{
"NDC": [
{
"NDCCode": "58809-111-30",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (58809-111-30) ",
"NDC11Code": "58809-0111-30",
"ProductNDC": "58809-111",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dayclear Allergy Immune Therapy",
"NonProprietaryName": "Dayclear",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "ORAL",
"StartMarketingDate": "20180813",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "GM Pharmaceuticals, INC",
"SubstanceName": "ACACIA POLLEN; ACER NEGUNDO POLLEN; ACER SACCHARINUM POLLEN; ACER SACCHARUM POLLEN; AGROSTIS GIGANTEA POLLEN; AILANTHUS ALTISSIMA POLLEN; ALLENROLFEA OCCIDENTALIS POLLEN; ALNUS INCANA SUBSP. RUGOSA POLLEN; AMARANTHUS HYBRIDUS POLLEN; AMARANTHUS PALMERI POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMARANTHUS SPINOSUS POLLEN; AMARANTHUS TUBERCULATUS POLLEN; AMBROSIA ACANTHICARPA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA BIDENTATA POLLEN; AMBROSIA CONFERTIFLORA POLLEN; AMBROSIA DUMOSA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; ARTEMISIA ANNUA POLLEN; ARTEMISIA LUDOVICIANA WHOLE; ARTEMISIA TRIDENTATA POLLEN; ARTEMISIA VULGARIS WHOLE; ATRIPLEX CANESCENS POLLEN; AVENA SATIVA POLLEN; BACCHARIS HALIMIFOLIA WHOLE; BAPTISIA TINCTORIA ROOT; BASSIA SCOPARIA POLLEN; BETULA NIGRA POLLEN; BETULA OCCIDENTALIS WHOLE; BROMUS INERMIS POLLEN; BROUSSONETIA PAPYRIFERA POLLEN; CARPINUS CAROLINIANA WHOLE; CARYA ALBA POLLEN; CARYA CORDIFORMIS WHOLE; CARYA GLABRA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA LACINIOSA POLLEN; CARYA OVATA POLLEN; CELTIS OCCIDENTALIS POLLEN; CHENOPODIUM ALBUM POLLEN; CUPRESSUS ARIZONICA POLLEN; CYCLACHAENA XANTHIFOLIA POLLEN; CYNODON DACTYLON POLLEN; DACTYLIS GLOMERATA POLLEN; DISTICHLIS SPICATA POLLEN; ECHINACEA, UNSPECIFIED; ELYMUS REPENS POLLEN; FAGUS GRANDIFOLIA POLLEN; FESTUCA PRATENSIS POLLEN; FRAXINUS AMERICANA POLLEN; FRAXINUS PENNSYLVANICA POLLEN; FRAXINUS VELUTINA POLLEN; GUTIERREZIA SAROTHRAE WHOLE; HOLCUS LANATUS POLLEN; HYDRASTIS CANADENSIS WHOLE; IVA ANGUSTIFOLIA POLLEN; IVA ANNUA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS ASHEI POLLEN; JUNIPERUS DEPPEANA WHOLE; JUNIPERUS MONOSPERMA POLLEN; JUNIPERUS OSTEOSPERMA POLLEN; JUNIPERUS PINCHOTII POLLEN; JUNIPERUS SCOPULORUM POLLEN; JUNIPERUS VIRGINIANA POLLEN; LIGUSTRUM LUCIDUM WHOLE; LIQUIDAMBAR STYRACIFLUA POLLEN; LOLIUM MULTIFLORUM POLLEN; LOLIUM PERENNE POLLEN; MELALEUCA QUINQUENERVIA POLLEN; MORUS ALBA WHOLE; MORUS RUBRA POLLEN; MYRRH; OSTRYA VIRGINIANA WHOLE; PASPALUM NOTATUM POLLEN; PHALARIS ARUNDINACEA POLLEN; PHLEUM PRATENSE POLLEN; PHYTOLACCA AMERICANA ROOT; PINUS NIGRA POLLEN; PINUS PONDEROSA POLLEN; PINUS STROBUS POLLEN; PINUS SYLVESTRIS POLLEN; PINUS TAEDA POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POA ANNUA POLLEN; POA PRATENSIS POLLEN; POPULUS ALBA POLLEN; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN; POPULUS FREMONTII POLLEN; POPULUS NIGRA POLLEN; PROSOPIS PALLIDA POLLEN; QUERCUS ALBA WHOLE; QUERCUS GAMBELII POLLEN; QUERCUS MACROCARPA POLLEN; QUERCUS NIGRA POLLEN; QUERCUS RUBRA BARK; QUERCUS STELLATA POLLEN; QUERCUS VELUTINA WHOLE; QUERCUS VIRGINIANA POLLEN; RORIPPA NASTURTIUM-AQUATICUM; RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS POLLEN; SALIX NIGRA WHOLE; SALSOLA KALI WHOLE; SECALE CEREALE POLLEN; SOLIDAGO CANADENSIS WHOLE; SORGHUM HALEPENSE POLLEN; SORGHUM X DRUMMONDII WHOLE; TAMARIX GALLICA POLLEN; TAXODIUM DISTICHUM POLLEN; TRIADICA SEBIFERA WHOLE; TRIGONELLA FOENUM-GRAECUM WHOLE; TRITICUM AESTIVUM POLLEN; ULMUS AMERICANA POLLEN; ULMUS CRASSIFOLIA POLLEN; ULMUS CRASSIFOLIA WHOLE; ULMUS PUMILA POLLEN; URTICA DIOICA POLLEN; XANTHIUM STRUMARIUM POLLEN; ZEA MAYS POLLEN",
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"Status": "Deprecated",
"LastUpdate": "2023-11-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20180813",
"SamplePackage": "N"
},
{
"NDCCode": "58809-186-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (58809-186-30) ",
"NDC11Code": "58809-0186-30",
"ProductNDC": "58809-186",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Texaclear",
"NonProprietaryName": "Allergy Relief",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20151201",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M12",
"LabelerName": "GM Pharmaceuticals, INC",
"SubstanceName": "CHLOPHEDIANOL HYDROCHLORIDE; PYRILAMINE MALEATE",
"StrengthNumber": "25; 50",
"StrengthUnit": "mg/1; mg/1",
"Status": "Active",
"LastUpdate": "2026-01-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20151201",
"SamplePackage": "N"
},
{
"NDCCode": "58809-206-30",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (58809-206-30) ",
"NDC11Code": "58809-0206-30",
"ProductNDC": "58809-206",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Texaclear Homeopathic Allergy Relief",
"NonProprietaryName": "Over 100 Extracts",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "ORAL",
"StartMarketingDate": "20200801",
"EndMarketingDate": "20250101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "GM Pharmaceuticals, INC",
"SubstanceName": "ACACIA POLLEN; ACER NEGUNDO POLLEN; ACER RUBRUM POLLEN; ACER SACCHARINUM POLLEN; ACER SACCHARUM POLLEN; AGROSTIS GIGANTEA POLLEN; ALLENROLFEA OCCIDENTALIS POLLEN; ALNUS RHOMBIFOLIA POLLEN; AMARANTHUS HYBRIDUS POLLEN; AMARANTHUS PALMERI POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMARANTHUS SPINOSUS POLLEN; AMARANTHUS TUBERCULATUS POLLEN; AMBROSIA ACANTHICARPA POLLEN; AMBROSIA BIDENTATA POLLEN; AMBROSIA CONFERTIFLORA POLLEN; AMBROSIA DUMOSA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; ARTEMISIA ANNUA POLLEN; ARTEMISIA TRIDENTATA POLLEN; ARTEMISIA VULGARIS WHOLE; ATRIPLEX CANESCENS POLLEN; BACCHARIS HALIMIFOLIA WHOLE; BAPTISIA TINCTORIA ROOT; BASSIA SCOPARIA POLLEN; BETULA LENTA POLLEN; BETULA OCCIDENTALIS WHOLE; BROMUS INERMIS POLLEN; BROUSSONETIA PAPYRIFERA POLLEN; CARYA CORDIFORMIS WHOLE; CARYA GLABRA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA LACINIOSA POLLEN; CARYA OVATA POLLEN; CHENOPODIUM ALBUM POLLEN; CUPRESSUS ARIZONICA POLLEN; CYCLACHAENA XANTHIFOLIA POLLEN; DACTYLIS GLOMERATA POLLEN; DISTICHLIS SPICATA POLLEN; ECHINACEA, UNSPECIFIED; ELYMUS REPENS POLLEN; FAGUS GRANDIFOLIA POLLEN; FESTUCA PRATENSIS POLLEN; FRAXINUS AMERICANA POLLEN; FRAXINUS PENNSYLVANICA POLLEN; FRAXINUS VELUTINA POLLEN; GUTIERREZIA SAROTHRAE WHOLE; HYDRASTIS CANADENSIS WHOLE; IVA ANNUA POLLEN; JUGLANS NIGRA POLLEN; JUNIPER BERRY; JUNIPERUS DEPPEANA WHOLE; JUNIPERUS OSTEOSPERMA POLLEN; JUNIPERUS SCOPULORUM POLLEN; JUNIPERUS VIRGINIANA POLLEN; LIGUSTRUM LUCIDUM WHOLE; LIQUIDAMBAR STYRACIFLUA POLLEN; LOLIUM MULTIFLORUM POLLEN; LOLIUM PERENNE POLLEN; MELALEUCA QUINQUENERVIA POLLEN; MORUS ALBA WHOLE; MORUS RUBRA POLLEN; MYRRH; PASCOPYRUM SMITHII POLLEN; PHALARIS ARUNDINACEA POLLEN; PHLEUM PRATENSE POLLEN; PHYTOLACCA AMERICANA ROOT; PINUS PONDEROSA POLLEN; PINUS STROBUS POLLEN; PINUS TAEDA POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS ALBA POLLEN; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; POPULUS FREMONTII POLLEN; POPULUS NIGRA POLLEN; QUERCUS ALBA WHOLE; QUERCUS GAMBELII POLLEN; QUERCUS MACROCARPA POLLEN; QUERCUS NIGRA POLLEN; QUERCUS RUBRA BARK; QUERCUS STELLATA POLLEN; QUERCUS VELUTINA WHOLE; RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS POLLEN; SALSOLA KALI WHOLE; SECALE CEREALE POLLEN; SOLIDAGO CANADENSIS WHOLE; SORGHUM HALEPENSE POLLEN; TAXODIUM DISTICHUM POLLEN; THUJA OCCIDENTALIS LEAF; THUJA PLICATA LEAF; TRIADICA SEBIFERA WHOLE; TRITICUM AESTIVUM POLLEN; ULMUS AMERICANA POLLEN; ULMUS CRASSIFOLIA POLLEN; ULMUS PUMILA POLLEN; URTICA DIOICA POLLEN; XANTHIUM STRUMARIUM POLLEN; ZEA MAYS POLLEN",
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"Status": "Deprecated",
"LastUpdate": "2025-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200801",
"EndMarketingDatePackage": "20250101",
"SamplePackage": "N",
"IndicationAndUsage": "this product is a Homeopathic Dilution, formulated to support the body’s immunity for the temporary relief of allergies*."
},
{
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"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (58809-207-30) ",
"NDC11Code": "58809-0207-30",
"ProductNDC": "58809-207",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Texaclear Homeopathic Allergy Relief",
"ProprietaryNameSuffix": "Kids Cedar Fever",
"NonProprietaryName": "Over 100 Extracts",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "ORAL",
"StartMarketingDate": "20200821",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "GM Pharmaceuticals, INC",
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"LastUpdate": "2023-11-28",
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"StartMarketingDatePackage": "20200821",
"SamplePackage": "N"
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{
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"NDC11Code": "58809-0209-30",
"ProductNDC": "58809-209",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Texaclear Homeopathic Allergy Relief",
"ProprietaryNameSuffix": "Cedar Fever",
"NonProprietaryName": "Over 100 Extracts",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "ORAL",
"StartMarketingDate": "20200831",
"EndMarketingDate": "20250101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "GM Pharmaceuticals, INC",
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"Status": "Deprecated",
"LastUpdate": "2025-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200831",
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"SamplePackage": "N",
"IndicationAndUsage": "this product is a homeopathic dilution, formulated to support the body’s immunity for the temporary relief of allergies*."
},
{
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"ProductNDC": "58809-210",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Texaclear Natural Allergy Relief",
"NonProprietaryName": "Antigens 6x,12x,30x",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "ORAL",
"StartMarketingDate": "20180210",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "GM Pharmaceuticals, INC",
"SubstanceName": "ACACIA POLLEN; ACER SACCHARUM POLLEN; AGROSTIS GIGANTEA POLLEN; AILANTHUS ALTISSIMA POLLEN; ALLENROLFEA OCCIDENTALIS POLLEN; ALNUS INCANA SUBSP. RUGOSA POLLEN; AMARANTHUS HYBRIDUS POLLEN; AMARANTHUS PALMERI POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMARANTHUS SPINOSUS POLLEN; AMARANTHUS TUBERCULATUS POLLEN; AMBROSIA ACANTHICARPA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA BIDENTATA POLLEN; AMBROSIA CONFERTIFLORA POLLEN; AMBROSIA DUMOSA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; ARTEMISIA ANNUA POLLEN; ARTEMISIA LUDOVICIANA WHOLE; ARTEMISIA TRIDENTATA POLLEN; ARTEMISIA VULGARIS WHOLE; ATRIPLEX CANESCENS POLLEN; AVENA SATIVA POLLEN; BACCHARIS HALIMIFOLIA WHOLE; BAPTISIA TINCTORIA ROOT; BASSIA SCOPARIA POLLEN; BETULA NIGRA POLLEN; BETULA OCCIDENTALIS WHOLE; BROMUS INERMIS POLLEN; BROUSSONETIA PAPYRIFERA POLLEN; CARPINUS CAROLINIANA WHOLE; CARYA ALBA POLLEN; CARYA CORDIFORMIS WHOLE; CARYA GLABRA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA LACINIOSA POLLEN; CARYA OVATA POLLEN; CELTIS OCCIDENTALIS POLLEN; CHENOPODIUM ALBUM POLLEN; CUPRESSUS ARIZONICA POLLEN; CYCLACHAENA XANTHIFOLIA POLLEN; CYNODON DACTYLON POLLEN; DACTYLIS GLOMERATA POLLEN; DISTICHLIS SPICATA POLLEN; ECHINACEA, UNSPECIFIED; ELYMUS REPENS POLLEN; FAGUS GRANDIFOLIA POLLEN; FESTUCA PRATENSIS POLLEN; FRAXINUS PENNSYLVANICA POLLEN; FRAXINUS VELUTINA POLLEN; GUTIERREZIA SAROTHRAE WHOLE; HOLCUS LANATUS POLLEN; HYDRASTIS CANADENSIS WHOLE; IVA ANGUSTIFOLIA POLLEN; IVA ANNUA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS ASHEI POLLEN; JUNIPERUS DEPPEANA WHOLE; JUNIPERUS MONOSPERMA POLLEN; JUNIPERUS OSTEOSPERMA POLLEN; JUNIPERUS PINCHOTII POLLEN; JUNIPERUS SCOPULORUM POLLEN; JUNIPERUS VIRGINIANA POLLEN; LIGUSTRUM LUCIDUM WHOLE; LIQUIDAMBAR STYRACIFLUA POLLEN; LOLIUM MULTIFLORUM POLLEN; LOLIUM PERENNE POLLEN; MELALEUCA QUINQUENERVIA POLLEN; MORUS ALBA WHOLE; MORUS RUBRA POLLEN; MYRRH; OSTRYA VIRGINIANA WHOLE; PASPALUM NOTATUM POLLEN; PHALARIS ARUNDINACEA POLLEN; PHLEUM PRATENSE POLLEN; PHYTOLACCA AMERICANA ROOT; PINUS NIGRA POLLEN; PINUS PONDEROSA POLLEN; PINUS STROBUS POLLEN; PINUS SYLVESTRIS POLLEN; PINUS TAEDA POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POA ANNUA POLLEN; POA PRATENSIS POLLEN; POPULUS ALBA POLLEN; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN; POPULUS FREMONTII POLLEN; POPULUS NIGRA POLLEN; PROSOPIS PALLIDA POLLEN; QUERCUS ALBA WHOLE; QUERCUS GAMBELII POLLEN; QUERCUS MACROCARPA POLLEN; QUERCUS NIGRA POLLEN; QUERCUS RUBRA BARK; QUERCUS STELLATA POLLEN; QUERCUS VELUTINA WHOLE; QUERCUS VIRGINIANA POLLEN; RORIPPA NASTURTIUM-AQUATICUM; RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS POLLEN; SALIX NIGRA WHOLE; SALSOLA KALI WHOLE; SECALE CEREALE POLLEN; SOLIDAGO CANADENSIS WHOLE; SORGHUM HALEPENSE POLLEN; SORGHUM X DRUMMONDII WHOLE; TAMARIX GALLICA POLLEN; TAXODIUM DISTICHUM POLLEN; TRIADICA SEBIFERA WHOLE; TRIGONELLA FOENUM-GRAECUM WHOLE; TRITICUM AESTIVUM POLLEN; ULMUS AMERICANA POLLEN; ULMUS CRASSIFOLIA POLLEN; ULMUS CRASSIFOLIA WHOLE; ULMUS PUMILA POLLEN; URTICA DIOICA POLLEN; XANTHIUM STRUMARIUM POLLEN; ZEA MAYS POLLEN",
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"Status": "Deprecated",
"LastUpdate": "2022-03-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20180210",
"SamplePackage": "N"
},
{
"NDCCode": "58809-213-01",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (58809-213-01) ",
"NDC11Code": "58809-0213-01",
"ProductNDC": "58809-213",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Texaclear All Season Allergy Relief",
"NonProprietaryName": "Antigens All Zones Grasses Trees And Weeds. Baptisia Tinctoria, Echinacea, Hydrastis Canadensis, Myrrha, Nasturtium Aquaticum, Phytolacca Decandra, Urtica Urens",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20231110",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "GM Pharmaceuticals, INC",
"SubstanceName": "HOLCUS LANATUS POLLEN; MORUS RUBRA POLLEN; PINUS STROBUS POLLEN; NASTURTIUM OFFICINALE; AMARANTHUS SPINOSUS POLLEN; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS VIRGINIANA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN; QUERCUS RUBRA POLLEN; SORGHUM HALEPENSE POLLEN; TRITICUM AESTIVUM POLLEN; URTICA DIOICA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; RUMEX CRISPUS POLLEN; SECALE CEREALE POLLEN; TAXODIUM DISTICHUM POLLEN; XANTHIUM STRUMARIUM POLLEN; QUERCUS NIGRA POLLEN; QUERCUS STELLATA POLLEN; SOLIDAGO CANADENSIS POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA CONFERTIFLORA POLLEN; EUCALYPTUS GLOBULUS POLLEN; MYRRH; SALSOLA KALI POLLEN; QUERCUS MACROCARPA POLLEN; SYAGRUS ROMANZOFFIANA POLLEN; ZEA MAYS POLLEN; CHENOPODIUM ALBUM POLLEN; ARTEMISIA TRIDENTATA POLLEN; GOLDENSEAL; FAGUS GRANDIFOLIA POLLEN; FRAXINUS VELUTINA POLLEN; BROUSSONETIA PAPYRIFERA POLLEN; PINUS ECHINATA POLLEN; URTICA URENS WHOLE; AMARANTHUS PALMERI POLLEN; AMARANTHUS TUBERCULATUS POLLEN; CARYA ILLINOINENSIS POLLEN; LIQUIDAMBAR STYRACIFLUA POLLEN; MELALEUCA QUINQUENERVIA POLLEN; MORUS ALBA POLLEN; HESPEROCYPARIS ARIZONICA POLLEN; JUNIPERUS OCCIDENTALIS POLLEN; OLEA EUROPAEA POLLEN; ECHINACEA ANGUSTIFOLIA ROOT; ACER SACCHARUM POLLEN; ANTHOXANTHUM ODORATUM POLLEN; AVENA SATIVA POLLEN; PHYTOLACCA AMERICANA ROOT; BAPTISIA TINCTORIA ROOT; ACER NEGUNDO POLLEN; AMBROSIA ACANTHICARPA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA TRIFIDA POLLEN; ARTEMISIA VULGARIS POLLEN; CARYA OVATA POLLEN; CELTIS OCCIDENTALIS POLLEN; CYCLACHAENA XANTHIFOLIA POLLEN; JUNIPERUS ASHEI POLLEN; LIGUSTRUM VULGARE POLLEN; MYRICA CERIFERA POLLEN; POA PRATENSIS POLLEN; POPULUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALIX NIGRA POLLEN; SCHINUS MOLLE POLLEN; ACACIA DEALBATA POLLEN; ATRIPLEX WRIGHTII POLLEN; PASPALUM NOTATUM POLLEN; POPULUS NIGRA POLLEN; QUERCUS ALBA POLLEN; QUERCUS GAMBELII POLLEN; PLANTAGO LANCEOLATA POLLEN; PROSOPIS JULIFLORA POLLEN; QUERCUS VIRGINIANA POLLEN; ULMUS AMERICANA POLLEN; AMBROSIA BIDENTATA POLLEN; BASSIA SCOPARIA POLLEN; BETULA NIGRA POLLEN; DISTICHLIS SPICATA POLLEN; EUPATORIUM CAPILLIFOLIUM POLLEN",
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"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
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"IndicationAndUsage": "This product is a homeopathic dilution, formulated to support the body's immunity for the temporary relief of allergies.*."
},
{
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"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (58809-214-01) ",
"NDC11Code": "58809-0214-01",
"ProductNDC": "58809-214",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Texaclear Texas Allergy Relief Plus Cedar Fever",
"NonProprietaryName": "Antigens All Zones Grasses Trees And Weeds. Baptisia Tinctoria, Echinacea, Hydrastis Canadensis, Myrrha, Nasturtium Aquaticum, Phytolacca Decandra, Urtica Urens",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "SUBLINGUAL",
"StartMarketingDate": "20231110",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "GM Pharmaceuticals, INC",
"SubstanceName": "PLANTAGO LANCEOLATA POLLEN; PROSOPIS JULIFLORA POLLEN; QUERCUS VIRGINIANA POLLEN; ULMUS AMERICANA POLLEN; AMBROSIA BIDENTATA POLLEN; BASSIA SCOPARIA POLLEN; BETULA NIGRA POLLEN; DISTICHLIS SPICATA POLLEN; EUPATORIUM CAPILLIFOLIUM POLLEN; HOLCUS LANATUS POLLEN; MORUS RUBRA POLLEN; PINUS STROBUS POLLEN; NASTURTIUM OFFICINALE; AMARANTHUS SPINOSUS POLLEN; FRAXINUS AMERICANA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS VIRGINIANA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN; QUERCUS RUBRA POLLEN; SORGHUM HALEPENSE POLLEN; TRITICUM AESTIVUM POLLEN; URTICA DIOICA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; RUMEX CRISPUS POLLEN; SECALE CEREALE POLLEN; TAXODIUM DISTICHUM POLLEN; XANTHIUM STRUMARIUM POLLEN; QUERCUS NIGRA POLLEN; QUERCUS STELLATA POLLEN; SOLIDAGO CANADENSIS POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMBROSIA CONFERTIFLORA POLLEN; EUCALYPTUS GLOBULUS POLLEN; MYRRH; SALSOLA KALI POLLEN; QUERCUS MACROCARPA POLLEN; SYAGRUS ROMANZOFFIANA POLLEN; ZEA MAYS POLLEN; CHENOPODIUM ALBUM POLLEN; ARTEMISIA TRIDENTATA POLLEN; GOLDENSEAL; FAGUS GRANDIFOLIA POLLEN; FRAXINUS VELUTINA POLLEN; BROUSSONETIA PAPYRIFERA POLLEN; PINUS ECHINATA POLLEN; URTICA URENS WHOLE; AMARANTHUS PALMERI POLLEN; AMARANTHUS TUBERCULATUS POLLEN; CARYA ILLINOINENSIS POLLEN; LIQUIDAMBAR STYRACIFLUA POLLEN; MELALEUCA QUINQUENERVIA POLLEN; MORUS ALBA POLLEN; HESPEROCYPARIS ARIZONICA POLLEN; JUNIPERUS OCCIDENTALIS POLLEN; OLEA EUROPAEA POLLEN; ECHINACEA ANGUSTIFOLIA ROOT; ACER SACCHARUM POLLEN; ANTHOXANTHUM ODORATUM POLLEN; AVENA SATIVA POLLEN; PHYTOLACCA AMERICANA ROOT; BAPTISIA TINCTORIA ROOT; ACER NEGUNDO POLLEN; AMBROSIA ACANTHICARPA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA TRIFIDA POLLEN; ARTEMISIA VULGARIS POLLEN; CARYA OVATA POLLEN; CELTIS OCCIDENTALIS POLLEN; CYCLACHAENA XANTHIFOLIA POLLEN; JUNIPERUS ASHEI POLLEN; LIGUSTRUM VULGARE POLLEN; MYRICA CERIFERA POLLEN; POA PRATENSIS POLLEN; POPULUS ALBA POLLEN; RUMEX ACETOSELLA POLLEN; SALIX NIGRA POLLEN; SCHINUS MOLLE POLLEN; ACACIA DEALBATA POLLEN; ATRIPLEX WRIGHTII POLLEN; PASPALUM NOTATUM POLLEN; QUERCUS GAMBELII POLLEN; POPULUS NIGRA POLLEN; QUERCUS ALBA POLLEN",
"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",
"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]",
"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": "58809-221-30",
"PackageDescription": "30 TABLET in 1 BOTTLE (58809-221-30) ",
"NDC11Code": "58809-0221-30",
"ProductNDC": "58809-221",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dayclear Allergy Relief",
"NonProprietaryName": "Chlophedianol Hcl, Pyrilamine Maleate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20180813",
"EndMarketingDate": "20240229",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "GM Pharmaceuticals, INC",
"SubstanceName": "CHLOPHEDIANOL HYDROCHLORIDE; PYRILAMINE MALEATE",
"StrengthNumber": "25; 50",
"StrengthUnit": "mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2024-03-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180813",
"EndMarketingDatePackage": "20240229",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: 1 runny nose , 2 sneezing , 3 itching of the nose or throat , 4 itchy watery eyes , 5 cough due to minor throat and bronchial irritation."
},
{
"NDCCode": "58809-287-30",
"PackageDescription": "1 BOTTLE, PLASTIC in 1 CARTON (58809-287-30) > 30 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC",
"NDC11Code": "58809-0287-30",
"ProductNDC": "58809-287",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Active Ob",
"NonProprietaryName": "Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, D-, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Iron Pentacarbonyl, Zinc Oxide, Cupric Sulfate, And Doconexent",
"DosageFormName": "CAPSULE, LIQUID FILLED",
"RouteName": "ORAL",
"StartMarketingDate": "20131028",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "GM Pharmaceuticals, Inc.",
"SubstanceName": "ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, D-; THIAMINE MONONITRATE; RIBOFLAVIN; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; IRON PENTACARBONYL; ZINC OXIDE; CUPRIC SULFATE; DOCONEXENT",
"StrengthNumber": "100; 400; 30; 2; 4; 20; 1; 30; 20; 30; 2; 320",
"StrengthUnit": "mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-09-13"
},
{
"NDCCode": "58809-359-30",
"PackageDescription": "12 BOTTLE in 1 CARTON (58809-359-30) > 30 mL in 1 BOTTLE",
"NDC11Code": "58809-0359-30",
"ProductNDC": "58809-359",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Vanatol",
"ProprietaryNameSuffix": "S",
"NonProprietaryName": "Butalbital, Acetaminophen And Caffeine",
"DosageFormName": "SYRUP",
"RouteName": "ORAL",
"StartMarketingDate": "20170701",
"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": "2020-11-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20170701",
"SamplePackage": "N"
},
{
"NDCCode": "58809-501-30",
"PackageDescription": "1 BOTTLE, DROPPER in 1 CARTON (58809-501-30) > 30 mL in 1 BOTTLE, DROPPER",
"NDC11Code": "58809-0501-30",
"ProductNDC": "58809-501",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Vanahist Pd",
"NonProprietaryName": "Triprolidine Hydrochloride",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20140319",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "GM Pharmaceuticals, INC",
"SubstanceName": "TRIPROLIDINE HYDROCHLORIDE",
"StrengthNumber": ".625",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"StartMarketingDatePackage": "20140319",
"SamplePackage": "N"
},
{
"NDCCode": "58809-643-30",
"PackageDescription": "30 mL in 1 BOTTLE (58809-643-30) ",
"NDC11Code": "58809-0643-30",
"ProductNDC": "58809-643",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Vanamine Pd",
"NonProprietaryName": "Diphenhydramine Hydrochloride",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20160404",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "GM Pharmaceuticals, INC",
"SubstanceName": "DIPHENHYDRAMINE HYDROCHLORIDE",
"StrengthNumber": "6.25",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2021-01-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20160404",
"SamplePackage": "N"
},
{
"NDCCode": "58809-725-30",
"PackageDescription": "1 BOTTLE in 1 CARTON (58809-725-30) > 30 TABLET in 1 BOTTLE",
"NDC11Code": "58809-0725-30",
"ProductNDC": "58809-725",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Active Fe",
"NonProprietaryName": ".beta.-carotene, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Thiamine Hydrochloride, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Iron Pentacarbonyl, Magnesium Oxide, Zinc Oxide, And Cupric Oxide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20131111",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "GM Pharmaceuticals, Inc.",
"SubstanceName": ".BETA.-CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE HYDROCHLORIDE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; IRON PENTACARBONYL; MAGNESIUM OXIDE; ZINC OXIDE; CUPRIC OXIDE",
"StrengthNumber": "2100; 160; 400; 40; 4; 4; 20; 20; 1250; 30; 75; 30; 20; 1",
"StrengthUnit": "[iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Vitamin C [EPC],Ascorbic Acid [CS],Vitamin D [CS],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"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": "58809-206-60",
"PackageDescription": "57 mL in 1 BOTTLE, DROPPER (58809-206-60) ",
"NDC11Code": "58809-0206-60",
"ProductNDC": "58809-206",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Texaclear Homeopathic Allergy Relief",
"NonProprietaryName": "Over 100 Extracts",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "ORAL",
"StartMarketingDate": "20200801",
"EndMarketingDate": "20250101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "GM Pharmaceuticals, INC",
"SubstanceName": "ACACIA POLLEN; ACER NEGUNDO POLLEN; ACER RUBRUM POLLEN; ACER SACCHARINUM POLLEN; ACER SACCHARUM POLLEN; AGROSTIS GIGANTEA POLLEN; ALLENROLFEA OCCIDENTALIS POLLEN; ALNUS RHOMBIFOLIA POLLEN; AMARANTHUS HYBRIDUS POLLEN; AMARANTHUS PALMERI POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMARANTHUS SPINOSUS POLLEN; AMARANTHUS TUBERCULATUS POLLEN; AMBROSIA ACANTHICARPA POLLEN; AMBROSIA BIDENTATA POLLEN; AMBROSIA CONFERTIFLORA POLLEN; AMBROSIA DUMOSA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; ARTEMISIA ANNUA POLLEN; ARTEMISIA TRIDENTATA POLLEN; ARTEMISIA VULGARIS WHOLE; ATRIPLEX CANESCENS POLLEN; BACCHARIS HALIMIFOLIA WHOLE; BAPTISIA TINCTORIA ROOT; BASSIA SCOPARIA POLLEN; BETULA LENTA POLLEN; BETULA OCCIDENTALIS WHOLE; BROMUS INERMIS POLLEN; BROUSSONETIA PAPYRIFERA POLLEN; CARYA CORDIFORMIS WHOLE; CARYA GLABRA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA LACINIOSA POLLEN; CARYA OVATA POLLEN; CHENOPODIUM ALBUM POLLEN; CUPRESSUS ARIZONICA POLLEN; CYCLACHAENA XANTHIFOLIA POLLEN; DACTYLIS GLOMERATA POLLEN; DISTICHLIS SPICATA POLLEN; ECHINACEA, UNSPECIFIED; ELYMUS REPENS POLLEN; FAGUS GRANDIFOLIA POLLEN; FESTUCA PRATENSIS POLLEN; FRAXINUS AMERICANA POLLEN; FRAXINUS PENNSYLVANICA POLLEN; FRAXINUS VELUTINA POLLEN; GUTIERREZIA SAROTHRAE WHOLE; HYDRASTIS CANADENSIS WHOLE; IVA ANNUA POLLEN; JUGLANS NIGRA POLLEN; JUNIPER BERRY; JUNIPERUS DEPPEANA WHOLE; JUNIPERUS OSTEOSPERMA POLLEN; JUNIPERUS SCOPULORUM POLLEN; JUNIPERUS VIRGINIANA POLLEN; LIGUSTRUM LUCIDUM WHOLE; LIQUIDAMBAR STYRACIFLUA POLLEN; LOLIUM MULTIFLORUM POLLEN; LOLIUM PERENNE POLLEN; MELALEUCA QUINQUENERVIA POLLEN; MORUS ALBA WHOLE; MORUS RUBRA POLLEN; MYRRH; PASCOPYRUM SMITHII POLLEN; PHALARIS ARUNDINACEA POLLEN; PHLEUM PRATENSE POLLEN; PHYTOLACCA AMERICANA ROOT; PINUS PONDEROSA POLLEN; PINUS STROBUS POLLEN; PINUS TAEDA POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS ALBA POLLEN; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; POPULUS FREMONTII POLLEN; POPULUS NIGRA POLLEN; QUERCUS ALBA WHOLE; QUERCUS GAMBELII POLLEN; QUERCUS MACROCARPA POLLEN; QUERCUS NIGRA POLLEN; QUERCUS RUBRA BARK; QUERCUS STELLATA POLLEN; QUERCUS VELUTINA WHOLE; RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS POLLEN; SALSOLA KALI WHOLE; SECALE CEREALE POLLEN; SOLIDAGO CANADENSIS WHOLE; SORGHUM HALEPENSE POLLEN; TAXODIUM DISTICHUM POLLEN; THUJA OCCIDENTALIS LEAF; THUJA PLICATA LEAF; TRIADICA SEBIFERA WHOLE; TRITICUM AESTIVUM POLLEN; ULMUS AMERICANA POLLEN; ULMUS CRASSIFOLIA POLLEN; ULMUS PUMILA POLLEN; URTICA DIOICA POLLEN; XANTHIUM STRUMARIUM POLLEN; ZEA MAYS POLLEN",
"StrengthNumber": "30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 6; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 6; 30; 30; 30; 30; 30; 30; 30; 6; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 6; 30; 30; 30; 6; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30",
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"Status": "Deprecated",
"LastUpdate": "2025-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200801",
"EndMarketingDatePackage": "20250101",
"SamplePackage": "N",
"IndicationAndUsage": "this product is a Homeopathic Dilution, formulated to support the body’s immunity for the temporary relief of allergies*."
},
{
"NDCCode": "58809-208-90",
"PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (58809-208-90) ",
"NDC11Code": "58809-0208-90",
"ProductNDC": "58809-208",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Texaclear Homeopathic Allergy Releif",
"ProprietaryNameSuffix": "Plus Cedar Fever",
"NonProprietaryName": "Over 100 Extracts Trees,weeds And Grasses",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20201001",
"EndMarketingDate": "20250101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "GM Pharmaceuticals INC",
"SubstanceName": "ACACIA POLLEN; ACER NEGUNDO POLLEN; ACER RUBRUM POLLEN; ACER SACCHARINUM POLLEN; AGROSTIS GIGANTEA POLLEN; AILANTHUS ALTISSIMA POLLEN; ALLENROLFEA OCCIDENTALIS POLLEN; ALNUS INCANA SUBSP. RUGOSA POLLEN; ALNUS RHOMBIFOLIA POLLEN; AMARANTHUS HYBRIDUS POLLEN; AMARANTHUS PALMERI POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMARANTHUS SPINOSUS POLLEN; AMBROSIA ACANTHICARPA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA BIDENTATA POLLEN; AMBROSIA CONFERTIFLORA POLLEN; AMBROSIA DUMOSA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; ARTEMISIA ANNUA POLLEN; ARTEMISIA LUDOVICIANA WHOLE; ARTEMISIA TRIDENTATA POLLEN; ARTEMISIA VULGARIS WHOLE; ATRIPLEX CANESCENS POLLEN; AVENA SATIVA POLLEN; BACCHARIS HALIMIFOLIA WHOLE; BAPTISIA TINCTORIA ROOT; BASSIA SCOPARIA POLLEN; BETULA LENTA POLLEN; BETULA NIGRA POLLEN; BETULA OCCIDENTALIS WHOLE; BROUSSONETIA PAPYRIFERA POLLEN; CARPINUS CAROLINIANA WHOLE; CARYA ALBA POLLEN; CARYA CORDIFORMIS WHOLE; CARYA GLABRA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA LACINIOSA POLLEN; CARYA OVATA POLLEN; CEDRUS DEODARA WOOD; CELTIS OCCIDENTALIS POLLEN; CHENOPODIUM ALBUM POLLEN; CUPRESSUS ARIZONICA POLLEN; CYCLACHAENA XANTHIFOLIA POLLEN; CYNODON DACTYLON POLLEN; DACTYLIS GLOMERATA POLLEN; DISTICHLIS SPICATA POLLEN; ECHINACEA, UNSPECIFIED; ELYMUS REPENS POLLEN; FAGUS GRANDIFOLIA POLLEN; FESTUCA PRATENSIS POLLEN; FRAXINUS AMERICANA POLLEN; FRAXINUS PENNSYLVANICA POLLEN; FRAXINUS VELUTINA POLLEN; GUTIERREZIA SAROTHRAE WHOLE; HOLCUS LANATUS POLLEN; HYDRASTIS CANADENSIS WHOLE; IVA ANGUSTIFOLIA POLLEN; IVA ANNUA POLLEN; JUNIPER BERRY; JUNIPERUS ASHEI POLLEN; JUNIPERUS DEPPEANA WHOLE; JUNIPERUS MONOSPERMA POLLEN; JUNIPERUS OSTEOSPERMA POLLEN; JUNIPERUS PINCHOTII POLLEN; JUNIPERUS SCOPULORUM POLLEN; JUNIPERUS VIRGINIANA POLLEN; LIGUSTRUM LUCIDUM WHOLE; LIQUIDAMBAR STYRACIFLUA POLLEN; LOLIUM MULTIFLORUM POLLEN; LOLIUM PERENNE POLLEN; MELALEUCA QUINQUENERVIA POLLEN; MORUS ALBA WHOLE; MORUS RUBRA POLLEN; MYRRH; OSTRYA VIRGINIANA WHOLE; PASCOPYRUM SMITHII POLLEN; PASPALUM NOTATUM POLLEN; PHALARIS ARUNDINACEA POLLEN; PHLEUM PRATENSE POLLEN; PHYTOLACCA AMERICANA ROOT; PINUS NIGRA POLLEN; PINUS PONDEROSA POLLEN; PINUS STROBUS BARK; PINUS STROBUS POLLEN; PINUS SYLVESTRIS POLLEN; PINUS TAEDA POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POA ANNUA POLLEN; POA PRATENSIS POLLEN; POPULUS ALBA POLLEN; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN; POPULUS FREMONTII POLLEN; POPULUS NIGRA POLLEN; PROSOPIS PALLIDA POLLEN; QUERCUS ALBA WHOLE; QUERCUS GAMBELII POLLEN; QUERCUS MACROCARPA POLLEN; QUERCUS NIGRA POLLEN; QUERCUS RUBRA BARK; QUERCUS STELLATA POLLEN; QUERCUS VELUTINA WHOLE; QUERCUS VIRGINIANA POLLEN; RORIPPA NASTURTIUM-AQUATICUM; RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS POLLEN; SALIX NIGRA POLLEN; SECALE CEREALE POLLEN; SOLIDAGO CANADENSIS WHOLE; SORGHUM HALEPENSE POLLEN; SORGHUM X DRUMMONDII WHOLE; TAMARIX GALLICA POLLEN; TAXODIUM DISTICHUM POLLEN; THUJA OCCIDENTALIS LEAF; THUJA PLICATA LEAF; TRIGONELLA FOENUM-GRAECUM WHOLE; TRITICUM AESTIVUM POLLEN; ULMUS AMERICANA POLLEN; ULMUS CRASSIFOLIA POLLEN; ULMUS CRASSIFOLIA WHOLE; ULMUS PUMILA POLLEN; URTICA DIOICA POLLEN; XANTHIUM STRUMARIUM POLLEN; ZEA MAYS POLLEN",
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"Status": "Deprecated",
"LastUpdate": "2025-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20201001",
"EndMarketingDatePackage": "20250101",
"SamplePackage": "N",
"IndicationAndUsage": "this product is a homeopathic dilution,formulated to support the body's immunity for the temporary releif of allergies*."
},
{
"NDCCode": "58809-209-04",
"PackageDescription": "118 mL in 1 BOTTLE, DROPPER (58809-209-04) ",
"NDC11Code": "58809-0209-04",
"ProductNDC": "58809-209",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Texaclear Homeopathic Allergy Relief",
"ProprietaryNameSuffix": "Cedar Fever",
"NonProprietaryName": "Over 100 Extracts",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "ORAL",
"StartMarketingDate": "20200831",
"EndMarketingDate": "20250101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "GM Pharmaceuticals, INC",
"SubstanceName": "ACACIA POLLEN; ACER NEGUNDO POLLEN; ACER RUBRUM POLLEN; ACER SACCHARINUM POLLEN; ACER SACCHARUM POLLEN; AGROSTIS GIGANTEA POLLEN; AILANTHUS ALTISSIMA POLLEN; ALLENROLFEA OCCIDENTALIS POLLEN; ALNUS INCANA SUBSP. RUGOSA POLLEN; ALNUS RHOMBIFOLIA POLLEN; AMARANTHUS HYBRIDUS POLLEN; AMARANTHUS PALMERI POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMARANTHUS SPINOSUS POLLEN; AMARANTHUS TUBERCULATUS POLLEN; AMBROSIA ACANTHICARPA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA BIDENTATA POLLEN; AMBROSIA CONFERTIFLORA POLLEN; AMBROSIA DUMOSA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; ARTEMISIA ANNUA POLLEN; ARTEMISIA LUDOVICIANA WHOLE; ARTEMISIA TRIDENTATA POLLEN; ARTEMISIA VULGARIS WHOLE; ATRIPLEX CANESCENS POLLEN; AVENA SATIVA POLLEN; BACCHARIS HALIMIFOLIA WHOLE; BAPTISIA TINCTORIA ROOT; BASSIA SCOPARIA POLLEN; BETULA LENTA POLLEN; BETULA NIGRA POLLEN; BETULA OCCIDENTALIS WHOLE; BROMUS INERMIS POLLEN; BROUSSONETIA PAPYRIFERA POLLEN; CARPINUS CAROLINIANA WHOLE; CARYA ALBA POLLEN; CARYA CORDIFORMIS WHOLE; CARYA GLABRA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA LACINIOSA POLLEN; CARYA OVATA POLLEN; CEDRUS DEODARA WOOD; CELTIS OCCIDENTALIS POLLEN; CHENOPODIUM ALBUM POLLEN; CUPRESSUS ARIZONICA POLLEN; CYCLACHAENA XANTHIFOLIA POLLEN; CYNODON DACTYLON POLLEN; DACTYLIS GLOMERATA POLLEN; DISTICHLIS SPICATA POLLEN; ECHINACEA, UNSPECIFIED; ELYMUS REPENS POLLEN; FAGUS GRANDIFOLIA POLLEN; FESTUCA PRATENSIS POLLEN; FRAXINUS AMERICANA POLLEN; FRAXINUS PENNSYLVANICA POLLEN; FRAXINUS VELUTINA POLLEN; GUTIERREZIA SAROTHRAE WHOLE; HOLCUS LANATUS POLLEN; HYDRASTIS CANADENSIS WHOLE; IVA ANGUSTIFOLIA POLLEN; IVA ANNUA POLLEN; JUGLANS NIGRA POLLEN; JUNIPER BERRY; JUNIPERUS ASHEI POLLEN; JUNIPERUS DEPPEANA WHOLE; JUNIPERUS MONOSPERMA POLLEN; JUNIPERUS OSTEOSPERMA POLLEN; JUNIPERUS PINCHOTII POLLEN; JUNIPERUS SCOPULORUM POLLEN; JUNIPERUS VIRGINIANA POLLEN; LIGUSTRUM LUCIDUM WHOLE; LIQUIDAMBAR STYRACIFLUA POLLEN; LOLIUM MULTIFLORUM POLLEN; LOLIUM PERENNE POLLEN; MELALEUCA QUINQUENERVIA POLLEN; MORUS ALBA WHOLE; MORUS RUBRA POLLEN; MYRRH; OSTRYA VIRGINIANA WHOLE; PASCOPYRUM SMITHII POLLEN; PASPALUM NOTATUM POLLEN; PHALARIS ARUNDINACEA POLLEN; PHLEUM PRATENSE POLLEN; PHYTOLACCA AMERICANA ROOT; PINUS NIGRA POLLEN; PINUS PONDEROSA POLLEN; PINUS STROBUS BARK; PINUS STROBUS POLLEN; PINUS SYLVESTRIS POLLEN; PINUS TAEDA POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POA ANNUA POLLEN; POA PRATENSIS POLLEN; POPULUS ALBA POLLEN; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN; POPULUS FREMONTII POLLEN; POPULUS NIGRA POLLEN; PROSOPIS PALLIDA POLLEN; QUERCUS ALBA WHOLE; QUERCUS GAMBELII POLLEN; QUERCUS MACROCARPA POLLEN; QUERCUS NIGRA POLLEN; QUERCUS RUBRA BARK; QUERCUS STELLATA POLLEN; QUERCUS VELUTINA WHOLE; QUERCUS VIRGINIANA POLLEN; RORIPPA NASTURTIUM-AQUATICUM; RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS POLLEN; SALIX NIGRA POLLEN; SALSOLA KALI WHOLE; SECALE CEREALE POLLEN; SOLIDAGO CANADENSIS WHOLE; SORGHUM HALEPENSE POLLEN; SORGHUM X DRUMMONDII WHOLE; TAMARIX GALLICA POLLEN; TAXODIUM DISTICHUM POLLEN; THUJA OCCIDENTALIS LEAF; THUJA PLICATA LEAF; TRIADICA SEBIFERA WHOLE; TRIGONELLA FOENUM-GRAECUM WHOLE; TRITICUM AESTIVUM POLLEN; ULMUS AMERICANA POLLEN; ULMUS CRASSIFOLIA POLLEN; ULMUS CRASSIFOLIA WHOLE; ULMUS PUMILA POLLEN; URTICA DIOICA POLLEN; XANTHIUM STRUMARIUM POLLEN; ZEA MAYS POLLEN",
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"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], 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]",
"Status": "Deprecated",
"LastUpdate": "2025-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20220818",
"EndMarketingDatePackage": "20250101",
"SamplePackage": "N",
"IndicationAndUsage": "this product is a homeopathic dilution, formulated to support the body’s immunity for the temporary relief of allergies*."
},
{
"NDCCode": "58809-209-60",
"PackageDescription": "60 mL in 1 BOTTLE, DROPPER (58809-209-60) ",
"NDC11Code": "58809-0209-60",
"ProductNDC": "58809-209",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Texaclear Homeopathic Allergy Relief",
"ProprietaryNameSuffix": "Cedar Fever",
"NonProprietaryName": "Over 100 Extracts",
"DosageFormName": "SOLUTION/ DROPS",
"RouteName": "ORAL",
"StartMarketingDate": "20200831",
"EndMarketingDate": "20250101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "GM Pharmaceuticals, INC",
"SubstanceName": "ACACIA POLLEN; ACER NEGUNDO POLLEN; ACER RUBRUM POLLEN; ACER SACCHARINUM POLLEN; ACER SACCHARUM POLLEN; AGROSTIS GIGANTEA POLLEN; AILANTHUS ALTISSIMA POLLEN; ALLENROLFEA OCCIDENTALIS POLLEN; ALNUS INCANA SUBSP. RUGOSA POLLEN; ALNUS RHOMBIFOLIA POLLEN; AMARANTHUS HYBRIDUS POLLEN; AMARANTHUS PALMERI POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMARANTHUS SPINOSUS POLLEN; AMARANTHUS TUBERCULATUS POLLEN; AMBROSIA ACANTHICARPA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA BIDENTATA POLLEN; AMBROSIA CONFERTIFLORA POLLEN; AMBROSIA DUMOSA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; ARTEMISIA ANNUA POLLEN; ARTEMISIA LUDOVICIANA WHOLE; ARTEMISIA TRIDENTATA POLLEN; ARTEMISIA VULGARIS WHOLE; ATRIPLEX CANESCENS POLLEN; AVENA SATIVA POLLEN; BACCHARIS HALIMIFOLIA WHOLE; BAPTISIA TINCTORIA ROOT; BASSIA SCOPARIA POLLEN; BETULA LENTA POLLEN; BETULA NIGRA POLLEN; BETULA OCCIDENTALIS WHOLE; BROMUS INERMIS POLLEN; BROUSSONETIA PAPYRIFERA POLLEN; CARPINUS CAROLINIANA WHOLE; CARYA ALBA POLLEN; CARYA CORDIFORMIS WHOLE; CARYA GLABRA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA LACINIOSA POLLEN; CARYA OVATA POLLEN; CEDRUS DEODARA WOOD; CELTIS OCCIDENTALIS POLLEN; CHENOPODIUM ALBUM POLLEN; CUPRESSUS ARIZONICA POLLEN; CYCLACHAENA XANTHIFOLIA POLLEN; CYNODON DACTYLON POLLEN; DACTYLIS GLOMERATA POLLEN; DISTICHLIS SPICATA POLLEN; ECHINACEA, UNSPECIFIED; ELYMUS REPENS POLLEN; FAGUS GRANDIFOLIA POLLEN; FESTUCA PRATENSIS POLLEN; FRAXINUS AMERICANA POLLEN; FRAXINUS PENNSYLVANICA POLLEN; FRAXINUS VELUTINA POLLEN; GUTIERREZIA SAROTHRAE WHOLE; HOLCUS LANATUS POLLEN; HYDRASTIS CANADENSIS WHOLE; IVA ANGUSTIFOLIA POLLEN; IVA ANNUA POLLEN; JUGLANS NIGRA POLLEN; JUNIPER BERRY; JUNIPERUS ASHEI POLLEN; JUNIPERUS DEPPEANA WHOLE; JUNIPERUS MONOSPERMA POLLEN; JUNIPERUS OSTEOSPERMA POLLEN; JUNIPERUS PINCHOTII POLLEN; JUNIPERUS SCOPULORUM POLLEN; JUNIPERUS VIRGINIANA POLLEN; LIGUSTRUM LUCIDUM WHOLE; LIQUIDAMBAR STYRACIFLUA POLLEN; LOLIUM MULTIFLORUM POLLEN; LOLIUM PERENNE POLLEN; MELALEUCA QUINQUENERVIA POLLEN; MORUS ALBA WHOLE; MORUS RUBRA POLLEN; MYRRH; OSTRYA VIRGINIANA WHOLE; PASCOPYRUM SMITHII POLLEN; PASPALUM NOTATUM POLLEN; PHALARIS ARUNDINACEA POLLEN; PHLEUM PRATENSE POLLEN; PHYTOLACCA AMERICANA ROOT; PINUS NIGRA POLLEN; PINUS PONDEROSA POLLEN; PINUS STROBUS BARK; PINUS STROBUS POLLEN; PINUS SYLVESTRIS POLLEN; PINUS TAEDA POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POA ANNUA POLLEN; POA PRATENSIS POLLEN; POPULUS ALBA POLLEN; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN; POPULUS FREMONTII POLLEN; POPULUS NIGRA POLLEN; PROSOPIS PALLIDA POLLEN; QUERCUS ALBA WHOLE; QUERCUS GAMBELII POLLEN; QUERCUS MACROCARPA POLLEN; QUERCUS NIGRA POLLEN; QUERCUS RUBRA BARK; QUERCUS STELLATA POLLEN; QUERCUS VELUTINA WHOLE; QUERCUS VIRGINIANA POLLEN; RORIPPA NASTURTIUM-AQUATICUM; RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS POLLEN; SALIX NIGRA POLLEN; SALSOLA KALI WHOLE; SECALE CEREALE POLLEN; SOLIDAGO CANADENSIS WHOLE; SORGHUM HALEPENSE POLLEN; SORGHUM X DRUMMONDII WHOLE; TAMARIX GALLICA POLLEN; TAXODIUM DISTICHUM POLLEN; THUJA OCCIDENTALIS LEAF; THUJA PLICATA LEAF; TRIADICA SEBIFERA WHOLE; TRIGONELLA FOENUM-GRAECUM WHOLE; TRITICUM AESTIVUM POLLEN; ULMUS AMERICANA POLLEN; ULMUS CRASSIFOLIA POLLEN; ULMUS CRASSIFOLIA WHOLE; ULMUS PUMILA POLLEN; URTICA DIOICA POLLEN; XANTHIUM STRUMARIUM POLLEN; ZEA MAYS POLLEN",
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"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], 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]",
"Status": "Deprecated",
"LastUpdate": "2025-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200831",
"EndMarketingDatePackage": "20250101",
"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": "58809-407-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (58809-407-01)",
"NDC11Code": "58809-0407-01",
"ProductNDC": "58809-407",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Vanatab Dx",
"NonProprietaryName": "Chlophedianol Hydrochloride, Guaifenesin, Pseudoephedrine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110906",
"EndMarketingDate": "20150228",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "GM Pharmaceuticals, Inc.",
"SubstanceName": "CHLOPHEDIANOL HYDROCHLORIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE",
"StrengthNumber": "12.5; 200; 30",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Status": "Deprecated",
"LastUpdate": "2015-03-06"
},
{
"NDCCode": "58809-578-01",
"PackageDescription": "473 mL in 1 BOTTLE (58809-578-01)",
"NDC11Code": "58809-0578-01",
"ProductNDC": "58809-578",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Nasopen",
"NonProprietaryName": "Chlorcyclizine Hydrochloride, Pseudoephedrine Hydrochloride",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20110606",
"EndMarketingDate": "20150228",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "GM Pharmaceuticals, Inc.",
"SubstanceName": "CHLORCYCLIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE",
"StrengthNumber": "9.375; 30",
"StrengthUnit": "mg/5mL; mg/5mL",
"Status": "Deprecated",
"LastUpdate": "2015-03-06"
},
{
"NDCCode": "58809-578-02",
"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": "58809-829-60",
"PackageDescription": "60 TABLET, CHEWABLE in 1 BOTTLE (58809-829-60) ",
"NDC11Code": "58809-0829-60",
"ProductNDC": "58809-829",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Escavite D",
"NonProprietaryName": ".beta.-carotene, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol, Dl-, Thiamine Hydrochloride, Riboflavin, Niacin, Pyridoxine Hydrochloride, Folic Acid, Hydroxocobalamin, Biotin, Calcium Pantothenate, Ferrous Cysteine Glycinate, Magnesium Oxide, Zinc Oxide, Cupric Oxide, And Sodium Fluoride",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20140303",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "GM Pharmaceuticals, INC",
"SubstanceName": ".BETA.-CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL, DL-; THIAMINE HYDROCHLORIDE; RIBOFLAVIN; NIACIN; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; HYDROXOCOBALAMIN; BIOTIN; CALCIUM PANTOTHENATE; FERROUS CYSTEINE GLYCINATE; MAGNESIUM OXIDE; ZINC OXIDE; CUPRIC OXIDE; SODIUM FLUORIDE",
"StrengthNumber": "2500; 100; 600; 30; 1.5; 1.7; 20; 2; 400; 6; 45; 10; 6; 60; 15; 2; .25",
"StrengthUnit": "[iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Vitamin C [EPC],Ascorbic Acid [CS],Vitamin D [CS],Vitamin D [EPC],Nicotinic Acid [EPC],Nicotinic Acids [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Antidote [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"StartMarketingDatePackage": "20140303",
"SamplePackage": "N"
},
{
"NDCCode": "58809-888-01",
"PackageDescription": "100 TABLET, CHEWABLE in 1 BOTTLE (58809-888-01)",
"NDC11Code": "58809-0888-01",
"ProductNDC": "58809-888",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Escavite",
"NonProprietaryName": "Sodium Fluoride, Vitamin A Acetate, Biotin, Magnesium, Zinc, Copper, Calcium Pantothenate, Folic Acid, Iron, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, And Cyanocobalamin",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20120201",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "GM Pharmaceuticals, Inc.",
"SubstanceName": "SODIUM FLUORIDE; VITAMIN A ACETATE; BIOTIN; MAGNESIUM; ZINC; COPPER; CALCIUM PANTOTHENATE; FOLIC ACID; IRON; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN",
"StrengthNumber": ".25; 1000; 45; 60; 7.4; 1; 10; .4; 7.5; 100; 400; 30; 1.5; 1.7; 20; 2; 9",
"StrengthUnit": "mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; ug/1",
"Pharm_Classes": "Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC],Vitamin A [CS],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Vitamin D [CS],Vitamin D [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "58809-907-01",
"PackageDescription": "473 mL in 1 BOTTLE (58809-907-01)",
"NDC11Code": "58809-0907-01",
"ProductNDC": "58809-907",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Vanacof",
"ProprietaryNameSuffix": "Dx",
"NonProprietaryName": "Chlophedianol Hydrochloride, Guaifenesin, And Pseudoephedrine Hydrochloride",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20080423",
"EndMarketingDate": "20150430",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "GM Pharmaceuticals",
"SubstanceName": "CHLOPHEDIANOL HYDROCHLORIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE",
"StrengthNumber": "12.5; 100; 30",
"StrengthUnit": "mg/5mL; mg/5mL; mg/5mL",
"Status": "Deprecated",
"LastUpdate": "2015-05-15"
},
{
"NDCCode": "58809-907-02",
"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": "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": "58809-999-02",
"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",
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"RouteName": "ORAL",
"StartMarketingDate": "20080422",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
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"LabelerName": "GM Pharmaceuticals, INC",
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"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",
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},
{
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"PackageDescription": "1 BOTTLE, SPRAY in 1 POUCH (10237-111-01) / 30 mL in 1 BOTTLE, SPRAY",
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"ProductTypeName": "HUMAN OTC DRUG",
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"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "Church & Dwight Co., Inc.",
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"StrengthUnit": "mL/mL",
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"PackageNdcExcludeFlag": "N",
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}
]
}
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<LastUpdate>2023-11-28</LastUpdate>
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<SamplePackage>N</SamplePackage>
</NDC>
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<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
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<LabelerName>GM Pharmaceuticals, INC</LabelerName>
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<Status>Active</Status>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
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<Status>Deprecated</Status>
<LastUpdate>2025-01-02</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200801</StartMarketingDatePackage>
<EndMarketingDatePackage>20250101</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>this product is a Homeopathic Dilution, formulated to support the body’s immunity for the temporary relief of allergies*.</IndicationAndUsage>
</NDC>
<NDC>
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<ProductNDC>58809-207</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Texaclear Homeopathic Allergy Relief</ProprietaryName>
<ProprietaryNameSuffix>Kids Cedar Fever</ProprietaryNameSuffix>
<NonProprietaryName>Over 100 Extracts</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200821</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>GM Pharmaceuticals, INC</LabelerName>
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<Status>Deprecated</Status>
<LastUpdate>2023-11-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200821</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
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<PackageDescription>30 mL in 1 BOTTLE, DROPPER (58809-209-30) </PackageDescription>
<NDC11Code>58809-0209-30</NDC11Code>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Texaclear Homeopathic Allergy Relief</ProprietaryName>
<ProprietaryNameSuffix>Cedar Fever</ProprietaryNameSuffix>
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<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200831</StartMarketingDate>
<EndMarketingDate>20250101</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
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<SubstanceName>ACACIA POLLEN; ACER NEGUNDO POLLEN; ACER RUBRUM POLLEN; ACER SACCHARINUM POLLEN; ACER SACCHARUM POLLEN; AGROSTIS GIGANTEA POLLEN; AILANTHUS ALTISSIMA POLLEN; ALLENROLFEA OCCIDENTALIS POLLEN; ALNUS INCANA SUBSP. RUGOSA POLLEN; ALNUS RHOMBIFOLIA POLLEN; AMARANTHUS HYBRIDUS POLLEN; AMARANTHUS PALMERI POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMARANTHUS SPINOSUS POLLEN; AMARANTHUS TUBERCULATUS POLLEN; AMBROSIA ACANTHICARPA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA BIDENTATA POLLEN; AMBROSIA CONFERTIFLORA POLLEN; AMBROSIA DUMOSA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; ARTEMISIA ANNUA POLLEN; ARTEMISIA LUDOVICIANA WHOLE; ARTEMISIA TRIDENTATA POLLEN; ARTEMISIA VULGARIS WHOLE; ATRIPLEX CANESCENS POLLEN; AVENA SATIVA POLLEN; BACCHARIS HALIMIFOLIA WHOLE; BAPTISIA TINCTORIA ROOT; BASSIA SCOPARIA POLLEN; BETULA LENTA POLLEN; BETULA NIGRA POLLEN; BETULA OCCIDENTALIS WHOLE; BROMUS INERMIS POLLEN; BROUSSONETIA PAPYRIFERA POLLEN; CARPINUS CAROLINIANA WHOLE; CARYA ALBA POLLEN; CARYA CORDIFORMIS WHOLE; CARYA GLABRA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA LACINIOSA POLLEN; CARYA OVATA POLLEN; CEDRUS DEODARA WOOD; CELTIS OCCIDENTALIS POLLEN; CHENOPODIUM ALBUM POLLEN; CUPRESSUS ARIZONICA POLLEN; CYCLACHAENA XANTHIFOLIA POLLEN; CYNODON DACTYLON POLLEN; DACTYLIS GLOMERATA POLLEN; DISTICHLIS SPICATA POLLEN; ECHINACEA, UNSPECIFIED; ELYMUS REPENS POLLEN; FAGUS GRANDIFOLIA POLLEN; FESTUCA PRATENSIS POLLEN; FRAXINUS AMERICANA POLLEN; FRAXINUS PENNSYLVANICA POLLEN; FRAXINUS VELUTINA POLLEN; GUTIERREZIA SAROTHRAE WHOLE; HOLCUS LANATUS POLLEN; HYDRASTIS CANADENSIS WHOLE; IVA ANGUSTIFOLIA POLLEN; IVA ANNUA POLLEN; JUGLANS NIGRA POLLEN; JUNIPER BERRY; JUNIPERUS ASHEI POLLEN; JUNIPERUS DEPPEANA WHOLE; JUNIPERUS MONOSPERMA POLLEN; JUNIPERUS OSTEOSPERMA POLLEN; JUNIPERUS PINCHOTII POLLEN; JUNIPERUS SCOPULORUM POLLEN; JUNIPERUS VIRGINIANA POLLEN; LIGUSTRUM LUCIDUM WHOLE; LIQUIDAMBAR STYRACIFLUA POLLEN; LOLIUM MULTIFLORUM POLLEN; LOLIUM PERENNE POLLEN; MELALEUCA QUINQUENERVIA POLLEN; MORUS ALBA WHOLE; MORUS RUBRA POLLEN; MYRRH; OSTRYA VIRGINIANA WHOLE; PASCOPYRUM SMITHII POLLEN; PASPALUM NOTATUM POLLEN; PHALARIS ARUNDINACEA POLLEN; PHLEUM PRATENSE POLLEN; PHYTOLACCA AMERICANA ROOT; PINUS NIGRA POLLEN; PINUS PONDEROSA POLLEN; PINUS STROBUS BARK; PINUS STROBUS POLLEN; PINUS SYLVESTRIS POLLEN; PINUS TAEDA POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POA ANNUA POLLEN; POA PRATENSIS POLLEN; POPULUS ALBA POLLEN; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN; POPULUS FREMONTII POLLEN; POPULUS NIGRA POLLEN; PROSOPIS PALLIDA POLLEN; QUERCUS ALBA WHOLE; QUERCUS GAMBELII POLLEN; QUERCUS MACROCARPA POLLEN; QUERCUS NIGRA POLLEN; QUERCUS RUBRA BARK; QUERCUS STELLATA POLLEN; QUERCUS VELUTINA WHOLE; QUERCUS VIRGINIANA POLLEN; RORIPPA NASTURTIUM-AQUATICUM; RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS POLLEN; SALIX NIGRA POLLEN; SALSOLA KALI WHOLE; SECALE CEREALE POLLEN; SOLIDAGO CANADENSIS WHOLE; SORGHUM HALEPENSE POLLEN; SORGHUM X DRUMMONDII WHOLE; TAMARIX GALLICA POLLEN; TAXODIUM DISTICHUM POLLEN; THUJA OCCIDENTALIS LEAF; THUJA PLICATA LEAF; TRIADICA SEBIFERA WHOLE; TRIGONELLA FOENUM-GRAECUM WHOLE; TRITICUM AESTIVUM POLLEN; ULMUS AMERICANA POLLEN; ULMUS CRASSIFOLIA POLLEN; ULMUS CRASSIFOLIA WHOLE; ULMUS PUMILA POLLEN; URTICA DIOICA POLLEN; XANTHIUM STRUMARIUM POLLEN; ZEA MAYS POLLEN</SubstanceName>
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<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], 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]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200831</StartMarketingDatePackage>
<EndMarketingDatePackage>20250101</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>this product is a homeopathic dilution, formulated to support the body’s immunity for the temporary relief of allergies*.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58809-210-30</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (58809-210-30) </PackageDescription>
<NDC11Code>58809-0210-30</NDC11Code>
<ProductNDC>58809-210</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Texaclear Natural Allergy Relief</ProprietaryName>
<NonProprietaryName>Antigens 6x,12x,30x</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180210</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>GM Pharmaceuticals, INC</LabelerName>
<SubstanceName>ACACIA POLLEN; ACER SACCHARUM POLLEN; AGROSTIS GIGANTEA POLLEN; AILANTHUS ALTISSIMA POLLEN; ALLENROLFEA OCCIDENTALIS POLLEN; ALNUS INCANA SUBSP. RUGOSA POLLEN; AMARANTHUS HYBRIDUS POLLEN; AMARANTHUS PALMERI POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMARANTHUS SPINOSUS POLLEN; AMARANTHUS TUBERCULATUS POLLEN; AMBROSIA ACANTHICARPA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA BIDENTATA POLLEN; AMBROSIA CONFERTIFLORA POLLEN; AMBROSIA DUMOSA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; ARTEMISIA ANNUA POLLEN; ARTEMISIA LUDOVICIANA WHOLE; ARTEMISIA TRIDENTATA POLLEN; ARTEMISIA VULGARIS WHOLE; ATRIPLEX CANESCENS POLLEN; AVENA SATIVA POLLEN; BACCHARIS HALIMIFOLIA WHOLE; BAPTISIA TINCTORIA ROOT; BASSIA SCOPARIA POLLEN; BETULA NIGRA POLLEN; BETULA OCCIDENTALIS WHOLE; BROMUS INERMIS POLLEN; BROUSSONETIA PAPYRIFERA POLLEN; CARPINUS CAROLINIANA WHOLE; CARYA ALBA POLLEN; CARYA CORDIFORMIS WHOLE; CARYA GLABRA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA LACINIOSA POLLEN; CARYA OVATA POLLEN; CELTIS OCCIDENTALIS POLLEN; CHENOPODIUM ALBUM POLLEN; CUPRESSUS ARIZONICA POLLEN; CYCLACHAENA XANTHIFOLIA POLLEN; CYNODON DACTYLON POLLEN; DACTYLIS GLOMERATA POLLEN; DISTICHLIS SPICATA POLLEN; ECHINACEA, UNSPECIFIED; ELYMUS REPENS POLLEN; FAGUS GRANDIFOLIA POLLEN; FESTUCA PRATENSIS POLLEN; FRAXINUS PENNSYLVANICA POLLEN; FRAXINUS VELUTINA POLLEN; GUTIERREZIA SAROTHRAE WHOLE; HOLCUS LANATUS POLLEN; HYDRASTIS CANADENSIS WHOLE; IVA ANGUSTIFOLIA POLLEN; IVA ANNUA POLLEN; JUGLANS NIGRA POLLEN; JUNIPERUS ASHEI POLLEN; JUNIPERUS DEPPEANA WHOLE; JUNIPERUS MONOSPERMA POLLEN; JUNIPERUS OSTEOSPERMA POLLEN; JUNIPERUS PINCHOTII POLLEN; JUNIPERUS SCOPULORUM POLLEN; JUNIPERUS VIRGINIANA POLLEN; LIGUSTRUM LUCIDUM WHOLE; LIQUIDAMBAR STYRACIFLUA POLLEN; LOLIUM MULTIFLORUM POLLEN; LOLIUM PERENNE POLLEN; MELALEUCA QUINQUENERVIA POLLEN; MORUS ALBA WHOLE; MORUS RUBRA POLLEN; MYRRH; OSTRYA VIRGINIANA WHOLE; PASPALUM NOTATUM POLLEN; PHALARIS ARUNDINACEA POLLEN; PHLEUM PRATENSE POLLEN; PHYTOLACCA AMERICANA ROOT; PINUS NIGRA POLLEN; PINUS PONDEROSA POLLEN; PINUS STROBUS POLLEN; PINUS SYLVESTRIS POLLEN; PINUS TAEDA POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POA ANNUA POLLEN; POA PRATENSIS POLLEN; POPULUS ALBA POLLEN; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN; POPULUS FREMONTII POLLEN; POPULUS NIGRA POLLEN; PROSOPIS PALLIDA POLLEN; QUERCUS ALBA WHOLE; QUERCUS GAMBELII POLLEN; QUERCUS MACROCARPA POLLEN; QUERCUS NIGRA POLLEN; QUERCUS RUBRA BARK; QUERCUS STELLATA POLLEN; QUERCUS VELUTINA WHOLE; QUERCUS VIRGINIANA POLLEN; RORIPPA NASTURTIUM-AQUATICUM; RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS POLLEN; SALIX NIGRA WHOLE; SALSOLA KALI WHOLE; SECALE CEREALE POLLEN; SOLIDAGO CANADENSIS WHOLE; SORGHUM HALEPENSE POLLEN; SORGHUM X DRUMMONDII WHOLE; TAMARIX GALLICA POLLEN; TAXODIUM DISTICHUM POLLEN; TRIADICA SEBIFERA WHOLE; TRIGONELLA FOENUM-GRAECUM WHOLE; TRITICUM AESTIVUM POLLEN; ULMUS AMERICANA POLLEN; ULMUS CRASSIFOLIA POLLEN; ULMUS CRASSIFOLIA WHOLE; ULMUS PUMILA POLLEN; URTICA DIOICA POLLEN; XANTHIUM STRUMARIUM POLLEN; ZEA MAYS POLLEN</SubstanceName>
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<NonProprietaryName>Antigens All Zones Grasses Trees And Weeds. Baptisia Tinctoria, Echinacea, Hydrastis Canadensis, Myrrha, Nasturtium Aquaticum, Phytolacca Decandra, Urtica Urens</NonProprietaryName>
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<LastUpdate>2025-12-16</LastUpdate>
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<IndicationAndUsage>This product is a homeopathic dilution, formulated to support the body's immunity for the temporary relief of allergies.*.</IndicationAndUsage>
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<StrengthNumber>6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 5; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 5; 6; 6; 6; 6; 6; 6; 5; 6; 6; 6; 6; 5; 6; 6; 6; 6; 6; 6; 6; 6; 6; 5; 6; 6; 6; 5; 5; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6; 6</StrengthNumber>
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<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>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>58809-221-30</NDCCode>
<PackageDescription>30 TABLET in 1 BOTTLE (58809-221-30) </PackageDescription>
<NDC11Code>58809-0221-30</NDC11Code>
<ProductNDC>58809-221</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dayclear Allergy Relief</ProprietaryName>
<NonProprietaryName>Chlophedianol Hcl, Pyrilamine Maleate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180813</StartMarketingDate>
<EndMarketingDate>20240229</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>GM Pharmaceuticals, INC</LabelerName>
<SubstanceName>CHLOPHEDIANOL HYDROCHLORIDE; PYRILAMINE MALEATE</SubstanceName>
<StrengthNumber>25; 50</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-03-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180813</StartMarketingDatePackage>
<EndMarketingDatePackage>20240229</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: 1 runny nose , 2 sneezing , 3 itching of the nose or throat , 4 itchy watery eyes , 5 cough due to minor throat and bronchial irritation.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58809-287-30</NDCCode>
<PackageDescription>1 BOTTLE, PLASTIC in 1 CARTON (58809-287-30) > 30 CAPSULE, LIQUID FILLED in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>58809-0287-30</NDC11Code>
<ProductNDC>58809-287</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Active Ob</ProprietaryName>
<NonProprietaryName>Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, D-, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Iron Pentacarbonyl, Zinc Oxide, Cupric Sulfate, And Doconexent</NonProprietaryName>
<DosageFormName>CAPSULE, LIQUID FILLED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131028</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>GM Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, D-; THIAMINE MONONITRATE; RIBOFLAVIN; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; IRON PENTACARBONYL; ZINC OXIDE; CUPRIC SULFATE; DOCONEXENT</SubstanceName>
<StrengthNumber>100; 400; 30; 2; 4; 20; 1; 30; 20; 30; 2; 320</StrengthNumber>
<StrengthUnit>mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Vitamin D [Chemical/Ingredient],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [Chemical/Ingredient],Vitamin B12 [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-09-13</LastUpdate>
</NDC>
<NDC>
<NDCCode>58809-359-30</NDCCode>
<PackageDescription>12 BOTTLE in 1 CARTON (58809-359-30) > 30 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>58809-0359-30</NDC11Code>
<ProductNDC>58809-359</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Vanatol</ProprietaryName>
<ProprietaryNameSuffix>S</ProprietaryNameSuffix>
<NonProprietaryName>Butalbital, Acetaminophen And Caffeine</NonProprietaryName>
<DosageFormName>SYRUP</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170701</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>2020-11-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>58809-501-30</NDCCode>
<PackageDescription>1 BOTTLE, DROPPER in 1 CARTON (58809-501-30) > 30 mL in 1 BOTTLE, DROPPER</PackageDescription>
<NDC11Code>58809-0501-30</NDC11Code>
<ProductNDC>58809-501</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Vanahist Pd</ProprietaryName>
<NonProprietaryName>Triprolidine Hydrochloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140319</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>GM Pharmaceuticals, INC</LabelerName>
<SubstanceName>TRIPROLIDINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.625</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140319</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>58809-643-30</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE (58809-643-30) </PackageDescription>
<NDC11Code>58809-0643-30</NDC11Code>
<ProductNDC>58809-643</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Vanamine Pd</ProprietaryName>
<NonProprietaryName>Diphenhydramine Hydrochloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160404</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>GM Pharmaceuticals, INC</LabelerName>
<SubstanceName>DIPHENHYDRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>6.25</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160404</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>58809-725-30</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (58809-725-30) > 30 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>58809-0725-30</NDC11Code>
<ProductNDC>58809-725</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Active Fe</ProprietaryName>
<NonProprietaryName>.beta.-carotene, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Dl-, Thiamine Hydrochloride, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Iron Pentacarbonyl, Magnesium Oxide, Zinc Oxide, And Cupric Oxide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20131111</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>GM Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>.BETA.-CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE, DL-; THIAMINE HYDROCHLORIDE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; IRON PENTACARBONYL; MAGNESIUM OXIDE; ZINC OXIDE; CUPRIC OXIDE</SubstanceName>
<StrengthNumber>2100; 160; 400; 40; 4; 4; 20; 20; 1250; 30; 75; 30; 20; 1</StrengthNumber>
<StrengthUnit>[iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Vitamin C [EPC],Ascorbic Acid [CS],Vitamin D [CS],Vitamin D [EPC],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</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>58809-206-60</NDCCode>
<PackageDescription>57 mL in 1 BOTTLE, DROPPER (58809-206-60) </PackageDescription>
<NDC11Code>58809-0206-60</NDC11Code>
<ProductNDC>58809-206</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Texaclear Homeopathic Allergy Relief</ProprietaryName>
<NonProprietaryName>Over 100 Extracts</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200801</StartMarketingDate>
<EndMarketingDate>20250101</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>GM Pharmaceuticals, INC</LabelerName>
<SubstanceName>ACACIA POLLEN; ACER NEGUNDO POLLEN; ACER RUBRUM POLLEN; ACER SACCHARINUM POLLEN; ACER SACCHARUM POLLEN; AGROSTIS GIGANTEA POLLEN; ALLENROLFEA OCCIDENTALIS POLLEN; ALNUS RHOMBIFOLIA POLLEN; AMARANTHUS HYBRIDUS POLLEN; AMARANTHUS PALMERI POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMARANTHUS SPINOSUS POLLEN; AMARANTHUS TUBERCULATUS POLLEN; AMBROSIA ACANTHICARPA POLLEN; AMBROSIA BIDENTATA POLLEN; AMBROSIA CONFERTIFLORA POLLEN; AMBROSIA DUMOSA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; ARTEMISIA ANNUA POLLEN; ARTEMISIA TRIDENTATA POLLEN; ARTEMISIA VULGARIS WHOLE; ATRIPLEX CANESCENS POLLEN; BACCHARIS HALIMIFOLIA WHOLE; BAPTISIA TINCTORIA ROOT; BASSIA SCOPARIA POLLEN; BETULA LENTA POLLEN; BETULA OCCIDENTALIS WHOLE; BROMUS INERMIS POLLEN; BROUSSONETIA PAPYRIFERA POLLEN; CARYA CORDIFORMIS WHOLE; CARYA GLABRA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA LACINIOSA POLLEN; CARYA OVATA POLLEN; CHENOPODIUM ALBUM POLLEN; CUPRESSUS ARIZONICA POLLEN; CYCLACHAENA XANTHIFOLIA POLLEN; DACTYLIS GLOMERATA POLLEN; DISTICHLIS SPICATA POLLEN; ECHINACEA, UNSPECIFIED; ELYMUS REPENS POLLEN; FAGUS GRANDIFOLIA POLLEN; FESTUCA PRATENSIS POLLEN; FRAXINUS AMERICANA POLLEN; FRAXINUS PENNSYLVANICA POLLEN; FRAXINUS VELUTINA POLLEN; GUTIERREZIA SAROTHRAE WHOLE; HYDRASTIS CANADENSIS WHOLE; IVA ANNUA POLLEN; JUGLANS NIGRA POLLEN; JUNIPER BERRY; JUNIPERUS DEPPEANA WHOLE; JUNIPERUS OSTEOSPERMA POLLEN; JUNIPERUS SCOPULORUM POLLEN; JUNIPERUS VIRGINIANA POLLEN; LIGUSTRUM LUCIDUM WHOLE; LIQUIDAMBAR STYRACIFLUA POLLEN; LOLIUM MULTIFLORUM POLLEN; LOLIUM PERENNE POLLEN; MELALEUCA QUINQUENERVIA POLLEN; MORUS ALBA WHOLE; MORUS RUBRA POLLEN; MYRRH; PASCOPYRUM SMITHII POLLEN; PHALARIS ARUNDINACEA POLLEN; PHLEUM PRATENSE POLLEN; PHYTOLACCA AMERICANA ROOT; PINUS PONDEROSA POLLEN; PINUS STROBUS POLLEN; PINUS TAEDA POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POPULUS ALBA POLLEN; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; POPULUS FREMONTII POLLEN; POPULUS NIGRA POLLEN; QUERCUS ALBA WHOLE; QUERCUS GAMBELII POLLEN; QUERCUS MACROCARPA POLLEN; QUERCUS NIGRA POLLEN; QUERCUS RUBRA BARK; QUERCUS STELLATA POLLEN; QUERCUS VELUTINA WHOLE; RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS POLLEN; SALSOLA KALI WHOLE; SECALE CEREALE POLLEN; SOLIDAGO CANADENSIS WHOLE; SORGHUM HALEPENSE POLLEN; TAXODIUM DISTICHUM POLLEN; THUJA OCCIDENTALIS LEAF; THUJA PLICATA LEAF; TRIADICA SEBIFERA WHOLE; TRITICUM AESTIVUM POLLEN; ULMUS AMERICANA POLLEN; ULMUS CRASSIFOLIA POLLEN; ULMUS PUMILA POLLEN; URTICA DIOICA POLLEN; XANTHIUM STRUMARIUM POLLEN; ZEA MAYS POLLEN</SubstanceName>
<StrengthNumber>30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 6; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 6; 30; 30; 30; 30; 30; 30; 30; 6; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 6; 30; 30; 30; 6; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30</StrengthNumber>
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<Status>Deprecated</Status>
<LastUpdate>2025-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200801</StartMarketingDatePackage>
<EndMarketingDatePackage>20250101</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>this product is a Homeopathic Dilution, formulated to support the body’s immunity for the temporary relief of allergies*.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58809-208-90</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (58809-208-90) </PackageDescription>
<NDC11Code>58809-0208-90</NDC11Code>
<ProductNDC>58809-208</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Texaclear Homeopathic Allergy Releif</ProprietaryName>
<ProprietaryNameSuffix>Plus Cedar Fever</ProprietaryNameSuffix>
<NonProprietaryName>Over 100 Extracts Trees,weeds And Grasses</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20201001</StartMarketingDate>
<EndMarketingDate>20250101</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>GM Pharmaceuticals INC</LabelerName>
<SubstanceName>ACACIA POLLEN; ACER NEGUNDO POLLEN; ACER RUBRUM POLLEN; ACER SACCHARINUM POLLEN; AGROSTIS GIGANTEA POLLEN; AILANTHUS ALTISSIMA POLLEN; ALLENROLFEA OCCIDENTALIS POLLEN; ALNUS INCANA SUBSP. RUGOSA POLLEN; ALNUS RHOMBIFOLIA POLLEN; AMARANTHUS HYBRIDUS POLLEN; AMARANTHUS PALMERI POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMARANTHUS SPINOSUS POLLEN; AMBROSIA ACANTHICARPA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA BIDENTATA POLLEN; AMBROSIA CONFERTIFLORA POLLEN; AMBROSIA DUMOSA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; ARTEMISIA ANNUA POLLEN; ARTEMISIA LUDOVICIANA WHOLE; ARTEMISIA TRIDENTATA POLLEN; ARTEMISIA VULGARIS WHOLE; ATRIPLEX CANESCENS POLLEN; AVENA SATIVA POLLEN; BACCHARIS HALIMIFOLIA WHOLE; BAPTISIA TINCTORIA ROOT; BASSIA SCOPARIA POLLEN; BETULA LENTA POLLEN; BETULA NIGRA POLLEN; BETULA OCCIDENTALIS WHOLE; BROUSSONETIA PAPYRIFERA POLLEN; CARPINUS CAROLINIANA WHOLE; CARYA ALBA POLLEN; CARYA CORDIFORMIS WHOLE; CARYA GLABRA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA LACINIOSA POLLEN; CARYA OVATA POLLEN; CEDRUS DEODARA WOOD; CELTIS OCCIDENTALIS POLLEN; CHENOPODIUM ALBUM POLLEN; CUPRESSUS ARIZONICA POLLEN; CYCLACHAENA XANTHIFOLIA POLLEN; CYNODON DACTYLON POLLEN; DACTYLIS GLOMERATA POLLEN; DISTICHLIS SPICATA POLLEN; ECHINACEA, UNSPECIFIED; ELYMUS REPENS POLLEN; FAGUS GRANDIFOLIA POLLEN; FESTUCA PRATENSIS POLLEN; FRAXINUS AMERICANA POLLEN; FRAXINUS PENNSYLVANICA POLLEN; FRAXINUS VELUTINA POLLEN; GUTIERREZIA SAROTHRAE WHOLE; HOLCUS LANATUS POLLEN; HYDRASTIS CANADENSIS WHOLE; IVA ANGUSTIFOLIA POLLEN; IVA ANNUA POLLEN; JUNIPER BERRY; JUNIPERUS ASHEI POLLEN; JUNIPERUS DEPPEANA WHOLE; JUNIPERUS MONOSPERMA POLLEN; JUNIPERUS OSTEOSPERMA POLLEN; JUNIPERUS PINCHOTII POLLEN; JUNIPERUS SCOPULORUM POLLEN; JUNIPERUS VIRGINIANA POLLEN; LIGUSTRUM LUCIDUM WHOLE; LIQUIDAMBAR STYRACIFLUA POLLEN; LOLIUM MULTIFLORUM POLLEN; LOLIUM PERENNE POLLEN; MELALEUCA QUINQUENERVIA POLLEN; MORUS ALBA WHOLE; MORUS RUBRA POLLEN; MYRRH; OSTRYA VIRGINIANA WHOLE; PASCOPYRUM SMITHII POLLEN; PASPALUM NOTATUM POLLEN; PHALARIS ARUNDINACEA POLLEN; PHLEUM PRATENSE POLLEN; PHYTOLACCA AMERICANA ROOT; PINUS NIGRA POLLEN; PINUS PONDEROSA POLLEN; PINUS STROBUS BARK; PINUS STROBUS POLLEN; PINUS SYLVESTRIS POLLEN; PINUS TAEDA POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POA ANNUA POLLEN; POA PRATENSIS POLLEN; POPULUS ALBA POLLEN; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN; POPULUS FREMONTII POLLEN; POPULUS NIGRA POLLEN; PROSOPIS PALLIDA POLLEN; QUERCUS ALBA WHOLE; QUERCUS GAMBELII POLLEN; QUERCUS MACROCARPA POLLEN; QUERCUS NIGRA POLLEN; QUERCUS RUBRA BARK; QUERCUS STELLATA POLLEN; QUERCUS VELUTINA WHOLE; QUERCUS VIRGINIANA POLLEN; RORIPPA NASTURTIUM-AQUATICUM; RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS POLLEN; SALIX NIGRA POLLEN; SECALE CEREALE POLLEN; SOLIDAGO CANADENSIS WHOLE; SORGHUM HALEPENSE POLLEN; SORGHUM X DRUMMONDII WHOLE; TAMARIX GALLICA POLLEN; TAXODIUM DISTICHUM POLLEN; THUJA OCCIDENTALIS LEAF; THUJA PLICATA LEAF; TRIGONELLA FOENUM-GRAECUM WHOLE; TRITICUM AESTIVUM POLLEN; ULMUS AMERICANA POLLEN; ULMUS CRASSIFOLIA POLLEN; ULMUS CRASSIFOLIA WHOLE; ULMUS PUMILA POLLEN; URTICA DIOICA POLLEN; XANTHIUM STRUMARIUM POLLEN; ZEA MAYS POLLEN</SubstanceName>
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<Status>Deprecated</Status>
<LastUpdate>2025-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20201001</StartMarketingDatePackage>
<EndMarketingDatePackage>20250101</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>this product is a homeopathic dilution,formulated to support the body's immunity for the temporary releif of allergies*.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58809-209-04</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE, DROPPER (58809-209-04) </PackageDescription>
<NDC11Code>58809-0209-04</NDC11Code>
<ProductNDC>58809-209</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Texaclear Homeopathic Allergy Relief</ProprietaryName>
<ProprietaryNameSuffix>Cedar Fever</ProprietaryNameSuffix>
<NonProprietaryName>Over 100 Extracts</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200831</StartMarketingDate>
<EndMarketingDate>20250101</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>GM Pharmaceuticals, INC</LabelerName>
<SubstanceName>ACACIA POLLEN; ACER NEGUNDO POLLEN; ACER RUBRUM POLLEN; ACER SACCHARINUM POLLEN; ACER SACCHARUM POLLEN; AGROSTIS GIGANTEA POLLEN; AILANTHUS ALTISSIMA POLLEN; ALLENROLFEA OCCIDENTALIS POLLEN; ALNUS INCANA SUBSP. RUGOSA POLLEN; ALNUS RHOMBIFOLIA POLLEN; AMARANTHUS HYBRIDUS POLLEN; AMARANTHUS PALMERI POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMARANTHUS SPINOSUS POLLEN; AMARANTHUS TUBERCULATUS POLLEN; AMBROSIA ACANTHICARPA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA BIDENTATA POLLEN; AMBROSIA CONFERTIFLORA POLLEN; AMBROSIA DUMOSA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; ARTEMISIA ANNUA POLLEN; ARTEMISIA LUDOVICIANA WHOLE; ARTEMISIA TRIDENTATA POLLEN; ARTEMISIA VULGARIS WHOLE; ATRIPLEX CANESCENS POLLEN; AVENA SATIVA POLLEN; BACCHARIS HALIMIFOLIA WHOLE; BAPTISIA TINCTORIA ROOT; BASSIA SCOPARIA POLLEN; BETULA LENTA POLLEN; BETULA NIGRA POLLEN; BETULA OCCIDENTALIS WHOLE; BROMUS INERMIS POLLEN; BROUSSONETIA PAPYRIFERA POLLEN; CARPINUS CAROLINIANA WHOLE; CARYA ALBA POLLEN; CARYA CORDIFORMIS WHOLE; CARYA GLABRA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA LACINIOSA POLLEN; CARYA OVATA POLLEN; CEDRUS DEODARA WOOD; CELTIS OCCIDENTALIS POLLEN; CHENOPODIUM ALBUM POLLEN; CUPRESSUS ARIZONICA POLLEN; CYCLACHAENA XANTHIFOLIA POLLEN; CYNODON DACTYLON POLLEN; DACTYLIS GLOMERATA POLLEN; DISTICHLIS SPICATA POLLEN; ECHINACEA, UNSPECIFIED; ELYMUS REPENS POLLEN; FAGUS GRANDIFOLIA POLLEN; FESTUCA PRATENSIS POLLEN; FRAXINUS AMERICANA POLLEN; FRAXINUS PENNSYLVANICA POLLEN; FRAXINUS VELUTINA POLLEN; GUTIERREZIA SAROTHRAE WHOLE; HOLCUS LANATUS POLLEN; HYDRASTIS CANADENSIS WHOLE; IVA ANGUSTIFOLIA POLLEN; IVA ANNUA POLLEN; JUGLANS NIGRA POLLEN; JUNIPER BERRY; JUNIPERUS ASHEI POLLEN; JUNIPERUS DEPPEANA WHOLE; JUNIPERUS MONOSPERMA POLLEN; JUNIPERUS OSTEOSPERMA POLLEN; JUNIPERUS PINCHOTII POLLEN; JUNIPERUS SCOPULORUM POLLEN; JUNIPERUS VIRGINIANA POLLEN; LIGUSTRUM LUCIDUM WHOLE; LIQUIDAMBAR STYRACIFLUA POLLEN; LOLIUM MULTIFLORUM POLLEN; LOLIUM PERENNE POLLEN; MELALEUCA QUINQUENERVIA POLLEN; MORUS ALBA WHOLE; MORUS RUBRA POLLEN; MYRRH; OSTRYA VIRGINIANA WHOLE; PASCOPYRUM SMITHII POLLEN; PASPALUM NOTATUM POLLEN; PHALARIS ARUNDINACEA POLLEN; PHLEUM PRATENSE POLLEN; PHYTOLACCA AMERICANA ROOT; PINUS NIGRA POLLEN; PINUS PONDEROSA POLLEN; PINUS STROBUS BARK; PINUS STROBUS POLLEN; PINUS SYLVESTRIS POLLEN; PINUS TAEDA POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POA ANNUA POLLEN; POA PRATENSIS POLLEN; POPULUS ALBA POLLEN; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN; POPULUS FREMONTII POLLEN; POPULUS NIGRA POLLEN; PROSOPIS PALLIDA POLLEN; QUERCUS ALBA WHOLE; QUERCUS GAMBELII POLLEN; QUERCUS MACROCARPA POLLEN; QUERCUS NIGRA POLLEN; QUERCUS RUBRA BARK; QUERCUS STELLATA POLLEN; QUERCUS VELUTINA WHOLE; QUERCUS VIRGINIANA POLLEN; RORIPPA NASTURTIUM-AQUATICUM; RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS POLLEN; SALIX NIGRA POLLEN; SALSOLA KALI WHOLE; SECALE CEREALE POLLEN; SOLIDAGO CANADENSIS WHOLE; SORGHUM HALEPENSE POLLEN; SORGHUM X DRUMMONDII WHOLE; TAMARIX GALLICA POLLEN; TAXODIUM DISTICHUM POLLEN; THUJA OCCIDENTALIS LEAF; THUJA PLICATA LEAF; TRIADICA SEBIFERA WHOLE; TRIGONELLA FOENUM-GRAECUM WHOLE; TRITICUM AESTIVUM POLLEN; ULMUS AMERICANA POLLEN; ULMUS CRASSIFOLIA POLLEN; ULMUS CRASSIFOLIA WHOLE; ULMUS PUMILA POLLEN; URTICA DIOICA POLLEN; XANTHIUM STRUMARIUM POLLEN; ZEA MAYS POLLEN</SubstanceName>
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<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], 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]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20220818</StartMarketingDatePackage>
<EndMarketingDatePackage>20250101</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>this product is a homeopathic dilution, formulated to support the body’s immunity for the temporary relief of allergies*.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58809-209-60</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE, DROPPER (58809-209-60) </PackageDescription>
<NDC11Code>58809-0209-60</NDC11Code>
<ProductNDC>58809-209</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Texaclear Homeopathic Allergy Relief</ProprietaryName>
<ProprietaryNameSuffix>Cedar Fever</ProprietaryNameSuffix>
<NonProprietaryName>Over 100 Extracts</NonProprietaryName>
<DosageFormName>SOLUTION/ DROPS</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200831</StartMarketingDate>
<EndMarketingDate>20250101</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>GM Pharmaceuticals, INC</LabelerName>
<SubstanceName>ACACIA POLLEN; ACER NEGUNDO POLLEN; ACER RUBRUM POLLEN; ACER SACCHARINUM POLLEN; ACER SACCHARUM POLLEN; AGROSTIS GIGANTEA POLLEN; AILANTHUS ALTISSIMA POLLEN; ALLENROLFEA OCCIDENTALIS POLLEN; ALNUS INCANA SUBSP. RUGOSA POLLEN; ALNUS RHOMBIFOLIA POLLEN; AMARANTHUS HYBRIDUS POLLEN; AMARANTHUS PALMERI POLLEN; AMARANTHUS RETROFLEXUS POLLEN; AMARANTHUS SPINOSUS POLLEN; AMARANTHUS TUBERCULATUS POLLEN; AMBROSIA ACANTHICARPA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; AMBROSIA BIDENTATA POLLEN; AMBROSIA CONFERTIFLORA POLLEN; AMBROSIA DUMOSA POLLEN; AMBROSIA PSILOSTACHYA POLLEN; AMBROSIA TRIFIDA POLLEN; ANTHOXANTHUM ODORATUM POLLEN; ARTEMISIA ANNUA POLLEN; ARTEMISIA LUDOVICIANA WHOLE; ARTEMISIA TRIDENTATA POLLEN; ARTEMISIA VULGARIS WHOLE; ATRIPLEX CANESCENS POLLEN; AVENA SATIVA POLLEN; BACCHARIS HALIMIFOLIA WHOLE; BAPTISIA TINCTORIA ROOT; BASSIA SCOPARIA POLLEN; BETULA LENTA POLLEN; BETULA NIGRA POLLEN; BETULA OCCIDENTALIS WHOLE; BROMUS INERMIS POLLEN; BROUSSONETIA PAPYRIFERA POLLEN; CARPINUS CAROLINIANA WHOLE; CARYA ALBA POLLEN; CARYA CORDIFORMIS WHOLE; CARYA GLABRA POLLEN; CARYA ILLINOINENSIS POLLEN; CARYA LACINIOSA POLLEN; CARYA OVATA POLLEN; CEDRUS DEODARA WOOD; CELTIS OCCIDENTALIS POLLEN; CHENOPODIUM ALBUM POLLEN; CUPRESSUS ARIZONICA POLLEN; CYCLACHAENA XANTHIFOLIA POLLEN; CYNODON DACTYLON POLLEN; DACTYLIS GLOMERATA POLLEN; DISTICHLIS SPICATA POLLEN; ECHINACEA, UNSPECIFIED; ELYMUS REPENS POLLEN; FAGUS GRANDIFOLIA POLLEN; FESTUCA PRATENSIS POLLEN; FRAXINUS AMERICANA POLLEN; FRAXINUS PENNSYLVANICA POLLEN; FRAXINUS VELUTINA POLLEN; GUTIERREZIA SAROTHRAE WHOLE; HOLCUS LANATUS POLLEN; HYDRASTIS CANADENSIS WHOLE; IVA ANGUSTIFOLIA POLLEN; IVA ANNUA POLLEN; JUGLANS NIGRA POLLEN; JUNIPER BERRY; JUNIPERUS ASHEI POLLEN; JUNIPERUS DEPPEANA WHOLE; JUNIPERUS MONOSPERMA POLLEN; JUNIPERUS OSTEOSPERMA POLLEN; JUNIPERUS PINCHOTII POLLEN; JUNIPERUS SCOPULORUM POLLEN; JUNIPERUS VIRGINIANA POLLEN; LIGUSTRUM LUCIDUM WHOLE; LIQUIDAMBAR STYRACIFLUA POLLEN; LOLIUM MULTIFLORUM POLLEN; LOLIUM PERENNE POLLEN; MELALEUCA QUINQUENERVIA POLLEN; MORUS ALBA WHOLE; MORUS RUBRA POLLEN; MYRRH; OSTRYA VIRGINIANA WHOLE; PASCOPYRUM SMITHII POLLEN; PASPALUM NOTATUM POLLEN; PHALARIS ARUNDINACEA POLLEN; PHLEUM PRATENSE POLLEN; PHYTOLACCA AMERICANA ROOT; PINUS NIGRA POLLEN; PINUS PONDEROSA POLLEN; PINUS STROBUS BARK; PINUS STROBUS POLLEN; PINUS SYLVESTRIS POLLEN; PINUS TAEDA POLLEN; PLANTAGO LANCEOLATA POLLEN; PLATANUS OCCIDENTALIS POLLEN; POA ANNUA POLLEN; POA PRATENSIS POLLEN; POPULUS ALBA POLLEN; POPULUS DELTOIDES SUBSP. DELTOIDES POLLEN; POPULUS DELTOIDES SUBSP. MONILIFERA POLLEN; POPULUS FREMONTII POLLEN; POPULUS NIGRA POLLEN; PROSOPIS PALLIDA POLLEN; QUERCUS ALBA WHOLE; QUERCUS GAMBELII POLLEN; QUERCUS MACROCARPA POLLEN; QUERCUS NIGRA POLLEN; QUERCUS RUBRA BARK; QUERCUS STELLATA POLLEN; QUERCUS VELUTINA WHOLE; QUERCUS VIRGINIANA POLLEN; RORIPPA NASTURTIUM-AQUATICUM; RUMEX ACETOSELLA POLLEN; RUMEX CRISPUS POLLEN; SALIX NIGRA POLLEN; SALSOLA KALI WHOLE; SECALE CEREALE POLLEN; SOLIDAGO CANADENSIS WHOLE; SORGHUM HALEPENSE POLLEN; SORGHUM X DRUMMONDII WHOLE; TAMARIX GALLICA POLLEN; TAXODIUM DISTICHUM POLLEN; THUJA OCCIDENTALIS LEAF; THUJA PLICATA LEAF; TRIADICA SEBIFERA WHOLE; TRIGONELLA FOENUM-GRAECUM WHOLE; TRITICUM AESTIVUM POLLEN; ULMUS AMERICANA POLLEN; ULMUS CRASSIFOLIA POLLEN; ULMUS CRASSIFOLIA WHOLE; ULMUS PUMILA POLLEN; URTICA DIOICA POLLEN; XANTHIUM STRUMARIUM POLLEN; ZEA MAYS POLLEN</SubstanceName>
<StrengthNumber>12; 12; 12; 12; 12; 6; 12; 30; 12; 12; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 6; 30; 30; 6; 30; 30; 6; 12; 5; 30; 12; 12; 12; 6; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30; 12; 30; 6; 6; 6; 5; 6; 12; 6; 12; 12; 12; 30; 6; 5; 30; 30; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 6; 6; 12; 12; 12; 5; 12; 12; 6; 6; 6; 5; 12; 12; 12; 12; 12; 12; 30; 12; 6; 6; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30; 12; 5; 30; 30; 12; 30; 6; 30; 6; 12; 12; 12; 12; 12; 12; 5; 6; 12; 12; 12; 12; 30; 30; 6</StrengthNumber>
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<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], 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]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200831</StartMarketingDatePackage>
<EndMarketingDatePackage>20250101</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>this product is a homeopathic dilution, formulated to support the body’s immunity for the temporary relief of allergies*.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58809-219-02</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>58809-407-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (58809-407-01)</PackageDescription>
<NDC11Code>58809-0407-01</NDC11Code>
<ProductNDC>58809-407</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Vanatab Dx</ProprietaryName>
<NonProprietaryName>Chlophedianol Hydrochloride, Guaifenesin, Pseudoephedrine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110906</StartMarketingDate>
<EndMarketingDate>20150228</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>GM Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CHLOPHEDIANOL HYDROCHLORIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>12.5; 200; 30</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2015-03-06</LastUpdate>
</NDC>
<NDC>
<NDCCode>58809-578-01</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (58809-578-01)</PackageDescription>
<NDC11Code>58809-0578-01</NDC11Code>
<ProductNDC>58809-578</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Nasopen</ProprietaryName>
<NonProprietaryName>Chlorcyclizine Hydrochloride, Pseudoephedrine Hydrochloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110606</StartMarketingDate>
<EndMarketingDate>20150228</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>GM Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>CHLORCYCLIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>9.375; 30</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2015-03-06</LastUpdate>
</NDC>
<NDC>
<NDCCode>58809-578-02</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>58809-829-60</NDCCode>
<PackageDescription>60 TABLET, CHEWABLE in 1 BOTTLE (58809-829-60) </PackageDescription>
<NDC11Code>58809-0829-60</NDC11Code>
<ProductNDC>58809-829</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Escavite D</ProprietaryName>
<NonProprietaryName>.beta.-carotene, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol, Dl-, Thiamine Hydrochloride, Riboflavin, Niacin, Pyridoxine Hydrochloride, Folic Acid, Hydroxocobalamin, Biotin, Calcium Pantothenate, Ferrous Cysteine Glycinate, Magnesium Oxide, Zinc Oxide, Cupric Oxide, And Sodium Fluoride</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140303</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>GM Pharmaceuticals, INC</LabelerName>
<SubstanceName>.BETA.-CAROTENE; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL, DL-; THIAMINE HYDROCHLORIDE; RIBOFLAVIN; NIACIN; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; HYDROXOCOBALAMIN; BIOTIN; CALCIUM PANTOTHENATE; FERROUS CYSTEINE GLYCINATE; MAGNESIUM OXIDE; ZINC OXIDE; CUPRIC OXIDE; SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>2500; 100; 600; 30; 1.5; 1.7; 20; 2; 400; 6; 45; 10; 6; 60; 15; 2; .25</StrengthNumber>
<StrengthUnit>[iU]/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; ug/1; ug/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Vitamin C [EPC],Ascorbic Acid [CS],Vitamin D [CS],Vitamin D [EPC],Nicotinic Acid [EPC],Nicotinic Acids [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Antidote [EPC],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140303</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>58809-888-01</NDCCode>
<PackageDescription>100 TABLET, CHEWABLE in 1 BOTTLE (58809-888-01)</PackageDescription>
<NDC11Code>58809-0888-01</NDC11Code>
<ProductNDC>58809-888</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Escavite</ProprietaryName>
<NonProprietaryName>Sodium Fluoride, Vitamin A Acetate, Biotin, Magnesium, Zinc, Copper, Calcium Pantothenate, Folic Acid, Iron, Ascorbic Acid, Cholecalciferol, .alpha.-tocopherol Acetate, Thiamine Mononitrate, Riboflavin, Niacinamide, Pyridoxine Hydrochloride, And Cyanocobalamin</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120201</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>GM Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>SODIUM FLUORIDE; VITAMIN A ACETATE; BIOTIN; MAGNESIUM; ZINC; COPPER; CALCIUM PANTOTHENATE; FOLIC ACID; IRON; ASCORBIC ACID; CHOLECALCIFEROL; .ALPHA.-TOCOPHEROL ACETATE; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; CYANOCOBALAMIN</SubstanceName>
<StrengthNumber>.25; 1000; 45; 60; 7.4; 1; 10; .4; 7.5; 100; 400; 30; 1.5; 1.7; 20; 2; 9</StrengthNumber>
<StrengthUnit>mg/1; [iU]/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; [iU]/1; [iU]/1; mg/1; mg/1; mg/1; mg/1; ug/1</StrengthUnit>
<Pharm_Classes>Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC],Vitamin A [CS],Vitamin A [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Vitamin D [CS],Vitamin D [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>58809-907-01</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (58809-907-01)</PackageDescription>
<NDC11Code>58809-0907-01</NDC11Code>
<ProductNDC>58809-907</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Vanacof</ProprietaryName>
<ProprietaryNameSuffix>Dx</ProprietaryNameSuffix>
<NonProprietaryName>Chlophedianol Hydrochloride, Guaifenesin, And Pseudoephedrine Hydrochloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080423</StartMarketingDate>
<EndMarketingDate>20150430</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>GM Pharmaceuticals</LabelerName>
<SubstanceName>CHLOPHEDIANOL HYDROCHLORIDE; GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>12.5; 100; 30</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL; mg/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2015-05-15</LastUpdate>
</NDC>
<NDC>
<NDCCode>58809-907-02</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>58809-999-01</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (58809-999-01) </PackageDescription>
<NDC11Code>58809-0999-01</NDC11Code>
<ProductNDC>58809-999</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Vanacof</ProprietaryName>
<NonProprietaryName>Chlophedianol Hydrochloride, Dexchlorpheniramine Maleate, And Pseudoephedrine Hydrochloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080422</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>GM Pharmaceuticals, INC</LabelerName>
<SubstanceName>CHLOPHEDIANOL HYDROCHLORIDE; DEXCHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>12.5; 1; 30</StrengthNumber>
<StrengthUnit>mg/5mL; mg/5mL; mg/5mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-10-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080422</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to the common cold, hay fever (allergic rhinitis) or other upper respiratory allergies: runny nosesneezingitching of the nose or throatitchy, watery eyesnasal congestionreduces swelling of nasal passages. cough due to minor throat and bronchial irritation.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>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>10237-111-01</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 POUCH (10237-111-01) / 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>10237-0111-01</NDC11Code>
<ProductNDC>10237-111</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Touchland Power Mist Hand Sanitizer Velvet Peach</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>Church & Dwight Co., Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>.7</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-09-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand sanitizer to decrease bacteria on the skin recommended for repeated use.</IndicationAndUsage>
</NDC>
</NDCList>