{
"NDC": [
{
"NDCCode": "58809-999-02",
"PackageDescription": "12 BOTTLE in 1 TRAY (58809-999-02) / 15 mL in 1 BOTTLE",
"NDC11Code": "58809-0999-02",
"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": "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": "58809-213-02",
"PackageDescription": "60 mL in 1 BOTTLE, DROPPER (58809-213-02) ",
"NDC11Code": "58809-0213-02",
"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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"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",
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"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"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": "58809-214-02",
"PackageDescription": "60 mL in 1 BOTTLE, DROPPER (58809-214-02) ",
"NDC11Code": "58809-0214-02",
"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",
"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",
"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",
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"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"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": "58809-219-02",
"PackageDescription": "59.1 mL in 1 BOTTLE, DROPPER (58809-219-02) ",
"NDC11Code": "58809-0219-02",
"ProductNDC": "58809-219",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Texaclear Mold Mix Allergy Relief",
"NonProprietaryName": "Alternaria Alt, Aspergillus Fum, Aspergillus Nig, Aureobasidium Pul, Bipolaris Sor, Boletus Sat, Botrytis Cin, Candida Alb, Cladosporium Clad, Epicoccum Nig, Gibberella Pul, Mucor Plu, Rhodotorula Muc, Saccharomyces Cer, Trichophyton Men, Ustilago May, Histaminum, Baptisia Tinctoria, Echinacea, Hydrastis Canadensis, Myrrha, Nasturtium Aquaticum, Phytolacca Decandra, Urtica Urens",
"DosageFormName": "LIQUID",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20260920",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "GM Pharmaceuticals, INC",
"SubstanceName": "ALTERNARIA ALTERNATA; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIGER VAR. NIGER; BOLETUS SATANAS FRUITING BODY; BOTRYTIS CINEREA; PASSALORA FULVA; FUSARIUM OXYSPORUM; COCHLIOBOLUS SATIVUS; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; USTILAGO MAYDIS; HISTAMINE DIHYDROCHLORIDE; SACCHAROMYCES CEREVISIAE; CLADOSPORIUM CLADOSPORIOIDES; EPICOCCUM NIGRUM; MUCOR RACEMOSUS; RHODOTORULA RUBRA; TRICHOPHYTON MENTAGROPHYTES; BAPTISIA TINCTORIA ROOT; ECHINACEA ANGUSTIFOLIA ROOT; GOLDENSEAL; MYRRH; NASTURTIUM OFFICINALE; PHYTOLACCA AMERICANA ROOT; URTICA URENS",
"StrengthNumber": "15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 30; 15; 15; 15; 15; 15; 15; 5; 5; 5; 5; 5; 5; 5",
"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",
"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], 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], Dietary Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], 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], 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 IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260920",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: Temporarily relieves sneezing, runny nose, itchy, watery eyes, and nasal congestion associated with mold.*."
},
{
"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"
},
{
"NDCCode": "58809-226-02",
"PackageDescription": "59 mL in 1 TUBE (58809-226-02) ",
"NDC11Code": "58809-0226-02",
"ProductNDC": "58809-226",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dayclear Hand Sanitizer Gel",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200330",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "GM Pharmaceuticals, Inc",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "550",
"StrengthUnit": "g/59mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200408",
"SamplePackage": "N"
},
{
"NDCCode": "58809-536-02",
"PackageDescription": "15 mL in 1 BOTTLE (58809-536-02)",
"NDC11Code": "58809-0536-02",
"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": "58809-571-02",
"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": "58809-578-02",
"PackageDescription": "12 BOTTLE in 1 CARTON (58809-578-02) > 15 mL in 1 BOTTLE",
"NDC11Code": "58809-0578-02",
"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": "58809-820-02",
"PackageDescription": "30 mL in 1 BOTTLE, PLASTIC (58809-820-02) ",
"NDC11Code": "58809-0820-02",
"ProductNDC": "58809-820",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vanatol",
"ProprietaryNameSuffix": "Lq",
"NonProprietaryName": "Butalbital, Acetaminophen And Caffeine",
"DosageFormName": "SYRUP",
"RouteName": "ORAL",
"StartMarketingDate": "20150428",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040387",
"LabelerName": "GM Pharmaceuticals",
"SubstanceName": "BUTALBITAL; ACETAMINOPHEN; CAFFEINE",
"StrengthNumber": "50; 325; 40",
"StrengthUnit": "mg/15mL; mg/15mL; mg/15mL",
"Pharm_Classes": "Barbiturates [CS],Barbiturate [EPC],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE]",
"DEASchedule": "CIII",
"Status": "Deprecated",
"LastUpdate": "2020-12-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20150428",
"SamplePackage": "N"
},
{
"NDCCode": "58809-907-02",
"PackageDescription": "12 BOTTLE in 1 TRAY (58809-907-02) > 15 mL in 1 BOTTLE",
"NDC11Code": "58809-0907-02",
"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": "10812-999-02",
"PackageDescription": "2 CAN in 1 CARTON (10812-999-02) > 141 g in 1 CAN",
"NDC11Code": "10812-0999-02",
"ProductNDC": "10812-999",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Neutrogena Wet Skin Kids",
"ProprietaryNameSuffix": "Sunscreen Broad Spectrum Spf70 Plus",
"NonProprietaryName": "Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone",
"DosageFormName": "AEROSOL, SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20151101",
"EndMarketingDate": "20181201",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Johnson & Johnson Consumer Inc.",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE",
"StrengthNumber": "30; 150; 50; 100; 60",
"StrengthUnit": "mg/g; mg/g; mg/g; mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2018-12-04",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "11054-999-02",
"PackageDescription": "30 L in 1 TANK (11054-999-02)",
"NDC11Code": "11054-0999-02",
"ProductNDC": "11054-999",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxygen",
"NonProprietaryName": "Oxygen",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20150101",
"MarketingCategoryName": "UNAPPROVED MEDICAL GAS",
"LabelerName": "Airgas USA, LLC",
"SubstanceName": "OXYGEN",
"StrengthNumber": "100",
"StrengthUnit": "L/99L",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "13537-999-02",
"PackageDescription": "1 TUBE in 1 CARTON (13537-999-02) > 30 g in 1 TUBE (13537-999-01)",
"NDC11Code": "13537-0999-02",
"ProductNDC": "13537-999",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Esika Triple Accion Max Bb",
"ProprietaryNameSuffix": "Light Beige",
"NonProprietaryName": "Zinc Oxide And Octinoxate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140310",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura Corporation LTD",
"SubstanceName": "ZINC OXIDE; OCTINOXATE",
"StrengthNumber": ".084; .07",
"StrengthUnit": "g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Ayuda a prevenir quemaduras solares."
},
{
"NDCCode": "37012-999-02",
"PackageDescription": "1 TUBE in 1 CARTON (37012-999-02) > 28.4 g in 1 TUBE",
"NDC11Code": "37012-0999-02",
"ProductNDC": "37012-999",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Triple Antibiotic",
"NonProprietaryName": "Bacitracin Zinc, Neomycin Sulfate, And Polymyxin B Sulfate",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20181023",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333B",
"LabelerName": "Shopko Stores Operating Co., LLC",
"SubstanceName": "BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE",
"StrengthNumber": "400; 3.5; 5000",
"StrengthUnit": "[iU]/g; mg/g; [iU]/g",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20181023",
"SamplePackage": "N",
"IndicationAndUsage": "first aid to help prevent infection in minor: 1 cuts, 2 scrapes, 3 burns."
},
{
"NDCCode": "49349-999-02",
"PackageDescription": "60 TABLET, FILM COATED in 1 BLISTER PACK (49349-999-02)",
"NDC11Code": "49349-0999-02",
"ProductNDC": "49349-999",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Abacavir Sulfate",
"NonProprietaryName": "Abacavir Sulfate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20130227",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091294",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "ABACAVIR SULFATE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "50241-999-02",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 BOX (50241-999-02) > 3.80564 kg in 1 BOTTLE, PLASTIC (50241-999-01) ",
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"ProductNDC": "50241-999",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cole Antimicrobial Premium Hand",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180415",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc.",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": ".13",
"StrengthUnit": "kg/100kg",
"Status": "Deprecated",
"LastUpdate": "2020-07-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20180415",
"SamplePackage": "N"
},
{
"NDCCode": "52125-999-02",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (52125-999-02) ",
"NDC11Code": "52125-0999-02",
"ProductNDC": "52125-999",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cimetidine",
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"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140804",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA074151",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "CIMETIDINE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-11-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20140804",
"SamplePackage": "N"
},
{
"NDCCode": "60913-999-02",
"PackageDescription": "200 PACKET in 1 CARTON (60913-999-02) / 1 mL in 1 PACKET",
"NDC11Code": "60913-0999-02",
"ProductNDC": "60913-999",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Povidone Iodine Prep",
"NonProprietaryName": "Povidone Iodine",
"DosageFormName": "SWAB",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150226",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "PHOENIX HEALTHCARE SOLUTIONS, LLC",
"SubstanceName": "POVIDONE-IODINE",
"StrengthNumber": "1",
"StrengthUnit": "g/100mL",
"Status": "Active",
"LastUpdate": "2025-10-24",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20150226",
"SamplePackage": "N",
"IndicationAndUsage": "Health-care antiseptic for preparation of the skin prior to surgery. First aid antiseptic to help prevent the risk of skin infection in minor cuts, scrapes and burns ."
},
{
"NDCCode": "61786-999-02",
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"ProductNDC": "61786-999",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"NonProprietaryName": "Lamotrigine",
"DosageFormName": "TABLET, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20161116",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202383",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "LAMOTRIGINE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-12-02",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "62713-999-02",
"PackageDescription": "59 mL in 1 BOTTLE, DROPPER (62713-999-02) ",
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"StartMarketingDate": "20240619",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Meditrend, Inc. DBA Progena Professional Formulations",
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"StrengthNumber": "3; 3; 3; 3; 3; 3; 3; 30; 30; 30; 30; 12",
"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",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Allergens [Chemical/Ingredient], Antigens, Dermatophagoides [CS], Antigens, Dermatophagoides [CS], 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 IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Insect Proteins [CS], Insect Proteins [CS], Insect Proteins [CS], Insect Proteins [Chemical/Ingredient], Non-Standardized Insect Allergenic Extract [EPC], Non-Standardized Insect Allergenic Extract [EPC], Standardized Insect Allergenic Extract [EPC], Standardized Insect Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2024-06-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20240619",
"SamplePackage": "N",
"IndicationAndUsage": "Use:This product is a Homeopathic Dilution formulated to support the body's immunity for the temporary relief of allergies.*."
},
{
"NDCCode": "63545-999-02",
"PackageDescription": "1200 PELLET in 1 BOTTLE, GLASS (63545-999-02) ",
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"ProductNDC": "63545-999",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Angustura Vera",
"NonProprietaryName": "Angustura Vera",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20201222",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, Inc.",
"SubstanceName": "ANGOSTURA BARK",
"StrengthNumber": "12",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2025-01-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20201222",
"SamplePackage": "N"
},
{
"NDCCode": "64117-999-02",
"PackageDescription": "7.5 mL in 1 BOTTLE, GLASS (64117-999-02) ",
"NDC11Code": "64117-0999-02",
"ProductNDC": "64117-999",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nhs Rheumatism Eczema",
"NonProprietaryName": "Rheumatism Eczema",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "19980604",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Natural Health Supply",
"SubstanceName": "BERBERIS VULGARIS ROOT BARK",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "19980604",
"SamplePackage": "N",
"IndicationAndUsage": "Indications: To be used for acute self-limiting conditions according to standard homeopathic indications."
},
{
"NDCCode": "66767-999-02",
"PackageDescription": "229 L in 1 CYLINDER (66767-999-02) ",
"NDC11Code": "66767-0999-02",
"ProductNDC": "66767-999",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Oxygen",
"NonProprietaryName": "Oxygen",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20151125",
"MarketingCategoryName": "UNAPPROVED MEDICAL GAS",
"LabelerName": "Metz Medical, Inc",
"SubstanceName": "OXYGEN",
"StrengthNumber": "1",
"StrengthUnit": "L/L",
"Status": "Deprecated",
"LastUpdate": "2023-12-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20151125",
"SamplePackage": "N"
},
{
"NDCCode": "67457-999-02",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (67457-999-02) / 2 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "67457-0999-02",
"ProductNDC": "67457-999",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Nitroprusside",
"NonProprietaryName": "Sodium Nitroprusside",
"DosageFormName": "INJECTION, SOLUTION, CONCENTRATE",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20201005",
"EndMarketingDate": "20270831",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210763",
"LabelerName": "Mylan Institutional LLC",
"SubstanceName": "SODIUM NITROPRUSSIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Vasodilation [PE], Vasodilator [EPC]",
"Status": "Active",
"LastUpdate": "2025-11-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20201005",
"EndMarketingDatePackage": "20270831",
"SamplePackage": "N",
"IndicationAndUsage": "Sodium nitroprusside injection is indicated for the immediate reduction of blood pressure of adult and pediatric patients in hypertensive crises. Concomitant longer-acting antihypertensive medication should be administered so that the duration of treatment with sodium nitroprusside can be minimized. Sodium nitroprusside injection is also indicated for producing controlled hypotension in order to reduce bleeding during surgery. Sodium nitroprusside injection is also indicated for the treatment of acute congestive heart failure.",
"Description": "Sodium nitroprusside, USP is disodium pentacyanonitrosylferrate (2-) dihydrate, a hypotensive agent whose structural formula is. whose molecular formula is Na2[Fe(CN)5NO] 2H2O, and whose molecular weight is 297.95. Sodium nitroprusside, USP is a reddish brown crystals or powder soluble in water. In an aqueous solution infused intravenously, sodium nitroprusside is a rapid-acting vasodilator, active on both arteries and veins. Sodium nitroprusside solution is rapidly degraded by trace contaminants, often with resulting color changes. (See DOSAGE AND ADMINISTRATION section.) The solution is also sensitive to certain wavelengths of light, and it must be protected from light in clinical use. Sodium Nitroprusside Injection is a clear, reddish brown solution and is available as. 50 mg Single Dose Vial – Each 2 mL vial contains the equivalent of 50 mg sodium nitroprusside dihydrate in sterile water for injection."
},
{
"NDCCode": "69097-999-02",
"PackageDescription": "30 TABLET in 1 BOTTLE (69097-999-02) ",
"NDC11Code": "69097-0999-02",
"ProductNDC": "69097-999",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Phytonadione",
"NonProprietaryName": "Phytonadione",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20231201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA213329",
"LabelerName": "Cipla USA., Inc.",
"SubstanceName": "PHYTONADIONE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Increased Prothrombin Activity [PE], Reversed Anticoagulation Activity [PE], Vitamin K [CS], Vitamin K [EPC], Warfarin Reversal Agent [EPC]",
"Status": "Active",
"LastUpdate": "2024-01-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20231201",
"SamplePackage": "N",
"IndicationAndUsage": "Phytonadione is indicated for the treatment of adults with the following coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity. : 1 anticoagulant-induced hypoprothrombinemia caused by coumarin or indanedione derivatives;, 2 hypoprothrombinemia secondary to antibacterial therapy;, 3 hypoprothrombinemia secondary to factors limiting absorpsion or synthesis of vitamin K, e.g., obstructive jaundice, biliary fistula, sprue, ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis of the pancrease, and regional enteritis;, 4 Other drug-induced hypoprothrombinemia where it is definitely shown that the result is due to interference with vitamin K metabolism, e.g., salicylates.",
"Description": "Phytonadione is 2-methyl-3-phytyl-1, 4-naphthoquinone. Its empirical formula is C31H46O2 and its structural formula is. Phytonadione tablets, USP for oral administration contain 5 mg of phytonadione, USP and are pale yellow colored, round tablets, scored on one side. Inactive ingredients are acacia, anhydrous dibasic calcium phosphate, lactose monohydrate, magnesium stearate, pregelatinized starch, silicon dioxide and talc."
},
{
"NDCCode": "69997-999-02",
"PackageDescription": "40 BOTTLE in 1 CARTON (69997-999-02) / 30 g in 1 BOTTLE (69997-999-01) ",
"NDC11Code": "69997-0999-02",
"ProductNDC": "69997-999",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Touch In Sol No Poreblem Airbrushed Primer",
"NonProprietaryName": "Octocrylene, Homosalate, Octisalate, Avobenzone",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20260119",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "BONNE Co., Ltd",
"SubstanceName": "OCTOCRYLENE; OCTISALATE; AVOBENZONE; HOMOSALATE",
"StrengthNumber": "2.85; 1.44; .84; 2.19",
"StrengthUnit": "g/30g; g/30g; g/30g; g/30g",
"Status": "Active",
"LastUpdate": "2026-01-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260119",
"SamplePackage": "N",
"IndicationAndUsage": "Helps prevent sunburn, if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun."
},
{
"NDCCode": "76339-116-02",
"PackageDescription": "1 BAG in 1 DRUM (76339-116-02) > 1 BAG in 1 BAG > 9.999 kg in 1 BAG",
"NDC11Code": "76339-0116-02",
"ProductNDC": "76339-116",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Benzoic Acid",
"DosageFormName": "POWDER",
"StartMarketingDate": "20190906",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Apothecon Pharmaceuticals Pvt Ltd",
"SubstanceName": "BENZOIC ACID",
"StrengthNumber": "9.999",
"StrengthUnit": "kg/9.999kg",
"Status": "Unfinished",
"LastUpdate": "2022-11-10",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "06-SEP-19"
},
{
"NDCCode": "76339-124-02",
"PackageDescription": "1 BAG in 1 DRUM (76339-124-02) / 1 BAG in 1 BAG / 9.999 kg in 1 BAG",
"NDC11Code": "76339-0124-02",
"ProductNDC": "76339-124",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Ropivacaine Hydrochloride",
"DosageFormName": "POWDER",
"StartMarketingDate": "20211124",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Apothecon Pharmaceuticals Pvt Ltd",
"SubstanceName": "ROPIVACAINE HYDROCHLORIDE",
"StrengthNumber": "29.999",
"StrengthUnit": "kg/29.999kg",
"Status": "Unfinished",
"LastUpdate": "2023-11-30",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "24-NOV-21"
}
]
}
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<NDCList>
<NDC>
<NDCCode>58809-999-02</NDCCode>
<PackageDescription>12 BOTTLE in 1 TRAY (58809-999-02) / 15 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>58809-0999-02</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>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>
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<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>58809-213-02</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE, DROPPER (58809-213-02) </PackageDescription>
<NDC11Code>58809-0213-02</NDC11Code>
<ProductNDC>58809-213</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Texaclear All Season Allergy Relief</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>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</SubstanceName>
<StrengthNumber>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; 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>20271231</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>58809-214-02</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE, DROPPER (58809-214-02) </PackageDescription>
<NDC11Code>58809-0214-02</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>
<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>20271231</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>58809-219-02</NDCCode>
<PackageDescription>59.1 mL in 1 BOTTLE, DROPPER (58809-219-02) </PackageDescription>
<NDC11Code>58809-0219-02</NDC11Code>
<ProductNDC>58809-219</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Texaclear Mold Mix Allergy Relief</ProprietaryName>
<NonProprietaryName>Alternaria Alt, Aspergillus Fum, Aspergillus Nig, Aureobasidium Pul, Bipolaris Sor, Boletus Sat, Botrytis Cin, Candida Alb, Cladosporium Clad, Epicoccum Nig, Gibberella Pul, Mucor Plu, Rhodotorula Muc, Saccharomyces Cer, Trichophyton Men, Ustilago May, Histaminum, Baptisia Tinctoria, Echinacea, Hydrastis Canadensis, Myrrha, Nasturtium Aquaticum, Phytolacca Decandra, Urtica Urens</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>20260920</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>GM Pharmaceuticals, INC</LabelerName>
<SubstanceName>ALTERNARIA ALTERNATA; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIGER VAR. NIGER; BOLETUS SATANAS FRUITING BODY; BOTRYTIS CINEREA; PASSALORA FULVA; FUSARIUM OXYSPORUM; COCHLIOBOLUS SATIVUS; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; USTILAGO MAYDIS; HISTAMINE DIHYDROCHLORIDE; SACCHAROMYCES CEREVISIAE; CLADOSPORIUM CLADOSPORIOIDES; EPICOCCUM NIGRUM; MUCOR RACEMOSUS; RHODOTORULA RUBRA; TRICHOPHYTON MENTAGROPHYTES; BAPTISIA TINCTORIA ROOT; ECHINACEA ANGUSTIFOLIA ROOT; GOLDENSEAL; MYRRH; NASTURTIUM OFFICINALE; PHYTOLACCA AMERICANA ROOT; URTICA URENS</SubstanceName>
<StrengthNumber>15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 30; 15; 15; 15; 15; 15; 15; 5; 5; 5; 5; 5; 5; 5</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</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], 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], Dietary Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], 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], 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 IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260920</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: Temporarily relieves sneezing, runny nose, itchy, watery eyes, and nasal congestion associated with mold.*.</IndicationAndUsage>
</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>
<NDC>
<NDCCode>58809-226-02</NDCCode>
<PackageDescription>59 mL in 1 TUBE (58809-226-02) </PackageDescription>
<NDC11Code>58809-0226-02</NDC11Code>
<ProductNDC>58809-226</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dayclear Hand Sanitizer Gel</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200330</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>GM Pharmaceuticals, Inc</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>550</StrengthNumber>
<StrengthUnit>g/59mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200408</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>58809-536-02</NDCCode>
<PackageDescription>15 mL in 1 BOTTLE (58809-536-02)</PackageDescription>
<NDC11Code>58809-0536-02</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>58809-571-02</NDCCode>
<PackageDescription>12 BOTTLE in 1 CARTON (58809-571-02) > 15 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>58809-0571-02</NDC11Code>
<ProductNDC>58809-571</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Vanacof</ProprietaryName>
<ProprietaryNameSuffix>G</ProprietaryNameSuffix>
<NonProprietaryName>Chlophedianol Hydrochloride, Guaifenesin</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110606</StartMarketingDate>
<EndMarketingDate>20140930</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>GM Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CHLOPHEDIANOL HYDROCHLORIDE; GUAIFENESIN</SubstanceName>
<StrengthNumber>25; 200</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-10-03</LastUpdate>
</NDC>
<NDC>
<NDCCode>58809-578-02</NDCCode>
<PackageDescription>12 BOTTLE in 1 CARTON (58809-578-02) > 15 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>58809-0578-02</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>58809-820-02</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, PLASTIC (58809-820-02) </PackageDescription>
<NDC11Code>58809-0820-02</NDC11Code>
<ProductNDC>58809-820</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vanatol</ProprietaryName>
<ProprietaryNameSuffix>Lq</ProprietaryNameSuffix>
<NonProprietaryName>Butalbital, Acetaminophen And Caffeine</NonProprietaryName>
<DosageFormName>SYRUP</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150428</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040387</ApplicationNumber>
<LabelerName>GM Pharmaceuticals</LabelerName>
<SubstanceName>BUTALBITAL; ACETAMINOPHEN; CAFFEINE</SubstanceName>
<StrengthNumber>50; 325; 40</StrengthNumber>
<StrengthUnit>mg/15mL; mg/15mL; mg/15mL</StrengthUnit>
<Pharm_Classes>Barbiturates [CS],Barbiturate [EPC],Central Nervous System Stimulant [EPC],Methylxanthine [EPC],Xanthines [CS],Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CIII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2020-12-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150428</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>58809-907-02</NDCCode>
<PackageDescription>12 BOTTLE in 1 TRAY (58809-907-02) > 15 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>58809-0907-02</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>10812-999-02</NDCCode>
<PackageDescription>2 CAN in 1 CARTON (10812-999-02) > 141 g in 1 CAN</PackageDescription>
<NDC11Code>10812-0999-02</NDC11Code>
<ProductNDC>10812-999</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Neutrogena Wet Skin Kids</ProprietaryName>
<ProprietaryNameSuffix>Sunscreen Broad Spectrum Spf70 Plus</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Homosalate, Octisalate, Octocrylene, And Oxybenzone</NonProprietaryName>
<DosageFormName>AEROSOL, SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20151101</StartMarketingDate>
<EndMarketingDate>20181201</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Johnson & Johnson Consumer Inc.</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE</SubstanceName>
<StrengthNumber>30; 150; 50; 100; 60</StrengthNumber>
<StrengthUnit>mg/g; mg/g; mg/g; mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-12-04</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
</NDC>
<NDC>
<NDCCode>11054-999-02</NDCCode>
<PackageDescription>30 L in 1 TANK (11054-999-02)</PackageDescription>
<NDC11Code>11054-0999-02</NDC11Code>
<ProductNDC>11054-999</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxygen</ProprietaryName>
<NonProprietaryName>Oxygen</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20150101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED MEDICAL GAS</MarketingCategoryName>
<LabelerName>Airgas USA, LLC</LabelerName>
<SubstanceName>OXYGEN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>L/99L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>13537-999-02</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (13537-999-02) > 30 g in 1 TUBE (13537-999-01)</PackageDescription>
<NDC11Code>13537-0999-02</NDC11Code>
<ProductNDC>13537-999</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Esika Triple Accion Max Bb</ProprietaryName>
<ProprietaryNameSuffix>Light Beige</ProprietaryNameSuffix>
<NonProprietaryName>Zinc Oxide And Octinoxate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140310</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura Corporation LTD</LabelerName>
<SubstanceName>ZINC OXIDE; OCTINOXATE</SubstanceName>
<StrengthNumber>.084; .07</StrengthNumber>
<StrengthUnit>g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Ayuda a prevenir quemaduras solares.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>37012-999-02</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (37012-999-02) > 28.4 g in 1 TUBE</PackageDescription>
<NDC11Code>37012-0999-02</NDC11Code>
<ProductNDC>37012-999</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Triple Antibiotic</ProprietaryName>
<NonProprietaryName>Bacitracin Zinc, Neomycin Sulfate, And Polymyxin B Sulfate</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20181023</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333B</ApplicationNumber>
<LabelerName>Shopko Stores Operating Co., LLC</LabelerName>
<SubstanceName>BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE</SubstanceName>
<StrengthNumber>400; 3.5; 5000</StrengthNumber>
<StrengthUnit>[iU]/g; mg/g; [iU]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181023</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>first aid to help prevent infection in minor: 1 cuts, 2 scrapes, 3 burns.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49349-999-02</NDCCode>
<PackageDescription>60 TABLET, FILM COATED in 1 BLISTER PACK (49349-999-02)</PackageDescription>
<NDC11Code>49349-0999-02</NDC11Code>
<ProductNDC>49349-999</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Abacavir Sulfate</ProprietaryName>
<NonProprietaryName>Abacavir Sulfate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20130227</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091294</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>ABACAVIR SULFATE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient],Nucleoside Reverse Transcriptase Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>50241-999-02</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 BOX (50241-999-02) > 3.80564 kg in 1 BOTTLE, PLASTIC (50241-999-01) </PackageDescription>
<NDC11Code>50241-0999-02</NDC11Code>
<ProductNDC>50241-999</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cole Antimicrobial Premium Hand</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180415</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc.</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>.13</StrengthNumber>
<StrengthUnit>kg/100kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-07-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180415</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>52125-999-02</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (52125-999-02) </PackageDescription>
<NDC11Code>52125-0999-02</NDC11Code>
<ProductNDC>52125-999</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cimetidine</ProprietaryName>
<NonProprietaryName>Cimetidine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140804</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA074151</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>CIMETIDINE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H2 Receptor Antagonists [MoA],Histamine-2 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-11-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140804</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>60913-999-02</NDCCode>
<PackageDescription>200 PACKET in 1 CARTON (60913-999-02) / 1 mL in 1 PACKET</PackageDescription>
<NDC11Code>60913-0999-02</NDC11Code>
<ProductNDC>60913-999</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Povidone Iodine Prep</ProprietaryName>
<NonProprietaryName>Povidone Iodine</NonProprietaryName>
<DosageFormName>SWAB</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150226</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>PHOENIX HEALTHCARE SOLUTIONS, LLC</LabelerName>
<SubstanceName>POVIDONE-IODINE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-10-24</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150226</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Health-care antiseptic for preparation of the skin prior to surgery. First aid antiseptic to help prevent the risk of skin infection in minor cuts, scrapes and burns .</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61786-999-02</NDCCode>
<PackageDescription>30 TABLET, EXTENDED RELEASE in 1 BLISTER PACK (61786-999-02)</PackageDescription>
<NDC11Code>61786-0999-02</NDC11Code>
<ProductNDC>61786-999</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lamotrigine</ProprietaryName>
<NonProprietaryName>Lamotrigine</NonProprietaryName>
<DosageFormName>TABLET, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20161116</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202383</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>LAMOTRIGINE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-epileptic Agent [EPC],Decreased Central Nervous System Disorganized Electrical Activity [PE],Mood Stabilizer [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-12-02</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>62713-999-02</NDCCode>
<PackageDescription>59 mL in 1 BOTTLE, DROPPER (62713-999-02) </PackageDescription>
<NDC11Code>62713-0999-02</NDC11Code>
<ProductNDC>62713-999</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergena</ProprietaryName>
<ProprietaryNameSuffix>Dust Plus Mite</ProprietaryNameSuffix>
<NonProprietaryName>Echinacea, Baptisia Tinctoria, Hydrastis Canadensis, Myrrha, Nasturtium Aquaticum, Phytolacca Decandra, Trigonella Foenum-graecum, Blatta Germanica (german Cockroach), Dust Mite (d.pteronyssinus, D. Farinae), Periplaneta Americana, Stannum Metallicum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240619</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Meditrend, Inc. DBA Progena Professional Formulations</LabelerName>
<SubstanceName>ECHINACEA, UNSPECIFIED; BAPTISIA TINCTORIA ROOT; GOLDENSEAL; MYRRH; NASTURTIUM OFFICINALE; PHYTOLACCA AMERICANA ROOT; FENUGREEK LEAF; BLATTELLA GERMANICA; DERMATOPHAGOIDES PTERONYSSINUS; DERMATOPHAGOIDES FARINAE; PERIPLANETA AMERICANA; TIN</SubstanceName>
<StrengthNumber>3; 3; 3; 3; 3; 3; 3; 30; 30; 30; 30; 12</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</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Allergens [Chemical/Ingredient], Antigens, Dermatophagoides [CS], Antigens, Dermatophagoides [CS], 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 IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Insect Proteins [CS], Insect Proteins [CS], Insect Proteins [CS], Insect Proteins [Chemical/Ingredient], Non-Standardized Insect Allergenic Extract [EPC], Non-Standardized Insect Allergenic Extract [EPC], Standardized Insect Allergenic Extract [EPC], Standardized Insect Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240619</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Use:This product is a Homeopathic Dilution formulated to support the body's immunity for the temporary relief of allergies.*.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63545-999-02</NDCCode>
<PackageDescription>1200 PELLET in 1 BOTTLE, GLASS (63545-999-02) </PackageDescription>
<NDC11Code>63545-0999-02</NDC11Code>
<ProductNDC>63545-999</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Angustura Vera</ProprietaryName>
<NonProprietaryName>Angustura Vera</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201222</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, Inc.</LabelerName>
<SubstanceName>ANGOSTURA BARK</SubstanceName>
<StrengthNumber>12</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-01-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>64117-999-02</NDCCode>
<PackageDescription>7.5 mL in 1 BOTTLE, GLASS (64117-999-02) </PackageDescription>
<NDC11Code>64117-0999-02</NDC11Code>
<ProductNDC>64117-999</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nhs Rheumatism Eczema</ProprietaryName>
<NonProprietaryName>Rheumatism Eczema</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19980604</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Natural Health Supply</LabelerName>
<SubstanceName>BERBERIS VULGARIS ROOT BARK</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19980604</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indications: To be used for acute self-limiting conditions according to standard homeopathic indications.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>66767-999-02</NDCCode>
<PackageDescription>229 L in 1 CYLINDER (66767-999-02) </PackageDescription>
<NDC11Code>66767-0999-02</NDC11Code>
<ProductNDC>66767-999</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Oxygen</ProprietaryName>
<NonProprietaryName>Oxygen</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20151125</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED MEDICAL GAS</MarketingCategoryName>
<LabelerName>Metz Medical, Inc</LabelerName>
<SubstanceName>OXYGEN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>L/L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-12-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151125</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>67457-999-02</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (67457-999-02) / 2 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>67457-0999-02</NDC11Code>
<ProductNDC>67457-999</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Nitroprusside</ProprietaryName>
<NonProprietaryName>Sodium Nitroprusside</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20201005</StartMarketingDate>
<EndMarketingDate>20270831</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210763</ApplicationNumber>
<LabelerName>Mylan Institutional LLC</LabelerName>
<SubstanceName>SODIUM NITROPRUSSIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Vasodilation [PE], Vasodilator [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-11-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20201005</StartMarketingDatePackage>
<EndMarketingDatePackage>20270831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sodium nitroprusside injection is indicated for the immediate reduction of blood pressure of adult and pediatric patients in hypertensive crises. Concomitant longer-acting antihypertensive medication should be administered so that the duration of treatment with sodium nitroprusside can be minimized. Sodium nitroprusside injection is also indicated for producing controlled hypotension in order to reduce bleeding during surgery. Sodium nitroprusside injection is also indicated for the treatment of acute congestive heart failure.</IndicationAndUsage>
<Description>Sodium nitroprusside, USP is disodium pentacyanonitrosylferrate (2-) dihydrate, a hypotensive agent whose structural formula is. whose molecular formula is Na2[Fe(CN)5NO] 2H2O, and whose molecular weight is 297.95. Sodium nitroprusside, USP is a reddish brown crystals or powder soluble in water. In an aqueous solution infused intravenously, sodium nitroprusside is a rapid-acting vasodilator, active on both arteries and veins. Sodium nitroprusside solution is rapidly degraded by trace contaminants, often with resulting color changes. (See DOSAGE AND ADMINISTRATION section.) The solution is also sensitive to certain wavelengths of light, and it must be protected from light in clinical use. Sodium Nitroprusside Injection is a clear, reddish brown solution and is available as. 50 mg Single Dose Vial – Each 2 mL vial contains the equivalent of 50 mg sodium nitroprusside dihydrate in sterile water for injection.</Description>
</NDC>
<NDC>
<NDCCode>69097-999-02</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (69097-999-02) </PackageDescription>
<NDC11Code>69097-0999-02</NDC11Code>
<ProductNDC>69097-999</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Phytonadione</ProprietaryName>
<NonProprietaryName>Phytonadione</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231201</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA213329</ApplicationNumber>
<LabelerName>Cipla USA., Inc.</LabelerName>
<SubstanceName>PHYTONADIONE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Increased Prothrombin Activity [PE], Reversed Anticoagulation Activity [PE], Vitamin K [CS], Vitamin K [EPC], Warfarin Reversal Agent [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-01-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Phytonadione is indicated for the treatment of adults with the following coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity. : 1 anticoagulant-induced hypoprothrombinemia caused by coumarin or indanedione derivatives;, 2 hypoprothrombinemia secondary to antibacterial therapy;, 3 hypoprothrombinemia secondary to factors limiting absorpsion or synthesis of vitamin K, e.g., obstructive jaundice, biliary fistula, sprue, ulcerative colitis, celiac disease, intestinal resection, cystic fibrosis of the pancrease, and regional enteritis;, 4 Other drug-induced hypoprothrombinemia where it is definitely shown that the result is due to interference with vitamin K metabolism, e.g., salicylates.</IndicationAndUsage>
<Description>Phytonadione is 2-methyl-3-phytyl-1, 4-naphthoquinone. Its empirical formula is C31H46O2 and its structural formula is. Phytonadione tablets, USP for oral administration contain 5 mg of phytonadione, USP and are pale yellow colored, round tablets, scored on one side. Inactive ingredients are acacia, anhydrous dibasic calcium phosphate, lactose monohydrate, magnesium stearate, pregelatinized starch, silicon dioxide and talc.</Description>
</NDC>
<NDC>
<NDCCode>69997-999-02</NDCCode>
<PackageDescription>40 BOTTLE in 1 CARTON (69997-999-02) / 30 g in 1 BOTTLE (69997-999-01) </PackageDescription>
<NDC11Code>69997-0999-02</NDC11Code>
<ProductNDC>69997-999</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Touch In Sol No Poreblem Airbrushed Primer</ProprietaryName>
<NonProprietaryName>Octocrylene, Homosalate, Octisalate, Avobenzone</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20260119</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>BONNE Co., Ltd</LabelerName>
<SubstanceName>OCTOCRYLENE; OCTISALATE; AVOBENZONE; HOMOSALATE</SubstanceName>
<StrengthNumber>2.85; 1.44; .84; 2.19</StrengthNumber>
<StrengthUnit>g/30g; g/30g; g/30g; g/30g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260119</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn, if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>76339-116-02</NDCCode>
<PackageDescription>1 BAG in 1 DRUM (76339-116-02) > 1 BAG in 1 BAG > 9.999 kg in 1 BAG</PackageDescription>
<NDC11Code>76339-0116-02</NDC11Code>
<ProductNDC>76339-116</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Benzoic Acid</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20190906</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Apothecon Pharmaceuticals Pvt Ltd</LabelerName>
<SubstanceName>BENZOIC ACID</SubstanceName>
<StrengthNumber>9.999</StrengthNumber>
<StrengthUnit>kg/9.999kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2022-11-10</LastUpdate>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>06-SEP-19</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>76339-124-02</NDCCode>
<PackageDescription>1 BAG in 1 DRUM (76339-124-02) / 1 BAG in 1 BAG / 9.999 kg in 1 BAG</PackageDescription>
<NDC11Code>76339-0124-02</NDC11Code>
<ProductNDC>76339-124</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Ropivacaine Hydrochloride</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20211124</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Apothecon Pharmaceuticals Pvt Ltd</LabelerName>
<SubstanceName>ROPIVACAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>29.999</StrengthNumber>
<StrengthUnit>kg/29.999kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2023-11-30</LastUpdate>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>24-NOV-21</StartMarketingDatePackage>
</NDC>
</NDCList>