{
"NDC": [
{
"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": "72617-3001-2",
"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": "72617-3003-2",
"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": "11770-3002-2",
"PackageDescription": "18 kg in 1 PAIL (11770-3002-2) ",
"NDC11Code": "11770-3002-02",
"ProductNDC": "11770-3002",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Simethicone",
"DosageFormName": "LIQUID",
"StartMarketingDate": "20210331",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "DDP Specialty Electronic Materials US 9, LLC",
"SubstanceName": "DIMETHICONE; SILICON DIOXIDE",
"StrengthNumber": "95.9; 4.1",
"StrengthUnit": "kg/100kg; kg/100kg",
"Status": "Unfinished",
"LastUpdate": "2022-02-18",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "31-MAR-21"
},
{
"NDCCode": "14799-3002-2",
"PackageDescription": "500 g in 1 BAG (14799-3002-2) ",
"NDC11Code": "14799-3002-02",
"ProductNDC": "14799-3002",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Sermorelin Acetate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20180306",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Zhejiang Supor Pharmaceuticals Co., Ltd",
"SubstanceName": "ARGIPRESSIN",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "06-MAR-18"
},
{
"NDCCode": "36987-3002-2",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (36987-3002-2)",
"NDC11Code": "36987-3002-02",
"ProductNDC": "36987-3002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Yellow Pine",
"NonProprietaryName": "Yellow Pine",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRADERMAL; SUBCUTANEOUS",
"StartMarketingDate": "19720829",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA102192",
"LabelerName": "Nelco Laboratories, Inc.",
"SubstanceName": "PINUS ECHINATA POLLEN",
"StrengthNumber": ".05",
"StrengthUnit": "g/mL",
"Pharm_Classes": "Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.",
"Description": "Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections."
},
{
"NDCCode": "37662-3002-2",
"PackageDescription": "500 PELLET in 1 VIAL, GLASS (37662-3002-2) ",
"NDC11Code": "37662-3002-02",
"ProductNDC": "37662-3002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Scandium Iodatum",
"NonProprietaryName": "Scandium Iodatum",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "20230420",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Hahnemann Laboratories, INC.",
"SubstanceName": "SCANDIUM IODIDE",
"StrengthNumber": "500",
"StrengthUnit": "[hp_C]/1",
"Status": "Active",
"LastUpdate": "2023-04-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230420",
"SamplePackage": "N"
},
{
"NDCCode": "54565-3003-9",
"PackageDescription": "1 KIT in 1 KIT (54565-3003-9) * 2 g in 1 TUBE (54565-3001-1) * 3 g in 1 APPLICATOR (54565-3002-1) ",
"NDC11Code": "54565-3003-09",
"ProductNDC": "54565-3003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Zims Advanced Cold Sore And Fever Blister Moisturizing Protectant With Purified Propolis",
"NonProprietaryName": "Petrolatum",
"DosageFormName": "KIT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140115",
"MarketingCategoryName": "OTC MONOGRAPH DRUG PRODUCT MANUFACTURED UNDER CONTRACT",
"LabelerName": "Les Emballages Knowlton Inc.",
"Status": "Deprecated",
"LastUpdate": "2017-12-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "60722-3002-1",
"PackageDescription": "2.5 kg in 1 DRUM (60722-3002-1) ",
"NDC11Code": "60722-3002-01",
"ProductNDC": "60722-3002",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Mifepristone",
"DosageFormName": "POWDER",
"StartMarketingDate": "20201023",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "zhejiang xianju pharmaceutical co., Ltd.",
"SubstanceName": "MIFEPRISTONE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2025-12-25",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "23-OCT-20"
},
{
"NDCCode": "60722-3002-2",
"PackageDescription": "15 kg in 1 DRUM (60722-3002-2) ",
"NDC11Code": "60722-3002-02",
"ProductNDC": "60722-3002",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Mifepristone",
"DosageFormName": "POWDER",
"StartMarketingDate": "20201023",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "zhejiang xianju pharmaceutical co., Ltd.",
"SubstanceName": "MIFEPRISTONE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2025-12-25",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "23-OCT-20"
},
{
"NDCCode": "61252-3002-2",
"PackageDescription": "10 kg in 1 DRUM (61252-3002-2) ",
"NDC11Code": "61252-3002-02",
"ProductNDC": "61252-3002",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Nicotine Polacrilex",
"DosageFormName": "POWDER",
"StartMarketingDate": "19940201",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Nicobrand LTD",
"SubstanceName": "NICOTINE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2026-10-12",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "01-FEB-94"
},
{
"NDCCode": "61957-3002-2",
"PackageDescription": "2.7 mL in 1 TUBE (61957-3002-2) ",
"NDC11Code": "61957-3002-02",
"ProductNDC": "61957-3002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Forever Transfer-proof - 24h Foundation High Perfection Concentrated Floral Skincare With Sunscreen Broad Spectrum Spf 15 8n",
"NonProprietaryName": "Octisalate, Titanium Dioxide",
"DosageFormName": "EMULSION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "Parfums Christian Dior",
"SubstanceName": "OCTISALATE; TITANIUM DIOXIDE",
"StrengthNumber": "35; 9.4",
"StrengthUnit": "mg/mL; mg/mL",
"Status": "Deprecated",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220101",
"SamplePackage": "Y",
"IndicationAndUsage": "Helps prevent sunburn. If used as directed with other sun protection measures ( ), decreases the risk of skin cancer and early skin aging caused by the sun. see Directions."
},
{
"NDCCode": "63471-3000-0",
"PackageDescription": "1 KIT in 1 KIT (63471-3000-0) * 1 TUBE in 1 CARTON (63471-3001-2) / 57 g in 1 TUBE * 1 TUBE in 1 CARTON (63471-3002-2) / 57 g in 1 TUBE",
"NDC11Code": "63471-3000-00",
"ProductNDC": "63471-3000",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Boudreauxs Rash Kicking",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "KIT",
"StartMarketingDate": "20180525",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Geodis Logistics LLC",
"Status": "Deprecated",
"LastUpdate": "2024-03-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20180525",
"SamplePackage": "N"
},
{
"NDCCode": "63471-3002-2",
"PackageDescription": "1 TUBE in 1 CARTON (63471-3002-2) / 57 g in 1 TUBE",
"NDC11Code": "63471-3002-02",
"ProductNDC": "63471-3002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Boudreauxs Butt Diaper Rash Original",
"NonProprietaryName": "Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20191202",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M016",
"LabelerName": "Geodis Logistics LLC",
"SubstanceName": "ZINC OXIDE",
"StrengthNumber": "16",
"StrengthUnit": "g/113g",
"Status": "Active",
"LastUpdate": "2023-11-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20191202",
"SamplePackage": "N",
"IndicationAndUsage": "Helps treat and prevent diaper rash. Protects chafed skin due to diaper rash and helps seal out wetness."
},
{
"NDCCode": "68071-3002-2",
"PackageDescription": "12 TABLET in 1 BOTTLE (68071-3002-2)",
"NDC11Code": "68071-3002-02",
"ProductNDC": "68071-3002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Rugby",
"ProprietaryNameSuffix": "Meclizine Hcl, 12.5 Mg Each Antiemetic",
"NonProprietaryName": "Meclizine Hcl",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140307",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part336",
"LabelerName": "NuCare Pharmaceuticals, Inc.",
"SubstanceName": "MECLIZINE HYDROCHLORIDE",
"StrengthNumber": "12.5",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2020-05-07",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231"
},
{
"NDCCode": "78863-3002-2",
"PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (78863-3002-2) / 50 mL in 1 BOTTLE, PUMP",
"NDC11Code": "78863-3002-02",
"ProductNDC": "78863-3002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Acno Solution",
"ProprietaryNameSuffix": "Acne Treatment",
"NonProprietaryName": "Salicylic Acid",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240615",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M006",
"LabelerName": "Noon Aesthetics M.R. Ltd",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": "50",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-07-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260728",
"SamplePackage": "N",
"IndicationAndUsage": "Use for the treatment of Acne."
},
{
"NDCCode": "84504-3002-2",
"PackageDescription": "1 BOTTLE, PUMP in 1 CARTON (84504-3002-2) / 30 mL in 1 BOTTLE, PUMP (84504-3002-1) ",
"NDC11Code": "84504-3002-02",
"ProductNDC": "84504-3002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Co-bb-54432 Featuring You Hydrating Skin Enhancing Tint Spf30-30 Insist",
"NonProprietaryName": "Avobenzone, Homosalate,octisalate, Octocrylene",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20240401",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M020",
"LabelerName": "SW-SANGHVI BEAUTY USA, INC.",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "3; 10; 5; 7",
"StrengthUnit": "g/100mL; g/100mL; g/100mL; g/100mL",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20240401",
"SamplePackage": "N",
"IndicationAndUsage": "Uses helps prevent sunburn. if used as directed with other sun protection (see Directions), decreases risk of skin cancer & early skin aging caused by the sun."
},
{
"NDCCode": "0002-3002-01",
"PackageDescription": "1 VIAL, SINGLE-DOSE in 1 CARTON (0002-3002-01) / .5 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "00002-3002-01",
"ProductNDC": "0002-3002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mounjaro",
"NonProprietaryName": "Tirzepatide",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "20230728",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA215866",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "TIRZEPATIDE",
"StrengthNumber": "15",
"StrengthUnit": "mg/.5mL",
"Pharm_Classes": "G-Protein-linked Receptor Interactions [MoA], GLP-1 Receptor Agonist [EPC], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA], Glucose-dependent Insulinotropic Polypeptide Receptor Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20230728",
"SamplePackage": "N",
"IndicationAndUsage": "MOUNJARO® is indicated: : 1 as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. , 2 to reduce the risk of major adverse cardiovascular (CV) events (CV death, non-fatal myocardial infarction (MI), or non-fatal stroke) in adults with type 2 diabetes mellitus who are at high risk for these events. .",
"Description": "MOUNJARO (tirzepatide) injection, for subcutaneous use, contains tirzepatide, a once weekly GIP receptor and GLP-1 receptor agonist. Tirzepatide is based on the GIP sequence and contains aminoisobutyric acid (Aib) in positions 2 and 13, a C-terminal amide, and Lys residue at position 20 that is attached to 1,20-eicosanedioic acid via a linker. The molecular weight is 4813.53 Da and the empirical formula is C225H348N48O68. Structural formula:. MOUNJARO is a clear, colorless to slightly yellow, sterile solution for subcutaneous use. Each single-dose pen or single-dose vial contains a 0.5 mL solution of 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg of tirzepatide and the following excipients: sodium chloride (4.1 mg), sodium phosphate dibasic heptahydrate (0.7 mg), and water for injection. Each multi-dose vial or single-patient-use KwikPen contains 2.4 mL of solution, which provides 4 doses of 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg of tirzepatide per 0.6 mL. Each dose contains the following excipients: benzyl alcohol (5.4 mg), glycerin (4.8 mg), phenol (1.08 mg), sodium chloride (1.05 mg), sodium phosphate dibasic heptahydrate (0.8 mg), and water for injection. Hydrochloric acid solution and/or sodium hydroxide solution may have been added to adjust the pH. MOUNJARO has a pH of 6.5 to 7.5. Each single-patient-use KwikPen contains additional volume to allow for device priming."
},
{
"NDCCode": "0093-3002-56",
"PackageDescription": "30 CAPSULE in 1 BOTTLE (0093-3002-56) ",
"NDC11Code": "00093-3002-56",
"ProductNDC": "0093-3002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Quinine Sulfate",
"NonProprietaryName": "Quinine Sulfate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20120928",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091661",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "QUININE SULFATE",
"StrengthNumber": "324",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antimalarial [EPC]",
"Status": "Active",
"LastUpdate": "2025-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120928",
"SamplePackage": "N",
"IndicationAndUsage": "Quinine sulfate capsules are an antimalarial drug indicated only for treatment of uncomplicated Plasmodium falciparum malaria. Quinine sulfate has been shown to be effective in geographical regions where resistance to chloroquine has been documented [see Clinical Studies (14)]. Limitations of Use:Quinine sulfate capsules are not approved for: 1 Treatment of severe or complicated P. falciparum malaria., 2 Prevention of malaria., 3 Treatment or prevention of nocturnal leg cramps [see Warnings and Precautions (5.1)].",
"Description": "Quinine sulfate, USP is a cinchona alkaloid chemically described as bis[(R)-(6-methoxyquinolin-4-yl)-[2S,4S,5R)-5-ethenyl-1-azabicyclo[2.2.2]oct-2-yl]methanol] sulfate. The structural formula of quinine sulfate, USP is. C40H50N4O8S2H2O M.W. 783.0. Quinine sulfate, USP occurs as a white or almost white, crystalline powder that darkens on exposure to light. It is odorless and has a persistent very bitter taste. It is slightly soluble in water, sparingly soluble in boiling water and in alcohol, and practically insoluble in ether. Quinine Sulfate Capsules USP are supplied for oral administration as capsules containing 324 mg of the active ingredient quinine sulfate, USP equivalent to 269 mg free base. Inactive ingredients: colloidal silicon dioxide, gelatin, iron oxide black, magnesium stearate, pregelatinized corn starch, propylene glycol, shellac, sodium lauryl sulfate, and titanium dioxide. The imprinting ink may contain potassium hydroxide. FDA approved dissolution test specifications differ from USP."
},
{
"NDCCode": "0378-3002-05",
"PackageDescription": "500 TABLET in 1 BOTTLE, PLASTIC (0378-3002-05) ",
"NDC11Code": "00378-3002-05",
"ProductNDC": "0378-3002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Candesartan Cilexetil And Hydrochlorothiazide",
"NonProprietaryName": "Candesartan Cilexetil And Hydrochlorothiazide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20121204",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090704",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "32; 12.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-08-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20121204",
"EndMarketingDatePackage": "20210731",
"SamplePackage": "N",
"IndicationAndUsage": "Candesartan cilexetil and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with candesartan cilexetil and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. This fixed dose combination is not indicated for initial therapy (see DOSAGE AND ADMINISTRATION).",
"Description": "Candesartan cilexetil and hydrochlorothiazide tablets, USP combine an angiotensin II receptor (type AT1) antagonist and a diuretic, hydrochlorothiazide. Candesartan cilexetil, a nonpeptide, is chemically described as (±)2-Ethoxy-1-[[2’-(1H-tetrazol-5-yl)[1,1’-biphenyl]-4-yl]methyl]-1H-benzimidazole-7-carboxylic acid-1-[[(cyclohexyloxy)carbonyl]oxy]ethyl ester. Its molecular formula is C33H34N6O6, and its structural formula is:. Candesartan cilexetil, USP is a white to off-white powder with a molecular weight of 610.66. It is practically insoluble in water and sparingly soluble in methanol. Candesartan cilexetil is a racemic mixture containing one chiral center at the cyclohexyloxycarbonyloxy ethyl ester group. Following oral administration, candesartan cilexetil undergoes hydrolysis at the ester link to form the active drug, candesartan, which is achiral. Hydrochlorothiazide is 2H-1,2,4-Benzothiadiazine-7-sulfonamide, 6-chloro-3,4-dihydro-,1,1-dioxide. Its molecular formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide, USP is a white, or practically white, practically odorless crystalline powder with a molecular weight of 297.7, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Candesartan cilexetil and hydrochlorothiazide tablets are available for oral administration in three tablet strengths of candesartan cilexetil and hydrochlorothiazide. Candesartan cilexetil and hydrochlorothiazide tablets contain 16 mg or 32 mg of candesartan cilexetil and 12.5 mg or 25 mg of hydrochlorothiazide providing for the following available combinations: 16 mg/12.5 mg, 32 mg/12.5 mg or 32 mg/25 mg. The inactive ingredients of the tablets are carboxymethylcellulose calcium, corn starch, glyceryl stearate, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and yellow iron oxide. The 16 mg/12.5 mg tablet and 32 mg/25 mg tablet also contain red iron oxide as a colorant."
},
{
"NDCCode": "0378-3002-77",
"PackageDescription": "90 TABLET in 1 BOTTLE, PLASTIC (0378-3002-77) ",
"NDC11Code": "00378-3002-77",
"ProductNDC": "0378-3002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Candesartan Cilexetil And Hydrochlorothiazide",
"NonProprietaryName": "Candesartan Cilexetil And Hydrochlorothiazide",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20121204",
"EndMarketingDate": "20260430",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA090704",
"LabelerName": "Mylan Pharmaceuticals Inc.",
"SubstanceName": "CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE",
"StrengthNumber": "32; 12.5",
"StrengthUnit": "mg/1; mg/1",
"Pharm_Classes": "Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]",
"Status": "Deprecated",
"LastUpdate": "2026-04-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20121204",
"EndMarketingDatePackage": "20260430",
"SamplePackage": "N",
"IndicationAndUsage": "Candesartan cilexetil and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with candesartan cilexetil and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. This fixed dose combination is not indicated for initial therapy (see DOSAGE AND ADMINISTRATION).",
"Description": "Candesartan cilexetil and hydrochlorothiazide tablets, USP combine an angiotensin II receptor (type AT1) antagonist and a diuretic, hydrochlorothiazide. Candesartan cilexetil, a nonpeptide, is chemically described as (±)2-Ethoxy-1-[[2’-(1H-tetrazol-5-yl)[1,1’-biphenyl]-4-yl]methyl]-1H-benzimidazole-7-carboxylic acid-1-[[(cyclohexyloxy)carbonyl]oxy]ethyl ester. Its molecular formula is C33H34N6O6, and its structural formula is:. Candesartan cilexetil, USP is a white to off-white powder with a molecular weight of 610.66. It is practically insoluble in water and sparingly soluble in methanol. Candesartan cilexetil is a racemic mixture containing one chiral center at the cyclohexyloxycarbonyloxy ethyl ester group. Following oral administration, candesartan cilexetil undergoes hydrolysis at the ester link to form the active drug, candesartan, which is achiral. Hydrochlorothiazide is 2H-1,2,4-Benzothiadiazine-7-sulfonamide, 6-chloro-3,4-dihydro-,1,1-dioxide. Its molecular formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide, USP is a white, or practically white, practically odorless crystalline powder with a molecular weight of 297.7, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Candesartan cilexetil and hydrochlorothiazide tablets are available for oral administration in three tablet strengths of candesartan cilexetil and hydrochlorothiazide. Candesartan cilexetil and hydrochlorothiazide tablets contain 16 mg or 32 mg of candesartan cilexetil and 12.5 mg or 25 mg of hydrochlorothiazide providing for the following available combinations: 16 mg/12.5 mg, 32 mg/12.5 mg or 32 mg/25 mg. The inactive ingredients of the tablets are carboxymethylcellulose calcium, corn starch, glyceryl stearate, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and yellow iron oxide. The 16 mg/12.5 mg tablet and 32 mg/25 mg tablet also contain red iron oxide as a colorant."
},
{
"NDCCode": "33992-3002-1",
"PackageDescription": "237 mL in 1 BOTTLE (33992-3002-1) ",
"NDC11Code": "33992-3002-01",
"ProductNDC": "33992-3002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sweet Pea Blossom Hand Sanitizer",
"NonProprietaryName": "Ethyl Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130524",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Greenbrier International, Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "147",
"StrengthUnit": "mL/237mL",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20130524",
"SamplePackage": "N",
"IndicationAndUsage": "Other information: 1 store at 20oC to 25oC (68o to 77oF), 2 may discolor certain fabrics."
},
{
"NDCCode": "43948-3002-1",
"PackageDescription": "30 mL in 1 BOTTLE, PUMP (43948-3002-1)",
"NDC11Code": "43948-3002-01",
"ProductNDC": "43948-3002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Dr G Dewrinkle Fortifier By Egf",
"NonProprietaryName": "Adenosine Glycerin",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20091101",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part347",
"LabelerName": "The Doctor's Cosmetic Inc",
"SubstanceName": "ADENOSINE; GLYCERIN",
"StrengthNumber": ".012; 2.1",
"StrengthUnit": "mL/30mL; mL/30mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "50090-3002-0",
"PackageDescription": "180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-3002-0) ",
"NDC11Code": "50090-3002-00",
"ProductNDC": "50090-3002",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Delzicol",
"NonProprietaryName": "Mesalamine",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20160516",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA204412",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "MESALAMINE",
"StrengthNumber": "400",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Aminosalicylate [EPC], Aminosalicylic Acids [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-01-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20170504",
"SamplePackage": "N",
"IndicationAndUsage": "DELZICOL is an aminosalicylate indicated for: 1 Treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older. (1.1), 2 Maintenance of remission of ulcerative colitis in adults. (1.2).",
"Description": "Each DELZICOL (mesalamine) delayed-release capsule for oral administration contains four 100 mg tablets of mesalamine, an aminosalicylate. DELZICOL (mesalamine) delayed-release capsules contain acrylic based resin, methacrylic acid and methyl methacrylate copolymer (Eudragit S), which dissolves at pH 7 or greater and releases mesalamine in the terminal ileum and beyond for topical anti-inflammatory action in the colon. Mesalamine (also referred to as 5-aminosalicylic acid or 5-ASA) has the chemical name 5-amino-2-hydroxybenzoic acid. Its structural formula is. Inactive Ingredients: Each capsule contains colloidal silicon dioxide, dibutyl sebacate, ferric oxide red (3.44 mg), ferric oxide yellow (0.62 mg), lactose monohydrate, magnesium stearate, methacrylic acid and methyl methancrylate copolymer (Eudragit S), polyethylene glycol, povidone, sodium starch glycolate, talc and hydroxypropyl methylcellulose (HPMC)."
},
{
"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": "72617-4001-3",
"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."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<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>72617-3001-2</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>72617-3003-2</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>11770-3002-2</NDCCode>
<PackageDescription>18 kg in 1 PAIL (11770-3002-2) </PackageDescription>
<NDC11Code>11770-3002-02</NDC11Code>
<ProductNDC>11770-3002</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Simethicone</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<StartMarketingDate>20210331</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>DDP Specialty Electronic Materials US 9, LLC</LabelerName>
<SubstanceName>DIMETHICONE; SILICON DIOXIDE</SubstanceName>
<StrengthNumber>95.9; 4.1</StrengthNumber>
<StrengthUnit>kg/100kg; kg/100kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2022-02-18</LastUpdate>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>31-MAR-21</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>14799-3002-2</NDCCode>
<PackageDescription>500 g in 1 BAG (14799-3002-2) </PackageDescription>
<NDC11Code>14799-3002-02</NDC11Code>
<ProductNDC>14799-3002</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Sermorelin Acetate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20180306</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Zhejiang Supor Pharmaceuticals Co., Ltd</LabelerName>
<SubstanceName>ARGIPRESSIN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>06-MAR-18</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>36987-3002-2</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (36987-3002-2)</PackageDescription>
<NDC11Code>36987-3002-02</NDC11Code>
<ProductNDC>36987-3002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Yellow Pine</ProprietaryName>
<NonProprietaryName>Yellow Pine</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19720829</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA102192</ApplicationNumber>
<LabelerName>Nelco Laboratories, Inc.</LabelerName>
<SubstanceName>PINUS ECHINATA POLLEN</SubstanceName>
<StrengthNumber>.05</StrengthNumber>
<StrengthUnit>g/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized Pollen Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Pollen [CS],Allergens [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Allergenic extracts are indicated for use in diagnostic testing and as part of a treatment regime for allergic disease, as established by allergy history and skin test reactivity. Allergenic extracts are indicated for the treatment of allergen specific allergic disease for use as hyposensitization or immunotherapy when avoidance of specific allergens can not be attained. The use of allergenic extracts for therapeutic purpose has been established by well-controlled clinical studies. Allergenic extracts may be used as adjunctive therapy along with pharmacotherapy which includes antihistamines, corticosteroids, and cromoglycate, and avoidance measures. Allergenic extracts for therapeutic use should be given using only the allergen selection to which the patient is allergic, has a history of exposure and are likely to be exposed to again.</IndicationAndUsage>
<Description>Allergenic extracts are sterile solutions consisting of the extractable components from various biological sources including pollens, inhalants, molds, animal epidermals and insects. Aqueous extracts are prepared using cocas fluid containing NaCl 0.5%, NaHCO3 0.0275%, WFI, preservative 0.4% Phenol. Glycerinated allergenic extracts are prepared with cocas fluid and glycerin to produce a 50% (v/v) allergenic extract. Allergenic Extracts are supplied as concentrations designated as protein nitrogen units (PNU) or weight/volume (w/v) ratio. Standardized extracts are designated in Bioequivalent Allergy Units (BAU) or Allergy Units (AU). (See product insert for standardized extracts). For diagnostic purposes, allergenic extracts are to be administered by prick-puncture or intradermal routes. Allergenic extracts are administered subcutaneously for immunotherapy injections.</Description>
</NDC>
<NDC>
<NDCCode>37662-3002-2</NDCCode>
<PackageDescription>500 PELLET in 1 VIAL, GLASS (37662-3002-2) </PackageDescription>
<NDC11Code>37662-3002-02</NDC11Code>
<ProductNDC>37662-3002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Scandium Iodatum</ProprietaryName>
<NonProprietaryName>Scandium Iodatum</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20230420</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Hahnemann Laboratories, INC.</LabelerName>
<SubstanceName>SCANDIUM IODIDE</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>[hp_C]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-04-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230420</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>54565-3003-9</NDCCode>
<PackageDescription>1 KIT in 1 KIT (54565-3003-9) * 2 g in 1 TUBE (54565-3001-1) * 3 g in 1 APPLICATOR (54565-3002-1) </PackageDescription>
<NDC11Code>54565-3003-09</NDC11Code>
<ProductNDC>54565-3003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Zims Advanced Cold Sore And Fever Blister Moisturizing Protectant With Purified Propolis</ProprietaryName>
<NonProprietaryName>Petrolatum</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140115</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG PRODUCT MANUFACTURED UNDER CONTRACT</MarketingCategoryName>
<LabelerName>Les Emballages Knowlton Inc.</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2017-12-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>60722-3002-1</NDCCode>
<PackageDescription>2.5 kg in 1 DRUM (60722-3002-1) </PackageDescription>
<NDC11Code>60722-3002-01</NDC11Code>
<ProductNDC>60722-3002</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Mifepristone</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20201023</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>zhejiang xianju pharmaceutical co., Ltd.</LabelerName>
<SubstanceName>MIFEPRISTONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-12-25</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>23-OCT-20</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>60722-3002-2</NDCCode>
<PackageDescription>15 kg in 1 DRUM (60722-3002-2) </PackageDescription>
<NDC11Code>60722-3002-02</NDC11Code>
<ProductNDC>60722-3002</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Mifepristone</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20201023</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>zhejiang xianju pharmaceutical co., Ltd.</LabelerName>
<SubstanceName>MIFEPRISTONE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-12-25</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>23-OCT-20</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>61252-3002-2</NDCCode>
<PackageDescription>10 kg in 1 DRUM (61252-3002-2) </PackageDescription>
<NDC11Code>61252-3002-02</NDC11Code>
<ProductNDC>61252-3002</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Nicotine Polacrilex</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>19940201</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Nicobrand LTD</LabelerName>
<SubstanceName>NICOTINE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2026-10-12</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>01-FEB-94</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>61957-3002-2</NDCCode>
<PackageDescription>2.7 mL in 1 TUBE (61957-3002-2) </PackageDescription>
<NDC11Code>61957-3002-02</NDC11Code>
<ProductNDC>61957-3002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Forever Transfer-proof - 24h Foundation High Perfection Concentrated Floral Skincare With Sunscreen Broad Spectrum Spf 15 8n</ProprietaryName>
<NonProprietaryName>Octisalate, Titanium Dioxide</NonProprietaryName>
<DosageFormName>EMULSION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>Parfums Christian Dior</LabelerName>
<SubstanceName>OCTISALATE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>35; 9.4</StrengthNumber>
<StrengthUnit>mg/mL; mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220101</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>Helps prevent sunburn. If used as directed with other sun protection measures ( ), decreases the risk of skin cancer and early skin aging caused by the sun. see Directions.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63471-3000-0</NDCCode>
<PackageDescription>1 KIT in 1 KIT (63471-3000-0) * 1 TUBE in 1 CARTON (63471-3001-2) / 57 g in 1 TUBE * 1 TUBE in 1 CARTON (63471-3002-2) / 57 g in 1 TUBE</PackageDescription>
<NDC11Code>63471-3000-00</NDC11Code>
<ProductNDC>63471-3000</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Boudreauxs Rash Kicking</ProprietaryName>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20180525</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Geodis Logistics LLC</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2024-03-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20180525</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63471-3002-2</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (63471-3002-2) / 57 g in 1 TUBE</PackageDescription>
<NDC11Code>63471-3002-02</NDC11Code>
<ProductNDC>63471-3002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Boudreauxs Butt Diaper Rash Original</ProprietaryName>
<NonProprietaryName>Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20191202</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M016</ApplicationNumber>
<LabelerName>Geodis Logistics LLC</LabelerName>
<SubstanceName>ZINC OXIDE</SubstanceName>
<StrengthNumber>16</StrengthNumber>
<StrengthUnit>g/113g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-11-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20191202</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Helps treat and prevent diaper rash. Protects chafed skin due to diaper rash and helps seal out wetness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>68071-3002-2</NDCCode>
<PackageDescription>12 TABLET in 1 BOTTLE (68071-3002-2)</PackageDescription>
<NDC11Code>68071-3002-02</NDC11Code>
<ProductNDC>68071-3002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Rugby</ProprietaryName>
<ProprietaryNameSuffix>Meclizine Hcl, 12.5 Mg Each Antiemetic</ProprietaryNameSuffix>
<NonProprietaryName>Meclizine Hcl</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140307</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part336</ApplicationNumber>
<LabelerName>NuCare Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>MECLIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>12.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-05-07</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>78863-3002-2</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 CARTON (78863-3002-2) / 50 mL in 1 BOTTLE, PUMP</PackageDescription>
<NDC11Code>78863-3002-02</NDC11Code>
<ProductNDC>78863-3002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Acno Solution</ProprietaryName>
<ProprietaryNameSuffix>Acne Treatment</ProprietaryNameSuffix>
<NonProprietaryName>Salicylic Acid</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240615</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M006</ApplicationNumber>
<LabelerName>Noon Aesthetics M.R. Ltd</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-07-28</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260728</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Use for the treatment of Acne.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>84504-3002-2</NDCCode>
<PackageDescription>1 BOTTLE, PUMP in 1 CARTON (84504-3002-2) / 30 mL in 1 BOTTLE, PUMP (84504-3002-1) </PackageDescription>
<NDC11Code>84504-3002-02</NDC11Code>
<ProductNDC>84504-3002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Co-bb-54432 Featuring You Hydrating Skin Enhancing Tint Spf30-30 Insist</ProprietaryName>
<NonProprietaryName>Avobenzone, Homosalate,octisalate, Octocrylene</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20240401</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M020</ApplicationNumber>
<LabelerName>SW-SANGHVI BEAUTY USA, INC.</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>3; 10; 5; 7</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL; g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses helps prevent sunburn. if used as directed with other sun protection (see Directions), decreases risk of skin cancer & early skin aging caused by the sun.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0002-3002-01</NDCCode>
<PackageDescription>1 VIAL, SINGLE-DOSE in 1 CARTON (0002-3002-01) / .5 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>00002-3002-01</NDC11Code>
<ProductNDC>0002-3002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mounjaro</ProprietaryName>
<NonProprietaryName>Tirzepatide</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>20230728</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA215866</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>TIRZEPATIDE</SubstanceName>
<StrengthNumber>15</StrengthNumber>
<StrengthUnit>mg/.5mL</StrengthUnit>
<Pharm_Classes>G-Protein-linked Receptor Interactions [MoA], GLP-1 Receptor Agonist [EPC], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA], Glucose-dependent Insulinotropic Polypeptide Receptor Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230728</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>MOUNJARO® is indicated: : 1 as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients 10 years of age and older with type 2 diabetes mellitus. , 2 to reduce the risk of major adverse cardiovascular (CV) events (CV death, non-fatal myocardial infarction (MI), or non-fatal stroke) in adults with type 2 diabetes mellitus who are at high risk for these events. .</IndicationAndUsage>
<Description>MOUNJARO (tirzepatide) injection, for subcutaneous use, contains tirzepatide, a once weekly GIP receptor and GLP-1 receptor agonist. Tirzepatide is based on the GIP sequence and contains aminoisobutyric acid (Aib) in positions 2 and 13, a C-terminal amide, and Lys residue at position 20 that is attached to 1,20-eicosanedioic acid via a linker. The molecular weight is 4813.53 Da and the empirical formula is C225H348N48O68. Structural formula:. MOUNJARO is a clear, colorless to slightly yellow, sterile solution for subcutaneous use. Each single-dose pen or single-dose vial contains a 0.5 mL solution of 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg of tirzepatide and the following excipients: sodium chloride (4.1 mg), sodium phosphate dibasic heptahydrate (0.7 mg), and water for injection. Each multi-dose vial or single-patient-use KwikPen contains 2.4 mL of solution, which provides 4 doses of 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg of tirzepatide per 0.6 mL. Each dose contains the following excipients: benzyl alcohol (5.4 mg), glycerin (4.8 mg), phenol (1.08 mg), sodium chloride (1.05 mg), sodium phosphate dibasic heptahydrate (0.8 mg), and water for injection. Hydrochloric acid solution and/or sodium hydroxide solution may have been added to adjust the pH. MOUNJARO has a pH of 6.5 to 7.5. Each single-patient-use KwikPen contains additional volume to allow for device priming.</Description>
</NDC>
<NDC>
<NDCCode>0093-3002-56</NDCCode>
<PackageDescription>30 CAPSULE in 1 BOTTLE (0093-3002-56) </PackageDescription>
<NDC11Code>00093-3002-56</NDC11Code>
<ProductNDC>0093-3002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Quinine Sulfate</ProprietaryName>
<NonProprietaryName>Quinine Sulfate</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120928</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091661</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>QUININE SULFATE</SubstanceName>
<StrengthNumber>324</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antimalarial [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120928</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Quinine sulfate capsules are an antimalarial drug indicated only for treatment of uncomplicated Plasmodium falciparum malaria. Quinine sulfate has been shown to be effective in geographical regions where resistance to chloroquine has been documented [see Clinical Studies (14)]. Limitations of Use:Quinine sulfate capsules are not approved for: 1 Treatment of severe or complicated P. falciparum malaria., 2 Prevention of malaria., 3 Treatment or prevention of nocturnal leg cramps [see Warnings and Precautions (5.1)].</IndicationAndUsage>
<Description>Quinine sulfate, USP is a cinchona alkaloid chemically described as bis[(R)-(6-methoxyquinolin-4-yl)-[2S,4S,5R)-5-ethenyl-1-azabicyclo[2.2.2]oct-2-yl]methanol] sulfate. The structural formula of quinine sulfate, USP is. C40H50N4O8S2H2O M.W. 783.0. Quinine sulfate, USP occurs as a white or almost white, crystalline powder that darkens on exposure to light. It is odorless and has a persistent very bitter taste. It is slightly soluble in water, sparingly soluble in boiling water and in alcohol, and practically insoluble in ether. Quinine Sulfate Capsules USP are supplied for oral administration as capsules containing 324 mg of the active ingredient quinine sulfate, USP equivalent to 269 mg free base. Inactive ingredients: colloidal silicon dioxide, gelatin, iron oxide black, magnesium stearate, pregelatinized corn starch, propylene glycol, shellac, sodium lauryl sulfate, and titanium dioxide. The imprinting ink may contain potassium hydroxide. FDA approved dissolution test specifications differ from USP.</Description>
</NDC>
<NDC>
<NDCCode>0378-3002-05</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE, PLASTIC (0378-3002-05) </PackageDescription>
<NDC11Code>00378-3002-05</NDC11Code>
<ProductNDC>0378-3002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Candesartan Cilexetil And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Candesartan Cilexetil And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121204</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090704</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>32; 12.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-08-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20121204</StartMarketingDatePackage>
<EndMarketingDatePackage>20210731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Candesartan cilexetil and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with candesartan cilexetil and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. This fixed dose combination is not indicated for initial therapy (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Candesartan cilexetil and hydrochlorothiazide tablets, USP combine an angiotensin II receptor (type AT1) antagonist and a diuretic, hydrochlorothiazide. Candesartan cilexetil, a nonpeptide, is chemically described as (±)2-Ethoxy-1-[[2’-(1H-tetrazol-5-yl)[1,1’-biphenyl]-4-yl]methyl]-1H-benzimidazole-7-carboxylic acid-1-[[(cyclohexyloxy)carbonyl]oxy]ethyl ester. Its molecular formula is C33H34N6O6, and its structural formula is:. Candesartan cilexetil, USP is a white to off-white powder with a molecular weight of 610.66. It is practically insoluble in water and sparingly soluble in methanol. Candesartan cilexetil is a racemic mixture containing one chiral center at the cyclohexyloxycarbonyloxy ethyl ester group. Following oral administration, candesartan cilexetil undergoes hydrolysis at the ester link to form the active drug, candesartan, which is achiral. Hydrochlorothiazide is 2H-1,2,4-Benzothiadiazine-7-sulfonamide, 6-chloro-3,4-dihydro-,1,1-dioxide. Its molecular formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide, USP is a white, or practically white, practically odorless crystalline powder with a molecular weight of 297.7, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Candesartan cilexetil and hydrochlorothiazide tablets are available for oral administration in three tablet strengths of candesartan cilexetil and hydrochlorothiazide. Candesartan cilexetil and hydrochlorothiazide tablets contain 16 mg or 32 mg of candesartan cilexetil and 12.5 mg or 25 mg of hydrochlorothiazide providing for the following available combinations: 16 mg/12.5 mg, 32 mg/12.5 mg or 32 mg/25 mg. The inactive ingredients of the tablets are carboxymethylcellulose calcium, corn starch, glyceryl stearate, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and yellow iron oxide. The 16 mg/12.5 mg tablet and 32 mg/25 mg tablet also contain red iron oxide as a colorant.</Description>
</NDC>
<NDC>
<NDCCode>0378-3002-77</NDCCode>
<PackageDescription>90 TABLET in 1 BOTTLE, PLASTIC (0378-3002-77) </PackageDescription>
<NDC11Code>00378-3002-77</NDC11Code>
<ProductNDC>0378-3002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Candesartan Cilexetil And Hydrochlorothiazide</ProprietaryName>
<NonProprietaryName>Candesartan Cilexetil And Hydrochlorothiazide</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20121204</StartMarketingDate>
<EndMarketingDate>20260430</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA090704</ApplicationNumber>
<LabelerName>Mylan Pharmaceuticals Inc.</LabelerName>
<SubstanceName>CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE</SubstanceName>
<StrengthNumber>32; 12.5</StrengthNumber>
<StrengthUnit>mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin 2 Receptor Antagonists [MoA], Angiotensin 2 Receptor Blocker [EPC], Increased Diuresis [PE], Thiazide Diuretic [EPC], Thiazides [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-04-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20121204</StartMarketingDatePackage>
<EndMarketingDatePackage>20260430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Candesartan cilexetil and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with candesartan cilexetil and hydrochlorothiazide tablets. Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC). Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly. Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal. Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy. This fixed dose combination is not indicated for initial therapy (see DOSAGE AND ADMINISTRATION).</IndicationAndUsage>
<Description>Candesartan cilexetil and hydrochlorothiazide tablets, USP combine an angiotensin II receptor (type AT1) antagonist and a diuretic, hydrochlorothiazide. Candesartan cilexetil, a nonpeptide, is chemically described as (±)2-Ethoxy-1-[[2’-(1H-tetrazol-5-yl)[1,1’-biphenyl]-4-yl]methyl]-1H-benzimidazole-7-carboxylic acid-1-[[(cyclohexyloxy)carbonyl]oxy]ethyl ester. Its molecular formula is C33H34N6O6, and its structural formula is:. Candesartan cilexetil, USP is a white to off-white powder with a molecular weight of 610.66. It is practically insoluble in water and sparingly soluble in methanol. Candesartan cilexetil is a racemic mixture containing one chiral center at the cyclohexyloxycarbonyloxy ethyl ester group. Following oral administration, candesartan cilexetil undergoes hydrolysis at the ester link to form the active drug, candesartan, which is achiral. Hydrochlorothiazide is 2H-1,2,4-Benzothiadiazine-7-sulfonamide, 6-chloro-3,4-dihydro-,1,1-dioxide. Its molecular formula is C7H8ClN3O4S2 and its structural formula is. Hydrochlorothiazide, USP is a white, or practically white, practically odorless crystalline powder with a molecular weight of 297.7, which is slightly soluble in water, but freely soluble in sodium hydroxide solution. Candesartan cilexetil and hydrochlorothiazide tablets are available for oral administration in three tablet strengths of candesartan cilexetil and hydrochlorothiazide. Candesartan cilexetil and hydrochlorothiazide tablets contain 16 mg or 32 mg of candesartan cilexetil and 12.5 mg or 25 mg of hydrochlorothiazide providing for the following available combinations: 16 mg/12.5 mg, 32 mg/12.5 mg or 32 mg/25 mg. The inactive ingredients of the tablets are carboxymethylcellulose calcium, corn starch, glyceryl stearate, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate and yellow iron oxide. The 16 mg/12.5 mg tablet and 32 mg/25 mg tablet also contain red iron oxide as a colorant.</Description>
</NDC>
<NDC>
<NDCCode>33992-3002-1</NDCCode>
<PackageDescription>237 mL in 1 BOTTLE (33992-3002-1) </PackageDescription>
<NDC11Code>33992-3002-01</NDC11Code>
<ProductNDC>33992-3002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sweet Pea Blossom Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Ethyl Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130524</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Greenbrier International, Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>147</StrengthNumber>
<StrengthUnit>mL/237mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130524</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Other information: 1 store at 20oC to 25oC (68o to 77oF), 2 may discolor certain fabrics.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>43948-3002-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, PUMP (43948-3002-1)</PackageDescription>
<NDC11Code>43948-3002-01</NDC11Code>
<ProductNDC>43948-3002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Dr G Dewrinkle Fortifier By Egf</ProprietaryName>
<NonProprietaryName>Adenosine Glycerin</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20091101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part347</ApplicationNumber>
<LabelerName>The Doctor's Cosmetic Inc</LabelerName>
<SubstanceName>ADENOSINE; GLYCERIN</SubstanceName>
<StrengthNumber>.012; 2.1</StrengthNumber>
<StrengthUnit>mL/30mL; mL/30mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>50090-3002-0</NDCCode>
<PackageDescription>180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-3002-0) </PackageDescription>
<NDC11Code>50090-3002-00</NDC11Code>
<ProductNDC>50090-3002</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Delzicol</ProprietaryName>
<NonProprietaryName>Mesalamine</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160516</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA204412</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>MESALAMINE</SubstanceName>
<StrengthNumber>400</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Aminosalicylate [EPC], Aminosalicylic Acids [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170504</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DELZICOL is an aminosalicylate indicated for: 1 Treatment of mildly to moderately active ulcerative colitis in patients 5 years of age and older. (1.1), 2 Maintenance of remission of ulcerative colitis in adults. (1.2).</IndicationAndUsage>
<Description>Each DELZICOL (mesalamine) delayed-release capsule for oral administration contains four 100 mg tablets of mesalamine, an aminosalicylate. DELZICOL (mesalamine) delayed-release capsules contain acrylic based resin, methacrylic acid and methyl methacrylate copolymer (Eudragit S), which dissolves at pH 7 or greater and releases mesalamine in the terminal ileum and beyond for topical anti-inflammatory action in the colon. Mesalamine (also referred to as 5-aminosalicylic acid or 5-ASA) has the chemical name 5-amino-2-hydroxybenzoic acid. Its structural formula is. Inactive Ingredients: Each capsule contains colloidal silicon dioxide, dibutyl sebacate, ferric oxide red (3.44 mg), ferric oxide yellow (0.62 mg), lactose monohydrate, magnesium stearate, methacrylic acid and methyl methancrylate copolymer (Eudragit S), polyethylene glycol, povidone, sodium starch glycolate, talc and hydroxypropyl methylcellulose (HPMC).</Description>
</NDC>
<NDC>
<NDCCode>72617-0001-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (72617-0001-1) </PackageDescription>
<NDC11Code>72617-0001-01</NDC11Code>
<ProductNDC>72617-0001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergy Mix Las Vegas</ProprietaryName>
<NonProprietaryName>Alternaria Alternata, Bermuda Grass Pollen (cynodon Dactylon), Cladosporium Herbarum, Histaminum Hydrochloricum, Juniperus Communis, Oleander, Olive Pollen (olea Europaea), Ragweed Pollen (ambrosia Artemisiaefolia), Sabina, Ustilago Maidis, White Mulberry Pollen (morus Alba)</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260326</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>American Standard Nutraceuticals</LabelerName>
<SubstanceName>ALTERNARIA ALTERNATA; CYNODON DACTYLON POLLEN; CLADOSPORIUM HERBARUM; HISTAMINE DIHYDROCHLORIDE; JUNIPER BERRY; NERIUM OLEANDER LEAF; OLEA EUROPAEA POLLEN; AMBROSIA ARTEMISIIFOLIA POLLEN; JUNIPERUS SABINA LEAFY TWIG; USTILAGO MAYDIS; MORUS ALBA POLLEN</SubstanceName>
<StrengthNumber>12; 12; 12; 12; 6; 6; 12; 12; 6; 6; 12</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Plant Proteins [CS], Pollen [CS], Pollen [CS], Pollen [CS], Standardized Pollen Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-03-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260326</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For temporary relief of allergy symptoms including sneezing, runny nose, itchy, watery eyes, congestion, and stuffy nose.†. †Claims based on traditional practice, not accepted medical evidence. Not FDA evaluated.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72617-2001-1</NDCCode>
<PackageDescription>29.6 mL in 1 BOTTLE, DROPPER (72617-2001-1) </PackageDescription>
<NDC11Code>72617-2001-01</NDC11Code>
<ProductNDC>72617-2001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergy Mix Las Vegas</ProprietaryName>
<NonProprietaryName>Local Remedy Las Vegas</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190123</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>ASN</LabelerName>
<SubstanceName>ALTERNARIA ALTERNATA; JUNIPERUS ASHEI POLLEN; JUNIPERUS SCOPULORUM POLLEN; NERIUM OLEANDER FLOWER; OLEA EUROPAEA FLOWER; PASSALORA FULVA; USTILAGO MAYDIS; WHITE MULBERRY</SubstanceName>
<StrengthNumber>6; 6; 6; 6; 6; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190123</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: Allergy symptom reliefFor temporary relief of symptoms due to hay fever or otherrespiratory allergies. Runny nose, sneezing, irritated eyes,nasal congestion, itchy nose and throat, sinus pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72617-2002-1</NDCCode>
<PackageDescription>29.6 mL in 1 BOTTLE, DROPPER (72617-2002-1) </PackageDescription>
<NDC11Code>72617-2002-01</NDC11Code>
<ProductNDC>72617-2002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergy Mix Phoenix</ProprietaryName>
<NonProprietaryName>Local Remedy Phoenix</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190123</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>ASN</LabelerName>
<SubstanceName>ALTERNARIA ALTERNATA; AMBROSIA ARTEMISIIFOLIA; CYNODON DACTYLON; JUNIPERUS ASHEI POLLEN; JUNIPERUS SCOPULORUM POLLEN; NERIUM OLEANDER FLOWER; OLEA EUROPAEA FLOWER; PASSALORA FULVA; USTILAGO MAYDIS; WHITE MULBERRY</SubstanceName>
<StrengthNumber>6; 12; 12; 6; 6; 6; 6; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL; [hp_X]/29.6mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS], Pollen [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190123</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses: Allergy symptom reliefFor temporary relief of symptoms due to hay fever or otherrespiratory allergies. Runny nose, sneezing, irritated eyes,nasal congestion, itchy nose and throat, sinus pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>72617-2003-1</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>72617-4001-3</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>
</NDCList>