{
"NDC": [
{
"NDCCode": "62795-6000-7",
"PackageDescription": "1 TUBE in 1 CARTON (62795-6000-7) > 50 g in 1 TUBE",
"NDC11Code": "62795-6000-07",
"ProductNDC": "62795-6000",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "T-relief Arthritis",
"NonProprietaryName": "Arnica Montana Root, Bryonia Alba Whole, Sus Scrofa Umbilical Cord, Solanum Dulcamara Top, Sus Scrofa Embryo, Sus Scrofa Umbilical Cord, Ledum Palustre Twig, Sus Scrofa Placenta, Rhododendron Aureum Leaf, Toxicodendron Pubescens Leaf, Sanguinaria Canadensis Root, Sulfur, And Comfrey Root",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140830",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "MediNatura Inc",
"SubstanceName": "ARNICA MONTANA ROOT; BRYONIA ALBA WHOLE; SUS SCROFA UMBILICAL CORD; SOLANUM DULCAMARA TOP; SUS SCROFA EMBRYO; SUS SCROFA CARTILAGE; LEDUM PALUSTRE TWIG; SUS SCROFA PLACENTA; RHODODENDRON AUREUM LEAF; TOXICODENDRON PUBESCENS LEAF; SANGUINARIA CANADENSIS ROOT; SULFUR; COMFREY ROOT",
"StrengthNumber": "3; 3; 4; 2; 6; 4; 6; 4; 8; 4; 3; 6; 7",
"StrengthUnit": "[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g",
"Status": "Deprecated",
"LastUpdate": "2019-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "44087-6000-7",
"PackageDescription": "7 BLISTER PACK in 1 CARTON (44087-6000-7) > 1 TABLET in 1 BLISTER PACK",
"NDC11Code": "44087-6000-07",
"ProductNDC": "44087-6000",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Mavenclad",
"NonProprietaryName": "Cladribine",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022561",
"LabelerName": "EMD Serono, Inc.",
"SubstanceName": "CLADRIBINE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Purine Antimetabolite [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-04-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20190329",
"SamplePackage": "N"
},
{
"NDCCode": "51885-6000-7",
"PackageDescription": "1 L in 1 CONTAINER (51885-6000-7)",
"NDC11Code": "51885-6000-07",
"ProductNDC": "51885-6000",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Bellis Perennis",
"DosageFormName": "LIQUID",
"StartMarketingDate": "20120821",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Biologische Heilmittel Heel",
"SubstanceName": "BELLIS PERENNIS",
"StrengthNumber": "1",
"StrengthUnit": "L/L",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "61577-6000-1",
"PackageDescription": "88.7 g in 1 BOTTLE (61577-6000-1) ",
"NDC11Code": "61577-6000-01",
"ProductNDC": "61577-6000",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Provault Dryspray Cbd Pain Relief",
"NonProprietaryName": "Menthol, Camphor",
"DosageFormName": "SPRAY",
"RouteName": "TOPICAL",
"StartMarketingDate": "20221018",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Sombra Cosmetics Inc",
"SubstanceName": "CAMPHOR (SYNTHETIC); MENTHOL",
"StrengthNumber": ".02; .09",
"StrengthUnit": "g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20221018",
"SamplePackage": "N",
"IndicationAndUsage": "Temporary relief of monor aches and pains of muscles and joints associated with strains, bruises and sprains."
},
{
"NDCCode": "78502-6000-7",
"PackageDescription": "30 g in 1 BAG (78502-6000-7) ",
"NDC11Code": "78502-6000-07",
"ProductNDC": "78502-6000",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Medically Minded",
"NonProprietaryName": "Benzalkonium Chloride",
"DosageFormName": "CLOTH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200628",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "BELSKIN S. DE, R.L. DE C.V",
"SubstanceName": "BENZALKONIUM CHLORIDE; ALCOHOL",
"StrengthNumber": ".25; 5",
"StrengthUnit": "g/100g; g/100g",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200628",
"SamplePackage": "N",
"IndicationAndUsage": "APPLY TO HANDS. ALLOW TO DRY WITHOUT WIPING."
},
{
"NDCCode": "62795-1041-7",
"PackageDescription": "60 TABLET, CHEWABLE in 1 BOTTLE (62795-1041-7) ",
"NDC11Code": "62795-1041-07",
"ProductNDC": "62795-1041",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "T-relief Extra Strength",
"NonProprietaryName": "Arnica Montana, Calendula Officinalis Flowering, Hamamelis Virginiana Root Bark/stem, Baptisia Tinctoria Root, Bellis Perennis, Echinacea, Unspecified, Aconitum Napellus, Matricaria Chamomilla, Achillea Millefolium, Atropa Belladonna, Hypericum Perforatum, Ruta Graveolens Flowering Top And Comfrey Root",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20180201",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "MediNatura Inc",
"SubstanceName": "ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; BAPTISIA TINCTORIA ROOT; BELLIS PERENNIS; ECHINACEA, UNSPECIFIED; ACONITUM NAPELLUS; MATRICARIA CHAMOMILLA; ACHILLEA MILLEFOLIUM; ATROPA BELLADONNA; HYPERICUM PERFORATUM; RUTA GRAVEOLENS FLOWERING TOP; COMFREY ROOT",
"StrengthNumber": "3; 2; 2; 2; 2; 2; 3; 2; 2; 3; 3; 3; 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; [hp_X]/1; [hp_X]/1",
"Status": "Active",
"LastUpdate": "2023-09-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230918",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of minor: Joint Pain Back Pain Muscular Pain Arthritis Pain."
},
{
"NDCCode": "62795-6001-4",
"PackageDescription": "1 KIT in 1 KIT (62795-6001-4) * 100 TABLET in 1 BOTTLE (62795-1029-2) * 50 g in 1 TUBE (62795-7002-7)",
"NDC11Code": "62795-6001-04",
"ProductNDC": "62795-6001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "T-relief Value Pack",
"NonProprietaryName": "T-relief",
"DosageFormName": "KIT",
"StartMarketingDate": "20140830",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "MediNatura",
"Status": "Deprecated",
"LastUpdate": "2018-04-05",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "62795-6006-7",
"PackageDescription": "1 TUBE in 1 CARTON (62795-6006-7) / 57 g in 1 TUBE",
"NDC11Code": "62795-6006-07",
"ProductNDC": "62795-6006",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "T-relief Arthritis",
"NonProprietaryName": "Arnica Montana Root, Bryonia Alba Whole, Sus Scrofa Umbilical Cord, Solanum Dulcamara Top, Sus Scrofa Embryo, Sus Scrofa Umbilical Cord, Ledum Palustre Twig, Sus Scrofa Placenta, Rhododendron Aureum Leaf, Toxicodendron Pubescens Leaf, Sanguinaria Canadensis Root, Sulfur, And Comfrey Root",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20170131",
"EndMarketingDate": "20260531",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "MediNatura Inc",
"SubstanceName": "ARNICA MONTANA ROOT; BRYONIA ALBA WHOLE; COMFREY ROOT; LEDUM PALUSTRE TWIG; RHODODENDRON AUREUM LEAF; SANGUINARIA CANADENSIS ROOT; SOLANUM DULCAMARA TOP; SULFUR; SUS SCROFA CARTILAGE; SUS SCROFA EMBRYO; SUS SCROFA PLACENTA; SUS SCROFA UMBILICAL CORD; TOXICODENDRON PUBESCENS LEAF",
"StrengthNumber": "2; 2; 7; 6; 8; 3; 2; 6; 4; 4; 4; 4; 4",
"StrengthUnit": "[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g",
"Status": "Deprecated",
"LastUpdate": "2026-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170131",
"EndMarketingDatePackage": "20260531",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of minor: Arthritis Pain Joint Pain Joint Stiffness."
},
{
"NDCCode": "62795-6050-7",
"PackageDescription": "85 g in 1 TUBE (62795-6050-7) ",
"NDC11Code": "62795-6050-07",
"ProductNDC": "62795-6050",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "T-relief Lidocaine Hcl 4%",
"NonProprietaryName": "Lidocaine Hcl 4%",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20251101",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Medinatura New Mexico Inc.",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE",
"StrengthNumber": "3.4",
"StrengthUnit": "g/85g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20251101",
"SamplePackage": "N"
},
{
"NDCCode": "62795-7002-7",
"PackageDescription": "1 TUBE in 1 CARTON (62795-7002-7) > 50 g in 1 TUBE",
"NDC11Code": "62795-7002-07",
"ProductNDC": "62795-7002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "T-relief",
"NonProprietaryName": "Aconitum Napellus, Arnica Montana Root,baptisia Tinctoria Root, Atropa Belladonna,bellis Perennis, Calendula Officinalis Flowering Top,matricaria Recutita, Echinacea, Unspecified, Hamamelis Virginiana Root Bark/stem Bark,hypericum Perforatum, Achillea Millefolium, Ruta Graveolens Flowering Top, And Comfrey Root",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140901",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "MediNatura Inc",
"SubstanceName": "ACONITUM NAPELLUS; ARNICA MONTANA ROOT; BAPTISIA TINCTORIA ROOT; ATROPA BELLADONNA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; ACHILLEA MILLEFOLIUM; RUTA GRAVEOLENS FLOWERING TOP; COMFREY ROOT",
"StrengthNumber": "1; 1; 4; 2; 2; 1; 2; 2; 6; 2; 4; 4",
"StrengthUnit": "[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; 1/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g",
"Status": "Deprecated",
"LastUpdate": "2019-02-15",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "62795-7003-7",
"PackageDescription": "1 TUBE in 1 CARTON (62795-7003-7) > 50 g in 1 TUBE",
"NDC11Code": "62795-7003-07",
"ProductNDC": "62795-7003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "T-relief",
"NonProprietaryName": "Aconitum Napellus, Arnica Montana Root, Baptisia Tinctoria Root, Atropa Belladonna, Bellis Perennis, Calendula Officinalis Flowering Top, Matricaria Recutita, Echinacea, Unspecified, Hamamelis Virginiana Root Bark/stem Bark, Hypericum Perforatum, Achillea Millefolium, Ruta Graveolens Flowering Top, And Comfrey Root",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150731",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "MediNatura Inc",
"SubstanceName": "ACONITUM NAPELLUS; ARNICA MONTANA ROOT; BAPTISIA TINCTORIA ROOT; ATROPA BELLADONNA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; ACHILLEA MILLEFOLIUM; RUTA GRAVEOLENS FLOWERING TOP; COMFREY ROOT",
"StrengthNumber": "1; 1; 4; 2; 2; 1; 2; 1; 2; 6; 2; 4; 4",
"StrengthUnit": "[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g",
"Status": "Deprecated",
"LastUpdate": "2019-01-30",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "62795-7004-7",
"PackageDescription": "1 TUBE in 1 CARTON (62795-7004-7) / 57 g in 1 TUBE",
"NDC11Code": "62795-7004-07",
"ProductNDC": "62795-7004",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "T-relief",
"NonProprietaryName": "Achillea Millefolium, Hypericum Perforatum, Hamamelis Virginiana Root Bark/stem Bark, Echinacea, Unspecified, Matricaria Recutita, Atropa Belladonna,comfrey Root, Aconitum Napellus, Bellis Perennis,arnica Montana, And Ruta Graveolens Flowering Top",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20151201",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "MediNatura Inc",
"SubstanceName": "ARNICA MONTANA; BAPTISIA TINCTORIA ROOT; ATROPA BELLADONNA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; RUTA GRAVEOLENS FLOWERING TOP; ACONITUM NAPELLUS; COMFREY ROOT; ACHILLEA MILLEFOLIUM",
"StrengthNumber": "1; 4; 2; 2; 1; 2; 1; 2; 6; 4; 1; 4; 2",
"StrengthUnit": "[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g",
"Status": "Active",
"LastUpdate": "2023-10-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20151201",
"SamplePackage": "N",
"IndicationAndUsage": "Relieves. Joint Pain. Back Pain. Muscular Pain."
},
{
"NDCCode": "62795-7007-7",
"PackageDescription": "1 TUBE in 1 CARTON (62795-7007-7) / 85 g in 1 TUBE",
"NDC11Code": "62795-7007-07",
"ProductNDC": "62795-7007",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "T-relief Extra Strength Cream",
"NonProprietaryName": "Arnica Montana, Calendula Officinalis Flowering Top, Echinacea Unspecified, Aconitum Napellus, Achillea Millefolium, Hamamelis Virginiana Root Bark Stem Bark, Matricaria Chamomilla, Atropa Belladonna, Bellis Perennis, Ruta Graveolens Flowering Top, Baptisia Tinctoria Root, Comfrey Root And Hypericum Perforatum",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20171019",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "MediNatura Inc",
"SubstanceName": "ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA, UNSPECIFIED; ACONITUM NAPELLUS; ACHILLEA MILLEFOLIUM; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; MATRICARIA CHAMOMILLA; ATROPA BELLADONNA; BELLIS PERENNIS; RUTA GRAVEOLENS FLOWERING TOP; BAPTISIA TINCTORIA ROOT; COMFREY ROOT; HYPERICUM PERFORATUM",
"StrengthNumber": "1; 1; 1; 1; 2; 2; 2; 2; 2; 4; 4; 4; 6",
"StrengthUnit": "[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g",
"Status": "Active",
"LastUpdate": "2023-10-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171019",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of minor: Joint Pain Back Pain Muscular Pain Nerve Pain Arthritis Pain."
},
{
"NDCCode": "62795-7008-7",
"PackageDescription": "1 TUBE in 1 CARTON (62795-7008-7) > 85 g in 1 TUBE",
"NDC11Code": "62795-7008-07",
"ProductNDC": "62795-7008",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "T-relief Pro Cream",
"NonProprietaryName": "Arnica Montana,calendula Officinalis Flowering Top,echinacea, Unspecified,aconitum Napellus, Achillea Millefolium, Hamamelis Virginiana Root Bark/stem Bark,matricaria Chamomilla,atropa Belladonna,bellis Perennis,ruta Graveolens Flowering Top,baptisia Tinctoria Root,comfrey Root And Hypericum Perforatum",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180611",
"EndMarketingDate": "20220731",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Medinatura New Mexico, Inc",
"SubstanceName": "ACHILLEA MILLEFOLIUM; ACONITUM NAPELLUS; ARNICA MONTANA; ATROPA BELLADONNA; BAPTISIA TINCTORIA ROOT; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; MATRICARIA CHAMOMILLA; RUTA GRAVEOLENS FLOWERING TOP",
"StrengthNumber": "2; 1; 1; 2; 4; 2; 1; 4; 1; 2; 6; 2; 4",
"StrengthUnit": "[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180611",
"EndMarketingDatePackage": "20220731",
"SamplePackage": "N"
},
{
"NDCCode": "62795-1018-2",
"PackageDescription": "100 TABLET in 1 BOTTLE (62795-1018-2)",
"NDC11Code": "62795-1018-02",
"ProductNDC": "62795-1018",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bhi Restore",
"NonProprietaryName": "Arnica Montana Root, Ilex Aquifolium Flowering Top, Nerium Oleander Leaf, Ovis Aries Testicle, And Lactic Acid, L-",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20150101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Medinatura Inc",
"SubstanceName": "ARNICA MONTANA ROOT; ILEX AQUIFOLIUM FLOWERING TOP; NERIUM OLEANDER LEAF; OVIS ARIES TESTICLE; LACTIC ACID, L-",
"StrengthNumber": "7; 2; 5; 10; 11",
"StrengthUnit": "[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2018-11-16",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "62795-1028-2",
"PackageDescription": "1 BOTTLE in 1 CARTON (62795-1028-2) > 100 TABLET in 1 BOTTLE",
"NDC11Code": "62795-1028-02",
"ProductNDC": "62795-1028",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Clearlife",
"NonProprietaryName": "Antimony Trisulfide, Arnica Montana Root, Euphrasia Stricta,formic Acid,graphite,histamine Dihydrochloride,strychnos Ignatii Seed, Arctium Lappa Root, Ledum Palustre Twig, Lycopodium Clavatum Spore, Pine Tar, Selenium, Sulfur, Sulfuric Acid, Tellurium, And Thuja Occidentalis Leafy Twig",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20140930",
"EndMarketingDate": "20250430",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "MediNatura Inc.",
"SubstanceName": "ANTIMONY TRISULFIDE; ARCTIUM LAPPA ROOT; ARNICA MONTANA ROOT; EUPHRASIA STRICTA; FORMIC ACID; GRAPHITE; HISTAMINE DIHYDROCHLORIDE; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; PINE TAR; SELENIUM; STRYCHNOS IGNATII SEED; SULFUR; SULFURIC ACID; TELLURIUM; THUJA OCCIDENTALIS LEAFY TWIG",
"StrengthNumber": "10; 8; 5; 6; 8; 10; 8; 7; 6; 10; 12; 6; 12; 21; 10; 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; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2025-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20140930",
"EndMarketingDatePackage": "20250430",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of minor allergy symptoms: 1 Runny nose, 2 Watery eyes, 3 Skin irritations."
},
{
"NDCCode": "62795-1030-2",
"PackageDescription": "1 BOTTLE in 1 CARTON (62795-1030-2) > 100 TABLET in 1 BOTTLE",
"NDC11Code": "62795-1030-02",
"ProductNDC": "62795-1030",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "T Relief Arthritis",
"NonProprietaryName": "T Relief Arthritis",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20141001",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Medinatura",
"SubstanceName": "ARNICA MONTANA ROOT; SUS SCROFA UMBILICAL CORD; BRYONIA ALBA ROOT; SOLANUM DULCAMARA TOP; SUS SCROFA EMBRYO; LEDUM PALUSTRE TWIG; RHODODENDRON AUREUM LEAF; TOXICODENDRON PUBESCENS LEAF; SANGUINARIA CANADENSIS ROOT; SULFUR; COMFREY ROOT; SUS SCROFA PLACENTA; SUS SCROFA CARTILAGE",
"StrengthNumber": "3; 6; 3; 2; 6; 6; 8; 4; 3; 6; 7; 6; 4",
"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; [hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2019-02-07",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "62795-1033-2",
"PackageDescription": "1 BOTTLE in 1 CARTON (62795-1033-2) / 100 TABLET in 1 BOTTLE",
"NDC11Code": "62795-1033-02",
"ProductNDC": "62795-1033",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "T Relief Arthritis",
"NonProprietaryName": "Arnica Montana, Bryonia Alba Root, Sus Scrofa Cartilage, Solanum Dulcamara Top, Sus Scrofa Embryo,sus Scrofa Umbilical Cord, Ledum Palustre Twig,sus Scrofa Umbilical Cord, Ledum Palustre Twig,sus Scrofa Placenta, Rhododendron Aureum Leaf,toxicodendron Pubescens Leaf, Sanguinaria Canadensis Root, Sulfur, And Comfrey Root",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "MediNatura Inc",
"SubstanceName": "ARNICA MONTANA; BRYONIA ALBA ROOT; COMFREY ROOT; LEDUM PALUSTRE TWIG; RHODODENDRON AUREUM LEAF; SANGUINARIA CANADENSIS ROOT; SOLANUM DULCAMARA TOP; SULFUR; SUS SCROFA CARTILAGE; SUS SCROFA EMBRYO; SUS SCROFA PLACENTA; SUS SCROFA UMBILICAL CORD; TOXICODENDRON PUBESCENS LEAF",
"StrengthNumber": "3; 3; 7; 6; 8; 3; 2; 6; 4; 6; 6; 6; 4",
"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; [hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20160301",
"SamplePackage": "N",
"IndicationAndUsage": "Relieves: 1 Arthritis pain, 2 Joint pain, 3 Joint stiffness."
},
{
"NDCCode": "62795-1033-4",
"PackageDescription": "100 TABLET in 1 BOTTLE (62795-1033-4) ",
"NDC11Code": "62795-1033-04",
"ProductNDC": "62795-1033",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "T Relief Arthritis",
"NonProprietaryName": "Arnica Montana, Bryonia Alba Root, Sus Scrofa Cartilage, Solanum Dulcamara Top, Sus Scrofa Embryo,sus Scrofa Umbilical Cord, Ledum Palustre Twig,sus Scrofa Umbilical Cord, Ledum Palustre Twig,sus Scrofa Placenta, Rhododendron Aureum Leaf,toxicodendron Pubescens Leaf, Sanguinaria Canadensis Root, Sulfur, And Comfrey Root",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160301",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "MediNatura Inc",
"SubstanceName": "ARNICA MONTANA; BRYONIA ALBA ROOT; COMFREY ROOT; LEDUM PALUSTRE TWIG; RHODODENDRON AUREUM LEAF; SANGUINARIA CANADENSIS ROOT; SOLANUM DULCAMARA TOP; SULFUR; SUS SCROFA CARTILAGE; SUS SCROFA EMBRYO; SUS SCROFA PLACENTA; SUS SCROFA UMBILICAL CORD; TOXICODENDRON PUBESCENS LEAF",
"StrengthNumber": "3; 3; 7; 6; 8; 3; 2; 6; 4; 6; 6; 6; 4",
"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; [hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2026-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20221116",
"SamplePackage": "N",
"IndicationAndUsage": "Relieves: 1 Arthritis pain, 2 Joint pain, 3 Joint stiffness."
},
{
"NDCCode": "62795-1039-2",
"PackageDescription": "100 TABLET in 1 PACKAGE (62795-1039-2) ",
"NDC11Code": "62795-1039-02",
"ProductNDC": "62795-1039",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "T-relief Pro Arthritis",
"NonProprietaryName": "Arnica Montana, Bryonia Alba Whole, Sus Scrofa Cartilage,solanum Dulcamara Top,sus Scrofa Embryo,sus Scrofa Umbilical Cord,rhododendron Tomentosum Leafy Twig,sus Scrofa Placenta,rhododendron Aureum Leaf,toxicodendron Pubescens Leaf, Sanguinaria Canadensis Root, Sulfur And Comfrey Root",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20171213",
"EndMarketingDate": "20260327",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "MediNatura Inc",
"SubstanceName": "ARNICA MONTANA; BRYONIA ALBA WHOLE; COMFREY ROOT; RHODODENDRON AUREUM LEAF; RHODODENDRON TOMENTOSUM LEAFY TWIG; SANGUINARIA CANADENSIS ROOT; SOLANUM DULCAMARA TOP; SULFUR; SUS SCROFA CARTILAGE; SUS SCROFA EMBRYO; SUS SCROFA PLACENTA; SUS SCROFA UMBILICAL CORD; TOXICODENDRON PUBESCENS LEAF",
"StrengthNumber": "3; 3; 7; 8; 6; 3; 2; 6; 4; 6; 6; 6; 4",
"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; [hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2026-03-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20171213",
"EndMarketingDatePackage": "20260327",
"SamplePackage": "N",
"IndicationAndUsage": "Arthritis Pain relief tablets Supports Mobility Joint Stiffness Arthritis Pain Joint Pain."
},
{
"NDCCode": "62795-1053-2",
"PackageDescription": "250 TABLET in 1 BOTTLE (62795-1053-2) ",
"NDC11Code": "62795-1053-02",
"ProductNDC": "62795-1053",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "T Relief Arthritis Extra Strength",
"NonProprietaryName": "Arnica Montana, Bryonia Alba Root, Sus Scrofa Cartilage, Solanum Dulcamara Top, Sus Scrofa Embryo,sus Scrofa Umbilical Cord, Ledum Palustre Twig,sus Scrofa Umbilical Cord, Ledum Palustre Twig,sus Scrofa Placenta, Rhododendron Aureum Leaf,toxicodendron Pubescens Leaf, Sanguinaria Canadensis Root, Sulfur, And Comfrey Root",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20220405",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "MediNatura Inc",
"SubstanceName": "ARNICA MONTANA; BRYONIA ALBA ROOT; COMFREY ROOT; LEDUM PALUSTRE TWIG; RHODODENDRON AUREUM LEAF; SANGUINARIA CANADENSIS ROOT; SOLANUM DULCAMARA TOP; SULFUR; SUS SCROFA CARTILAGE; SUS SCROFA EMBRYO; SUS SCROFA PLACENTA; SUS SCROFA UMBILICAL CORD; TOXICODENDRON PUBESCENS LEAF",
"StrengthNumber": "3; 3; 7; 6; 8; 3; 2; 6; 4; 6; 6; 6; 4",
"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; [hp_X]/1; [hp_X]/1",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20220405",
"SamplePackage": "N",
"IndicationAndUsage": "For the temporary relief of minor:Arthritis Pain Joint Pain Joint Stiffness."
},
{
"NDCCode": "62795-3000-1",
"PackageDescription": "1 BOTTLE in 1 CARTON (62795-3000-1) > 125 mL in 1 BOTTLE",
"NDC11Code": "62795-3000-01",
"ProductNDC": "62795-3000",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Reboost Cough",
"NonProprietaryName": "Antimony Potassium Tartrate, Pulsatilla Vulgaris, Drosera Rotundifolia, Hyoscyamus Niger, Ipecac, Pulsatilla Vulgaris, Rumex Crispus Root, Spongia Officinalis Skeleton, Roasted, And Lobaria Pulmonaria",
"DosageFormName": "SYRUP",
"RouteName": "ORAL",
"StartMarketingDate": "20140830",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "MediNatura",
"SubstanceName": "ANTIMONY POTASSIUM TARTRATE; DROSERA ROTUNDIFOLIA; HYOSCYAMUS NIGER; IPECAC; PULSATILLA VULGARIS; RUMEX CRISPUS ROOT; SPONGIA OFFICINALIS SKELETON, ROASTED; LOBARIA PULMONARIA",
"StrengthNumber": "6; 3; 6; 4; 9; 4; 7; 6",
"StrengthUnit": "[hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL",
"Status": "Deprecated",
"LastUpdate": "2019-01-10",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0024-1171-90",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (0024-1171-90) ",
"NDC11Code": "00024-1171-90",
"ProductNDC": "0024-1171",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Plavix",
"NonProprietaryName": "Clopidogrel",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19971117",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020839",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "CLOPIDOGREL BISULFATE",
"StrengthNumber": "75",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-06-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200713",
"SamplePackage": "N",
"IndicationAndUsage": "Plavix is a P2Y12 platelet inhibitor indicated for: 1 Acute coronary syndrome –For patients with non–ST-segment elevation ACS (unstable angina [UA]/non–ST-elevation myocardial infarction [NSTEMI]), Plavix has been shown to reduce the rate of myocardial infarction (MI) and stroke. (1.1)–For patients with ST-elevation myocardial infarction (STEMI), Plavix has been shown to reduce the rate of MI and stroke. (1.1), 2 Recent MI, recent stroke, or established peripheral arterial disease. Plavix has been shown to reduce the rate of MI and stroke. (1.2).",
"Description": "Plavix (clopidogrel tablets) is a thienopyridine class inhibitor of P2Y12 ADP platelet receptors. Chemically it is methyl (+)-(S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)-acetate sulfate (1:1). The empirical formula of clopidogrel bisulfate is C16H16ClNO2SH2SO4 and its molecular weight is 419.9. The structural formula is as follows. Clopidogrel bisulfate is a white to off-white powder. It is practically insoluble in water at neutral pH but freely soluble at pH 1. It also dissolves freely in methanol, dissolves sparingly in methylene chloride, and is practically insoluble in ethyl ether. It has a specific optical rotation of about +56°. Plavix for oral administration is provided as either pink, round, biconvex, debossed, film-coated tablets containing 97.875 mg of clopidogrel bisulfate which is the molar equivalent of 75 mg of clopidogrel base or pink, oblong, debossed, film-coated tablets containing 391.5 mg of clopidogrel bisulfate which is the molar equivalent of 300 mg of clopidogrel base. Each tablet contains hydrogenated castor oil, hydroxypropyl cellulose, mannitol, microcrystalline cellulose, and polyethylene glycol 6000 as inactive ingredients. The pink film coating contains ferric oxide, hypromellose 2910, lactose monohydrate, titanium dioxide, and triacetin. The tablets are polished with Carnauba wax."
},
{
"NDCCode": "0024-1332-30",
"PackageDescription": "3 BLISTER PACK in 1 CARTON (0024-1332-30) / 10 TABLET, FILM COATED in 1 BLISTER PACK",
"NDC11Code": "00024-1332-30",
"ProductNDC": "0024-1332",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Plavix",
"NonProprietaryName": "Clopidogrel",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20090509",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020839",
"LabelerName": "Sanofi-Aventis U.S. LLC",
"SubstanceName": "CLOPIDOGREL BISULFATE",
"StrengthNumber": "300",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2C8 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2025-06-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200713",
"SamplePackage": "N",
"IndicationAndUsage": "Plavix is a P2Y12 platelet inhibitor indicated for: 1 Acute coronary syndrome –For patients with non–ST-segment elevation ACS (unstable angina [UA]/non–ST-elevation myocardial infarction [NSTEMI]), Plavix has been shown to reduce the rate of myocardial infarction (MI) and stroke. (1.1)–For patients with ST-elevation myocardial infarction (STEMI), Plavix has been shown to reduce the rate of MI and stroke. (1.1), 2 Recent MI, recent stroke, or established peripheral arterial disease. Plavix has been shown to reduce the rate of MI and stroke. (1.2).",
"Description": "Plavix (clopidogrel tablets) is a thienopyridine class inhibitor of P2Y12 ADP platelet receptors. Chemically it is methyl (+)-(S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)-acetate sulfate (1:1). The empirical formula of clopidogrel bisulfate is C16H16ClNO2SH2SO4 and its molecular weight is 419.9. The structural formula is as follows. Clopidogrel bisulfate is a white to off-white powder. It is practically insoluble in water at neutral pH but freely soluble at pH 1. It also dissolves freely in methanol, dissolves sparingly in methylene chloride, and is practically insoluble in ethyl ether. It has a specific optical rotation of about +56°. Plavix for oral administration is provided as either pink, round, biconvex, debossed, film-coated tablets containing 97.875 mg of clopidogrel bisulfate which is the molar equivalent of 75 mg of clopidogrel base or pink, oblong, debossed, film-coated tablets containing 391.5 mg of clopidogrel bisulfate which is the molar equivalent of 300 mg of clopidogrel base. Each tablet contains hydrogenated castor oil, hydroxypropyl cellulose, mannitol, microcrystalline cellulose, and polyethylene glycol 6000 as inactive ingredients. The pink film coating contains ferric oxide, hypromellose 2910, lactose monohydrate, titanium dioxide, and triacetin. The tablets are polished with Carnauba wax."
},
{
"NDCCode": "0091-3707-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (0091-3707-01)",
"NDC11Code": "00091-3707-01",
"ProductNDC": "0091-3707",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Univasc",
"NonProprietaryName": "Moexipril Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19950715",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020312",
"LabelerName": "UCB, Inc.",
"SubstanceName": "MOEXIPRIL HYDROCHLORIDE",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "univasc ® is indicated for treatment of patients with hypertension. It may be used alone or in combination with thiazide diuretics. In using univasc ®, consideration should be given to the fact that another ACE inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that univasc ® does not have a similar risk (see WARNINGS). In considering use of univasc ®, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS, Angioedema).",
"Description": "univasc ® (moexipril hydrochloride), the hydrochloride salt of moexipril, has the empirical formula C 27H 34N 2O 7HCl and a molecular weight of 535.04. It is chemically described as [3S-[2[R*(R*)],3R*]]-2-[2-[[1-(ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-1,2,3,4-tetrahydro-6,7-dimethoxy-3-isoquinolinecarboxylic acid, monohydrochloride. It is a non-sulfhydryl containing precursor of the active angiotensin-converting enzyme (ACE) inhibitor moexiprilat and its structural formula is:. Moexipril hydrochloride is a fine white to off-white powder. It is soluble (about 10% weight-to-volume) in distilled water at room temperature. univasc ® is supplied as scored, coated tablets containing 7.5 mg and 15 mg of moexipril hydrochloride for oral administration. In addition to the active ingredient, moexipril hydrochloride, the tablet core contains the following inactive ingredients: lactose, magnesium oxide, crospovidone, magnesium stearate and gelatin. The film coating contains hydroxypropyl cellulose, hypromellose, polyethylene glycol 6000, magnesium stearate, titanium dioxide, and ferric oxide."
},
{
"NDCCode": "0091-3707-09",
"PackageDescription": "90 TABLET, FILM COATED in 1 BOTTLE (0091-3707-09)",
"NDC11Code": "00091-3707-09",
"ProductNDC": "0091-3707",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Univasc",
"NonProprietaryName": "Moexipril Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19950715",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020312",
"LabelerName": "UCB, Inc.",
"SubstanceName": "MOEXIPRIL HYDROCHLORIDE",
"StrengthNumber": "7.5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "univasc ® is indicated for treatment of patients with hypertension. It may be used alone or in combination with thiazide diuretics. In using univasc ®, consideration should be given to the fact that another ACE inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that univasc ® does not have a similar risk (see WARNINGS). In considering use of univasc ®, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS, Angioedema).",
"Description": "univasc ® (moexipril hydrochloride), the hydrochloride salt of moexipril, has the empirical formula C 27H 34N 2O 7HCl and a molecular weight of 535.04. It is chemically described as [3S-[2[R*(R*)],3R*]]-2-[2-[[1-(ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-1,2,3,4-tetrahydro-6,7-dimethoxy-3-isoquinolinecarboxylic acid, monohydrochloride. It is a non-sulfhydryl containing precursor of the active angiotensin-converting enzyme (ACE) inhibitor moexiprilat and its structural formula is:. Moexipril hydrochloride is a fine white to off-white powder. It is soluble (about 10% weight-to-volume) in distilled water at room temperature. univasc ® is supplied as scored, coated tablets containing 7.5 mg and 15 mg of moexipril hydrochloride for oral administration. In addition to the active ingredient, moexipril hydrochloride, the tablet core contains the following inactive ingredients: lactose, magnesium oxide, crospovidone, magnesium stearate and gelatin. The film coating contains hydroxypropyl cellulose, hypromellose, polyethylene glycol 6000, magnesium stearate, titanium dioxide, and ferric oxide."
},
{
"NDCCode": "0115-1724-01",
"PackageDescription": "100 TABLET, COATED in 1 BOTTLE, PLASTIC (0115-1724-01) ",
"NDC11Code": "00115-1724-01",
"ProductNDC": "0115-1724",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ultramicrosize Griseofulvin",
"NonProprietaryName": "Ultramicrosize Griseofulvin Tablets",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140929",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204371",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "GRISEOFULVIN",
"StrengthNumber": "125",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Mitosis [PE], Microtubule Inhibition [PE], Tubulin Inhibiting Agent [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140929",
"SamplePackage": "N",
"IndicationAndUsage": "Ultramicrosize griseofulvin tablets are indicated for the treatment of the following ringworm infections; tinea corporis (ringworm of the body), tinea pedis (athlete's foot), tinea cruris (ringworm of the groin and thigh), tinea barbae (barber's itch), tinea capitis (ringworm of the scalp), and tinea unguium (onychomycosis, ringworm of the nails), when caused by one or more of the following genera of fungi: Trichophyton rubrum, Trichophyton tonsurans, Trichophyton mentagrophytes, Trichophyton interdigitalis, Trichophyton verrucosum, Trichophyton megnini, Trichophyton gallinae, Trichophyton crateriform, Trichophyton sulphureum, Trichophyton schoenleini, Microsporum audouini, Microsporum canis, Microsporum gypseum and Epidermophyton floccosum. NOTE: Prior to therapy, the type of fungi responsible for the infection should be identified. The use of the drug is not justified in minor or trivial infections which will respond to topical agents alone. Griseofulvin is not effective in the following: bacterial infections, candidiasis (moniliasis), histoplasmosis, actinomycosis, sporotrichosis, chromoblastomycosis, coccidioidomycosis, North American blastomycosis, cryptococcosis (torulosis), tinea versicolor and nocardiosis.",
"Description": "Ultramicrosize griseofulvin tablets, USP contain ultramicrosize crystals of griseofulvin, an antibiotic derived from a species of Penicillium. The chemical name of griseofulvin, USP is 7-Chloro- 2’,4,6-trimethoxy-6’β-methylspiro[benzofuran-2(3H),1’-[2]cyclohexene]-3,4’-dione. Its structural formula is. Griseofulvin, USP occurs as a white or yellowish-white, odorless powder which is practically insoluble in water, freely soluble in dimethylformamide,slightly soluble in anhydrous ethanol and in methanol. Each ultramicrosize griseofulvin tablet, USP contains. Active Ingredient. Ultramicrosize Griseofulvin..........................125 mg. Inactive Ingredients: Colloidal silicon dioxide, magnesium stearate, polyethylene glycol 3350, polyethylene glycol 6000, polyethylene glycol 8000, polyvinyl alcohol, sodium lauryl sulfate, talc and titanium dioxide. OR. Active Ingredient. Ultramicrosize Griseofulvin..........................250 mg. Inactive Ingredients: Colloidal silicon dioxide, magnesium stearate, polyethylene glycol 3350, polyethylene glycol 6000, polyethylene glycol 8000, polyvinyl alcohol, sodium lauryl sulfate, talc and titanium dioxide."
},
{
"NDCCode": "0115-1724-02",
"PackageDescription": "500 TABLET, COATED in 1 BOTTLE, PLASTIC (0115-1724-02) ",
"NDC11Code": "00115-1724-02",
"ProductNDC": "0115-1724",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ultramicrosize Griseofulvin",
"NonProprietaryName": "Ultramicrosize Griseofulvin Tablets",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140929",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204371",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "GRISEOFULVIN",
"StrengthNumber": "125",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Mitosis [PE], Microtubule Inhibition [PE], Tubulin Inhibiting Agent [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140929",
"SamplePackage": "N",
"IndicationAndUsage": "Ultramicrosize griseofulvin tablets are indicated for the treatment of the following ringworm infections; tinea corporis (ringworm of the body), tinea pedis (athlete's foot), tinea cruris (ringworm of the groin and thigh), tinea barbae (barber's itch), tinea capitis (ringworm of the scalp), and tinea unguium (onychomycosis, ringworm of the nails), when caused by one or more of the following genera of fungi: Trichophyton rubrum, Trichophyton tonsurans, Trichophyton mentagrophytes, Trichophyton interdigitalis, Trichophyton verrucosum, Trichophyton megnini, Trichophyton gallinae, Trichophyton crateriform, Trichophyton sulphureum, Trichophyton schoenleini, Microsporum audouini, Microsporum canis, Microsporum gypseum and Epidermophyton floccosum. NOTE: Prior to therapy, the type of fungi responsible for the infection should be identified. The use of the drug is not justified in minor or trivial infections which will respond to topical agents alone. Griseofulvin is not effective in the following: bacterial infections, candidiasis (moniliasis), histoplasmosis, actinomycosis, sporotrichosis, chromoblastomycosis, coccidioidomycosis, North American blastomycosis, cryptococcosis (torulosis), tinea versicolor and nocardiosis.",
"Description": "Ultramicrosize griseofulvin tablets, USP contain ultramicrosize crystals of griseofulvin, an antibiotic derived from a species of Penicillium. The chemical name of griseofulvin, USP is 7-Chloro- 2’,4,6-trimethoxy-6’β-methylspiro[benzofuran-2(3H),1’-[2]cyclohexene]-3,4’-dione. Its structural formula is. Griseofulvin, USP occurs as a white or yellowish-white, odorless powder which is practically insoluble in water, freely soluble in dimethylformamide,slightly soluble in anhydrous ethanol and in methanol. Each ultramicrosize griseofulvin tablet, USP contains. Active Ingredient. Ultramicrosize Griseofulvin..........................125 mg. Inactive Ingredients: Colloidal silicon dioxide, magnesium stearate, polyethylene glycol 3350, polyethylene glycol 6000, polyethylene glycol 8000, polyvinyl alcohol, sodium lauryl sulfate, talc and titanium dioxide. OR. Active Ingredient. Ultramicrosize Griseofulvin..........................250 mg. Inactive Ingredients: Colloidal silicon dioxide, magnesium stearate, polyethylene glycol 3350, polyethylene glycol 6000, polyethylene glycol 8000, polyvinyl alcohol, sodium lauryl sulfate, talc and titanium dioxide."
},
{
"NDCCode": "0115-1725-01",
"PackageDescription": "100 TABLET, COATED in 1 BOTTLE, PLASTIC (0115-1725-01) ",
"NDC11Code": "00115-1725-01",
"ProductNDC": "0115-1725",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ultramicrosize Griseofulvin",
"NonProprietaryName": "Ultramicrosize Griseofulvin Tablets",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140929",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204371",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "GRISEOFULVIN",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Mitosis [PE], Microtubule Inhibition [PE], Tubulin Inhibiting Agent [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140929",
"SamplePackage": "N",
"IndicationAndUsage": "Ultramicrosize griseofulvin tablets are indicated for the treatment of the following ringworm infections; tinea corporis (ringworm of the body), tinea pedis (athlete's foot), tinea cruris (ringworm of the groin and thigh), tinea barbae (barber's itch), tinea capitis (ringworm of the scalp), and tinea unguium (onychomycosis, ringworm of the nails), when caused by one or more of the following genera of fungi: Trichophyton rubrum, Trichophyton tonsurans, Trichophyton mentagrophytes, Trichophyton interdigitalis, Trichophyton verrucosum, Trichophyton megnini, Trichophyton gallinae, Trichophyton crateriform, Trichophyton sulphureum, Trichophyton schoenleini, Microsporum audouini, Microsporum canis, Microsporum gypseum and Epidermophyton floccosum. NOTE: Prior to therapy, the type of fungi responsible for the infection should be identified. The use of the drug is not justified in minor or trivial infections which will respond to topical agents alone. Griseofulvin is not effective in the following: bacterial infections, candidiasis (moniliasis), histoplasmosis, actinomycosis, sporotrichosis, chromoblastomycosis, coccidioidomycosis, North American blastomycosis, cryptococcosis (torulosis), tinea versicolor and nocardiosis.",
"Description": "Ultramicrosize griseofulvin tablets, USP contain ultramicrosize crystals of griseofulvin, an antibiotic derived from a species of Penicillium. The chemical name of griseofulvin, USP is 7-Chloro- 2’,4,6-trimethoxy-6’β-methylspiro[benzofuran-2(3H),1’-[2]cyclohexene]-3,4’-dione. Its structural formula is. Griseofulvin, USP occurs as a white or yellowish-white, odorless powder which is practically insoluble in water, freely soluble in dimethylformamide,slightly soluble in anhydrous ethanol and in methanol. Each ultramicrosize griseofulvin tablet, USP contains. Active Ingredient. Ultramicrosize Griseofulvin..........................125 mg. Inactive Ingredients: Colloidal silicon dioxide, magnesium stearate, polyethylene glycol 3350, polyethylene glycol 6000, polyethylene glycol 8000, polyvinyl alcohol, sodium lauryl sulfate, talc and titanium dioxide. OR. Active Ingredient. Ultramicrosize Griseofulvin..........................250 mg. Inactive Ingredients: Colloidal silicon dioxide, magnesium stearate, polyethylene glycol 3350, polyethylene glycol 6000, polyethylene glycol 8000, polyvinyl alcohol, sodium lauryl sulfate, talc and titanium dioxide."
},
{
"NDCCode": "0115-1725-03",
"PackageDescription": "1000 TABLET, COATED in 1 BOTTLE, PLASTIC (0115-1725-03) ",
"NDC11Code": "00115-1725-03",
"ProductNDC": "0115-1725",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ultramicrosize Griseofulvin",
"NonProprietaryName": "Ultramicrosize Griseofulvin Tablets",
"DosageFormName": "TABLET, COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20140929",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204371",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "GRISEOFULVIN",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Mitosis [PE], Microtubule Inhibition [PE], Tubulin Inhibiting Agent [EPC]",
"Status": "Active",
"LastUpdate": "2025-12-23",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140929",
"SamplePackage": "N",
"IndicationAndUsage": "Ultramicrosize griseofulvin tablets are indicated for the treatment of the following ringworm infections; tinea corporis (ringworm of the body), tinea pedis (athlete's foot), tinea cruris (ringworm of the groin and thigh), tinea barbae (barber's itch), tinea capitis (ringworm of the scalp), and tinea unguium (onychomycosis, ringworm of the nails), when caused by one or more of the following genera of fungi: Trichophyton rubrum, Trichophyton tonsurans, Trichophyton mentagrophytes, Trichophyton interdigitalis, Trichophyton verrucosum, Trichophyton megnini, Trichophyton gallinae, Trichophyton crateriform, Trichophyton sulphureum, Trichophyton schoenleini, Microsporum audouini, Microsporum canis, Microsporum gypseum and Epidermophyton floccosum. NOTE: Prior to therapy, the type of fungi responsible for the infection should be identified. The use of the drug is not justified in minor or trivial infections which will respond to topical agents alone. Griseofulvin is not effective in the following: bacterial infections, candidiasis (moniliasis), histoplasmosis, actinomycosis, sporotrichosis, chromoblastomycosis, coccidioidomycosis, North American blastomycosis, cryptococcosis (torulosis), tinea versicolor and nocardiosis.",
"Description": "Ultramicrosize griseofulvin tablets, USP contain ultramicrosize crystals of griseofulvin, an antibiotic derived from a species of Penicillium. The chemical name of griseofulvin, USP is 7-Chloro- 2’,4,6-trimethoxy-6’β-methylspiro[benzofuran-2(3H),1’-[2]cyclohexene]-3,4’-dione. Its structural formula is. Griseofulvin, USP occurs as a white or yellowish-white, odorless powder which is practically insoluble in water, freely soluble in dimethylformamide,slightly soluble in anhydrous ethanol and in methanol. Each ultramicrosize griseofulvin tablet, USP contains. Active Ingredient. Ultramicrosize Griseofulvin..........................125 mg. Inactive Ingredients: Colloidal silicon dioxide, magnesium stearate, polyethylene glycol 3350, polyethylene glycol 6000, polyethylene glycol 8000, polyvinyl alcohol, sodium lauryl sulfate, talc and titanium dioxide. OR. Active Ingredient. Ultramicrosize Griseofulvin..........................250 mg. Inactive Ingredients: Colloidal silicon dioxide, magnesium stearate, polyethylene glycol 3350, polyethylene glycol 6000, polyethylene glycol 8000, polyvinyl alcohol, sodium lauryl sulfate, talc and titanium dioxide."
}
]
}
{"NDC":[{"NDCCode":"62795-6000-7","ProprietaryName":"T-relief Arthritis","NonProprietaryName":"Arnica Montana Root, Bryonia Alba Whole, Sus Scrofa Umbilical Cord, Solanum Dulcamara Top, Sus Scrofa Embryo, Sus Scrofa Umbilical Cord, Ledum Palustre Twig, Sus Scrofa Placenta, Rhododendron Aureum Leaf, Toxicodendron Pubescens Leaf, Sanguinaria Canadensis Root, Sulfur, And Comfrey Root"},{"NDCCode":"44087-6000-7","ProprietaryName":"Mavenclad","NonProprietaryName":"Cladribine"},{"NDCCode":"51885-6000-7","NonProprietaryName":"Bellis Perennis"},{"NDCCode":"61577-6000-1","ProprietaryName":"Provault Dryspray Cbd Pain Relief","NonProprietaryName":"Menthol, Camphor"},{"NDCCode":"78502-6000-7","ProprietaryName":"Medically Minded","NonProprietaryName":"Benzalkonium Chloride"},{"NDCCode":"62795-1041-7","ProprietaryName":"T-relief Extra Strength","NonProprietaryName":"Arnica Montana, Calendula Officinalis Flowering, Hamamelis Virginiana Root Bark/stem, Baptisia Tinctoria Root, Bellis Perennis, Echinacea, Unspecified, Aconitum Napellus, Matricaria Chamomilla, Achillea Millefolium, Atropa Belladonna, Hypericum Perforatum, Ruta Graveolens Flowering Top And Comfrey Root"},{"NDCCode":"62795-6001-4","ProprietaryName":"T-relief Value Pack","NonProprietaryName":"T-relief"},{"NDCCode":"62795-6006-7","ProprietaryName":"T-relief Arthritis","NonProprietaryName":"Arnica Montana Root, Bryonia Alba Whole, Sus Scrofa Umbilical Cord, Solanum Dulcamara Top, Sus Scrofa Embryo, Sus Scrofa Umbilical Cord, Ledum Palustre Twig, Sus Scrofa Placenta, Rhododendron Aureum Leaf, Toxicodendron Pubescens Leaf, Sanguinaria Canadensis Root, Sulfur, And Comfrey Root"},{"NDCCode":"62795-6050-7","ProprietaryName":"T-relief Lidocaine Hcl 4%","NonProprietaryName":"Lidocaine Hcl 4%"},{"NDCCode":"62795-7002-7","ProprietaryName":"T-relief","NonProprietaryName":"Aconitum Napellus, Arnica Montana Root,baptisia Tinctoria Root, Atropa Belladonna,bellis Perennis, Calendula Officinalis Flowering Top,matricaria Recutita, Echinacea, Unspecified, Hamamelis Virginiana Root Bark/stem Bark,hypericum Perforatum, Achillea Millefolium, Ruta Graveolens Flowering Top, And Comfrey Root"},{"NDCCode":"62795-7003-7","ProprietaryName":"T-relief","NonProprietaryName":"Aconitum Napellus, Arnica Montana Root, Baptisia Tinctoria Root, Atropa Belladonna, Bellis Perennis, Calendula Officinalis Flowering Top, Matricaria Recutita, Echinacea, Unspecified, Hamamelis Virginiana Root Bark/stem Bark, Hypericum Perforatum, Achillea Millefolium, Ruta Graveolens Flowering Top, And Comfrey Root"},{"NDCCode":"62795-7004-7","ProprietaryName":"T-relief","NonProprietaryName":"Achillea Millefolium, Hypericum Perforatum, Hamamelis Virginiana Root Bark/stem Bark, Echinacea, Unspecified, Matricaria Recutita, Atropa Belladonna,comfrey Root, Aconitum Napellus, Bellis Perennis,arnica Montana, And Ruta Graveolens Flowering Top"},{"NDCCode":"62795-7007-7","ProprietaryName":"T-relief Extra Strength Cream","NonProprietaryName":"Arnica Montana, Calendula Officinalis Flowering Top, Echinacea Unspecified, Aconitum Napellus, Achillea Millefolium, Hamamelis Virginiana Root Bark Stem Bark, Matricaria Chamomilla, Atropa Belladonna, Bellis Perennis, Ruta Graveolens Flowering Top, Baptisia Tinctoria Root, Comfrey Root And Hypericum Perforatum"},{"NDCCode":"62795-7008-7","ProprietaryName":"T-relief Pro Cream","NonProprietaryName":"Arnica Montana,calendula Officinalis Flowering Top,echinacea, Unspecified,aconitum Napellus, Achillea Millefolium, Hamamelis Virginiana Root Bark/stem Bark,matricaria Chamomilla,atropa Belladonna,bellis Perennis,ruta Graveolens Flowering Top,baptisia Tinctoria Root,comfrey Root And Hypericum Perforatum"},{"NDCCode":"62795-1018-2","ProprietaryName":"Bhi Restore","NonProprietaryName":"Arnica Montana Root, Ilex Aquifolium Flowering Top, Nerium Oleander Leaf, Ovis Aries Testicle, And Lactic Acid, L-"},{"NDCCode":"62795-1028-2","ProprietaryName":"Clearlife","NonProprietaryName":"Antimony Trisulfide, Arnica Montana Root, Euphrasia Stricta,formic Acid,graphite,histamine Dihydrochloride,strychnos Ignatii Seed, Arctium Lappa Root, Ledum Palustre Twig, Lycopodium Clavatum Spore, Pine Tar, Selenium, Sulfur, Sulfuric Acid, Tellurium, And Thuja Occidentalis Leafy Twig"},{"NDCCode":"62795-1030-2","ProprietaryName":"T Relief Arthritis","NonProprietaryName":"T Relief Arthritis"},{"NDCCode":"62795-1033-2","ProprietaryName":"T Relief Arthritis","NonProprietaryName":"Arnica Montana, Bryonia Alba Root, Sus Scrofa Cartilage, Solanum Dulcamara Top, Sus Scrofa Embryo,sus Scrofa Umbilical Cord, Ledum Palustre Twig,sus Scrofa Umbilical Cord, Ledum Palustre Twig,sus Scrofa Placenta, Rhododendron Aureum Leaf,toxicodendron Pubescens Leaf, Sanguinaria Canadensis Root, Sulfur, And Comfrey Root"},{"NDCCode":"62795-1033-4","ProprietaryName":"T Relief Arthritis","NonProprietaryName":"Arnica Montana, Bryonia Alba Root, Sus Scrofa Cartilage, Solanum Dulcamara Top, Sus Scrofa Embryo,sus Scrofa Umbilical Cord, Ledum Palustre Twig,sus Scrofa Umbilical Cord, Ledum Palustre Twig,sus Scrofa Placenta, Rhododendron Aureum Leaf,toxicodendron Pubescens Leaf, Sanguinaria Canadensis Root, Sulfur, And Comfrey Root"},{"NDCCode":"62795-1039-2","ProprietaryName":"T-relief Pro Arthritis","NonProprietaryName":"Arnica Montana, Bryonia Alba Whole, Sus Scrofa Cartilage,solanum Dulcamara Top,sus Scrofa Embryo,sus Scrofa Umbilical Cord,rhododendron Tomentosum Leafy Twig,sus Scrofa Placenta,rhododendron Aureum Leaf,toxicodendron Pubescens Leaf, Sanguinaria Canadensis Root, Sulfur And Comfrey Root"},{"NDCCode":"62795-1053-2","ProprietaryName":"T Relief Arthritis Extra Strength","NonProprietaryName":"Arnica Montana, Bryonia Alba Root, Sus Scrofa Cartilage, Solanum Dulcamara Top, Sus Scrofa Embryo,sus Scrofa Umbilical Cord, Ledum Palustre Twig,sus Scrofa Umbilical Cord, Ledum Palustre Twig,sus Scrofa Placenta, Rhododendron Aureum Leaf,toxicodendron Pubescens Leaf, Sanguinaria Canadensis Root, Sulfur, And Comfrey Root"},{"NDCCode":"62795-3000-1","ProprietaryName":"Reboost Cough","NonProprietaryName":"Antimony Potassium Tartrate, Pulsatilla Vulgaris, Drosera Rotundifolia, Hyoscyamus Niger, Ipecac, Pulsatilla Vulgaris, Rumex Crispus Root, Spongia Officinalis Skeleton, Roasted, And Lobaria Pulmonaria"},{"NDCCode":"0024-1171-90","ProprietaryName":"Plavix","NonProprietaryName":"Clopidogrel"},{"NDCCode":"0024-1332-30","ProprietaryName":"Plavix","NonProprietaryName":"Clopidogrel"},{"NDCCode":"0091-3707-01","ProprietaryName":"Univasc","NonProprietaryName":"Moexipril Hydrochloride"},{"NDCCode":"0091-3707-09","ProprietaryName":"Univasc","NonProprietaryName":"Moexipril Hydrochloride"},{"NDCCode":"0115-1724-01","ProprietaryName":"Ultramicrosize Griseofulvin","NonProprietaryName":"Ultramicrosize Griseofulvin Tablets"},{"NDCCode":"0115-1724-02","ProprietaryName":"Ultramicrosize Griseofulvin","NonProprietaryName":"Ultramicrosize Griseofulvin Tablets"},{"NDCCode":"0115-1725-01","ProprietaryName":"Ultramicrosize Griseofulvin","NonProprietaryName":"Ultramicrosize Griseofulvin Tablets"},{"NDCCode":"0115-1725-03","ProprietaryName":"Ultramicrosize Griseofulvin","NonProprietaryName":"Ultramicrosize Griseofulvin Tablets"}]}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>62795-6000-7</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (62795-6000-7) > 50 g in 1 TUBE</PackageDescription>
<NDC11Code>62795-6000-07</NDC11Code>
<ProductNDC>62795-6000</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>T-relief Arthritis</ProprietaryName>
<NonProprietaryName>Arnica Montana Root, Bryonia Alba Whole, Sus Scrofa Umbilical Cord, Solanum Dulcamara Top, Sus Scrofa Embryo, Sus Scrofa Umbilical Cord, Ledum Palustre Twig, Sus Scrofa Placenta, Rhododendron Aureum Leaf, Toxicodendron Pubescens Leaf, Sanguinaria Canadensis Root, Sulfur, And Comfrey Root</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140830</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>MediNatura Inc</LabelerName>
<SubstanceName>ARNICA MONTANA ROOT; BRYONIA ALBA WHOLE; SUS SCROFA UMBILICAL CORD; SOLANUM DULCAMARA TOP; SUS SCROFA EMBRYO; SUS SCROFA CARTILAGE; LEDUM PALUSTRE TWIG; SUS SCROFA PLACENTA; RHODODENDRON AUREUM LEAF; TOXICODENDRON PUBESCENS LEAF; SANGUINARIA CANADENSIS ROOT; SULFUR; COMFREY ROOT</SubstanceName>
<StrengthNumber>3; 3; 4; 2; 6; 4; 6; 4; 8; 4; 3; 6; 7</StrengthNumber>
<StrengthUnit>[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>44087-6000-7</NDCCode>
<PackageDescription>7 BLISTER PACK in 1 CARTON (44087-6000-7) > 1 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>44087-6000-07</NDC11Code>
<ProductNDC>44087-6000</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Mavenclad</ProprietaryName>
<NonProprietaryName>Cladribine</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022561</ApplicationNumber>
<LabelerName>EMD Serono, Inc.</LabelerName>
<SubstanceName>CLADRIBINE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Purine Antimetabolite [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-04-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190329</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>51885-6000-7</NDCCode>
<PackageDescription>1 L in 1 CONTAINER (51885-6000-7)</PackageDescription>
<NDC11Code>51885-6000-07</NDC11Code>
<ProductNDC>51885-6000</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Bellis Perennis</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<StartMarketingDate>20120821</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Biologische Heilmittel Heel</LabelerName>
<SubstanceName>BELLIS PERENNIS</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>L/L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>61577-6000-1</NDCCode>
<PackageDescription>88.7 g in 1 BOTTLE (61577-6000-1) </PackageDescription>
<NDC11Code>61577-6000-01</NDC11Code>
<ProductNDC>61577-6000</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Provault Dryspray Cbd Pain Relief</ProprietaryName>
<NonProprietaryName>Menthol, Camphor</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20221018</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>Sombra Cosmetics Inc</LabelerName>
<SubstanceName>CAMPHOR (SYNTHETIC); MENTHOL</SubstanceName>
<StrengthNumber>.02; .09</StrengthNumber>
<StrengthUnit>g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221018</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporary relief of monor aches and pains of muscles and joints associated with strains, bruises and sprains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>78502-6000-7</NDCCode>
<PackageDescription>30 g in 1 BAG (78502-6000-7) </PackageDescription>
<NDC11Code>78502-6000-07</NDC11Code>
<ProductNDC>78502-6000</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Medically Minded</ProprietaryName>
<NonProprietaryName>Benzalkonium Chloride</NonProprietaryName>
<DosageFormName>CLOTH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200628</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>BELSKIN S. DE, R.L. DE C.V</LabelerName>
<SubstanceName>BENZALKONIUM CHLORIDE; ALCOHOL</SubstanceName>
<StrengthNumber>.25; 5</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200628</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>APPLY TO HANDS. ALLOW TO DRY WITHOUT WIPING.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62795-1041-7</NDCCode>
<PackageDescription>60 TABLET, CHEWABLE in 1 BOTTLE (62795-1041-7) </PackageDescription>
<NDC11Code>62795-1041-07</NDC11Code>
<ProductNDC>62795-1041</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>T-relief Extra Strength</ProprietaryName>
<NonProprietaryName>Arnica Montana, Calendula Officinalis Flowering, Hamamelis Virginiana Root Bark/stem, Baptisia Tinctoria Root, Bellis Perennis, Echinacea, Unspecified, Aconitum Napellus, Matricaria Chamomilla, Achillea Millefolium, Atropa Belladonna, Hypericum Perforatum, Ruta Graveolens Flowering Top And Comfrey Root</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20180201</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>MediNatura Inc</LabelerName>
<SubstanceName>ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; BAPTISIA TINCTORIA ROOT; BELLIS PERENNIS; ECHINACEA, UNSPECIFIED; ACONITUM NAPELLUS; MATRICARIA CHAMOMILLA; ACHILLEA MILLEFOLIUM; ATROPA BELLADONNA; HYPERICUM PERFORATUM; RUTA GRAVEOLENS FLOWERING TOP; COMFREY ROOT</SubstanceName>
<StrengthNumber>3; 2; 2; 2; 2; 2; 3; 2; 2; 3; 3; 3; 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; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-09-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230918</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of minor: Joint Pain Back Pain Muscular Pain Arthritis Pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62795-6001-4</NDCCode>
<PackageDescription>1 KIT in 1 KIT (62795-6001-4) * 100 TABLET in 1 BOTTLE (62795-1029-2) * 50 g in 1 TUBE (62795-7002-7)</PackageDescription>
<NDC11Code>62795-6001-04</NDC11Code>
<ProductNDC>62795-6001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>T-relief Value Pack</ProprietaryName>
<NonProprietaryName>T-relief</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20140830</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>MediNatura</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2018-04-05</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>62795-6006-7</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (62795-6006-7) / 57 g in 1 TUBE</PackageDescription>
<NDC11Code>62795-6006-07</NDC11Code>
<ProductNDC>62795-6006</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>T-relief Arthritis</ProprietaryName>
<NonProprietaryName>Arnica Montana Root, Bryonia Alba Whole, Sus Scrofa Umbilical Cord, Solanum Dulcamara Top, Sus Scrofa Embryo, Sus Scrofa Umbilical Cord, Ledum Palustre Twig, Sus Scrofa Placenta, Rhododendron Aureum Leaf, Toxicodendron Pubescens Leaf, Sanguinaria Canadensis Root, Sulfur, And Comfrey Root</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20170131</StartMarketingDate>
<EndMarketingDate>20260531</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>MediNatura Inc</LabelerName>
<SubstanceName>ARNICA MONTANA ROOT; BRYONIA ALBA WHOLE; COMFREY ROOT; LEDUM PALUSTRE TWIG; RHODODENDRON AUREUM LEAF; SANGUINARIA CANADENSIS ROOT; SOLANUM DULCAMARA TOP; SULFUR; SUS SCROFA CARTILAGE; SUS SCROFA EMBRYO; SUS SCROFA PLACENTA; SUS SCROFA UMBILICAL CORD; TOXICODENDRON PUBESCENS LEAF</SubstanceName>
<StrengthNumber>2; 2; 7; 6; 8; 3; 2; 6; 4; 4; 4; 4; 4</StrengthNumber>
<StrengthUnit>[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170131</StartMarketingDatePackage>
<EndMarketingDatePackage>20260531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of minor: Arthritis Pain Joint Pain Joint Stiffness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62795-6050-7</NDCCode>
<PackageDescription>85 g in 1 TUBE (62795-6050-7) </PackageDescription>
<NDC11Code>62795-6050-07</NDC11Code>
<ProductNDC>62795-6050</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>T-relief Lidocaine Hcl 4%</ProprietaryName>
<NonProprietaryName>Lidocaine Hcl 4%</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20251101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Medinatura New Mexico Inc.</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>3.4</StrengthNumber>
<StrengthUnit>g/85g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20251101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62795-7002-7</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (62795-7002-7) > 50 g in 1 TUBE</PackageDescription>
<NDC11Code>62795-7002-07</NDC11Code>
<ProductNDC>62795-7002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>T-relief</ProprietaryName>
<NonProprietaryName>Aconitum Napellus, Arnica Montana Root,baptisia Tinctoria Root, Atropa Belladonna,bellis Perennis, Calendula Officinalis Flowering Top,matricaria Recutita, Echinacea, Unspecified, Hamamelis Virginiana Root Bark/stem Bark,hypericum Perforatum, Achillea Millefolium, Ruta Graveolens Flowering Top, And Comfrey Root</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140901</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>MediNatura Inc</LabelerName>
<SubstanceName>ACONITUM NAPELLUS; ARNICA MONTANA ROOT; BAPTISIA TINCTORIA ROOT; ATROPA BELLADONNA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; ACHILLEA MILLEFOLIUM; RUTA GRAVEOLENS FLOWERING TOP; COMFREY ROOT</SubstanceName>
<StrengthNumber>1; 1; 4; 2; 2; 1; 2; 2; 6; 2; 4; 4</StrengthNumber>
<StrengthUnit>[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; 1/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-02-15</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>62795-7003-7</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (62795-7003-7) > 50 g in 1 TUBE</PackageDescription>
<NDC11Code>62795-7003-07</NDC11Code>
<ProductNDC>62795-7003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>T-relief</ProprietaryName>
<NonProprietaryName>Aconitum Napellus, Arnica Montana Root, Baptisia Tinctoria Root, Atropa Belladonna, Bellis Perennis, Calendula Officinalis Flowering Top, Matricaria Recutita, Echinacea, Unspecified, Hamamelis Virginiana Root Bark/stem Bark, Hypericum Perforatum, Achillea Millefolium, Ruta Graveolens Flowering Top, And Comfrey Root</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150731</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>MediNatura Inc</LabelerName>
<SubstanceName>ACONITUM NAPELLUS; ARNICA MONTANA ROOT; BAPTISIA TINCTORIA ROOT; ATROPA BELLADONNA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; ACHILLEA MILLEFOLIUM; RUTA GRAVEOLENS FLOWERING TOP; COMFREY ROOT</SubstanceName>
<StrengthNumber>1; 1; 4; 2; 2; 1; 2; 1; 2; 6; 2; 4; 4</StrengthNumber>
<StrengthUnit>[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-01-30</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>62795-7004-7</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (62795-7004-7) / 57 g in 1 TUBE</PackageDescription>
<NDC11Code>62795-7004-07</NDC11Code>
<ProductNDC>62795-7004</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>T-relief</ProprietaryName>
<NonProprietaryName>Achillea Millefolium, Hypericum Perforatum, Hamamelis Virginiana Root Bark/stem Bark, Echinacea, Unspecified, Matricaria Recutita, Atropa Belladonna,comfrey Root, Aconitum Napellus, Bellis Perennis,arnica Montana, And Ruta Graveolens Flowering Top</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20151201</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>MediNatura Inc</LabelerName>
<SubstanceName>ARNICA MONTANA; BAPTISIA TINCTORIA ROOT; ATROPA BELLADONNA; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; MATRICARIA RECUTITA; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; RUTA GRAVEOLENS FLOWERING TOP; ACONITUM NAPELLUS; COMFREY ROOT; ACHILLEA MILLEFOLIUM</SubstanceName>
<StrengthNumber>1; 4; 2; 2; 1; 2; 1; 2; 6; 4; 1; 4; 2</StrengthNumber>
<StrengthUnit>[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-10-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20151201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Relieves. Joint Pain. Back Pain. Muscular Pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62795-7007-7</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (62795-7007-7) / 85 g in 1 TUBE</PackageDescription>
<NDC11Code>62795-7007-07</NDC11Code>
<ProductNDC>62795-7007</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>T-relief Extra Strength Cream</ProprietaryName>
<NonProprietaryName>Arnica Montana, Calendula Officinalis Flowering Top, Echinacea Unspecified, Aconitum Napellus, Achillea Millefolium, Hamamelis Virginiana Root Bark Stem Bark, Matricaria Chamomilla, Atropa Belladonna, Bellis Perennis, Ruta Graveolens Flowering Top, Baptisia Tinctoria Root, Comfrey Root And Hypericum Perforatum</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20171019</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>MediNatura Inc</LabelerName>
<SubstanceName>ARNICA MONTANA; CALENDULA OFFICINALIS FLOWERING TOP; ECHINACEA, UNSPECIFIED; ACONITUM NAPELLUS; ACHILLEA MILLEFOLIUM; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; MATRICARIA CHAMOMILLA; ATROPA BELLADONNA; BELLIS PERENNIS; RUTA GRAVEOLENS FLOWERING TOP; BAPTISIA TINCTORIA ROOT; COMFREY ROOT; HYPERICUM PERFORATUM</SubstanceName>
<StrengthNumber>1; 1; 1; 1; 2; 2; 2; 2; 2; 4; 4; 4; 6</StrengthNumber>
<StrengthUnit>[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-10-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171019</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of minor: Joint Pain Back Pain Muscular Pain Nerve Pain Arthritis Pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62795-7008-7</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (62795-7008-7) > 85 g in 1 TUBE</PackageDescription>
<NDC11Code>62795-7008-07</NDC11Code>
<ProductNDC>62795-7008</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>T-relief Pro Cream</ProprietaryName>
<NonProprietaryName>Arnica Montana,calendula Officinalis Flowering Top,echinacea, Unspecified,aconitum Napellus, Achillea Millefolium, Hamamelis Virginiana Root Bark/stem Bark,matricaria Chamomilla,atropa Belladonna,bellis Perennis,ruta Graveolens Flowering Top,baptisia Tinctoria Root,comfrey Root And Hypericum Perforatum</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180611</StartMarketingDate>
<EndMarketingDate>20220731</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Medinatura New Mexico, Inc</LabelerName>
<SubstanceName>ACHILLEA MILLEFOLIUM; ACONITUM NAPELLUS; ARNICA MONTANA; ATROPA BELLADONNA; BAPTISIA TINCTORIA ROOT; BELLIS PERENNIS; CALENDULA OFFICINALIS FLOWERING TOP; COMFREY ROOT; ECHINACEA, UNSPECIFIED; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; MATRICARIA CHAMOMILLA; RUTA GRAVEOLENS FLOWERING TOP</SubstanceName>
<StrengthNumber>2; 1; 1; 2; 4; 2; 1; 4; 1; 2; 6; 2; 4</StrengthNumber>
<StrengthUnit>[hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180611</StartMarketingDatePackage>
<EndMarketingDatePackage>20220731</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62795-1018-2</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (62795-1018-2)</PackageDescription>
<NDC11Code>62795-1018-02</NDC11Code>
<ProductNDC>62795-1018</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bhi Restore</ProprietaryName>
<NonProprietaryName>Arnica Montana Root, Ilex Aquifolium Flowering Top, Nerium Oleander Leaf, Ovis Aries Testicle, And Lactic Acid, L-</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Medinatura Inc</LabelerName>
<SubstanceName>ARNICA MONTANA ROOT; ILEX AQUIFOLIUM FLOWERING TOP; NERIUM OLEANDER LEAF; OVIS ARIES TESTICLE; LACTIC ACID, L-</SubstanceName>
<StrengthNumber>7; 2; 5; 10; 11</StrengthNumber>
<StrengthUnit>[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-11-16</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>62795-1028-2</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (62795-1028-2) > 100 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>62795-1028-02</NDC11Code>
<ProductNDC>62795-1028</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Clearlife</ProprietaryName>
<NonProprietaryName>Antimony Trisulfide, Arnica Montana Root, Euphrasia Stricta,formic Acid,graphite,histamine Dihydrochloride,strychnos Ignatii Seed, Arctium Lappa Root, Ledum Palustre Twig, Lycopodium Clavatum Spore, Pine Tar, Selenium, Sulfur, Sulfuric Acid, Tellurium, And Thuja Occidentalis Leafy Twig</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140930</StartMarketingDate>
<EndMarketingDate>20250430</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>MediNatura Inc.</LabelerName>
<SubstanceName>ANTIMONY TRISULFIDE; ARCTIUM LAPPA ROOT; ARNICA MONTANA ROOT; EUPHRASIA STRICTA; FORMIC ACID; GRAPHITE; HISTAMINE DIHYDROCHLORIDE; LEDUM PALUSTRE TWIG; LYCOPODIUM CLAVATUM SPORE; PINE TAR; SELENIUM; STRYCHNOS IGNATII SEED; SULFUR; SULFURIC ACID; TELLURIUM; THUJA OCCIDENTALIS LEAFY TWIG</SubstanceName>
<StrengthNumber>10; 8; 5; 6; 8; 10; 8; 7; 6; 10; 12; 6; 12; 21; 10; 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; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20140930</StartMarketingDatePackage>
<EndMarketingDatePackage>20250430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of minor allergy symptoms: 1 Runny nose, 2 Watery eyes, 3 Skin irritations.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62795-1030-2</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (62795-1030-2) > 100 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>62795-1030-02</NDC11Code>
<ProductNDC>62795-1030</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>T Relief Arthritis</ProprietaryName>
<NonProprietaryName>T Relief Arthritis</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20141001</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Medinatura</LabelerName>
<SubstanceName>ARNICA MONTANA ROOT; SUS SCROFA UMBILICAL CORD; BRYONIA ALBA ROOT; SOLANUM DULCAMARA TOP; SUS SCROFA EMBRYO; LEDUM PALUSTRE TWIG; RHODODENDRON AUREUM LEAF; TOXICODENDRON PUBESCENS LEAF; SANGUINARIA CANADENSIS ROOT; SULFUR; COMFREY ROOT; SUS SCROFA PLACENTA; SUS SCROFA CARTILAGE</SubstanceName>
<StrengthNumber>3; 6; 3; 2; 6; 6; 8; 4; 3; 6; 7; 6; 4</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; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-02-07</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>62795-1033-2</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (62795-1033-2) / 100 TABLET in 1 BOTTLE</PackageDescription>
<NDC11Code>62795-1033-02</NDC11Code>
<ProductNDC>62795-1033</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>T Relief Arthritis</ProprietaryName>
<NonProprietaryName>Arnica Montana, Bryonia Alba Root, Sus Scrofa Cartilage, Solanum Dulcamara Top, Sus Scrofa Embryo,sus Scrofa Umbilical Cord, Ledum Palustre Twig,sus Scrofa Umbilical Cord, Ledum Palustre Twig,sus Scrofa Placenta, Rhododendron Aureum Leaf,toxicodendron Pubescens Leaf, Sanguinaria Canadensis Root, Sulfur, And Comfrey Root</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>MediNatura Inc</LabelerName>
<SubstanceName>ARNICA MONTANA; BRYONIA ALBA ROOT; COMFREY ROOT; LEDUM PALUSTRE TWIG; RHODODENDRON AUREUM LEAF; SANGUINARIA CANADENSIS ROOT; SOLANUM DULCAMARA TOP; SULFUR; SUS SCROFA CARTILAGE; SUS SCROFA EMBRYO; SUS SCROFA PLACENTA; SUS SCROFA UMBILICAL CORD; TOXICODENDRON PUBESCENS LEAF</SubstanceName>
<StrengthNumber>3; 3; 7; 6; 8; 3; 2; 6; 4; 6; 6; 6; 4</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; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160301</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Relieves: 1 Arthritis pain, 2 Joint pain, 3 Joint stiffness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62795-1033-4</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (62795-1033-4) </PackageDescription>
<NDC11Code>62795-1033-04</NDC11Code>
<ProductNDC>62795-1033</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>T Relief Arthritis</ProprietaryName>
<NonProprietaryName>Arnica Montana, Bryonia Alba Root, Sus Scrofa Cartilage, Solanum Dulcamara Top, Sus Scrofa Embryo,sus Scrofa Umbilical Cord, Ledum Palustre Twig,sus Scrofa Umbilical Cord, Ledum Palustre Twig,sus Scrofa Placenta, Rhododendron Aureum Leaf,toxicodendron Pubescens Leaf, Sanguinaria Canadensis Root, Sulfur, And Comfrey Root</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160301</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>MediNatura Inc</LabelerName>
<SubstanceName>ARNICA MONTANA; BRYONIA ALBA ROOT; COMFREY ROOT; LEDUM PALUSTRE TWIG; RHODODENDRON AUREUM LEAF; SANGUINARIA CANADENSIS ROOT; SOLANUM DULCAMARA TOP; SULFUR; SUS SCROFA CARTILAGE; SUS SCROFA EMBRYO; SUS SCROFA PLACENTA; SUS SCROFA UMBILICAL CORD; TOXICODENDRON PUBESCENS LEAF</SubstanceName>
<StrengthNumber>3; 3; 7; 6; 8; 3; 2; 6; 4; 6; 6; 6; 4</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; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221116</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Relieves: 1 Arthritis pain, 2 Joint pain, 3 Joint stiffness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62795-1039-2</NDCCode>
<PackageDescription>100 TABLET in 1 PACKAGE (62795-1039-2) </PackageDescription>
<NDC11Code>62795-1039-02</NDC11Code>
<ProductNDC>62795-1039</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>T-relief Pro Arthritis</ProprietaryName>
<NonProprietaryName>Arnica Montana, Bryonia Alba Whole, Sus Scrofa Cartilage,solanum Dulcamara Top,sus Scrofa Embryo,sus Scrofa Umbilical Cord,rhododendron Tomentosum Leafy Twig,sus Scrofa Placenta,rhododendron Aureum Leaf,toxicodendron Pubescens Leaf, Sanguinaria Canadensis Root, Sulfur And Comfrey Root</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171213</StartMarketingDate>
<EndMarketingDate>20260327</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>MediNatura Inc</LabelerName>
<SubstanceName>ARNICA MONTANA; BRYONIA ALBA WHOLE; COMFREY ROOT; RHODODENDRON AUREUM LEAF; RHODODENDRON TOMENTOSUM LEAFY TWIG; SANGUINARIA CANADENSIS ROOT; SOLANUM DULCAMARA TOP; SULFUR; SUS SCROFA CARTILAGE; SUS SCROFA EMBRYO; SUS SCROFA PLACENTA; SUS SCROFA UMBILICAL CORD; TOXICODENDRON PUBESCENS LEAF</SubstanceName>
<StrengthNumber>3; 3; 7; 8; 6; 3; 2; 6; 4; 6; 6; 6; 4</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; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2026-03-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20171213</StartMarketingDatePackage>
<EndMarketingDatePackage>20260327</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Arthritis Pain relief tablets Supports Mobility Joint Stiffness Arthritis Pain Joint Pain.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62795-1053-2</NDCCode>
<PackageDescription>250 TABLET in 1 BOTTLE (62795-1053-2) </PackageDescription>
<NDC11Code>62795-1053-02</NDC11Code>
<ProductNDC>62795-1053</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>T Relief Arthritis Extra Strength</ProprietaryName>
<NonProprietaryName>Arnica Montana, Bryonia Alba Root, Sus Scrofa Cartilage, Solanum Dulcamara Top, Sus Scrofa Embryo,sus Scrofa Umbilical Cord, Ledum Palustre Twig,sus Scrofa Umbilical Cord, Ledum Palustre Twig,sus Scrofa Placenta, Rhododendron Aureum Leaf,toxicodendron Pubescens Leaf, Sanguinaria Canadensis Root, Sulfur, And Comfrey Root</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220405</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>MediNatura Inc</LabelerName>
<SubstanceName>ARNICA MONTANA; BRYONIA ALBA ROOT; COMFREY ROOT; LEDUM PALUSTRE TWIG; RHODODENDRON AUREUM LEAF; SANGUINARIA CANADENSIS ROOT; SOLANUM DULCAMARA TOP; SULFUR; SUS SCROFA CARTILAGE; SUS SCROFA EMBRYO; SUS SCROFA PLACENTA; SUS SCROFA UMBILICAL CORD; TOXICODENDRON PUBESCENS LEAF</SubstanceName>
<StrengthNumber>3; 3; 7; 6; 8; 3; 2; 6; 4; 6; 6; 6; 4</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; [hp_X]/1; [hp_X]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220405</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the temporary relief of minor:Arthritis Pain Joint Pain Joint Stiffness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>62795-3000-1</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (62795-3000-1) > 125 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>62795-3000-01</NDC11Code>
<ProductNDC>62795-3000</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Reboost Cough</ProprietaryName>
<NonProprietaryName>Antimony Potassium Tartrate, Pulsatilla Vulgaris, Drosera Rotundifolia, Hyoscyamus Niger, Ipecac, Pulsatilla Vulgaris, Rumex Crispus Root, Spongia Officinalis Skeleton, Roasted, And Lobaria Pulmonaria</NonProprietaryName>
<DosageFormName>SYRUP</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140830</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>MediNatura</LabelerName>
<SubstanceName>ANTIMONY POTASSIUM TARTRATE; DROSERA ROTUNDIFOLIA; HYOSCYAMUS NIGER; IPECAC; PULSATILLA VULGARIS; RUMEX CRISPUS ROOT; SPONGIA OFFICINALIS SKELETON, ROASTED; LOBARIA PULMONARIA</SubstanceName>
<StrengthNumber>6; 3; 6; 4; 9; 4; 7; 6</StrengthNumber>
<StrengthUnit>[hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL; [hp_X]/125mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-01-10</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0024-1171-90</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (0024-1171-90) </PackageDescription>
<NDC11Code>00024-1171-90</NDC11Code>
<ProductNDC>0024-1171</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Plavix</ProprietaryName>
<NonProprietaryName>Clopidogrel</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19971117</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020839</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>CLOPIDOGREL BISULFATE</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200713</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Plavix is a P2Y12 platelet inhibitor indicated for: 1 Acute coronary syndrome –For patients with non–ST-segment elevation ACS (unstable angina [UA]/non–ST-elevation myocardial infarction [NSTEMI]), Plavix has been shown to reduce the rate of myocardial infarction (MI) and stroke. (1.1)–For patients with ST-elevation myocardial infarction (STEMI), Plavix has been shown to reduce the rate of MI and stroke. (1.1), 2 Recent MI, recent stroke, or established peripheral arterial disease. Plavix has been shown to reduce the rate of MI and stroke. (1.2).</IndicationAndUsage>
<Description>Plavix (clopidogrel tablets) is a thienopyridine class inhibitor of P2Y12 ADP platelet receptors. Chemically it is methyl (+)-(S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)-acetate sulfate (1:1). The empirical formula of clopidogrel bisulfate is C16H16ClNO2SH2SO4 and its molecular weight is 419.9. The structural formula is as follows. Clopidogrel bisulfate is a white to off-white powder. It is practically insoluble in water at neutral pH but freely soluble at pH 1. It also dissolves freely in methanol, dissolves sparingly in methylene chloride, and is practically insoluble in ethyl ether. It has a specific optical rotation of about +56°. Plavix for oral administration is provided as either pink, round, biconvex, debossed, film-coated tablets containing 97.875 mg of clopidogrel bisulfate which is the molar equivalent of 75 mg of clopidogrel base or pink, oblong, debossed, film-coated tablets containing 391.5 mg of clopidogrel bisulfate which is the molar equivalent of 300 mg of clopidogrel base. Each tablet contains hydrogenated castor oil, hydroxypropyl cellulose, mannitol, microcrystalline cellulose, and polyethylene glycol 6000 as inactive ingredients. The pink film coating contains ferric oxide, hypromellose 2910, lactose monohydrate, titanium dioxide, and triacetin. The tablets are polished with Carnauba wax.</Description>
</NDC>
<NDC>
<NDCCode>0024-1332-30</NDCCode>
<PackageDescription>3 BLISTER PACK in 1 CARTON (0024-1332-30) / 10 TABLET, FILM COATED in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00024-1332-30</NDC11Code>
<ProductNDC>0024-1332</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Plavix</ProprietaryName>
<NonProprietaryName>Clopidogrel</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20090509</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020839</ApplicationNumber>
<LabelerName>Sanofi-Aventis U.S. LLC</LabelerName>
<SubstanceName>CLOPIDOGREL BISULFATE</SubstanceName>
<StrengthNumber>300</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2C8 Inhibitors [MoA], Decreased Platelet Aggregation [PE], P2Y12 Platelet Inhibitor [EPC], P2Y12 Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200713</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Plavix is a P2Y12 platelet inhibitor indicated for: 1 Acute coronary syndrome –For patients with non–ST-segment elevation ACS (unstable angina [UA]/non–ST-elevation myocardial infarction [NSTEMI]), Plavix has been shown to reduce the rate of myocardial infarction (MI) and stroke. (1.1)–For patients with ST-elevation myocardial infarction (STEMI), Plavix has been shown to reduce the rate of MI and stroke. (1.1), 2 Recent MI, recent stroke, or established peripheral arterial disease. Plavix has been shown to reduce the rate of MI and stroke. (1.2).</IndicationAndUsage>
<Description>Plavix (clopidogrel tablets) is a thienopyridine class inhibitor of P2Y12 ADP platelet receptors. Chemically it is methyl (+)-(S)-α-(2-chlorophenyl)-6,7-dihydrothieno[3,2-c]pyridine-5(4H)-acetate sulfate (1:1). The empirical formula of clopidogrel bisulfate is C16H16ClNO2SH2SO4 and its molecular weight is 419.9. The structural formula is as follows. Clopidogrel bisulfate is a white to off-white powder. It is practically insoluble in water at neutral pH but freely soluble at pH 1. It also dissolves freely in methanol, dissolves sparingly in methylene chloride, and is practically insoluble in ethyl ether. It has a specific optical rotation of about +56°. Plavix for oral administration is provided as either pink, round, biconvex, debossed, film-coated tablets containing 97.875 mg of clopidogrel bisulfate which is the molar equivalent of 75 mg of clopidogrel base or pink, oblong, debossed, film-coated tablets containing 391.5 mg of clopidogrel bisulfate which is the molar equivalent of 300 mg of clopidogrel base. Each tablet contains hydrogenated castor oil, hydroxypropyl cellulose, mannitol, microcrystalline cellulose, and polyethylene glycol 6000 as inactive ingredients. The pink film coating contains ferric oxide, hypromellose 2910, lactose monohydrate, titanium dioxide, and triacetin. The tablets are polished with Carnauba wax.</Description>
</NDC>
<NDC>
<NDCCode>0091-3707-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (0091-3707-01)</PackageDescription>
<NDC11Code>00091-3707-01</NDC11Code>
<ProductNDC>0091-3707</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Univasc</ProprietaryName>
<NonProprietaryName>Moexipril Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19950715</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020312</ApplicationNumber>
<LabelerName>UCB, Inc.</LabelerName>
<SubstanceName>MOEXIPRIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>univasc ® is indicated for treatment of patients with hypertension. It may be used alone or in combination with thiazide diuretics. In using univasc ®, consideration should be given to the fact that another ACE inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that univasc ® does not have a similar risk (see WARNINGS). In considering use of univasc ®, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS, Angioedema).</IndicationAndUsage>
<Description>univasc ® (moexipril hydrochloride), the hydrochloride salt of moexipril, has the empirical formula C 27H 34N 2O 7HCl and a molecular weight of 535.04. It is chemically described as [3S-[2[R*(R*)],3R*]]-2-[2-[[1-(ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-1,2,3,4-tetrahydro-6,7-dimethoxy-3-isoquinolinecarboxylic acid, monohydrochloride. It is a non-sulfhydryl containing precursor of the active angiotensin-converting enzyme (ACE) inhibitor moexiprilat and its structural formula is:. Moexipril hydrochloride is a fine white to off-white powder. It is soluble (about 10% weight-to-volume) in distilled water at room temperature. univasc ® is supplied as scored, coated tablets containing 7.5 mg and 15 mg of moexipril hydrochloride for oral administration. In addition to the active ingredient, moexipril hydrochloride, the tablet core contains the following inactive ingredients: lactose, magnesium oxide, crospovidone, magnesium stearate and gelatin. The film coating contains hydroxypropyl cellulose, hypromellose, polyethylene glycol 6000, magnesium stearate, titanium dioxide, and ferric oxide.</Description>
</NDC>
<NDC>
<NDCCode>0091-3707-09</NDCCode>
<PackageDescription>90 TABLET, FILM COATED in 1 BOTTLE (0091-3707-09)</PackageDescription>
<NDC11Code>00091-3707-09</NDC11Code>
<ProductNDC>0091-3707</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Univasc</ProprietaryName>
<NonProprietaryName>Moexipril Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19950715</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020312</ApplicationNumber>
<LabelerName>UCB, Inc.</LabelerName>
<SubstanceName>MOEXIPRIL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Angiotensin Converting Enzyme Inhibitor [EPC],Angiotensin-converting Enzyme Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>univasc ® is indicated for treatment of patients with hypertension. It may be used alone or in combination with thiazide diuretics. In using univasc ®, consideration should be given to the fact that another ACE inhibitor, captopril, has caused agranulocytosis, particularly in patients with renal impairment or collagen-vascular disease. Available data are insufficient to show that univasc ® does not have a similar risk (see WARNINGS). In considering use of univasc ®, it should be noted that in controlled trials ACE inhibitors have an effect on blood pressure that is less in black patients than in non-blacks. In addition, ACE inhibitors (for which adequate data are available) cause a higher rate of angioedema in black than in non-black patients (see WARNINGS, Angioedema).</IndicationAndUsage>
<Description>univasc ® (moexipril hydrochloride), the hydrochloride salt of moexipril, has the empirical formula C 27H 34N 2O 7HCl and a molecular weight of 535.04. It is chemically described as [3S-[2[R*(R*)],3R*]]-2-[2-[[1-(ethoxycarbonyl)-3-phenylpropyl]amino]-1-oxopropyl]-1,2,3,4-tetrahydro-6,7-dimethoxy-3-isoquinolinecarboxylic acid, monohydrochloride. It is a non-sulfhydryl containing precursor of the active angiotensin-converting enzyme (ACE) inhibitor moexiprilat and its structural formula is:. Moexipril hydrochloride is a fine white to off-white powder. It is soluble (about 10% weight-to-volume) in distilled water at room temperature. univasc ® is supplied as scored, coated tablets containing 7.5 mg and 15 mg of moexipril hydrochloride for oral administration. In addition to the active ingredient, moexipril hydrochloride, the tablet core contains the following inactive ingredients: lactose, magnesium oxide, crospovidone, magnesium stearate and gelatin. The film coating contains hydroxypropyl cellulose, hypromellose, polyethylene glycol 6000, magnesium stearate, titanium dioxide, and ferric oxide.</Description>
</NDC>
<NDC>
<NDCCode>0115-1724-01</NDCCode>
<PackageDescription>100 TABLET, COATED in 1 BOTTLE, PLASTIC (0115-1724-01) </PackageDescription>
<NDC11Code>00115-1724-01</NDC11Code>
<ProductNDC>0115-1724</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ultramicrosize Griseofulvin</ProprietaryName>
<NonProprietaryName>Ultramicrosize Griseofulvin Tablets</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140929</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204371</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
<SubstanceName>GRISEOFULVIN</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Mitosis [PE], Microtubule Inhibition [PE], Tubulin Inhibiting Agent [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140929</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ultramicrosize griseofulvin tablets are indicated for the treatment of the following ringworm infections; tinea corporis (ringworm of the body), tinea pedis (athlete's foot), tinea cruris (ringworm of the groin and thigh), tinea barbae (barber's itch), tinea capitis (ringworm of the scalp), and tinea unguium (onychomycosis, ringworm of the nails), when caused by one or more of the following genera of fungi: Trichophyton rubrum, Trichophyton tonsurans, Trichophyton mentagrophytes, Trichophyton interdigitalis, Trichophyton verrucosum, Trichophyton megnini, Trichophyton gallinae, Trichophyton crateriform, Trichophyton sulphureum, Trichophyton schoenleini, Microsporum audouini, Microsporum canis, Microsporum gypseum and Epidermophyton floccosum. NOTE: Prior to therapy, the type of fungi responsible for the infection should be identified. The use of the drug is not justified in minor or trivial infections which will respond to topical agents alone. Griseofulvin is not effective in the following: bacterial infections, candidiasis (moniliasis), histoplasmosis, actinomycosis, sporotrichosis, chromoblastomycosis, coccidioidomycosis, North American blastomycosis, cryptococcosis (torulosis), tinea versicolor and nocardiosis.</IndicationAndUsage>
<Description>Ultramicrosize griseofulvin tablets, USP contain ultramicrosize crystals of griseofulvin, an antibiotic derived from a species of Penicillium. The chemical name of griseofulvin, USP is 7-Chloro- 2’,4,6-trimethoxy-6’β-methylspiro[benzofuran-2(3H),1’-[2]cyclohexene]-3,4’-dione. Its structural formula is. Griseofulvin, USP occurs as a white or yellowish-white, odorless powder which is practically insoluble in water, freely soluble in dimethylformamide,slightly soluble in anhydrous ethanol and in methanol. Each ultramicrosize griseofulvin tablet, USP contains. Active Ingredient. Ultramicrosize Griseofulvin..........................125 mg. Inactive Ingredients: Colloidal silicon dioxide, magnesium stearate, polyethylene glycol 3350, polyethylene glycol 6000, polyethylene glycol 8000, polyvinyl alcohol, sodium lauryl sulfate, talc and titanium dioxide. OR. Active Ingredient. Ultramicrosize Griseofulvin..........................250 mg. Inactive Ingredients: Colloidal silicon dioxide, magnesium stearate, polyethylene glycol 3350, polyethylene glycol 6000, polyethylene glycol 8000, polyvinyl alcohol, sodium lauryl sulfate, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0115-1724-02</NDCCode>
<PackageDescription>500 TABLET, COATED in 1 BOTTLE, PLASTIC (0115-1724-02) </PackageDescription>
<NDC11Code>00115-1724-02</NDC11Code>
<ProductNDC>0115-1724</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ultramicrosize Griseofulvin</ProprietaryName>
<NonProprietaryName>Ultramicrosize Griseofulvin Tablets</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140929</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204371</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
<SubstanceName>GRISEOFULVIN</SubstanceName>
<StrengthNumber>125</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Mitosis [PE], Microtubule Inhibition [PE], Tubulin Inhibiting Agent [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140929</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ultramicrosize griseofulvin tablets are indicated for the treatment of the following ringworm infections; tinea corporis (ringworm of the body), tinea pedis (athlete's foot), tinea cruris (ringworm of the groin and thigh), tinea barbae (barber's itch), tinea capitis (ringworm of the scalp), and tinea unguium (onychomycosis, ringworm of the nails), when caused by one or more of the following genera of fungi: Trichophyton rubrum, Trichophyton tonsurans, Trichophyton mentagrophytes, Trichophyton interdigitalis, Trichophyton verrucosum, Trichophyton megnini, Trichophyton gallinae, Trichophyton crateriform, Trichophyton sulphureum, Trichophyton schoenleini, Microsporum audouini, Microsporum canis, Microsporum gypseum and Epidermophyton floccosum. NOTE: Prior to therapy, the type of fungi responsible for the infection should be identified. The use of the drug is not justified in minor or trivial infections which will respond to topical agents alone. Griseofulvin is not effective in the following: bacterial infections, candidiasis (moniliasis), histoplasmosis, actinomycosis, sporotrichosis, chromoblastomycosis, coccidioidomycosis, North American blastomycosis, cryptococcosis (torulosis), tinea versicolor and nocardiosis.</IndicationAndUsage>
<Description>Ultramicrosize griseofulvin tablets, USP contain ultramicrosize crystals of griseofulvin, an antibiotic derived from a species of Penicillium. The chemical name of griseofulvin, USP is 7-Chloro- 2’,4,6-trimethoxy-6’β-methylspiro[benzofuran-2(3H),1’-[2]cyclohexene]-3,4’-dione. Its structural formula is. Griseofulvin, USP occurs as a white or yellowish-white, odorless powder which is practically insoluble in water, freely soluble in dimethylformamide,slightly soluble in anhydrous ethanol and in methanol. Each ultramicrosize griseofulvin tablet, USP contains. Active Ingredient. Ultramicrosize Griseofulvin..........................125 mg. Inactive Ingredients: Colloidal silicon dioxide, magnesium stearate, polyethylene glycol 3350, polyethylene glycol 6000, polyethylene glycol 8000, polyvinyl alcohol, sodium lauryl sulfate, talc and titanium dioxide. OR. Active Ingredient. Ultramicrosize Griseofulvin..........................250 mg. Inactive Ingredients: Colloidal silicon dioxide, magnesium stearate, polyethylene glycol 3350, polyethylene glycol 6000, polyethylene glycol 8000, polyvinyl alcohol, sodium lauryl sulfate, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0115-1725-01</NDCCode>
<PackageDescription>100 TABLET, COATED in 1 BOTTLE, PLASTIC (0115-1725-01) </PackageDescription>
<NDC11Code>00115-1725-01</NDC11Code>
<ProductNDC>0115-1725</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ultramicrosize Griseofulvin</ProprietaryName>
<NonProprietaryName>Ultramicrosize Griseofulvin Tablets</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140929</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204371</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
<SubstanceName>GRISEOFULVIN</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Mitosis [PE], Microtubule Inhibition [PE], Tubulin Inhibiting Agent [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140929</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ultramicrosize griseofulvin tablets are indicated for the treatment of the following ringworm infections; tinea corporis (ringworm of the body), tinea pedis (athlete's foot), tinea cruris (ringworm of the groin and thigh), tinea barbae (barber's itch), tinea capitis (ringworm of the scalp), and tinea unguium (onychomycosis, ringworm of the nails), when caused by one or more of the following genera of fungi: Trichophyton rubrum, Trichophyton tonsurans, Trichophyton mentagrophytes, Trichophyton interdigitalis, Trichophyton verrucosum, Trichophyton megnini, Trichophyton gallinae, Trichophyton crateriform, Trichophyton sulphureum, Trichophyton schoenleini, Microsporum audouini, Microsporum canis, Microsporum gypseum and Epidermophyton floccosum. NOTE: Prior to therapy, the type of fungi responsible for the infection should be identified. The use of the drug is not justified in minor or trivial infections which will respond to topical agents alone. Griseofulvin is not effective in the following: bacterial infections, candidiasis (moniliasis), histoplasmosis, actinomycosis, sporotrichosis, chromoblastomycosis, coccidioidomycosis, North American blastomycosis, cryptococcosis (torulosis), tinea versicolor and nocardiosis.</IndicationAndUsage>
<Description>Ultramicrosize griseofulvin tablets, USP contain ultramicrosize crystals of griseofulvin, an antibiotic derived from a species of Penicillium. The chemical name of griseofulvin, USP is 7-Chloro- 2’,4,6-trimethoxy-6’β-methylspiro[benzofuran-2(3H),1’-[2]cyclohexene]-3,4’-dione. Its structural formula is. Griseofulvin, USP occurs as a white or yellowish-white, odorless powder which is practically insoluble in water, freely soluble in dimethylformamide,slightly soluble in anhydrous ethanol and in methanol. Each ultramicrosize griseofulvin tablet, USP contains. Active Ingredient. Ultramicrosize Griseofulvin..........................125 mg. Inactive Ingredients: Colloidal silicon dioxide, magnesium stearate, polyethylene glycol 3350, polyethylene glycol 6000, polyethylene glycol 8000, polyvinyl alcohol, sodium lauryl sulfate, talc and titanium dioxide. OR. Active Ingredient. Ultramicrosize Griseofulvin..........................250 mg. Inactive Ingredients: Colloidal silicon dioxide, magnesium stearate, polyethylene glycol 3350, polyethylene glycol 6000, polyethylene glycol 8000, polyvinyl alcohol, sodium lauryl sulfate, talc and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0115-1725-03</NDCCode>
<PackageDescription>1000 TABLET, COATED in 1 BOTTLE, PLASTIC (0115-1725-03) </PackageDescription>
<NDC11Code>00115-1725-03</NDC11Code>
<ProductNDC>0115-1725</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ultramicrosize Griseofulvin</ProprietaryName>
<NonProprietaryName>Ultramicrosize Griseofulvin Tablets</NonProprietaryName>
<DosageFormName>TABLET, COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140929</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204371</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
<SubstanceName>GRISEOFULVIN</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Mitosis [PE], Microtubule Inhibition [PE], Tubulin Inhibiting Agent [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-23</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140929</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Ultramicrosize griseofulvin tablets are indicated for the treatment of the following ringworm infections; tinea corporis (ringworm of the body), tinea pedis (athlete's foot), tinea cruris (ringworm of the groin and thigh), tinea barbae (barber's itch), tinea capitis (ringworm of the scalp), and tinea unguium (onychomycosis, ringworm of the nails), when caused by one or more of the following genera of fungi: Trichophyton rubrum, Trichophyton tonsurans, Trichophyton mentagrophytes, Trichophyton interdigitalis, Trichophyton verrucosum, Trichophyton megnini, Trichophyton gallinae, Trichophyton crateriform, Trichophyton sulphureum, Trichophyton schoenleini, Microsporum audouini, Microsporum canis, Microsporum gypseum and Epidermophyton floccosum. NOTE: Prior to therapy, the type of fungi responsible for the infection should be identified. The use of the drug is not justified in minor or trivial infections which will respond to topical agents alone. Griseofulvin is not effective in the following: bacterial infections, candidiasis (moniliasis), histoplasmosis, actinomycosis, sporotrichosis, chromoblastomycosis, coccidioidomycosis, North American blastomycosis, cryptococcosis (torulosis), tinea versicolor and nocardiosis.</IndicationAndUsage>
<Description>Ultramicrosize griseofulvin tablets, USP contain ultramicrosize crystals of griseofulvin, an antibiotic derived from a species of Penicillium. The chemical name of griseofulvin, USP is 7-Chloro- 2’,4,6-trimethoxy-6’β-methylspiro[benzofuran-2(3H),1’-[2]cyclohexene]-3,4’-dione. Its structural formula is. Griseofulvin, USP occurs as a white or yellowish-white, odorless powder which is practically insoluble in water, freely soluble in dimethylformamide,slightly soluble in anhydrous ethanol and in methanol. Each ultramicrosize griseofulvin tablet, USP contains. Active Ingredient. Ultramicrosize Griseofulvin..........................125 mg. Inactive Ingredients: Colloidal silicon dioxide, magnesium stearate, polyethylene glycol 3350, polyethylene glycol 6000, polyethylene glycol 8000, polyvinyl alcohol, sodium lauryl sulfate, talc and titanium dioxide. OR. Active Ingredient. Ultramicrosize Griseofulvin..........................250 mg. Inactive Ingredients: Colloidal silicon dioxide, magnesium stearate, polyethylene glycol 3350, polyethylene glycol 6000, polyethylene glycol 8000, polyvinyl alcohol, sodium lauryl sulfate, talc and titanium dioxide.</Description>
</NDC>
</NDCList>