{
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"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20181001",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "GM Pharmaceuticals, INC",
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"LastUpdate": "2023-11-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20181001",
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{
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"PackageDescription": "118 mL in 1 BOTTLE, DROPPER (58809-209-04) ",
"NDC11Code": "58809-0209-04",
"ProductNDC": "58809-209",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Texaclear Homeopathic Allergy Relief",
"ProprietaryNameSuffix": "Cedar Fever",
"NonProprietaryName": "Over 100 Extracts",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "ORAL",
"StartMarketingDate": "20200831",
"EndMarketingDate": "20250101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "GM Pharmaceuticals, INC",
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"Status": "Deprecated",
"LastUpdate": "2025-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"SamplePackage": "N",
"IndicationAndUsage": "this product is a homeopathic dilution, formulated to support the body’s immunity for the temporary relief of allergies*."
},
{
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"PackageDescription": "118 mL in 1 BOTTLE, DROPPER (58809-214-04) ",
"NDC11Code": "58809-0214-04",
"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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"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20231110",
"SamplePackage": "N",
"IndicationAndUsage": "This product is a homeopathic dilution, formulated to support the body's immunity for the temporary relief of allergies.*."
},
{
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"NDC11Code": "58809-0247-04",
"ProductNDC": "58809-247",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Vanacof",
"ProprietaryNameSuffix": "Ape",
"NonProprietaryName": "Chlophedianol Hydrochloride, Phenylephrine Hydrochloride, Thonzylamine Hydrochloride",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20121003",
"EndMarketingDate": "20140930",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "GM Pharmaceuticals, Inc.",
"SubstanceName": "CHLOPHEDIANOL HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE; THONZYLAMINE HYDROCHLORIDE",
"StrengthNumber": "25; 10; 50",
"StrengthUnit": "mg/15mL; mg/15mL; mg/15mL",
"Status": "Deprecated",
"LastUpdate": "2014-10-03"
},
{
"NDCCode": "58809-350-04",
"PackageDescription": "118 mL in 1 BOTTLE (58809-350-04)",
"NDC11Code": "58809-0350-04",
"ProductNDC": "58809-350",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Vanacof-8",
"NonProprietaryName": "Chlophedianol Hydrochloride And Pyrilamine Maleate",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20130601",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "GM PHARMACEUTICALS,INC",
"SubstanceName": "CHLOPHEDIANOL HYDROCHLORIDE; PYRILAMINE MALEATE",
"StrengthNumber": "25; 50",
"StrengthUnit": "mg/15mL; mg/15mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "58809-375-04",
"PackageDescription": "113 g in 1 TUBE (58809-375-04) ",
"NDC11Code": "58809-0375-04",
"ProductNDC": "58809-375",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Z-bum",
"NonProprietaryName": "Diaper Rash Cream",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20151201",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "GM Pharmaceuticals, Inc",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": "22",
"StrengthUnit": "g/100g",
"Status": "Active",
"LastUpdate": "2026-01-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20151201",
"SamplePackage": "N",
"IndicationAndUsage": "■ helps treat and prevent diaper rash. ■ protects chafed skin due to diaper rash and helps protect skin from wetness."
},
{
"NDCCode": "58809-624-04",
"PackageDescription": "118 mL in 1 BOTTLE (58809-624-04)",
"NDC11Code": "58809-0624-04",
"ProductNDC": "58809-624",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Vanacof",
"ProprietaryNameSuffix": "Gpe",
"NonProprietaryName": "Chlophedianol Hydrochloride, Guaifenesin, Phenylephrine Hydrochloride",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20120929",
"EndMarketingDate": "20140930",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "GM Pharmaceuticals, Inc.",
"SubstanceName": "CHLOPHEDIANOL HYDROCHLORIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "25; 200; 10",
"StrengthUnit": "mg/15mL; mg/15mL; mg/15mL",
"Status": "Deprecated",
"LastUpdate": "2014-10-03"
},
{
"NDCCode": "58809-729-04",
"PackageDescription": "118 mL in 1 BOTTLE (58809-729-04) ",
"NDC11Code": "58809-0729-04",
"ProductNDC": "58809-729",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nasopen",
"ProprietaryNameSuffix": "Pe",
"NonProprietaryName": "Phenylephrine Hydrochloride, Thonzylamine Hydrochloride",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20121003",
"EndMarketingDate": "20241130",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "GM Pharmaceuticals, INC",
"SubstanceName": "PHENYLEPHRINE HYDROCHLORIDE; THONZYLAMINE HYDROCHLORIDE",
"StrengthNumber": "10; 50",
"StrengthUnit": "mg/15mL; mg/15mL",
"Pharm_Classes": "Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-12-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20121003",
"EndMarketingDatePackage": "20241130",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: 1 nasal congestion , 2 reduces swelling of the nasal passages , 3 runny nose , 4 sneezing , 5 itching of the nose or throat , 6 itchy, watery eyes."
},
{
"NDCCode": "42658-151-04",
"PackageDescription": "450 mg in 1 BOTTLE (42658-151-04) ",
"NDC11Code": "42658-0151-04",
"ProductNDC": "42658-151",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20250101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206924",
"LabelerName": "Hisun Pharmaceuticals USA, Inc.",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "5",
"StrengthUnit": "mg/5mg",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-05-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250101",
"SamplePackage": "N",
"Description": "Olanzapine, USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)- 10H-thieno[2,3- b] [1,5]benzodiazepine. The molecular formula is C 17H 20N 4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine, USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine Tablets, USP are intended for oral administration only. Each tablet contains olanzapine equivalent to 2.5 mg (8 mcmol), 5 mg (16 mcmol), 7.5 mg (24 mcmol), 10 mg (32 mcmol), 15 mg (48 mcmol), or 20 mg (64 mcmol). Inactive ingredients are lactose monohydrate, maize starch, colloidal silicon dioxide, magnesium stearate, crospovidone, microcrystalline cellulose and talc. Olanzapine orally disintegrating tablets are intended for oral administration only. Each orally disintegrating tablet contains olanzapine equivalent to 5 mg (16 mcmol), 10 mg (32 mcmol), 15 mg (48 mcmol) or 20 mg (64 mcmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine orally disintegrating tablets also contain the following inactive ingredients: aspartame, lactose monohydrate, maize starch, colloidal silicon dioxide, magnesium stearate, crospovidone, microcrystalline cellulose and talc. Olanzapine orally disintegrating tablets meet USP Disintegration Test 2."
},
{
"NDCCode": "42658-156-04",
"PackageDescription": "450 mg in 1 BOTTLE (42658-156-04) ",
"NDC11Code": "42658-0156-04",
"ProductNDC": "42658-156",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Olanzapine",
"NonProprietaryName": "Olanzapine",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
"StartMarketingDate": "20250101",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206892",
"LabelerName": "Hisun Pharmaceuticals USA, Inc.",
"SubstanceName": "OLANZAPINE",
"StrengthNumber": "5",
"StrengthUnit": "mg/5mg",
"Pharm_Classes": "Atypical Antipsychotic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-05-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250101",
"SamplePackage": "N",
"Description": "Olanzapine, USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)- 10H-thieno[2,3- b] [1,5]benzodiazepine. The molecular formula is C 17H 20N 4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine, USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine Tablets, USP are intended for oral administration only. Each tablet contains olanzapine equivalent to 2.5 mg (8 mcmol), 5 mg (16 mcmol), 7.5 mg (24 mcmol), 10 mg (32 mcmol), 15 mg (48 mcmol), or 20 mg (64 mcmol). Inactive ingredients are lactose monohydrate, maize starch, colloidal silicon dioxide, magnesium stearate, crospovidone, microcrystalline cellulose and talc. Olanzapine orally disintegrating tablets are intended for oral administration only. Each orally disintegrating tablet contains olanzapine equivalent to 5 mg (16 mcmol), 10 mg (32 mcmol), 15 mg (48 mcmol) or 20 mg (64 mcmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine orally disintegrating tablets also contain the following inactive ingredients: aspartame, lactose monohydrate, maize starch, colloidal silicon dioxide, magnesium stearate, crospovidone, microcrystalline cellulose and talc. Olanzapine orally disintegrating tablets meet USP Disintegration Test 2."
},
{
"NDCCode": "51206-450-04",
"PackageDescription": "24 CARTON in 1 PACKAGE, COMBINATION (51206-450-04) / 1 CARTON in 1 CARTON / 28 g in 1 CARTON",
"NDC11Code": "51206-0450-04",
"ProductNDC": "51206-450",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Opalescence Whitening Original Cool Mint",
"ProprietaryNameSuffix": "Cool Mint",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "GEL, DENTIFRICE",
"RouteName": "DENTAL",
"StartMarketingDate": "20260513",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M021",
"LabelerName": "Ultradent Products, Inc.",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": "1.1",
"StrengthUnit": "mg/g",
"Status": "Active",
"LastUpdate": "2026-09-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260513",
"SamplePackage": "N",
"IndicationAndUsage": "Aids in the prevention of dental decay."
},
{
"NDCCode": "58559-001-04",
"PackageDescription": "450 g in 1 BOTTLE, PUMP (58559-001-04) ",
"NDC11Code": "58559-0001-04",
"ProductNDC": "58559-001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Relief Pain Relieving Cream",
"NonProprietaryName": "Menthol",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20040522",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Corganics, LP",
"SubstanceName": "MENTHOL",
"StrengthNumber": "2.5",
"StrengthUnit": "g/100g",
"Status": "Active",
"LastUpdate": "2026-01-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20040522",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary Relief of pain of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains."
},
{
"NDCCode": "58559-002-04",
"PackageDescription": "450 g in 1 BOTTLE, PUMP (58559-002-04) ",
"NDC11Code": "58559-0002-04",
"ProductNDC": "58559-002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Relief Pain Relieving Cream",
"NonProprietaryName": "Menthol",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20040522",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Corganics, LP",
"SubstanceName": "MENTHOL",
"StrengthNumber": "3",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20040522",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains."
},
{
"NDCCode": "61598-450-04",
"PackageDescription": "118 mL in 1 CYLINDER (61598-450-04) ",
"NDC11Code": "61598-0450-04",
"ProductNDC": "61598-450",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Instant Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20121012",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "LTC Products Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2026-01-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20121012",
"SamplePackage": "N",
"IndicationAndUsage": "Antiseptic."
},
{
"NDCCode": "63545-450-04",
"PackageDescription": "10000 PELLET in 1 BOTTLE, GLASS (63545-450-04) ",
"NDC11Code": "63545-0450-04",
"ProductNDC": "63545-450",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Beryllium Fluoratum",
"NonProprietaryName": "Beryllium Fluoratum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220420",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "BERYLLIUM FLUORIDE",
"StrengthNumber": "500",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2022-04-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220420",
"SamplePackage": "N"
},
{
"NDCCode": "63646-191-04",
"PackageDescription": "4 TRAY in 1 CARTON (63646-191-04) > 1 KIT in 1 TRAY (63646-191-06) * 500 mg in 1 SYRINGE (63646-193-08) * 450 mg in 1 SYRINGE (63646-192-07)",
"NDC11Code": "63646-0191-04",
"ProductNDC": "63646-191",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Atridox",
"NonProprietaryName": "Doxycycline Hyclate",
"DosageFormName": "KIT",
"RouteName": "ORAL",
"StartMarketingDate": "19980903",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA050751",
"LabelerName": "TOLMAR Inc.",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "66902-450-06",
"PackageDescription": "1 KIT in 1 CARTON (66902-450-06) * 1 PATCH in 1 POUCH (66902-270-05) / 11 g in 1 PATCH * 1 PATCH in 1 POUCH (66902-270-06) / 23 g in 1 PATCH * 1 PATCH in 1 POUCH (66902-270-04) / 7 g in 1 PATCH",
"NDC11Code": "66902-0450-06",
"ProductNDC": "66902-450",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cvs Health Lidocaine Pain-relieving",
"NonProprietaryName": "Lidocaine",
"DosageFormName": "KIT",
"RouteName": "TRANSDERMAL",
"StartMarketingDate": "20200602",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "NATURAL ESSENTIALS, INC.",
"Status": "Active",
"LastUpdate": "2024-10-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200602",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of pain."
},
{
"NDCCode": "69945-450-04",
"PackageDescription": "1 VIAL in 1 CAN (69945-450-04) > 4 mL in 1 VIAL",
"NDC11Code": "69945-0450-04",
"ProductNDC": "69945-450",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Iodide I-131",
"ProprietaryNameSuffix": "Therapeutic",
"NonProprietaryName": "Sodium Iodide, I-131",
"DosageFormName": "SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20151027",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA016515",
"LabelerName": "MALLINCKRODT NUCLEAR MEDICINE LLC",
"SubstanceName": "SODIUM IODIDE I-131",
"StrengthNumber": "5",
"StrengthUnit": "mCi/mL",
"Pharm_Classes": "Radioactive Therapeutic Agent [EPC],Radiopharmaceutical Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-07-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20151027",
"SamplePackage": "N"
},
{
"NDCCode": "70707-450-04",
"PackageDescription": "118 mL in 1 BOTTLE (70707-450-04) ",
"NDC11Code": "70707-0450-04",
"ProductNDC": "70707-450",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Daily Spf 30",
"NonProprietaryName": "Octisalate, Oxybenzone, Octocrylene, Avobenzone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160620",
"EndMarketingDate": "20251201",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Face Reality, Inc.",
"SubstanceName": "AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": "30; 47.5; 28; 42.5",
"StrengthUnit": "mg/mL; mg/mL; mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2025-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160620",
"EndMarketingDatePackage": "20251201",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun Directions."
},
{
"NDCCode": "75709-001-04",
"PackageDescription": "450 mL in 1 BOTTLE (75709-001-04) ",
"NDC11Code": "75709-0001-04",
"ProductNDC": "75709-001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "S D S",
"NonProprietaryName": "Disinfectant",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200429",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Xi'an Explution Tech Co.,Ltd.",
"SubstanceName": "DIDECYLDIMONIUM CHLORIDE",
"StrengthNumber": ".2",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2020-06-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200429",
"SamplePackage": "N"
},
{
"NDCCode": "75709-011-04",
"PackageDescription": "450 mL in 1 BOTTLE (75709-011-04) ",
"NDC11Code": "75709-0011-04",
"ProductNDC": "75709-011",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Surface Disinfectant",
"NonProprietaryName": "Surface Disinfectant Spray",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200429",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Xi'an Explution Tech Co.,Ltd.",
"SubstanceName": "DIDECYLDIMONIUM CHLORIDE",
"StrengthNumber": ".2",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2021-07-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200429",
"SamplePackage": "N",
"IndicationAndUsage": "Disinfect surfaces in public or family places,such as hand rail ,desk,tool, toy, pet appliance,wardrobe, sofa,carpet, etc.Suitable on plastic,wood,porcelain,glass, metal, etc."
},
{
"NDCCode": "77586-001-04",
"PackageDescription": "450 mL in 1 BOTTLE, PUMP (77586-001-04) ",
"NDC11Code": "77586-0001-04",
"ProductNDC": "77586-001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dmi Cosmetics Wash Me Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200512",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "DERMA INNOVATION COMPANY LIMITED",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200512",
"SamplePackage": "N",
"IndicationAndUsage": "Use(s) Hand Sanitizer Gel helps cleanse your hands instantly without rinse off. Gentle cleanses and nourishes your skin with all-round. protection."
},
{
"NDCCode": "79134-001-04",
"PackageDescription": "80 PACKET in 1 CANISTER (79134-001-04) > 450 mL in 1 PACKET",
"NDC11Code": "79134-0001-04",
"ProductNDC": "79134-001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Promedic",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200618",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Perfect Medics, Inc",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".13",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200618",
"SamplePackage": "N",
"IndicationAndUsage": "to decrease bacteria on the skin that could cause disease."
},
{
"NDCCode": "79173-001-04",
"PackageDescription": "450 mL in 1 BOTTLE (79173-001-04) ",
"NDC11Code": "79173-0001-04",
"ProductNDC": "79173-001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Eco Hand Sanitizer",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200625",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "ECO AERONAUTICS INC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "70",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200625",
"SamplePackage": "N",
"IndicationAndUsage": "Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available."
},
{
"NDCCode": "81476-101-04",
"PackageDescription": "450 mL in 1 BOTTLE (81476-101-04) ",
"NDC11Code": "81476-0101-04",
"ProductNDC": "81476-101",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Okgo Disinfectant",
"NonProprietaryName": "Didecyl Dimethyl Ammonium Chloride",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210126",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Henan Seagood Medical Equipment Co., Ltd.",
"SubstanceName": "DIDECYLDIMONIUM CHLORIDE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20210126",
"SamplePackage": "N",
"IndicationAndUsage": "OKGO®Disinfectant to help reduce bacteria that potentially can cause disease."
},
{
"NDCCode": "84522-450-04",
"PackageDescription": "50 mL in 1 BOTTLE (84522-450-04) ",
"NDC11Code": "84522-0450-04",
"ProductNDC": "84522-450",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Trstay Hair Vitamincapsule Serum",
"NonProprietaryName": "Trstay Hair Vitamin Capsule Serum",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241213",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Yiwu Luoxin E Commerce Co Ltd",
"SubstanceName": "NIACINAMIDE",
"StrengthNumber": "5",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20241213",
"SamplePackage": "N",
"IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
},
{
"NDCCode": "84756-450-04",
"PackageDescription": "50 g in 1 BOX (84756-450-04) ",
"NDC11Code": "84756-0450-04",
"ProductNDC": "84756-450",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Trstay Ganoderma Lucidum",
"NonProprietaryName": "Trstay Ganoderma Lucidum",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241125",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Yiwu Xinqian E Commerce Co Ltd",
"SubstanceName": "NIACINAMIDE",
"StrengthNumber": "5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20241125",
"SamplePackage": "N",
"IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
},
{
"NDCCode": "84827-450-04",
"PackageDescription": "50 g in 1 BOX (84827-450-04) ",
"NDC11Code": "84827-0450-04",
"ProductNDC": "84827-450",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Trstay Firming Neck Cream",
"NonProprietaryName": "Trstay Firming Neck Cream",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20241107",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Yiwu Xinqian E Commerce Co Ltd",
"SubstanceName": "NIACINAMIDE",
"StrengthNumber": "5",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2024-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20241107",
"SamplePackage": "N",
"IndicationAndUsage": "Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed."
},
{
"NDCCode": "58809-198-80",
"PackageDescription": "80 TABLET in 1 BOTTLE, PLASTIC (58809-198-80)",
"NDC11Code": "58809-0198-80",
"ProductNDC": "58809-198",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Vanatab Dm",
"NonProprietaryName": "Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20170301",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "GM Pharmaceuticals, Inc.",
"SubstanceName": "GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE",
"StrengthNumber": "198; 9; 5",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2017-04-04"
},
{
"NDCCode": "58809-225-02",
"PackageDescription": "59 mL in 1 BOTTLE (58809-225-02) ",
"NDC11Code": "58809-0225-02",
"ProductNDC": "58809-225",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dayclear Hand Sanitizer",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200401",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "GM Pharmaceuticals, INC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": ".62",
"StrengthUnit": "mL/mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200401",
"SamplePackage": "N"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>58809-450-04</NDCCode>
<PackageDescription>113 g in 1 BOTTLE (58809-450-04) </PackageDescription>
<NDC11Code>58809-0450-04</NDC11Code>
<ProductNDC>58809-450</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cozima</ProprietaryName>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20181001</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
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<LabelerName>GM Pharmaceuticals, INC</LabelerName>
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<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-11-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181001</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>58809-209-04</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE, DROPPER (58809-209-04) </PackageDescription>
<NDC11Code>58809-0209-04</NDC11Code>
<ProductNDC>58809-209</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Texaclear Homeopathic Allergy Relief</ProprietaryName>
<ProprietaryNameSuffix>Cedar Fever</ProprietaryNameSuffix>
<NonProprietaryName>Over 100 Extracts</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200831</StartMarketingDate>
<EndMarketingDate>20250101</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>GM Pharmaceuticals, INC</LabelerName>
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<Status>Deprecated</Status>
<LastUpdate>2025-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20220818</StartMarketingDatePackage>
<EndMarketingDatePackage>20250101</EndMarketingDatePackage>
<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>58809-214-04</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE, DROPPER (58809-214-04) </PackageDescription>
<NDC11Code>58809-0214-04</NDC11Code>
<ProductNDC>58809-214</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Texaclear Texas Allergy Relief Plus Cedar Fever</ProprietaryName>
<NonProprietaryName>Antigens All Zones Grasses Trees And Weeds. Baptisia Tinctoria, Echinacea, Hydrastis Canadensis, Myrrha, Nasturtium Aquaticum, Phytolacca Decandra, Urtica Urens</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<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>
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<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>58809-247-04</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE (58809-247-04)</PackageDescription>
<NDC11Code>58809-0247-04</NDC11Code>
<ProductNDC>58809-247</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Vanacof</ProprietaryName>
<ProprietaryNameSuffix>Ape</ProprietaryNameSuffix>
<NonProprietaryName>Chlophedianol Hydrochloride, Phenylephrine Hydrochloride, Thonzylamine Hydrochloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121003</StartMarketingDate>
<EndMarketingDate>20140930</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>GM Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CHLOPHEDIANOL HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE; THONZYLAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25; 10; 50</StrengthNumber>
<StrengthUnit>mg/15mL; mg/15mL; mg/15mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-10-03</LastUpdate>
</NDC>
<NDC>
<NDCCode>58809-350-04</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE (58809-350-04)</PackageDescription>
<NDC11Code>58809-0350-04</NDC11Code>
<ProductNDC>58809-350</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Vanacof-8</ProprietaryName>
<NonProprietaryName>Chlophedianol Hydrochloride And Pyrilamine Maleate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130601</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>GM PHARMACEUTICALS,INC</LabelerName>
<SubstanceName>CHLOPHEDIANOL HYDROCHLORIDE; PYRILAMINE MALEATE</SubstanceName>
<StrengthNumber>25; 50</StrengthNumber>
<StrengthUnit>mg/15mL; mg/15mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>58809-375-04</NDCCode>
<PackageDescription>113 g in 1 TUBE (58809-375-04) </PackageDescription>
<NDC11Code>58809-0375-04</NDC11Code>
<ProductNDC>58809-375</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Z-bum</ProprietaryName>
<NonProprietaryName>Diaper Rash Cream</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20151201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>GM Pharmaceuticals, Inc</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>22</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>■ helps treat and prevent diaper rash. ■ protects chafed skin due to diaper rash and helps protect skin from wetness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58809-624-04</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE (58809-624-04)</PackageDescription>
<NDC11Code>58809-0624-04</NDC11Code>
<ProductNDC>58809-624</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Vanacof</ProprietaryName>
<ProprietaryNameSuffix>Gpe</ProprietaryNameSuffix>
<NonProprietaryName>Chlophedianol Hydrochloride, Guaifenesin, Phenylephrine Hydrochloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120929</StartMarketingDate>
<EndMarketingDate>20140930</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>GM Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CHLOPHEDIANOL HYDROCHLORIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25; 200; 10</StrengthNumber>
<StrengthUnit>mg/15mL; mg/15mL; mg/15mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-10-03</LastUpdate>
</NDC>
<NDC>
<NDCCode>58809-729-04</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE (58809-729-04) </PackageDescription>
<NDC11Code>58809-0729-04</NDC11Code>
<ProductNDC>58809-729</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nasopen</ProprietaryName>
<ProprietaryNameSuffix>Pe</ProprietaryNameSuffix>
<NonProprietaryName>Phenylephrine Hydrochloride, Thonzylamine Hydrochloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121003</StartMarketingDate>
<EndMarketingDate>20241130</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>GM Pharmaceuticals, INC</LabelerName>
<SubstanceName>PHENYLEPHRINE HYDROCHLORIDE; THONZYLAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10; 50</StrengthNumber>
<StrengthUnit>mg/15mL; mg/15mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20121003</StartMarketingDatePackage>
<EndMarketingDatePackage>20241130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: 1 nasal congestion , 2 reduces swelling of the nasal passages , 3 runny nose , 4 sneezing , 5 itching of the nose or throat , 6 itchy, watery eyes.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>42658-151-04</NDCCode>
<PackageDescription>450 mg in 1 BOTTLE (42658-151-04) </PackageDescription>
<NDC11Code>42658-0151-04</NDC11Code>
<ProductNDC>42658-151</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206924</ApplicationNumber>
<LabelerName>Hisun Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/5mg</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-05-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Olanzapine, USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)- 10H-thieno[2,3- b] [1,5]benzodiazepine. The molecular formula is C 17H 20N 4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine, USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine Tablets, USP are intended for oral administration only. Each tablet contains olanzapine equivalent to 2.5 mg (8 mcmol), 5 mg (16 mcmol), 7.5 mg (24 mcmol), 10 mg (32 mcmol), 15 mg (48 mcmol), or 20 mg (64 mcmol). Inactive ingredients are lactose monohydrate, maize starch, colloidal silicon dioxide, magnesium stearate, crospovidone, microcrystalline cellulose and talc. Olanzapine orally disintegrating tablets are intended for oral administration only. Each orally disintegrating tablet contains olanzapine equivalent to 5 mg (16 mcmol), 10 mg (32 mcmol), 15 mg (48 mcmol) or 20 mg (64 mcmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine orally disintegrating tablets also contain the following inactive ingredients: aspartame, lactose monohydrate, maize starch, colloidal silicon dioxide, magnesium stearate, crospovidone, microcrystalline cellulose and talc. Olanzapine orally disintegrating tablets meet USP Disintegration Test 2.</Description>
</NDC>
<NDC>
<NDCCode>42658-156-04</NDCCode>
<PackageDescription>450 mg in 1 BOTTLE (42658-156-04) </PackageDescription>
<NDC11Code>42658-0156-04</NDC11Code>
<ProductNDC>42658-156</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Olanzapine</ProprietaryName>
<NonProprietaryName>Olanzapine</NonProprietaryName>
<DosageFormName>TABLET, ORALLY DISINTEGRATING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250101</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206892</ApplicationNumber>
<LabelerName>Hisun Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>OLANZAPINE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/5mg</StrengthUnit>
<Pharm_Classes>Atypical Antipsychotic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-05-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Olanzapine, USP is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)- 10H-thieno[2,3- b] [1,5]benzodiazepine. The molecular formula is C 17H 20N 4S, which corresponds to a molecular weight of 312.44. The chemical structure is:. Olanzapine, USP is a yellow crystalline solid, which is practically insoluble in water. Olanzapine Tablets, USP are intended for oral administration only. Each tablet contains olanzapine equivalent to 2.5 mg (8 mcmol), 5 mg (16 mcmol), 7.5 mg (24 mcmol), 10 mg (32 mcmol), 15 mg (48 mcmol), or 20 mg (64 mcmol). Inactive ingredients are lactose monohydrate, maize starch, colloidal silicon dioxide, magnesium stearate, crospovidone, microcrystalline cellulose and talc. Olanzapine orally disintegrating tablets are intended for oral administration only. Each orally disintegrating tablet contains olanzapine equivalent to 5 mg (16 mcmol), 10 mg (32 mcmol), 15 mg (48 mcmol) or 20 mg (64 mcmol). It begins disintegrating in the mouth within seconds, allowing its contents to be subsequently swallowed with or without liquid. Olanzapine orally disintegrating tablets also contain the following inactive ingredients: aspartame, lactose monohydrate, maize starch, colloidal silicon dioxide, magnesium stearate, crospovidone, microcrystalline cellulose and talc. Olanzapine orally disintegrating tablets meet USP Disintegration Test 2.</Description>
</NDC>
<NDC>
<NDCCode>51206-450-04</NDCCode>
<PackageDescription>24 CARTON in 1 PACKAGE, COMBINATION (51206-450-04) / 1 CARTON in 1 CARTON / 28 g in 1 CARTON</PackageDescription>
<NDC11Code>51206-0450-04</NDC11Code>
<ProductNDC>51206-450</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Opalescence Whitening Original Cool Mint</ProprietaryName>
<ProprietaryNameSuffix>Cool Mint</ProprietaryNameSuffix>
<NonProprietaryName>Sodium Fluoride</NonProprietaryName>
<DosageFormName>GEL, DENTIFRICE</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>20260513</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M021</ApplicationNumber>
<LabelerName>Ultradent Products, Inc.</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>1.1</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-09-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260513</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Aids in the prevention of dental decay.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58559-001-04</NDCCode>
<PackageDescription>450 g in 1 BOTTLE, PUMP (58559-001-04) </PackageDescription>
<NDC11Code>58559-0001-04</NDC11Code>
<ProductNDC>58559-001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Relief Pain Relieving Cream</ProprietaryName>
<NonProprietaryName>Menthol</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20040522</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Corganics, LP</LabelerName>
<SubstanceName>MENTHOL</SubstanceName>
<StrengthNumber>2.5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20040522</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary Relief of pain of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58559-002-04</NDCCode>
<PackageDescription>450 g in 1 BOTTLE, PUMP (58559-002-04) </PackageDescription>
<NDC11Code>58559-0002-04</NDC11Code>
<ProductNDC>58559-002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Relief Pain Relieving Cream</ProprietaryName>
<NonProprietaryName>Menthol</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20040522</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Corganics, LP</LabelerName>
<SubstanceName>MENTHOL</SubstanceName>
<StrengthNumber>3</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20040522</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61598-450-04</NDCCode>
<PackageDescription>118 mL in 1 CYLINDER (61598-450-04) </PackageDescription>
<NDC11Code>61598-0450-04</NDC11Code>
<ProductNDC>61598-450</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Instant Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20121012</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>LTC Products Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121012</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Antiseptic.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63545-450-04</NDCCode>
<PackageDescription>10000 PELLET in 1 BOTTLE, GLASS (63545-450-04) </PackageDescription>
<NDC11Code>63545-0450-04</NDC11Code>
<ProductNDC>63545-450</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Beryllium Fluoratum</ProprietaryName>
<NonProprietaryName>Beryllium Fluoratum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220420</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>BERYLLIUM FLUORIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-04-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220420</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63646-191-04</NDCCode>
<PackageDescription>4 TRAY in 1 CARTON (63646-191-04) > 1 KIT in 1 TRAY (63646-191-06) * 500 mg in 1 SYRINGE (63646-193-08) * 450 mg in 1 SYRINGE (63646-192-07)</PackageDescription>
<NDC11Code>63646-0191-04</NDC11Code>
<ProductNDC>63646-191</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Atridox</ProprietaryName>
<NonProprietaryName>Doxycycline Hyclate</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19980903</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA050751</ApplicationNumber>
<LabelerName>TOLMAR Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>66902-450-06</NDCCode>
<PackageDescription>1 KIT in 1 CARTON (66902-450-06) * 1 PATCH in 1 POUCH (66902-270-05) / 11 g in 1 PATCH * 1 PATCH in 1 POUCH (66902-270-06) / 23 g in 1 PATCH * 1 PATCH in 1 POUCH (66902-270-04) / 7 g in 1 PATCH</PackageDescription>
<NDC11Code>66902-0450-06</NDC11Code>
<ProductNDC>66902-450</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cvs Health Lidocaine Pain-relieving</ProprietaryName>
<NonProprietaryName>Lidocaine</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>TRANSDERMAL</RouteName>
<StartMarketingDate>20200602</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>NATURAL ESSENTIALS, INC.</LabelerName>
<Status>Active</Status>
<LastUpdate>2024-10-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200602</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>69945-450-04</NDCCode>
<PackageDescription>1 VIAL in 1 CAN (69945-450-04) > 4 mL in 1 VIAL</PackageDescription>
<NDC11Code>69945-0450-04</NDC11Code>
<ProductNDC>69945-450</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Iodide I-131</ProprietaryName>
<ProprietaryNameSuffix>Therapeutic</ProprietaryNameSuffix>
<NonProprietaryName>Sodium Iodide, I-131</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20151027</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA016515</ApplicationNumber>
<LabelerName>MALLINCKRODT NUCLEAR MEDICINE LLC</LabelerName>
<SubstanceName>SODIUM IODIDE I-131</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mCi/mL</StrengthUnit>
<Pharm_Classes>Radioactive Therapeutic Agent [EPC],Radiopharmaceutical Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151027</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>70707-450-04</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE (70707-450-04) </PackageDescription>
<NDC11Code>70707-0450-04</NDC11Code>
<ProductNDC>70707-450</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Daily Spf 30</ProprietaryName>
<NonProprietaryName>Octisalate, Oxybenzone, Octocrylene, Avobenzone</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160620</StartMarketingDate>
<EndMarketingDate>20251201</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Face Reality, Inc.</LabelerName>
<SubstanceName>AVOBENZONE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>30; 47.5; 28; 42.5</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160620</StartMarketingDatePackage>
<EndMarketingDatePackage>20251201</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun Directions.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>75709-001-04</NDCCode>
<PackageDescription>450 mL in 1 BOTTLE (75709-001-04) </PackageDescription>
<NDC11Code>75709-0001-04</NDC11Code>
<ProductNDC>75709-001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>S D S</ProprietaryName>
<NonProprietaryName>Disinfectant</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200429</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Xi'an Explution Tech Co.,Ltd.</LabelerName>
<SubstanceName>DIDECYLDIMONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.2</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-06-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200429</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>75709-011-04</NDCCode>
<PackageDescription>450 mL in 1 BOTTLE (75709-011-04) </PackageDescription>
<NDC11Code>75709-0011-04</NDC11Code>
<ProductNDC>75709-011</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Surface Disinfectant</ProprietaryName>
<NonProprietaryName>Surface Disinfectant Spray</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200429</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Xi'an Explution Tech Co.,Ltd.</LabelerName>
<SubstanceName>DIDECYLDIMONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.2</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-07-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200429</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Disinfect surfaces in public or family places,such as hand rail ,desk,tool, toy, pet appliance,wardrobe, sofa,carpet, etc.Suitable on plastic,wood,porcelain,glass, metal, etc.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>77586-001-04</NDCCode>
<PackageDescription>450 mL in 1 BOTTLE, PUMP (77586-001-04) </PackageDescription>
<NDC11Code>77586-0001-04</NDC11Code>
<ProductNDC>77586-001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dmi Cosmetics Wash Me Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200512</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>DERMA INNOVATION COMPANY LIMITED</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200512</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Use(s) Hand Sanitizer Gel helps cleanse your hands instantly without rinse off. Gentle cleanses and nourishes your skin with all-round. protection.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>79134-001-04</NDCCode>
<PackageDescription>80 PACKET in 1 CANISTER (79134-001-04) > 450 mL in 1 PACKET</PackageDescription>
<NDC11Code>79134-0001-04</NDC11Code>
<ProductNDC>79134-001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Promedic</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200618</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Perfect Medics, Inc</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.13</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200618</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>to decrease bacteria on the skin that could cause disease.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>79173-001-04</NDCCode>
<PackageDescription>450 mL in 1 BOTTLE (79173-001-04) </PackageDescription>
<NDC11Code>79173-0001-04</NDC11Code>
<ProductNDC>79173-001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Eco Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200625</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>ECO AERONAUTICS INC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>70</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200625</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>81476-101-04</NDCCode>
<PackageDescription>450 mL in 1 BOTTLE (81476-101-04) </PackageDescription>
<NDC11Code>81476-0101-04</NDC11Code>
<ProductNDC>81476-101</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Okgo Disinfectant</ProprietaryName>
<NonProprietaryName>Didecyl Dimethyl Ammonium Chloride</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210126</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Henan Seagood Medical Equipment Co., Ltd.</LabelerName>
<SubstanceName>DIDECYLDIMONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210126</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>OKGO®Disinfectant to help reduce bacteria that potentially can cause disease.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>84522-450-04</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE (84522-450-04) </PackageDescription>
<NDC11Code>84522-0450-04</NDC11Code>
<ProductNDC>84522-450</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Trstay Hair Vitamincapsule Serum</ProprietaryName>
<NonProprietaryName>Trstay Hair Vitamin Capsule Serum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241213</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Yiwu Luoxin E Commerce Co Ltd</LabelerName>
<SubstanceName>NIACINAMIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241213</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>84756-450-04</NDCCode>
<PackageDescription>50 g in 1 BOX (84756-450-04) </PackageDescription>
<NDC11Code>84756-0450-04</NDC11Code>
<ProductNDC>84756-450</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Trstay Ganoderma Lucidum</ProprietaryName>
<NonProprietaryName>Trstay Ganoderma Lucidum</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241125</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Yiwu Xinqian E Commerce Co Ltd</LabelerName>
<SubstanceName>NIACINAMIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241125</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>84827-450-04</NDCCode>
<PackageDescription>50 g in 1 BOX (84827-450-04) </PackageDescription>
<NDC11Code>84827-0450-04</NDC11Code>
<ProductNDC>84827-450</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Trstay Firming Neck Cream</ProprietaryName>
<NonProprietaryName>Trstay Firming Neck Cream</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20241107</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Yiwu Xinqian E Commerce Co Ltd</LabelerName>
<SubstanceName>NIACINAMIDE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241107</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Apply twice daly(moring and night as a man and once as a woman.Afer apicaion, proeed with an acive masage for 3-5 minutes unthe product is fuy absorbed.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58809-198-80</NDCCode>
<PackageDescription>80 TABLET in 1 BOTTLE, PLASTIC (58809-198-80)</PackageDescription>
<NDC11Code>58809-0198-80</NDC11Code>
<ProductNDC>58809-198</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Vanatab Dm</ProprietaryName>
<NonProprietaryName>Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170301</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>GM Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>198; 9; 5</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-04-04</LastUpdate>
</NDC>
<NDC>
<NDCCode>58809-225-02</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE (58809-225-02) </PackageDescription>
<NDC11Code>58809-0225-02</NDC11Code>
<ProductNDC>58809-225</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dayclear Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200401</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>GM Pharmaceuticals, INC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>.62</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>