80</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-18</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20080226</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Simvastatin tablet is indicated:  To reduce the risk of total mortality by reducing risk of coronary heart disease death, non-fatal myocardial infarction and stroke, and the need for coronary and non-coronary revascularization procedures in adults with established coronary heart disease, cerebrovascular disease, peripheral vascular disease, and/or diabetes, who are at high risk of coronary heart disease events.  As an adjunct to diet to reduce low-density lipoprotein cholesterol (LDL-C):       o In adults with primary hyperlipidemia.       o In adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH).  As an adjunct to other LDL-C-lowering therapies to reduce LDL-C in adults with homozygous familial hypercholesterolemia (HoFH).  As an adjunct to diet for the treatment of adults with:       o Primary dysbetalipoproteinemia.       o Hypertriglyceridemia.</IndicationAndUsage>
    <Description>Simvastatin is a prodrug of 3-hydoroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor that is derived synthetically from a fermentation product of Aspergillus terreus. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β(2S *,4S *),-8aβ]]. The empirical formula of simvastatin is C 25H 38O 5and its molecular weight is 418.57. Its structural formula is:. Simvastatin is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets USP for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin and the following inactive ingredients: microcrystalline cellulose, hydroxypropyl cellulose, hypromellose E5, croscarmellose sodium, ferric oxide red, lactose monohydrate, magnesium stearate, maize starch, talc, titanium dioxide, butylated hydroxyanisole, ascorbic acid, citric acid monohydrate, and triethyl citrate.</Description>
  </NDC>
  <NDC>
    <NDCCode>25682-007-01</NDCCode>
    <PackageDescription>1 VIAL, GLASS in 1 CARTON (25682-007-01)  / 10 mL in 1 VIAL, GLASS</PackageDescription>
    <NDC11Code>25682-0007-01</NDC11Code>
    <ProductNDC>25682-007</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Kanuma</ProprietaryName>
    <NonProprietaryName>Sebelipase Alfa</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20151208</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA125561</ApplicationNumber>
    <LabelerName>Alexion Pharmaceuticals, Inc.</LabelerName>
    <SubstanceName>SEBELIPASE ALFA</SubstanceName>
    <StrengthNumber>2</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Hydrolytic Lysosomal Cholesteryl Ester-specific Enzyme [EPC], Hydrolytic Lysosomal Triacylglycerol-specific Enzyme [EPC], Sterol Esterase [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2026-08-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20151208</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>KANUMA® is indicated for the treatment of patients with a diagnosis of Lysosomal Acid Lipase (LAL) deficiency.</IndicationAndUsage>
    <Description>Sebelipase alfa is a recombinant human lysosomal acid lipase (rhLAL) that is a lysosomal glycoprotein enzyme produced by recombinant DNA technology in the egg white of eggs laid by genetically engineered chickens. Purified sebelipase alfa is a monomeric glycoprotein containing 6 N-linked glycosylation sites and has a molecular mass of approximately 55 kDa. The amino acid sequence for sebelipase alfa is the same as the amino acid sequence for human LAL. The specific activity of sebelipase alfa is 195 to 345 units/mg. One unit is the amount of enzyme activity that catalyzes the hydrolysis of 1 micromole of the synthetic substrate 4-methylumbelliferyl oleate per minute at 37°C under specified assay conditions. KANUMA (sebelipase alfa) injection is supplied as a sterile, preservative-free, non-pyrogenic clear to slightly opalescent, colorless to slightly colored aqueous solution in single-dose vials for intravenous infusion. Each vial contains sebelipase alfa 20 mg/10 mL. Each mL of solution contains sebelipase alfa (2 mg), citric acid monohydrate (1.57 mg), Human Serum Albumin (10 mg), and trisodium citrate dihydrate (13.7 mg) at pH 5.9.</Description>
  </NDC>
  <NDC>
    <NDCCode>43353-007-45</NDCCode>
    <PackageDescription>45 TABLET, FILM COATED in 1 BOTTLE (43353-007-45) </PackageDescription>
    <NDC11Code>43353-0007-45</NDC11Code>
    <ProductNDC>43353-007</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Simvastatin</ProprietaryName>
    <NonProprietaryName>Simvastatin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20061220</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077691</ApplicationNumber>
    <LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
    <SubstanceName>SIMVASTATIN</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180518</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with coronary heart disease (CHD) or at high risk of CHD, simvastatin tablets can be started simultaneously with diet.</IndicationAndUsage>
    <Description>Simvastatin is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β (2S*,4S*),-8aβ]]. The molecular formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is. Simvastatin USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets USP for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin USP and the following inactive ingredients: ascorbic acid, lactose monohydrate, microcrystalline cellulose, pregelatinized starch (maize), hydroxypropyl cellulose, hypromellose, titanium dioxide, talc, citric acid monohydrate, isopropyl alcohol, magnesium stearate and butylated hydroxyanisole. Simvastatin 5 mg also contains ferric oxide yellow, simvastatin 10 mg and simvastatin 20 mg also contains ferric oxide red and ferric oxide yellow, simvastatin 40 mg and simvastatin 80 mg also contains ferric oxide red.</Description>
  </NDC>
  <NDC>
    <NDCCode>43353-007-60</NDCCode>
    <PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (43353-007-60) </PackageDescription>
    <NDC11Code>43353-0007-60</NDC11Code>
    <ProductNDC>43353-007</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Simvastatin</ProprietaryName>
    <NonProprietaryName>Simvastatin</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20061220</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA077691</ApplicationNumber>
    <LabelerName>Aphena Pharma Solutions - Tennessee, LLC</LabelerName>
    <SubstanceName>SIMVASTATIN</SubstanceName>
    <StrengthNumber>40</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>HMG-CoA Reductase Inhibitor [EPC], Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180518</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Therapy with lipid-altering agents should be only one component of multiple risk factor intervention in individuals at significantly increased risk for atherosclerotic vascular disease due to hypercholesterolemia. Drug therapy is indicated as an adjunct to diet when the response to a diet restricted in saturated fat and cholesterol and other nonpharmacologic measures alone has been inadequate. In patients with coronary heart disease (CHD) or at high risk of CHD, simvastatin tablets can be started simultaneously with diet.</IndicationAndUsage>
    <Description>Simvastatin is a lipid-lowering agent that is derived synthetically from a fermentation product of Aspergillus terreus. After oral ingestion, simvastatin, which is an inactive lactone, is hydrolyzed to the corresponding β-hydroxyacid form. This is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, which is an early and rate-limiting step in the biosynthesis of cholesterol. Simvastatin is butanoic acid, 2,2-dimethyl-,1,2,3,7,8,8a-hexahydro-3,7-dimethyl-8-[2-(tetrahydro-4-hydroxy-6-oxo-2H-pyran-2-yl)-ethyl]-1-naphthalenyl ester, [1S-[1α,3α,7β,8β (2S*,4S*),-8aβ]]. The molecular formula of simvastatin is C25H38O5 and its molecular weight is 418.57. Its structural formula is. Simvastatin USP is a white to off-white, nonhygroscopic, crystalline powder that is practically insoluble in water, and freely soluble in chloroform, methanol and ethanol. Simvastatin tablets USP for oral administration contain either 5 mg, 10 mg, 20 mg, 40 mg or 80 mg of simvastatin USP and the following inactive ingredients: ascorbic acid, lactose monohydrate, microcrystalline cellulose, pregelatinized starch (maize), hydroxypropyl cellulose, hypromellose, titanium dioxide, talc, citric acid monohydrate, isopropyl alcohol, magnesium stearate and butylated hydroxyanisole. Simvastatin 5 mg also contains ferric oxide yellow, simvastatin 10 mg and simvastatin 20 mg also contains ferric oxide red and ferric oxide yellow, simvastatin 40 mg and simvastatin 80 mg also contains ferric oxide red.</Description>
  </NDC>
  <NDC>
    <NDCCode>65008-007-06</NDCCode>
    <PackageDescription>170 g in 1 TUBE (65008-007-06) </PackageDescription>
    <NDC11Code>65008-0007-06</NDC11Code>
    <ProductNDC>65008-007</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sunsorb Reef Safe Spf50</ProprietaryName>
    <NonProprietaryName>Homosalate, Zinc Oxide, Octocrylene</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20190715</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>QS Key West Aloe, LLC</LabelerName>
    <SubstanceName>HOMOSALATE; ZINC OXIDE; OCTOCRYLENE</SubstanceName>
    <StrengthNumber>100; 57; 50</StrengthNumber>
    <StrengthUnit>mg/g; mg/g; mg/g</StrengthUnit>
    <Pharm_Classes>Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-11-13</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20190715</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>- Helps prevent sunburn. - If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>65278-007-15</NDCCode>
    <PackageDescription>1 TUBE in 1 CARTON (65278-007-15)  &gt; 50 mL in 1 TUBE</PackageDescription>
    <NDC11Code>65278-0007-15</NDC11Code>
    <ProductNDC>65278-007</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Peter Thomas Roth Cc</ProprietaryName>
    <ProprietaryNameSuffix>Light To Medium</ProprietaryNameSuffix>
    <NonProprietaryName>Titanium Dioxide And Zinc Oxide</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20130222</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>June Jacobs Laboratories LLC</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>102.6; 57.6</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>65278-007-16</NDCCode>
    <PackageDescription>15 mL in 1 TUBE (65278-007-16)</PackageDescription>
    <NDC11Code>65278-0007-16</NDC11Code>
    <ProductNDC>65278-007</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Peter Thomas Roth Cc</ProprietaryName>
    <ProprietaryNameSuffix>Light To Medium</ProprietaryNameSuffix>
    <NonProprietaryName>Titanium Dioxide And Zinc Oxide</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20130222</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>June Jacobs Laboratories LLC</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>102.6; 57.6</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>55312-000-56</NDCCode>
    <PackageDescription>226 g in 1 BOTTLE, PLASTIC (55312-000-56)</PackageDescription>
    <NDC11Code>55312-0000-56</NDC11Code>
    <ProductNDC>55312-000</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Western Family Broad Spectrum Sunscreen</ProprietaryName>
    <ProprietaryNameSuffix>Spf 70</ProprietaryNameSuffix>
    <NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20140303</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>WESTERN FAMILY FOODS, INC.</LabelerName>
    <SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
    <StrengthNumber>3; 15; 5; 10; 6</StrengthNumber>
    <StrengthUnit>g/100g; g/100g; g/100g; g/100g; g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>helps prevent sunburn. if used as directed with other sun protection measures( see directions) , decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>55312-001-10</NDCCode>
    <PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (55312-001-10) </PackageDescription>
    <NDC11Code>55312-0001-10</NDC11Code>
    <ProductNDC>55312-001</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Stool Softener Plus Stimulant Laxative</ProprietaryName>
    <NonProprietaryName>Docusate Sodium And Sennosides</NonProprietaryName>
    <DosageFormName>TABLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20100701</StartMarketingDate>
    <EndMarketingDate>20191231</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part334</ApplicationNumber>
    <LabelerName>Western Family Foods, Inc.</LabelerName>
    <SubstanceName>DOCUSATE SODIUM; SENNOSIDES</SubstanceName>
    <StrengthNumber>50; 8.6</StrengthNumber>
    <StrengthUnit>mg/1; mg/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <StartMarketingDatePackage>20100701</StartMarketingDatePackage>
    <EndMarketingDatePackage>20191231</EndMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>55312-002-01</NDCCode>
    <PackageDescription>100 PACKET in 1 CARTON (55312-002-01)  &gt; .6 mL in 1 PACKET</PackageDescription>
    <NDC11Code>55312-0002-01</NDC11Code>
    <ProductNDC>55312-002</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Western Family Alcohol Swabs</ProprietaryName>
    <NonProprietaryName>Isopropyl Alcohol</NonProprietaryName>
    <DosageFormName>LIQUID</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20120114</StartMarketingDate>
    <EndMarketingDate>20180310</EndMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part333A</ApplicationNumber>
    <LabelerName>Western Family Foods, Inc.</LabelerName>
    <SubstanceName>ISOPROPYL ALCOHOL</SubstanceName>
    <StrengthNumber>70</StrengthNumber>
    <StrengthUnit>mL/100mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2018-03-14</LastUpdate>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>55312-003-01</NDCCode>
    <PackageDescription>181.4 g in 1 TUBE (55312-003-01)</PackageDescription>
    <NDC11Code>55312-0003-01</NDC11Code>
    <ProductNDC>55312-003</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Western Family Complete Whitening</ProprietaryName>
    <NonProprietaryName>Sodium Fluoride</NonProprietaryName>
    <DosageFormName>PASTE, DENTIFRICE</DosageFormName>
    <RouteName>DENTAL</RouteName>
    <StartMarketingDate>20081124</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part355</ApplicationNumber>
    <LabelerName>Western Family Foods, Inc</LabelerName>
    <SubstanceName>SODIUM FLUORIDE</SubstanceName>
    <StrengthNumber>2.43</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Helps protect against cavities.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>55312-004-44</NDCCode>
    <PackageDescription>532 mL in 1 BOTTLE, PLASTIC (55312-004-44) </PackageDescription>
    <NDC11Code>55312-0004-44</NDC11Code>
    <ProductNDC>55312-004</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Anti Cavity Rinse</ProprietaryName>
    <NonProprietaryName>Sodium Fluoride</NonProprietaryName>
    <DosageFormName>RINSE</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20090512</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part355</ApplicationNumber>
    <LabelerName>Western Family Foods, Inc</LabelerName>
    <SubstanceName>SODIUM FLUORIDE</SubstanceName>
    <StrengthNumber>.2</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2020-09-25</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20090512</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>55312-005-22</NDCCode>
    <PackageDescription>85 g in 1 BOTTLE, PLASTIC (55312-005-22)</PackageDescription>
    <NDC11Code>55312-0005-22</NDC11Code>
    <ProductNDC>55312-005</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Western Family Sport Sunscreen</ProprietaryName>
    <ProprietaryNameSuffix>Spf 30</ProprietaryNameSuffix>
    <NonProprietaryName>Avobenzone Homosalate Octisalate Octocrylene Oxybenzone</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20140702</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>WESTERN FAMILY FOODS, INC.</LabelerName>
    <SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
    <StrengthNumber>2; 10; 5; 4; 5</StrengthNumber>
    <StrengthUnit>g/100g; g/100g; g/100g; g/100g; g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decrease the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>55312-005-56</NDCCode>
    <PackageDescription>226 g in 1 BOTTLE, PLASTIC (55312-005-56)</PackageDescription>
    <NDC11Code>55312-0005-56</NDC11Code>
    <ProductNDC>55312-005</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Western Family Sport Sunscreen</ProprietaryName>
    <ProprietaryNameSuffix>Spf 30</ProprietaryNameSuffix>
    <NonProprietaryName>Avobenzone Homosalate Octisalate Octocrylene Oxybenzone</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20140702</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>WESTERN FAMILY FOODS, INC.</LabelerName>
    <SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
    <StrengthNumber>2; 10; 5; 4; 5</StrengthNumber>
    <StrengthUnit>g/100g; g/100g; g/100g; g/100g; g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decrease the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
  </NDC>
</NDCList>
                    
<NDCList><NDC><NDCCode>55312-007-57</NDCCode><ProprietaryName>Western Family Baby Broad Spectrum Sunscreen</ProprietaryName><NonProprietaryName>Avobenzone,homosalate, Octocrylene, Octisalate, Oxybenzone</NonProprietaryName></NDC><NDC><NDCCode>55312-006-57</NDCCode><ProprietaryName>Western Family Broad Spectrum Sunscreenspf 50</ProprietaryName><NonProprietaryName>Avobenzone Homosalate Octisalate Octocrylene Oxybenzone</NonProprietaryName></NDC><NDC><NDCCode>55312-017-57</NDCCode><ProprietaryName>Western Family</ProprietaryName><NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene</NonProprietaryName></NDC><NDC><NDCCode>55312-034-02</NDCCode><ProprietaryName>Western Family Hemorrhoidal</ProprietaryName><NonProprietaryName>Mineral Oil, Petrolatum, Phenylephrine Hcl</NonProprietaryName></NDC><NDC><NDCCode>55312-035-57</NDCCode><ProprietaryName>Western Family Hemorrhoidal</ProprietaryName><NonProprietaryName>Mineral Oil</NonProprietaryName></NDC><NDC><NDCCode>55312-173-24</NDCCode><ProprietaryName>Lice</ProprietaryName><NonProprietaryName>Piperonyl Butoxide, Pyrethrum Extract</NonProprietaryName></NDC><NDC><NDCCode>10095-007-01</NDCCode><ProprietaryName>Sulfur</ProprietaryName><NonProprietaryName>Sulfur</NonProprietaryName></NDC><NDC><NDCCode>41701-007-39</NDCCode><NonProprietaryName>Desmopressin</NonProprietaryName></NDC><NDC><NDCCode>42913-007-00</NDCCode><ProprietaryName>Xtreme Power Stick Ignition</ProprietaryName><NonProprietaryName>Aluminum Sesquichlorohydrate</NonProprietaryName></NDC><NDC><NDCCode>49252-007-57</NDCCode><ProprietaryName>Duloxetine</ProprietaryName><NonProprietaryName>Duloxetine</NonProprietaryName></NDC><NDC><NDCCode>71564-007-02</NDCCode><ProprietaryName>Okeeffes Working Hands Eczema Relief</ProprietaryName><NonProprietaryName>Colloidal Oatmeal</NonProprietaryName></NDC><NDC><NDCCode>80948-007-57</NDCCode><ProprietaryName>Puroma Foaming Hand Alcohol Free Fragrance Free</ProprietaryName><NonProprietaryName>Benzalkonium Chloride</NonProprietaryName></NDC><NDC><NDCCode>85162-007-02</NDCCode><ProprietaryName>Amerfresh Toothpowder</ProprietaryName><NonProprietaryName>Sodium Fluoride</NonProprietaryName></NDC><NDC><NDCCode>85398-018-01</NDCCode><ProprietaryName>Hermon Athletes Foot Tolnaftate 1% Kit</ProprietaryName><NonProprietaryName>Tolnaftate 1% Kit</NonProprietaryName></NDC><NDC><NDCCode>16729-007-10</NDCCode><ProprietaryName>Simvastatin</ProprietaryName><NonProprietaryName>Simvastatin</NonProprietaryName></NDC><NDC><NDCCode>16729-007-15</NDCCode><ProprietaryName>Simvastatin</ProprietaryName><NonProprietaryName>Simvastatin</NonProprietaryName></NDC><NDC><NDCCode>16729-007-17</NDCCode><ProprietaryName>Simvastatin</ProprietaryName><NonProprietaryName>Simvastatin</NonProprietaryName></NDC><NDC><NDCCode>25682-007-01</NDCCode><ProprietaryName>Kanuma</ProprietaryName><NonProprietaryName>Sebelipase Alfa</NonProprietaryName></NDC><NDC><NDCCode>43353-007-45</NDCCode><ProprietaryName>Simvastatin</ProprietaryName><NonProprietaryName>Simvastatin</NonProprietaryName></NDC><NDC><NDCCode>43353-007-60</NDCCode><ProprietaryName>Simvastatin</ProprietaryName><NonProprietaryName>Simvastatin</NonProprietaryName></NDC><NDC><NDCCode>65008-007-06</NDCCode><ProprietaryName>Sunsorb Reef Safe Spf50</ProprietaryName><NonProprietaryName>Homosalate, Zinc Oxide, Octocrylene</NonProprietaryName></NDC><NDC><NDCCode>65278-007-15</NDCCode><ProprietaryName>Peter Thomas Roth Cc</ProprietaryName><NonProprietaryName>Titanium Dioxide And Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>65278-007-16</NDCCode><ProprietaryName>Peter Thomas Roth Cc</ProprietaryName><NonProprietaryName>Titanium Dioxide And Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>55312-000-56</NDCCode><ProprietaryName>Western Family Broad Spectrum Sunscreen</ProprietaryName><NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene, Oxybenzone</NonProprietaryName></NDC><NDC><NDCCode>55312-001-10</NDCCode><ProprietaryName>Stool Softener Plus Stimulant Laxative</ProprietaryName><NonProprietaryName>Docusate Sodium And Sennosides</NonProprietaryName></NDC><NDC><NDCCode>55312-002-01</NDCCode><ProprietaryName>Western Family Alcohol Swabs</ProprietaryName><NonProprietaryName>Isopropyl Alcohol</NonProprietaryName></NDC><NDC><NDCCode>55312-003-01</NDCCode><ProprietaryName>Western Family Complete Whitening</ProprietaryName><NonProprietaryName>Sodium Fluoride</NonProprietaryName></NDC><NDC><NDCCode>55312-004-44</NDCCode><ProprietaryName>Anti Cavity Rinse</ProprietaryName><NonProprietaryName>Sodium Fluoride</NonProprietaryName></NDC><NDC><NDCCode>55312-005-22</NDCCode><ProprietaryName>Western Family Sport Sunscreen</ProprietaryName><NonProprietaryName>Avobenzone Homosalate Octisalate Octocrylene Oxybenzone</NonProprietaryName></NDC><NDC><NDCCode>55312-005-56</NDCCode><ProprietaryName>Western Family Sport Sunscreen</ProprietaryName><NonProprietaryName>Avobenzone Homosalate Octisalate Octocrylene Oxybenzone</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.

Parameter Meaning Notes
domain Domain
  • Currently following data domains are supported:
    • NPI - NPI Number Lookup
    • HCPCS - Healthcare Provider Procedure Coding System Lookup
    • NDC - National Drug Code Lookup
    • NDCA - Animal Drug Product Listing Directory Lookup
    • CLIA - Clinical Laboratory Improvement Amendments
    • HPTC - Healthcare Provider Taxonomy Code Lookup
    • NAICS - North American Industry Classification System Lookup
    • LOINC - Logical Observation Identifiers Names and Codes (LOINC®) Lookup
    • DRG - Diagnosis-Related Group Lookup
    • ICD9 - Ninth Revision of the International Classification of Diseases Lookup
    • ICD10 - Tenth Revision of the International Classification of Diseases Lookup
    • ICD10DRUGS - ICD-10-CM Table Of Drugs And Chemicals Lookup
    • ZIP - Postal Codes used by the United States Postal Service
operation Operation
  • Generic operations:
    • check_status - this method allows to get current code status.
    • search - allows retrieval of set of items (up to 30) 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.
    • 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.
  • 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.
q Query
  • The search expression. May vary depending on the operation.
    • Free form text like: “q=blood glucose monitor” (search operation)
    • Exact code value : “q=1285636522” (getcode operation)
    • List of codes : “q=1285636522,1730198755,1427145176,1487730636” (getcodes operation)
zipcode Query for NPI by Zip code/radius Lookup
  • The search expression for zip code.
    • Exact code value : “zipcode=98052” (search operation)
radius Query for NPI by Zip code/radius Lookup
  • The search expression for radius.
    • Exact code value : “radius=20” (search operation)
fromdate Query for Deactivated NPI
  • The search expression for fromdate.
    • Exact code value : “fromdate=05/01/2023” (search operation - format MM/DD/YYYY)
todate Query for Deactivated NPI
  • The search expression for tomdate.
    • Exact code value : “todate=05/31/2023” (search operation - format MM/DD/YYYY)
tin Query for IRS Lookup
  • The search expression for tin number.
    • Exact code value : “tin=942404110” (search operation)
tinname Query for IRS Lookup
  • The search expression for tin name.
    • Free form text like: “tinname=apple inc.” (search operation)
rt Data format
  • If you don't specify an rt parameter, the API returns data in the JSON format. This is equivalent to rt=json.
  • Accepted values are:
    • json
    • minjson (minified json)
    • xml
    • minxml (minified xml)
token Your API key
num Number of search results to return
  • You can specify the how many results to return for the current search.
  • Valid values are integers between 1 and 100, inclusive.
  • If num is not used, a value of 30 is assumed.
friendlyprint Returns a response with indentations and line breaks
  • If friendlyprint is not used, a “true” value is assumed. This is equivalent to friendlyprint=true.
  • Accepted values are:
    • true - the results returned by the server will be more “human readable”.
    • false - the results returned by the server will not have indentations and line breaks.
ICD9/ICD10 Parameters
codeType Specifies whether ICD code is "dx"(Diagnosis) or "pcs"(Procedure).
  • Required for ICD only.
  • If you don't specify an codeType parameter this is equivalent to codeType=dx.
  • Accepted values are:
    • dx (diagnosis)
    • pcs (procedure)
qf Specifies predicate in form of tuple "qf=City:true:Phoenix".
  • Expected to be one or many "qf" parameters in request.
  • Required for following operations:
    • validate
    • paginate_with_predicates
    • search_with_predicates
  • Tuple values are (order based):
    • NPI Field Name
      • NPI
      • Phone
      • Fax
      • FirstName
      • LastName
      • OrganizationName
      • OtherOrganizationName
      • Address1
      • Address2
      • Zip
      • City
      • State
      • IndividualOrganizationCode
    • Exact Match
      • true
      • false
    • Expected Field Value
orderField Sort order field name
  • Expected to be one "orderField" parameter in request.
  • Required for following operations:
    • paginate_with_predicates
  • Values are:
    • NPI
    • Phone
    • Fax
    • FirstName
    • LastName
    • OrganizationName
    • OtherOrganizationName
    • Address1
    • Address2
    • Zip
    • City
    • State
    • IndividualOrganizationCode
pageNo Page Number
  • Ordinal page number.
  • Required for following operations:
    • paginate_with_predicates
    • zipradius
    • npideactivated
pageSize Page Size
  • Expected page size.
  • Required for following operations:
    • paginate_with_predicates

DataLabs Coding Library - Quering NPI Registry - REST API Examples

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();
    }
}
            
        

Output

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

Done. Press any key to exit ...
            
        

Full Text Search Fundamentals

Facts

Everybody uses full text search. Full-text search is the most common technique used in search engines. The amount of information has just become too much to access it using navigation and categories alone. Full-text search reduces the hassle of searching for a keyword in huge amounts of metadata, such as the World Wide Web and commercial-scale databases. Full-text search became popular in late 1990s, when the Internet and Big Data began to became a part of everyday life.

How does it work

Users only provide keywords and expect the search engine to provide good results. Relevancy of documents is expected to be good and users want the results they are looking to be present in the top ten. How relevant a document is search engine decides based on scientifically proven algorithms. Besides getting the best results the user wants to be supported during the search process. Features like suggestions and highlighting on the result excerpt can help with this.

Full Text Search & DataLabs REST API

DataLabs REST API allows you to search the full text of healthcare providers database (NPI Registry). To find the information you need and make your search easy, please use our REST API for automation, or visit our NPI Lookup page for manual search ( NPI Number Lookup). We are still improving and enhancing Full Text NPI Search based on users feedbacks. Please email your comments and suggestions for improvement using our feedback page.

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();
        }
    }
                
            

Output

                
    {
      "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();
        }
    }
                
            

Output

                
    {
      "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();
        }
    }
                
            

Output

                
    {
      "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();
        }
    }
                
            

Output

                
{
  "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"
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}
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