RESTful Lookup — Test-Drive (2007 – 2026)

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{
  "NDC": [
    {
      "NDCCode": "61995-0205-4",
      "PackageDescription": "113 g in 1 TUBE (61995-0205-4)",
      "NDC11Code": "61995-0205-04",
      "ProductNDC": "61995-0205",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sunbrellas Family Sunblock Spf 45",
      "NonProprietaryName": "Homosalate, Octocrylene, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicilate, Titanium Dioxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20091103",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "The Hain Celestial Group, Inc.",
      "SubstanceName": "HOMOSALATE; OCTOCRYLENE; OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE",
      "StrengthNumber": "10; 10; 7.5; 5; 2",
      "StrengthUnit": "g/100g; g/100g; g/100g; g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "USES: 1 Helps prevent sunburns, 2 Higher SPF gives more sunburn protection, 3 Moderate sun protection product, 4 apply sunscreen liberally to all exposed skin area 15 to 20 minutes before sun exposure, 5 Reapply as needed after towel drying, swimming or sweating, 6 Children after 6 months, ask doctor."
    },
    {
      "NDCCode": "13630-0205-4",
      "PackageDescription": "192 mL in 1 CAN (13630-0205-4) ",
      "NDC11Code": "13630-0205-04",
      "ProductNDC": "13630-0205",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Aloe Up",
      "ProprietaryNameSuffix": "Broad Spectrum Spf 15",
      "NonProprietaryName": "Avobenzone, Octisalate, And Octocrylene",
      "DosageFormName": "SPRAY",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20210930",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Prime Packaging, Inc.",
      "SubstanceName": "AVOBENZONE; OCTISALATE; OCTOCRYLENE",
      "StrengthNumber": "16.24; 40.6; 15.02",
      "StrengthUnit": "mg/mL; mg/mL; mg/mL",
      "Status": "Deprecated",
      "LastUpdate": "2024-09-27",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20210930",
      "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": "15631-0205-4",
      "PackageDescription": "2500 PELLET in 1 PACKAGE (15631-0205-4) ",
      "NDC11Code": "15631-0205-04",
      "ProductNDC": "15631-0205",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Gentiana Quinqueflora",
      "NonProprietaryName": "Gentiana Quinqueflora",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20151027",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Rxhomeo Private Limited d.b.a. Rxhomeo, Inc",
      "SubstanceName": "GENTIANELLA QUINQUEFOLIA",
      "StrengthNumber": "1",
      "StrengthUnit": "[hp_X]/1",
      "Status": "Deprecated",
      "LastUpdate": "2022-01-04",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20211231",
      "StartMarketingDatePackage": "20180101",
      "SamplePackage": "N",
      "IndicationAndUsage": "Condition listed above or as directed by the physician."
    },
    {
      "NDCCode": "22840-0205-4",
      "PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (22840-0205-4) ",
      "NDC11Code": "22840-0205-04",
      "ProductNDC": "22840-0205",
      "ProductTypeName": "STANDARDIZED ALLERGENIC",
      "ProprietaryName": "Standardized Orchard Grass Pollen",
      "NonProprietaryName": "Dactylis Glomerata",
      "DosageFormName": "SOLUTION",
      "RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
      "StartMarketingDate": "19680915",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA101839",
      "LabelerName": "Greer Laboratories, Inc.",
      "SubstanceName": "DACTYLIS GLOMERATA POLLEN",
      "StrengthNumber": "10000",
      "StrengthUnit": "[BAU]/mL",
      "Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]",
      "Status": "Active",
      "LastUpdate": "2025-06-12",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "19680915",
      "SamplePackage": "N",
      "IndicationAndUsage": "GREER Standardized Grass Pollen Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergy to one or more of the following grass pollens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, Timothy., 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen. .",
      "Description": "Standardized Grass Pollen Allergenic Extracts include Standardized Bermuda Grass Pollen ( Cynodon dactylon) at 10,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol (preservative); and the following grasses at both 10,000 BAU/milliliter and 100,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol: Standardized Kentucky Blue (June) Grass Pollen ( Poa pratensis), Standardized Meadow Fescue Grass Pollen ( Festuca elatior), Standardized Orchard Grass Pollen ( Dactylis glomerata), Standardized Perennial Rye Grass Pollen ( Lolium perenne), Standardized Redtop Grass Pollen ( Agrostis alba), Standardized Sweet Vernal Grass Pollen ( Anthoxanthum odoratum), and Standardized Timothy Grass Pollen ( Phleum pratense). Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Allergenic Extracts should be clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Allergenic Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing. 4,5,6,7 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter."
    },
    {
      "NDCCode": "37662-0205-4",
      "PackageDescription": "10000 PELLET in 1 BOTTLE, GLASS (37662-0205-4) ",
      "NDC11Code": "37662-0205-04",
      "ProductNDC": "37662-0205",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Castoreum",
      "NonProprietaryName": "Castoreum",
      "DosageFormName": "PELLET",
      "RouteName": "ORAL",
      "StartMarketingDate": "20220526",
      "MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
      "LabelerName": "Hahnemann Laboratories, INC.",
      "SubstanceName": "CASTOR FIBER SCENT GLAND SECRETION",
      "StrengthNumber": "200",
      "StrengthUnit": "[hp_C]/1",
      "Status": "Active",
      "LastUpdate": "2022-05-28",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20220526",
      "SamplePackage": "N"
    },
    {
      "NDCCode": "49288-0205-4",
      "PackageDescription": "30 mL in 1 VIAL, MULTI-DOSE (49288-0205-4)",
      "NDC11Code": "49288-0205-04",
      "ProductNDC": "49288-0205",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Standardized Meadow Fescue Grass Pollen",
      "NonProprietaryName": "Standardized Meadow Fescue Grass Pollen",
      "DosageFormName": "INJECTION, SOLUTION",
      "RouteName": "INTRADERMAL; SUBCUTANEOUS",
      "StartMarketingDate": "19970613",
      "MarketingCategoryName": "BLA",
      "ApplicationNumber": "BLA102227",
      "LabelerName": "Antigen Laboratories, Inc.",
      "SubstanceName": "FESTUCA PRATENSIS POLLEN",
      "StrengthNumber": "100000",
      "StrengthUnit": "[BAU]/mL",
      "Pharm_Classes": "Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "INDICATIONS AND USAGE     Allergenic extract is indicated for diagnostic testing and treatment (immunotherapy) of patients whose histories indicate allergic symptoms upon natural exposure to grass allergens. Confirmation is determined by skin testing. 10,000 BAU/ml extracts are intended for percutaneous testing. If negative, 100,000 BAU/ml products can be used for percutaneous test. Dilutions made from 10,000 BAU/ml products are indicated for immunotherapy of previously untreated patients. If 10,000 BAU/ml product is tolerated and symptoms persist, dilutions made from 100,000 BAU/ml can be administered. Standardized Grass Pollen extracts labeled in Bioequivalent Allergy Units (BAU/ml) are not interchangeable with grass pollen extracts labeled In Allergy Units (AU/ml) or with non-standardized grass pollen extracts.",
      "Description": "DESCRIPTION     Antigen Laboratories' Standardized Grass Pollen allergenic extracts are sterile and intended for dilution prior to skin testing and/or immunotherapy. The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. Standardized Grass Pollen allergenic extract labeled in BAU/ml is not interchangeable with grass pollen extract labeled in AU/ml or with non-standardized grass pollen extract.     Potency of Standardized Grass Pollen allergenic extract is determined by comparison to a Center for Biologics Evaluation and Research (CBER) approved reference. References are available for pollen extracts of Orchard Grass (Dactylis glomerata), Perennial Rye Grass (Lolium perenne), Timothy Grass (Phleum pratense), Redtop Grass (Agrostis alba), Kentucky (June) Bluegrass (Poa pratensis), Bermuda Grass (Cynodon dactylon), Meadow Fescue Grass (Festuca elatior), and Sweet Vernal Grass (Anthoxanthum odoratum). Quantitative skin testing is used by CBER to establish reference's potency as Bioequivalent Allergy Units (BAU). CBER reference labeled 10,000 BAU/ml produces a sum of erythema diameter of 50 mm with highly puncture reactive subjects at an intradermal dilution of approximately 1:500,000.11,17 CBER references labeled 100,000 BAU/ml produce a SumE=50 mm at an intradermal dilution of 1:5,000,000. Relative potency of Standardized Grass Pollen allergenic extracts to CBER reference is determined by Enzyme-linked Immunosorbent Assay (ELISA).     In addition to relative potency testing of Standardized Grass Pollen extract the following testing is performed:     1. Microscopic examination to confirm identity and purity of source pollens.     2. lsoelectric focusing (IEF) pattern of source material is compared to respective CBER reference extract.     3. lsoelectric focusing pattern of final 100,000 BAU/ml (10,000 BAU/ml Bermuda Grass) product is compared to CBER reference extract.     4. Ninhydrin Protein Analysis.     5. Glycerine Analysis. (A minimum of 50% v/v glycerine for optimal stability during the entire dating period.)     6. Sterility Testing.     7. Animal Safety Testing.     Standardized Grass Pollen allergenic extracts are extracted at 1:10 weight to volume (w/v) ratio of source material to extraction fluid. Bermuda Grass is only available in 10,000 BAU/ml. Standardized Grass Pollen extracts are diluted after extraction to fall in acceptable relative potency range for a 100,000 BAU/ml or 10,000 BAU/ml (Bermuda Grass) product. Standardized Grass Pollen allergenic extracts (except Bermuda) of 10,000 BAU/ml potency are prepared by diluting the 100,000 BAU/ml extract 1:10 with extracting fluid.    Various mixtures of eight Standardized Grass Pollen extracts are available. Mixtures of Standardized Grass Pollen extracts with non-standardized grass pollen extracts are available. Concentrations of Standardized Grass Pollen extracts (BAU/ml) and non-standardized grass pollen extracts (w/v) in a mixture are printed on the last page of this circular, if applicable.     Active Ingredients: Allergens are described by common and scientific name on container label or last page of this circular. Preservative is 50% v/v glycerine. Inactive ingredients are 0.95% sodium chloride, 0.24% sodium bicarbonate and water for injection."
    },
    {
      "NDCCode": "51514-0205-1",
      "PackageDescription": "4 g in 1 CONTAINER (51514-0205-1)",
      "NDC11Code": "51514-0205-01",
      "ProductNDC": "51514-0205",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Gap Favorite Lip Balm",
      "ProprietaryNameSuffix": "Juicy Pear Spf 18",
      "NonProprietaryName": "Octinoxate And Oxybenzone",
      "DosageFormName": "STICK",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20111116",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "Autumn Harp, Inc",
      "SubstanceName": "OCTINOXATE; OXYBENZONE",
      "StrengthNumber": "7.5; 6",
      "StrengthUnit": "g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231"
    },
    {
      "NDCCode": "51754-0205-2",
      "PackageDescription": "5 VIAL in 1 CARTON (51754-0205-2)  > 4 mL in 1 VIAL",
      "NDC11Code": "51754-0205-02",
      "ProductNDC": "51754-0205",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Verapamil Hydrochloride",
      "NonProprietaryName": "Verapamil Hydrochloride",
      "DosageFormName": "INJECTION",
      "RouteName": "INTRAVENOUS",
      "StartMarketingDate": "20180611",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA018925",
      "LabelerName": "EXELA PHARMA SCIENCES, LLC",
      "SubstanceName": "VERAPAMIL HYDROCHLORIDE",
      "StrengthNumber": "2.5",
      "StrengthUnit": "mg/mL",
      "Pharm_Classes": "Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]",
      "Status": "Deprecated",
      "LastUpdate": "2025-01-01",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20241231",
      "StartMarketingDatePackage": "20180611",
      "SamplePackage": "N",
      "IndicationAndUsage": "Verapamil is indicated for the treatment of supraventricular tachyarrhythmias, including: 1 Rapid conversion to sinus rhythm of paroxysmal supraventricular tachycardias, including those associated with accessory bypass tracts (Wolff-Parkinson-White [WPW] and Lown-Ganong-Levine [LGL] syndromes). When clinically advisable, appropriate vagal maneuvers (e.g., Valsalva maneuver) should be attempted prior to Verapamil administration., 2 Temporary control of rapid ventricular rate in atrial flutter or atrial fibrillation, except when the atrial flutter and/or atrial fibrillation are associated with accessory bypass tracts (Wolff-Parkinson-White [WPW] and Lown-Ganong-Levine [LGL] syndromes).",
      "Description": "Verapamil hydrochloride is a calcium antagonist or slow-channel inhibitor available as a sterile solution for intravenous injection in 5-mg (2 ml) and 10-mg (4 ml) vials. Each form contains Verapamil HCl 2.5 mg/ml and sodium chloride 8.5 mg/ml in water for injection. Hydrochloric acid and/or sodium hydroxide is used for pH adjustment. The pH of the solution is between 4.1 and 6.0. The structural formula of verapamil HCl is given below. Benzeneacetonitrile, α-[3-[[2-(3,4-dimethoxyphenyl)ethyl] methylamino]propyl]-3,4-dimethoxy-α-(1-methylethyl) hydrochloride. Verapamil hydrochloride is an almost white, crystalline powder, practically free of odor, with a bitter taste. It is soluble in water, chloroform, and methanol. Verapamil hydrochloride is not chemically related to other antiarrhythmic drugs."
    },
    {
      "NDCCode": "68599-0205-1",
      "PackageDescription": "144 PACKET in 1 CARTON (68599-0205-1)  / 4 g in 1 PACKET",
      "NDC11Code": "68599-0205-01",
      "ProductNDC": "68599-0205",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Thera Calazinc Body Shield",
      "NonProprietaryName": "Zinc Oxide",
      "DosageFormName": "PASTE",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20110901",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M016",
      "LabelerName": "McKesson Medical-Surgical Inc.",
      "SubstanceName": "ZINC OXIDE",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/g",
      "Status": "Active",
      "LastUpdate": "2024-06-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20110901",
      "SamplePackage": "N",
      "IndicationAndUsage": ": 1 For the treatment and/or prevention of diaper rash, 2 temporarily protects and helps relieve minor skin irritation and itching due to rashes ."
    },
    {
      "NDCCode": "68599-0205-4",
      "PackageDescription": "113 g in 1 TUBE (68599-0205-4) ",
      "NDC11Code": "68599-0205-04",
      "ProductNDC": "68599-0205",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Thera Calazinc Body Shield",
      "NonProprietaryName": "Zinc Oxide",
      "DosageFormName": "PASTE",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20110901",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M016",
      "LabelerName": "McKesson Medical-Surgical Inc.",
      "SubstanceName": "ZINC OXIDE",
      "StrengthNumber": "200",
      "StrengthUnit": "mg/g",
      "Status": "Active",
      "LastUpdate": "2024-06-19",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20110901",
      "SamplePackage": "N",
      "IndicationAndUsage": ": 1 For the treatment and/or prevention of diaper rash, 2 temporarily protects and helps relieve minor skin irritation and itching due to rashes ."
    },
    {
      "NDCCode": "71335-0205-4",
      "PackageDescription": "15 TABLET, FILM COATED in 1 BOTTLE (71335-0205-4) ",
      "NDC11Code": "71335-0205-04",
      "ProductNDC": "71335-0205",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ondansetron Hydrochloride",
      "NonProprietaryName": "Ondansetron Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20070731",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078539",
      "LabelerName": "Bryant Ranch Prepack",
      "SubstanceName": "ONDANSETRON HYDROCHLORIDE",
      "StrengthNumber": "4",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-08-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20180214",
      "SamplePackage": "N",
      "IndicationAndUsage": "Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with. Ondansetron tablets are also indicated for the prevention of postoperative nausea and/or vomiting.",
      "Description": "The active ingredient in ondansetron tablets, USP is ondansetron hydrochloride as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula: The molecular formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.9 g/mol. Ondansetron hydrochloride USP (dihydrate) is a white to off-white powder that is soluble in water and normal saline. Ondansetron tablets, USP for oral administration contain ondansetron hydrochloride USP (dihydrate) equivalent to 4 mg or 8 mg or 24 mg of ondansetron. Each film-coated tablet also contains the inactive ingredients anhydrous lactose, microcrystalline cellulose, pregelatinized starch (maize), magnesium stearate, triacetin, titanium dioxide and hypromellose. In addition 8 mg tablet also contains iron oxide yellow and 24 mg tablet also contains iron oxide red. Meets USP dissolution test 6."
    },
    {
      "NDCCode": "71335-0205-6",
      "PackageDescription": "4 TABLET, FILM COATED in 1 BOTTLE (71335-0205-6) ",
      "NDC11Code": "71335-0205-06",
      "ProductNDC": "71335-0205",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Ondansetron Hydrochloride",
      "NonProprietaryName": "Ondansetron Hydrochloride",
      "DosageFormName": "TABLET, FILM COATED",
      "RouteName": "ORAL",
      "StartMarketingDate": "20070731",
      "MarketingCategoryName": "ANDA",
      "ApplicationNumber": "ANDA078539",
      "LabelerName": "Bryant Ranch Prepack",
      "SubstanceName": "ONDANSETRON HYDROCHLORIDE",
      "StrengthNumber": "4",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]",
      "Status": "Active",
      "LastUpdate": "2024-08-22",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20261231",
      "StartMarketingDatePackage": "20211227",
      "SamplePackage": "N",
      "IndicationAndUsage": "Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with. Ondansetron tablets are also indicated for the prevention of postoperative nausea and/or vomiting.",
      "Description": "The active ingredient in ondansetron tablets, USP is ondansetron hydrochloride as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula: The molecular formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.9 g/mol. Ondansetron hydrochloride USP (dihydrate) is a white to off-white powder that is soluble in water and normal saline. Ondansetron tablets, USP for oral administration contain ondansetron hydrochloride USP (dihydrate) equivalent to 4 mg or 8 mg or 24 mg of ondansetron. Each film-coated tablet also contains the inactive ingredients anhydrous lactose, microcrystalline cellulose, pregelatinized starch (maize), magnesium stearate, triacetin, titanium dioxide and hypromellose. In addition 8 mg tablet also contains iron oxide yellow and 24 mg tablet also contains iron oxide red. Meets USP dissolution test 6."
    },
    {
      "NDCCode": "71858-0205-4",
      "PackageDescription": "1 FILM in 1 POUCH (71858-0205-4) ",
      "NDC11Code": "71858-0205-04",
      "ProductNDC": "71858-0205",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Vybrique",
      "NonProprietaryName": "Sildenafil Citrate",
      "DosageFormName": "FILM",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260215",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA210858",
      "LabelerName": "IBSA Pharma Inc.",
      "SubstanceName": "SILDENAFIL CITRATE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-07-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260215",
      "SamplePackage": "N",
      "IndicationAndUsage": "VYBRIQUE TM is indicated for the treatment of erectile dysfunction.",
      "Description": "VYBRIQUE (sildenafil) oral film is for treatment of erectile dysfunction and contains sildenafil citrate, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate, has the molecular formula C 22H 39N 6O 4S ‧ C 6H 8O 7, and the following structural formula:. Sildenafil citrate is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7. VYBRIQUE is formulated as an opaque light blue, thin, flexible oral film with the characteristic lemon and grapefruit scent. The product is available in four different strengths 25, 50, 75, or 100 mg of sildenafil equivalent to 35, 70, 105, 140 mg sildenafil citrate respectively for oral administration. In addition to the active ingredient, sildenafil citrate, each oral film contains the following inactive ingredients:  Blue Videojet ink, FD&C Blue No.2, glycerin, grapefruit flavor, lemon flavor, maltodextrin, polysorbate 20, polyvinyl acetate dispersion, propylene glycol monocaprylate, sucralose, titanium dioxide. VYBRIQUE contains no ingredient made from a gluten-containing grain (wheat, barley, or rye)."
    },
    {
      "NDCCode": "71858-0205-5",
      "PackageDescription": "4 POUCH in 1 CARTON (71858-0205-5)  / 1 FILM in 1 POUCH",
      "NDC11Code": "71858-0205-05",
      "ProductNDC": "71858-0205",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Vybrique",
      "NonProprietaryName": "Sildenafil Citrate",
      "DosageFormName": "FILM",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260215",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA210858",
      "LabelerName": "IBSA Pharma Inc.",
      "SubstanceName": "SILDENAFIL CITRATE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-07-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260215",
      "SamplePackage": "N",
      "IndicationAndUsage": "VYBRIQUE TM is indicated for the treatment of erectile dysfunction.",
      "Description": "VYBRIQUE (sildenafil) oral film is for treatment of erectile dysfunction and contains sildenafil citrate, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate, has the molecular formula C 22H 39N 6O 4S ‧ C 6H 8O 7, and the following structural formula:. Sildenafil citrate is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7. VYBRIQUE is formulated as an opaque light blue, thin, flexible oral film with the characteristic lemon and grapefruit scent. The product is available in four different strengths 25, 50, 75, or 100 mg of sildenafil equivalent to 35, 70, 105, 140 mg sildenafil citrate respectively for oral administration. In addition to the active ingredient, sildenafil citrate, each oral film contains the following inactive ingredients:  Blue Videojet ink, FD&C Blue No.2, glycerin, grapefruit flavor, lemon flavor, maltodextrin, polysorbate 20, polyvinyl acetate dispersion, propylene glycol monocaprylate, sucralose, titanium dioxide. VYBRIQUE contains no ingredient made from a gluten-containing grain (wheat, barley, or rye)."
    },
    {
      "NDCCode": "82347-0205-4",
      "PackageDescription": "1 FILM in 1 POUCH (82347-0205-4) ",
      "NDC11Code": "82347-0205-04",
      "ProductNDC": "82347-0205",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sildenafil",
      "NonProprietaryName": "Sildenafil Citrate",
      "DosageFormName": "FILM",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260215",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA210858",
      "LabelerName": "Yaral Pharma Inc.",
      "SubstanceName": "SILDENAFIL CITRATE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-07-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260215",
      "SamplePackage": "N",
      "IndicationAndUsage": "SILDENAFIL ORAL FILM is indicated for the treatment of erectile dysfunction.",
      "Description": "SILDENAFIL ORAL FILM (sildenafil) oral film is for treatment of erectile dysfunction and contains sildenafil citrate, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate, has the molecular formula C 22H 39N 6O 4S ‧ C 6H 8O 7, and the following structural formula:. Sildenafil citrate is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7. SILDENAFIL ORAL FILM is formulated as an opaque light blue, thin, flexible oral film with the characteristic lemon and grapefruit scent. The product is available in four different strengths 25, 50, 75, or 100 mg of sildenafil equivalent to 35, 70, 105, 140 mg sildenafil citrate respectively for oral administration. In addition to the active ingredient, sildenafil citrate, each oral film contains the following inactive ingredients:  Blue Videojet ink, FD&C Blue No.2, glycerin, grapefruit flavor, lemon flavor, maltodextrin, polysorbate 20, polyvinyl acetate dispersion, propylene glycol monocaprylate, sucralose, titanium dioxide. SILDENAFIL ORAL FILM contains no ingredient made from a gluten-containing grain (wheat, barley, or rye)."
    },
    {
      "NDCCode": "82347-0205-5",
      "PackageDescription": "4 POUCH in 1 CARTON (82347-0205-5)  / 1 FILM in 1 POUCH",
      "NDC11Code": "82347-0205-05",
      "ProductNDC": "82347-0205",
      "ProductTypeName": "HUMAN PRESCRIPTION DRUG",
      "ProprietaryName": "Sildenafil",
      "NonProprietaryName": "Sildenafil Citrate",
      "DosageFormName": "FILM",
      "RouteName": "ORAL",
      "StartMarketingDate": "20260215",
      "MarketingCategoryName": "NDA",
      "ApplicationNumber": "NDA210858",
      "LabelerName": "Yaral Pharma Inc.",
      "SubstanceName": "SILDENAFIL CITRATE",
      "StrengthNumber": "25",
      "StrengthUnit": "mg/1",
      "Pharm_Classes": "Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]",
      "Status": "Active",
      "LastUpdate": "2026-07-21",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20271231",
      "StartMarketingDatePackage": "20260215",
      "SamplePackage": "N",
      "IndicationAndUsage": "SILDENAFIL ORAL FILM is indicated for the treatment of erectile dysfunction.",
      "Description": "SILDENAFIL ORAL FILM (sildenafil) oral film is for treatment of erectile dysfunction and contains sildenafil citrate, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate, has the molecular formula C 22H 39N 6O 4S ‧ C 6H 8O 7, and the following structural formula:. Sildenafil citrate is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7. SILDENAFIL ORAL FILM is formulated as an opaque light blue, thin, flexible oral film with the characteristic lemon and grapefruit scent. The product is available in four different strengths 25, 50, 75, or 100 mg of sildenafil equivalent to 35, 70, 105, 140 mg sildenafil citrate respectively for oral administration. In addition to the active ingredient, sildenafil citrate, each oral film contains the following inactive ingredients:  Blue Videojet ink, FD&C Blue No.2, glycerin, grapefruit flavor, lemon flavor, maltodextrin, polysorbate 20, polyvinyl acetate dispersion, propylene glycol monocaprylate, sucralose, titanium dioxide. SILDENAFIL ORAL FILM contains no ingredient made from a gluten-containing grain (wheat, barley, or rye)."
    },
    {
      "NDCCode": "61995-0014-4",
      "PackageDescription": "113 g in 1 TUBE (61995-0014-4) ",
      "NDC11Code": "61995-0014-04",
      "ProductNDC": "61995-0014",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "J0830014 Jason Sun Family Sunscreen Spf45",
      "NonProprietaryName": "Homosalate, Octyl Salicylate, Octocrylene, Avobenzone",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20170207",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "The Hain Celestial Group, Inc.",
      "SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
      "StrengthNumber": "3; 10; 5; 10",
      "StrengthUnit": "g/100g; g/100g; g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20170207",
      "SamplePackage": "N",
      "IndicationAndUsage": "Helps prevents sunburns. If used as directed with other sun protection measures, decreases risk of skin cancer and early skin aging caused by sun exposure. Skin Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use sunscreen with Broad Spectrum SPF 15 or higher and other protective measures including: limit time in sun, especially from10am to 2pm, and wear long sleeved shirts, pants, hats and sunglases."
    },
    {
      "NDCCode": "61995-0015-4",
      "PackageDescription": "113 g in 1 TUBE (61995-0015-4) ",
      "NDC11Code": "61995-0015-04",
      "ProductNDC": "61995-0015",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Jason Mineral Sunscreen Spf30 Broad Spectrum",
      "NonProprietaryName": "Zinc Oxide, Titanium Dioxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20170330",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "The Hain Celestial Group, Inc.",
      "SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
      "StrengthNumber": "2; 14.5",
      "StrengthUnit": "g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20170330",
      "SamplePackage": "N",
      "IndicationAndUsage": "Helps prevent sunburns. If used as directed with other sun protection measures decreases the risk of skin cancer and skin aging caused by the sun. Sun Protection Measures: Spending time on the sun increases your risk of skin cancer and skin aging. To decrease the risk regulary use Broad Spectrum Sunscreen with SPF 15 or higher and other protective measures including: limit time in sun, especially from 10am to 2 pm, and wear long-sleeved shirts, pants, hats ans sunglasses."
    },
    {
      "NDCCode": "61995-0020-4",
      "PackageDescription": "113 g in 1 TUBE (61995-0020-4) ",
      "NDC11Code": "61995-0020-04",
      "ProductNDC": "61995-0020",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "J0832014 Jason Sun Sport Sunscreen Spf45",
      "NonProprietaryName": "Avobenzone, Homosalate, Octocrylene, Octyl Salicylate",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20171207",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "The Hain Celestial Group, Inc.",
      "SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
      "StrengthNumber": "3; 10; 5; 10",
      "StrengthUnit": "g/100g; g/100g; g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20171207",
      "SamplePackage": "N",
      "IndicationAndUsage": "Helps prevents sunburns. If used as directed with other sun protection measures, decreases risk of skin cancer and early skin aging caused by sun exposure. Skin Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use sunscreen with Broad Spectrum SPF 15 or higher and other protective measures including: limit time in sun, especially from10am to 2pm, and wear long sleeved shirts, pants, hats and sunglases."
    },
    {
      "NDCCode": "61995-0022-4",
      "PackageDescription": "113 g in 1 TUBE (61995-0022-4) ",
      "NDC11Code": "61995-0022-04",
      "ProductNDC": "61995-0022",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "J0832212 Jason Kids Sunscreen Spf45",
      "NonProprietaryName": "Homosalate, Octyl Salicylate, Octocrylene, Avobenzone",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20171207",
      "MarketingCategoryName": "OTC MONOGRAPH DRUG",
      "ApplicationNumber": "M020",
      "LabelerName": "The Hain Celestial Group, Inc.",
      "SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
      "StrengthNumber": "3; 10; 5; 10",
      "StrengthUnit": "g/100g; g/100g; g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2025-07-30",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20251231",
      "StartMarketingDatePackage": "20171207",
      "SamplePackage": "N",
      "IndicationAndUsage": "Helps prevents sunburns. If used as directed with other sun protection measures, decreases risk of skin cancer and early skin aging caused by sun exposure. Skin Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use sunscreen with Broad Spectrum SPF 15 or higher and other protective measures including: limit time in sun, especially from10am to 2pm, and wear long sleeved shirts, pants, hats and sunglases."
    },
    {
      "NDCCode": "61995-0027-4",
      "PackageDescription": "128 g in 1 BOTTLE (61995-0027-4) ",
      "NDC11Code": "61995-0027-04",
      "ProductNDC": "61995-0027",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "J0832706 Jason Sun Facial Sunscreen Spf20",
      "NonProprietaryName": "Homosalate, Octyl Salicylate, Octocrylene, Avobenzone",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20170620",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "The Hain Celestial Group, Inc.",
      "SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
      "StrengthNumber": "2; 7.5; 3; 5",
      "StrengthUnit": "g/100g; g/100g; g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2023-01-03",
      "PackageNdcExcludeFlag": "N",
      "ProductNdcExcludeFlag": "N",
      "ListingRecordCertifiedThrough": "20221231",
      "StartMarketingDatePackage": "20170620",
      "SamplePackage": "N",
      "IndicationAndUsage": "Helps prevents sunburns. If used as directed with other sun protection measures, decreases risk of skin cancer and early skin aging caused by sun exposure. Skin Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use sunscreen with Broad Spectrum SPF 15 or higher and other protective measures including: limit time in sun, especially from10am to 2pm, and wear long sleeved shirts, pants, hats and sunglases."
    },
    {
      "NDCCode": "61995-0201-4",
      "PackageDescription": "113 g in 1 TUBE (61995-0201-4)",
      "NDC11Code": "61995-0201-04",
      "ProductNDC": "61995-0201",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sunbrellas Sport Sunblock Spf 45",
      "NonProprietaryName": "Homosalate, Octocrylene, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicylate, Titanium Dioxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20091103",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "The Hain Celestial Group",
      "SubstanceName": "HOMOSALATE; OCTOCRYLENE; OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE",
      "StrengthNumber": "10; 10; 7.5; 5; 2",
      "StrengthUnit": "g/100g; g/100g; g/100g; g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "USES: 1 Helps prevent sunburns, 2 Higher SPF gives more sunburn protection, 3 Moderate sun protection product, 4 Apply sunscreen liberally to all exposed skin area 15 to 20 minutes before sun exposure, 5 Reapply as needed after towel drying, swimming or sweating, 6 Children after 6 months, ask doctor."
    },
    {
      "NDCCode": "61995-0204-4",
      "PackageDescription": "113 g in 1 TUBE (61995-0204-4)",
      "NDC11Code": "61995-0204-04",
      "ProductNDC": "61995-0204",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sunbrellas Kids Sunblock Spf 45",
      "NonProprietaryName": "Homosalate, Octocrylene, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicilate, Titanium Dioxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20091103",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "The Hain Celestial Group, Inc.",
      "SubstanceName": "HOMOSALATE; OCTOCRYLENE; OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE",
      "StrengthNumber": "10; 10; 7.5; 5; 2",
      "StrengthUnit": "g/100g; g/100g; g/100g; g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "USES: 1     Helps prevent sunburns, 2     Higher SPF gives more sunburn protection, 3     Moderate sun protection product."
    },
    {
      "NDCCode": "61995-0209-4",
      "PackageDescription": "128 g in 1 BOTTLE (61995-0209-4)",
      "NDC11Code": "61995-0209-04",
      "ProductNDC": "61995-0209",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Jason Facial Natural Sunscreen Broad Spectrum Spf20",
      "NonProprietaryName": "Homosalate, Octocrylene, Ethylhexyl Salicylate, Titanium Dioxide",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20110811",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "The Hain Celestial Group, Inc.",
      "SubstanceName": "HOMOSALATE; OCTOCRYLENE; OCTISALATE; TITANIUM DIOXIDE",
      "StrengthNumber": "7.5; 5; 3; 2",
      "StrengthUnit": "g/100g; g/100g; g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Helps prevent sunburns . If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging, caused by the sun."
    },
    {
      "NDCCode": "61995-0210-4",
      "PackageDescription": "113 g in 1 TUBE (61995-0210-4)",
      "NDC11Code": "61995-0210-04",
      "ProductNDC": "61995-0210",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Sunbrellas Mineral Sunblock Spf 30",
      "NonProprietaryName": "Zinc Oxide, Titanium Dioxide",
      "DosageFormName": "CREAM",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20091103",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "The Hain Celestial Group, Inc.",
      "SubstanceName": "ZINC OXIDE; TITANIUM DIOXIDE",
      "StrengthNumber": "14.5; 2",
      "StrengthUnit": "g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "USES: 1 Helps prevent sunburns, 2 Higher SPF gives more sunburn protection, 3 Moderate sun protection product, 4 apply sunscreen liberally to all exposed skin area 15 to 20 minutes before sun exposure, 5 Reapply as needed after towel drying, swimming or sweating, 6 Children after 6 months, ask doctor."
    },
    {
      "NDCCode": "61995-0212-4",
      "PackageDescription": "113 g in 1 BOTTLE (61995-0212-4)",
      "NDC11Code": "61995-0212-04",
      "ProductNDC": "61995-0212",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Earths Best Mineral Sunscreen Broad Spectrum Spf30",
      "NonProprietaryName": "Zinc Oxide, Titanium Dioxide",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20111019",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "The Hain Celestial Group, Inc.",
      "SubstanceName": "ZINC OXIDE; TITANIUM DIOXIDE",
      "StrengthNumber": "14.5; 2",
      "StrengthUnit": "g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Helps prevent sunburns . If used as described with other sun protection measures, decreases the risk of skin cancer and early skin aging, caused by the sun."
    },
    {
      "NDCCode": "61995-0300-4",
      "PackageDescription": "113 g in 1 TUBE (61995-0300-4)",
      "NDC11Code": "61995-0300-04",
      "ProductNDC": "61995-0300",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Jason Pure Natural Sun Family Natural Sunscreen Broad Spectrum Spf45",
      "NonProprietaryName": "Homosalate, Octocrylene, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicylate, Titanium Dioxide",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20110911",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "The Hain Celestial Group, Inc.",
      "SubstanceName": "HOMOSALATE; OCTOCRYLENE; OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE",
      "StrengthNumber": "10; 10; 7.5; 5; 2",
      "StrengthUnit": "g/100g; g/100g; g/100g; g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Helps prevent sunburns . If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging, caused by the sun."
    },
    {
      "NDCCode": "61995-0315-4",
      "PackageDescription": "113 g in 1 TUBE (61995-0315-4)",
      "NDC11Code": "61995-0315-04",
      "ProductNDC": "61995-0315",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Jason Pure Natural Sun Mineral Natural Sunscreen Broad Spectrum Spf30",
      "NonProprietaryName": "Zinc Oxide, Titanium Oxide",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20110820",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "The Hain Celestial Group, Inc.",
      "SubstanceName": "ZINC OXIDE; TITANIUM DIOXIDE",
      "StrengthNumber": "14.5; 2",
      "StrengthUnit": "g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Helps Prevent Sunburns. If used as described with other sunscreen protection measures, decrease the risk of skin cancer and early skin aging, caused by sun."
    },
    {
      "NDCCode": "61995-0320-4",
      "PackageDescription": "113 g in 1 TUBE (61995-0320-4)",
      "NDC11Code": "61995-0320-04",
      "ProductNDC": "61995-0320",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Jason Pure Natural Sun Sport Natural Sunscreen Broad Spectrum Spf45",
      "NonProprietaryName": "Homosalate, Octocrylene, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicylate, Titanium Dioxide",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20110810",
      "MarketingCategoryName": "OTC MONOGRAPH FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "The Hain Celestial Group, Inc.",
      "SubstanceName": "HOMOSALATE; OCTOCRYLENE; OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE",
      "StrengthNumber": "10; 10; 7.5; 5; 2",
      "StrengthUnit": "g/100g; g/100g; g/100g; g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Helps prevent sunburns . If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging, caused by sun."
    },
    {
      "NDCCode": "61995-0322-4",
      "PackageDescription": "113 g in 1 TUBE (61995-0322-4)",
      "NDC11Code": "61995-0322-04",
      "ProductNDC": "61995-0322",
      "ProductTypeName": "HUMAN OTC DRUG",
      "ProprietaryName": "Jason Pure Natural Sun Kids Natural Sunscren Broad Spectrum Spf45",
      "NonProprietaryName": "Homosalate, Octocrylene, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicylate, Titanium Dioxide",
      "DosageFormName": "LOTION",
      "RouteName": "TOPICAL",
      "StartMarketingDate": "20110811",
      "MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
      "ApplicationNumber": "part352",
      "LabelerName": "The Hain Celestial Group, Inc.",
      "SubstanceName": "HOMOSALATE; OCTOCRYLENE; OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE",
      "StrengthNumber": "10; 10; 7.5; 5; 2",
      "StrengthUnit": "g/100g; g/100g; g/100g; g/100g; g/100g",
      "Status": "Deprecated",
      "LastUpdate": "2019-09-21",
      "ProductNdcExcludeFlag": "E",
      "ListingRecordCertifiedThrough": "20171231",
      "IndicationAndUsage": "Helps prevent sunburns. If used as directed with other sun protection measures, decreases the risk  of skin cancer and early skin aging, caused by the sun."
    }
  ]
}
                    

{"NDC":[{"NDCCode":"61995-0205-4","ProprietaryName":"Sunbrellas Family Sunblock Spf 45","NonProprietaryName":"Homosalate, Octocrylene, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicilate, Titanium Dioxide"},{"NDCCode":"13630-0205-4","ProprietaryName":"Aloe Up","NonProprietaryName":"Avobenzone, Octisalate, And Octocrylene"},{"NDCCode":"15631-0205-4","ProprietaryName":"Gentiana Quinqueflora","NonProprietaryName":"Gentiana Quinqueflora"},{"NDCCode":"22840-0205-4","ProprietaryName":"Standardized Orchard Grass Pollen","NonProprietaryName":"Dactylis Glomerata"},{"NDCCode":"37662-0205-4","ProprietaryName":"Castoreum","NonProprietaryName":"Castoreum"},{"NDCCode":"49288-0205-4","ProprietaryName":"Standardized Meadow Fescue Grass Pollen","NonProprietaryName":"Standardized Meadow Fescue Grass Pollen"},{"NDCCode":"51514-0205-1","ProprietaryName":"Gap Favorite Lip Balm","NonProprietaryName":"Octinoxate And Oxybenzone"},{"NDCCode":"51754-0205-2","ProprietaryName":"Verapamil Hydrochloride","NonProprietaryName":"Verapamil Hydrochloride"},{"NDCCode":"68599-0205-1","ProprietaryName":"Thera Calazinc Body Shield","NonProprietaryName":"Zinc Oxide"},{"NDCCode":"68599-0205-4","ProprietaryName":"Thera Calazinc Body Shield","NonProprietaryName":"Zinc Oxide"},{"NDCCode":"71335-0205-4","ProprietaryName":"Ondansetron Hydrochloride","NonProprietaryName":"Ondansetron Hydrochloride"},{"NDCCode":"71335-0205-6","ProprietaryName":"Ondansetron Hydrochloride","NonProprietaryName":"Ondansetron Hydrochloride"},{"NDCCode":"71858-0205-4","ProprietaryName":"Vybrique","NonProprietaryName":"Sildenafil Citrate"},{"NDCCode":"71858-0205-5","ProprietaryName":"Vybrique","NonProprietaryName":"Sildenafil Citrate"},{"NDCCode":"82347-0205-4","ProprietaryName":"Sildenafil","NonProprietaryName":"Sildenafil Citrate"},{"NDCCode":"82347-0205-5","ProprietaryName":"Sildenafil","NonProprietaryName":"Sildenafil Citrate"},{"NDCCode":"61995-0014-4","ProprietaryName":"J0830014 Jason Sun Family Sunscreen Spf45","NonProprietaryName":"Homosalate, Octyl Salicylate, Octocrylene, Avobenzone"},{"NDCCode":"61995-0015-4","ProprietaryName":"Jason Mineral Sunscreen Spf30 Broad Spectrum","NonProprietaryName":"Zinc Oxide, Titanium Dioxide"},{"NDCCode":"61995-0020-4","ProprietaryName":"J0832014 Jason Sun Sport Sunscreen Spf45","NonProprietaryName":"Avobenzone, Homosalate, Octocrylene, Octyl Salicylate"},{"NDCCode":"61995-0022-4","ProprietaryName":"J0832212 Jason Kids Sunscreen Spf45","NonProprietaryName":"Homosalate, Octyl Salicylate, Octocrylene, Avobenzone"},{"NDCCode":"61995-0027-4","ProprietaryName":"J0832706 Jason Sun Facial Sunscreen Spf20","NonProprietaryName":"Homosalate, Octyl Salicylate, Octocrylene, Avobenzone"},{"NDCCode":"61995-0201-4","ProprietaryName":"Sunbrellas Sport Sunblock Spf 45","NonProprietaryName":"Homosalate, Octocrylene, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicylate, Titanium Dioxide"},{"NDCCode":"61995-0204-4","ProprietaryName":"Sunbrellas Kids Sunblock Spf 45","NonProprietaryName":"Homosalate, Octocrylene, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicilate, Titanium Dioxide"},{"NDCCode":"61995-0209-4","ProprietaryName":"Jason Facial Natural Sunscreen Broad Spectrum Spf20","NonProprietaryName":"Homosalate, Octocrylene, Ethylhexyl Salicylate, Titanium Dioxide"},{"NDCCode":"61995-0210-4","ProprietaryName":"Sunbrellas Mineral Sunblock Spf 30","NonProprietaryName":"Zinc Oxide, Titanium Dioxide"},{"NDCCode":"61995-0212-4","ProprietaryName":"Earths Best Mineral Sunscreen Broad Spectrum Spf30","NonProprietaryName":"Zinc Oxide, Titanium Dioxide"},{"NDCCode":"61995-0300-4","ProprietaryName":"Jason Pure Natural Sun Family Natural Sunscreen Broad Spectrum Spf45","NonProprietaryName":"Homosalate, Octocrylene, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicylate, Titanium Dioxide"},{"NDCCode":"61995-0315-4","ProprietaryName":"Jason Pure Natural Sun Mineral Natural Sunscreen Broad Spectrum Spf30","NonProprietaryName":"Zinc Oxide, Titanium Oxide"},{"NDCCode":"61995-0320-4","ProprietaryName":"Jason Pure Natural Sun Sport Natural Sunscreen Broad Spectrum Spf45","NonProprietaryName":"Homosalate, Octocrylene, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicylate, Titanium Dioxide"},{"NDCCode":"61995-0322-4","ProprietaryName":"Jason Pure Natural Sun Kids Natural Sunscren Broad Spectrum Spf45","NonProprietaryName":"Homosalate, Octocrylene, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicylate, Titanium Dioxide"}]}
                    

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  <NDC>
    <NDCCode>61995-0205-4</NDCCode>
    <PackageDescription>113 g in 1 TUBE (61995-0205-4)</PackageDescription>
    <NDC11Code>61995-0205-04</NDC11Code>
    <ProductNDC>61995-0205</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sunbrellas Family Sunblock Spf 45</ProprietaryName>
    <NonProprietaryName>Homosalate, Octocrylene, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicilate, Titanium Dioxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20091103</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>The Hain Celestial Group, Inc.</LabelerName>
    <SubstanceName>HOMOSALATE; OCTOCRYLENE; OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE</SubstanceName>
    <StrengthNumber>10; 10; 7.5; 5; 2</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>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>USES: 1 Helps prevent sunburns, 2 Higher SPF gives more sunburn protection, 3 Moderate sun protection product, 4 apply sunscreen liberally to all exposed skin area 15 to 20 minutes before sun exposure, 5 Reapply as needed after towel drying, swimming or sweating, 6 Children after 6 months, ask doctor.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>13630-0205-4</NDCCode>
    <PackageDescription>192 mL in 1 CAN (13630-0205-4) </PackageDescription>
    <NDC11Code>13630-0205-04</NDC11Code>
    <ProductNDC>13630-0205</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Aloe Up</ProprietaryName>
    <ProprietaryNameSuffix>Broad Spectrum Spf 15</ProprietaryNameSuffix>
    <NonProprietaryName>Avobenzone, Octisalate, And Octocrylene</NonProprietaryName>
    <DosageFormName>SPRAY</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20210930</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Prime Packaging, Inc.</LabelerName>
    <SubstanceName>AVOBENZONE; OCTISALATE; OCTOCRYLENE</SubstanceName>
    <StrengthNumber>16.24; 40.6; 15.02</StrengthNumber>
    <StrengthUnit>mg/mL; mg/mL; mg/mL</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2024-09-27</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20210930</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>15631-0205-4</NDCCode>
    <PackageDescription>2500 PELLET in 1 PACKAGE (15631-0205-4) </PackageDescription>
    <NDC11Code>15631-0205-04</NDC11Code>
    <ProductNDC>15631-0205</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Gentiana Quinqueflora</ProprietaryName>
    <NonProprietaryName>Gentiana Quinqueflora</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20151027</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Rxhomeo Private Limited d.b.a. Rxhomeo, Inc</LabelerName>
    <SubstanceName>GENTIANELLA QUINQUEFOLIA</SubstanceName>
    <StrengthNumber>1</StrengthNumber>
    <StrengthUnit>[hp_X]/1</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2022-01-04</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180101</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Condition listed above or as directed by the physician.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>22840-0205-4</NDCCode>
    <PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (22840-0205-4) </PackageDescription>
    <NDC11Code>22840-0205-04</NDC11Code>
    <ProductNDC>22840-0205</ProductNDC>
    <ProductTypeName>STANDARDIZED ALLERGENIC</ProductTypeName>
    <ProprietaryName>Standardized Orchard Grass Pollen</ProprietaryName>
    <NonProprietaryName>Dactylis Glomerata</NonProprietaryName>
    <DosageFormName>SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19680915</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA101839</ApplicationNumber>
    <LabelerName>Greer Laboratories, Inc.</LabelerName>
    <SubstanceName>DACTYLIS GLOMERATA POLLEN</SubstanceName>
    <StrengthNumber>10000</StrengthNumber>
    <StrengthUnit>[BAU]/mL</StrengthUnit>
    <Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2025-06-12</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>19680915</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>GREER Standardized Grass Pollen Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergy to one or more of the following grass pollens: Bermuda, Kentucky Blue (June), Meadow Fescue, Orchard, Perennial Rye, Redtop, Sweet Vernal, Timothy., 2 Immunotherapy for the reduction of grass pollen-induced allergic symptoms confirmed by positive skin test or by in vitro testing for pollen-specific IgE antibodies for Bermuda grass pollen, Kentucky Blue (June) grass pollen, Meadow Fescue grass pollen, Orchard grass pollen, Perennial Rye grass pollen, Redtop grass pollen, Sweet Vernal grass pollen, or Timothy grass pollen. .</IndicationAndUsage>
    <Description>Standardized Grass Pollen Allergenic Extracts include Standardized Bermuda Grass Pollen ( Cynodon dactylon) at 10,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol (preservative); and the following grasses at both 10,000 BAU/milliliter and 100,000 BAU/milliliter, 50% glycerin volume/volume, and 0.4% phenol: Standardized Kentucky Blue (June) Grass Pollen ( Poa pratensis), Standardized Meadow Fescue Grass Pollen ( Festuca elatior), Standardized Orchard Grass Pollen ( Dactylis glomerata), Standardized Perennial Rye Grass Pollen ( Lolium perenne), Standardized Redtop Grass Pollen ( Agrostis alba), Standardized Sweet Vernal Grass Pollen ( Anthoxanthum odoratum), and Standardized Timothy Grass Pollen ( Phleum pratense). Inactive ingredients include 0.25% sodium chloride for isotonicity and 0.25% sodium bicarbonate as a buffer. Standardized Grass Pollen Allergenic Extracts should be clear light yellow to brownish solutions that are free of particulate matter. Standardized Grass Pollen Allergenic Extracts are labeled in BAU/milliliter. Bioequivalent Allergy Units are assigned based on comparison by enzyme-linked immunosorbent assay (ELISA) to references from the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research (CBER). CBER references are assigned unitage based on quantitative skin testing. 4,5,6,7 CBER references which can be diluted 1:5,000,000 to intradermally elicit a 50 millimeter sum of erythema diameter response in highly puncture reactive subjects are assigned 100,000 BAU/milliliter; whereas references diluted 1:500,000 which elicit the same 50 millimeter sum of erythema diameter response are assigned 10,000 BAU/milliliter.</Description>
  </NDC>
  <NDC>
    <NDCCode>37662-0205-4</NDCCode>
    <PackageDescription>10000 PELLET in 1 BOTTLE, GLASS (37662-0205-4) </PackageDescription>
    <NDC11Code>37662-0205-04</NDC11Code>
    <ProductNDC>37662-0205</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Castoreum</ProprietaryName>
    <NonProprietaryName>Castoreum</NonProprietaryName>
    <DosageFormName>PELLET</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20220526</StartMarketingDate>
    <MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
    <LabelerName>Hahnemann Laboratories, INC.</LabelerName>
    <SubstanceName>CASTOR FIBER SCENT GLAND SECRETION</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>[hp_C]/1</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2022-05-28</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20220526</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
  </NDC>
  <NDC>
    <NDCCode>49288-0205-4</NDCCode>
    <PackageDescription>30 mL in 1 VIAL, MULTI-DOSE (49288-0205-4)</PackageDescription>
    <NDC11Code>49288-0205-04</NDC11Code>
    <ProductNDC>49288-0205</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Standardized Meadow Fescue Grass Pollen</ProprietaryName>
    <NonProprietaryName>Standardized Meadow Fescue Grass Pollen</NonProprietaryName>
    <DosageFormName>INJECTION, SOLUTION</DosageFormName>
    <RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
    <StartMarketingDate>19970613</StartMarketingDate>
    <MarketingCategoryName>BLA</MarketingCategoryName>
    <ApplicationNumber>BLA102227</ApplicationNumber>
    <LabelerName>Antigen Laboratories, Inc.</LabelerName>
    <SubstanceName>FESTUCA PRATENSIS POLLEN</SubstanceName>
    <StrengthNumber>100000</StrengthNumber>
    <StrengthUnit>[BAU]/mL</StrengthUnit>
    <Pharm_Classes>Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>INDICATIONS AND USAGE     Allergenic extract is indicated for diagnostic testing and treatment (immunotherapy) of patients whose histories indicate allergic symptoms upon natural exposure to grass allergens. Confirmation is determined by skin testing. 10,000 BAU/ml extracts are intended for percutaneous testing. If negative, 100,000 BAU/ml products can be used for percutaneous test. Dilutions made from 10,000 BAU/ml products are indicated for immunotherapy of previously untreated patients. If 10,000 BAU/ml product is tolerated and symptoms persist, dilutions made from 100,000 BAU/ml can be administered. Standardized Grass Pollen extracts labeled in Bioequivalent Allergy Units (BAU/ml) are not interchangeable with grass pollen extracts labeled In Allergy Units (AU/ml) or with non-standardized grass pollen extracts.</IndicationAndUsage>
    <Description>DESCRIPTION     Antigen Laboratories' Standardized Grass Pollen allergenic extracts are sterile and intended for dilution prior to skin testing and/or immunotherapy. The route of administration for immunotherapy is subcutaneous. The routes of administration for diagnostic purposes are intradermal or prick-puncture of the skin. Standardized Grass Pollen allergenic extract labeled in BAU/ml is not interchangeable with grass pollen extract labeled in AU/ml or with non-standardized grass pollen extract.     Potency of Standardized Grass Pollen allergenic extract is determined by comparison to a Center for Biologics Evaluation and Research (CBER) approved reference. References are available for pollen extracts of Orchard Grass (Dactylis glomerata), Perennial Rye Grass (Lolium perenne), Timothy Grass (Phleum pratense), Redtop Grass (Agrostis alba), Kentucky (June) Bluegrass (Poa pratensis), Bermuda Grass (Cynodon dactylon), Meadow Fescue Grass (Festuca elatior), and Sweet Vernal Grass (Anthoxanthum odoratum). Quantitative skin testing is used by CBER to establish reference's potency as Bioequivalent Allergy Units (BAU). CBER reference labeled 10,000 BAU/ml produces a sum of erythema diameter of 50 mm with highly puncture reactive subjects at an intradermal dilution of approximately 1:500,000.11,17 CBER references labeled 100,000 BAU/ml produce a SumE=50 mm at an intradermal dilution of 1:5,000,000. Relative potency of Standardized Grass Pollen allergenic extracts to CBER reference is determined by Enzyme-linked Immunosorbent Assay (ELISA).     In addition to relative potency testing of Standardized Grass Pollen extract the following testing is performed:     1. Microscopic examination to confirm identity and purity of source pollens.     2. lsoelectric focusing (IEF) pattern of source material is compared to respective CBER reference extract.     3. lsoelectric focusing pattern of final 100,000 BAU/ml (10,000 BAU/ml Bermuda Grass) product is compared to CBER reference extract.     4. Ninhydrin Protein Analysis.     5. Glycerine Analysis. (A minimum of 50% v/v glycerine for optimal stability during the entire dating period.)     6. Sterility Testing.     7. Animal Safety Testing.     Standardized Grass Pollen allergenic extracts are extracted at 1:10 weight to volume (w/v) ratio of source material to extraction fluid. Bermuda Grass is only available in 10,000 BAU/ml. Standardized Grass Pollen extracts are diluted after extraction to fall in acceptable relative potency range for a 100,000 BAU/ml or 10,000 BAU/ml (Bermuda Grass) product. Standardized Grass Pollen allergenic extracts (except Bermuda) of 10,000 BAU/ml potency are prepared by diluting the 100,000 BAU/ml extract 1:10 with extracting fluid.    Various mixtures of eight Standardized Grass Pollen extracts are available. Mixtures of Standardized Grass Pollen extracts with non-standardized grass pollen extracts are available. Concentrations of Standardized Grass Pollen extracts (BAU/ml) and non-standardized grass pollen extracts (w/v) in a mixture are printed on the last page of this circular, if applicable.     Active Ingredients: Allergens are described by common and scientific name on container label or last page of this circular. Preservative is 50% v/v glycerine. Inactive ingredients are 0.95% sodium chloride, 0.24% sodium bicarbonate and water for injection.</Description>
  </NDC>
  <NDC>
    <NDCCode>51514-0205-1</NDCCode>
    <PackageDescription>4 g in 1 CONTAINER (51514-0205-1)</PackageDescription>
    <NDC11Code>51514-0205-01</NDC11Code>
    <ProductNDC>51514-0205</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Gap Favorite Lip Balm</ProprietaryName>
    <ProprietaryNameSuffix>Juicy Pear Spf 18</ProprietaryNameSuffix>
    <NonProprietaryName>Octinoxate And Oxybenzone</NonProprietaryName>
    <DosageFormName>STICK</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20111116</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>Autumn Harp, Inc</LabelerName>
    <SubstanceName>OCTINOXATE; OXYBENZONE</SubstanceName>
    <StrengthNumber>7.5; 6</StrengthNumber>
    <StrengthUnit>g/100g; g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
  </NDC>
  <NDC>
    <NDCCode>51754-0205-2</NDCCode>
    <PackageDescription>5 VIAL in 1 CARTON (51754-0205-2)  &gt; 4 mL in 1 VIAL</PackageDescription>
    <NDC11Code>51754-0205-02</NDC11Code>
    <ProductNDC>51754-0205</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Verapamil Hydrochloride</ProprietaryName>
    <NonProprietaryName>Verapamil Hydrochloride</NonProprietaryName>
    <DosageFormName>INJECTION</DosageFormName>
    <RouteName>INTRAVENOUS</RouteName>
    <StartMarketingDate>20180611</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA018925</ApplicationNumber>
    <LabelerName>EXELA PHARMA SCIENCES, LLC</LabelerName>
    <SubstanceName>VERAPAMIL HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>2.5</StrengthNumber>
    <StrengthUnit>mg/mL</StrengthUnit>
    <Pharm_Classes>Calcium Channel Antagonists [MoA], Calcium Channel Blocker [EPC], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]</Pharm_Classes>
    <Status>Deprecated</Status>
    <LastUpdate>2025-01-01</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180611</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Verapamil is indicated for the treatment of supraventricular tachyarrhythmias, including: 1 Rapid conversion to sinus rhythm of paroxysmal supraventricular tachycardias, including those associated with accessory bypass tracts (Wolff-Parkinson-White [WPW] and Lown-Ganong-Levine [LGL] syndromes). When clinically advisable, appropriate vagal maneuvers (e.g., Valsalva maneuver) should be attempted prior to Verapamil administration., 2 Temporary control of rapid ventricular rate in atrial flutter or atrial fibrillation, except when the atrial flutter and/or atrial fibrillation are associated with accessory bypass tracts (Wolff-Parkinson-White [WPW] and Lown-Ganong-Levine [LGL] syndromes).</IndicationAndUsage>
    <Description>Verapamil hydrochloride is a calcium antagonist or slow-channel inhibitor available as a sterile solution for intravenous injection in 5-mg (2 ml) and 10-mg (4 ml) vials. Each form contains Verapamil HCl 2.5 mg/ml and sodium chloride 8.5 mg/ml in water for injection. Hydrochloric acid and/or sodium hydroxide is used for pH adjustment. The pH of the solution is between 4.1 and 6.0. The structural formula of verapamil HCl is given below. Benzeneacetonitrile, α-[3-[[2-(3,4-dimethoxyphenyl)ethyl] methylamino]propyl]-3,4-dimethoxy-α-(1-methylethyl) hydrochloride. Verapamil hydrochloride is an almost white, crystalline powder, practically free of odor, with a bitter taste. It is soluble in water, chloroform, and methanol. Verapamil hydrochloride is not chemically related to other antiarrhythmic drugs.</Description>
  </NDC>
  <NDC>
    <NDCCode>68599-0205-1</NDCCode>
    <PackageDescription>144 PACKET in 1 CARTON (68599-0205-1)  / 4 g in 1 PACKET</PackageDescription>
    <NDC11Code>68599-0205-01</NDC11Code>
    <ProductNDC>68599-0205</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Thera Calazinc Body Shield</ProprietaryName>
    <NonProprietaryName>Zinc Oxide</NonProprietaryName>
    <DosageFormName>PASTE</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20110901</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M016</ApplicationNumber>
    <LabelerName>McKesson Medical-Surgical Inc.</LabelerName>
    <SubstanceName>ZINC OXIDE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-06-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110901</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>: 1 For the treatment and/or prevention of diaper rash, 2 temporarily protects and helps relieve minor skin irritation and itching due to rashes .</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>68599-0205-4</NDCCode>
    <PackageDescription>113 g in 1 TUBE (68599-0205-4) </PackageDescription>
    <NDC11Code>68599-0205-04</NDC11Code>
    <ProductNDC>68599-0205</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Thera Calazinc Body Shield</ProprietaryName>
    <NonProprietaryName>Zinc Oxide</NonProprietaryName>
    <DosageFormName>PASTE</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20110901</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M016</ApplicationNumber>
    <LabelerName>McKesson Medical-Surgical Inc.</LabelerName>
    <SubstanceName>ZINC OXIDE</SubstanceName>
    <StrengthNumber>200</StrengthNumber>
    <StrengthUnit>mg/g</StrengthUnit>
    <Status>Active</Status>
    <LastUpdate>2024-06-19</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20110901</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>: 1 For the treatment and/or prevention of diaper rash, 2 temporarily protects and helps relieve minor skin irritation and itching due to rashes .</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>71335-0205-4</NDCCode>
    <PackageDescription>15 TABLET, FILM COATED in 1 BOTTLE (71335-0205-4) </PackageDescription>
    <NDC11Code>71335-0205-04</NDC11Code>
    <ProductNDC>71335-0205</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ondansetron Hydrochloride</ProprietaryName>
    <NonProprietaryName>Ondansetron Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070731</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078539</ApplicationNumber>
    <LabelerName>Bryant Ranch Prepack</LabelerName>
    <SubstanceName>ONDANSETRON HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-08-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20180214</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with. Ondansetron tablets are also indicated for the prevention of postoperative nausea and/or vomiting.</IndicationAndUsage>
    <Description>The active ingredient in ondansetron tablets, USP is ondansetron hydrochloride as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula: The molecular formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.9 g/mol. Ondansetron hydrochloride USP (dihydrate) is a white to off-white powder that is soluble in water and normal saline. Ondansetron tablets, USP for oral administration contain ondansetron hydrochloride USP (dihydrate) equivalent to 4 mg or 8 mg or 24 mg of ondansetron. Each film-coated tablet also contains the inactive ingredients anhydrous lactose, microcrystalline cellulose, pregelatinized starch (maize), magnesium stearate, triacetin, titanium dioxide and hypromellose. In addition 8 mg tablet also contains iron oxide yellow and 24 mg tablet also contains iron oxide red. Meets USP dissolution test 6.</Description>
  </NDC>
  <NDC>
    <NDCCode>71335-0205-6</NDCCode>
    <PackageDescription>4 TABLET, FILM COATED in 1 BOTTLE (71335-0205-6) </PackageDescription>
    <NDC11Code>71335-0205-06</NDC11Code>
    <ProductNDC>71335-0205</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Ondansetron Hydrochloride</ProprietaryName>
    <NonProprietaryName>Ondansetron Hydrochloride</NonProprietaryName>
    <DosageFormName>TABLET, FILM COATED</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20070731</StartMarketingDate>
    <MarketingCategoryName>ANDA</MarketingCategoryName>
    <ApplicationNumber>ANDA078539</ApplicationNumber>
    <LabelerName>Bryant Ranch Prepack</LabelerName>
    <SubstanceName>ONDANSETRON HYDROCHLORIDE</SubstanceName>
    <StrengthNumber>4</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2024-08-22</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20211227</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Ondansetron tablets are indicated for the prevention of nausea and vomiting associated with. Ondansetron tablets are also indicated for the prevention of postoperative nausea and/or vomiting.</IndicationAndUsage>
    <Description>The active ingredient in ondansetron tablets, USP is ondansetron hydrochloride as the dihydrate, the racemic form of ondansetron and a selective blocking agent of the serotonin 5-HT3 receptor type. Chemically it is (±) 1, 2, 3, 9-tetrahydro-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-4H-carbazol-4-one, monohydrochloride, dihydrate. It has the following structural formula: The molecular formula is C18H19N3OHCl2H2O, representing a molecular weight of 365.9 g/mol. Ondansetron hydrochloride USP (dihydrate) is a white to off-white powder that is soluble in water and normal saline. Ondansetron tablets, USP for oral administration contain ondansetron hydrochloride USP (dihydrate) equivalent to 4 mg or 8 mg or 24 mg of ondansetron. Each film-coated tablet also contains the inactive ingredients anhydrous lactose, microcrystalline cellulose, pregelatinized starch (maize), magnesium stearate, triacetin, titanium dioxide and hypromellose. In addition 8 mg tablet also contains iron oxide yellow and 24 mg tablet also contains iron oxide red. Meets USP dissolution test 6.</Description>
  </NDC>
  <NDC>
    <NDCCode>71858-0205-4</NDCCode>
    <PackageDescription>1 FILM in 1 POUCH (71858-0205-4) </PackageDescription>
    <NDC11Code>71858-0205-04</NDC11Code>
    <ProductNDC>71858-0205</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Vybrique</ProprietaryName>
    <NonProprietaryName>Sildenafil Citrate</NonProprietaryName>
    <DosageFormName>FILM</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260215</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA210858</ApplicationNumber>
    <LabelerName>IBSA Pharma Inc.</LabelerName>
    <SubstanceName>SILDENAFIL CITRATE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260215</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>VYBRIQUE TM is indicated for the treatment of erectile dysfunction.</IndicationAndUsage>
    <Description>VYBRIQUE (sildenafil) oral film is for treatment of erectile dysfunction and contains sildenafil citrate, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate, has the molecular formula C 22H 39N 6O 4S ‧ C 6H 8O 7, and the following structural formula:. Sildenafil citrate is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7. VYBRIQUE is formulated as an opaque light blue, thin, flexible oral film with the characteristic lemon and grapefruit scent. The product is available in four different strengths 25, 50, 75, or 100 mg of sildenafil equivalent to 35, 70, 105, 140 mg sildenafil citrate respectively for oral administration. In addition to the active ingredient, sildenafil citrate, each oral film contains the following inactive ingredients:  Blue Videojet ink, FD&amp;C Blue No.2, glycerin, grapefruit flavor, lemon flavor, maltodextrin, polysorbate 20, polyvinyl acetate dispersion, propylene glycol monocaprylate, sucralose, titanium dioxide. VYBRIQUE contains no ingredient made from a gluten-containing grain (wheat, barley, or rye).</Description>
  </NDC>
  <NDC>
    <NDCCode>71858-0205-5</NDCCode>
    <PackageDescription>4 POUCH in 1 CARTON (71858-0205-5)  / 1 FILM in 1 POUCH</PackageDescription>
    <NDC11Code>71858-0205-05</NDC11Code>
    <ProductNDC>71858-0205</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Vybrique</ProprietaryName>
    <NonProprietaryName>Sildenafil Citrate</NonProprietaryName>
    <DosageFormName>FILM</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260215</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA210858</ApplicationNumber>
    <LabelerName>IBSA Pharma Inc.</LabelerName>
    <SubstanceName>SILDENAFIL CITRATE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260215</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>VYBRIQUE TM is indicated for the treatment of erectile dysfunction.</IndicationAndUsage>
    <Description>VYBRIQUE (sildenafil) oral film is for treatment of erectile dysfunction and contains sildenafil citrate, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate, has the molecular formula C 22H 39N 6O 4S ‧ C 6H 8O 7, and the following structural formula:. Sildenafil citrate is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7. VYBRIQUE is formulated as an opaque light blue, thin, flexible oral film with the characteristic lemon and grapefruit scent. The product is available in four different strengths 25, 50, 75, or 100 mg of sildenafil equivalent to 35, 70, 105, 140 mg sildenafil citrate respectively for oral administration. In addition to the active ingredient, sildenafil citrate, each oral film contains the following inactive ingredients:  Blue Videojet ink, FD&amp;C Blue No.2, glycerin, grapefruit flavor, lemon flavor, maltodextrin, polysorbate 20, polyvinyl acetate dispersion, propylene glycol monocaprylate, sucralose, titanium dioxide. VYBRIQUE contains no ingredient made from a gluten-containing grain (wheat, barley, or rye).</Description>
  </NDC>
  <NDC>
    <NDCCode>82347-0205-4</NDCCode>
    <PackageDescription>1 FILM in 1 POUCH (82347-0205-4) </PackageDescription>
    <NDC11Code>82347-0205-04</NDC11Code>
    <ProductNDC>82347-0205</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sildenafil</ProprietaryName>
    <NonProprietaryName>Sildenafil Citrate</NonProprietaryName>
    <DosageFormName>FILM</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260215</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA210858</ApplicationNumber>
    <LabelerName>Yaral Pharma Inc.</LabelerName>
    <SubstanceName>SILDENAFIL CITRATE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260215</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>SILDENAFIL ORAL FILM is indicated for the treatment of erectile dysfunction.</IndicationAndUsage>
    <Description>SILDENAFIL ORAL FILM (sildenafil) oral film is for treatment of erectile dysfunction and contains sildenafil citrate, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate, has the molecular formula C 22H 39N 6O 4S ‧ C 6H 8O 7, and the following structural formula:. Sildenafil citrate is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7. SILDENAFIL ORAL FILM is formulated as an opaque light blue, thin, flexible oral film with the characteristic lemon and grapefruit scent. The product is available in four different strengths 25, 50, 75, or 100 mg of sildenafil equivalent to 35, 70, 105, 140 mg sildenafil citrate respectively for oral administration. In addition to the active ingredient, sildenafil citrate, each oral film contains the following inactive ingredients:  Blue Videojet ink, FD&amp;C Blue No.2, glycerin, grapefruit flavor, lemon flavor, maltodextrin, polysorbate 20, polyvinyl acetate dispersion, propylene glycol monocaprylate, sucralose, titanium dioxide. SILDENAFIL ORAL FILM contains no ingredient made from a gluten-containing grain (wheat, barley, or rye).</Description>
  </NDC>
  <NDC>
    <NDCCode>82347-0205-5</NDCCode>
    <PackageDescription>4 POUCH in 1 CARTON (82347-0205-5)  / 1 FILM in 1 POUCH</PackageDescription>
    <NDC11Code>82347-0205-05</NDC11Code>
    <ProductNDC>82347-0205</ProductNDC>
    <ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
    <ProprietaryName>Sildenafil</ProprietaryName>
    <NonProprietaryName>Sildenafil Citrate</NonProprietaryName>
    <DosageFormName>FILM</DosageFormName>
    <RouteName>ORAL</RouteName>
    <StartMarketingDate>20260215</StartMarketingDate>
    <MarketingCategoryName>NDA</MarketingCategoryName>
    <ApplicationNumber>NDA210858</ApplicationNumber>
    <LabelerName>Yaral Pharma Inc.</LabelerName>
    <SubstanceName>SILDENAFIL CITRATE</SubstanceName>
    <StrengthNumber>25</StrengthNumber>
    <StrengthUnit>mg/1</StrengthUnit>
    <Pharm_Classes>Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]</Pharm_Classes>
    <Status>Active</Status>
    <LastUpdate>2026-07-21</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20260215</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>SILDENAFIL ORAL FILM is indicated for the treatment of erectile dysfunction.</IndicationAndUsage>
    <Description>SILDENAFIL ORAL FILM (sildenafil) oral film is for treatment of erectile dysfunction and contains sildenafil citrate, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate, has the molecular formula C 22H 39N 6O 4S ‧ C 6H 8O 7, and the following structural formula:. Sildenafil citrate is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7. SILDENAFIL ORAL FILM is formulated as an opaque light blue, thin, flexible oral film with the characteristic lemon and grapefruit scent. The product is available in four different strengths 25, 50, 75, or 100 mg of sildenafil equivalent to 35, 70, 105, 140 mg sildenafil citrate respectively for oral administration. In addition to the active ingredient, sildenafil citrate, each oral film contains the following inactive ingredients:  Blue Videojet ink, FD&amp;C Blue No.2, glycerin, grapefruit flavor, lemon flavor, maltodextrin, polysorbate 20, polyvinyl acetate dispersion, propylene glycol monocaprylate, sucralose, titanium dioxide. SILDENAFIL ORAL FILM contains no ingredient made from a gluten-containing grain (wheat, barley, or rye).</Description>
  </NDC>
  <NDC>
    <NDCCode>61995-0014-4</NDCCode>
    <PackageDescription>113 g in 1 TUBE (61995-0014-4) </PackageDescription>
    <NDC11Code>61995-0014-04</NDC11Code>
    <ProductNDC>61995-0014</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>J0830014 Jason Sun Family Sunscreen Spf45</ProprietaryName>
    <NonProprietaryName>Homosalate, Octyl Salicylate, Octocrylene, Avobenzone</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20170207</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>The Hain Celestial Group, Inc.</LabelerName>
    <SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
    <StrengthNumber>3; 10; 5; 10</StrengthNumber>
    <StrengthUnit>g/100g; g/100g; g/100g; g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170207</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Helps prevents sunburns. If used as directed with other sun protection measures, decreases risk of skin cancer and early skin aging caused by sun exposure. Skin Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use sunscreen with Broad Spectrum SPF 15 or higher and other protective measures including: limit time in sun, especially from10am to 2pm, and wear long sleeved shirts, pants, hats and sunglases.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>61995-0015-4</NDCCode>
    <PackageDescription>113 g in 1 TUBE (61995-0015-4) </PackageDescription>
    <NDC11Code>61995-0015-04</NDC11Code>
    <ProductNDC>61995-0015</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Jason Mineral Sunscreen Spf30 Broad Spectrum</ProprietaryName>
    <NonProprietaryName>Zinc Oxide, Titanium Dioxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20170330</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>The Hain Celestial Group, Inc.</LabelerName>
    <SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
    <StrengthNumber>2; 14.5</StrengthNumber>
    <StrengthUnit>g/100g; g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170330</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Helps prevent sunburns. If used as directed with other sun protection measures decreases the risk of skin cancer and skin aging caused by the sun. Sun Protection Measures: Spending time on the sun increases your risk of skin cancer and skin aging. To decrease the risk regulary use Broad Spectrum Sunscreen with SPF 15 or higher and other protective measures including: limit time in sun, especially from 10am to 2 pm, and wear long-sleeved shirts, pants, hats ans sunglasses.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>61995-0020-4</NDCCode>
    <PackageDescription>113 g in 1 TUBE (61995-0020-4) </PackageDescription>
    <NDC11Code>61995-0020-04</NDC11Code>
    <ProductNDC>61995-0020</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>J0832014 Jason Sun Sport Sunscreen Spf45</ProprietaryName>
    <NonProprietaryName>Avobenzone, Homosalate, Octocrylene, Octyl Salicylate</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20171207</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>The Hain Celestial Group, Inc.</LabelerName>
    <SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
    <StrengthNumber>3; 10; 5; 10</StrengthNumber>
    <StrengthUnit>g/100g; g/100g; g/100g; g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20171207</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Helps prevents sunburns. If used as directed with other sun protection measures, decreases risk of skin cancer and early skin aging caused by sun exposure. Skin Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use sunscreen with Broad Spectrum SPF 15 or higher and other protective measures including: limit time in sun, especially from10am to 2pm, and wear long sleeved shirts, pants, hats and sunglases.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>61995-0022-4</NDCCode>
    <PackageDescription>113 g in 1 TUBE (61995-0022-4) </PackageDescription>
    <NDC11Code>61995-0022-04</NDC11Code>
    <ProductNDC>61995-0022</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>J0832212 Jason Kids Sunscreen Spf45</ProprietaryName>
    <NonProprietaryName>Homosalate, Octyl Salicylate, Octocrylene, Avobenzone</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20171207</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
    <ApplicationNumber>M020</ApplicationNumber>
    <LabelerName>The Hain Celestial Group, Inc.</LabelerName>
    <SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
    <StrengthNumber>3; 10; 5; 10</StrengthNumber>
    <StrengthUnit>g/100g; g/100g; g/100g; g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2025-07-30</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20171207</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Helps prevents sunburns. If used as directed with other sun protection measures, decreases risk of skin cancer and early skin aging caused by sun exposure. Skin Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use sunscreen with Broad Spectrum SPF 15 or higher and other protective measures including: limit time in sun, especially from10am to 2pm, and wear long sleeved shirts, pants, hats and sunglases.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>61995-0027-4</NDCCode>
    <PackageDescription>128 g in 1 BOTTLE (61995-0027-4) </PackageDescription>
    <NDC11Code>61995-0027-04</NDC11Code>
    <ProductNDC>61995-0027</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>J0832706 Jason Sun Facial Sunscreen Spf20</ProprietaryName>
    <NonProprietaryName>Homosalate, Octyl Salicylate, Octocrylene, Avobenzone</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20170620</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>The Hain Celestial Group, Inc.</LabelerName>
    <SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
    <StrengthNumber>2; 7.5; 3; 5</StrengthNumber>
    <StrengthUnit>g/100g; g/100g; g/100g; g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2023-01-03</LastUpdate>
    <PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
    <ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
    <StartMarketingDatePackage>20170620</StartMarketingDatePackage>
    <SamplePackage>N</SamplePackage>
    <IndicationAndUsage>Helps prevents sunburns. If used as directed with other sun protection measures, decreases risk of skin cancer and early skin aging caused by sun exposure. Skin Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease risk, regularly use sunscreen with Broad Spectrum SPF 15 or higher and other protective measures including: limit time in sun, especially from10am to 2pm, and wear long sleeved shirts, pants, hats and sunglases.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>61995-0201-4</NDCCode>
    <PackageDescription>113 g in 1 TUBE (61995-0201-4)</PackageDescription>
    <NDC11Code>61995-0201-04</NDC11Code>
    <ProductNDC>61995-0201</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sunbrellas Sport Sunblock Spf 45</ProprietaryName>
    <NonProprietaryName>Homosalate, Octocrylene, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicylate, Titanium Dioxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20091103</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>The Hain Celestial Group</LabelerName>
    <SubstanceName>HOMOSALATE; OCTOCRYLENE; OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE</SubstanceName>
    <StrengthNumber>10; 10; 7.5; 5; 2</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>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>USES: 1 Helps prevent sunburns, 2 Higher SPF gives more sunburn protection, 3 Moderate sun protection product, 4 Apply sunscreen liberally to all exposed skin area 15 to 20 minutes before sun exposure, 5 Reapply as needed after towel drying, swimming or sweating, 6 Children after 6 months, ask doctor.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>61995-0204-4</NDCCode>
    <PackageDescription>113 g in 1 TUBE (61995-0204-4)</PackageDescription>
    <NDC11Code>61995-0204-04</NDC11Code>
    <ProductNDC>61995-0204</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sunbrellas Kids Sunblock Spf 45</ProprietaryName>
    <NonProprietaryName>Homosalate, Octocrylene, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicilate, Titanium Dioxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20091103</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>The Hain Celestial Group, Inc.</LabelerName>
    <SubstanceName>HOMOSALATE; OCTOCRYLENE; OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE</SubstanceName>
    <StrengthNumber>10; 10; 7.5; 5; 2</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>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>USES: 1     Helps prevent sunburns, 2     Higher SPF gives more sunburn protection, 3     Moderate sun protection product.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>61995-0209-4</NDCCode>
    <PackageDescription>128 g in 1 BOTTLE (61995-0209-4)</PackageDescription>
    <NDC11Code>61995-0209-04</NDC11Code>
    <ProductNDC>61995-0209</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Jason Facial Natural Sunscreen Broad Spectrum Spf20</ProprietaryName>
    <NonProprietaryName>Homosalate, Octocrylene, Ethylhexyl Salicylate, Titanium Dioxide</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20110811</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>The Hain Celestial Group, Inc.</LabelerName>
    <SubstanceName>HOMOSALATE; OCTOCRYLENE; OCTISALATE; TITANIUM DIOXIDE</SubstanceName>
    <StrengthNumber>7.5; 5; 3; 2</StrengthNumber>
    <StrengthUnit>g/100g; g/100g; g/100g; g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Helps prevent sunburns . If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging, caused by the sun.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>61995-0210-4</NDCCode>
    <PackageDescription>113 g in 1 TUBE (61995-0210-4)</PackageDescription>
    <NDC11Code>61995-0210-04</NDC11Code>
    <ProductNDC>61995-0210</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Sunbrellas Mineral Sunblock Spf 30</ProprietaryName>
    <NonProprietaryName>Zinc Oxide, Titanium Dioxide</NonProprietaryName>
    <DosageFormName>CREAM</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20091103</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>The Hain Celestial Group, Inc.</LabelerName>
    <SubstanceName>ZINC OXIDE; TITANIUM DIOXIDE</SubstanceName>
    <StrengthNumber>14.5; 2</StrengthNumber>
    <StrengthUnit>g/100g; g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>USES: 1 Helps prevent sunburns, 2 Higher SPF gives more sunburn protection, 3 Moderate sun protection product, 4 apply sunscreen liberally to all exposed skin area 15 to 20 minutes before sun exposure, 5 Reapply as needed after towel drying, swimming or sweating, 6 Children after 6 months, ask doctor.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>61995-0212-4</NDCCode>
    <PackageDescription>113 g in 1 BOTTLE (61995-0212-4)</PackageDescription>
    <NDC11Code>61995-0212-04</NDC11Code>
    <ProductNDC>61995-0212</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Earths Best Mineral Sunscreen Broad Spectrum Spf30</ProprietaryName>
    <NonProprietaryName>Zinc Oxide, Titanium Dioxide</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20111019</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>The Hain Celestial Group, Inc.</LabelerName>
    <SubstanceName>ZINC OXIDE; TITANIUM DIOXIDE</SubstanceName>
    <StrengthNumber>14.5; 2</StrengthNumber>
    <StrengthUnit>g/100g; g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Helps prevent sunburns . If used as described with other sun protection measures, decreases the risk of skin cancer and early skin aging, caused by the sun.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>61995-0300-4</NDCCode>
    <PackageDescription>113 g in 1 TUBE (61995-0300-4)</PackageDescription>
    <NDC11Code>61995-0300-04</NDC11Code>
    <ProductNDC>61995-0300</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Jason Pure Natural Sun Family Natural Sunscreen Broad Spectrum Spf45</ProprietaryName>
    <NonProprietaryName>Homosalate, Octocrylene, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicylate, Titanium Dioxide</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20110911</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>The Hain Celestial Group, Inc.</LabelerName>
    <SubstanceName>HOMOSALATE; OCTOCRYLENE; OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE</SubstanceName>
    <StrengthNumber>10; 10; 7.5; 5; 2</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>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Helps prevent sunburns . If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging, caused by the sun.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>61995-0315-4</NDCCode>
    <PackageDescription>113 g in 1 TUBE (61995-0315-4)</PackageDescription>
    <NDC11Code>61995-0315-04</NDC11Code>
    <ProductNDC>61995-0315</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Jason Pure Natural Sun Mineral Natural Sunscreen Broad Spectrum Spf30</ProprietaryName>
    <NonProprietaryName>Zinc Oxide, Titanium Oxide</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20110820</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>The Hain Celestial Group, Inc.</LabelerName>
    <SubstanceName>ZINC OXIDE; TITANIUM DIOXIDE</SubstanceName>
    <StrengthNumber>14.5; 2</StrengthNumber>
    <StrengthUnit>g/100g; g/100g</StrengthUnit>
    <Status>Deprecated</Status>
    <LastUpdate>2019-09-21</LastUpdate>
    <ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
    <ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Helps Prevent Sunburns. If used as described with other sunscreen protection measures, decrease the risk of skin cancer and early skin aging, caused by sun.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>61995-0320-4</NDCCode>
    <PackageDescription>113 g in 1 TUBE (61995-0320-4)</PackageDescription>
    <NDC11Code>61995-0320-04</NDC11Code>
    <ProductNDC>61995-0320</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Jason Pure Natural Sun Sport Natural Sunscreen Broad Spectrum Spf45</ProprietaryName>
    <NonProprietaryName>Homosalate, Octocrylene, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicylate, Titanium Dioxide</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20110810</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>The Hain Celestial Group, Inc.</LabelerName>
    <SubstanceName>HOMOSALATE; OCTOCRYLENE; OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE</SubstanceName>
    <StrengthNumber>10; 10; 7.5; 5; 2</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>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Helps prevent sunburns . If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging, caused by sun.</IndicationAndUsage>
  </NDC>
  <NDC>
    <NDCCode>61995-0322-4</NDCCode>
    <PackageDescription>113 g in 1 TUBE (61995-0322-4)</PackageDescription>
    <NDC11Code>61995-0322-04</NDC11Code>
    <ProductNDC>61995-0322</ProductNDC>
    <ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
    <ProprietaryName>Jason Pure Natural Sun Kids Natural Sunscren Broad Spectrum Spf45</ProprietaryName>
    <NonProprietaryName>Homosalate, Octocrylene, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicylate, Titanium Dioxide</NonProprietaryName>
    <DosageFormName>LOTION</DosageFormName>
    <RouteName>TOPICAL</RouteName>
    <StartMarketingDate>20110811</StartMarketingDate>
    <MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
    <ApplicationNumber>part352</ApplicationNumber>
    <LabelerName>The Hain Celestial Group, Inc.</LabelerName>
    <SubstanceName>HOMOSALATE; OCTOCRYLENE; OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE</SubstanceName>
    <StrengthNumber>10; 10; 7.5; 5; 2</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>20171231</ListingRecordCertifiedThrough>
    <IndicationAndUsage>Helps prevent sunburns. If used as directed with other sun protection measures, decreases the risk  of skin cancer and early skin aging, caused by the sun.</IndicationAndUsage>
  </NDC>
</NDCList>
                    

<NDCList><NDC><NDCCode>61995-0205-4</NDCCode><ProprietaryName>Sunbrellas Family Sunblock Spf 45</ProprietaryName><NonProprietaryName>Homosalate, Octocrylene, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicilate, Titanium Dioxide</NonProprietaryName></NDC><NDC><NDCCode>13630-0205-4</NDCCode><ProprietaryName>Aloe Up</ProprietaryName><NonProprietaryName>Avobenzone, Octisalate, And Octocrylene</NonProprietaryName></NDC><NDC><NDCCode>15631-0205-4</NDCCode><ProprietaryName>Gentiana Quinqueflora</ProprietaryName><NonProprietaryName>Gentiana Quinqueflora</NonProprietaryName></NDC><NDC><NDCCode>22840-0205-4</NDCCode><ProprietaryName>Standardized Orchard Grass Pollen</ProprietaryName><NonProprietaryName>Dactylis Glomerata</NonProprietaryName></NDC><NDC><NDCCode>37662-0205-4</NDCCode><ProprietaryName>Castoreum</ProprietaryName><NonProprietaryName>Castoreum</NonProprietaryName></NDC><NDC><NDCCode>49288-0205-4</NDCCode><ProprietaryName>Standardized Meadow Fescue Grass Pollen</ProprietaryName><NonProprietaryName>Standardized Meadow Fescue Grass Pollen</NonProprietaryName></NDC><NDC><NDCCode>51514-0205-1</NDCCode><ProprietaryName>Gap Favorite Lip Balm</ProprietaryName><NonProprietaryName>Octinoxate And Oxybenzone</NonProprietaryName></NDC><NDC><NDCCode>51754-0205-2</NDCCode><ProprietaryName>Verapamil Hydrochloride</ProprietaryName><NonProprietaryName>Verapamil Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>68599-0205-1</NDCCode><ProprietaryName>Thera Calazinc Body Shield</ProprietaryName><NonProprietaryName>Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>68599-0205-4</NDCCode><ProprietaryName>Thera Calazinc Body Shield</ProprietaryName><NonProprietaryName>Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>71335-0205-4</NDCCode><ProprietaryName>Ondansetron Hydrochloride</ProprietaryName><NonProprietaryName>Ondansetron Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>71335-0205-6</NDCCode><ProprietaryName>Ondansetron Hydrochloride</ProprietaryName><NonProprietaryName>Ondansetron Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>71858-0205-4</NDCCode><ProprietaryName>Vybrique</ProprietaryName><NonProprietaryName>Sildenafil Citrate</NonProprietaryName></NDC><NDC><NDCCode>71858-0205-5</NDCCode><ProprietaryName>Vybrique</ProprietaryName><NonProprietaryName>Sildenafil Citrate</NonProprietaryName></NDC><NDC><NDCCode>82347-0205-4</NDCCode><ProprietaryName>Sildenafil</ProprietaryName><NonProprietaryName>Sildenafil Citrate</NonProprietaryName></NDC><NDC><NDCCode>82347-0205-5</NDCCode><ProprietaryName>Sildenafil</ProprietaryName><NonProprietaryName>Sildenafil Citrate</NonProprietaryName></NDC><NDC><NDCCode>61995-0014-4</NDCCode><ProprietaryName>J0830014 Jason Sun Family Sunscreen Spf45</ProprietaryName><NonProprietaryName>Homosalate, Octyl Salicylate, Octocrylene, Avobenzone</NonProprietaryName></NDC><NDC><NDCCode>61995-0015-4</NDCCode><ProprietaryName>Jason Mineral Sunscreen Spf30 Broad Spectrum</ProprietaryName><NonProprietaryName>Zinc Oxide, Titanium Dioxide</NonProprietaryName></NDC><NDC><NDCCode>61995-0020-4</NDCCode><ProprietaryName>J0832014 Jason Sun Sport Sunscreen Spf45</ProprietaryName><NonProprietaryName>Avobenzone, Homosalate, Octocrylene, Octyl Salicylate</NonProprietaryName></NDC><NDC><NDCCode>61995-0022-4</NDCCode><ProprietaryName>J0832212 Jason Kids Sunscreen Spf45</ProprietaryName><NonProprietaryName>Homosalate, Octyl Salicylate, Octocrylene, Avobenzone</NonProprietaryName></NDC><NDC><NDCCode>61995-0027-4</NDCCode><ProprietaryName>J0832706 Jason Sun Facial Sunscreen Spf20</ProprietaryName><NonProprietaryName>Homosalate, Octyl Salicylate, Octocrylene, Avobenzone</NonProprietaryName></NDC><NDC><NDCCode>61995-0201-4</NDCCode><ProprietaryName>Sunbrellas Sport Sunblock Spf 45</ProprietaryName><NonProprietaryName>Homosalate, Octocrylene, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicylate, Titanium Dioxide</NonProprietaryName></NDC><NDC><NDCCode>61995-0204-4</NDCCode><ProprietaryName>Sunbrellas Kids Sunblock Spf 45</ProprietaryName><NonProprietaryName>Homosalate, Octocrylene, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicilate, Titanium Dioxide</NonProprietaryName></NDC><NDC><NDCCode>61995-0209-4</NDCCode><ProprietaryName>Jason Facial Natural Sunscreen Broad Spectrum Spf20</ProprietaryName><NonProprietaryName>Homosalate, Octocrylene, Ethylhexyl Salicylate, Titanium Dioxide</NonProprietaryName></NDC><NDC><NDCCode>61995-0210-4</NDCCode><ProprietaryName>Sunbrellas Mineral Sunblock Spf 30</ProprietaryName><NonProprietaryName>Zinc Oxide, Titanium Dioxide</NonProprietaryName></NDC><NDC><NDCCode>61995-0212-4</NDCCode><ProprietaryName>Earths Best Mineral Sunscreen Broad Spectrum Spf30</ProprietaryName><NonProprietaryName>Zinc Oxide, Titanium Dioxide</NonProprietaryName></NDC><NDC><NDCCode>61995-0300-4</NDCCode><ProprietaryName>Jason Pure Natural Sun Family Natural Sunscreen Broad Spectrum Spf45</ProprietaryName><NonProprietaryName>Homosalate, Octocrylene, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicylate, Titanium Dioxide</NonProprietaryName></NDC><NDC><NDCCode>61995-0315-4</NDCCode><ProprietaryName>Jason Pure Natural Sun Mineral Natural Sunscreen Broad Spectrum Spf30</ProprietaryName><NonProprietaryName>Zinc Oxide, Titanium Oxide</NonProprietaryName></NDC><NDC><NDCCode>61995-0320-4</NDCCode><ProprietaryName>Jason Pure Natural Sun Sport Natural Sunscreen Broad Spectrum Spf45</ProprietaryName><NonProprietaryName>Homosalate, Octocrylene, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicylate, Titanium Dioxide</NonProprietaryName></NDC><NDC><NDCCode>61995-0322-4</NDCCode><ProprietaryName>Jason Pure Natural Sun Kids Natural Sunscren Broad Spectrum Spf45</ProprietaryName><NonProprietaryName>Homosalate, Octocrylene, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicylate, Titanium Dioxide</NonProprietaryName></NDC></NDCList>
                    

Using REST to Invoke DataLabs API

Introduction

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

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

Working With DataLabs REST API

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

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

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

Four parameters are required with each “search” request:

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

Optional parameter:

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

All other query parameters (if any) are optional.

Full list of API parameters:

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

Operations Currently Available in the DataLabs REST API

Currently DataLabs RESTful Lookup Service supports following operations:

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

Plus there are three NPI-specific operations:

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

REST Search Examples

Query Parameter Reference

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

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

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

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

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

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

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

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

        Console.WriteLine(response);

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

            
{
  "NPI": [
    {
      "NPI": "1295783033",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "REDMOND EYE DOCTORS, PLLC",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3554",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-7363",
      "MailingAddressFaxNumber": "425-861-5585",
      "FirstLinePracticeLocationAddress": "16375 NE 85TH ST",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3554",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-7363",
      "PracticeLocationAddressFaxNumber": "425-861-5585",
      "EnumerationDate": "05/04/2006",
      "LastUpdateDate": "12/11/2007",
      "AuthorizedOfficialLastName": "MONTECILLO",
      "AuthorizedOfficialFirstName": "RANIA",
      "AuthorizedOfficialTitle": "OWNER",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-7363",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "801TX",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization."
    },
    {
      "NPI": "1346319878",
      "EntityType": "Organization",
      "EIN": "N/A",
      "OrgName": "REDMOND EYE CLINIC PLLC",
      "FirstLineMailingAddress": "16150 NE 85TH ST STE 206",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3543",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-3574",
      "MailingAddressFaxNumber": "425-881-0230",
      "FirstLinePracticeLocationAddress": "16150 NE 85TH ST STE 206",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3543",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-3574",
      "PracticeLocationAddressFaxNumber": "425-881-0230",
      "EnumerationDate": "11/07/2006",
      "LastUpdateDate": "07/08/2007",
      "AuthorizedOfficialLastName": "OTTEN",
      "AuthorizedOfficialFirstName": "LARRY",
      "AuthorizedOfficialMiddleName": "C",
      "AuthorizedOfficialTitle": "DR",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-885-3574",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "OD00001172",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
      "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."
    },
    {
      "NPI": "1376755009",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "PERIMAN",
      "FirstName": "LAURA",
      "MiddleName": "MARIE",
      "NamePrefix": "DR.",
      "Credential": "MD",
      "FirstLineMailingAddress": "623 W HIGHLAND DR",
      "MailingAddressCityName": "SEATTLE",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98119-3446",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "206-282-2716",
      "FirstLinePracticeLocationAddress": "16150 NE 85TH ST STE 206",
      "SecondLinePracticeLocationAddress": "REDMOND EYE CLINIC",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3543",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-3574",
      "EnumerationDate": "05/04/2007",
      "LastUpdateDate": "07/08/2007",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207W00000X",
      "Taxonomy1": "Ophthalmology",
      "LicenseNumber1": "MD00039796",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1659320539",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "MONTECILLO",
      "FirstName": "RANIA",
      "MiddleName": "B",
      "NamePrefix": "DR.",
      "Credential": "OD",
      "FirstLineMailingAddress": "16375 NE 85TH ST",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-3554",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-7363",
      "MailingAddressFaxNumber": "425-861-5585",
      "FirstLinePracticeLocationAddress": "16375 NE 85TH ST",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-3554",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-7363",
      "PracticeLocationAddressFaxNumber": "425-861-5585",
      "EnumerationDate": "05/09/2006",
      "LastUpdateDate": "12/19/2007",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "3680",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1427560267",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "ABOU SHADI",
      "FirstName": "RANIA",
      "NamePrefix": "MRS.",
      "Credential": "RPH",
      "FirstLineMailingAddress": "8862 161ST AVENUE NE",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-883-9532",
      "MailingAddressFaxNumber": "425-882-2743",
      "FirstLinePracticeLocationAddress": "8862 161ST AVENUE NE",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-883-9532",
      "PracticeLocationAddressFaxNumber": "425-882-2743",
      "EnumerationDate": "11/02/2017",
      "LastUpdateDate": "11/02/2017",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "3336C0003X",
      "Taxonomy1": "Community/Retail Pharmacy",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1528050523",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "DESCHUTES EYE CLINIC PC",
      "OtherOrgName": "THE EYE SURGERY INSTITUTE",
      "OtherOrgNameTypeCode": "3",
      "FirstLineMailingAddress": "813 SW HIGHLAND AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-3123",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-548-7170",
      "MailingAddressFaxNumber": "541-548-3842",
      "FirstLinePracticeLocationAddress": "813 SW HIGHLAND AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-3123",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-548-7170",
      "PracticeLocationAddressFaxNumber": "541-548-3842",
      "EnumerationDate": "08/17/2005",
      "LastUpdateDate": "12/01/2010",
      "AuthorizedOfficialLastName": "TRAUSTASON",
      "AuthorizedOfficialFirstName": "OLI",
      "AuthorizedOfficialMiddleName": "I",
      "AuthorizedOfficialTitle": "PRESIDENT",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "M.D.",
      "AuthorizedOfficialTelephoneNumber": "541-548-7170",
      "TaxonomyCode1": "207W00000X",
      "Taxonomy1": "Ophthalmology",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "053857000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierState1": "OR",
      "OtherIdentifierIssuer1": "REGENCE BCBS",
      "OtherIdentifier2": "CJ8770",
      "OtherIdentifierType2": "OTHER",
      "OtherIdentifierState2": "OR",
      "OtherIdentifierIssuer2": "RAILROAD MEDICARE",
      "OtherIdentifier3": "38080A",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierState3": "OR",
      "OtherIdentifierIssuer3": "CLEAR CHOICE",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization."
    },
    {
      "NPI": "1477596252",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "EYE CARE SPECIALISTS NORTHWEST PLLC",
      "OtherOrgName": "THE CHILDRENS EYE DOCTORS, THE FAMILY EYE DOCTORS, WOODLAWN OPTICAL",
      "OtherOrgNameTypeCode": "3",
      "FirstLineMailingAddress": "17130 AVONDALE WAY NE",
      "SecondLineMailingAddress": "SUITE 111",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-885-6600",
      "MailingAddressFaxNumber": "425-885-6580",
      "FirstLinePracticeLocationAddress": "17130 AVONDALE WAY NE",
      "SecondLinePracticeLocationAddress": "SUITE 111",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-885-6600",
      "PracticeLocationAddressFaxNumber": "425-885-6580",
      "EnumerationDate": "06/13/2006",
      "LastUpdateDate": "03/03/2008",
      "AuthorizedOfficialLastName": "LENART",
      "AuthorizedOfficialFirstName": "THOMAS",
      "AuthorizedOfficialTitle": "OWNER",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "MD PHD",
      "AuthorizedOfficialTelephoneNumber": "425-885-6600",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "156FX1800X",
      "Taxonomy2": "Optician",
      "PrimaryTaxonomySwitch2": "N",
      "TaxonomyCode3": "207W00000X",
      "Taxonomy3": "Ophthalmology",
      "PrimaryTaxonomySwitch3": "Y",
      "OtherIdentifier1": "1568514032",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "NPI",
      "OtherIdentifier2": "1740297829",
      "OtherIdentifierType2": "OTHER",
      "OtherIdentifierIssuer2": "NPI",
      "OtherIdentifier3": "1205989522",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "NPI",
      "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.",
      "HealthcareProviderTaxonomyGroup2": "193200000X MULTI-SPECIALTY GROUP",
      "HealthcareProviderTaxonomyGroupDescription2": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization.",
      "HealthcareProviderTaxonomyGroup3": "193200000X MULTI-SPECIALTY GROUP",
      "HealthcareProviderTaxonomyGroupDescription3": "Multi-Specialty Group - A business group of one or more individual practitioners, who practice with different areas of specialization."
    },
    {
      "NPI": "1215029343",
      "EntityType": "Organization",
      "EIN": "N/A",
      "IsOrgSubpart": "N",
      "OrgName": "EYE HEALTH PROFESSIONALS, P.C.",
      "FirstLineMailingAddress": "85 BARNES RD",
      "SecondLineMailingAddress": "SUITE 102",
      "MailingAddressCityName": "WALLINGFORD",
      "MailingAddressStateName": "CT",
      "MailingAddressPostalCode": "06492-1832",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "203-284-9448",
      "MailingAddressFaxNumber": "203-269-1361",
      "FirstLinePracticeLocationAddress": "85 BARNES RD",
      "SecondLinePracticeLocationAddress": "SUITE 102",
      "PracticeLocationAddressCityName": "WALLINGFORD",
      "PracticeLocationAddressStateName": "CT",
      "PracticeLocationAddressPostalCode": "06492-1832",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "203-284-9448",
      "PracticeLocationAddressFaxNumber": "203-269-1361",
      "EnumerationDate": "09/28/2006",
      "LastUpdateDate": "03/07/2008",
      "AuthorizedOfficialLastName": "REDMOND",
      "AuthorizedOfficialFirstName": "JOHN",
      "AuthorizedOfficialMiddleName": "W",
      "AuthorizedOfficialTitle": "PRESIDENT",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "M.D.",
      "AuthorizedOfficialTelephoneNumber": "203-284-9448",
      "TaxonomyCode1": "207W00000X",
      "Taxonomy1": "Ophthalmology",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization."
    },
    {
      "NPI": "1982789863",
      "EntityType": "Organization",
      "EIN": "N/A",
      "OrgName": "OVERLAKE EYE DESIGNS, P.C.",
      "FirstLineMailingAddress": "15230 NE 24TH ST STE Q",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "WA",
      "MailingAddressPostalCode": "98052-5540",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "425-562-2015",
      "MailingAddressFaxNumber": "425-562-2010",
      "FirstLinePracticeLocationAddress": "15230 NE 24TH ST STE Q",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "WA",
      "PracticeLocationAddressPostalCode": "98052-5540",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "425-562-2015",
      "PracticeLocationAddressFaxNumber": "425-562-2010",
      "EnumerationDate": "10/26/2006",
      "LastUpdateDate": "07/08/2007",
      "AuthorizedOfficialLastName": "WONG",
      "AuthorizedOfficialFirstName": "TONY",
      "AuthorizedOfficialTitle": "OPTOMETRIST",
      "AuthorizedOfficialNamePrefix": "DR.",
      "AuthorizedOfficialCredential": "O.D.",
      "AuthorizedOfficialTelephoneNumber": "425-562-2015",
      "TaxonomyCode1": "152W00000X",
      "Taxonomy1": "Optometrist",
      "LicenseNumber1": "WA 3422 TX",
      "LicenseNumberStateCode1": "WA",
      "PrimaryTaxonomySwitch1": "Y",
      "HealthcareProviderTaxonomyGroup1": "193400000X SINGLE SPECIALTY  GROUP",
      "HealthcareProviderTaxonomyGroupDescription1": "Single Specialty Group - A business group of one or more individual practitioners, all of who practice with the same area of specialization."
    },
    {
      "NPI": "1760539969",
      "EntityType": "Organization",
      "EIN": "N/A",
      "OrgName": "DR TIFFANY J HOLLENBECK PLLC",
      "OtherOrgName": "REDMOND RIDGE EYE CARE",
      "OtherOrgNameTypeCode": "3",
      "FirstLineMailingAddress": "22310 NE MARKETPLACE DR",
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      "MiddleName": "QASSIEM",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "11476 OKEECHOBEE BLVD",
      "MailingAddressCityName": "ROYAL PALM BEACH",
      "MailingAddressStateName": "FL",
      "MailingAddressPostalCode": "33411-8715",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "561-204-5111",
      "MailingAddressFaxNumber": "561-204-5150",
      "FirstLinePracticeLocationAddress": "11476 OKEECHOBEE BLVD",
      "PracticeLocationAddressCityName": "ROYAL PALM BEACH",
      "PracticeLocationAddressStateName": "FL",
      "PracticeLocationAddressPostalCode": "33411-8715",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "561-204-5111",
      "PracticeLocationAddressFaxNumber": "561-204-5150",
      "EnumerationDate": "05/21/2006",
      "LastUpdateDate": "09/11/2007",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "ME 79876",
      "LicenseNumberStateCode1": "FL",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1326095100",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "ROSBOROUGH",
      "FirstName": "RANIA",
      "MiddleName": "BAJWA",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "3100 WYMAN PARK DR",
      "MailingAddressCityName": "BALTIMORE",
      "MailingAddressStateName": "MD",
      "MailingAddressPostalCode": "21211-2803",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "410-338-3500",
      "FirstLinePracticeLocationAddress": "3601 SW 160TH AVE",
      "SecondLinePracticeLocationAddress": "SUITE 250",
      "PracticeLocationAddressCityName": "MIRAMAR",
      "PracticeLocationAddressStateName": "FL",
      "PracticeLocationAddressPostalCode": "33027-6308",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "877-866-7123",
      "EnumerationDate": "05/27/2006",
      "LastUpdateDate": "12/10/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "D0063732",
      "LicenseNumberStateCode1": "MD",
      "PrimaryTaxonomySwitch1": "Y",
      "TaxonomyCode2": "207Q00000X",
      "Taxonomy2": "Family Medicine",
      "LicenseNumber2": "0101257197",
      "LicenseNumberStateCode2": "VA",
      "PrimaryTaxonomySwitch2": "N"
    },
    {
      "NPI": "1528015310",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "HUSSEINI",
      "FirstName": "RANIA",
      "MiddleName": "I",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "111 CYPRESS ST",
      "MailingAddressCityName": "BROOKLINE",
      "MailingAddressStateName": "MA",
      "MailingAddressPostalCode": "02445-6002",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "508-718-4050",
      "FirstLinePracticeLocationAddress": "20 PATRIOT PL",
      "PracticeLocationAddressCityName": "FOXBORO",
      "PracticeLocationAddressStateName": "MA",
      "PracticeLocationAddressPostalCode": "02035-1375",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "508-718-4050",
      "EnumerationDate": "05/27/2006",
      "LastUpdateDate": "04/17/2012",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "209649",
      "LicenseNumberStateCode1": "MA",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1760429591",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "RAYES-DANAN",
      "FirstName": "RANIA",
      "NamePrefix": "DR.",
      "Credential": "MD",
      "OtherLastName": "RAYES",
      "OtherFirstName": "RANIA",
      "OtherLastNameTypeCode": "1",
      "FirstLineMailingAddress": "2500 METROHEALTH DR",
      "MailingAddressCityName": "CLEVELAND",
      "MailingAddressStateName": "OH",
      "MailingAddressPostalCode": "44109-1900",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "216-778-7800",
      "FirstLinePracticeLocationAddress": "2500 METROHEALTH DR",
      "PracticeLocationAddressCityName": "CLEVELAND",
      "PracticeLocationAddressStateName": "OH",
      "PracticeLocationAddressPostalCode": "44109-1900",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "216-778-7800",
      "EnumerationDate": "06/01/2006",
      "LastUpdateDate": "01/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207ZP0102X",
      "Taxonomy1": "Anatomic Pathology & Clinical Pathology",
      "LicenseNumber1": "35086346",
      "LicenseNumberStateCode1": "OH",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "2687703",
      "OtherIdentifierType1": "MEDICAID",
      "OtherIdentifierState1": "OH"
    },
    {
      "NPI": "1699717660",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "AMPEY",
      "FirstName": "RANIA",
      "MiddleName": "L",
      "Credential": "LPC",
      "FirstLineMailingAddress": "5930 LOVERS LN",
      "SecondLineMailingAddress": "PREMIER NEUROPSYCHIATRY, PLC",
      "MailingAddressCityName": "PORTAGE",
      "MailingAddressStateName": "MI",
      "MailingAddressPostalCode": "49002-1673",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "269-873-1611",
      "FirstLinePracticeLocationAddress": "5930 LOVERS LN",
      "SecondLinePracticeLocationAddress": "PREMIER NEUROPSYCHIATRY, PLC",
      "PracticeLocationAddressCityName": "PORTAGE",
      "PracticeLocationAddressStateName": "MI",
      "PracticeLocationAddressPostalCode": "49002-1673",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "269-873-1611",
      "EnumerationDate": "06/12/2006",
      "LastUpdateDate": "12/30/2010",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YP2500X",
      "Taxonomy1": "Professional",
      "LicenseNumber1": "6401007658",
      "LicenseNumberStateCode1": "MI",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1801839667",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "ABOUJAOUDE",
      "FirstName": "RANIA",
      "Credential": "M.D.",
      "FirstLineMailingAddress": "PO BOX 1283",
      "MailingAddressCityName": "MEDFORD",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08055-6283",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "609-677-1046",
      "MailingAddressFaxNumber": "609-677-1306",
      "FirstLinePracticeLocationAddress": "200 TRENTON RD",
      "PracticeLocationAddressCityName": "BROWNS MILLS",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08015-1705",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "609-677-1046",
      "PracticeLocationAddressFaxNumber": "609-677-1306",
      "EnumerationDate": "06/13/2006",
      "LastUpdateDate": "09/15/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207RI0200X",
      "Taxonomy1": "Infectious Disease",
      "LicenseNumber1": "39215",
      "LicenseNumberStateCode1": "KY",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "207RI0200X",
      "Taxonomy2": "Infectious Disease",
      "LicenseNumber2": "25MA07672000",
      "LicenseNumberStateCode2": "NJ",
      "PrimaryTaxonomySwitch2": "Y"
    },
    {
      "NPI": "1184645301",
      "EntityType": "Individual",
      "IsSoleProprietor": "Y",
      "LastName": "BAIK",
      "FirstName": "RANIA",
      "Credential": "D.O.",
      "FirstLineMailingAddress": "602 ROUTE 169",
      "SecondLineMailingAddress": "PO BOX 865",
      "MailingAddressCityName": "WOODSTOCK",
      "MailingAddressStateName": "CT",
      "MailingAddressPostalCode": "06281-2225",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "860-821-3406",
      "MailingAddressFaxNumber": "860-821-3407",
      "FirstLinePracticeLocationAddress": "602 ROUTE 169",
      "PracticeLocationAddressCityName": "WOODSTOCK",
      "PracticeLocationAddressStateName": "CT",
      "PracticeLocationAddressPostalCode": "06281-2225",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "860-821-3406",
      "PracticeLocationAddressFaxNumber": "860-821-3407",
      "EnumerationDate": "07/22/2006",
      "LastUpdateDate": "01/14/2016",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207Q00000X",
      "Taxonomy1": "Family Medicine",
      "LicenseNumber1": "000260",
      "LicenseNumberStateCode1": "CT",
      "PrimaryTaxonomySwitch1": "Y"
    },
    {
      "NPI": "1265443618",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "LOUTFI",
      "FirstName": "RANIA",
      "MiddleName": "H",
      "Credential": "MD",
      "FirstLineMailingAddress": "1 COOPER PLZ",
      "SecondLineMailingAddress": "THE COOPER HOSPITALIST TEAM",
      "MailingAddressCityName": "CAMDEN",
      "MailingAddressStateName": "NJ",
      "MailingAddressPostalCode": "08103-1461",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "856-342-3150",
      "MailingAddressFaxNumber": "856-968-8418",
      "FirstLinePracticeLocationAddress": "1 COOPER PLZ",
      "SecondLinePracticeLocationAddress": "THE COOPER HOSPITALIST TEAM",
      "PracticeLocationAddressCityName": "CAMDEN",
      "PracticeLocationAddressStateName": "NJ",
      "PracticeLocationAddressPostalCode": "08103-1461",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "856-342-3150",
      "PracticeLocationAddressFaxNumber": "856-968-8418",
      "EnumerationDate": "08/11/2006",
      "LastUpdateDate": "06/30/2014",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "207R00000X",
      "Taxonomy1": "Internal Medicine",
      "LicenseNumber1": "MA080819",
      "LicenseNumberStateCode1": "NJ",
      "PrimaryTaxonomySwitch1": "Y",
      "OtherIdentifier1": "01007800000",
      "OtherIdentifierType1": "OTHER",
      "OtherIdentifierIssuer1": "AMERICHOICE",
      "OtherIdentifier2": "0118460",
      "OtherIdentifierType2": "MEDICAID",
      "OtherIdentifierState2": "NJ",
      "OtherIdentifier3": "P00381177",
      "OtherIdentifierType3": "OTHER",
      "OtherIdentifierIssuer3": "RAIL ROAD MEDICARE",
      "OtherIdentifier4": "2798670000",
      "OtherIdentifierType4": "OTHER",
      "OtherIdentifierIssuer4": "AMERIHEALTH, HMO, KEYSTONE, IBC",
      "OtherIdentifier5": "1376273",
      "OtherIdentifierType5": "OTHER",
      "OtherIdentifierIssuer5": "AETNA US-HEALTHCARE",
      "OtherIdentifier6": "44132",
      "OtherIdentifierType6": "OTHER",
      "OtherIdentifierIssuer6": "UNIVERSITY HEALTH PLAN",
      "OtherIdentifier7": "60027465",
      "OtherIdentifierType7": "OTHER",
      "OtherIdentifierIssuer7": "HORIZON NJ HEALTH",
      "OtherIdentifier8": "3K6229",
      "OtherIdentifierType8": "OTHER",
      "OtherIdentifierIssuer8": "HEALTHNET",
      "OtherIdentifier9": "6761897",
      "OtherIdentifierType9": "OTHER",
      "OtherIdentifierIssuer9": "CIGNA"
    }
  ]
}

Done. Press any key to exit ...
            
        

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

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

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

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

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

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

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

            Console.WriteLine(response);

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

                
{
  "NPI": [
    {
      "NPI": "1083349906",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "STAFFORD",
      "FirstName": "KADY",
      "NamePrefix": "MS.",
      "Credential": "LPC",
      "FirstLineMailingAddress": "13574 SW HIGHWAY 126",
      "MailingAddressCityName": "POWELL BUTTE",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97753-1541",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-480-6360",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-203-0307",
      "EnumerationDate": "07/24/2022",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101YP2500X",
      "Taxonomy1": "Professional Counselor",
      "LicenseNumber1": "LPC6225",
      "LicenseNumberStateCode1": "ID",
      "PrimaryTaxonomySwitch1": "N",
      "TaxonomyCode2": "101YP2500X",
      "Taxonomy2": "Professional Counselor",
      "LicenseNumber2": "C9084",
      "LicenseNumberStateCode2": "OR",
      "PrimaryTaxonomySwitch2": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101YP2500X",
      "PrimaryTaxonomy": "Professional Counselor"
    },
    {
      "NPI": "1215724679",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "SCHAY",
      "FirstName": "ANGELICA",
      "MiddleName": "NICOLE",
      "FirstLineMailingAddress": "6396 SW MCVEY AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-9069",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "541-389-1841",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "541-389-1841",
      "EnumerationDate": "04/21/2025",
      "LastUpdateDate": "04/21/2025",
      "GenderCode": "F",
      "Gender": "Female",
      "TaxonomyCode1": "101Y00000X",
      "Taxonomy1": "Counselor",
      "PrimaryTaxonomySwitch1": "Y",
      "CertificationDate": "04/21/2025",
      "PrimaryTaxonomyCode": "101Y00000X",
      "PrimaryTaxonomy": "Counselor"
    },
    {
      "NPI": "1013556505",
      "EntityType": "Individual",
      "IsSoleProprietor": "N",
      "LastName": "IVENS",
      "FirstName": "KRYSTA",
      "FirstLineMailingAddress": "743 NW QUINCE AVE",
      "MailingAddressCityName": "REDMOND",
      "MailingAddressStateName": "OR",
      "MailingAddressPostalCode": "97756-1250",
      "MailingAddressCountryCode": "US",
      "MailingAddressTelephoneNumber": "360-526-1448",
      "FirstLinePracticeLocationAddress": "6396 SW MCVEY AVE",
      "PracticeLocationAddressCityName": "REDMOND",
      "PracticeLocationAddressStateName": "OR",
      "PracticeLocationAddressPostalCode": "97756-9069",
      "PracticeLocationAddressCountryCode": "US",
      "PracticeLocationAddressTelephoneNumber": "971-217-6150",
      "EnumerationDate": "12/31/2019",
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}
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