{
"NDC": [
{
"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": "72617-0001-1",
"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": "72617-2001-1",
"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": "72617-2002-1",
"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": "72617-3001-2",
"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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"PackageDescription": "30 TABLET, CHEWABLE in 1 BOTTLE (72617-5001-4) ",
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"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",
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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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"ProductNdcExcludeFlag": "N",
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{
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"ProductTypeName": "HUMAN OTC DRUG",
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"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",
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"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190123",
"SamplePackage": "N",
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},
{
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"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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"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"SamplePackage": "N",
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},
{
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"ProductNDC": "0002-2003",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Olanzapine Pamoate",
"DosageFormName": "INJECTION, POWDER, FOR SUSPENSION, EXTENDED RELEASE",
"StartMarketingDate": "20091211",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "OLANZAPINE PAMOATE",
"StrengthNumber": "300",
"StrengthUnit": "mg/2mL",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "11-DEC-09"
},
{
"NDCCode": "0067-2003-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (0067-2003-01) / 100 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "00067-2003-01",
"ProductNDC": "0067-2003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Excedrin",
"ProprietaryNameSuffix": "Extra Strength Headache",
"NonProprietaryName": "Acetaminophen, Aspirin (nsaid), Caffeine",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20240101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Haleon US Holdings LLC",
"SubstanceName": "ACETAMINOPHEN; ASPIRIN; CAFFEINE",
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"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": "2024-01-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20240101",
"SamplePackage": "N",
"IndicationAndUsage": " temporarily relieves minor aches and pains due to: 1 headache, 2 a cold, 3 arthritis, 4 muscular aches, 5 toothache, 6 premenstrual and menstrual cramps."
},
{
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"PackageDescription": "1 BOTTLE in 1 CARTON (0067-2003-02) / 200 TABLET, FILM COATED in 1 BOTTLE",
"NDC11Code": "00067-2003-02",
"ProductNDC": "0067-2003",
"ProductTypeName": "HUMAN OTC DRUG",
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"DosageFormName": "TABLET, FILM COATED",
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"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M013",
"LabelerName": "Haleon US Holdings LLC",
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"Status": "Active",
"LastUpdate": "2024-01-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"StartMarketingDatePackage": "20240101",
"SamplePackage": "N",
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},
{
"NDCCode": "0113-2003-12",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (0113-2003-12) > 1 TABLET in 1 BLISTER PACK",
"NDC11Code": "00113-2003-12",
"ProductNDC": "0113-2003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Option 2",
"NonProprietaryName": "Levonorgestrel",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160129",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA202334",
"LabelerName": "L. Perrigo Company",
"SubstanceName": "LEVONORGESTREL",
"StrengthNumber": "1.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Inhibit Ovum Fertilization [PE], Progesterone Congeners [CS], Progesterone Congeners [CS], Progestin [EPC], Progestin-containing Intrauterine Device [EPC]",
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"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160129",
"SamplePackage": "N",
"IndicationAndUsage": "for women to reduce chance of pregnancy after unprotected sex (if a contraceptive failed or if you did not use birth control)."
},
{
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"PackageDescription": "100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0378-2003-01)",
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"ProductNDC": "0378-2003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Paroxetine Hydrochloride",
"NonProprietaryName": "Paroxetine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20080514",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077873",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "PAROXETINE HYDROCHLORIDE HEMIHYDRATE",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2014-10-31"
},
{
"NDCCode": "0378-2003-05",
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"LastUpdate": "2019-12-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20080514",
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"SamplePackage": "N"
},
{
"NDCCode": "0378-2003-93",
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"ProductNDC": "0378-2003",
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"DosageFormName": "TABLET, FILM COATED, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20080514",
"EndMarketingDate": "20211130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077873",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "PAROXETINE HYDROCHLORIDE HEMIHYDRATE",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2021-12-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20080514",
"EndMarketingDatePackage": "20211130",
"SamplePackage": "N"
},
{
"NDCCode": "0574-2003-02",
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"ProductNDC": "0574-2003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Polystyrene Sulfonate",
"NonProprietaryName": "Sodium Polystyrene Sulfonate",
"DosageFormName": "SUSPENSION",
"RouteName": "ORAL; RECTAL",
"StartMarketingDate": "20110921",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090590",
"LabelerName": "Paddock Laboratories, LLC",
"SubstanceName": "SODIUM POLYSTYRENE SULFONATE",
"StrengthNumber": "15",
"StrengthUnit": "g/60mL",
"Status": "Deprecated",
"LastUpdate": "2020-12-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20140402",
"SamplePackage": "N"
},
{
"NDCCode": "0574-2003-16",
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"NDC11Code": "00574-2003-16",
"ProductNDC": "0574-2003",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Polystyrene Sulfonate",
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"DosageFormName": "SUSPENSION",
"RouteName": "ORAL; RECTAL",
"StartMarketingDate": "20110921",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090590",
"LabelerName": "Paddock Laboratories, LLC",
"SubstanceName": "SODIUM POLYSTYRENE SULFONATE",
"StrengthNumber": "15",
"StrengthUnit": "g/60mL",
"Status": "Deprecated",
"LastUpdate": "2020-12-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20140414",
"SamplePackage": "N"
},
{
"NDCCode": "10106-2003-1",
"PackageDescription": "25 kg in 1 BAG (10106-2003-1)",
"NDC11Code": "10106-2003-01",
"ProductNDC": "10106-2003",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Calcium Acetate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20160805",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Avantor Performance Materials, LLC",
"SubstanceName": "CALCIUM ACETATE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "10106-2003-2",
"PackageDescription": "50 kg in 1 DRUM (10106-2003-2)",
"NDC11Code": "10106-2003-02",
"ProductNDC": "10106-2003",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Calcium Acetate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20160805",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Avantor Performance Materials, LLC",
"SubstanceName": "CALCIUM ACETATE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "11532-2003-1",
"PackageDescription": "40000 TABLET in 1 DRUM (11532-2003-1) ",
"NDC11Code": "11532-2003-01",
"ProductNDC": "11532-2003",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Azilsartan Kamedoxomil",
"DosageFormName": "TABLET",
"StartMarketingDate": "20110225",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Takeda Pharmaceutical Company Limited",
"SubstanceName": "AZILSARTAN KAMEDOXOMIL",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Status": "Unfinished",
"LastUpdate": "2022-12-27",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "25-FEB-11"
},
{
"NDCCode": "11822-2003-1",
"PackageDescription": "332 mL in 1 BOTTLE, PLASTIC (11822-2003-1) ",
"NDC11Code": "11822-2003-01",
"ProductNDC": "11822-2003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Simplify Clean And Protect Cool Splash Lhs",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20250116",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "505G(a)(3)",
"LabelerName": "RITE AID CORPORATION",
"SubstanceName": "BENZALKONIUM CHLORIDE",
"StrengthNumber": "130",
"StrengthUnit": "mg/100mL",
"Status": "Active",
"LastUpdate": "2026-05-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250116",
"SamplePackage": "N",
"IndicationAndUsage": "For Hand washing to decrease bacteria on the skin."
},
{
"NDCCode": "12079-2003-1",
"PackageDescription": "1 BAG in 1 DRUM (12079-2003-1) > 10 kg in 1 BAG",
"NDC11Code": "12079-2003-01",
"ProductNDC": "12079-2003",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Istradefylline",
"DosageFormName": "POWDER",
"StartMarketingDate": "20160121",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Kyowa Pharma Chemical Co., Ltd.",
"SubstanceName": "ISTRADEFYLLINE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2020-12-30",
"ListingRecordCertifiedThrough": "20211231"
},
{
"NDCCode": "12497-2003-1",
"PackageDescription": "1 BAG in 1 DRUM (12497-2003-1) / 50 kg in 1 BAG",
"NDC11Code": "12497-2003-01",
"ProductNDC": "12497-2003",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "L-serine",
"DosageFormName": "POWDER",
"StartMarketingDate": "19870223",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Kyowa Hakko Bio Co., Ltd.",
"SubstanceName": "SERINE",
"StrengthNumber": "50",
"StrengthUnit": "kg/50kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "23-FEB-87"
},
{
"NDCCode": "13636-2003-1",
"PackageDescription": "25 kg in 1 DRUM (13636-2003-1)",
"NDC11Code": "13636-2003-01",
"ProductNDC": "13636-2003",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Croscarmellose Sodium",
"DosageFormName": "POWDER",
"StartMarketingDate": "20100830",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Amishi Drugs and Chemicals Limited",
"SubstanceName": "CROSCARMELLOSE SODIUM",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "14222-2003-2",
"PackageDescription": "1 TUBE in 1 BOX (14222-2003-2) > 30 mL in 1 TUBE (14222-2003-1)",
"NDC11Code": "14222-2003-02",
"ProductNDC": "14222-2003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Soothe",
"ProprietaryNameSuffix": "Rodan Fields",
"NonProprietaryName": "Hydrocortisone",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110607",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Rodan & Fields, LLC.",
"SubstanceName": "HYDROCORTISONE",
"StrengthNumber": "1",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<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>72617-0001-1</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>
<StrengthNumber>12; 12; 12; 12; 6; 6; 12; 12; 6; 6; 12</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<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]</Pharm_Classes>
<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>72617-2001-1</NDCCode>
<PackageDescription>29.6 mL in 1 BOTTLE, DROPPER (72617-2001-1) </PackageDescription>
<NDC11Code>72617-2001-01</NDC11Code>
<ProductNDC>72617-2001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergy Mix Las Vegas</ProprietaryName>
<NonProprietaryName>Local Remedy Las Vegas</NonProprietaryName>
<DosageFormName>LIQUID</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]/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>72617-2002-1</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>
<StrengthNumber>6; 12; 12; 6; 6; 6; 6; 6; 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</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>0002-2003-00</NDCCode>
<PackageDescription>2 mL in 1 VIAL (0002-2003-00) </PackageDescription>
<NDC11Code>00002-2003-00</NDC11Code>
<ProductNDC>0002-2003</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Olanzapine Pamoate</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SUSPENSION, EXTENDED RELEASE</DosageFormName>
<StartMarketingDate>20091211</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>OLANZAPINE PAMOATE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/2mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>11-DEC-09</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>0067-2003-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0067-2003-01) / 100 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>00067-2003-01</NDC11Code>
<ProductNDC>0067-2003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Excedrin</ProprietaryName>
<ProprietaryNameSuffix>Extra Strength Headache</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Aspirin (nsaid), Caffeine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240101</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>2024-01-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> temporarily relieves minor aches and pains due to: 1 headache, 2 a cold, 3 arthritis, 4 muscular aches, 5 toothache, 6 premenstrual and menstrual cramps.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0067-2003-02</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0067-2003-02) / 200 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>00067-2003-02</NDC11Code>
<ProductNDC>0067-2003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Excedrin</ProprietaryName>
<ProprietaryNameSuffix>Extra Strength Headache</ProprietaryNameSuffix>
<NonProprietaryName>Acetaminophen, Aspirin (nsaid), Caffeine</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240101</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>2024-01-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage> temporarily relieves minor aches and pains due to: 1 headache, 2 a cold, 3 arthritis, 4 muscular aches, 5 toothache, 6 premenstrual and menstrual cramps.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0113-2003-12</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (0113-2003-12) > 1 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00113-2003-12</NDC11Code>
<ProductNDC>0113-2003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Option 2</ProprietaryName>
<NonProprietaryName>Levonorgestrel</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160129</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA202334</ApplicationNumber>
<LabelerName>L. Perrigo Company</LabelerName>
<SubstanceName>LEVONORGESTREL</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Inhibit Ovum Fertilization [PE], Progesterone Congeners [CS], Progesterone Congeners [CS], Progestin [EPC], Progestin-containing Intrauterine Device [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2020-08-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160129</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>for women to reduce chance of pregnancy after unprotected sex (if a contraceptive failed or if you did not use birth control).</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0378-2003-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0378-2003-01)</PackageDescription>
<NDC11Code>00378-2003-01</NDC11Code>
<ProductNDC>0378-2003</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Paroxetine Hydrochloride</ProprietaryName>
<NonProprietaryName>Paroxetine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080514</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077873</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>PAROXETINE HYDROCHLORIDE HEMIHYDRATE</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2014-10-31</LastUpdate>
</NDC>
<NDC>
<NDCCode>0378-2003-05</NDCCode>
<PackageDescription>500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0378-2003-05) </PackageDescription>
<NDC11Code>00378-2003-05</NDC11Code>
<ProductNDC>0378-2003</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Paroxetine Hydrochloride</ProprietaryName>
<NonProprietaryName>Paroxetine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080514</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077873</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>PAROXETINE HYDROCHLORIDE HEMIHYDRATE</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-12-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20080514</StartMarketingDatePackage>
<EndMarketingDatePackage>20191130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0378-2003-93</NDCCode>
<PackageDescription>30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0378-2003-93) </PackageDescription>
<NDC11Code>00378-2003-93</NDC11Code>
<ProductNDC>0378-2003</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Paroxetine Hydrochloride</ProprietaryName>
<NonProprietaryName>Paroxetine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20080514</StartMarketingDate>
<EndMarketingDate>20211130</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077873</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>PAROXETINE HYDROCHLORIDE HEMIHYDRATE</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-12-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20080514</StartMarketingDatePackage>
<EndMarketingDatePackage>20211130</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0574-2003-02</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE (0574-2003-02) </PackageDescription>
<NDC11Code>00574-2003-02</NDC11Code>
<ProductNDC>0574-2003</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Polystyrene Sulfonate</ProprietaryName>
<NonProprietaryName>Sodium Polystyrene Sulfonate</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL; RECTAL</RouteName>
<StartMarketingDate>20110921</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090590</ApplicationNumber>
<LabelerName>Paddock Laboratories, LLC</LabelerName>
<SubstanceName>SODIUM POLYSTYRENE SULFONATE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>g/60mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-12-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140402</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0574-2003-16</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (0574-2003-16) </PackageDescription>
<NDC11Code>00574-2003-16</NDC11Code>
<ProductNDC>0574-2003</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Polystyrene Sulfonate</ProprietaryName>
<NonProprietaryName>Sodium Polystyrene Sulfonate</NonProprietaryName>
<DosageFormName>SUSPENSION</DosageFormName>
<RouteName>ORAL; RECTAL</RouteName>
<StartMarketingDate>20110921</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090590</ApplicationNumber>
<LabelerName>Paddock Laboratories, LLC</LabelerName>
<SubstanceName>SODIUM POLYSTYRENE SULFONATE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>g/60mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-12-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140414</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>10106-2003-1</NDCCode>
<PackageDescription>25 kg in 1 BAG (10106-2003-1)</PackageDescription>
<NDC11Code>10106-2003-01</NDC11Code>
<ProductNDC>10106-2003</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Calcium Acetate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20160805</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Avantor Performance Materials, LLC</LabelerName>
<SubstanceName>CALCIUM ACETATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>10106-2003-2</NDCCode>
<PackageDescription>50 kg in 1 DRUM (10106-2003-2)</PackageDescription>
<NDC11Code>10106-2003-02</NDC11Code>
<ProductNDC>10106-2003</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Calcium Acetate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20160805</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Avantor Performance Materials, LLC</LabelerName>
<SubstanceName>CALCIUM ACETATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>11532-2003-1</NDCCode>
<PackageDescription>40000 TABLET in 1 DRUM (11532-2003-1) </PackageDescription>
<NDC11Code>11532-2003-01</NDC11Code>
<ProductNDC>11532-2003</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Azilsartan Kamedoxomil</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<StartMarketingDate>20110225</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Takeda Pharmaceutical Company Limited</LabelerName>
<SubstanceName>AZILSARTAN KAMEDOXOMIL</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2022-12-27</LastUpdate>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>25-FEB-11</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>11822-2003-1</NDCCode>
<PackageDescription>332 mL in 1 BOTTLE, PLASTIC (11822-2003-1) </PackageDescription>
<NDC11Code>11822-2003-01</NDC11Code>
<ProductNDC>11822-2003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Simplify Clean And Protect Cool Splash Lhs</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20250116</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>505G(a)(3)</ApplicationNumber>
<LabelerName>RITE AID CORPORATION</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE</SubstanceName>
<StrengthNumber>130</StrengthNumber>
<StrengthUnit>mg/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-05-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250116</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For Hand washing to decrease bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>12079-2003-1</NDCCode>
<PackageDescription>1 BAG in 1 DRUM (12079-2003-1) > 10 kg in 1 BAG</PackageDescription>
<NDC11Code>12079-2003-01</NDC11Code>
<ProductNDC>12079-2003</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Istradefylline</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20160121</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Kyowa Pharma Chemical Co., Ltd.</LabelerName>
<SubstanceName>ISTRADEFYLLINE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2020-12-30</LastUpdate>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>12497-2003-1</NDCCode>
<PackageDescription>1 BAG in 1 DRUM (12497-2003-1) / 50 kg in 1 BAG</PackageDescription>
<NDC11Code>12497-2003-01</NDC11Code>
<ProductNDC>12497-2003</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>L-serine</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>19870223</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Kyowa Hakko Bio Co., Ltd.</LabelerName>
<SubstanceName>SERINE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>kg/50kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>23-FEB-87</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>13636-2003-1</NDCCode>
<PackageDescription>25 kg in 1 DRUM (13636-2003-1)</PackageDescription>
<NDC11Code>13636-2003-01</NDC11Code>
<ProductNDC>13636-2003</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Croscarmellose Sodium</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20100830</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Amishi Drugs and Chemicals Limited</LabelerName>
<SubstanceName>CROSCARMELLOSE SODIUM</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>14222-2003-2</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (14222-2003-2) > 30 mL in 1 TUBE (14222-2003-1)</PackageDescription>
<NDC11Code>14222-2003-02</NDC11Code>
<ProductNDC>14222-2003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Soothe</ProprietaryName>
<ProprietaryNameSuffix>Rodan Fields</ProprietaryNameSuffix>
<NonProprietaryName>Hydrocortisone</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110607</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>Rodan & Fields, LLC.</LabelerName>
<SubstanceName>HYDROCORTISONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
</NDCList>