{
"NDC": [
{
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"PackageDescription": "473 mL in 1 BOTTLE (58809-571-01)",
"NDC11Code": "58809-0571-01",
"ProductNDC": "58809-571",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Vanacof",
"ProprietaryNameSuffix": "G",
"NonProprietaryName": "Chlophedianol Hydrochloride, Guaifenesin",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110606",
"EndMarketingDate": "20140930",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "GM Pharmaceuticals, Inc.",
"SubstanceName": "CHLOPHEDIANOL HYDROCHLORIDE; GUAIFENESIN",
"StrengthNumber": "25; 200",
"StrengthUnit": "mg/5mL; mg/5mL",
"Status": "Deprecated",
"LastUpdate": "2014-10-03"
},
{
"NDCCode": "58809-571-02",
"PackageDescription": "12 BOTTLE in 1 CARTON (58809-571-02) > 15 mL in 1 BOTTLE",
"NDC11Code": "58809-0571-02",
"ProductNDC": "58809-571",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Vanacof",
"ProprietaryNameSuffix": "G",
"NonProprietaryName": "Chlophedianol Hydrochloride, Guaifenesin",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110606",
"EndMarketingDate": "20140930",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "GM Pharmaceuticals, Inc.",
"SubstanceName": "CHLOPHEDIANOL HYDROCHLORIDE; GUAIFENESIN",
"StrengthNumber": "25; 200",
"StrengthUnit": "mg/5mL; mg/5mL",
"Status": "Deprecated",
"LastUpdate": "2014-10-03"
},
{
"NDCCode": "58809-213-01",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (58809-213-01) ",
"NDC11Code": "58809-0213-01",
"ProductNDC": "58809-213",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Texaclear All Season Allergy Relief",
"NonProprietaryName": "Antigens All Zones Grasses Trees And Weeds. Baptisia Tinctoria, Echinacea, Hydrastis Canadensis, Myrrha, Nasturtium Aquaticum, Phytolacca Decandra, Urtica Urens",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20231110",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "GM Pharmaceuticals, INC",
"SubstanceName": "HOLCUS LANATUS POLLEN; MORUS RUBRA POLLEN; PINUS STROBUS POLLEN; NASTURTIUM OFFICINALE; AMARANTHUS SPINOSUS POLLEN; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS VIRGINIANA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN; QUERCUS RUBRA POLLEN; SORGHUM HALEPENSE POLLEN; TRITICUM AESTIVUM POLLEN; URTICA DIOICA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; RUMEX CRISPUS POLLEN; SECALE CEREALE POLLEN; TAXODIUM DISTICHUM POLLEN; XANTHIUM STRUMARIUM POLLEN; QUERCUS NIGRA POLLEN; QUERCUS STELLATA POLLEN; SOLIDAGO CANADENSIS POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA CONFERTIFLORA POLLEN; EUCALYPTUS GLOBULUS POLLEN; MYRRH; SALSOLA KALI POLLEN; QUERCUS MACROCARPA POLLEN; SYAGRUS ROMANZOFFIANA POLLEN; ZEA MAYS POLLEN; CHENOPODIUM ALBUM POLLEN; ARTEMISIA TRIDENTATA POLLEN; GOLDENSEAL; FAGUS GRANDIFOLIA POLLEN; FRAXINUS VELUTINA POLLEN; BROUSSONETIA PAPYRIFERA POLLEN; PINUS ECHINATA POLLEN; URTICA URENS WHOLE; AMARANTHUS PALMERI POLLEN; AMARANTHUS TUBERCULATUS POLLEN; CARYA ILLINOINENSIS POLLEN; LIQUIDAMBAR STYRACIFLUA POLLEN; MELALEUCA QUINQUENERVIA POLLEN; MORUS ALBA POLLEN; HESPEROCYPARIS ARIZONICA POLLEN; JUNIPERUS OCCIDENTALIS POLLEN; OLEA EUROPAEA POLLEN; ECHINACEA ANGUSTIFOLIA ROOT; ACER SACCHARUM POLLEN; ANTHOXANTHUM ODORATUM POLLEN; AVENA SATIVA POLLEN; PHYTOLACCA AMERICANA ROOT; BAPTISIA TINCTORIA ROOT; ACER NEGUNDO POLLEN; AMBROSIA ACANTHICARPA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA TRIFIDA POLLEN; ARTEMISIA VULGARIS POLLEN; CARYA OVATA POLLEN; CELTIS OCCIDENTALIS POLLEN; CYCLACHAENA XANTHIFOLIA POLLEN; JUNIPERUS ASHEI POLLEN; LIGUSTRUM VULGARE POLLEN; MYRICA CERIFERA POLLEN; POA PRATENSIS POLLEN; POPULUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALIX NIGRA POLLEN; SCHINUS MOLLE POLLEN; ACACIA DEALBATA POLLEN; ATRIPLEX WRIGHTII POLLEN; PASPALUM NOTATUM POLLEN; POPULUS NIGRA POLLEN; QUERCUS ALBA POLLEN; QUERCUS GAMBELII POLLEN; PLANTAGO LANCEOLATA POLLEN; PROSOPIS JULIFLORA POLLEN; QUERCUS VIRGINIANA POLLEN; ULMUS AMERICANA POLLEN; AMBROSIA BIDENTATA POLLEN; BASSIA SCOPARIA POLLEN; BETULA NIGRA POLLEN; DISTICHLIS SPICATA POLLEN; EUPATORIUM CAPILLIFOLIUM POLLEN",
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"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231110",
"SamplePackage": "N",
"IndicationAndUsage": "This product is a homeopathic dilution, formulated to support the body's immunity for the temporary relief of allergies.*."
},
{
"NDCCode": "58809-214-01",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (58809-214-01) ",
"NDC11Code": "58809-0214-01",
"ProductNDC": "58809-214",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Texaclear Texas Allergy Relief Plus Cedar Fever",
"NonProprietaryName": "Antigens All Zones Grasses Trees And Weeds. Baptisia Tinctoria, Echinacea, Hydrastis Canadensis, Myrrha, Nasturtium Aquaticum, Phytolacca Decandra, Urtica Urens",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20231110",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "GM Pharmaceuticals, INC",
"SubstanceName": "PLANTAGO LANCEOLATA POLLEN; PROSOPIS JULIFLORA POLLEN; QUERCUS VIRGINIANA POLLEN; ULMUS AMERICANA POLLEN; AMBROSIA BIDENTATA POLLEN; BASSIA SCOPARIA POLLEN; BETULA NIGRA POLLEN; DISTICHLIS SPICATA POLLEN; EUPATORIUM CAPILLIFOLIUM POLLEN; HOLCUS LANATUS POLLEN; MORUS RUBRA POLLEN; PINUS STROBUS POLLEN; NASTURTIUM OFFICINALE; AMARANTHUS SPINOSUS POLLEN; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS VIRGINIANA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN; QUERCUS RUBRA POLLEN; SORGHUM HALEPENSE POLLEN; TRITICUM AESTIVUM POLLEN; URTICA DIOICA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; RUMEX CRISPUS POLLEN; SECALE CEREALE POLLEN; TAXODIUM DISTICHUM POLLEN; XANTHIUM STRUMARIUM POLLEN; QUERCUS NIGRA POLLEN; QUERCUS STELLATA POLLEN; SOLIDAGO CANADENSIS POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA CONFERTIFLORA POLLEN; EUCALYPTUS GLOBULUS POLLEN; MYRRH; SALSOLA KALI POLLEN; QUERCUS MACROCARPA POLLEN; SYAGRUS ROMANZOFFIANA POLLEN; ZEA MAYS POLLEN; CHENOPODIUM ALBUM POLLEN; ARTEMISIA TRIDENTATA POLLEN; GOLDENSEAL; FAGUS GRANDIFOLIA POLLEN; FRAXINUS VELUTINA POLLEN; BROUSSONETIA PAPYRIFERA POLLEN; PINUS ECHINATA POLLEN; URTICA URENS WHOLE; AMARANTHUS PALMERI POLLEN; AMARANTHUS TUBERCULATUS POLLEN; CARYA ILLINOINENSIS POLLEN; LIQUIDAMBAR STYRACIFLUA POLLEN; MELALEUCA QUINQUENERVIA POLLEN; MORUS ALBA POLLEN; HESPEROCYPARIS ARIZONICA POLLEN; JUNIPERUS OCCIDENTALIS POLLEN; OLEA EUROPAEA POLLEN; ECHINACEA ANGUSTIFOLIA ROOT; ACER SACCHARUM POLLEN; ANTHOXANTHUM ODORATUM POLLEN; AVENA SATIVA POLLEN; PHYTOLACCA AMERICANA ROOT; BAPTISIA TINCTORIA ROOT; ACER NEGUNDO POLLEN; AMBROSIA ACANTHICARPA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA TRIFIDA POLLEN; ARTEMISIA VULGARIS POLLEN; CARYA OVATA POLLEN; CELTIS OCCIDENTALIS POLLEN; CYCLACHAENA XANTHIFOLIA POLLEN; JUNIPERUS ASHEI POLLEN; LIGUSTRUM VULGARE POLLEN; MYRICA CERIFERA POLLEN; POA PRATENSIS POLLEN; POPULUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALIX NIGRA POLLEN; SCHINUS MOLLE POLLEN; ACACIA DEALBATA POLLEN; ATRIPLEX WRIGHTII POLLEN; PASPALUM NOTATUM POLLEN; QUERCUS GAMBELII POLLEN; POPULUS NIGRA POLLEN; QUERCUS ALBA POLLEN",
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"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
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"SamplePackage": "N",
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},
{
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"ProductNDC": "58809-363",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Chlorphen Sr",
"NonProprietaryName": "Chlorpheniramine Maleate",
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"RouteName": "ORAL",
"StartMarketingDate": "20100615",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040829",
"LabelerName": "GM Pharmaceuticals, INC",
"SubstanceName": "CHLORPHENIRAMINE MALEATE",
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"StrengthUnit": "mg/1",
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"LastUpdate": "2019-11-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20160104",
"SamplePackage": "N"
},
{
"NDCCode": "58809-407-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (58809-407-01)",
"NDC11Code": "58809-0407-01",
"ProductNDC": "58809-407",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Vanatab Dx",
"NonProprietaryName": "Chlophedianol Hydrochloride, Guaifenesin, Pseudoephedrine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110906",
"EndMarketingDate": "20150228",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "GM Pharmaceuticals, Inc.",
"SubstanceName": "CHLOPHEDIANOL HYDROCHLORIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE",
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"StrengthUnit": "mg/1; mg/1; mg/1",
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"LastUpdate": "2015-03-06"
},
{
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"PackageDescription": "473 mL in 1 BOTTLE (58809-536-01)",
"NDC11Code": "58809-0536-01",
"ProductNDC": "58809-536",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Carbatuss",
"NonProprietaryName": "Carbetapentane Citrate, Phenylephrine Hydrochloride, Guaifenesin",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20001101",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "GM Pharmaceuticals, Inc.",
"SubstanceName": "CARBETAPENTANE CITRATE; PHENYLEPHRINE HYDROCHLORIDE; GUAIFENESIN",
"StrengthNumber": "20; 10; 100",
"StrengthUnit": "mg/5mL; mg/5mL; mg/5mL",
"Pharm_Classes": "alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-08-15"
},
{
"NDCCode": "58809-578-01",
"PackageDescription": "473 mL in 1 BOTTLE (58809-578-01)",
"NDC11Code": "58809-0578-01",
"ProductNDC": "58809-578",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nasopen",
"NonProprietaryName": "Chlorcyclizine Hydrochloride, Pseudoephedrine Hydrochloride",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110606",
"EndMarketingDate": "20150228",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "GM Pharmaceuticals, Inc.",
"SubstanceName": "CHLORCYCLIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE",
"StrengthNumber": "9.375; 30",
"StrengthUnit": "mg/5mL; mg/5mL",
"Status": "Deprecated",
"LastUpdate": "2015-03-06"
},
{
"NDCCode": "58809-888-01",
"PackageDescription": "100 TABLET, CHEWABLE in 1 BOTTLE (58809-888-01)",
"NDC11Code": "58809-0888-01",
"ProductNDC": "58809-888",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Escavite",
"NonProprietaryName": "Sodium Fluoride, Vitamin A Acetate, Biotin, Magnesium, Zinc, Copper, Calcium Pantothenate, Folic Acid, Iron, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, And Cyanocobalamin",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20120201",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "GM Pharmaceuticals, Inc.",
"SubstanceName": "SODIUM FLUORIDE; VITAMIN A ACETATE; BIOTIN; MAGNESIUM; ZINC; COPPER; CALCIUM PANTOTHENATE; FOLIC ACID; IRON; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN",
"StrengthNumber": ".25; 1000; 45; 60; 7.4; 1; 10; .4; 7.5; 100; 400; 30; 1.5; 1.7; 20; 2; 9",
"StrengthUnit": "mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; ug/1",
"Pharm_Classes": "Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC],Vitamin A [CS],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Vitamin D [CS],Vitamin D [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "58809-907-01",
"PackageDescription": "473 mL in 1 BOTTLE (58809-907-01)",
"NDC11Code": "58809-0907-01",
"ProductNDC": "58809-907",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Vanacof",
"ProprietaryNameSuffix": "Dx",
"NonProprietaryName": "Chlophedianol Hydrochloride, Guaifenesin, And Pseudoephedrine Hydrochloride",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20080423",
"EndMarketingDate": "20150430",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "GM Pharmaceuticals",
"SubstanceName": "CHLOPHEDIANOL HYDROCHLORIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE",
"StrengthNumber": "12.5; 100; 30",
"StrengthUnit": "mg/5mL; mg/5mL; mg/5mL",
"Status": "Deprecated",
"LastUpdate": "2015-05-15"
},
{
"NDCCode": "58809-999-01",
"PackageDescription": "473 mL in 1 BOTTLE (58809-999-01) ",
"NDC11Code": "58809-0999-01",
"ProductNDC": "58809-999",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Vanacof",
"NonProprietaryName": "Chlophedianol Hydrochloride, Dexchlorpheniramine Maleate, And Pseudoephedrine Hydrochloride",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20080422",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "GM Pharmaceuticals, INC",
"SubstanceName": "CHLOPHEDIANOL HYDROCHLORIDE; DEXCHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE",
"StrengthNumber": "12.5; 1; 30",
"StrengthUnit": "mg/5mL; mg/5mL; mg/5mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-10-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20080422",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: runny nosesneezingitching of the nose or throatitchy, watery eyesnasal congestionreduces swelling of nasal passages. cough due to minor throat and bronchial irritation."
},
{
"NDCCode": "10920-571-01",
"PackageDescription": "25 kg in 1 DRUM (10920-571-01)",
"NDC11Code": "10920-0571-01",
"ProductNDC": "10920-571",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Bisoprolol Fumarate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20101123",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Arevipharma GmbH",
"SubstanceName": "BISOPROLOL FUMARATE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "11673-571-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (11673-571-01) > 70 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "11673-0571-01",
"ProductNDC": "11673-571",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Up And Up Allergy Relief",
"NonProprietaryName": "Fexofenadine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110413",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076447",
"LabelerName": "Target Corporation",
"SubstanceName": "FEXOFENADINE HYDROCHLORIDE",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-10-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20150317",
"EndMarketingDatePackage": "20220930",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 itchy, watery eye, 3 sneezing, 4 itching of the nose or throat."
},
{
"NDCCode": "13537-571-01",
"PackageDescription": "1 TUBE in 1 BOX (13537-571-01) > 30 g in 1 TUBE",
"NDC11Code": "13537-0571-01",
"ProductNDC": "13537-571",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cyzone Studio Look Base De Alta Cobertura Para El Rostro Con Fps 20",
"ProprietaryNameSuffix": "(light 2) - Beige",
"NonProprietaryName": "Octinoxate And Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150826",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation LTD",
"SubstanceName": "OCTINOXATE; ZINC OXIDE",
"StrengthNumber": ".04; .024",
"StrengthUnit": "g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20150826",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn."
},
{
"NDCCode": "14141-571-01",
"PackageDescription": "1 TUBE in 1 BOX (14141-571-01) > 30 g in 1 TUBE",
"NDC11Code": "14141-0571-01",
"ProductNDC": "14141-571",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cyzone Studio Look Base De Alta Cobertura Para El Rostro Con Fps 20",
"ProprietaryNameSuffix": "(light 2) - Beige",
"NonProprietaryName": "Octinoxate And Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150826",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Bel Star S.A. (Colombia)",
"SubstanceName": "OCTINOXATE; ZINC OXIDE",
"StrengthNumber": ".04; .024",
"StrengthUnit": "g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2022-12-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20150826",
"SamplePackage": "N"
},
{
"NDCCode": "16252-571-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE, PLASTIC (16252-571-01) ",
"NDC11Code": "16252-0571-01",
"ProductNDC": "16252-571",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ramipril",
"NonProprietaryName": "Ramipril",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20080114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076549",
"LabelerName": "Actavis Pharma, Inc.",
"SubstanceName": "RAMIPRIL",
"StrengthNumber": "2.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-09-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "16714-571-01",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (16714-571-01) ",
"NDC11Code": "16714-0571-01",
"ProductNDC": "16714-571",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Bicalutamide",
"NonProprietaryName": "Bicalutamide",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090828",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078634",
"LabelerName": "Northstar RxLLC",
"SubstanceName": "BICALUTAMIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20090828",
"SamplePackage": "N"
},
{
"NDCCode": "31722-571-01",
"PackageDescription": "100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-571-01) ",
"NDC11Code": "31722-0571-01",
"ProductNDC": "31722-571",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lansoprazole",
"NonProprietaryName": "Lansoprazole",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20200518",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203083",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "LANSOPRAZOLE",
"StrengthNumber": "30",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2020-08-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200518",
"SamplePackage": "N",
"IndicationAndUsage": "Lansoprazole delayed-release capsules are proton pump inhibitor (PPIs) indicated for the: Treatment of active duodenal ulcer in adults. (1.1) Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults. (1.2) Maintenance of healed duodenal ulcers in adults. (1.3) Treatment of active benign gastric ulcer in adults. (1.4) Healing of non-steroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults. (1.5) Risk reduction of NSAID-associated gastric ulcer in adults. (1.6) Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older. (1.7) Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. (1.8) Maintenance of healing of EE in adults. (1.9) Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults. (1.10).",
"Description": "The active ingredient in lansoprazole delayed-release capsules, USP is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]-methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.36. Lansoprazole has the following structure. Lansoprazole, USP is a white to brownish-white powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide and practically insoluble in water. The rate of degradation of the compound in aqueous solution increases with decreasing pH. Lansoprazole is supplied in delayed-release capsules for oral administration. Lansoprazole delayed-release capsules, USP are available in two dosage strengths: 15 mg and 30 mg of lansoprazole, USP per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 mg or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: colloidal silicon dioxide, corn starch, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, magnesium carbonate, methacrylic acid copolymer dispersion, polysorbate 80, sucrose, sugar spheres (contains sucrose and starch (maize)), talc, titanium dioxide and triethyl citrate. The hard gelatin capsule shell consists of gelatin, FD&C Blue No. 1, D&C Red No. 28, FD&C Red No. 40 and titanium dioxide. In addition 15 mg capsule contains FD&C Green No. 3. The imprinting ink contains polysorbate 80, propylene glycol, shellac and titanium dioxide."
},
{
"NDCCode": "40032-571-01",
"PackageDescription": "100 TABLET, CHEWABLE in 1 BOTTLE (40032-571-01) ",
"NDC11Code": "40032-0571-01",
"ProductNDC": "40032-571",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20150225",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204115",
"LabelerName": "Novel Laboratories, Inc.",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20150225",
"SamplePackage": "N",
"IndicationAndUsage": "Attention Deficit Disorders, Narcolepsy. Attention Deficit Disorders (previously known as Minimal Brain Dysfunction in Children). Other terms being used to describe the behavioral syndrome below include: Hyperkinetic Child Syndrome, Minimal Brain Damage, Minimal Cerebral Dysfunction, Minor Cerebral Dysfunction. Methylphenidate Hydrochloride Chewable Tablets are indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate-to-severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted. Special Diagnostic Considerations. Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but of special psychological, educational, and social resources. Characteristics commonly reported include: chronic history of short attention span, distractibility, emotional lability, impulsivity, and moderate-to-severe hyperactivity; minor neurological signs and abnormal EEG. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of one or more of these characteristics. Drug treatment is not indicated for all children with this syndrome. Stimulants are not intended for use in the child who exhibits symptoms secondary to environmental factors and/or primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is generally necessary. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician's assessment of the chronicity and severity of the child's symptoms.",
"Description": "Methylphenidate hydrochloride is a mild central nervous system (CNS) stimulant, available as 2.5 mg, 5 mg and 10 mg chewable tablets for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is. Methylphenidate hydrochloride USP is a white to off-white powder. Its solutions are acid to litmus. It is soluble in water, alcohol, and chloroform. Each Methylphenidate Hydrochloride Chewable Tablet, for oral administration, contains 2.5 mg, 5 mg or 10 mg of methylphenidate hydrochloride USP. In addition, Methylphenidate Hydrochloride Chewable Tablets also contain the following inactive ingredients: aspartame, maltose, microcrystalline cellulose, grape flavor, pregelatinized starch, phosphoric acid, and stearic acid."
},
{
"NDCCode": "41163-571-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (41163-571-01) > 70 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "41163-0571-01",
"ProductNDC": "41163-571",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Equaline Aller Ease",
"NonProprietaryName": "Fexofenadine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20110414",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076447",
"LabelerName": "Supervalu Inc",
"SubstanceName": "FEXOFENADINE HYDROCHLORIDE",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-08-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20151219",
"SamplePackage": "N"
},
{
"NDCCode": "41190-571-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (41190-571-01) > 70 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "41190-0571-01",
"ProductNDC": "41190-571",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Shoprite Aller Ease",
"NonProprietaryName": "Fexofenadine Hcl",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130709",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076447",
"LabelerName": "Wakefern Food Corporation",
"SubstanceName": "FEXOFENADINE HYDROCHLORIDE",
"StrengthNumber": "180",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-12-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20161024",
"SamplePackage": "N"
},
{
"NDCCode": "43386-571-01",
"PackageDescription": "100 TABLET, CHEWABLE in 1 BOTTLE (43386-571-01) ",
"NDC11Code": "43386-0571-01",
"ProductNDC": "43386-571",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methylphenidate Hydrochloride",
"NonProprietaryName": "Methylphenidate Hydrochloride",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20150406",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204115",
"LabelerName": "Lupin Pharmaceuticals,Inc.",
"SubstanceName": "METHYLPHENIDATE HYDROCHLORIDE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Active",
"LastUpdate": "2023-12-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150406",
"SamplePackage": "N",
"IndicationAndUsage": "Attention Deficit Disorders, Narcolepsy. Attention Deficit Disorders (previously known as Minimal Brain Dysfunction in Children). Other terms being used to describe the behavioral syndrome below include: Hyperkinetic Child Syndrome, Minimal Brain Damage, Minimal Cerebral Dysfunction, Minor Cerebral Dysfunction. Methylphenidate hydrochloride chewable tablets are indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate-to-severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted.",
"Description": "Methylphenidate hydrochloride is a mild central nervous system (CNS) stimulant, available as 2.5 mg, 5 mg and 10 mg chewable tablets for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is. Methylphenidate hydrochloride USP is a white to off-white powder. Its solutions are acid to litmus. It is soluble in water, alcohol, and chloroform. Each methylphenidate hydrochloride chewable tablet, for oral administration, contains 2.5 mg, 5 mg or 10 mg of methylphenidate hydrochloride USP. In addition, methylphenidate hydrochloride chewable tablets also contain the following inactive ingredients: aspartame, maltose, microcrystalline cellulose, grape flavor, pregelatinized starch, phosphoric acid, and stearic acid."
},
{
"NDCCode": "43744-571-01",
"PackageDescription": "1 g in 1 PACKAGE (43744-571-01) ",
"NDC11Code": "43744-0571-01",
"ProductNDC": "43744-571",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Ticarcillin Disodium And Clavulanate Potassium",
"DosageFormName": "POWDER",
"StartMarketingDate": "20200503",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "CBSCHEM LIMITED",
"SubstanceName": "TICARCILLIN DISODIUM; CLAVULANATE POTASSIUM",
"StrengthNumber": "968; 32",
"StrengthUnit": "mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "03-MAY-20"
},
{
"NDCCode": "49358-571-01",
"PackageDescription": "1 TUBE in 1 CARTON (49358-571-01) / 50 mL in 1 TUBE",
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]
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<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<StartMarketingDatePackage>20231110</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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</NDC>
<NDC>
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<StartMarketingDate>20231110</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>GM Pharmaceuticals, INC</LabelerName>
<SubstanceName>PLANTAGO LANCEOLATA POLLEN; PROSOPIS JULIFLORA POLLEN; QUERCUS VIRGINIANA POLLEN; ULMUS AMERICANA POLLEN; AMBROSIA BIDENTATA POLLEN; BASSIA SCOPARIA POLLEN; BETULA NIGRA POLLEN; DISTICHLIS SPICATA POLLEN; EUPATORIUM CAPILLIFOLIUM POLLEN; HOLCUS LANATUS POLLEN; MORUS RUBRA POLLEN; PINUS STROBUS POLLEN; NASTURTIUM OFFICINALE; AMARANTHUS SPINOSUS POLLEN; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS VIRGINIANA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN; QUERCUS RUBRA POLLEN; SORGHUM HALEPENSE POLLEN; TRITICUM AESTIVUM POLLEN; URTICA DIOICA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; RUMEX CRISPUS POLLEN; SECALE CEREALE POLLEN; TAXODIUM DISTICHUM POLLEN; XANTHIUM STRUMARIUM POLLEN; QUERCUS NIGRA POLLEN; QUERCUS STELLATA POLLEN; SOLIDAGO CANADENSIS POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA CONFERTIFLORA POLLEN; EUCALYPTUS GLOBULUS POLLEN; MYRRH; SALSOLA KALI POLLEN; QUERCUS MACROCARPA POLLEN; SYAGRUS ROMANZOFFIANA POLLEN; ZEA MAYS POLLEN; CHENOPODIUM ALBUM POLLEN; ARTEMISIA TRIDENTATA POLLEN; GOLDENSEAL; FAGUS GRANDIFOLIA POLLEN; FRAXINUS VELUTINA POLLEN; BROUSSONETIA PAPYRIFERA POLLEN; PINUS ECHINATA POLLEN; URTICA URENS WHOLE; AMARANTHUS PALMERI POLLEN; AMARANTHUS TUBERCULATUS POLLEN; CARYA ILLINOINENSIS POLLEN; LIQUIDAMBAR STYRACIFLUA POLLEN; MELALEUCA QUINQUENERVIA POLLEN; MORUS ALBA POLLEN; HESPEROCYPARIS ARIZONICA POLLEN; JUNIPERUS OCCIDENTALIS POLLEN; OLEA EUROPAEA POLLEN; ECHINACEA ANGUSTIFOLIA ROOT; ACER SACCHARUM POLLEN; ANTHOXANTHUM ODORATUM POLLEN; AVENA SATIVA POLLEN; PHYTOLACCA AMERICANA ROOT; BAPTISIA TINCTORIA ROOT; ACER NEGUNDO POLLEN; AMBROSIA ACANTHICARPA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA TRIFIDA POLLEN; ARTEMISIA VULGARIS POLLEN; CARYA OVATA POLLEN; CELTIS OCCIDENTALIS POLLEN; CYCLACHAENA XANTHIFOLIA POLLEN; JUNIPERUS ASHEI POLLEN; LIGUSTRUM VULGARE POLLEN; MYRICA CERIFERA POLLEN; POA PRATENSIS POLLEN; POPULUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALIX NIGRA POLLEN; SCHINUS MOLLE POLLEN; ACACIA DEALBATA POLLEN; ATRIPLEX WRIGHTII POLLEN; PASPALUM NOTATUM POLLEN; QUERCUS GAMBELII POLLEN; POPULUS NIGRA POLLEN; QUERCUS ALBA POLLEN</SubstanceName>
<StrengthNumber>6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 5; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 5; 6; 6; 6; 6; 6; 6; 5; 6; 6; 6; 6; 5; 6; 6; 6; 6; 6; 6; 6; 6; 6; 5; 6; 6; 6; 5; 5; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231110</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>This product is a homeopathic dilution, formulated to support the body's immunity for the temporary relief of allergies.*.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58809-363-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (58809-363-01) </PackageDescription>
<NDC11Code>58809-0363-01</NDC11Code>
<ProductNDC>58809-363</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Chlorphen Sr</ProprietaryName>
<NonProprietaryName>Chlorpheniramine Maleate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100615</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040829</ApplicationNumber>
<LabelerName>GM Pharmaceuticals, INC</LabelerName>
<SubstanceName>CHLORPHENIRAMINE MALEATE</SubstanceName>
<StrengthNumber>12</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-11-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160104</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>58809-407-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (58809-407-01)</PackageDescription>
<NDC11Code>58809-0407-01</NDC11Code>
<ProductNDC>58809-407</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Vanatab Dx</ProprietaryName>
<NonProprietaryName>Chlophedianol Hydrochloride, Guaifenesin, Pseudoephedrine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110906</StartMarketingDate>
<EndMarketingDate>20150228</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>GM Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CHLOPHEDIANOL HYDROCHLORIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>12.5; 200; 30</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2015-03-06</LastUpdate>
</NDC>
<NDC>
<NDCCode>58809-536-01</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (58809-536-01)</PackageDescription>
<NDC11Code>58809-0536-01</NDC11Code>
<ProductNDC>58809-536</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Carbatuss</ProprietaryName>
<NonProprietaryName>Carbetapentane Citrate, Phenylephrine Hydrochloride, Guaifenesin</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20001101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>GM Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CARBETAPENTANE CITRATE; PHENYLEPHRINE HYDROCHLORIDE; GUAIFENESIN</SubstanceName>
<StrengthNumber>20; 10; 100</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>alpha-1 Adrenergic Agonist [EPC],Adrenergic alpha1-Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-08-15</LastUpdate>
</NDC>
<NDC>
<NDCCode>58809-578-01</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (58809-578-01)</PackageDescription>
<NDC11Code>58809-0578-01</NDC11Code>
<ProductNDC>58809-578</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nasopen</ProprietaryName>
<NonProprietaryName>Chlorcyclizine Hydrochloride, Pseudoephedrine Hydrochloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110606</StartMarketingDate>
<EndMarketingDate>20150228</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>GM Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CHLORCYCLIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>9.375; 30</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2015-03-06</LastUpdate>
</NDC>
<NDC>
<NDCCode>58809-888-01</NDCCode>
<PackageDescription>100 TABLET, CHEWABLE in 1 BOTTLE (58809-888-01)</PackageDescription>
<NDC11Code>58809-0888-01</NDC11Code>
<ProductNDC>58809-888</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Escavite</ProprietaryName>
<NonProprietaryName>Sodium Fluoride, Vitamin A Acetate, Biotin, Magnesium, Zinc, Copper, Calcium Pantothenate, Folic Acid, Iron, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, And Cyanocobalamin</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120201</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>GM Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>SODIUM FLUORIDE; VITAMIN A ACETATE; BIOTIN; MAGNESIUM; ZINC; COPPER; CALCIUM PANTOTHENATE; FOLIC ACID; IRON; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN</SubstanceName>
<StrengthNumber>.25; 1000; 45; 60; 7.4; 1; 10; .4; 7.5; 100; 400; 30; 1.5; 1.7; 20; 2; 9</StrengthNumber>
<StrengthUnit>mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; ug/1</StrengthUnit>
<Pharm_Classes>Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC],Vitamin A [CS],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Vitamin D [CS],Vitamin D [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>58809-907-01</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (58809-907-01)</PackageDescription>
<NDC11Code>58809-0907-01</NDC11Code>
<ProductNDC>58809-907</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Vanacof</ProprietaryName>
<ProprietaryNameSuffix>Dx</ProprietaryNameSuffix>
<NonProprietaryName>Chlophedianol Hydrochloride, Guaifenesin, And Pseudoephedrine Hydrochloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080423</StartMarketingDate>
<EndMarketingDate>20150430</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>GM Pharmaceuticals</LabelerName>
<SubstanceName>CHLOPHEDIANOL HYDROCHLORIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>12.5; 100; 30</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL; mg/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2015-05-15</LastUpdate>
</NDC>
<NDC>
<NDCCode>58809-999-01</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (58809-999-01) </PackageDescription>
<NDC11Code>58809-0999-01</NDC11Code>
<ProductNDC>58809-999</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Vanacof</ProprietaryName>
<NonProprietaryName>Chlophedianol Hydrochloride, Dexchlorpheniramine Maleate, And Pseudoephedrine Hydrochloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080422</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>GM Pharmaceuticals, INC</LabelerName>
<SubstanceName>CHLOPHEDIANOL HYDROCHLORIDE; DEXCHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>12.5; 1; 30</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080422</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: runny nosesneezingitching of the nose or throatitchy, watery eyesnasal congestionreduces swelling of nasal passages. cough due to minor throat and bronchial irritation.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10920-571-01</NDCCode>
<PackageDescription>25 kg in 1 DRUM (10920-571-01)</PackageDescription>
<NDC11Code>10920-0571-01</NDC11Code>
<ProductNDC>10920-571</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Bisoprolol Fumarate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20101123</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Arevipharma GmbH</LabelerName>
<SubstanceName>BISOPROLOL FUMARATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>11673-571-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (11673-571-01) > 70 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>11673-0571-01</NDC11Code>
<ProductNDC>11673-571</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Up And Up Allergy Relief</ProprietaryName>
<NonProprietaryName>Fexofenadine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110413</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076447</ApplicationNumber>
<LabelerName>Target Corporation</LabelerName>
<SubstanceName>FEXOFENADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>180</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-10-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150317</StartMarketingDatePackage>
<EndMarketingDatePackage>20220930</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 itchy, watery eye, 3 sneezing, 4 itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>13537-571-01</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (13537-571-01) > 30 g in 1 TUBE</PackageDescription>
<NDC11Code>13537-0571-01</NDC11Code>
<ProductNDC>13537-571</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cyzone Studio Look Base De Alta Cobertura Para El Rostro Con Fps 20</ProprietaryName>
<ProprietaryNameSuffix>(light 2) - Beige</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150826</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura Corporation LTD</LabelerName>
<SubstanceName>OCTINOXATE; ZINC OXIDE</SubstanceName>
<StrengthNumber>.04; .024</StrengthNumber>
<StrengthUnit>g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150826</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>14141-571-01</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (14141-571-01) > 30 g in 1 TUBE</PackageDescription>
<NDC11Code>14141-0571-01</NDC11Code>
<ProductNDC>14141-571</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cyzone Studio Look Base De Alta Cobertura Para El Rostro Con Fps 20</ProprietaryName>
<ProprietaryNameSuffix>(light 2) - Beige</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
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<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Bel Star S.A. (Colombia)</LabelerName>
<SubstanceName>OCTINOXATE; ZINC OXIDE</SubstanceName>
<StrengthNumber>.04; .024</StrengthNumber>
<StrengthUnit>g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-12-09</LastUpdate>
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<SamplePackage>N</SamplePackage>
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<PackageDescription>100 CAPSULE in 1 BOTTLE, PLASTIC (16252-571-01) </PackageDescription>
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<ProductNDC>16252-571</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ramipril</ProprietaryName>
<NonProprietaryName>Ramipril</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080114</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076549</ApplicationNumber>
<LabelerName>Actavis Pharma, Inc.</LabelerName>
<SubstanceName>RAMIPRIL</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-09-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
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<NDCCode>16714-571-01</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (16714-571-01) </PackageDescription>
<NDC11Code>16714-0571-01</NDC11Code>
<ProductNDC>16714-571</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Bicalutamide</ProprietaryName>
<NonProprietaryName>Bicalutamide</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090828</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078634</ApplicationNumber>
<LabelerName>Northstar RxLLC</LabelerName>
<SubstanceName>BICALUTAMIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Androgen Receptor Antagonists [MoA],Androgen Receptor Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-12-06</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20090828</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
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<NDC>
<NDCCode>31722-571-01</NDCCode>
<PackageDescription>100 CAPSULE, DELAYED RELEASE in 1 BOTTLE (31722-571-01) </PackageDescription>
<NDC11Code>31722-0571-01</NDC11Code>
<ProductNDC>31722-571</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lansoprazole</ProprietaryName>
<NonProprietaryName>Lansoprazole</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200518</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203083</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>LANSOPRAZOLE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Inhibition Gastric Acid Secretion [PE], Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2020-08-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200518</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lansoprazole delayed-release capsules are proton pump inhibitor (PPIs) indicated for the: Treatment of active duodenal ulcer in adults. (1.1) Eradication of H. pylori to reduce the risk of duodenal ulcer recurrence in adults. (1.2) Maintenance of healed duodenal ulcers in adults. (1.3) Treatment of active benign gastric ulcer in adults. (1.4) Healing of non-steroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults. (1.5) Risk reduction of NSAID-associated gastric ulcer in adults. (1.6) Treatment of symptomatic gastroesophageal reflux disease (GERD) in adults and pediatric patients 1 year of age and older. (1.7) Treatment of erosive esophagitis (EE) in adults and pediatric patients 1 year of age and older. (1.8) Maintenance of healing of EE in adults. (1.9) Pathological hypersecretory conditions, including Zollinger-Ellison syndrome (ZES) in adults. (1.10).</IndicationAndUsage>
<Description>The active ingredient in lansoprazole delayed-release capsules, USP is lansoprazole, a substituted benzimidazole, 2-[[[3-methyl-4-(2,2,2-trifluoroethoxy)-2-pyridyl]-methyl] sulfinyl] benzimidazole, a compound that inhibits gastric acid secretion. Its empirical formula is C16H14F3N3O2S with a molecular weight of 369.36. Lansoprazole has the following structure. Lansoprazole, USP is a white to brownish-white powder which melts with decomposition at approximately 166°C. Lansoprazole is freely soluble in dimethylformamide and practically insoluble in water. The rate of degradation of the compound in aqueous solution increases with decreasing pH. Lansoprazole is supplied in delayed-release capsules for oral administration. Lansoprazole delayed-release capsules, USP are available in two dosage strengths: 15 mg and 30 mg of lansoprazole, USP per capsule. Each delayed-release capsule contains enteric-coated granules consisting of 15 mg or 30 mg of lansoprazole (active ingredient) and the following inactive ingredients: colloidal silicon dioxide, corn starch, hydroxypropyl cellulose, low substituted hydroxypropyl cellulose, magnesium carbonate, methacrylic acid copolymer dispersion, polysorbate 80, sucrose, sugar spheres (contains sucrose and starch (maize)), talc, titanium dioxide and triethyl citrate. The hard gelatin capsule shell consists of gelatin, FD&C Blue No. 1, D&C Red No. 28, FD&C Red No. 40 and titanium dioxide. In addition 15 mg capsule contains FD&C Green No. 3. The imprinting ink contains polysorbate 80, propylene glycol, shellac and titanium dioxide.</Description>
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<NDCCode>40032-571-01</NDCCode>
<PackageDescription>100 TABLET, CHEWABLE in 1 BOTTLE (40032-571-01) </PackageDescription>
<NDC11Code>40032-0571-01</NDC11Code>
<ProductNDC>40032-571</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methylphenidate Hydrochloride</ProprietaryName>
<NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150225</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204115</ApplicationNumber>
<LabelerName>Novel Laboratories, Inc.</LabelerName>
<SubstanceName>METHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
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<IndicationAndUsage>Attention Deficit Disorders, Narcolepsy. Attention Deficit Disorders (previously known as Minimal Brain Dysfunction in Children). Other terms being used to describe the behavioral syndrome below include: Hyperkinetic Child Syndrome, Minimal Brain Damage, Minimal Cerebral Dysfunction, Minor Cerebral Dysfunction. Methylphenidate Hydrochloride Chewable Tablets are indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate-to-severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted. Special Diagnostic Considerations. Specific etiology of this syndrome is unknown, and there is no single diagnostic test. Adequate diagnosis requires the use not only of medical but of special psychological, educational, and social resources. Characteristics commonly reported include: chronic history of short attention span, distractibility, emotional lability, impulsivity, and moderate-to-severe hyperactivity; minor neurological signs and abnormal EEG. Learning may or may not be impaired. The diagnosis must be based upon a complete history and evaluation of the child and not solely on the presence of one or more of these characteristics. Drug treatment is not indicated for all children with this syndrome. Stimulants are not intended for use in the child who exhibits symptoms secondary to environmental factors and/or primary psychiatric disorders, including psychosis. Appropriate educational placement is essential and psychosocial intervention is generally necessary. When remedial measures alone are insufficient, the decision to prescribe stimulant medication will depend upon the physician's assessment of the chronicity and severity of the child's symptoms.</IndicationAndUsage>
<Description>Methylphenidate hydrochloride is a mild central nervous system (CNS) stimulant, available as 2.5 mg, 5 mg and 10 mg chewable tablets for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is. Methylphenidate hydrochloride USP is a white to off-white powder. Its solutions are acid to litmus. It is soluble in water, alcohol, and chloroform. Each Methylphenidate Hydrochloride Chewable Tablet, for oral administration, contains 2.5 mg, 5 mg or 10 mg of methylphenidate hydrochloride USP. In addition, Methylphenidate Hydrochloride Chewable Tablets also contain the following inactive ingredients: aspartame, maltose, microcrystalline cellulose, grape flavor, pregelatinized starch, phosphoric acid, and stearic acid.</Description>
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<ProductNDC>41163-571</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Equaline Aller Ease</ProprietaryName>
<NonProprietaryName>Fexofenadine Hydrochloride</NonProprietaryName>
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<RouteName>ORAL</RouteName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076447</ApplicationNumber>
<LabelerName>Supervalu Inc</LabelerName>
<SubstanceName>FEXOFENADINE HYDROCHLORIDE</SubstanceName>
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<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-08-05</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
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<ProductNDC>41190-571</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Shoprite Aller Ease</ProprietaryName>
<NonProprietaryName>Fexofenadine Hcl</NonProprietaryName>
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<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076447</ApplicationNumber>
<LabelerName>Wakefern Food Corporation</LabelerName>
<SubstanceName>FEXOFENADINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>180</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-12-04</LastUpdate>
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<ProductNDC>43386-571</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methylphenidate Hydrochloride</ProprietaryName>
<NonProprietaryName>Methylphenidate Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150406</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204115</ApplicationNumber>
<LabelerName>Lupin Pharmaceuticals,Inc.</LabelerName>
<SubstanceName>METHYLPHENIDATE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Active</Status>
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<IndicationAndUsage>Attention Deficit Disorders, Narcolepsy. Attention Deficit Disorders (previously known as Minimal Brain Dysfunction in Children). Other terms being used to describe the behavioral syndrome below include: Hyperkinetic Child Syndrome, Minimal Brain Damage, Minimal Cerebral Dysfunction, Minor Cerebral Dysfunction. Methylphenidate hydrochloride chewable tablets are indicated as an integral part of a total treatment program which typically includes other remedial measures (psychological, educational, social) for a stabilizing effect in children with a behavioral syndrome characterized by the following group of developmentally inappropriate symptoms: moderate-to-severe distractibility, short attention span, hyperactivity, emotional lability, and impulsivity. The diagnosis of this syndrome should not be made with finality when these symptoms are only of comparatively recent origin. Nonlocalizing (soft) neurological signs, learning disability, and abnormal EEG may or may not be present, and a diagnosis of central nervous system dysfunction may or may not be warranted.</IndicationAndUsage>
<Description>Methylphenidate hydrochloride is a mild central nervous system (CNS) stimulant, available as 2.5 mg, 5 mg and 10 mg chewable tablets for oral administration. Methylphenidate hydrochloride is methyl α-phenyl-2-piperidineacetate hydrochloride, and its structural formula is. Methylphenidate hydrochloride USP is a white to off-white powder. Its solutions are acid to litmus. It is soluble in water, alcohol, and chloroform. Each methylphenidate hydrochloride chewable tablet, for oral administration, contains 2.5 mg, 5 mg or 10 mg of methylphenidate hydrochloride USP. In addition, methylphenidate hydrochloride chewable tablets also contain the following inactive ingredients: aspartame, maltose, microcrystalline cellulose, grape flavor, pregelatinized starch, phosphoric acid, and stearic acid.</Description>
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<NDC>
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<PackageDescription>1 g in 1 PACKAGE (43744-571-01) </PackageDescription>
<NDC11Code>43744-0571-01</NDC11Code>
<ProductNDC>43744-571</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Ticarcillin Disodium And Clavulanate Potassium</NonProprietaryName>
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<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>CBSCHEM LIMITED</LabelerName>
<SubstanceName>TICARCILLIN DISODIUM; CLAVULANATE POTASSIUM</SubstanceName>
<StrengthNumber>968; 32</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>03-MAY-20</StartMarketingDatePackage>
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<NDC>
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<PackageDescription>1 TUBE in 1 CARTON (49358-571-01) / 50 mL in 1 TUBE</PackageDescription>
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<ProductNDC>49358-571</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mineral Tinted Spf 30</ProprietaryName>
<ProprietaryNameSuffix>Mineral Tinted Spf 30 Broad Spectrum Sunscreen Water Resistant (80 Min)</ProprietaryNameSuffix>
<NonProprietaryName>Titanium Dioxide And Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
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<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
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<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
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<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
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<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<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>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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<ProprietaryNameSuffix>Deodorant Roll-on</ProprietaryNameSuffix>
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<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
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<SubstanceName>ALUMINUM CHLOROHYDRATE</SubstanceName>
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<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>DIRECTIONS: APPLY TO UNDERARMS ONLY.</IndicationAndUsage>
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<ProprietaryName>Kiehls Since 1851 Ultra Facial Meltdown Recovery</ProprietaryName>
<NonProprietaryName>Colloidal Oatmeal</NonProprietaryName>
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<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
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<IndicationAndUsage>temporarily protects and helps relieve minor skin irritation and itching due to: 1 rashes, 2 eczema, 3 poison ivy, oak, or sumac, 4 insect bites.</IndicationAndUsage>
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<SubstanceName>ALCOHOL</SubstanceName>
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<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-04-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
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<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<PackageDescription>1 KIT in 1 PACKAGE (50580-241-01) * 240 mL in 1 BOTTLE, PLASTIC (50580-403-08) * 240 mL in 1 BOTTLE, PLASTIC (50580-571-01) </PackageDescription>
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<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Kenvue Brands LLC</LabelerName>
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<LastUpdate>2024-11-13</LastUpdate>
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