{
"NDC": [
{
"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": "72617-2003-1",
"PackageDescription": "29.6 mL in 1 BOTTLE, DROPPER (72617-2003-1) ",
"NDC11Code": "72617-2003-01",
"ProductNDC": "72617-2003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allergy Mix Los Angeles",
"NonProprietaryName": "Local Remedy Los Angeles",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20190123",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "ASN",
"SubstanceName": "ALTERNARIA ALTERNATA; AMBROSIA ARTEMISIIFOLIA; HISTAMINE DIHYDROCHLORIDE; JUNIPERUS ASHEI POLLEN; JUNIPERUS SCOPULORUM POLLEN; NERIUM OLEANDER FLOWER; OLEA EUROPAEA FLOWER; PASSALORA FULVA; SCHOENOCAULON OFFICINALE SEED; USTILAGO MAYDIS; WHITE MULBERRY",
"StrengthNumber": "6; 12; 12; 6; 6; 6; 6; 6; 12; 6; 6",
"StrengthUnit": "[hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190123",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: Allergy symptom reliefFor temporary relief of symptoms due to hay fever or otherrespiratory allergies. Runny nose, sneezing, irritated eyes,nasal congestion, itchy nose and throat, sinus pain."
},
{
"NDCCode": "72617-3001-2",
"PackageDescription": "1 BOTTLE in 1 PACKAGE (72617-3001-2) > 15 mL in 1 BOTTLE",
"NDC11Code": "72617-3001-02",
"ProductNDC": "72617-3001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allergy Mix Las Vegas",
"NonProprietaryName": "Local Remedy Las Vegas",
"DosageFormName": "SPRAY",
"RouteName": "NASAL",
"StartMarketingDate": "20190101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "ASN",
"SubstanceName": "ALTERNARIA ALTERNATA; JUNIPERUS ASHEI POLLEN; JUNIPERUS SCOPULORUM POLLEN; NERIUM OLEANDER FLOWER; OLEA EUROPAEA FLOWER; PASSALORA FULVA; USTILAGO MAYDIS; WHITE MULBERRY",
"StrengthNumber": "6; 6; 6; 6; 6; 6; 6; 6",
"StrengthUnit": "[hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190123",
"SamplePackage": "N",
"IndicationAndUsage": "UsesFor temporary relief of symptoms due to hay feveror other respiratory allergies. Runny nose, sneezing,irritated eyes, nasal congestion, itchy nose andthroat, sinus pain."
},
{
"NDCCode": "72617-3002-2",
"PackageDescription": "1 BOTTLE in 1 PACKAGE (72617-3002-2) > 15 mL in 1 BOTTLE",
"NDC11Code": "72617-3002-02",
"ProductNDC": "72617-3002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allergy Mix Phoenix",
"NonProprietaryName": "Local Remedy Phoenix",
"DosageFormName": "SPRAY",
"RouteName": "NASAL",
"StartMarketingDate": "20190101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "ASN",
"SubstanceName": "ALTERNARIA ALTERNATA; AMBROSIA ARTEMISIIFOLIA; CYNODON DACTYLON; JUNIPERUS ASHEI POLLEN; JUNIPERUS SCOPULORUM POLLEN; NERIUM OLEANDER FLOWER; OLEA EUROPAEA FLOWER; PASSALORA FULVA; USTILAGO MAYDIS; WHITE MULBERRY",
"StrengthNumber": "6; 12; 12; 6; 6; 6; 6; 6; 6; 6",
"StrengthUnit": "[hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190123",
"SamplePackage": "N",
"IndicationAndUsage": "UsesFor temporary relief of symptoms due to hay feveror other respiratory allergies. Runny nose, sneezing,irritated eyes, nasal congestion, itchy nose andthroat, sinus pain."
},
{
"NDCCode": "72617-3003-2",
"PackageDescription": "120 TABLET, CHEWABLE in 1 BOTTLE (72617-3003-2) ",
"NDC11Code": "72617-3003-02",
"ProductNDC": "72617-3003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allergy Mix Los Angeles",
"NonProprietaryName": "Local Remedy Los Angeles",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20190123",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "ASN",
"SubstanceName": "ALTERNARIA ALTERNATA; AMBROSIA ARTEMISIIFOLIA; HISTAMINE DIHYDROCHLORIDE; JUNIPERUS ASHEI POLLEN; JUNIPERUS SCOPULORUM POLLEN; NERIUM OLEANDER FLOWER; OLEA EUROPAEA FLOWER; PASSALORA FULVA; SCHOENOCAULON OFFICINALE SEED; USTILAGO MAYDIS; WHITE MULBERRY",
"StrengthNumber": "6; 12; 12; 6; 6; 6; 6; 6; 12; 6; 6",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190123",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: Allergy symptom reliefFor temporary relief of symptoms due to hay feveror other respiratory allergies. Runny nose,sneezing, irritated eyes, nasal congestion, itchynose and throat, sinus pain."
},
{
"NDCCode": "72617-4001-3",
"PackageDescription": "120 TABLET, CHEWABLE in 1 BOTTLE (72617-4001-3) ",
"NDC11Code": "72617-4001-03",
"ProductNDC": "72617-4001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allergy Mix Las Vegas",
"NonProprietaryName": "Local Remedy Las Vegas",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20190123",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "ASN",
"SubstanceName": "ALTERNARIA ALTERNATA; JUNIPERUS ASHEI POLLEN; JUNIPERUS SCOPULORUM POLLEN; NERIUM OLEANDER FLOWER; OLEA EUROPAEA FLOWER; PASSALORA FULVA; USTILAGO MAYDIS; WHITE MULBERRY",
"StrengthNumber": "6; 6; 6; 6; 6; 6; 6; 6",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190123",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: Allergy symptom reliefFor temporary relief of symptoms due to hay feveror other respiratory allergies. Runny nose,sneezing, irritated eyes, nasal congestion, itchynose and throat, sinus pain."
},
{
"NDCCode": "72617-4002-3",
"PackageDescription": "120 TABLET, CHEWABLE in 1 BOTTLE (72617-4002-3) ",
"NDC11Code": "72617-4002-03",
"ProductNDC": "72617-4002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allergy Mix Phoenix",
"NonProprietaryName": "Local Remedy Phoenix",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20190123",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "ASN",
"SubstanceName": "ALTERNARIA ALTERNATA; AMBROSIA ARTEMISIIFOLIA; CYNODON DACTYLON; JUNIPERUS ASHEI POLLEN; JUNIPERUS SCOPULORUM POLLEN; NERIUM OLEANDER FLOWER; OLEA EUROPAEA FLOWER; PASSALORA FULVA; USTILAGO MAYDIS; WHITE MULBERRY",
"StrengthNumber": "6; 12; 12; 6; 6; 6; 6; 6; 6; 6",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190123",
"SamplePackage": "N",
"IndicationAndUsage": "Uses: Allergy symptom reliefFor temporary relief of symptoms due to hay feveror other respiratory allergies. Runny nose,sneezing, irritated eyes, nasal congestion, itchynose and throat, sinus pain."
},
{
"NDCCode": "72617-4003-3",
"PackageDescription": "1 BOTTLE in 1 PACKAGE (72617-4003-3) > 15 mL in 1 BOTTLE",
"NDC11Code": "72617-4003-03",
"ProductNDC": "72617-4003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allergy Mix",
"NonProprietaryName": "Local Remedy Los Angeles",
"DosageFormName": "SPRAY",
"RouteName": "NASAL",
"StartMarketingDate": "20190101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "ASN",
"SubstanceName": "ALTERNARIA ALTERNATA; AMBROSIA ARTEMISIIFOLIA; HISTAMINE DIHYDROCHLORIDE; JUNIPERUS ASHEI POLLEN; JUNIPERUS SCOPULORUM POLLEN; NERIUM OLEANDER FLOWER; OLEA EUROPAEA FLOWER; PASSALORA FULVA; SCHOENOCAULON OFFICINALE SEED; USTILAGO MAYDIS; WHITE MULBERRY",
"StrengthNumber": "6; 12; 12; 6; 6; 6; 6; 6; 12; 6; 6",
"StrengthUnit": "[hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190101",
"SamplePackage": "N",
"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": "72617-5001-4",
"PackageDescription": "30 TABLET, CHEWABLE in 1 BOTTLE (72617-5001-4) ",
"NDC11Code": "72617-5001-04",
"ProductNDC": "72617-5001",
"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": "72617-5002-4",
"PackageDescription": "30 TABLET, CHEWABLE in 1 BOTTLE (72617-5002-4) ",
"NDC11Code": "72617-5002-04",
"ProductNDC": "72617-5002",
"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": "72617-5003-4",
"PackageDescription": "30 TABLET, CHEWABLE in 1 BOTTLE (72617-5003-4) ",
"NDC11Code": "72617-5003-04",
"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",
"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": "0006-0001-01",
"PackageDescription": "1 BAG in 1 DRUM (0006-0001-01) > 480000 TABLET, FILM COATED in 1 BAG",
"NDC11Code": "00006-0001-01",
"ProductNDC": "0006-0001",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Suvorexant",
"DosageFormName": "TABLET, FILM COATED",
"StartMarketingDate": "20140815",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Merck Sharp & Dohme LLC.",
"SubstanceName": "SUVOREXANT",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"DEASchedule": "CIV",
"Status": "Unfinished",
"LastUpdate": "2022-11-04",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "15-AUG-14"
},
{
"NDCCode": "0268-0001-10",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (0268-0001-10)",
"NDC11Code": "00268-0001-10",
"ProductNDC": "0268-0001",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "House Dust",
"NonProprietaryName": "House Dust",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "19650101",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103753",
"LabelerName": "ALK-Abello, Inc.",
"SubstanceName": "HOUSE DUST",
"StrengthNumber": "1000",
"StrengthUnit": "[PNU]/mL",
"Pharm_Classes": "Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "0280-0001-01",
"PackageDescription": "2 BLISTER PACK in 1 CARTON (0280-0001-01) / 8 GUM, CHEWING in 1 BLISTER PACK",
"NDC11Code": "00280-0001-01",
"ProductNDC": "0280-0001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Alka-seltzer Cool Action Heartburn Relief",
"ProprietaryNameSuffix": "Mint",
"NonProprietaryName": "Calcium Carbonate",
"DosageFormName": "GUM, CHEWING",
"RouteName": "ORAL",
"StartMarketingDate": "20200301",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M001",
"LabelerName": "Bayer HealthCare LLC.",
"SubstanceName": "CALCIUM CARBONATE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200301",
"SamplePackage": "N",
"IndicationAndUsage": "Uses for the relief of:. ● acid indigestion ● heartburn ● sour stomach. ● upset stomach associated with these symptoms."
},
{
"NDCCode": "0280-0001-02",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (0280-0001-02) / 8 GUM, CHEWING in 1 BLISTER PACK",
"NDC11Code": "00280-0001-02",
"ProductNDC": "0280-0001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Alka-seltzer Cool Action Heartburn Relief",
"ProprietaryNameSuffix": "Mint",
"NonProprietaryName": "Calcium Carbonate",
"DosageFormName": "GUM, CHEWING",
"RouteName": "ORAL",
"StartMarketingDate": "20200301",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M001",
"LabelerName": "Bayer HealthCare LLC.",
"SubstanceName": "CALCIUM CARBONATE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200501",
"SamplePackage": "N",
"IndicationAndUsage": "Uses for the relief of:. ● acid indigestion ● heartburn ● sour stomach. ● upset stomach associated with these symptoms."
},
{
"NDCCode": "0280-0001-03",
"PackageDescription": "1 GUM, CHEWING in 1 POUCH (0280-0001-03) ",
"NDC11Code": "00280-0001-03",
"ProductNDC": "0280-0001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Alka-seltzer Cool Action Heartburn Relief",
"ProprietaryNameSuffix": "Mint",
"NonProprietaryName": "Calcium Carbonate",
"DosageFormName": "GUM, CHEWING",
"RouteName": "ORAL",
"StartMarketingDate": "20200301",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M001",
"LabelerName": "Bayer HealthCare LLC.",
"SubstanceName": "CALCIUM CARBONATE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200601",
"SamplePackage": "N",
"IndicationAndUsage": "Uses for the relief of:. ● acid indigestion ● heartburn ● sour stomach. ● upset stomach associated with these symptoms."
},
{
"NDCCode": "0280-0001-04",
"PackageDescription": "6 BLISTER PACK in 1 CARTON (0280-0001-04) / 10 GUM, CHEWING in 1 BLISTER PACK",
"NDC11Code": "00280-0001-04",
"ProductNDC": "0280-0001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Alka-seltzer Cool Action Heartburn Relief",
"ProprietaryNameSuffix": "Mint",
"NonProprietaryName": "Calcium Carbonate",
"DosageFormName": "GUM, CHEWING",
"RouteName": "ORAL",
"StartMarketingDate": "20200301",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M001",
"LabelerName": "Bayer HealthCare LLC.",
"SubstanceName": "CALCIUM CARBONATE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20241115",
"SamplePackage": "N",
"IndicationAndUsage": "Uses for the relief of:. ● acid indigestion ● heartburn ● sour stomach. ● upset stomach associated with these symptoms."
},
{
"NDCCode": "0327-0001-10",
"PackageDescription": "5 VIAL in 1 BOX (0327-0001-10) > 2 g in 1 VIAL",
"NDC11Code": "00327-0001-10",
"ProductNDC": "0327-0001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Clorpactin Wcs-90",
"NonProprietaryName": "Chlorine",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "19550101",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "United-Guardian, Inc.",
"SubstanceName": "CHLORINE",
"StrengthNumber": ".16",
"StrengthUnit": "g/2g",
"Status": "Active",
"LastUpdate": "2022-10-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19550101",
"SamplePackage": "N",
"IndicationAndUsage": "Topical Antisepsis."
},
{
"NDCCode": "0363-0001-44",
"PackageDescription": ".5 L in 1 BOTTLE, PLASTIC (0363-0001-44)",
"NDC11Code": "00363-0001-44",
"ProductNDC": "0363-0001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anticavity Rinse",
"NonProprietaryName": "Sodium Fluoride",
"DosageFormName": "MOUTHWASH",
"RouteName": "ORAL",
"StartMarketingDate": "20020627",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part355",
"LabelerName": "Walgreen Co",
"SubstanceName": "SODIUM FLUORIDE",
"StrengthNumber": ".05",
"StrengthUnit": "kg/100L",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "0378-0001-01",
"PackageDescription": "100 TABLET in 1 BOTTLE, PLASTIC (0378-0001-01)",
"NDC11Code": "00378-0001-01",
"ProductNDC": "0378-0001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Clorpres",
"NonProprietaryName": "Clonidine Hydrochloride And Chlorthalidone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19980313",
"EndMarketingDate": "20180228",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA071325",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "CLONIDINE HYDROCHLORIDE; CHLORTHALIDONE",
"StrengthNumber": ".1; 15",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC],Increased Diuresis [PE],Thiazide-like Diuretic [EPC]",
"Status": "Deprecated",
"LastUpdate": "2018-03-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0404-0001-01",
"PackageDescription": "3785 mL in 1 BOTTLE, PLASTIC (0404-0001-01) ",
"NDC11Code": "00404-0001-01",
"ProductNDC": "0404-0001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hydrogen Peroxide",
"NonProprietaryName": "Hydrogen Peroxide",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140601",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "Henry Schein Inc.",
"SubstanceName": "HYDROGEN PEROXIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-01-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140601",
"SamplePackage": "N"
},
{
"NDCCode": "0404-0001-08",
"PackageDescription": "237 mL in 1 BOTTLE, PLASTIC (0404-0001-08) ",
"NDC11Code": "00404-0001-08",
"ProductNDC": "0404-0001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hydrogen Peroxide",
"NonProprietaryName": "Hydrogen Peroxide",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140601",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "Henry Schein Inc.",
"SubstanceName": "HYDROGEN PEROXIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-01-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140601",
"SamplePackage": "N"
},
{
"NDCCode": "0404-0001-16",
"PackageDescription": "473 mL in 1 BOTTLE, PLASTIC (0404-0001-16) ",
"NDC11Code": "00404-0001-16",
"ProductNDC": "0404-0001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hydrogen Peroxide",
"NonProprietaryName": "Hydrogen Peroxide",
"DosageFormName": "SOLUTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140601",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M003",
"LabelerName": "Henry Schein Inc.",
"SubstanceName": "HYDROGEN PEROXIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-01-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20140601",
"SamplePackage": "N"
},
{
"NDCCode": "0409-0001-25",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (0409-0001-25) / 2 mL in 1 VIAL, SINGLE-DOSE (0409-0001-01) ",
"NDC11Code": "00409-0001-25",
"ProductNDC": "0409-0001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Midazolam",
"NonProprietaryName": "Midazolam Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20250127",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075857",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "MIDAZOLAM HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Benzodiazepine [EPC], Benzodiazepines [CS]",
"DEASchedule": "CIV",
"Status": "Active",
"LastUpdate": "2026-08-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20250127",
"SamplePackage": "N",
"IndicationAndUsage": "Midazolam injection is indicated: 1 intramuscularly or intravenously for preoperative sedation/anxiolysis/amnesia;, 2 intravenously as an agent for sedation/anxiolysis/amnesia prior to or during diagnostic, therapeutic or endoscopic procedures, such as bronchoscopy, gastroscopy, cystoscopy, coronary angiography, cardiac catheterization, oncology procedures, radiologic procedures, suture of lacerations and other procedures either alone or in combination with other CNS depressants;, 3 intravenously for induction of general anesthesia, before administration of other anesthetic agents. With the use of narcotic premedication, induction of anesthesia can be attained within a relatively narrow dose range and in a short period of time. Intravenous midazolam can also be used as a component of intravenous supplementation of nitrous oxide and oxygen (balanced anesthesia);, 4 continuous intravenous infusion for sedation of intubated and mechanically ventilated patients as a component of anesthesia or during treatment in a critical care setting.",
"Description": "Midazolam hydrochloride injection is a water-soluble benzodiazepine available as a sterile, nonpyrogenic parenteral dosage form for intravenous or intramuscular injection. Each mL contains midazolam hydrochloride equivalent to 1 mg or 5 mg midazolam compounded with 0.8% sodium chloride. The pH is adjusted to approximately 3 with hydrochloric acid and, if necessary, sodium hydroxide. Midazolam is a white to light yellow crystalline compound, insoluble in water. The hydrochloride salt of midazolam, which is formed in situ, is soluble in aqueous solutions. Chemically, midazolam HCl is 8-chloro-6-(2-fluorophenyl)-1-methyl-4H-imidazo[1,5-a][1,4]benzodiazepine hydrochloride. Midazolam hydrochloride has the empirical formula C18H13ClFN3∙HCl, a calculated molecular weight of 362.25 and the following structural formula. Under the acidic conditions required to solubilize midazolam in the product, midazolam is present as an equilibrium mixture (shown below) of the closed-ring form shown above and an open-ring structure formed by the acid-catalyzed ring opening of the 4,5-double bond of the diazepine ring. The amount of open-ring form is dependent upon the pH of the solution. At the specified pH of the product, the solution may contain up to about 25% of the open-ring compound. At the physiologic conditions under which the product is absorbed (pH of 5 to 8) into the systemic circulation, any open-ring form present reverts to the physiologically active, lipophilic, closed-ring form (midazolam) and is absorbed as such. The following chart plots the percentage of midazolam present as the open-ring form as a function of pH in aqueous solutions. As indicated in the graph, the amount of open-ring compound present in solution is sensitive to changes in pH over the pH range specified for the product: 3.0 to 4.0 for the 1 mg/mL concentration and 3.0 to 3.6 for the 5 mg/mL concentration. Above pH 5, at least 99% of the mixture is present in the closed-ring form."
},
{
"NDCCode": "0597-0001-11",
"PackageDescription": "1 BOTTLE in 1 CARTON (0597-0001-11) > 10 CAPSULE, EXTENDED RELEASE in 1 BOTTLE",
"NDC11Code": "00597-0001-11",
"ProductNDC": "0597-0001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aggrenox",
"NonProprietaryName": "Aspirin And Dipyridamole",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19991219",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020884",
"LabelerName": "Boehringer Ingelheim Pharmaceuticals, Inc.",
"SubstanceName": "ASPIRIN; DIPYRIDAMOLE",
"StrengthNumber": "25; 200",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2017-04-24"
},
{
"NDCCode": "0597-0001-60",
"PackageDescription": "1 BOTTLE in 1 CARTON (0597-0001-60) > 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE",
"NDC11Code": "00597-0001-60",
"ProductNDC": "0597-0001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Aggrenox",
"NonProprietaryName": "Aspirin And Dipyridamole",
"DosageFormName": "CAPSULE, EXTENDED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "19991219",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020884",
"LabelerName": "Boehringer Ingelheim Pharmaceuticals Inc.",
"SubstanceName": "ASPIRIN; DIPYRIDAMOLE",
"StrengthNumber": "25; 200",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC]",
"Status": "Deprecated",
"LastUpdate": "2021-08-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "19991219",
"SamplePackage": "N"
},
{
"NDCCode": "0662-0001-99",
"PackageDescription": "10 TRAY in 1 CASE (0662-0001-99) / 10 CARTON in 1 TRAY (0662-0001-10) / 1 VIAL in 1 CARTON (0662-0001-01) / 20 mL in 1 VIAL (0662-0001-20) ",
"NDC11Code": "00662-0001-99",
"ProductNDC": "0662-0001",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Lidocaine Hydrochloride And Epinephrine",
"DosageFormName": "SOLUTION",
"StartMarketingDate": "20191010",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "EPINEPHRINE; LIDOCAINE HYDROCHLORIDE",
"StrengthNumber": "10; 20",
"StrengthUnit": "ug/mL; mg/mL",
"Status": "Unfinished",
"LastUpdate": "2026-04-15",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "10-OCT-19"
},
{
"NDCCode": "0699-0001-01",
"PackageDescription": "33.57 g in 1 BOTTLE, GLASS (0699-0001-01)",
"NDC11Code": "00699-0001-01",
"ProductNDC": "0699-0001",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Formo Cresol",
"NonProprietaryName": "Cresol",
"DosageFormName": "LIQUID",
"RouteName": "DENTAL",
"StartMarketingDate": "19630219",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "DSHealthcare",
"SubstanceName": "CRESOL",
"StrengthNumber": "485",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Indicated as a disinfectant and devitalizing solution used as part of endodontic treatment.",
"Description": "Formocresol: 48.5% formaldehyde, 48.5% cresol, 3% glycerine. Buckley's Formocresol: 19% formaldehyde, 35% cresol, 17.5% gylcerine."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<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>72617-2003-1</NDCCode>
<PackageDescription>29.6 mL in 1 BOTTLE, DROPPER (72617-2003-1) </PackageDescription>
<NDC11Code>72617-2003-01</NDC11Code>
<ProductNDC>72617-2003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergy Mix Los Angeles</ProprietaryName>
<NonProprietaryName>Local Remedy Los Angeles</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190123</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>ASN</LabelerName>
<SubstanceName>ALTERNARIA ALTERNATA; AMBROSIA ARTEMISIIFOLIA; HISTAMINE DIHYDROCHLORIDE; JUNIPERUS ASHEI POLLEN; JUNIPERUS SCOPULORUM POLLEN; NERIUM OLEANDER FLOWER; OLEA EUROPAEA FLOWER; PASSALORA FULVA; SCHOENOCAULON OFFICINALE SEED; USTILAGO MAYDIS; WHITE MULBERRY</SubstanceName>
<StrengthNumber>6; 12; 12; 6; 6; 6; 6; 6; 12; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190123</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: Allergy symptom reliefFor temporary relief of symptoms due to hay fever or otherrespiratory allergies. Runny nose, sneezing, irritated eyes,nasal congestion, itchy nose and throat, sinus pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72617-3001-2</NDCCode>
<PackageDescription>1 BOTTLE in 1 PACKAGE (72617-3001-2) > 15 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>72617-3001-02</NDC11Code>
<ProductNDC>72617-3001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergy Mix Las Vegas</ProprietaryName>
<NonProprietaryName>Local Remedy Las Vegas</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20190101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>ASN</LabelerName>
<SubstanceName>ALTERNARIA ALTERNATA; JUNIPERUS ASHEI POLLEN; JUNIPERUS SCOPULORUM POLLEN; NERIUM OLEANDER FLOWER; OLEA EUROPAEA FLOWER; PASSALORA FULVA; USTILAGO MAYDIS; WHITE MULBERRY</SubstanceName>
<StrengthNumber>6; 6; 6; 6; 6; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190123</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>UsesFor temporary relief of symptoms due to hay feveror other respiratory allergies. Runny nose, sneezing,irritated eyes, nasal congestion, itchy nose andthroat, sinus pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72617-3002-2</NDCCode>
<PackageDescription>1 BOTTLE in 1 PACKAGE (72617-3002-2) > 15 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>72617-3002-02</NDC11Code>
<ProductNDC>72617-3002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergy Mix Phoenix</ProprietaryName>
<NonProprietaryName>Local Remedy Phoenix</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20190101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>ASN</LabelerName>
<SubstanceName>ALTERNARIA ALTERNATA; AMBROSIA ARTEMISIIFOLIA; CYNODON DACTYLON; JUNIPERUS ASHEI POLLEN; JUNIPERUS SCOPULORUM POLLEN; NERIUM OLEANDER FLOWER; OLEA EUROPAEA FLOWER; PASSALORA FULVA; USTILAGO MAYDIS; WHITE MULBERRY</SubstanceName>
<StrengthNumber>6; 12; 12; 6; 6; 6; 6; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190123</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>UsesFor temporary relief of symptoms due to hay feveror other respiratory allergies. Runny nose, sneezing,irritated eyes, nasal congestion, itchy nose andthroat, sinus pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72617-3003-2</NDCCode>
<PackageDescription>120 TABLET, CHEWABLE in 1 BOTTLE (72617-3003-2) </PackageDescription>
<NDC11Code>72617-3003-02</NDC11Code>
<ProductNDC>72617-3003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergy Mix Los Angeles</ProprietaryName>
<NonProprietaryName>Local Remedy Los Angeles</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190123</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>ASN</LabelerName>
<SubstanceName>ALTERNARIA ALTERNATA; AMBROSIA ARTEMISIIFOLIA; HISTAMINE DIHYDROCHLORIDE; JUNIPERUS ASHEI POLLEN; JUNIPERUS SCOPULORUM POLLEN; NERIUM OLEANDER FLOWER; OLEA EUROPAEA FLOWER; PASSALORA FULVA; SCHOENOCAULON OFFICINALE SEED; USTILAGO MAYDIS; WHITE MULBERRY</SubstanceName>
<StrengthNumber>6; 12; 12; 6; 6; 6; 6; 6; 12; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190123</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: Allergy symptom reliefFor temporary relief of symptoms due to hay feveror other respiratory allergies. Runny nose,sneezing, irritated eyes, nasal congestion, itchynose and throat, sinus pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72617-4001-3</NDCCode>
<PackageDescription>120 TABLET, CHEWABLE in 1 BOTTLE (72617-4001-3) </PackageDescription>
<NDC11Code>72617-4001-03</NDC11Code>
<ProductNDC>72617-4001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergy Mix Las Vegas</ProprietaryName>
<NonProprietaryName>Local Remedy Las Vegas</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190123</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>ASN</LabelerName>
<SubstanceName>ALTERNARIA ALTERNATA; JUNIPERUS ASHEI POLLEN; JUNIPERUS SCOPULORUM POLLEN; NERIUM OLEANDER FLOWER; OLEA EUROPAEA FLOWER; PASSALORA FULVA; USTILAGO MAYDIS; WHITE MULBERRY</SubstanceName>
<StrengthNumber>6; 6; 6; 6; 6; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190123</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: Allergy symptom reliefFor temporary relief of symptoms due to hay feveror other respiratory allergies. Runny nose,sneezing, irritated eyes, nasal congestion, itchynose and throat, sinus pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72617-4002-3</NDCCode>
<PackageDescription>120 TABLET, CHEWABLE in 1 BOTTLE (72617-4002-3) </PackageDescription>
<NDC11Code>72617-4002-03</NDC11Code>
<ProductNDC>72617-4002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergy Mix Phoenix</ProprietaryName>
<NonProprietaryName>Local Remedy Phoenix</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190123</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>ASN</LabelerName>
<SubstanceName>ALTERNARIA ALTERNATA; AMBROSIA ARTEMISIIFOLIA; CYNODON DACTYLON; JUNIPERUS ASHEI POLLEN; JUNIPERUS SCOPULORUM POLLEN; NERIUM OLEANDER FLOWER; OLEA EUROPAEA FLOWER; PASSALORA FULVA; USTILAGO MAYDIS; WHITE MULBERRY</SubstanceName>
<StrengthNumber>6; 12; 12; 6; 6; 6; 6; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190123</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: Allergy symptom reliefFor temporary relief of symptoms due to hay feveror other respiratory allergies. Runny nose,sneezing, irritated eyes, nasal congestion, itchynose and throat, sinus pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72617-4003-3</NDCCode>
<PackageDescription>1 BOTTLE in 1 PACKAGE (72617-4003-3) > 15 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>72617-4003-03</NDC11Code>
<ProductNDC>72617-4003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergy Mix</ProprietaryName>
<NonProprietaryName>Local Remedy Los Angeles</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>NASAL</RouteName>
<StartMarketingDate>20190101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>ASN</LabelerName>
<SubstanceName>ALTERNARIA ALTERNATA; AMBROSIA ARTEMISIIFOLIA; HISTAMINE DIHYDROCHLORIDE; JUNIPERUS ASHEI POLLEN; JUNIPERUS SCOPULORUM POLLEN; NERIUM OLEANDER FLOWER; OLEA EUROPAEA FLOWER; PASSALORA FULVA; SCHOENOCAULON OFFICINALE SEED; USTILAGO MAYDIS; WHITE MULBERRY</SubstanceName>
<StrengthNumber>6; 12; 12; 6; 6; 6; 6; 6; 12; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL; [hp_X]/15mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>UsesFor temporary relief of symptoms due to hay feveror other respiratory allergies. Runny nose, sneezing,irritated eyes, nasal congestion, itchy nose andthroat, sinus pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72617-5001-4</NDCCode>
<PackageDescription>30 TABLET, CHEWABLE in 1 BOTTLE (72617-5001-4) </PackageDescription>
<NDC11Code>72617-5001-04</NDC11Code>
<ProductNDC>72617-5001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergy Mix Las Vegas</ProprietaryName>
<NonProprietaryName>Local Remedy Las Vegas</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190123</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>ASN</LabelerName>
<SubstanceName>ALTERNARIA ALTERNATA; JUNIPERUS ASHEI POLLEN; JUNIPERUS SCOPULORUM POLLEN; NERIUM OLEANDER FLOWER; OLEA EUROPAEA FLOWER; PASSALORA FULVA; USTILAGO MAYDIS; WHITE MULBERRY</SubstanceName>
<StrengthNumber>6; 6; 6; 6; 6; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190123</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: Allergy symptom reliefFor temporary relief of symptoms due to hay feveror other respiratory allergies. Runny nose,sneezing, irritated eyes, nasal congestion, itchynose and throat, sinus pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72617-5002-4</NDCCode>
<PackageDescription>30 TABLET, CHEWABLE in 1 BOTTLE (72617-5002-4) </PackageDescription>
<NDC11Code>72617-5002-04</NDC11Code>
<ProductNDC>72617-5002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergy Mix Phoenix</ProprietaryName>
<NonProprietaryName>Local Remedy Phoenix</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190123</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>ASN</LabelerName>
<SubstanceName>ALTERNARIA ALTERNATA; AMBROSIA ARTEMISIIFOLIA; CYNODON DACTYLON; JUNIPERUS ASHEI POLLEN; JUNIPERUS SCOPULORUM POLLEN; NERIUM OLEANDER FLOWER; OLEA EUROPAEA FLOWER; PASSALORA FULVA; USTILAGO MAYDIS; WHITE MULBERRY</SubstanceName>
<StrengthNumber>6; 12; 12; 6; 6; 6; 6; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190123</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: Allergy symptom reliefFor temporary relief of symptoms due to hay feveror other respiratory allergies. Runny nose,sneezing, irritated eyes, nasal congestion, itchynose and throat, sinus pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72617-5003-4</NDCCode>
<PackageDescription>30 TABLET, CHEWABLE in 1 BOTTLE (72617-5003-4) </PackageDescription>
<NDC11Code>72617-5003-04</NDC11Code>
<ProductNDC>72617-5003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergy Mix Los Angeles</ProprietaryName>
<NonProprietaryName>Local Remedy Los Angeles</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190123</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>ASN</LabelerName>
<SubstanceName>ALTERNARIA ALTERNATA; AMBROSIA ARTEMISIIFOLIA; HISTAMINE DIHYDROCHLORIDE; JUNIPERUS ASHEI POLLEN; JUNIPERUS SCOPULORUM POLLEN; NERIUM OLEANDER FLOWER; OLEA EUROPAEA FLOWER; PASSALORA FULVA; SCHOENOCAULON OFFICINALE SEED; USTILAGO MAYDIS; WHITE MULBERRY</SubstanceName>
<StrengthNumber>6; 12; 12; 6; 6; 6; 6; 6; 12; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190123</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: Allergy symptom reliefFor temporary relief of symptoms due to hay feveror other respiratory allergies. Runny nose,sneezing, irritated eyes, nasal congestion, itchynose and throat, sinus pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0006-0001-01</NDCCode>
<PackageDescription>1 BAG in 1 DRUM (0006-0001-01) > 480000 TABLET, FILM COATED in 1 BAG</PackageDescription>
<NDC11Code>00006-0001-01</NDC11Code>
<ProductNDC>0006-0001</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Suvorexant</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<StartMarketingDate>20140815</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Merck Sharp & Dohme LLC.</LabelerName>
<SubstanceName>SUVOREXANT</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<DEASchedule>CIV</DEASchedule>
<Status>Unfinished</Status>
<LastUpdate>2022-11-04</LastUpdate>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>15-AUG-14</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>0268-0001-10</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (0268-0001-10)</PackageDescription>
<NDC11Code>00268-0001-10</NDC11Code>
<ProductNDC>0268-0001</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>House Dust</ProprietaryName>
<NonProprietaryName>House Dust</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>19650101</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103753</ApplicationNumber>
<LabelerName>ALK-Abello, Inc.</LabelerName>
<SubstanceName>HOUSE DUST</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>[PNU]/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>0280-0001-01</NDCCode>
<PackageDescription>2 BLISTER PACK in 1 CARTON (0280-0001-01) / 8 GUM, CHEWING in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00280-0001-01</NDC11Code>
<ProductNDC>0280-0001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Alka-seltzer Cool Action Heartburn Relief</ProprietaryName>
<ProprietaryNameSuffix>Mint</ProprietaryNameSuffix>
<NonProprietaryName>Calcium Carbonate</NonProprietaryName>
<DosageFormName>GUM, CHEWING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200301</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M001</ApplicationNumber>
<LabelerName>Bayer HealthCare LLC.</LabelerName>
<SubstanceName>CALCIUM CARBONATE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses for the relief of:. ● acid indigestion ● heartburn ● sour stomach. ● upset stomach associated with these symptoms.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0280-0001-02</NDCCode>
<PackageDescription>1 BLISTER PACK in 1 CARTON (0280-0001-02) / 8 GUM, CHEWING in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00280-0001-02</NDC11Code>
<ProductNDC>0280-0001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Alka-seltzer Cool Action Heartburn Relief</ProprietaryName>
<ProprietaryNameSuffix>Mint</ProprietaryNameSuffix>
<NonProprietaryName>Calcium Carbonate</NonProprietaryName>
<DosageFormName>GUM, CHEWING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200301</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M001</ApplicationNumber>
<LabelerName>Bayer HealthCare LLC.</LabelerName>
<SubstanceName>CALCIUM CARBONATE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200501</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses for the relief of:. ● acid indigestion ● heartburn ● sour stomach. ● upset stomach associated with these symptoms.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0280-0001-03</NDCCode>
<PackageDescription>1 GUM, CHEWING in 1 POUCH (0280-0001-03) </PackageDescription>
<NDC11Code>00280-0001-03</NDC11Code>
<ProductNDC>0280-0001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Alka-seltzer Cool Action Heartburn Relief</ProprietaryName>
<ProprietaryNameSuffix>Mint</ProprietaryNameSuffix>
<NonProprietaryName>Calcium Carbonate</NonProprietaryName>
<DosageFormName>GUM, CHEWING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200301</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M001</ApplicationNumber>
<LabelerName>Bayer HealthCare LLC.</LabelerName>
<SubstanceName>CALCIUM CARBONATE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses for the relief of:. ● acid indigestion ● heartburn ● sour stomach. ● upset stomach associated with these symptoms.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0280-0001-04</NDCCode>
<PackageDescription>6 BLISTER PACK in 1 CARTON (0280-0001-04) / 10 GUM, CHEWING in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00280-0001-04</NDC11Code>
<ProductNDC>0280-0001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Alka-seltzer Cool Action Heartburn Relief</ProprietaryName>
<ProprietaryNameSuffix>Mint</ProprietaryNameSuffix>
<NonProprietaryName>Calcium Carbonate</NonProprietaryName>
<DosageFormName>GUM, CHEWING</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200301</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M001</ApplicationNumber>
<LabelerName>Bayer HealthCare LLC.</LabelerName>
<SubstanceName>CALCIUM CARBONATE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20241115</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses for the relief of:. ● acid indigestion ● heartburn ● sour stomach. ● upset stomach associated with these symptoms.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0327-0001-10</NDCCode>
<PackageDescription>5 VIAL in 1 BOX (0327-0001-10) > 2 g in 1 VIAL</PackageDescription>
<NDC11Code>00327-0001-10</NDC11Code>
<ProductNDC>0327-0001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Clorpactin Wcs-90</ProprietaryName>
<NonProprietaryName>Chlorine</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19550101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>United-Guardian, Inc.</LabelerName>
<SubstanceName>CHLORINE</SubstanceName>
<StrengthNumber>.16</StrengthNumber>
<StrengthUnit>g/2g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2022-10-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19550101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Topical Antisepsis.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0363-0001-44</NDCCode>
<PackageDescription>.5 L in 1 BOTTLE, PLASTIC (0363-0001-44)</PackageDescription>
<NDC11Code>00363-0001-44</NDC11Code>
<ProductNDC>0363-0001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anticavity Rinse</ProprietaryName>
<NonProprietaryName>Sodium Fluoride</NonProprietaryName>
<DosageFormName>MOUTHWASH</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20020627</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part355</ApplicationNumber>
<LabelerName>Walgreen Co</LabelerName>
<SubstanceName>SODIUM FLUORIDE</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>kg/100L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>0378-0001-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE, PLASTIC (0378-0001-01)</PackageDescription>
<NDC11Code>00378-0001-01</NDC11Code>
<ProductNDC>0378-0001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Clorpres</ProprietaryName>
<NonProprietaryName>Clonidine Hydrochloride And Chlorthalidone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19980313</StartMarketingDate>
<EndMarketingDate>20180228</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA071325</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CLONIDINE HYDROCHLORIDE; CHLORTHALIDONE</SubstanceName>
<StrengthNumber>.1; 15</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic alpha2-Agonists [MoA],Central alpha-2 Adrenergic Agonist [EPC],Increased Diuresis [PE],Thiazide-like Diuretic [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-03-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0404-0001-01</NDCCode>
<PackageDescription>3785 mL in 1 BOTTLE, PLASTIC (0404-0001-01) </PackageDescription>
<NDC11Code>00404-0001-01</NDC11Code>
<ProductNDC>0404-0001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hydrogen Peroxide</ProprietaryName>
<NonProprietaryName>Hydrogen Peroxide</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140601</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>Henry Schein Inc.</LabelerName>
<SubstanceName>HYDROGEN PEROXIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0404-0001-08</NDCCode>
<PackageDescription>237 mL in 1 BOTTLE, PLASTIC (0404-0001-08) </PackageDescription>
<NDC11Code>00404-0001-08</NDC11Code>
<ProductNDC>0404-0001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hydrogen Peroxide</ProprietaryName>
<NonProprietaryName>Hydrogen Peroxide</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140601</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>Henry Schein Inc.</LabelerName>
<SubstanceName>HYDROGEN PEROXIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0404-0001-16</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE, PLASTIC (0404-0001-16) </PackageDescription>
<NDC11Code>00404-0001-16</NDC11Code>
<ProductNDC>0404-0001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hydrogen Peroxide</ProprietaryName>
<NonProprietaryName>Hydrogen Peroxide</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140601</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M003</ApplicationNumber>
<LabelerName>Henry Schein Inc.</LabelerName>
<SubstanceName>HYDROGEN PEROXIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-01-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0409-0001-25</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (0409-0001-25) / 2 mL in 1 VIAL, SINGLE-DOSE (0409-0001-01) </PackageDescription>
<NDC11Code>00409-0001-25</NDC11Code>
<ProductNDC>0409-0001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Midazolam</ProprietaryName>
<NonProprietaryName>Midazolam Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20250127</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075857</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>MIDAZOLAM HYDROCHLORIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Benzodiazepine [EPC], Benzodiazepines [CS]</Pharm_Classes>
<DEASchedule>CIV</DEASchedule>
<Status>Active</Status>
<LastUpdate>2026-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250127</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Midazolam injection is indicated: 1 intramuscularly or intravenously for preoperative sedation/anxiolysis/amnesia;, 2 intravenously as an agent for sedation/anxiolysis/amnesia prior to or during diagnostic, therapeutic or endoscopic procedures, such as bronchoscopy, gastroscopy, cystoscopy, coronary angiography, cardiac catheterization, oncology procedures, radiologic procedures, suture of lacerations and other procedures either alone or in combination with other CNS depressants;, 3 intravenously for induction of general anesthesia, before administration of other anesthetic agents. With the use of narcotic premedication, induction of anesthesia can be attained within a relatively narrow dose range and in a short period of time. Intravenous midazolam can also be used as a component of intravenous supplementation of nitrous oxide and oxygen (balanced anesthesia);, 4 continuous intravenous infusion for sedation of intubated and mechanically ventilated patients as a component of anesthesia or during treatment in a critical care setting.</IndicationAndUsage>
<Description>Midazolam hydrochloride injection is a water-soluble benzodiazepine available as a sterile, nonpyrogenic parenteral dosage form for intravenous or intramuscular injection. Each mL contains midazolam hydrochloride equivalent to 1 mg or 5 mg midazolam compounded with 0.8% sodium chloride. The pH is adjusted to approximately 3 with hydrochloric acid and, if necessary, sodium hydroxide. Midazolam is a white to light yellow crystalline compound, insoluble in water. The hydrochloride salt of midazolam, which is formed in situ, is soluble in aqueous solutions. Chemically, midazolam HCl is 8-chloro-6-(2-fluorophenyl)-1-methyl-4H-imidazo[1,5-a][1,4]benzodiazepine hydrochloride. Midazolam hydrochloride has the empirical formula C18H13ClFN3∙HCl, a calculated molecular weight of 362.25 and the following structural formula. Under the acidic conditions required to solubilize midazolam in the product, midazolam is present as an equilibrium mixture (shown below) of the closed-ring form shown above and an open-ring structure formed by the acid-catalyzed ring opening of the 4,5-double bond of the diazepine ring. The amount of open-ring form is dependent upon the pH of the solution. At the specified pH of the product, the solution may contain up to about 25% of the open-ring compound. At the physiologic conditions under which the product is absorbed (pH of 5 to 8) into the systemic circulation, any open-ring form present reverts to the physiologically active, lipophilic, closed-ring form (midazolam) and is absorbed as such. The following chart plots the percentage of midazolam present as the open-ring form as a function of pH in aqueous solutions. As indicated in the graph, the amount of open-ring compound present in solution is sensitive to changes in pH over the pH range specified for the product: 3.0 to 4.0 for the 1 mg/mL concentration and 3.0 to 3.6 for the 5 mg/mL concentration. Above pH 5, at least 99% of the mixture is present in the closed-ring form.</Description>
</NDC>
<NDC>
<NDCCode>0597-0001-11</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0597-0001-11) > 10 CAPSULE, EXTENDED RELEASE in 1 BOTTLE</PackageDescription>
<NDC11Code>00597-0001-11</NDC11Code>
<ProductNDC>0597-0001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aggrenox</ProprietaryName>
<NonProprietaryName>Aspirin And Dipyridamole</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19991219</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020884</ApplicationNumber>
<LabelerName>Boehringer Ingelheim Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>ASPIRIN; DIPYRIDAMOLE</SubstanceName>
<StrengthNumber>25; 200</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-04-24</LastUpdate>
</NDC>
<NDC>
<NDCCode>0597-0001-60</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0597-0001-60) > 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE</PackageDescription>
<NDC11Code>00597-0001-60</NDC11Code>
<ProductNDC>0597-0001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Aggrenox</ProprietaryName>
<NonProprietaryName>Aspirin And Dipyridamole</NonProprietaryName>
<DosageFormName>CAPSULE, EXTENDED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19991219</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020884</ApplicationNumber>
<LabelerName>Boehringer Ingelheim Pharmaceuticals Inc.</LabelerName>
<SubstanceName>ASPIRIN; DIPYRIDAMOLE</SubstanceName>
<StrengthNumber>25; 200</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC],Decreased Platelet Aggregation [PE],Platelet Aggregation Inhibitor [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-08-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19991219</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0662-0001-99</NDCCode>
<PackageDescription>10 TRAY in 1 CASE (0662-0001-99) / 10 CARTON in 1 TRAY (0662-0001-10) / 1 VIAL in 1 CARTON (0662-0001-01) / 20 mL in 1 VIAL (0662-0001-20) </PackageDescription>
<NDC11Code>00662-0001-99</NDC11Code>
<ProductNDC>0662-0001</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Lidocaine Hydrochloride And Epinephrine</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<StartMarketingDate>20191010</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>EPINEPHRINE; LIDOCAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10; 20</StrengthNumber>
<StrengthUnit>ug/mL; mg/mL</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-04-15</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>10-OCT-19</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>0699-0001-01</NDCCode>
<PackageDescription>33.57 g in 1 BOTTLE, GLASS (0699-0001-01)</PackageDescription>
<NDC11Code>00699-0001-01</NDC11Code>
<ProductNDC>0699-0001</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Formo Cresol</ProprietaryName>
<NonProprietaryName>Cresol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>DENTAL</RouteName>
<StartMarketingDate>19630219</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>DSHealthcare</LabelerName>
<SubstanceName>CRESOL</SubstanceName>
<StrengthNumber>485</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Indicated as a disinfectant and devitalizing solution used as part of endodontic treatment.</IndicationAndUsage>
<Description>Formocresol: 48.5% formaldehyde, 48.5% cresol, 3% glycerine. Buckley's Formocresol: 19% formaldehyde, 35% cresol, 17.5% gylcerine.</Description>
</NDC>
</NDCList>