{
"NDC": [
{
"NDCCode": "63776-205-14",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (63776-205-14) > 30 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "63776-0205-14",
"ProductNDC": "63776-205",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Viatrexx-h Metals",
"NonProprietaryName": "Allum Sativa, Arsenicum Alb., Ascorbic Acid, Berberis, Iridium, Selenium, Cysteinum, Formaldehyde, Lappa M., Lycopodium, Methionine, Nat Mur, Nux Vomica, Phenol, Phytolacca, Stillinga, Trifolium",
"DosageFormName": "SPRAY",
"RouteName": "ORAL; TOPICAL",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "ARCTIUM LAPPA ROOT; ARSENIC TRIOXIDE; ASCORBIC ACID; BERBERIS VULGARIS ROOT BARK; CYSTEINE; FORMALDEHYDE; GARLIC; IRIDIUM; LYCOPODIUM CLAVATUM SPORE; METHIONINE; PHENOL; PHYTOLACCA AMERICANA ROOT; RED CLOVER; SELENIUM; SODIUM CHLORIDE; STILLINGIA SYLVATICA ROOT; STRYCHNOS NUX-VOMICA SEED",
"StrengthNumber": "3; 12; 3; 3; 6; 12; 3; 6; 12; 3; 12; 3; 3; 6; 12; 3; 12",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Ascorbic Acid [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS], Standardized Chemical Allergen [EPC], Vitamin C [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190705",
"SamplePackage": "N",
"IndicationAndUsage": "May help encourage heavy metal drainage.",
"Description": "Viatrexx-H Metals is a homeopathic product composed of physiological (low dose and low low dose) natural micro nutrients. These micro particles are designed to nourish the system."
},
{
"NDCCode": "63776-205-11",
"PackageDescription": "1 AMPULE in 1 BOX (63776-205-11) > .5 mL in 1 AMPULE",
"NDC11Code": "63776-0205-11",
"ProductNDC": "63776-205",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Viatrexx-h Metals",
"NonProprietaryName": "Allum Sativa, Arsenicum Alb., Ascorbic Acid, Berberis, Iridium, Selenium, Cysteinum, Formaldehyde, Lappa M., Lycopodium, Methionine, Nat Mur, Nux Vomica, Phenol, Phytolacca, Stillinga, Trifolium",
"DosageFormName": "SPRAY",
"RouteName": "ORAL; TOPICAL",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "ARCTIUM LAPPA ROOT; ARSENIC TRIOXIDE; ASCORBIC ACID; BERBERIS VULGARIS ROOT BARK; CYSTEINE; FORMALDEHYDE; GARLIC; IRIDIUM; LYCOPODIUM CLAVATUM SPORE; METHIONINE; PHENOL; PHYTOLACCA AMERICANA ROOT; RED CLOVER; SELENIUM; SODIUM CHLORIDE; STILLINGIA SYLVATICA ROOT; STRYCHNOS NUX-VOMICA SEED",
"StrengthNumber": "3; 12; 3; 3; 6; 12; 3; 6; 12; 3; 12; 3; 3; 6; 12; 3; 12",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Ascorbic Acid [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS], Standardized Chemical Allergen [EPC], Vitamin C [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190705",
"SamplePackage": "N",
"IndicationAndUsage": "May help encourage heavy metal drainage.",
"Description": "Viatrexx-H Metals is a homeopathic product composed of physiological (low dose and low low dose) natural micro nutrients. These micro particles are designed to nourish the system."
},
{
"NDCCode": "63776-205-15",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (63776-205-15) > 50 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "63776-0205-15",
"ProductNDC": "63776-205",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Viatrexx-h Metals",
"NonProprietaryName": "Allum Sativa, Arsenicum Alb., Ascorbic Acid, Berberis, Iridium, Selenium, Cysteinum, Formaldehyde, Lappa M., Lycopodium, Methionine, Nat Mur, Nux Vomica, Phenol, Phytolacca, Stillinga, Trifolium",
"DosageFormName": "SPRAY",
"RouteName": "ORAL; TOPICAL",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "ARCTIUM LAPPA ROOT; ARSENIC TRIOXIDE; ASCORBIC ACID; BERBERIS VULGARIS ROOT BARK; CYSTEINE; FORMALDEHYDE; GARLIC; IRIDIUM; LYCOPODIUM CLAVATUM SPORE; METHIONINE; PHENOL; PHYTOLACCA AMERICANA ROOT; RED CLOVER; SELENIUM; SODIUM CHLORIDE; STILLINGIA SYLVATICA ROOT; STRYCHNOS NUX-VOMICA SEED",
"StrengthNumber": "3; 12; 3; 3; 6; 12; 3; 6; 12; 3; 12; 3; 3; 6; 12; 3; 12",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Ascorbic Acid [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS], Standardized Chemical Allergen [EPC], Vitamin C [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190705",
"SamplePackage": "N",
"IndicationAndUsage": "May help encourage heavy metal drainage.",
"Description": "Viatrexx-H Metals is a homeopathic product composed of physiological (low dose and low low dose) natural micro nutrients. These micro particles are designed to nourish the system."
},
{
"NDCCode": "63776-205-16",
"PackageDescription": "1 BOTTLE in 1 BOX (63776-205-16) > 100 mL in 1 BOTTLE",
"NDC11Code": "63776-0205-16",
"ProductNDC": "63776-205",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Viatrexx-h Metals",
"NonProprietaryName": "Allum Sativa, Arsenicum Alb., Ascorbic Acid, Berberis, Iridium, Selenium, Cysteinum, Formaldehyde, Lappa M., Lycopodium, Methionine, Nat Mur, Nux Vomica, Phenol, Phytolacca, Stillinga, Trifolium",
"DosageFormName": "SPRAY",
"RouteName": "ORAL; TOPICAL",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "ARCTIUM LAPPA ROOT; ARSENIC TRIOXIDE; ASCORBIC ACID; BERBERIS VULGARIS ROOT BARK; CYSTEINE; FORMALDEHYDE; GARLIC; IRIDIUM; LYCOPODIUM CLAVATUM SPORE; METHIONINE; PHENOL; PHYTOLACCA AMERICANA ROOT; RED CLOVER; SELENIUM; SODIUM CHLORIDE; STILLINGIA SYLVATICA ROOT; STRYCHNOS NUX-VOMICA SEED",
"StrengthNumber": "3; 12; 3; 3; 6; 12; 3; 6; 12; 3; 12; 3; 3; 6; 12; 3; 12",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Ascorbic Acid [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS], Standardized Chemical Allergen [EPC], Vitamin C [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190705",
"SamplePackage": "N",
"IndicationAndUsage": "May help encourage heavy metal drainage.",
"Description": "Viatrexx-H Metals is a homeopathic product composed of physiological (low dose and low low dose) natural micro nutrients. These micro particles are designed to nourish the system."
},
{
"NDCCode": "63776-205-17",
"PackageDescription": "1 BOTTLE in 1 BOX (63776-205-17) > 250 mL in 1 BOTTLE",
"NDC11Code": "63776-0205-17",
"ProductNDC": "63776-205",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Viatrexx-h Metals",
"NonProprietaryName": "Allum Sativa, Arsenicum Alb., Ascorbic Acid, Berberis, Iridium, Selenium, Cysteinum, Formaldehyde, Lappa M., Lycopodium, Methionine, Nat Mur, Nux Vomica, Phenol, Phytolacca, Stillinga, Trifolium",
"DosageFormName": "SPRAY",
"RouteName": "ORAL; TOPICAL",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "ARCTIUM LAPPA ROOT; ARSENIC TRIOXIDE; ASCORBIC ACID; BERBERIS VULGARIS ROOT BARK; CYSTEINE; FORMALDEHYDE; GARLIC; IRIDIUM; LYCOPODIUM CLAVATUM SPORE; METHIONINE; PHENOL; PHYTOLACCA AMERICANA ROOT; RED CLOVER; SELENIUM; SODIUM CHLORIDE; STILLINGIA SYLVATICA ROOT; STRYCHNOS NUX-VOMICA SEED",
"StrengthNumber": "3; 12; 3; 3; 6; 12; 3; 6; 12; 3; 12; 3; 3; 6; 12; 3; 12",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Ascorbic Acid [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS], Standardized Chemical Allergen [EPC], Vitamin C [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190705",
"SamplePackage": "N",
"IndicationAndUsage": "May help encourage heavy metal drainage.",
"Description": "Viatrexx-H Metals is a homeopathic product composed of physiological (low dose and low low dose) natural micro nutrients. These micro particles are designed to nourish the system."
},
{
"NDCCode": "10812-205-02",
"PackageDescription": "14 mL in 1 TUBE (10812-205-02)",
"NDC11Code": "10812-0205-02",
"ProductNDC": "10812-205",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Neutrogena Oil Free Acne Wash Daily Scrub",
"ProprietaryNameSuffix": "With Microclear Technology",
"NonProprietaryName": "Salicylic Acid",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110315",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333D",
"LabelerName": "Neutrogena Corporation",
"SubstanceName": "SALICYLIC ACID",
"StrengthNumber": "20",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2015-12-18"
},
{
"NDCCode": "24385-205-01",
"PackageDescription": "1 TUBE in 1 CARTON (24385-205-01) / 14.2 g in 1 TUBE",
"NDC11Code": "24385-0205-01",
"ProductNDC": "24385-205",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Good Neighbor Pharmacy",
"ProprietaryNameSuffix": "Clotrimazole",
"NonProprietaryName": "Clotrimazole",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "19930831",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M005",
"LabelerName": "AmerisourceBergen",
"SubstanceName": "CLOTRIMAZOLE",
"StrengthNumber": "10",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Azole Antifungal [EPC], Azoles [CS]",
"Status": "Active",
"LastUpdate": "2025-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19930831",
"SamplePackage": "N",
"IndicationAndUsage": "cures most athlete's foot, jock itch and ringworm. relieves itching, burning, cracking, scaling and discomfort which accompany these conditions."
},
{
"NDCCode": "24909-205-14",
"PackageDescription": "14 g in 1 TUBE (24909-205-14) ",
"NDC11Code": "24909-0205-14",
"ProductNDC": "24909-205",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Terrasil Wart Remover For Kids 14g",
"NonProprietaryName": "Thuja Occidentalis 6x Hpus",
"DosageFormName": "SOAP",
"RouteName": "TOPICAL",
"StartMarketingDate": "20210825",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Aidance Skincare & Topical Solutions, LLC",
"SubstanceName": "THUJA OCCIDENTALIS WHOLE",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/g",
"Status": "Deprecated",
"LastUpdate": "2025-07-15",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20210826",
"SamplePackage": "N",
"IndicationAndUsage": "Wart Symptom Relief."
},
{
"NDCCode": "49349-205-04",
"PackageDescription": "14 TABLET in 1 BLISTER PACK (49349-205-04)",
"NDC11Code": "49349-0205-04",
"ProductNDC": "49349-205",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ibuprofen",
"NonProprietaryName": "Ibuprofen",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110421",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075682",
"LabelerName": "REMEDYREPACK INC.",
"SubstanceName": "IBUPROFEN",
"StrengthNumber": "800",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "59316-205-14",
"PackageDescription": "74 mL in 1 BOTTLE (59316-205-14) ",
"NDC11Code": "59316-0205-14",
"ProductNDC": "59316-205",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Biofreeze Roll-on",
"NonProprietaryName": "Menthol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130117",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Reckitt Benckiser LLC",
"SubstanceName": "MENTHOL, UNSPECIFIED FORM",
"StrengthNumber": "40",
"StrengthUnit": "mg/mL",
"Status": "Active",
"LastUpdate": "2026-05-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20130117",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves minor aches and pains of muscles and joints associated with: 1 simple backache, 2 arthritis, 3 strains, 4 bruises, 5 sprains."
},
{
"NDCCode": "59316-209-14",
"PackageDescription": "2 BOTTLE in 1 KIT (59316-209-14) / 1 KIT in 1 BOTTLE * 74 mL in 1 BOTTLE (59316-205-14) * 74 mL in 1 BOTTLE (59316-207-14) ",
"NDC11Code": "59316-0209-14",
"ProductNDC": "59316-209",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Biofreeze Roll-on And Overnight Roll-on",
"NonProprietaryName": "Menthol",
"DosageFormName": "KIT",
"StartMarketingDate": "20260401",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M017",
"LabelerName": "Reckitt Benckiser LLC",
"Status": "Active",
"LastUpdate": "2026-05-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260401",
"SamplePackage": "N",
"IndicationAndUsage": "Uses. Roll-on. Temporarily relieves minor aches and pains of muscles and joints associated with: ■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains. Uses. Overnight Roll-on. Temporarily relieves minor aches and pains of muscles and joints associated with: ■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains."
},
{
"NDCCode": "59572-205-94",
"PackageDescription": "10 BLISTER PACK in 1 BOX (59572-205-94) / 28 CAPSULE in 1 BLISTER PACK (59572-205-14) ",
"NDC11Code": "59572-0205-94",
"ProductNDC": "59572-205",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Thalomid",
"NonProprietaryName": "Thalidomide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20030620",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA020785",
"LabelerName": "Celgene Corporation",
"SubstanceName": "THALIDOMIDE",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Decreased Immunologically Active Molecule Activity [PE]",
"Status": "Active",
"LastUpdate": "2023-04-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20030620",
"SamplePackage": "N",
"IndicationAndUsage": "THALOMID in combination with dexamethasone is indicated for the treatment of patients with newly diagnosed multiple myeloma (MM). (1.1). THALOMID is indicated for the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL).THALOMID is not indicated as monotherapy for such ENL treatment in the presence of moderate to severe neuritis.THALOMID is also indicated as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence. (1.2).",
"Description": "THALOMID, α-(N-phthalimido) glutarimide, is an immunomodulatory agent. The empirical formula for thalidomide is C13H10N2O4 and the gram molecular weight is 258.2. The CAS number of thalidomide is 50-35-1. Thalidomide is an off-white to white, odorless, crystalline powder that is soluble at 25°C in dimethyl sulfoxide and sparingly soluble in water and ethanol. The glutarimide moiety contains a single asymmetric center and, therefore, may exist in either of two optically active forms designated S-(-) or R-(+). THALOMID is an equal mixture of the S-(-) and R-(+) forms and, therefore, has a net optical rotation of zero. THALOMID is available in 50 mg, 100 mg, 150 mg and 200 mg capsules for oral administration. Active ingredient: thalidomide. Inactive ingredients: pregelatinized starch and magnesium stearate. The 50 mg capsule shell contains gelatin, titanium dioxide, and black ink. The 100 mg capsule shell contains black iron oxide, yellow iron oxide, titanium dioxide, gelatin, and black ink. The 150 mg capsule shell contains FD&C blue #2, black iron oxide, yellow iron oxide, titanium dioxide, gelatin, and black and white ink. The 200 mg capsule shell contains FD&C blue #2, titanium dioxide, gelatin, and white ink."
},
{
"NDCCode": "61477-205-14",
"PackageDescription": "118 mL in 1 TUBE (61477-205-14) ",
"NDC11Code": "61477-0205-14",
"ProductNDC": "61477-205",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aloe Up Lil Kids",
"ProprietaryNameSuffix": "Spf 50",
"NonProprietaryName": "Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20140224",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Aloe Care International, LLC",
"SubstanceName": "AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE",
"StrengthNumber": "3; 5; 6; 5; 10",
"StrengthUnit": "g/100mL; g/100mL; 1/100mL; g/100mL; 1/100mL",
"Status": "Deprecated",
"LastUpdate": "2020-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20140224",
"SamplePackage": "N"
},
{
"NDCCode": "71334-205-05",
"PackageDescription": "4 BLISTER PACK in 1 CARTON (71334-205-05) / 14 TABLET, FILM COATED in 1 BLISTER PACK (71334-205-14) ",
"NDC11Code": "71334-0205-05",
"ProductNDC": "71334-205",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pyrukynd",
"NonProprietaryName": "Mitapivat",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20220218",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA216196",
"LabelerName": "Agios Pharmaceuticals, Inc.",
"SubstanceName": "MITAPIVAT",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], P-Glycoprotein Inhibitors [MoA], Pyruvate Kinase Activator [EPC], Pyruvate Kinase Activators [MoA], UGT1A1 Inducers [MoA]",
"Status": "Active",
"LastUpdate": "2026-07-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20220218",
"SamplePackage": "N",
"IndicationAndUsage": "PYRUKYND is indicated for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency.",
"Description": "The active ingredient of PYRUKYND is mitapivat, a pyruvate kinase activator, present as mitapivat sulfate. The chemical name of mitapivat sulfate is 8-quinolinesulfonamide, N-[4-[[4- (cyclopropylmethyl)-1-piperazinyl]carbonyl]phenyl]-, sulfate, hydrate (2:1:3). The chemical structure of mitapivat sulfate is. The molecular formula is (C 24H 26N 4SO 3) 2 H 2SO 4 3H 2O, and the molecular weight is 1053.23 for mitapivat sulfate. Mitapivat sulfate is a white to off-white solid and is slightly soluble in water. PYRUKYND is available as 5 mg, 20 mg, and 50 mg tablets for oral administration. Each tablet contains 5 mg, 20 mg, or 50 mg mitapivat free base, provided as 5.85 mg, 23.4 mg, or 58.5 mg, respectively, of the sulfate hydrate salt, and the following inactive ingredients: croscarmellose sodium, mannitol, microcrystalline cellulose, and sodium stearyl fumarate. The tablet film coating contains the inactive ingredients FD&C Blue No. 2, hypromellose, lactose monohydrate, titanium dioxide, and triacetin. The tablets are imprinted with black ink containing the inactive ingredients ammonium hydroxide, ferrosoferric oxide, isopropyl alcohol, n-butyl alcohol, propylene glycol, and shellac glaze."
},
{
"NDCCode": "77004-205-25",
"PackageDescription": "14.78 mL in 1 POUCH (77004-205-25) ",
"NDC11Code": "77004-0205-25",
"ProductNDC": "77004-205",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Impulse Antibacterial Hand Sanitizer",
"NonProprietaryName": "Isopropyl Alcohol 75%",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200801",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "Strata USA LLC",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "75",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2021-07-27",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200801",
"SamplePackage": "N",
"IndicationAndUsage": "To decrease bacteria on the skin that could cause diseae. Recommended for repeated use."
},
{
"NDCCode": "83114-205-14",
"PackageDescription": "1 TABLET, FILM COATED in 1 BLISTER PACK (83114-205-14) ",
"NDC11Code": "83114-0205-14",
"ProductNDC": "83114-205",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Xcopri Titration Pack 150 Mg, 200 Mg",
"NonProprietaryName": "Cenobamate",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20200312",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA212839",
"LabelerName": "PCI Pharma Services Canada, Inc.",
"SubstanceName": "CENOBAMATE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1501",
"Pharm_Classes": "Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2B6 Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], GABA A Receptor Positive Modulators [MoA], Sodium Channel Antagonists [MoA]",
"DEASchedule": "CV",
"Status": "Deprecated",
"LastUpdate": "2024-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20200312",
"SamplePackage": "N",
"IndicationAndUsage": "XCOPRI is indicated for the treatment of partial-onset seizures in adult patients."
},
{
"NDCCode": "83821-205-14",
"PackageDescription": "500 g in 1 BAG (83821-205-14) ",
"NDC11Code": "83821-0205-14",
"ProductNDC": "83821-205",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Orforglipron",
"DosageFormName": "POWDER",
"StartMarketingDate": "20260501",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Nanjing Hanxin Pharmaceutical Technology Co., Ltd.",
"SubstanceName": "ORFORGLIPRON",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "01-MAY-26"
},
{
"NDCCode": "85766-205-14",
"PackageDescription": "14 TABLET in 1 BLISTER PACK (85766-205-14) ",
"NDC11Code": "85766-0205-14",
"ProductNDC": "85766-205",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Cetirizine Hydrochloride",
"NonProprietaryName": "Cetirizine Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20071227",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077498",
"LabelerName": "Sportpharm LLC",
"SubstanceName": "CETIRIZINE HYDROCHLORIDE",
"StrengthNumber": "10",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]",
"Status": "Active",
"LastUpdate": "2026-05-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260508",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat."
},
{
"NDCCode": "63776-027-14",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (63776-027-14) > 30 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "63776-0027-14",
"ProductNDC": "63776-027",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Aller Balance",
"NonProprietaryName": "Acetylcholine Chloride, Bos Taurus Adrenal Gland, Sus Scrofa Adrenal Gland, Epinephrine, Onion, Ammonium Carbonate, Apis Mellifera, Arsenic Trioxide, Histamine, Interferon Gamma-1a, Interleukin-12 Human, Manganese Gluconate, Luffa Operculata Fruit, Sus Scrofa Lung, Beef Lung, Sus Scrofa Nasal Mucosa, Bos Taurus Nasal Mucosa, Sodium Chloride, Bos Taurus Peyers Patch, Sus Scrofa Peyers Patch, Schoenocaulon Officinale Seed, Serotonin, Bos Taurus Thymus, Sus Scrofa Thymus",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20120724",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "ACETYLCHOLINE CHLORIDE; BOS TAURUS ADRENAL GLAND; SUS SCROFA ADRENAL GLAND; EPINEPHRINE; ONION; AMMONIUM CARBONATE; APIS MELLIFERA; ARSENIC TRIOXIDE; HISTAMINE; INTERFERON GAMMA-1A; INTERLEUKIN-12 HUMAN; MANGANESE GLUCONATE; LUFFA OPERCULATA FRUIT; SUS SCROFA LUNG; BEEF LUNG; SUS SCROFA NASAL MUCOSA; BOS TAURUS NASAL MUCOSA; SODIUM CHLORIDE; BOS TAURUS PEYER'S PATCH; SUS SCROFA PEYER'S PATCH; SCHOENOCAULON OFFICINALE SEED; SEROTONIN; BOS TAURUS THYMUS; SUS SCROFA THYMUS",
"StrengthNumber": "200; 200; 200; 30; 200; 200; 200; 200; 200; 200; 200; 4; 30; 200; 200; 200; 200; 200; 30; 30; 200; 200; 200; 200",
"StrengthUnit": "{kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "63776-033-14",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (63776-033-14) > 30 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "63776-0033-14",
"ProductNDC": "63776-033",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Ans/cns",
"NonProprietaryName": "Acetylcholine Chloride, Epinephrine, .gamma.-aminobutyric Acid, Histamine, Goldenseal, Norepinephrine, Taraxacum Palustre Root, Tyramine",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20120724",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "ACETYLCHOLINE CHLORIDE; EPINEPHRINE; .GAMMA.-AMINOBUTYRIC ACID; HISTAMINE; GOLDENSEAL; NOREPINEPHRINE; TARAXACUM PALUSTRE ROOT; TYRAMINE",
"StrengthNumber": "200; 200; 200; 200; 3; 200; 30; 200",
"StrengthUnit": "{kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL",
"Status": "Deprecated",
"LastUpdate": "2018-01-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "63776-035-14",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (63776-035-14) > 30 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "63776-0035-14",
"ProductNDC": "63776-035",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Arthros",
"NonProprietaryName": "Anti-interleukin-1.alpha. Immunoglobulin G Rabbit, .alpha.-ketoglutaric Acid, .alpha.-lipoic Acid, Apomorphine, Bos Taurus Joint Capsule, Sus Scrofa Joint Capsule, Ascorbic Acid, Bos Taurus Adrenal Gland, Sus Scrofa Adrenal Gland, Brain-derived Neurotrophic Factor Human, Metenkefalin, Ersofermin, Bos Taurus Solar Plexus, Sus Scrofa Solar Plexus, Calcitonin, Bos Taurus Cartilage, Sus Scrofa Cartilage, Colchicum Autumnale Bulb, Pork Collagen, Bos Taurus Red Blood Cell, Sus Scrofa Red Blood Cell",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20120724",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": ".ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; APOMORPHINE; ASCORBIC ACID; BEEF LIVER; BOS TAURUS ADRENAL GLAND; BOS TAURUS CARTILAGE; BOS TAURUS JOINT CAPSULE; BOS TAURUS LYMPH; BOS TAURUS MESENCHYME; BOS TAURUS PARATHYROID GLAND; BOS TAURUS PLACENTA; BOS TAURUS RED BLOOD CELL; BOS TAURUS SOLAR PLEXUS; BOS TAURUS VEIN; BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; CALCITONIN; COLCHICUM AUTUMNALE BULB; EDODEKIN ALFA; ERSOFERMIN; INTERFERON GAMMA-1A; METENKEFALIN; NADIDE; PORK COLLAGEN; PORK LIVER; QUINHYDRONE; SULFUR; SUS SCROFA ADRENAL GLAND; SUS SCROFA CARTILAGE; SUS SCROFA JOINT CAPSULE; SUS SCROFA LYMPH; SUS SCROFA MESENCHYME; SUS SCROFA PARATHYROID GLAND; SUS SCROFA RED BLOOD CELL; SUS SCROFA SOLAR PLEXUS; SUS SCROFA VEIN",
"StrengthNumber": "30; 30; 200; 30; 30; 200; 200; 200; 200; 200; 200; 200; 30; 200; 200; 30; 200; 200; 200; 200; 200; 200; 200; 30; 200; 200; 30; 30; 200; 200; 200; 200; 200; 200; 200; 200; 30",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [hp_Q]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [hp_Q]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Allergens [CS], Ascorbic Acid [CS], Cell-mediated Immunity [PE], Depigmenting Activity [PE], Dietary Proteins [CS], Dopamine Agonists [MoA], Dopaminergic Agonist [EPC], Increased Histamine Release [PE], Meat Proteins [EXT], Melanin Synthesis Inhibitor [EPC], Melanin Synthesis Inhibitors [MoA], Non-Standardized Food Allergenic Extract [EPC], Vitamin C [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20120724",
"SamplePackage": "N",
"IndicationAndUsage": "For the relief of arthritic symptoms."
},
{
"NDCCode": "63776-037-14",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (63776-037-14) > 30 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "63776-0037-14",
"ProductNDC": "63776-037",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Articula",
"NonProprietaryName": "Anti-interleukin-1.alpha. Immunoglobulin G Rabbit, Bos Taurus Ankle Joint, Sus Scrofa Ankle Joint, Metenkefalin, Ersofermin, Bos Taurus Achilles Tendon, Sus Scrofa Achilles Tendon, Bos Taurus Hip Joint, Sus Scrofa Hip Joint, Bos Taurus Knee Joint, Sus Scrofa Knee Joint, Beef Liver, Pork Liver, Transforming Growth Factor Beta-1, Avotermin",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20120326",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; AVOTERMIN; BEEF LIVER; BOS TAURUS ACHILLES TENDON; BOS TAURUS ANKLE JOINT; BOS TAURUS HIP JOINT; BOS TAURUS KNEE JOINT; ERSOFERMIN; METENKEFALIN; PORK LIVER; SUS SCROFA ACHILLES TENDON; SUS SCROFA ANKLE JOINT; SUS SCROFA HIP JOINT; SUS SCROFA KNEE JOINT; TRANSFORMING GROWTH FACTOR BETA-1",
"StrengthNumber": "200; 30; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 30",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Meat Proteins [EXT], Non-Standardized Food Allergenic Extract [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20120526",
"SamplePackage": "N",
"IndicationAndUsage": "To help support the repair & regeneration of articulations & joints."
},
{
"NDCCode": "63776-073-14",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (63776-073-14) > 30 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "63776-0073-14",
"ProductNDC": "63776-073",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Candida",
"NonProprietaryName": "Ammoniac, Aspergillus Niger Var. Niger, Caffeic Acid, Candida Albicans, Candida Parapsilosis, Ipecac, Lycopodium Clavatum Spore, Yeast Mannan, Penicillin G Sodium, Vaccinium Vitis-idaea Leaf",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20120724",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "AMMONIAC; ASPERGILLUS NIGER VAR. NIGER; CAFFEIC ACID; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; IPECAC; LYCOPODIUM CLAVATUM SPORE; YEAST MANNAN; PENICILLIN G SODIUM; VACCINIUM VITIS-IDAEA LEAF",
"StrengthNumber": "200; 200; 200; 200; 200; 200; 200; 200; 200; 200",
"StrengthUnit": "{kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "63776-074-14",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (63776-074-14) > 30 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "63776-0074-14",
"ProductNDC": "63776-074",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Candida Plus",
"NonProprietaryName": "Ammoniac, Aspergillus Niger Var. Niger, Caffeic Acid, Candida Albicans, Candida Parapsilosis, Ipecac, Lycopodium Clavatum Spore, Yeast Mannan, Vaccinium Vitis-idaea Leaf",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20120724",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "AMMONIAC; ASPERGILLUS NIGER VAR. NIGER; CAFFEIC ACID; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; IPECAC; LYCOPODIUM CLAVATUM SPORE; VACCINIUM VITIS-IDAEA LEAF; YEAST MANNAN",
"StrengthNumber": "200; 200; 200; 200; 200; 200; 200; 200; 200",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Fungal Proteins [CS], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-01-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20120724",
"SamplePackage": "N",
"IndicationAndUsage": "For the relief of symptoms due to Candida, including precursors and byproducts."
},
{
"NDCCode": "63776-075-14",
"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (63776-075-14) > 30 mL in 1 BOTTLE, SPRAY",
"NDC11Code": "63776-0075-14",
"ProductNDC": "63776-075",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Candida I",
"NonProprietaryName": "Caffeic Acid, Candida Albicans, Tanacetum Parthenium, Centella Asiatica, Yeast Mannan, Penicillin G, Vaccinium Vitis-idaea Leaf Spray",
"DosageFormName": "SPRAY",
"RouteName": "ORAL",
"StartMarketingDate": "20120724",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "CAFFEIC ACID; CANDIDA ALBICANS; TANACETUM PARTHENIUM; CENTELLA ASIATICA; YEAST MANNAN; PENICILLIN G; VACCINIUM VITIS-IDAEA LEAF",
"StrengthNumber": "200; 200; 200; 200; 200; 200; 200",
"StrengthUnit": "{kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL",
"Status": "Deprecated",
"LastUpdate": "2018-01-19",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "63776-081-14",
"PackageDescription": "30 mL in 1 BOTTLE (63776-081-14) ",
"NDC11Code": "63776-0081-14",
"ProductNDC": "63776-081",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Viatrexx-cellulite",
"NonProprietaryName": "Androsterone, Artichoke, Atp, Bfgf, Camp, L-carnitine, Centella Asiatica, Citric Acid, Cobalt, Estrogen, Ferrum Fumaricum, Fumaric Acid, Ginkgo, Hamamelis, Hyaluronidase, Il-3, Kalium Asparticum, Lactic Acid, Lymphatic Vessel, Melilotus, Mn, Natrum Oxalaceticum, Natrum Pyruvicum, Quinhydrone, Succinic Acid, Vein, Vitamin A And Zinc",
"DosageFormName": "SPRAY",
"RouteName": "ORAL; TOPICAL",
"StartMarketingDate": "20190329",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
"SubstanceName": "ADENOSINE CYCLIC PHOSPHATE; ADENOSINE TRIPHOSPHATE; ANDROSTERONE; ARTICHOKE; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); BOS TAURUS LYMPH VESSEL; BOS TAURUS VEIN; CENTELLA ASIATICA; CITRIC ACID MONOHYDRATE; COBALT; ERSOFERMIN; ESTROGENS, ESTERIFIED; FERROUS FUMARATE; FUMARIC ACID; HAMAMELIS VIRGINIANA BARK; HEPTAMINOL; HYALURONIDASE; INTERLEUKIN-3; LACTIC ACID; LEVOCARNITINE; MANGANESE; MELILOTUS OFFICINALIS WHOLE; POTASSIUM ASPARTATE; QUINHYDRONE; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SUCCINIC ACID; SUS SCROFA LYMPH VESSEL; SUS SCROFA VEIN; VITAMIN A; ZINC",
"StrengthNumber": "30; 30; 30; 30; 200; 200; 200; 30; 30; 30; 200; 200; 30; 30; 30; 30; 30; 200; 30; 30; 30; 30; 30; 30; 30; 30; 30; 200; 200; 30; 30",
"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
"Pharm_Classes": "Acidifying Activity [MoA], Allergens [CS], Allergens [CS], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Carnitine Analog [EPC], Carnitine [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Decreased Coagulation Factor Activity [PE], Depigmenting Activity [PE], Dietary Proteins [CS], Endoglycosidase [EPC], Glycoside Hydrolases [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Melanin Synthesis Inhibitor [EPC], Melanin Synthesis Inhibitors [MoA], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Standardized Chemical Allergen [EPC], Vegetable Proteins [CS], Vitamin A [CS], Vitamin A [EPC]",
"Status": "Deprecated",
"LastUpdate": "2022-08-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20210224",
"SamplePackage": "N",
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{
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"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
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"StrengthUnit": "[kp_C]/mL",
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"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"SamplePackage": "N",
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"ProductNdcExcludeFlag": "N",
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},
{
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"PackageDescription": "1 BOTTLE, SPRAY in 1 BOX (63776-142-14) > 30 mL in 1 BOTTLE, SPRAY",
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"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "VIATREXX BIO INCORPORATED",
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"StrengthUnit": "[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL",
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"LastUpdate": "2022-08-02",
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"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20221231",
"StartMarketingDatePackage": "20190705",
"SamplePackage": "N",
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}
]
}
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>May help encourage heavy metal drainage.</IndicationAndUsage>
<Description>Viatrexx-H Metals is a homeopathic product composed of physiological (low dose and low low dose) natural micro nutrients. These micro particles are designed to nourish the system.</Description>
</NDC>
<NDC>
<NDCCode>63776-205-16</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (63776-205-16) > 100 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>63776-0205-16</NDC11Code>
<ProductNDC>63776-205</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-h Metals</ProprietaryName>
<NonProprietaryName>Allum Sativa, Arsenicum Alb., Ascorbic Acid, Berberis, Iridium, Selenium, Cysteinum, Formaldehyde, Lappa M., Lycopodium, Methionine, Nat Mur, Nux Vomica, Phenol, Phytolacca, Stillinga, Trifolium</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL; TOPICAL</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>ARCTIUM LAPPA ROOT; ARSENIC TRIOXIDE; ASCORBIC ACID; BERBERIS VULGARIS ROOT BARK; CYSTEINE; FORMALDEHYDE; GARLIC; IRIDIUM; LYCOPODIUM CLAVATUM SPORE; METHIONINE; PHENOL; PHYTOLACCA AMERICANA ROOT; RED CLOVER; SELENIUM; SODIUM CHLORIDE; STILLINGIA SYLVATICA ROOT; STRYCHNOS NUX-VOMICA SEED</SubstanceName>
<StrengthNumber>3; 12; 3; 3; 6; 12; 3; 6; 12; 3; 12; 3; 3; 6; 12; 3; 12</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Ascorbic Acid [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS], Standardized Chemical Allergen [EPC], Vitamin C [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190705</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>May help encourage heavy metal drainage.</IndicationAndUsage>
<Description>Viatrexx-H Metals is a homeopathic product composed of physiological (low dose and low low dose) natural micro nutrients. These micro particles are designed to nourish the system.</Description>
</NDC>
<NDC>
<NDCCode>63776-205-17</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (63776-205-17) > 250 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>63776-0205-17</NDC11Code>
<ProductNDC>63776-205</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-h Metals</ProprietaryName>
<NonProprietaryName>Allum Sativa, Arsenicum Alb., Ascorbic Acid, Berberis, Iridium, Selenium, Cysteinum, Formaldehyde, Lappa M., Lycopodium, Methionine, Nat Mur, Nux Vomica, Phenol, Phytolacca, Stillinga, Trifolium</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL; TOPICAL</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>ARCTIUM LAPPA ROOT; ARSENIC TRIOXIDE; ASCORBIC ACID; BERBERIS VULGARIS ROOT BARK; CYSTEINE; FORMALDEHYDE; GARLIC; IRIDIUM; LYCOPODIUM CLAVATUM SPORE; METHIONINE; PHENOL; PHYTOLACCA AMERICANA ROOT; RED CLOVER; SELENIUM; SODIUM CHLORIDE; STILLINGIA SYLVATICA ROOT; STRYCHNOS NUX-VOMICA SEED</SubstanceName>
<StrengthNumber>3; 12; 3; 3; 6; 12; 3; 6; 12; 3; 12; 3; 3; 6; 12; 3; 12</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Ascorbic Acid [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS], Standardized Chemical Allergen [EPC], Vitamin C [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190705</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>May help encourage heavy metal drainage.</IndicationAndUsage>
<Description>Viatrexx-H Metals is a homeopathic product composed of physiological (low dose and low low dose) natural micro nutrients. These micro particles are designed to nourish the system.</Description>
</NDC>
<NDC>
<NDCCode>10812-205-02</NDCCode>
<PackageDescription>14 mL in 1 TUBE (10812-205-02)</PackageDescription>
<NDC11Code>10812-0205-02</NDC11Code>
<ProductNDC>10812-205</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Neutrogena Oil Free Acne Wash Daily Scrub</ProprietaryName>
<ProprietaryNameSuffix>With Microclear Technology</ProprietaryNameSuffix>
<NonProprietaryName>Salicylic Acid</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110315</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333D</ApplicationNumber>
<LabelerName>Neutrogena Corporation</LabelerName>
<SubstanceName>SALICYLIC ACID</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2015-12-18</LastUpdate>
</NDC>
<NDC>
<NDCCode>24385-205-01</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (24385-205-01) / 14.2 g in 1 TUBE</PackageDescription>
<NDC11Code>24385-0205-01</NDC11Code>
<ProductNDC>24385-205</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Good Neighbor Pharmacy</ProprietaryName>
<ProprietaryNameSuffix>Clotrimazole</ProprietaryNameSuffix>
<NonProprietaryName>Clotrimazole</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>19930831</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M005</ApplicationNumber>
<LabelerName>AmerisourceBergen</LabelerName>
<SubstanceName>CLOTRIMAZOLE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Azole Antifungal [EPC], Azoles [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19930831</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>cures most athlete's foot, jock itch and ringworm. relieves itching, burning, cracking, scaling and discomfort which accompany these conditions.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>24909-205-14</NDCCode>
<PackageDescription>14 g in 1 TUBE (24909-205-14) </PackageDescription>
<NDC11Code>24909-0205-14</NDC11Code>
<ProductNDC>24909-205</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Terrasil Wart Remover For Kids 14g</ProprietaryName>
<NonProprietaryName>Thuja Occidentalis 6x Hpus</NonProprietaryName>
<DosageFormName>SOAP</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20210825</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Aidance Skincare & Topical Solutions, LLC</LabelerName>
<SubstanceName>THUJA OCCIDENTALIS WHOLE</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_X]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-07-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210826</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Wart Symptom Relief.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>49349-205-04</NDCCode>
<PackageDescription>14 TABLET in 1 BLISTER PACK (49349-205-04)</PackageDescription>
<NDC11Code>49349-0205-04</NDC11Code>
<ProductNDC>49349-205</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ibuprofen</ProprietaryName>
<NonProprietaryName>Ibuprofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110421</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075682</ApplicationNumber>
<LabelerName>REMEDYREPACK INC.</LabelerName>
<SubstanceName>IBUPROFEN</SubstanceName>
<StrengthNumber>800</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cyclooxygenase Inhibitors [MoA],Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient],Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>59316-205-14</NDCCode>
<PackageDescription>74 mL in 1 BOTTLE (59316-205-14) </PackageDescription>
<NDC11Code>59316-0205-14</NDC11Code>
<ProductNDC>59316-205</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Biofreeze Roll-on</ProprietaryName>
<NonProprietaryName>Menthol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130117</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Reckitt Benckiser LLC</LabelerName>
<SubstanceName>MENTHOL, UNSPECIFIED FORM</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-05-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130117</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves minor aches and pains of muscles and joints associated with: 1 simple backache, 2 arthritis, 3 strains, 4 bruises, 5 sprains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59316-209-14</NDCCode>
<PackageDescription>2 BOTTLE in 1 KIT (59316-209-14) / 1 KIT in 1 BOTTLE * 74 mL in 1 BOTTLE (59316-205-14) * 74 mL in 1 BOTTLE (59316-207-14) </PackageDescription>
<NDC11Code>59316-0209-14</NDC11Code>
<ProductNDC>59316-209</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Biofreeze Roll-on And Overnight Roll-on</ProprietaryName>
<NonProprietaryName>Menthol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20260401</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M017</ApplicationNumber>
<LabelerName>Reckitt Benckiser LLC</LabelerName>
<Status>Active</Status>
<LastUpdate>2026-05-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Uses. Roll-on. Temporarily relieves minor aches and pains of muscles and joints associated with: ■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains. Uses. Overnight Roll-on. Temporarily relieves minor aches and pains of muscles and joints associated with: ■ simple backache ■ arthritis ■ strains ■ bruises ■ sprains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59572-205-94</NDCCode>
<PackageDescription>10 BLISTER PACK in 1 BOX (59572-205-94) / 28 CAPSULE in 1 BLISTER PACK (59572-205-14) </PackageDescription>
<NDC11Code>59572-0205-94</NDC11Code>
<ProductNDC>59572-205</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Thalomid</ProprietaryName>
<NonProprietaryName>Thalidomide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030620</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA020785</ApplicationNumber>
<LabelerName>Celgene Corporation</LabelerName>
<SubstanceName>THALIDOMIDE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Immunologically Active Molecule Activity [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-04-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20030620</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>THALOMID in combination with dexamethasone is indicated for the treatment of patients with newly diagnosed multiple myeloma (MM). (1.1). THALOMID is indicated for the acute treatment of the cutaneous manifestations of moderate to severe erythema nodosum leprosum (ENL).THALOMID is not indicated as monotherapy for such ENL treatment in the presence of moderate to severe neuritis.THALOMID is also indicated as maintenance therapy for prevention and suppression of the cutaneous manifestations of ENL recurrence. (1.2).</IndicationAndUsage>
<Description>THALOMID, α-(N-phthalimido) glutarimide, is an immunomodulatory agent. The empirical formula for thalidomide is C13H10N2O4 and the gram molecular weight is 258.2. The CAS number of thalidomide is 50-35-1. Thalidomide is an off-white to white, odorless, crystalline powder that is soluble at 25°C in dimethyl sulfoxide and sparingly soluble in water and ethanol. The glutarimide moiety contains a single asymmetric center and, therefore, may exist in either of two optically active forms designated S-(-) or R-(+). THALOMID is an equal mixture of the S-(-) and R-(+) forms and, therefore, has a net optical rotation of zero. THALOMID is available in 50 mg, 100 mg, 150 mg and 200 mg capsules for oral administration. Active ingredient: thalidomide. Inactive ingredients: pregelatinized starch and magnesium stearate. The 50 mg capsule shell contains gelatin, titanium dioxide, and black ink. The 100 mg capsule shell contains black iron oxide, yellow iron oxide, titanium dioxide, gelatin, and black ink. The 150 mg capsule shell contains FD&C blue #2, black iron oxide, yellow iron oxide, titanium dioxide, gelatin, and black and white ink. The 200 mg capsule shell contains FD&C blue #2, titanium dioxide, gelatin, and white ink.</Description>
</NDC>
<NDC>
<NDCCode>61477-205-14</NDCCode>
<PackageDescription>118 mL in 1 TUBE (61477-205-14) </PackageDescription>
<NDC11Code>61477-0205-14</NDC11Code>
<ProductNDC>61477-205</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aloe Up Lil Kids</ProprietaryName>
<ProprietaryNameSuffix>Spf 50</ProprietaryNameSuffix>
<NonProprietaryName>Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20140224</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Aloe Care International, LLC</LabelerName>
<SubstanceName>AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE; OCTOCRYLENE</SubstanceName>
<StrengthNumber>3; 5; 6; 5; 10</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; 1/100mL; g/100mL; 1/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>71334-205-05</NDCCode>
<PackageDescription>4 BLISTER PACK in 1 CARTON (71334-205-05) / 14 TABLET, FILM COATED in 1 BLISTER PACK (71334-205-14) </PackageDescription>
<NDC11Code>71334-0205-05</NDC11Code>
<ProductNDC>71334-205</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pyrukynd</ProprietaryName>
<NonProprietaryName>Mitapivat</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220218</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA216196</ApplicationNumber>
<LabelerName>Agios Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>MITAPIVAT</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A Inducers [MoA], P-Glycoprotein Inhibitors [MoA], Pyruvate Kinase Activator [EPC], Pyruvate Kinase Activators [MoA], UGT1A1 Inducers [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-07-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220218</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PYRUKYND is indicated for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency.</IndicationAndUsage>
<Description>The active ingredient of PYRUKYND is mitapivat, a pyruvate kinase activator, present as mitapivat sulfate. The chemical name of mitapivat sulfate is 8-quinolinesulfonamide, N-[4-[[4- (cyclopropylmethyl)-1-piperazinyl]carbonyl]phenyl]-, sulfate, hydrate (2:1:3). The chemical structure of mitapivat sulfate is. The molecular formula is (C 24H 26N 4SO 3) 2 H 2SO 4 3H 2O, and the molecular weight is 1053.23 for mitapivat sulfate. Mitapivat sulfate is a white to off-white solid and is slightly soluble in water. PYRUKYND is available as 5 mg, 20 mg, and 50 mg tablets for oral administration. Each tablet contains 5 mg, 20 mg, or 50 mg mitapivat free base, provided as 5.85 mg, 23.4 mg, or 58.5 mg, respectively, of the sulfate hydrate salt, and the following inactive ingredients: croscarmellose sodium, mannitol, microcrystalline cellulose, and sodium stearyl fumarate. The tablet film coating contains the inactive ingredients FD&C Blue No. 2, hypromellose, lactose monohydrate, titanium dioxide, and triacetin. The tablets are imprinted with black ink containing the inactive ingredients ammonium hydroxide, ferrosoferric oxide, isopropyl alcohol, n-butyl alcohol, propylene glycol, and shellac glaze.</Description>
</NDC>
<NDC>
<NDCCode>77004-205-25</NDCCode>
<PackageDescription>14.78 mL in 1 POUCH (77004-205-25) </PackageDescription>
<NDC11Code>77004-0205-25</NDC11Code>
<ProductNDC>77004-205</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Impulse Antibacterial Hand Sanitizer</ProprietaryName>
<NonProprietaryName>Isopropyl Alcohol 75%</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200801</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>Strata USA LLC</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>75</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-07-27</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200801</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To decrease bacteria on the skin that could cause diseae. Recommended for repeated use.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>83114-205-14</NDCCode>
<PackageDescription>1 TABLET, FILM COATED in 1 BLISTER PACK (83114-205-14) </PackageDescription>
<NDC11Code>83114-0205-14</NDC11Code>
<ProductNDC>83114-205</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Xcopri Titration Pack 150 Mg, 200 Mg</ProprietaryName>
<NonProprietaryName>Cenobamate</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200312</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA212839</ApplicationNumber>
<LabelerName>PCI Pharma Services Canada, Inc.</LabelerName>
<SubstanceName>CENOBAMATE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1501</StrengthUnit>
<Pharm_Classes>Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2B6 Inhibitors [MoA], Cytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 2C8 Inducers [MoA], Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], GABA A Receptor Positive Modulators [MoA], Sodium Channel Antagonists [MoA]</Pharm_Classes>
<DEASchedule>CV</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2024-06-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200312</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>XCOPRI is indicated for the treatment of partial-onset seizures in adult patients.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>83821-205-14</NDCCode>
<PackageDescription>500 g in 1 BAG (83821-205-14) </PackageDescription>
<NDC11Code>83821-0205-14</NDC11Code>
<ProductNDC>83821-205</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Orforglipron</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20260501</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Nanjing Hanxin Pharmaceutical Technology Co., Ltd.</LabelerName>
<SubstanceName>ORFORGLIPRON</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>01-MAY-26</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>85766-205-14</NDCCode>
<PackageDescription>14 TABLET in 1 BLISTER PACK (85766-205-14) </PackageDescription>
<NDC11Code>85766-0205-14</NDC11Code>
<ProductNDC>85766-205</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Cetirizine Hydrochloride</ProprietaryName>
<NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20071227</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077498</ApplicationNumber>
<LabelerName>Sportpharm LLC</LabelerName>
<SubstanceName>CETIRIZINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-05-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260508</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: 1 runny nose, 2 sneezing, 3 itchy, watery eyes, 4 itching of the nose or throat.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63776-027-14</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 BOX (63776-027-14) > 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>63776-0027-14</NDC11Code>
<ProductNDC>63776-027</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Aller Balance</ProprietaryName>
<NonProprietaryName>Acetylcholine Chloride, Bos Taurus Adrenal Gland, Sus Scrofa Adrenal Gland, Epinephrine, Onion, Ammonium Carbonate, Apis Mellifera, Arsenic Trioxide, Histamine, Interferon Gamma-1a, Interleukin-12 Human, Manganese Gluconate, Luffa Operculata Fruit, Sus Scrofa Lung, Beef Lung, Sus Scrofa Nasal Mucosa, Bos Taurus Nasal Mucosa, Sodium Chloride, Bos Taurus Peyers Patch, Sus Scrofa Peyers Patch, Schoenocaulon Officinale Seed, Serotonin, Bos Taurus Thymus, Sus Scrofa Thymus</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120724</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>ACETYLCHOLINE CHLORIDE; BOS TAURUS ADRENAL GLAND; SUS SCROFA ADRENAL GLAND; EPINEPHRINE; ONION; AMMONIUM CARBONATE; APIS MELLIFERA; ARSENIC TRIOXIDE; HISTAMINE; INTERFERON GAMMA-1A; INTERLEUKIN-12 HUMAN; MANGANESE GLUCONATE; LUFFA OPERCULATA FRUIT; SUS SCROFA LUNG; BEEF LUNG; SUS SCROFA NASAL MUCOSA; BOS TAURUS NASAL MUCOSA; SODIUM CHLORIDE; BOS TAURUS PEYER'S PATCH; SUS SCROFA PEYER'S PATCH; SCHOENOCAULON OFFICINALE SEED; SEROTONIN; BOS TAURUS THYMUS; SUS SCROFA THYMUS</SubstanceName>
<StrengthNumber>200; 200; 200; 30; 200; 200; 200; 200; 200; 200; 200; 4; 30; 200; 200; 200; 200; 200; 30; 30; 200; 200; 200; 200</StrengthNumber>
<StrengthUnit>{kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>63776-033-14</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 BOX (63776-033-14) > 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>63776-0033-14</NDC11Code>
<ProductNDC>63776-033</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Ans/cns</ProprietaryName>
<NonProprietaryName>Acetylcholine Chloride, Epinephrine, .gamma.-aminobutyric Acid, Histamine, Goldenseal, Norepinephrine, Taraxacum Palustre Root, Tyramine</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120724</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>ACETYLCHOLINE CHLORIDE; EPINEPHRINE; .GAMMA.-AMINOBUTYRIC ACID; HISTAMINE; GOLDENSEAL; NOREPINEPHRINE; TARAXACUM PALUSTRE ROOT; TYRAMINE</SubstanceName>
<StrengthNumber>200; 200; 200; 200; 3; 200; 30; 200</StrengthNumber>
<StrengthUnit>{kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; [hp_X]/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-01-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>63776-035-14</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 BOX (63776-035-14) > 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>63776-0035-14</NDC11Code>
<ProductNDC>63776-035</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Arthros</ProprietaryName>
<NonProprietaryName>Anti-interleukin-1.alpha. Immunoglobulin G Rabbit, .alpha.-ketoglutaric Acid, .alpha.-lipoic Acid, Apomorphine, Bos Taurus Joint Capsule, Sus Scrofa Joint Capsule, Ascorbic Acid, Bos Taurus Adrenal Gland, Sus Scrofa Adrenal Gland, Brain-derived Neurotrophic Factor Human, Metenkefalin, Ersofermin, Bos Taurus Solar Plexus, Sus Scrofa Solar Plexus, Calcitonin, Bos Taurus Cartilage, Sus Scrofa Cartilage, Colchicum Autumnale Bulb, Pork Collagen, Bos Taurus Red Blood Cell, Sus Scrofa Red Blood Cell</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120724</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>.ALPHA.-KETOGLUTARIC ACID; .ALPHA.-LIPOIC ACID; ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; APOMORPHINE; ASCORBIC ACID; BEEF LIVER; BOS TAURUS ADRENAL GLAND; BOS TAURUS CARTILAGE; BOS TAURUS JOINT CAPSULE; BOS TAURUS LYMPH; BOS TAURUS MESENCHYME; BOS TAURUS PARATHYROID GLAND; BOS TAURUS PLACENTA; BOS TAURUS RED BLOOD CELL; BOS TAURUS SOLAR PLEXUS; BOS TAURUS VEIN; BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; CALCITONIN; COLCHICUM AUTUMNALE BULB; EDODEKIN ALFA; ERSOFERMIN; INTERFERON GAMMA-1A; METENKEFALIN; NADIDE; PORK COLLAGEN; PORK LIVER; QUINHYDRONE; SULFUR; SUS SCROFA ADRENAL GLAND; SUS SCROFA CARTILAGE; SUS SCROFA JOINT CAPSULE; SUS SCROFA LYMPH; SUS SCROFA MESENCHYME; SUS SCROFA PARATHYROID GLAND; SUS SCROFA RED BLOOD CELL; SUS SCROFA SOLAR PLEXUS; SUS SCROFA VEIN</SubstanceName>
<StrengthNumber>30; 30; 200; 30; 30; 200; 200; 200; 200; 200; 200; 200; 30; 200; 200; 30; 200; 200; 200; 200; 200; 200; 200; 30; 200; 200; 30; 30; 200; 200; 200; 200; 200; 200; 200; 200; 30</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [hp_Q]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [hp_Q]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Ascorbic Acid [CS], Cell-mediated Immunity [PE], Depigmenting Activity [PE], Dietary Proteins [CS], Dopamine Agonists [MoA], Dopaminergic Agonist [EPC], Increased Histamine Release [PE], Meat Proteins [EXT], Melanin Synthesis Inhibitor [EPC], Melanin Synthesis Inhibitors [MoA], Non-Standardized Food Allergenic Extract [EPC], Vitamin C [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120724</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the relief of arthritic symptoms.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63776-037-14</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 BOX (63776-037-14) > 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>63776-0037-14</NDC11Code>
<ProductNDC>63776-037</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Articula</ProprietaryName>
<NonProprietaryName>Anti-interleukin-1.alpha. Immunoglobulin G Rabbit, Bos Taurus Ankle Joint, Sus Scrofa Ankle Joint, Metenkefalin, Ersofermin, Bos Taurus Achilles Tendon, Sus Scrofa Achilles Tendon, Bos Taurus Hip Joint, Sus Scrofa Hip Joint, Bos Taurus Knee Joint, Sus Scrofa Knee Joint, Beef Liver, Pork Liver, Transforming Growth Factor Beta-1, Avotermin</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120326</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; AVOTERMIN; BEEF LIVER; BOS TAURUS ACHILLES TENDON; BOS TAURUS ANKLE JOINT; BOS TAURUS HIP JOINT; BOS TAURUS KNEE JOINT; ERSOFERMIN; METENKEFALIN; PORK LIVER; SUS SCROFA ACHILLES TENDON; SUS SCROFA ANKLE JOINT; SUS SCROFA HIP JOINT; SUS SCROFA KNEE JOINT; TRANSFORMING GROWTH FACTOR BETA-1</SubstanceName>
<StrengthNumber>200; 30; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 30</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Meat Proteins [EXT], Non-Standardized Food Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120526</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To help support the repair & regeneration of articulations & joints.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63776-073-14</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 BOX (63776-073-14) > 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>63776-0073-14</NDC11Code>
<ProductNDC>63776-073</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Candida</ProprietaryName>
<NonProprietaryName>Ammoniac, Aspergillus Niger Var. Niger, Caffeic Acid, Candida Albicans, Candida Parapsilosis, Ipecac, Lycopodium Clavatum Spore, Yeast Mannan, Penicillin G Sodium, Vaccinium Vitis-idaea Leaf</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120724</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>AMMONIAC; ASPERGILLUS NIGER VAR. NIGER; CAFFEIC ACID; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; IPECAC; LYCOPODIUM CLAVATUM SPORE; YEAST MANNAN; PENICILLIN G SODIUM; VACCINIUM VITIS-IDAEA LEAF</SubstanceName>
<StrengthNumber>200; 200; 200; 200; 200; 200; 200; 200; 200; 200</StrengthNumber>
<StrengthUnit>{kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>63776-074-14</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 BOX (63776-074-14) > 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>63776-0074-14</NDC11Code>
<ProductNDC>63776-074</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Candida Plus</ProprietaryName>
<NonProprietaryName>Ammoniac, Aspergillus Niger Var. Niger, Caffeic Acid, Candida Albicans, Candida Parapsilosis, Ipecac, Lycopodium Clavatum Spore, Yeast Mannan, Vaccinium Vitis-idaea Leaf</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120724</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>AMMONIAC; ASPERGILLUS NIGER VAR. NIGER; CAFFEIC ACID; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; IPECAC; LYCOPODIUM CLAVATUM SPORE; VACCINIUM VITIS-IDAEA LEAF; YEAST MANNAN</SubstanceName>
<StrengthNumber>200; 200; 200; 200; 200; 200; 200; 200; 200</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Fungal Proteins [CS], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-01-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120724</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For the relief of symptoms due to Candida, including precursors and byproducts.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63776-075-14</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 BOX (63776-075-14) > 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>63776-0075-14</NDC11Code>
<ProductNDC>63776-075</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Candida I</ProprietaryName>
<NonProprietaryName>Caffeic Acid, Candida Albicans, Tanacetum Parthenium, Centella Asiatica, Yeast Mannan, Penicillin G, Vaccinium Vitis-idaea Leaf Spray</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120724</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>CAFFEIC ACID; CANDIDA ALBICANS; TANACETUM PARTHENIUM; CENTELLA ASIATICA; YEAST MANNAN; PENICILLIN G; VACCINIUM VITIS-IDAEA LEAF</SubstanceName>
<StrengthNumber>200; 200; 200; 200; 200; 200; 200</StrengthNumber>
<StrengthUnit>{kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL; {kp_C}/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-01-19</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>63776-081-14</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE (63776-081-14) </PackageDescription>
<NDC11Code>63776-0081-14</NDC11Code>
<ProductNDC>63776-081</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-cellulite</ProprietaryName>
<NonProprietaryName>Androsterone, Artichoke, Atp, Bfgf, Camp, L-carnitine, Centella Asiatica, Citric Acid, Cobalt, Estrogen, Ferrum Fumaricum, Fumaric Acid, Ginkgo, Hamamelis, Hyaluronidase, Il-3, Kalium Asparticum, Lactic Acid, Lymphatic Vessel, Melilotus, Mn, Natrum Oxalaceticum, Natrum Pyruvicum, Quinhydrone, Succinic Acid, Vein, Vitamin A And Zinc</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL; TOPICAL</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>ADENOSINE CYCLIC PHOSPHATE; ADENOSINE TRIPHOSPHATE; ANDROSTERONE; ARTICHOKE; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); BOS TAURUS LYMPH VESSEL; BOS TAURUS VEIN; CENTELLA ASIATICA; CITRIC ACID MONOHYDRATE; COBALT; ERSOFERMIN; ESTROGENS, ESTERIFIED; FERROUS FUMARATE; FUMARIC ACID; HAMAMELIS VIRGINIANA BARK; HEPTAMINOL; HYALURONIDASE; INTERLEUKIN-3; LACTIC ACID; LEVOCARNITINE; MANGANESE; MELILOTUS OFFICINALIS WHOLE; POTASSIUM ASPARTATE; QUINHYDRONE; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SUCCINIC ACID; SUS SCROFA LYMPH VESSEL; SUS SCROFA VEIN; VITAMIN A; ZINC</SubstanceName>
<StrengthNumber>30; 30; 30; 30; 200; 200; 200; 30; 30; 30; 200; 200; 30; 30; 30; 30; 30; 200; 30; 30; 30; 30; 30; 30; 30; 30; 30; 200; 200; 30; 30</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA], Allergens [CS], Allergens [CS], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Carnitine Analog [EPC], Carnitine [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Decreased Coagulation Factor Activity [PE], Depigmenting Activity [PE], Dietary Proteins [CS], Endoglycosidase [EPC], Glycoside Hydrolases [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Melanin Synthesis Inhibitor [EPC], Melanin Synthesis Inhibitors [MoA], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Standardized Chemical Allergen [EPC], Vegetable Proteins [CS], Vitamin A [CS], Vitamin A [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210224</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cellulite drainage & tonification, metabolism and lipid balance, hormonal support, circulatory support and regeneration.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63776-095-14</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 BOX (63776-095-14) > 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>63776-0095-14</NDC11Code>
<ProductNDC>63776-095</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Collagen</ProprietaryName>
<NonProprietaryName>Pork Collagen</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120724</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>PORK COLLAGEN</SubstanceName>
<StrengthNumber>200</StrengthNumber>
<StrengthUnit>[kp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120724</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To help support collagen formation.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63776-100-14</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 BOX (63776-100-14) > 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>63776-0100-14</NDC11Code>
<ProductNDC>63776-100</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Connectissue</ProprietaryName>
<NonProprietaryName>Anti-interleukin-1.alpha. Immunoglobulin G Rabbit, Ascorbic Acid, Metenkefalin, Ersofermin, Bos Taurus Cartilage, Sus Scrofa Cartilage, Pork Collagen, Bos Taurus Red Blood Cell, Sus Scrofa Red Blood Cell, Interleukin-3, Interleukin-3, Beef Liver, Pork Liver, Beef, Pork, Bos Taurus Tendon, Sus Scrofa Tendon, Cetermin</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120326</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>ANTI-INTERLEUKIN-1.ALPHA. IMMUNOGLOBULIN G RABBIT; ASCORBIC ACID; BEEF; BEEF LIVER; BOS TAURUS CARTILAGE; BOS TAURUS RED BLOOD CELL; BOS TAURUS TENDON; CETERMIN; ERSOFERMIN; INTERLEUKIN-3; METENKEFALIN; PORK; PORK COLLAGEN; PORK LIVER; SUS SCROFA CARTILAGE; SUS SCROFA RED BLOOD CELL; SUS SCROFA TENDON</SubstanceName>
<StrengthNumber>200; 30; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 200</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Ascorbic Acid [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Meat Proteins [EXT], Meat Proteins [EXT], Meat Proteins [EXT], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Vitamin C [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120326</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To help support the repair & regeneration of connective tissue & cartilage.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63776-102-14</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE (63776-102-14) </PackageDescription>
<NDC11Code>63776-0102-14</NDC11Code>
<ProductNDC>63776-102</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-mesenchyme</ProprietaryName>
<NonProprietaryName>Adrenal, Ascorbic Acid, Bdnf, Dhea, Malic Acid, Bfgf, Fucus Vesiculosus, Histidine, Hyaluronidase, Il-6, Lactic Acid, Lymph Node, Mesenchyme, Nad, Natrum Oxalaceticum, Natrum Pyruvicum, Natrum Sulphuricum, Phenylalanine, Amino Acid, Pyrogenium, Thuja Occidentalis, Trichinoyl, Tyrosine</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL; TOPICAL</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>ASCORBIC ACID; BASIC FIBROBLAST GROWTH FACTOR (HUMAN); BOS TAURUS ADRENAL GLAND; BOS TAURUS LYMPH VESSEL; BRAIN-DERIVED NEUROTROPHIC FACTOR HUMAN; DODECAHYDROXYCYCLOHEXANE DIHYDRATE; FUCUS VESICULOSUS; HISTIDINE; HUMAN INTERLEUKIN-6 (NONGLYCOSYLATED); HYALURONIDASE; LACTIC ACID; MALIC ACID; NADIDE; PHENYLALANINE; PRASTERONE; PROLACTIN; RANCID BEEF; SODIUM DIETHYL OXALACETATE; SODIUM PYRUVATE; SODIUM SULFATE; SUS SCROFA ADRENAL GLAND; SUS SCROFA LYMPH VESSEL; SUS SCROFA MESENCHYME; THUJA OCCIDENTALIS LEAF; TYROSINE</SubstanceName>
<StrengthNumber>30; 30; 200; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 200; 200; 30; 30; 200; 30</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Ascorbic Acid [CS], Endoglycosidase [EPC], Glycoside Hydrolases [CS], Vitamin C [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190329</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To help encourage extra cellular / matrix / connective tissue drainage & support.</IndicationAndUsage>
<Description>Viatrexx-Mesenchyme is a homeopathic product composed of physiological (low dose and low low dose) natural micro nutrients. These micro particles are designed to nourish the system.</Description>
</NDC>
<NDC>
<NDCCode>63776-142-14</NDCCode>
<PackageDescription>1 BOTTLE, SPRAY in 1 BOX (63776-142-14) > 30 mL in 1 BOTTLE, SPRAY</PackageDescription>
<NDC11Code>63776-0142-14</NDC11Code>
<ProductNDC>63776-142</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Viatrexx-enzyme Plus</ProprietaryName>
<NonProprietaryName>Amylase, Cellulase, Lactase, Lipase, Maltase, Protease, Sucrase</NonProprietaryName>
<DosageFormName>SPRAY</DosageFormName>
<RouteName>ORAL; TOPICAL</RouteName>
<StartMarketingDate>20190329</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>VIATREXX BIO INCORPORATED</LabelerName>
<SubstanceName>CELLULASE (TRICHODERMA LONGIBRACHIATUM); LACTASE; LYSOSOMAL ALPHA-GLUCOSIDASE; PANCREATIC ALPHA-AMYLASE; PANCREATIC TRIACYLGLYCEROL LIPASE; PANCRELIPASE PROTEASE; SACROSIDASE</SubstanceName>
<StrengthNumber>30; 30; 30; 30; 30; 30; 30</StrengthNumber>
<StrengthUnit>[kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL; [kp_C]/mL</StrengthUnit>
<Pharm_Classes>Sucrose-specific Enzyme [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-08-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20221231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190705</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>To support healthy digestion.</IndicationAndUsage>
<Description>Viatrexx-Enzyme + is a homeopathic product composed of physiological (low dose and low low dose) natural micro nutrients. These micro particles are designed to nourish the system.</Description>
</NDC>
</NDCList>
<NDCList><NDC><NDCCode>63776-205-14</NDCCode><ProprietaryName>Viatrexx-h Metals</ProprietaryName><NonProprietaryName>Allum Sativa, Arsenicum Alb., Ascorbic Acid, Berberis, Iridium, Selenium, Cysteinum, Formaldehyde, Lappa M., Lycopodium, Methionine, Nat Mur, Nux Vomica, Phenol, Phytolacca, Stillinga, Trifolium</NonProprietaryName></NDC><NDC><NDCCode>63776-205-11</NDCCode><ProprietaryName>Viatrexx-h Metals</ProprietaryName><NonProprietaryName>Allum Sativa, Arsenicum Alb., Ascorbic Acid, Berberis, Iridium, Selenium, Cysteinum, Formaldehyde, Lappa M., Lycopodium, Methionine, Nat Mur, Nux Vomica, Phenol, Phytolacca, Stillinga, Trifolium</NonProprietaryName></NDC><NDC><NDCCode>63776-205-15</NDCCode><ProprietaryName>Viatrexx-h Metals</ProprietaryName><NonProprietaryName>Allum Sativa, Arsenicum Alb., Ascorbic Acid, Berberis, Iridium, Selenium, Cysteinum, Formaldehyde, Lappa M., Lycopodium, Methionine, Nat Mur, Nux Vomica, Phenol, Phytolacca, Stillinga, Trifolium</NonProprietaryName></NDC><NDC><NDCCode>63776-205-16</NDCCode><ProprietaryName>Viatrexx-h Metals</ProprietaryName><NonProprietaryName>Allum Sativa, Arsenicum Alb., Ascorbic Acid, Berberis, Iridium, Selenium, Cysteinum, Formaldehyde, Lappa M., Lycopodium, Methionine, Nat Mur, Nux Vomica, Phenol, Phytolacca, Stillinga, Trifolium</NonProprietaryName></NDC><NDC><NDCCode>63776-205-17</NDCCode><ProprietaryName>Viatrexx-h Metals</ProprietaryName><NonProprietaryName>Allum Sativa, Arsenicum Alb., Ascorbic Acid, Berberis, Iridium, Selenium, Cysteinum, Formaldehyde, Lappa M., Lycopodium, Methionine, Nat Mur, Nux Vomica, Phenol, Phytolacca, Stillinga, Trifolium</NonProprietaryName></NDC><NDC><NDCCode>10812-205-02</NDCCode><ProprietaryName>Neutrogena Oil Free Acne Wash Daily Scrub</ProprietaryName><NonProprietaryName>Salicylic Acid</NonProprietaryName></NDC><NDC><NDCCode>24385-205-01</NDCCode><ProprietaryName>Good Neighbor Pharmacy</ProprietaryName><NonProprietaryName>Clotrimazole</NonProprietaryName></NDC><NDC><NDCCode>24909-205-14</NDCCode><ProprietaryName>Terrasil Wart Remover For Kids 14g</ProprietaryName><NonProprietaryName>Thuja Occidentalis 6x Hpus</NonProprietaryName></NDC><NDC><NDCCode>49349-205-04</NDCCode><ProprietaryName>Ibuprofen</ProprietaryName><NonProprietaryName>Ibuprofen</NonProprietaryName></NDC><NDC><NDCCode>59316-205-14</NDCCode><ProprietaryName>Biofreeze Roll-on</ProprietaryName><NonProprietaryName>Menthol</NonProprietaryName></NDC><NDC><NDCCode>59316-209-14</NDCCode><ProprietaryName>Biofreeze Roll-on And Overnight Roll-on</ProprietaryName><NonProprietaryName>Menthol</NonProprietaryName></NDC><NDC><NDCCode>59572-205-94</NDCCode><ProprietaryName>Thalomid</ProprietaryName><NonProprietaryName>Thalidomide</NonProprietaryName></NDC><NDC><NDCCode>61477-205-14</NDCCode><ProprietaryName>Aloe Up Lil Kids</ProprietaryName><NonProprietaryName>Avobenzone, Homosalate, Octinoxate, Octisalate, Octocrylene</NonProprietaryName></NDC><NDC><NDCCode>71334-205-05</NDCCode><ProprietaryName>Pyrukynd</ProprietaryName><NonProprietaryName>Mitapivat</NonProprietaryName></NDC><NDC><NDCCode>77004-205-25</NDCCode><ProprietaryName>Impulse Antibacterial Hand Sanitizer</ProprietaryName><NonProprietaryName>Isopropyl Alcohol 75%</NonProprietaryName></NDC><NDC><NDCCode>83114-205-14</NDCCode><ProprietaryName>Xcopri Titration Pack 150 Mg, 200 Mg</ProprietaryName><NonProprietaryName>Cenobamate</NonProprietaryName></NDC><NDC><NDCCode>83821-205-14</NDCCode><NonProprietaryName>Orforglipron</NonProprietaryName></NDC><NDC><NDCCode>85766-205-14</NDCCode><ProprietaryName>Cetirizine Hydrochloride</ProprietaryName><NonProprietaryName>Cetirizine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>63776-027-14</NDCCode><ProprietaryName>Aller Balance</ProprietaryName><NonProprietaryName>Acetylcholine Chloride, Bos Taurus Adrenal Gland, Sus Scrofa Adrenal Gland, Epinephrine, Onion, Ammonium Carbonate, Apis Mellifera, Arsenic Trioxide, Histamine, Interferon Gamma-1a, Interleukin-12 Human, Manganese Gluconate, Luffa Operculata Fruit, Sus Scrofa Lung, Beef Lung, Sus Scrofa Nasal Mucosa, Bos Taurus Nasal Mucosa, Sodium Chloride, Bos Taurus Peyers Patch, Sus Scrofa Peyers Patch, Schoenocaulon Officinale Seed, Serotonin, Bos Taurus Thymus, Sus Scrofa Thymus</NonProprietaryName></NDC><NDC><NDCCode>63776-033-14</NDCCode><ProprietaryName>Ans/cns</ProprietaryName><NonProprietaryName>Acetylcholine Chloride, Epinephrine, .gamma.-aminobutyric Acid, Histamine, Goldenseal, Norepinephrine, Taraxacum Palustre Root, Tyramine</NonProprietaryName></NDC><NDC><NDCCode>63776-035-14</NDCCode><ProprietaryName>Arthros</ProprietaryName><NonProprietaryName>Anti-interleukin-1.alpha. Immunoglobulin G Rabbit, .alpha.-ketoglutaric Acid, .alpha.-lipoic Acid, Apomorphine, Bos Taurus Joint Capsule, Sus Scrofa Joint Capsule, Ascorbic Acid, Bos Taurus Adrenal Gland, Sus Scrofa Adrenal Gland, Brain-derived Neurotrophic Factor Human, Metenkefalin, Ersofermin, Bos Taurus Solar Plexus, Sus Scrofa Solar Plexus, Calcitonin, Bos Taurus Cartilage, Sus Scrofa Cartilage, Colchicum Autumnale Bulb, Pork Collagen, Bos Taurus Red Blood Cell, Sus Scrofa Red Blood Cell</NonProprietaryName></NDC><NDC><NDCCode>63776-037-14</NDCCode><ProprietaryName>Articula</ProprietaryName><NonProprietaryName>Anti-interleukin-1.alpha. Immunoglobulin G Rabbit, Bos Taurus Ankle Joint, Sus Scrofa Ankle Joint, Metenkefalin, Ersofermin, Bos Taurus Achilles Tendon, Sus Scrofa Achilles Tendon, Bos Taurus Hip Joint, Sus Scrofa Hip Joint, Bos Taurus Knee Joint, Sus Scrofa Knee Joint, Beef Liver, Pork Liver, Transforming Growth Factor Beta-1, Avotermin</NonProprietaryName></NDC><NDC><NDCCode>63776-073-14</NDCCode><ProprietaryName>Candida</ProprietaryName><NonProprietaryName>Ammoniac, Aspergillus Niger Var. Niger, Caffeic Acid, Candida Albicans, Candida Parapsilosis, Ipecac, Lycopodium Clavatum Spore, Yeast Mannan, Penicillin G Sodium, Vaccinium Vitis-idaea Leaf</NonProprietaryName></NDC><NDC><NDCCode>63776-074-14</NDCCode><ProprietaryName>Candida Plus</ProprietaryName><NonProprietaryName>Ammoniac, Aspergillus Niger Var. Niger, Caffeic Acid, Candida Albicans, Candida Parapsilosis, Ipecac, Lycopodium Clavatum Spore, Yeast Mannan, Vaccinium Vitis-idaea Leaf</NonProprietaryName></NDC><NDC><NDCCode>63776-075-14</NDCCode><ProprietaryName>Candida I</ProprietaryName><NonProprietaryName>Caffeic Acid, Candida Albicans, Tanacetum Parthenium, Centella Asiatica, Yeast Mannan, Penicillin G, Vaccinium Vitis-idaea Leaf Spray</NonProprietaryName></NDC><NDC><NDCCode>63776-081-14</NDCCode><ProprietaryName>Viatrexx-cellulite</ProprietaryName><NonProprietaryName>Androsterone, Artichoke, Atp, Bfgf, Camp, L-carnitine, Centella Asiatica, Citric Acid, Cobalt, Estrogen, Ferrum Fumaricum, Fumaric Acid, Ginkgo, Hamamelis, Hyaluronidase, Il-3, Kalium Asparticum, Lactic Acid, Lymphatic Vessel, Melilotus, Mn, Natrum Oxalaceticum, Natrum Pyruvicum, Quinhydrone, Succinic Acid, Vein, Vitamin A And Zinc</NonProprietaryName></NDC><NDC><NDCCode>63776-095-14</NDCCode><ProprietaryName>Collagen</ProprietaryName><NonProprietaryName>Pork Collagen</NonProprietaryName></NDC><NDC><NDCCode>63776-100-14</NDCCode><ProprietaryName>Connectissue</ProprietaryName><NonProprietaryName>Anti-interleukin-1.alpha. Immunoglobulin G Rabbit, Ascorbic Acid, Metenkefalin, Ersofermin, Bos Taurus Cartilage, Sus Scrofa Cartilage, Pork Collagen, Bos Taurus Red Blood Cell, Sus Scrofa Red Blood Cell, Interleukin-3, Interleukin-3, Beef Liver, Pork Liver, Beef, Pork, Bos Taurus Tendon, Sus Scrofa Tendon, Cetermin</NonProprietaryName></NDC><NDC><NDCCode>63776-102-14</NDCCode><ProprietaryName>Viatrexx-mesenchyme</ProprietaryName><NonProprietaryName>Adrenal, Ascorbic Acid, Bdnf, Dhea, Malic Acid, Bfgf, Fucus Vesiculosus, Histidine, Hyaluronidase, Il-6, Lactic Acid, Lymph Node, Mesenchyme, Nad, Natrum Oxalaceticum, Natrum Pyruvicum, Natrum Sulphuricum, Phenylalanine, Amino Acid, Pyrogenium, Thuja Occidentalis, Trichinoyl, Tyrosine</NonProprietaryName></NDC><NDC><NDCCode>63776-142-14</NDCCode><ProprietaryName>Viatrexx-enzyme Plus</ProprietaryName><NonProprietaryName>Amylase, Cellulase, Lactase, Lipase, Maltase, Protease, Sucrase</NonProprietaryName></NDC></NDCList>