{
"NDC": [
{
"NDCCode": "72617-2001-1",
"PackageDescription": "29.6 mL in 1 BOTTLE, DROPPER (72617-2001-1) ",
"NDC11Code": "72617-2001-01",
"ProductNDC": "72617-2001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allergy Mix Las Vegas",
"NonProprietaryName": "Local Remedy Las Vegas",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20190123",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "ASN",
"SubstanceName": "ALTERNARIA ALTERNATA; JUNIPERUS ASHEI POLLEN; JUNIPERUS SCOPULORUM POLLEN; NERIUM OLEANDER FLOWER; OLEA EUROPAEA FLOWER; PASSALORA FULVA; USTILAGO MAYDIS; WHITE MULBERRY",
"StrengthNumber": "6; 6; 6; 6; 6; 6; 6; 6",
"StrengthUnit": "[hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL",
"Pharm_Classes": "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], 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 IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190123",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: Allergy symptom reliefFor temporary relief of symptoms due to hay fever or otherrespiratory allergies. Runny nose, sneezing, irritated eyes,nasal congestion, itchy nose and throat, sinus pain."
},
{
"NDCCode": "72617-0001-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (72617-0001-1) ",
"NDC11Code": "72617-0001-01",
"ProductNDC": "72617-0001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allergy Mix Las Vegas",
"NonProprietaryName": "Alternaria Alternata, Bermuda Grass Pollen (cynodon Dactylon), Cladosporium Herbarum, Histaminum Hydrochloricum, Juniperus Communis, Oleander, Olive Pollen (olea Europaea), Ragweed Pollen (ambrosia Artemisiaefolia), Sabina, Ustilago Maidis, White Mulberry Pollen (morus Alba)",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20260326",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "American Standard Nutraceuticals",
"SubstanceName": "ALTERNARIA ALTERNATA; CYNODON DACTYLON POLLEN; CLADOSPORIUM HERBARUM; HISTAMINE DIHYDROCHLORIDE; JUNIPER BERRY; NERIUM OLEANDER LEAF; OLEA EUROPAEA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; JUNIPERUS SABINA LEAFY TWIG; USTILAGO MAYDIS; MORUS ALBA POLLEN",
"StrengthNumber": "12; 12; 12; 12; 6; 6; 12; 12; 6; 6; 12",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "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], Dietary Proteins [CS], Food Additives [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 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 Plant Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Plant Proteins [CS], Pollen [CS], Pollen [CS], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2026-03-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260326",
"SamplePackage": "N",
"IndicationAndUsage": "For temporary relief of allergy symptoms including sneezing, runny nose, itchy, watery eyes, congestion, and stuffy nose.†. †Claims based on traditional practice, not accepted medical evidence. Not FDA evaluated."
},
{
"NDCCode": "72617-2002-1",
"PackageDescription": "29.6 mL in 1 BOTTLE, DROPPER (72617-2002-1) ",
"NDC11Code": "72617-2002-01",
"ProductNDC": "72617-2002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allergy Mix Phoenix",
"NonProprietaryName": "Local Remedy Phoenix",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20190123",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "ASN",
"SubstanceName": "ALTERNARIA ALTERNATA; AMBROSIA ARTEMISIIFOLIA; CYNODON DACTYLON; JUNIPERUS ASHEI POLLEN; JUNIPERUS SCOPULORUM POLLEN; NERIUM OLEANDER FLOWER; OLEA EUROPAEA FLOWER; PASSALORA FULVA; USTILAGO MAYDIS; WHITE MULBERRY",
"StrengthNumber": "6; 12; 12; 6; 6; 6; 6; 6; 6; 6",
"StrengthUnit": "[hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL",
"Pharm_Classes": "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], 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 IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190123",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: Allergy symptom reliefFor temporary relief of symptoms due to hay fever or otherrespiratory allergies. Runny nose, sneezing, irritated eyes,nasal congestion, itchy nose and throat, sinus pain."
},
{
"NDCCode": "72617-2003-1",
"PackageDescription": "29.6 mL in 1 BOTTLE, DROPPER (72617-2003-1) ",
"NDC11Code": "72617-2003-01",
"ProductNDC": "72617-2003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allergy Mix Los Angeles",
"NonProprietaryName": "Local Remedy Los Angeles",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20190123",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "ASN",
"SubstanceName": "ALTERNARIA ALTERNATA; AMBROSIA ARTEMISIIFOLIA; HISTAMINE DIHYDROCHLORIDE; JUNIPERUS ASHEI POLLEN; JUNIPERUS SCOPULORUM POLLEN; NERIUM OLEANDER FLOWER; OLEA EUROPAEA FLOWER; PASSALORA FULVA; SCHOENOCAULON OFFICINALE SEED; USTILAGO MAYDIS; WHITE MULBERRY",
"StrengthNumber": "6; 12; 12; 6; 6; 6; 6; 6; 12; 6; 6",
"StrengthUnit": "[hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL",
"Pharm_Classes": "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], 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 IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190123",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: Allergy symptom reliefFor temporary relief of symptoms due to hay fever or otherrespiratory allergies. Runny nose, sneezing, irritated eyes,nasal congestion, itchy nose and throat, sinus pain."
},
{
"NDCCode": "72617-3001-2",
"PackageDescription": "1 BOTTLE in 1 PACKAGE (72617-3001-2) > 15 mL in 1 BOTTLE",
"NDC11Code": "72617-3001-02",
"ProductNDC": "72617-3001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allergy Mix Las Vegas",
"NonProprietaryName": "Local Remedy Las Vegas",
"DosageFormName": "SPRAY",
"RouteName": "NASAL",
"StartMarketingDate": "20190101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "ASN",
"SubstanceName": "ALTERNARIA ALTERNATA; JUNIPERUS ASHEI POLLEN; JUNIPERUS SCOPULORUM POLLEN; NERIUM OLEANDER FLOWER; OLEA EUROPAEA FLOWER; PASSALORA FULVA; USTILAGO MAYDIS; WHITE MULBERRY",
"StrengthNumber": "6; 6; 6; 6; 6; 6; 6; 6",
"StrengthUnit": "[hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL",
"Pharm_Classes": "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], 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 IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190123",
"SamplePackage": "N",
"IndicationAndUsage": "UsesFor temporary relief of symptoms due to hay feveror other respiratory allergies. Runny nose, sneezing,irritated eyes, nasal congestion, itchy nose andthroat, sinus pain."
},
{
"NDCCode": "72617-3002-2",
"PackageDescription": "1 BOTTLE in 1 PACKAGE (72617-3002-2) > 15 mL in 1 BOTTLE",
"NDC11Code": "72617-3002-02",
"ProductNDC": "72617-3002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allergy Mix Phoenix",
"NonProprietaryName": "Local Remedy Phoenix",
"DosageFormName": "SPRAY",
"RouteName": "NASAL",
"StartMarketingDate": "20190101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "ASN",
"SubstanceName": "ALTERNARIA ALTERNATA; AMBROSIA ARTEMISIIFOLIA; CYNODON DACTYLON; JUNIPERUS ASHEI POLLEN; JUNIPERUS SCOPULORUM POLLEN; NERIUM OLEANDER FLOWER; OLEA EUROPAEA FLOWER; PASSALORA FULVA; USTILAGO MAYDIS; WHITE MULBERRY",
"StrengthNumber": "6; 12; 12; 6; 6; 6; 6; 6; 6; 6",
"StrengthUnit": "[hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL",
"Pharm_Classes": "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], 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 IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190123",
"SamplePackage": "N",
"IndicationAndUsage": "UsesFor temporary relief of symptoms due to hay feveror other respiratory allergies. Runny nose, sneezing,irritated eyes, nasal congestion, itchy nose andthroat, sinus pain."
},
{
"NDCCode": "72617-3003-2",
"PackageDescription": "120 TABLET, CHEWABLE in 1 BOTTLE (72617-3003-2) ",
"NDC11Code": "72617-3003-02",
"ProductNDC": "72617-3003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allergy Mix Los Angeles",
"NonProprietaryName": "Local Remedy Los Angeles",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20190123",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "ASN",
"SubstanceName": "ALTERNARIA ALTERNATA; AMBROSIA ARTEMISIIFOLIA; HISTAMINE DIHYDROCHLORIDE; JUNIPERUS ASHEI POLLEN; JUNIPERUS SCOPULORUM POLLEN; NERIUM OLEANDER FLOWER; OLEA EUROPAEA FLOWER; PASSALORA FULVA; SCHOENOCAULON OFFICINALE SEED; USTILAGO MAYDIS; WHITE MULBERRY",
"StrengthNumber": "6; 12; 12; 6; 6; 6; 6; 6; 12; 6; 6",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "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], 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 IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190123",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: Allergy symptom reliefFor temporary relief of symptoms due to hay feveror other respiratory allergies. Runny nose,sneezing, irritated eyes, nasal congestion, itchynose and throat, sinus pain."
},
{
"NDCCode": "72617-4001-3",
"PackageDescription": "120 TABLET, CHEWABLE in 1 BOTTLE (72617-4001-3) ",
"NDC11Code": "72617-4001-03",
"ProductNDC": "72617-4001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allergy Mix Las Vegas",
"NonProprietaryName": "Local Remedy Las Vegas",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20190123",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "ASN",
"SubstanceName": "ALTERNARIA ALTERNATA; JUNIPERUS ASHEI POLLEN; JUNIPERUS SCOPULORUM POLLEN; NERIUM OLEANDER FLOWER; OLEA EUROPAEA FLOWER; PASSALORA FULVA; USTILAGO MAYDIS; WHITE MULBERRY",
"StrengthNumber": "6; 6; 6; 6; 6; 6; 6; 6",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "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], 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 IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190123",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: Allergy symptom reliefFor temporary relief of symptoms due to hay feveror other respiratory allergies. Runny nose,sneezing, irritated eyes, nasal congestion, itchynose and throat, sinus pain."
},
{
"NDCCode": "72617-4002-3",
"PackageDescription": "120 TABLET, CHEWABLE in 1 BOTTLE (72617-4002-3) ",
"NDC11Code": "72617-4002-03",
"ProductNDC": "72617-4002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allergy Mix Phoenix",
"NonProprietaryName": "Local Remedy Phoenix",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20190123",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "ASN",
"SubstanceName": "ALTERNARIA ALTERNATA; AMBROSIA ARTEMISIIFOLIA; CYNODON DACTYLON; JUNIPERUS ASHEI POLLEN; JUNIPERUS SCOPULORUM POLLEN; NERIUM OLEANDER FLOWER; OLEA EUROPAEA FLOWER; PASSALORA FULVA; USTILAGO MAYDIS; WHITE MULBERRY",
"StrengthNumber": "6; 12; 12; 6; 6; 6; 6; 6; 6; 6",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "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], 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 IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190123",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: Allergy symptom reliefFor temporary relief of symptoms due to hay feveror other respiratory allergies. Runny nose,sneezing, irritated eyes, nasal congestion, itchynose and throat, sinus pain."
},
{
"NDCCode": "72617-4003-3",
"PackageDescription": "1 BOTTLE in 1 PACKAGE (72617-4003-3) > 15 mL in 1 BOTTLE",
"NDC11Code": "72617-4003-03",
"ProductNDC": "72617-4003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allergy Mix",
"NonProprietaryName": "Local Remedy Los Angeles",
"DosageFormName": "SPRAY",
"RouteName": "NASAL",
"StartMarketingDate": "20190101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "ASN",
"SubstanceName": "ALTERNARIA ALTERNATA; AMBROSIA ARTEMISIIFOLIA; HISTAMINE DIHYDROCHLORIDE; JUNIPERUS ASHEI POLLEN; JUNIPERUS SCOPULORUM POLLEN; NERIUM OLEANDER FLOWER; OLEA EUROPAEA FLOWER; PASSALORA FULVA; SCHOENOCAULON OFFICINALE SEED; USTILAGO MAYDIS; WHITE MULBERRY",
"StrengthNumber": "6; 12; 12; 6; 6; 6; 6; 6; 12; 6; 6",
"StrengthUnit": "[hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL",
"Pharm_Classes": "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], 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 IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190101",
"SamplePackage": "N",
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{
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"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "ASN",
"SubstanceName": "ALTERNARIA ALTERNATA; JUNIPERUS ASHEI POLLEN; JUNIPERUS SCOPULORUM POLLEN; NERIUM OLEANDER FLOWER; OLEA EUROPAEA FLOWER; PASSALORA FULVA; USTILAGO MAYDIS; WHITE MULBERRY",
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"Pharm_Classes": "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], 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 IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS]",
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"ProductTypeName": "HUMAN OTC DRUG",
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"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20190123",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "ASN",
"SubstanceName": "ALTERNARIA ALTERNATA; AMBROSIA ARTEMISIIFOLIA; CYNODON DACTYLON; JUNIPERUS ASHEI POLLEN; JUNIPERUS SCOPULORUM POLLEN; NERIUM OLEANDER FLOWER; OLEA EUROPAEA FLOWER; PASSALORA FULVA; USTILAGO MAYDIS; WHITE MULBERRY",
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"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190123",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: Allergy symptom reliefFor temporary relief of symptoms due to hay feveror other respiratory allergies. Runny nose,sneezing, irritated eyes, nasal congestion, itchynose and throat, sinus pain."
},
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"NDCCode": "72617-5003-4",
"PackageDescription": "30 TABLET, CHEWABLE in 1 BOTTLE (72617-5003-4) ",
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"ProductNDC": "72617-5003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allergy Mix Los Angeles",
"NonProprietaryName": "Local Remedy Los Angeles",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20190123",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "ASN",
"SubstanceName": "ALTERNARIA ALTERNATA; AMBROSIA ARTEMISIIFOLIA; HISTAMINE DIHYDROCHLORIDE; JUNIPERUS ASHEI POLLEN; JUNIPERUS SCOPULORUM POLLEN; NERIUM OLEANDER FLOWER; OLEA EUROPAEA FLOWER; PASSALORA FULVA; SCHOENOCAULON OFFICINALE SEED; USTILAGO MAYDIS; WHITE MULBERRY",
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"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "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], 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 IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS]",
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"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20190123",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: Allergy symptom reliefFor temporary relief of symptoms due to hay feveror other respiratory allergies. Runny nose,sneezing, irritated eyes, nasal congestion, itchynose and throat, sinus pain."
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{
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"PackageDescription": "10 CARTON in 1 PACKAGE (0008-2001-10) > 1 VIAL in 1 CARTON (0008-2001-01) > 10 mL in 1 VIAL",
"NDC11Code": "00008-2001-10",
"ProductNDC": "0008-2001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Protonix",
"ProprietaryNameSuffix": "I.v.",
"NonProprietaryName": "Pantoprazole Sodium",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20140317",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020988",
"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "PANTOPRAZOLE SODIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/10mL",
"Pharm_Classes": "Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2023-06-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20140317",
"SamplePackage": "N"
},
{
"NDCCode": "0008-2001-25",
"PackageDescription": "25 CARTON in 1 PACKAGE (0008-2001-25) > 1 VIAL in 1 CARTON (0008-2001-01) > 10 mL in 1 VIAL",
"NDC11Code": "00008-2001-25",
"ProductNDC": "0008-2001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Protonix",
"ProprietaryNameSuffix": "I.v.",
"NonProprietaryName": "Pantoprazole Sodium",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAVENOUS",
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"MarketingCategoryName": "NDA",
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"LabelerName": "Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.",
"SubstanceName": "PANTOPRAZOLE SODIUM",
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"StrengthUnit": "mg/10mL",
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"Status": "Deprecated",
"LastUpdate": "2023-06-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20140317",
"SamplePackage": "N"
},
{
"NDCCode": "0037-2001-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (0037-2001-01) ",
"NDC11Code": "00037-2001-01",
"ProductNDC": "0037-2001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Soma",
"NonProprietaryName": "Carisoprodol",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19951101",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA011792",
"LabelerName": "Viatris Specialty LLC",
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"StrengthNumber": "350",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]",
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"LastUpdate": "2025-12-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19951101",
"SamplePackage": "N",
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"Description": "SOMA (carisoprodol) Tablets are available as 250 mg and 350 mg round, white tablets. Carisoprodol is a white, crystalline powder, having a mild, characteristic odor and a bitter taste. It is slightly soluble in water; freely soluble in alcohol, in chloroform, and in acetone; and its solubility is practically independent of pH. Carisoprodol is present as a racemic mixture. Chemically, carisoprodol is (±)-2-Methyl-2-propyl-1,3-propanediol carbamate isopropylcarbamate and the molecular formula is C12H24N2O4, with a molecular weight of 260.33. The structural formula is:. Other ingredients in the SOMA drug product include alginic acid, magnesium stearate, potassium sorbate, starch, and tribasic calcium phosphate."
},
{
"NDCCode": "0067-2001-01",
"PackageDescription": "2 TABLET, FILM COATED in 1 POUCH (0067-2001-01) ",
"NDC11Code": "00067-2001-01",
"ProductNDC": "0067-2001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Excedrin",
"ProprietaryNameSuffix": "Extra Strength Pain Reliever",
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"DosageFormName": "TABLET, FILM COATED",
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"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Haleon US Holdings LLC",
"SubstanceName": "ACETAMINOPHEN; ASPIRIN; CAFFEINE",
"StrengthNumber": "250; 250; 65",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]",
"Status": "Active",
"LastUpdate": "2024-04-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20210131",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to: headachea coldarthritismuscular achestoothachepremenstrual & menstrual cramps."
},
{
"NDCCode": "0067-2001-02",
"PackageDescription": "1 BOTTLE in 1 CARTON (0067-2001-02) / 24 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "00067-2001-02",
"ProductNDC": "0067-2001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Excedrin",
"ProprietaryNameSuffix": "Extra Strength Pain Reliever",
"NonProprietaryName": "Acetaminophen, Aspirin (nsaid), And Caffeine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190315",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Haleon US Holdings LLC",
"SubstanceName": "ACETAMINOPHEN; ASPIRIN; CAFFEINE",
"StrengthNumber": "250; 250; 65",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]",
"Status": "Active",
"LastUpdate": "2024-04-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200930",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to: headachea coldarthritismuscular achestoothachepremenstrual & menstrual cramps."
},
{
"NDCCode": "0067-2001-03",
"PackageDescription": "1 BOTTLE in 1 CARTON (0067-2001-03) / 30 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "00067-2001-03",
"ProductNDC": "0067-2001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Excedrin",
"ProprietaryNameSuffix": "Extra Strength Pain Reliever",
"NonProprietaryName": "Acetaminophen, Aspirin (nsaid), And Caffeine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190315",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Haleon US Holdings LLC",
"SubstanceName": "ACETAMINOPHEN; ASPIRIN; CAFFEINE",
"StrengthNumber": "250; 250; 65",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]",
"Status": "Active",
"LastUpdate": "2024-04-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200930",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to: headachea coldarthritismuscular achestoothachepremenstrual & menstrual cramps."
},
{
"NDCCode": "0067-2001-04",
"PackageDescription": "1 BOTTLE in 1 CARTON (0067-2001-04) / 50 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "00067-2001-04",
"ProductNDC": "0067-2001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Excedrin",
"ProprietaryNameSuffix": "Extra Strength Pain Reliever",
"NonProprietaryName": "Acetaminophen, Aspirin (nsaid), And Caffeine",
"DosageFormName": "TABLET, FILM COATED",
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"StartMarketingDate": "20190315",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Haleon US Holdings LLC",
"SubstanceName": "ACETAMINOPHEN; ASPIRIN; CAFFEINE",
"StrengthNumber": "250; 250; 65",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]",
"Status": "Active",
"LastUpdate": "2024-04-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200930",
"SamplePackage": "N",
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},
{
"NDCCode": "0067-2001-05",
"PackageDescription": "1 BOTTLE in 1 CARTON (0067-2001-05) / 100 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "00067-2001-05",
"ProductNDC": "0067-2001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Excedrin",
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"StartMarketingDate": "20190315",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Haleon US Holdings LLC",
"SubstanceName": "ACETAMINOPHEN; ASPIRIN; CAFFEINE",
"StrengthNumber": "250; 250; 65",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]",
"Status": "Active",
"LastUpdate": "2024-04-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20190315",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to: headachea coldarthritismuscular achestoothachepremenstrual & menstrual cramps."
},
{
"NDCCode": "0067-2001-06",
"PackageDescription": "1 BOTTLE in 1 CARTON (0067-2001-06) / 125 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "00067-2001-06",
"ProductNDC": "0067-2001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Excedrin",
"ProprietaryNameSuffix": "Extra Strength Pain Reliever",
"NonProprietaryName": "Acetaminophen, Aspirin (nsaid), And Caffeine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20190315",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Haleon US Holdings LLC",
"SubstanceName": "ACETAMINOPHEN; ASPIRIN; CAFFEINE",
"StrengthNumber": "250; 250; 65",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]",
"Status": "Active",
"LastUpdate": "2024-04-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200930",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to: headachea coldarthritismuscular achestoothachepremenstrual & menstrual cramps."
},
{
"NDCCode": "0067-2001-07",
"PackageDescription": "1 BOTTLE in 1 CARTON (0067-2001-07) / 200 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "00067-2001-07",
"ProductNDC": "0067-2001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Excedrin",
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"RouteName": "ORAL",
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"ApplicationNumber": "M013",
"LabelerName": "Haleon US Holdings LLC",
"SubstanceName": "ACETAMINOPHEN; ASPIRIN; CAFFEINE",
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"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]",
"Status": "Active",
"LastUpdate": "2024-04-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200930",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to: headachea coldarthritismuscular achestoothachepremenstrual & menstrual cramps."
},
{
"NDCCode": "0067-2001-08",
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"NDC11Code": "00067-2001-08",
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"ApplicationNumber": "M013",
"LabelerName": "Haleon US Holdings LLC",
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"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]",
"Status": "Active",
"LastUpdate": "2024-04-09",
"PackageNdcExcludeFlag": "N",
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"IndicationAndUsage": "temporarily relieves minor aches and pains due to: headachea coldarthritismuscular achestoothachepremenstrual & menstrual cramps."
},
{
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"PackageDescription": "1 BOTTLE in 1 CARTON (0067-2001-09) / 250 TABLET, FILM COATED in 1 BOTTLE",
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"MarketingCategoryName": "OTC MONOGRAPH DRUG",
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"LabelerName": "Haleon US Holdings LLC",
"SubstanceName": "ACETAMINOPHEN; ASPIRIN; CAFFEINE",
"StrengthNumber": "250; 250; 65",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]",
"Status": "Active",
"LastUpdate": "2024-04-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200930",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to: headachea coldarthritismuscular achestoothachepremenstrual & menstrual cramps."
},
{
"NDCCode": "0067-2001-14",
"PackageDescription": "1 VIAL in 1 BLISTER PACK (0067-2001-14) / 8 TABLET, FILM COATED in 1 VIAL",
"NDC11Code": "00067-2001-14",
"ProductNDC": "0067-2001",
"ProductTypeName": "HUMAN OTC DRUG",
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"ProprietaryNameSuffix": "Extra Strength Pain Reliever",
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"RouteName": "ORAL",
"StartMarketingDate": "20190315",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Haleon US Holdings LLC",
"SubstanceName": "ACETAMINOPHEN; ASPIRIN; CAFFEINE",
"StrengthNumber": "250; 250; 65",
"StrengthUnit": "mg/1; mg/1; mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]",
"Status": "Active",
"LastUpdate": "2024-04-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210131",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves minor aches and pains due to: headachea coldarthritismuscular achestoothachepremenstrual & menstrual cramps."
},
{
"NDCCode": "0116-2001-04",
"PackageDescription": "118 mL in 1 BOTTLE (0116-2001-04) ",
"NDC11Code": "00116-2001-04",
"ProductNDC": "0116-2001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Chlorhexidine Gluconate",
"NonProprietaryName": "Chlorhexidine Gluconate",
"DosageFormName": "RINSE",
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"StartMarketingDate": "20100601",
"MarketingCategoryName": "ANDA",
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"LabelerName": "Xttrium Laboratories, Inc.",
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"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Cell Wall Integrity [PE]",
"Status": "Active",
"LastUpdate": "2023-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20100601",
"SamplePackage": "N",
"IndicationAndUsage": "Chlorhexidine gluconate oral rinse is indicated for use between dental visits as part of a professional program for the treatment of gingivitis as characterized by redness and swelling of the gingivae, including gingival bleeding upon probing. Chlorhexidine gluconate oral rinse has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis, see PRECAUTIONS.",
"Description": "0.12% chlorhexidine gluconate (CHG) is an oral rinse containing (1,1'-hexamethylene bis [5-(p-chlorophenyl) biguanide]di-D-gluconate) in a base containing water, 11 .6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, sodium saccharin, and FD&C Blue No.1. Chlorhexidine gluconate product is a near neutral solution (pH range 5-7). Chlorhexidine gluconate is a salt of chlorhexidine and gluconic acid. Its chemical structure is:."
},
{
"NDCCode": "0116-2001-05",
"PackageDescription": "15 mL in 1 CUP, UNIT-DOSE (0116-2001-05) ",
"NDC11Code": "00116-2001-05",
"ProductNDC": "0116-2001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Chlorhexidine Gluconate",
"NonProprietaryName": "Chlorhexidine Gluconate",
"DosageFormName": "RINSE",
"RouteName": "ORAL",
"StartMarketingDate": "20100601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077789",
"LabelerName": "Xttrium Laboratories, Inc.",
"SubstanceName": "CHLORHEXIDINE GLUCONATE",
"StrengthNumber": "1.2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Decreased Cell Wall Integrity [PE]",
"Status": "Active",
"LastUpdate": "2023-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210101",
"SamplePackage": "N",
"IndicationAndUsage": "Chlorhexidine gluconate oral rinse is indicated for use between dental visits as part of a professional program for the treatment of gingivitis as characterized by redness and swelling of the gingivae, including gingival bleeding upon probing. Chlorhexidine gluconate oral rinse has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis, see PRECAUTIONS.",
"Description": "0.12% chlorhexidine gluconate (CHG) is an oral rinse containing (1,1'-hexamethylene bis [5-(p-chlorophenyl) biguanide]di-D-gluconate) in a base containing water, 11 .6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, sodium saccharin, and FD&C Blue No.1. Chlorhexidine gluconate product is a near neutral solution (pH range 5-7). Chlorhexidine gluconate is a salt of chlorhexidine and gluconic acid. Its chemical structure is:."
},
{
"NDCCode": "0116-2001-06",
"PackageDescription": "600 mL in 1 CASE (0116-2001-06) ",
"NDC11Code": "00116-2001-06",
"ProductNDC": "0116-2001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Chlorhexidine Gluconate",
"NonProprietaryName": "Chlorhexidine Gluconate",
"DosageFormName": "RINSE",
"RouteName": "ORAL",
"StartMarketingDate": "20100601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077789",
"LabelerName": "Xttrium Laboratories, Inc.",
"SubstanceName": "CHLORHEXIDINE GLUCONATE",
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"Pharm_Classes": "Decreased Cell Wall Integrity [PE]",
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"LastUpdate": "2023-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210101",
"SamplePackage": "N",
"IndicationAndUsage": "Chlorhexidine gluconate oral rinse is indicated for use between dental visits as part of a professional program for the treatment of gingivitis as characterized by redness and swelling of the gingivae, including gingival bleeding upon probing. Chlorhexidine gluconate oral rinse has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis, see PRECAUTIONS.",
"Description": "0.12% chlorhexidine gluconate (CHG) is an oral rinse containing (1,1'-hexamethylene bis [5-(p-chlorophenyl) biguanide]di-D-gluconate) in a base containing water, 11 .6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, sodium saccharin, and FD&C Blue No.1. Chlorhexidine gluconate product is a near neutral solution (pH range 5-7). Chlorhexidine gluconate is a salt of chlorhexidine and gluconic acid. Its chemical structure is:."
},
{
"NDCCode": "0116-2001-07",
"PackageDescription": "1500 mL in 1 CASE (0116-2001-07) ",
"NDC11Code": "00116-2001-07",
"ProductNDC": "0116-2001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Chlorhexidine Gluconate",
"NonProprietaryName": "Chlorhexidine Gluconate",
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"StartMarketingDate": "20100601",
"MarketingCategoryName": "ANDA",
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"LabelerName": "Xttrium Laboratories, Inc.",
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"LastUpdate": "2023-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20210101",
"SamplePackage": "N",
"IndicationAndUsage": "Chlorhexidine gluconate oral rinse is indicated for use between dental visits as part of a professional program for the treatment of gingivitis as characterized by redness and swelling of the gingivae, including gingival bleeding upon probing. Chlorhexidine gluconate oral rinse has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis, see PRECAUTIONS.",
"Description": "0.12% chlorhexidine gluconate (CHG) is an oral rinse containing (1,1'-hexamethylene bis [5-(p-chlorophenyl) biguanide]di-D-gluconate) in a base containing water, 11 .6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, sodium saccharin, and FD&C Blue No.1. Chlorhexidine gluconate product is a near neutral solution (pH range 5-7). Chlorhexidine gluconate is a salt of chlorhexidine and gluconic acid. Its chemical structure is:."
}
]
}
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<NDCList>
<NDC>
<NDCCode>72617-2001-1</NDCCode>
<PackageDescription>29.6 mL in 1 BOTTLE, DROPPER (72617-2001-1) </PackageDescription>
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<ProductNDC>72617-2001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>ASN</LabelerName>
<SubstanceName>ALTERNARIA ALTERNATA; JUNIPERUS ASHEI POLLEN; JUNIPERUS SCOPULORUM POLLEN; NERIUM OLEANDER FLOWER; OLEA EUROPAEA FLOWER; PASSALORA FULVA; USTILAGO MAYDIS; WHITE MULBERRY</SubstanceName>
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<StrengthUnit>[hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL</StrengthUnit>
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<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190123</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: Allergy symptom reliefFor temporary relief of symptoms due to hay fever or otherrespiratory allergies. Runny nose, sneezing, irritated eyes,nasal congestion, itchy nose and throat, sinus pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72617-0001-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (72617-0001-1) </PackageDescription>
<NDC11Code>72617-0001-01</NDC11Code>
<ProductNDC>72617-0001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergy Mix Las Vegas</ProprietaryName>
<NonProprietaryName>Alternaria Alternata, Bermuda Grass Pollen (cynodon Dactylon), Cladosporium Herbarum, Histaminum Hydrochloricum, Juniperus Communis, Oleander, Olive Pollen (olea Europaea), Ragweed Pollen (ambrosia Artemisiaefolia), Sabina, Ustilago Maidis, White Mulberry Pollen (morus Alba)</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260326</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>American Standard Nutraceuticals</LabelerName>
<SubstanceName>ALTERNARIA ALTERNATA; CYNODON DACTYLON POLLEN; CLADOSPORIUM HERBARUM; HISTAMINE DIHYDROCHLORIDE; JUNIPER BERRY; NERIUM OLEANDER LEAF; OLEA EUROPAEA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; JUNIPERUS SABINA LEAFY TWIG; USTILAGO MAYDIS; MORUS ALBA POLLEN</SubstanceName>
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<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
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<Status>Active</Status>
<LastUpdate>2026-03-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260326</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For temporary relief of allergy symptoms including sneezing, runny nose, itchy, watery eyes, congestion, and stuffy nose.†. †Claims based on traditional practice, not accepted medical evidence. Not FDA evaluated.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72617-2002-1</NDCCode>
<PackageDescription>29.6 mL in 1 BOTTLE, DROPPER (72617-2002-1) </PackageDescription>
<NDC11Code>72617-2002-01</NDC11Code>
<ProductNDC>72617-2002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergy Mix Phoenix</ProprietaryName>
<NonProprietaryName>Local Remedy Phoenix</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190123</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>ASN</LabelerName>
<SubstanceName>ALTERNARIA ALTERNATA; AMBROSIA ARTEMISIIFOLIA; CYNODON DACTYLON; JUNIPERUS ASHEI POLLEN; JUNIPERUS SCOPULORUM POLLEN; NERIUM OLEANDER FLOWER; OLEA EUROPAEA FLOWER; PASSALORA FULVA; USTILAGO MAYDIS; WHITE MULBERRY</SubstanceName>
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<StrengthUnit>[hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL</StrengthUnit>
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<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190123</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: Allergy symptom reliefFor temporary relief of symptoms due to hay fever or otherrespiratory allergies. Runny nose, sneezing, irritated eyes,nasal congestion, itchy nose and throat, sinus pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72617-2003-1</NDCCode>
<PackageDescription>29.6 mL in 1 BOTTLE, DROPPER (72617-2003-1) </PackageDescription>
<NDC11Code>72617-2003-01</NDC11Code>
<ProductNDC>72617-2003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergy Mix Los Angeles</ProprietaryName>
<NonProprietaryName>Local Remedy Los Angeles</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190123</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>ASN</LabelerName>
<SubstanceName>ALTERNARIA ALTERNATA; AMBROSIA ARTEMISIIFOLIA; HISTAMINE DIHYDROCHLORIDE; JUNIPERUS ASHEI POLLEN; JUNIPERUS SCOPULORUM POLLEN; NERIUM OLEANDER FLOWER; OLEA EUROPAEA FLOWER; PASSALORA FULVA; SCHOENOCAULON OFFICINALE SEED; USTILAGO MAYDIS; WHITE MULBERRY</SubstanceName>
<StrengthNumber>6; 12; 12; 6; 6; 6; 6; 6; 12; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL</StrengthUnit>
<Pharm_Classes>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], 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 IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190123</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: Allergy symptom reliefFor temporary relief of symptoms due to hay fever or otherrespiratory allergies. Runny nose, sneezing, irritated eyes,nasal congestion, itchy nose and throat, sinus pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72617-3001-2</NDCCode>
<PackageDescription>1 BOTTLE in 1 PACKAGE (72617-3001-2) > 15 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>72617-3001-02</NDC11Code>
<ProductNDC>72617-3001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergy Mix Las Vegas</ProprietaryName>
<NonProprietaryName>Local Remedy Las Vegas</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20190101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>ASN</LabelerName>
<SubstanceName>ALTERNARIA ALTERNATA; JUNIPERUS ASHEI POLLEN; JUNIPERUS SCOPULORUM POLLEN; NERIUM OLEANDER FLOWER; OLEA EUROPAEA FLOWER; PASSALORA FULVA; USTILAGO MAYDIS; WHITE MULBERRY</SubstanceName>
<StrengthNumber>6; 6; 6; 6; 6; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL</StrengthUnit>
<Pharm_Classes>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], 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 IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190123</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>UsesFor temporary relief of symptoms due to hay feveror other respiratory allergies. Runny nose, sneezing,irritated eyes, nasal congestion, itchy nose andthroat, sinus pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72617-3002-2</NDCCode>
<PackageDescription>1 BOTTLE in 1 PACKAGE (72617-3002-2) > 15 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>72617-3002-02</NDC11Code>
<ProductNDC>72617-3002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergy Mix Phoenix</ProprietaryName>
<NonProprietaryName>Local Remedy Phoenix</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20190101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>ASN</LabelerName>
<SubstanceName>ALTERNARIA ALTERNATA; AMBROSIA ARTEMISIIFOLIA; CYNODON DACTYLON; JUNIPERUS ASHEI POLLEN; JUNIPERUS SCOPULORUM POLLEN; NERIUM OLEANDER FLOWER; OLEA EUROPAEA FLOWER; PASSALORA FULVA; USTILAGO MAYDIS; WHITE MULBERRY</SubstanceName>
<StrengthNumber>6; 12; 12; 6; 6; 6; 6; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL</StrengthUnit>
<Pharm_Classes>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], 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 IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190123</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>UsesFor temporary relief of symptoms due to hay feveror other respiratory allergies. Runny nose, sneezing,irritated eyes, nasal congestion, itchy nose andthroat, sinus pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72617-3003-2</NDCCode>
<PackageDescription>120 TABLET, CHEWABLE in 1 BOTTLE (72617-3003-2) </PackageDescription>
<NDC11Code>72617-3003-02</NDC11Code>
<ProductNDC>72617-3003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergy Mix Los Angeles</ProprietaryName>
<NonProprietaryName>Local Remedy Los Angeles</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190123</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>ASN</LabelerName>
<SubstanceName>ALTERNARIA ALTERNATA; AMBROSIA ARTEMISIIFOLIA; HISTAMINE DIHYDROCHLORIDE; JUNIPERUS ASHEI POLLEN; JUNIPERUS SCOPULORUM POLLEN; NERIUM OLEANDER FLOWER; OLEA EUROPAEA FLOWER; PASSALORA FULVA; SCHOENOCAULON OFFICINALE SEED; USTILAGO MAYDIS; WHITE MULBERRY</SubstanceName>
<StrengthNumber>6; 12; 12; 6; 6; 6; 6; 6; 12; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>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], 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 IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190123</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: Allergy symptom reliefFor temporary relief of symptoms due to hay feveror other respiratory allergies. Runny nose,sneezing, irritated eyes, nasal congestion, itchynose and throat, sinus pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72617-4001-3</NDCCode>
<PackageDescription>120 TABLET, CHEWABLE in 1 BOTTLE (72617-4001-3) </PackageDescription>
<NDC11Code>72617-4001-03</NDC11Code>
<ProductNDC>72617-4001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergy Mix Las Vegas</ProprietaryName>
<NonProprietaryName>Local Remedy Las Vegas</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190123</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>ASN</LabelerName>
<SubstanceName>ALTERNARIA ALTERNATA; JUNIPERUS ASHEI POLLEN; JUNIPERUS SCOPULORUM POLLEN; NERIUM OLEANDER FLOWER; OLEA EUROPAEA FLOWER; PASSALORA FULVA; USTILAGO MAYDIS; WHITE MULBERRY</SubstanceName>
<StrengthNumber>6; 6; 6; 6; 6; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>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], 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 IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190123</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: Allergy symptom reliefFor temporary relief of symptoms due to hay feveror other respiratory allergies. Runny nose,sneezing, irritated eyes, nasal congestion, itchynose and throat, sinus pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72617-4002-3</NDCCode>
<PackageDescription>120 TABLET, CHEWABLE in 1 BOTTLE (72617-4002-3) </PackageDescription>
<NDC11Code>72617-4002-03</NDC11Code>
<ProductNDC>72617-4002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergy Mix Phoenix</ProprietaryName>
<NonProprietaryName>Local Remedy Phoenix</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190123</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>ASN</LabelerName>
<SubstanceName>ALTERNARIA ALTERNATA; AMBROSIA ARTEMISIIFOLIA; CYNODON DACTYLON; JUNIPERUS ASHEI POLLEN; JUNIPERUS SCOPULORUM POLLEN; NERIUM OLEANDER FLOWER; OLEA EUROPAEA FLOWER; PASSALORA FULVA; USTILAGO MAYDIS; WHITE MULBERRY</SubstanceName>
<StrengthNumber>6; 12; 12; 6; 6; 6; 6; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>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], 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 IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190123</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: Allergy symptom reliefFor temporary relief of symptoms due to hay feveror other respiratory allergies. Runny nose,sneezing, irritated eyes, nasal congestion, itchynose and throat, sinus pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72617-4003-3</NDCCode>
<PackageDescription>1 BOTTLE in 1 PACKAGE (72617-4003-3) > 15 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>72617-4003-03</NDC11Code>
<ProductNDC>72617-4003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergy Mix</ProprietaryName>
<NonProprietaryName>Local Remedy Los Angeles</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20190101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>ASN</LabelerName>
<SubstanceName>ALTERNARIA ALTERNATA; AMBROSIA ARTEMISIIFOLIA; HISTAMINE DIHYDROCHLORIDE; JUNIPERUS ASHEI POLLEN; JUNIPERUS SCOPULORUM POLLEN; NERIUM OLEANDER FLOWER; OLEA EUROPAEA FLOWER; PASSALORA FULVA; SCHOENOCAULON OFFICINALE SEED; USTILAGO MAYDIS; WHITE MULBERRY</SubstanceName>
<StrengthNumber>6; 12; 12; 6; 6; 6; 6; 6; 12; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL</StrengthUnit>
<Pharm_Classes>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], 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 IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>UsesFor temporary relief of symptoms due to hay feveror other respiratory allergies. Runny nose, sneezing,irritated eyes, nasal congestion, itchy nose andthroat, sinus pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72617-5001-4</NDCCode>
<PackageDescription>30 TABLET, CHEWABLE in 1 BOTTLE (72617-5001-4) </PackageDescription>
<NDC11Code>72617-5001-04</NDC11Code>
<ProductNDC>72617-5001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergy Mix Las Vegas</ProprietaryName>
<NonProprietaryName>Local Remedy Las Vegas</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190123</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>ASN</LabelerName>
<SubstanceName>ALTERNARIA ALTERNATA; JUNIPERUS ASHEI POLLEN; JUNIPERUS SCOPULORUM POLLEN; NERIUM OLEANDER FLOWER; OLEA EUROPAEA FLOWER; PASSALORA FULVA; USTILAGO MAYDIS; WHITE MULBERRY</SubstanceName>
<StrengthNumber>6; 6; 6; 6; 6; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>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], 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 IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190123</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: Allergy symptom reliefFor temporary relief of symptoms due to hay feveror other respiratory allergies. Runny nose,sneezing, irritated eyes, nasal congestion, itchynose and throat, sinus pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72617-5002-4</NDCCode>
<PackageDescription>30 TABLET, CHEWABLE in 1 BOTTLE (72617-5002-4) </PackageDescription>
<NDC11Code>72617-5002-04</NDC11Code>
<ProductNDC>72617-5002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergy Mix Phoenix</ProprietaryName>
<NonProprietaryName>Local Remedy Phoenix</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190123</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>ASN</LabelerName>
<SubstanceName>ALTERNARIA ALTERNATA; AMBROSIA ARTEMISIIFOLIA; CYNODON DACTYLON; JUNIPERUS ASHEI POLLEN; JUNIPERUS SCOPULORUM POLLEN; NERIUM OLEANDER FLOWER; OLEA EUROPAEA FLOWER; PASSALORA FULVA; USTILAGO MAYDIS; WHITE MULBERRY</SubstanceName>
<StrengthNumber>6; 12; 12; 6; 6; 6; 6; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>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], 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 IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190123</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: Allergy symptom reliefFor temporary relief of symptoms due to hay feveror other respiratory allergies. Runny nose,sneezing, irritated eyes, nasal congestion, itchynose and throat, sinus pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72617-5003-4</NDCCode>
<PackageDescription>30 TABLET, CHEWABLE in 1 BOTTLE (72617-5003-4) </PackageDescription>
<NDC11Code>72617-5003-04</NDC11Code>
<ProductNDC>72617-5003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergy Mix Los Angeles</ProprietaryName>
<NonProprietaryName>Local Remedy Los Angeles</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190123</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>ASN</LabelerName>
<SubstanceName>ALTERNARIA ALTERNATA; AMBROSIA ARTEMISIIFOLIA; HISTAMINE DIHYDROCHLORIDE; JUNIPERUS ASHEI POLLEN; JUNIPERUS SCOPULORUM POLLEN; NERIUM OLEANDER FLOWER; OLEA EUROPAEA FLOWER; PASSALORA FULVA; SCHOENOCAULON OFFICINALE SEED; USTILAGO MAYDIS; WHITE MULBERRY</SubstanceName>
<StrengthNumber>6; 12; 12; 6; 6; 6; 6; 6; 12; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>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], 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 IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190123</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: Allergy symptom reliefFor temporary relief of symptoms due to hay feveror other respiratory allergies. Runny nose,sneezing, irritated eyes, nasal congestion, itchynose and throat, sinus pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0008-2001-10</NDCCode>
<PackageDescription>10 CARTON in 1 PACKAGE (0008-2001-10) > 1 VIAL in 1 CARTON (0008-2001-01) > 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>00008-2001-10</NDC11Code>
<ProductNDC>0008-2001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Protonix</ProprietaryName>
<ProprietaryNameSuffix>I.v.</ProprietaryNameSuffix>
<NonProprietaryName>Pantoprazole Sodium</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20140317</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020988</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-06-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140317</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0008-2001-25</NDCCode>
<PackageDescription>25 CARTON in 1 PACKAGE (0008-2001-25) > 1 VIAL in 1 CARTON (0008-2001-01) > 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>00008-2001-25</NDC11Code>
<ProductNDC>0008-2001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Protonix</ProprietaryName>
<ProprietaryNameSuffix>I.v.</ProprietaryNameSuffix>
<NonProprietaryName>Pantoprazole Sodium</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20140317</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020988</ApplicationNumber>
<LabelerName>Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.</LabelerName>
<SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/10mL</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-06-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140317</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0037-2001-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (0037-2001-01) </PackageDescription>
<NDC11Code>00037-2001-01</NDC11Code>
<ProductNDC>0037-2001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Soma</ProprietaryName>
<NonProprietaryName>Carisoprodol</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19951101</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA011792</ApplicationNumber>
<LabelerName>Viatris Specialty LLC</LabelerName>
<SubstanceName>CARISOPRODOL</SubstanceName>
<StrengthNumber>350</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Centrally-mediated Muscle Relaxation [PE], Muscle Relaxant [EPC]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2025-12-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19951101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SOMA is indicated for the relief of discomfort associated with acute, painful musculoskeletal conditions in adults. Limitation of Use. SOMA should only be used for short periods (up to two or three weeks) because adequate evidence of effectiveness for more prolonged use has not been established and because acute, painful musculoskeletal conditions are generally of short duration [see Dosage and Administration (2)].</IndicationAndUsage>
<Description>SOMA (carisoprodol) Tablets are available as 250 mg and 350 mg round, white tablets. Carisoprodol is a white, crystalline powder, having a mild, characteristic odor and a bitter taste. It is slightly soluble in water; freely soluble in alcohol, in chloroform, and in acetone; and its solubility is practically independent of pH. Carisoprodol is present as a racemic mixture. Chemically, carisoprodol is (±)-2-Methyl-2-propyl-1,3-propanediol carbamate isopropylcarbamate and the molecular formula is C12H24N2O4, with a molecular weight of 260.33. The structural formula is:. Other ingredients in the SOMA drug product include alginic acid, magnesium stearate, potassium sorbate, starch, and tribasic calcium phosphate.</Description>
</NDC>
<NDC>
<NDCCode>0067-2001-01</NDCCode>
<PackageDescription>2 TABLET, FILM COATED in 1 POUCH (0067-2001-01) </PackageDescription>
<NDC11Code>00067-2001-01</NDC11Code>
<ProductNDC>0067-2001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Excedrin</ProprietaryName>
<ProprietaryNameSuffix>Extra Strength Pain Reliever</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Aspirin (nsaid), And Caffeine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190315</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>Haleon US Holdings LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN; ASPIRIN; CAFFEINE</SubstanceName>
<StrengthNumber>250; 250; 65</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-04-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210131</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains due to: headachea coldarthritismuscular achestoothachepremenstrual & menstrual cramps.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0067-2001-02</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0067-2001-02) / 24 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>00067-2001-02</NDC11Code>
<ProductNDC>0067-2001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Excedrin</ProprietaryName>
<ProprietaryNameSuffix>Extra Strength Pain Reliever</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Aspirin (nsaid), And Caffeine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190315</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>Haleon US Holdings LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN; ASPIRIN; CAFFEINE</SubstanceName>
<StrengthNumber>250; 250; 65</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-04-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains due to: headachea coldarthritismuscular achestoothachepremenstrual & menstrual cramps.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0067-2001-03</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0067-2001-03) / 30 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>00067-2001-03</NDC11Code>
<ProductNDC>0067-2001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Excedrin</ProprietaryName>
<ProprietaryNameSuffix>Extra Strength Pain Reliever</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Aspirin (nsaid), And Caffeine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190315</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>Haleon US Holdings LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN; ASPIRIN; CAFFEINE</SubstanceName>
<StrengthNumber>250; 250; 65</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-04-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains due to: headachea coldarthritismuscular achestoothachepremenstrual & menstrual cramps.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0067-2001-04</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0067-2001-04) / 50 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>00067-2001-04</NDC11Code>
<ProductNDC>0067-2001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Excedrin</ProprietaryName>
<ProprietaryNameSuffix>Extra Strength Pain Reliever</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Aspirin (nsaid), And Caffeine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190315</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>Haleon US Holdings LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN; ASPIRIN; CAFFEINE</SubstanceName>
<StrengthNumber>250; 250; 65</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-04-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains due to: headachea coldarthritismuscular achestoothachepremenstrual & menstrual cramps.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0067-2001-05</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0067-2001-05) / 100 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>00067-2001-05</NDC11Code>
<ProductNDC>0067-2001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Excedrin</ProprietaryName>
<ProprietaryNameSuffix>Extra Strength Pain Reliever</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Aspirin (nsaid), And Caffeine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190315</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>Haleon US Holdings LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN; ASPIRIN; CAFFEINE</SubstanceName>
<StrengthNumber>250; 250; 65</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-04-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190315</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains due to: headachea coldarthritismuscular achestoothachepremenstrual & menstrual cramps.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0067-2001-06</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0067-2001-06) / 125 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>00067-2001-06</NDC11Code>
<ProductNDC>0067-2001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Excedrin</ProprietaryName>
<ProprietaryNameSuffix>Extra Strength Pain Reliever</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Aspirin (nsaid), And Caffeine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190315</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>Haleon US Holdings LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN; ASPIRIN; CAFFEINE</SubstanceName>
<StrengthNumber>250; 250; 65</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-04-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains due to: headachea coldarthritismuscular achestoothachepremenstrual & menstrual cramps.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0067-2001-07</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0067-2001-07) / 200 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>00067-2001-07</NDC11Code>
<ProductNDC>0067-2001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Excedrin</ProprietaryName>
<ProprietaryNameSuffix>Extra Strength Pain Reliever</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Aspirin (nsaid), And Caffeine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190315</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>Haleon US Holdings LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN; ASPIRIN; CAFFEINE</SubstanceName>
<StrengthNumber>250; 250; 65</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-04-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains due to: headachea coldarthritismuscular achestoothachepremenstrual & menstrual cramps.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0067-2001-08</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0067-2001-08) / 300 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>00067-2001-08</NDC11Code>
<ProductNDC>0067-2001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Excedrin</ProprietaryName>
<ProprietaryNameSuffix>Extra Strength Pain Reliever</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Aspirin (nsaid), And Caffeine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190315</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>Haleon US Holdings LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN; ASPIRIN; CAFFEINE</SubstanceName>
<StrengthNumber>250; 250; 65</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-04-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190315</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains due to: headachea coldarthritismuscular achestoothachepremenstrual & menstrual cramps.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0067-2001-09</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0067-2001-09) / 250 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>00067-2001-09</NDC11Code>
<ProductNDC>0067-2001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Excedrin</ProprietaryName>
<ProprietaryNameSuffix>Extra Strength Pain Reliever</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Aspirin (nsaid), And Caffeine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190315</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>Haleon US Holdings LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN; ASPIRIN; CAFFEINE</SubstanceName>
<StrengthNumber>250; 250; 65</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-04-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200930</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains due to: headachea coldarthritismuscular achestoothachepremenstrual & menstrual cramps.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0067-2001-14</NDCCode>
<PackageDescription>1 VIAL in 1 BLISTER PACK (0067-2001-14) / 8 TABLET, FILM COATED in 1 VIAL</PackageDescription>
<NDC11Code>00067-2001-14</NDC11Code>
<ProductNDC>0067-2001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Excedrin</ProprietaryName>
<ProprietaryNameSuffix>Extra Strength Pain Reliever</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Aspirin (nsaid), And Caffeine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190315</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M013</ApplicationNumber>
<LabelerName>Haleon US Holdings LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN; ASPIRIN; CAFFEINE</SubstanceName>
<StrengthNumber>250; 250; 65</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-04-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210131</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves minor aches and pains due to: headachea coldarthritismuscular achestoothachepremenstrual & menstrual cramps.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0116-2001-04</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE (0116-2001-04) </PackageDescription>
<NDC11Code>00116-2001-04</NDC11Code>
<ProductNDC>0116-2001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Chlorhexidine Gluconate</ProprietaryName>
<NonProprietaryName>Chlorhexidine Gluconate</NonProprietaryName>
<DosageFormName>RINSE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077789</ApplicationNumber>
<LabelerName>Xttrium Laboratories, Inc.</LabelerName>
<SubstanceName>CHLORHEXIDINE GLUCONATE</SubstanceName>
<StrengthNumber>1.2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Decreased Cell Wall Integrity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Chlorhexidine gluconate oral rinse is indicated for use between dental visits as part of a professional program for the treatment of gingivitis as characterized by redness and swelling of the gingivae, including gingival bleeding upon probing. Chlorhexidine gluconate oral rinse has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis, see PRECAUTIONS.</IndicationAndUsage>
<Description>0.12% chlorhexidine gluconate (CHG) is an oral rinse containing (1,1'-hexamethylene bis [5-(p-chlorophenyl) biguanide]di-D-gluconate) in a base containing water, 11 .6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, sodium saccharin, and FD&C Blue No.1. Chlorhexidine gluconate product is a near neutral solution (pH range 5-7). Chlorhexidine gluconate is a salt of chlorhexidine and gluconic acid. Its chemical structure is:.</Description>
</NDC>
<NDC>
<NDCCode>0116-2001-05</NDCCode>
<PackageDescription>15 mL in 1 CUP, UNIT-DOSE (0116-2001-05) </PackageDescription>
<NDC11Code>00116-2001-05</NDC11Code>
<ProductNDC>0116-2001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Chlorhexidine Gluconate</ProprietaryName>
<NonProprietaryName>Chlorhexidine Gluconate</NonProprietaryName>
<DosageFormName>RINSE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077789</ApplicationNumber>
<LabelerName>Xttrium Laboratories, Inc.</LabelerName>
<SubstanceName>CHLORHEXIDINE GLUCONATE</SubstanceName>
<StrengthNumber>1.2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Decreased Cell Wall Integrity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Chlorhexidine gluconate oral rinse is indicated for use between dental visits as part of a professional program for the treatment of gingivitis as characterized by redness and swelling of the gingivae, including gingival bleeding upon probing. Chlorhexidine gluconate oral rinse has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis, see PRECAUTIONS.</IndicationAndUsage>
<Description>0.12% chlorhexidine gluconate (CHG) is an oral rinse containing (1,1'-hexamethylene bis [5-(p-chlorophenyl) biguanide]di-D-gluconate) in a base containing water, 11 .6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, sodium saccharin, and FD&C Blue No.1. Chlorhexidine gluconate product is a near neutral solution (pH range 5-7). Chlorhexidine gluconate is a salt of chlorhexidine and gluconic acid. Its chemical structure is:.</Description>
</NDC>
<NDC>
<NDCCode>0116-2001-06</NDCCode>
<PackageDescription>600 mL in 1 CASE (0116-2001-06) </PackageDescription>
<NDC11Code>00116-2001-06</NDC11Code>
<ProductNDC>0116-2001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Chlorhexidine Gluconate</ProprietaryName>
<NonProprietaryName>Chlorhexidine Gluconate</NonProprietaryName>
<DosageFormName>RINSE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077789</ApplicationNumber>
<LabelerName>Xttrium Laboratories, Inc.</LabelerName>
<SubstanceName>CHLORHEXIDINE GLUCONATE</SubstanceName>
<StrengthNumber>1.2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Decreased Cell Wall Integrity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Chlorhexidine gluconate oral rinse is indicated for use between dental visits as part of a professional program for the treatment of gingivitis as characterized by redness and swelling of the gingivae, including gingival bleeding upon probing. Chlorhexidine gluconate oral rinse has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis, see PRECAUTIONS.</IndicationAndUsage>
<Description>0.12% chlorhexidine gluconate (CHG) is an oral rinse containing (1,1'-hexamethylene bis [5-(p-chlorophenyl) biguanide]di-D-gluconate) in a base containing water, 11 .6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, sodium saccharin, and FD&C Blue No.1. Chlorhexidine gluconate product is a near neutral solution (pH range 5-7). Chlorhexidine gluconate is a salt of chlorhexidine and gluconic acid. Its chemical structure is:.</Description>
</NDC>
<NDC>
<NDCCode>0116-2001-07</NDCCode>
<PackageDescription>1500 mL in 1 CASE (0116-2001-07) </PackageDescription>
<NDC11Code>00116-2001-07</NDC11Code>
<ProductNDC>0116-2001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Chlorhexidine Gluconate</ProprietaryName>
<NonProprietaryName>Chlorhexidine Gluconate</NonProprietaryName>
<DosageFormName>RINSE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077789</ApplicationNumber>
<LabelerName>Xttrium Laboratories, Inc.</LabelerName>
<SubstanceName>CHLORHEXIDINE GLUCONATE</SubstanceName>
<StrengthNumber>1.2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Decreased Cell Wall Integrity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Chlorhexidine gluconate oral rinse is indicated for use between dental visits as part of a professional program for the treatment of gingivitis as characterized by redness and swelling of the gingivae, including gingival bleeding upon probing. Chlorhexidine gluconate oral rinse has not been tested among patients with acute necrotizing ulcerative gingivitis (ANUG). For patients having coexisting gingivitis and periodontitis, see PRECAUTIONS.</IndicationAndUsage>
<Description>0.12% chlorhexidine gluconate (CHG) is an oral rinse containing (1,1'-hexamethylene bis [5-(p-chlorophenyl) biguanide]di-D-gluconate) in a base containing water, 11 .6% alcohol, glycerin, PEG-40 sorbitan diisostearate, flavor, sodium saccharin, and FD&C Blue No.1. Chlorhexidine gluconate product is a near neutral solution (pH range 5-7). Chlorhexidine gluconate is a salt of chlorhexidine and gluconic acid. Its chemical structure is:.</Description>
</NDC>
</NDCList>