{
"NDC": [
{
"NDCCode": "61500-5547-8",
"PackageDescription": "454 g in 1 BOTTLE (61500-5547-8) ",
"NDC11Code": "61500-5547-08",
"ProductNDC": "61500-5547",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Topricin",
"NonProprietaryName": "Aesculus Hippocastanum, Arnica Montana, Belladonna, Calendula Officinalis, Crotalus Horridus, Echinacea, Graphites, Heloderma Horridum, Lachesis Mutus, Naja Tripudians, Phosphorus, Rhus Toxicodendron, Ruta Graveolens, Sulfur",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160401",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Topical BioMedics, Inc.",
"SubstanceName": "PHOSPHORUS; ARNICA MONTANA; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA ANGUSTIFOLIA; GRAPHITE; HELODERMA HORRIDUM VENOM; LACHESIS MUTA VENOM; NAJA NAJA VENOM; RUTA GRAVEOLENS FLOWERING TOP; AESCULUS HIPPOCASTANUM FLOWER; ATROPA BELLADONNA; TOXICODENDRON PUBESCENS LEAF; CALENDULA OFFICINALIS FLOWERING TOP; SULFUR",
"StrengthNumber": "9; 6; 8; 4; 6; 8; 8; 8; 6; 6; 6; 8; 4; 8",
"StrengthUnit": "[hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g",
"Status": "Active",
"LastUpdate": "2025-10-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160401",
"SamplePackage": "N",
"IndicationAndUsage": "Rapid, moisturizing healing pain relief from trauma injuries of the foot, ankle and lower extremity. Reduces swelling, numbness and burning pain associated with. Joint pain in the toes, feet and ankles. Heel pain/soreness (heel spurs). Bunions pain/soreness (big toe). Nerve pain (burning pain in feet). Gout (pain in big toe). Relieves arch pain, soft tissue pain, and ball of the foot. Relieves nerve pain between toes. Sports injuries, shin splints, ankle sprain, Achilles tendonitis, Plantar Fasciitis. Tired aching feet, Tarsal Tunnel Syndrome."
},
{
"NDCCode": "61500-5527-8",
"PackageDescription": "227 g in 1 BOTTLE (61500-5527-8) ",
"NDC11Code": "61500-5527-08",
"ProductNDC": "61500-5527",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Topricin",
"NonProprietaryName": "Aesculus Hippocastanum, Arnica Montana, Belladonna, Crotalus Horridus, Echinacea, Graphites, Heloderma, Lachesis Mutus, Naja Tripudians, Rhus Toxicodendron, Ruta Graveolens",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160401",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Topical BioMedics, Inc.",
"SubstanceName": "AESCULUS HIPPOCASTANUM FLOWER; ARNICA MONTANA; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA ANGUSTIFOLIA; GRAPHITE; HELODERMA HORRIDUM VENOM; LACHESIS MUTA VENOM; NAJA NAJA VENOM; RUTA GRAVEOLENS FLOWERING TOP; ATROPA BELLADONNA; TOXICODENDRON PUBESCENS LEAF",
"StrengthNumber": "6; 6; 8; 6; 6; 8; 8; 8; 6; 6; 6",
"StrengthUnit": "[hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g",
"Status": "Active",
"LastUpdate": "2025-10-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160401",
"SamplePackage": "N",
"IndicationAndUsage": "Rapid, soothing relief of pain, stiffness, tingling, or burning nerve pain associated with. Arthritis and other joint pain and discomfort. Fibromyalgia. Carpal Tunnel Syndrome and other types of nerve pain. Pains & muscle cramps of the back, neck, shoulder, legs, hands & feet. Sports injuries (muscle pulls & soreness, impact, sprains, dislocations). Repetitive motion injuries, such as bursitis, tendonitis and sciatica. First Aid for simple trauma (bruises, minor burns, cuts, scrapes & strains."
},
{
"NDCCode": "61500-5547-0",
"PackageDescription": "2 g in 1 PACKET (61500-5547-0) ",
"NDC11Code": "61500-5547-00",
"ProductNDC": "61500-5547",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Topricin",
"NonProprietaryName": "Aesculus Hippocastanum, Arnica Montana, Belladonna, Calendula Officinalis, Crotalus Horridus, Echinacea, Graphites, Heloderma Horridum, Lachesis Mutus, Naja Tripudians, Phosphorus, Rhus Toxicodendron, Ruta Graveolens, Sulfur",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160401",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Topical BioMedics, Inc.",
"SubstanceName": "PHOSPHORUS; ARNICA MONTANA; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA ANGUSTIFOLIA; GRAPHITE; HELODERMA HORRIDUM VENOM; LACHESIS MUTA VENOM; NAJA NAJA VENOM; RUTA GRAVEOLENS FLOWERING TOP; AESCULUS HIPPOCASTANUM FLOWER; ATROPA BELLADONNA; TOXICODENDRON PUBESCENS LEAF; CALENDULA OFFICINALIS FLOWERING TOP; SULFUR",
"StrengthNumber": "9; 6; 8; 4; 6; 8; 8; 8; 6; 6; 6; 8; 4; 8",
"StrengthUnit": "[hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g",
"Status": "Active",
"LastUpdate": "2025-10-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160401",
"SamplePackage": "N",
"IndicationAndUsage": "Rapid, moisturizing healing pain relief from trauma injuries of the foot, ankle and lower extremity. Reduces swelling, numbness and burning pain associated with. Joint pain in the toes, feet and ankles. Heel pain/soreness (heel spurs). Bunions pain/soreness (big toe). Nerve pain (burning pain in feet). Gout (pain in big toe). Relieves arch pain, soft tissue pain, and ball of the foot. Relieves nerve pain between toes. Sports injuries, shin splints, ankle sprain, Achilles tendonitis, Plantar Fasciitis. Tired aching feet, Tarsal Tunnel Syndrome."
},
{
"NDCCode": "61500-5547-1",
"PackageDescription": "21 g in 1 TUBE (61500-5547-1) ",
"NDC11Code": "61500-5547-01",
"ProductNDC": "61500-5547",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Topricin",
"NonProprietaryName": "Aesculus Hippocastanum, Arnica Montana, Belladonna, Calendula Officinalis, Crotalus Horridus, Echinacea, Graphites, Heloderma Horridum, Lachesis Mutus, Naja Tripudians, Phosphorus, Rhus Toxicodendron, Ruta Graveolens, Sulfur",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160401",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Topical BioMedics, Inc.",
"SubstanceName": "PHOSPHORUS; ARNICA MONTANA; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA ANGUSTIFOLIA; GRAPHITE; HELODERMA HORRIDUM VENOM; LACHESIS MUTA VENOM; NAJA NAJA VENOM; RUTA GRAVEOLENS FLOWERING TOP; AESCULUS HIPPOCASTANUM FLOWER; ATROPA BELLADONNA; TOXICODENDRON PUBESCENS LEAF; CALENDULA OFFICINALIS FLOWERING TOP; SULFUR",
"StrengthNumber": "9; 6; 8; 4; 6; 8; 8; 8; 6; 6; 6; 8; 4; 8",
"StrengthUnit": "[hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g",
"Status": "Active",
"LastUpdate": "2025-10-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160401",
"SamplePackage": "N",
"IndicationAndUsage": "Rapid, moisturizing healing pain relief from trauma injuries of the foot, ankle and lower extremity. Reduces swelling, numbness and burning pain associated with. Joint pain in the toes, feet and ankles. Heel pain/soreness (heel spurs). Bunions pain/soreness (big toe). Nerve pain (burning pain in feet). Gout (pain in big toe). Relieves arch pain, soft tissue pain, and ball of the foot. Relieves nerve pain between toes. Sports injuries, shin splints, ankle sprain, Achilles tendonitis, Plantar Fasciitis. Tired aching feet, Tarsal Tunnel Syndrome."
},
{
"NDCCode": "61500-5547-2",
"PackageDescription": "57 g in 1 TUBE (61500-5547-2) ",
"NDC11Code": "61500-5547-02",
"ProductNDC": "61500-5547",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Topricin",
"NonProprietaryName": "Aesculus Hippocastanum, Arnica Montana, Belladonna, Calendula Officinalis, Crotalus Horridus, Echinacea, Graphites, Heloderma Horridum, Lachesis Mutus, Naja Tripudians, Phosphorus, Rhus Toxicodendron, Ruta Graveolens, Sulfur",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160401",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Topical BioMedics, Inc.",
"SubstanceName": "PHOSPHORUS; ARNICA MONTANA; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA ANGUSTIFOLIA; GRAPHITE; HELODERMA HORRIDUM VENOM; LACHESIS MUTA VENOM; NAJA NAJA VENOM; RUTA GRAVEOLENS FLOWERING TOP; AESCULUS HIPPOCASTANUM FLOWER; ATROPA BELLADONNA; TOXICODENDRON PUBESCENS LEAF; CALENDULA OFFICINALIS FLOWERING TOP; SULFUR",
"StrengthNumber": "9; 6; 8; 4; 6; 8; 8; 8; 6; 6; 6; 8; 4; 8",
"StrengthUnit": "[hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g",
"Status": "Active",
"LastUpdate": "2025-10-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160401",
"SamplePackage": "N",
"IndicationAndUsage": "Rapid, moisturizing healing pain relief from trauma injuries of the foot, ankle and lower extremity. Reduces swelling, numbness and burning pain associated with. Joint pain in the toes, feet and ankles. Heel pain/soreness (heel spurs). Bunions pain/soreness (big toe). Nerve pain (burning pain in feet). Gout (pain in big toe). Relieves arch pain, soft tissue pain, and ball of the foot. Relieves nerve pain between toes. Sports injuries, shin splints, ankle sprain, Achilles tendonitis, Plantar Fasciitis. Tired aching feet, Tarsal Tunnel Syndrome."
},
{
"NDCCode": "61500-5547-4",
"PackageDescription": "113 g in 1 JAR (61500-5547-4) ",
"NDC11Code": "61500-5547-04",
"ProductNDC": "61500-5547",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Topricin",
"NonProprietaryName": "Aesculus Hippocastanum, Arnica Montana, Belladonna, Calendula Officinalis, Crotalus Horridus, Echinacea, Graphites, Heloderma Horridum, Lachesis Mutus, Naja Tripudians, Phosphorus, Rhus Toxicodendron, Ruta Graveolens, Sulfur",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160401",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Topical BioMedics, Inc.",
"SubstanceName": "PHOSPHORUS; ARNICA MONTANA; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA ANGUSTIFOLIA; GRAPHITE; HELODERMA HORRIDUM VENOM; LACHESIS MUTA VENOM; NAJA NAJA VENOM; RUTA GRAVEOLENS FLOWERING TOP; AESCULUS HIPPOCASTANUM FLOWER; ATROPA BELLADONNA; TOXICODENDRON PUBESCENS LEAF; CALENDULA OFFICINALIS FLOWERING TOP; SULFUR",
"StrengthNumber": "9; 6; 8; 4; 6; 8; 8; 8; 6; 6; 6; 8; 4; 8",
"StrengthUnit": "[hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g",
"Status": "Active",
"LastUpdate": "2025-10-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160401",
"SamplePackage": "N",
"IndicationAndUsage": "Rapid, moisturizing healing pain relief from trauma injuries of the foot, ankle and lower extremity. Reduces swelling, numbness and burning pain associated with. Joint pain in the toes, feet and ankles. Heel pain/soreness (heel spurs). Bunions pain/soreness (big toe). Nerve pain (burning pain in feet). Gout (pain in big toe). Relieves arch pain, soft tissue pain, and ball of the foot. Relieves nerve pain between toes. Sports injuries, shin splints, ankle sprain, Achilles tendonitis, Plantar Fasciitis. Tired aching feet, Tarsal Tunnel Syndrome."
},
{
"NDCCode": "61500-5547-9",
"PackageDescription": "227 g in 1 BOTTLE (61500-5547-9) ",
"NDC11Code": "61500-5547-09",
"ProductNDC": "61500-5547",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Topricin",
"NonProprietaryName": "Aesculus Hippocastanum, Arnica Montana, Belladonna, Calendula Officinalis, Crotalus Horridus, Echinacea, Graphites, Heloderma Horridum, Lachesis Mutus, Naja Tripudians, Phosphorus, Rhus Toxicodendron, Ruta Graveolens, Sulfur",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160401",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Topical BioMedics, Inc.",
"SubstanceName": "PHOSPHORUS; ARNICA MONTANA; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA ANGUSTIFOLIA; GRAPHITE; HELODERMA HORRIDUM VENOM; LACHESIS MUTA VENOM; NAJA NAJA VENOM; RUTA GRAVEOLENS FLOWERING TOP; AESCULUS HIPPOCASTANUM FLOWER; ATROPA BELLADONNA; TOXICODENDRON PUBESCENS LEAF; CALENDULA OFFICINALIS FLOWERING TOP; SULFUR",
"StrengthNumber": "9; 6; 8; 4; 6; 8; 8; 8; 6; 6; 6; 8; 4; 8",
"StrengthUnit": "[hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g",
"Status": "Active",
"LastUpdate": "2025-10-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160401",
"SamplePackage": "N",
"IndicationAndUsage": "Rapid, moisturizing healing pain relief from trauma injuries of the foot, ankle and lower extremity. Reduces swelling, numbness and burning pain associated with. Joint pain in the toes, feet and ankles. Heel pain/soreness (heel spurs). Bunions pain/soreness (big toe). Nerve pain (burning pain in feet). Gout (pain in big toe). Relieves arch pain, soft tissue pain, and ball of the foot. Relieves nerve pain between toes. Sports injuries, shin splints, ankle sprain, Achilles tendonitis, Plantar Fasciitis. Tired aching feet, Tarsal Tunnel Syndrome."
},
{
"NDCCode": "0409-5547-10",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (0409-5547-10) / 5 mL in 1 VIAL, SINGLE-DOSE (0409-5547-01) ",
"NDC11Code": "00409-5547-10",
"ProductNDC": "0409-5547",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cisatracurium Besylate",
"NonProprietaryName": "Cisatracurium Besylate",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20210601",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA203236",
"LabelerName": "Hospira, Inc.",
"SubstanceName": "CISATRACURIUM BESYLATE",
"StrengthNumber": "2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-11-21",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20210601",
"SamplePackage": "N",
"IndicationAndUsage": "Cisatracurium Besylate Injection is indicated: 1 as an adjunct to general anesthesia to facilitate tracheal intubation in adults and in pediatric patients 1 month to 12 years of age, 2 to provide skeletal muscle relaxation in adults during surgical procedures or during mechanical ventilation in the ICU, 3 to provide skeletal muscle relaxation during surgical procedures via infusion in pediatric patients 2 years and older.",
"Description": "Cisatracurium besylate is a nondepolarizing skeletal neuromuscular blocker for intravenous administration. Compared to other neuromuscular blockers, it is intermediate in its onset and duration of action. Cisatracurium besylate is one of 10 isomers of atracurium besylate and constitutes approximately 15% of that mixture. Cisatracurium besylate is [1R-[1α,2α(1'R*,2'R*)]]-2,2'-[1,5-pentanediylbis[oxy(3-oxo-3,1-propanediyl)]]bis[1-[(3,4-dimethoxyphenyl)methyl]-1,2,3,4-tetrahydro-6,7-dimethoxy-2-methylisoquinolinium] dibenzenesulfonate. The molecular formula of the cisatracurium parent bis-cation is C53H72N2O12 and the molecular weight is 929.2. The molecular formula of cisatracurium as the besylate salt is C65H82N2O18S2 and the molecular weight is 1243.5. The structural formula of cisatracurium besylate is. The log of the partition coefficient of cisatracurium besylate is -2.12 in a 1-octanol/distilled water system at 25°C. Cisatracurium Besylate Injection, USP is a sterile, non-pyrogenic aqueous solution provided in 5 mL, 10 mL, and 20 mL vials. The pH is adjusted to 3.0 to 3.8 with benzenesulfonic acid. : 1 The 5 mL single-dose vials contain 2 mg/mL cisatracurium, equivalent to 2.68 mg/mL cisatracurium besylate., 2 The 10 mL multiple-dose vials contain 2 mg/mL cisatracurium, equivalent to 2.68 mg/mL cisatracurium besylate, and 0.9% benzyl alcohol as a preservative., 3 The 20 mL single-dose vials contain 10 mg/mL cisatracurium, equivalent to 13.38 mg/mL cisatracurium besylate."
},
{
"NDCCode": "50090-5547-0",
"PackageDescription": "30 TABLET, FILM COATED in 1 BOTTLE (50090-5547-0) ",
"NDC11Code": "50090-5547-00",
"ProductNDC": "50090-5547",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Januvia",
"NonProprietaryName": "Sitagliptin",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20061016",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021995",
"LabelerName": "A-S Medication Solutions",
"SubstanceName": "SITAGLIPTIN PHOSPHATE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2026-07-09",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20210520",
"SamplePackage": "N",
"IndicationAndUsage": "JANUVIA® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.",
"Description": "JANUVIA Tablets contain sitagliptin phosphate, an orally-active inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. Sitagliptin phosphate monohydrate is described chemically as 7-[(3R)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazine phosphate (1:1) monohydrate. The empirical formula is C16H15F6N5OH3PO4H2O and the molecular weight is 523.32. The structural formula is:. Sitagliptin phosphate monohydrate is a white to off-white, crystalline, non-hygroscopic powder. It is soluble in water and N,N-dimethyl formamide; slightly soluble in methanol; very slightly soluble in ethanol, acetone, and acetonitrile; and insoluble in isopropanol and isopropyl acetate. Each film-coated tablet of JANUVIA contains 32.13, 64.25, or 128.5 mg of sitagliptin phosphate monohydrate, which is equivalent to 25, 50, or 100 mg, respectively, of free base and the following inactive ingredients: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, and sodium stearyl fumarate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, red iron oxide, and yellow iron oxide."
},
{
"NDCCode": "54868-5547-0",
"PackageDescription": "1 POUCH in 1 CARTON (54868-5547-0) > 1 INHALER in 1 POUCH > 60 INHALANT in 1 INHALER",
"NDC11Code": "54868-5547-00",
"ProductNDC": "54868-5547",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Asmanex",
"NonProprietaryName": "Mometasone Furoate",
"DosageFormName": "INHALANT",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20060309",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021067",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "MOMETASONE FUROATE",
"StrengthNumber": "220",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "ASMANEX TWISTHALER is a corticosteroid indicated for: 1 Maintenance treatment of asthma as prophylactic therapy in patients 4 years of age and older. (1.1).",
"Description": "Mometasone furoate, the active component of the ASMANEX TWISTHALER product, is a corticosteroid with the chemical name 9,21-dichloro-11(Beta),17-dihydroxy-16(alpha)-methylpregna-1,4-diene-3,20-dione 17-(2-furoate) and the following chemical structure. Mometasone furoate is a white powder with an empirical formula of C27H30Cl2O6, and molecular weight of 521.44 Daltons. The ASMANEX TWISTHALER 110 mcg and 220 mcg products are cap-activated, inhalation-driven, multidose dry powder inhalers containing mometasone furoate and anhydrous lactose (which contains trace amounts of milk proteins). Each actuation of the ASMANEX TWISTHALER 110 mcg or 220 mcg inhaler provides a measured dose of approximately 0.75 or 1.5 mg mometasone furoate inhalation powder, containing 110 or 220 mcg of mometasone furoate, respectively. This results in delivery of 100 or 200 mcg mometasone furoate from the mouthpiece, respectively, based on in vitro testing at flow rates of 30 L/min and 60 L/min with constant volume of 2 L. The amount of mometasone furoate emitted from the inhaler in vitro does not differ significantly for flow rates ranging from 28.3 L/min to 70 L/min at a constant volume of 2 L. However, the amount of drug delivered to the lung will depend on patient factors such as inspiratory flow and peak inspiratory flow through the device. In adult and adolescent patients (aged ≥12 years) with varied asthma severity, mean peak inspiratory flow rate through the device was 69 L/min (range: 54–77 L/min). In pediatric patients (aged 5–12 years) diagnosed with asthma, mean peak inspiratory flow rate in the 5- to 8-year-old subgroup was >50 L/min (minimum of 46 L/min) and for the 9- to 12-year-old subgroup was >60 L/min (minimum of 48 L/min)."
},
{
"NDCCode": "54868-5547-1",
"PackageDescription": "1 POUCH in 1 CARTON (54868-5547-1) > 1 INHALER in 1 POUCH > 30 INHALANT in 1 INHALER",
"NDC11Code": "54868-5547-01",
"ProductNDC": "54868-5547",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Asmanex",
"NonProprietaryName": "Mometasone Furoate",
"DosageFormName": "INHALANT",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20060309",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021067",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "MOMETASONE FUROATE",
"StrengthNumber": "220",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "ASMANEX TWISTHALER is a corticosteroid indicated for: 1 Maintenance treatment of asthma as prophylactic therapy in patients 4 years of age and older. (1.1).",
"Description": "Mometasone furoate, the active component of the ASMANEX TWISTHALER product, is a corticosteroid with the chemical name 9,21-dichloro-11(Beta),17-dihydroxy-16(alpha)-methylpregna-1,4-diene-3,20-dione 17-(2-furoate) and the following chemical structure. Mometasone furoate is a white powder with an empirical formula of C27H30Cl2O6, and molecular weight of 521.44 Daltons. The ASMANEX TWISTHALER 110 mcg and 220 mcg products are cap-activated, inhalation-driven, multidose dry powder inhalers containing mometasone furoate and anhydrous lactose (which contains trace amounts of milk proteins). Each actuation of the ASMANEX TWISTHALER 110 mcg or 220 mcg inhaler provides a measured dose of approximately 0.75 or 1.5 mg mometasone furoate inhalation powder, containing 110 or 220 mcg of mometasone furoate, respectively. This results in delivery of 100 or 200 mcg mometasone furoate from the mouthpiece, respectively, based on in vitro testing at flow rates of 30 L/min and 60 L/min with constant volume of 2 L. The amount of mometasone furoate emitted from the inhaler in vitro does not differ significantly for flow rates ranging from 28.3 L/min to 70 L/min at a constant volume of 2 L. However, the amount of drug delivered to the lung will depend on patient factors such as inspiratory flow and peak inspiratory flow through the device. In adult and adolescent patients (aged ≥12 years) with varied asthma severity, mean peak inspiratory flow rate through the device was 69 L/min (range: 54–77 L/min). In pediatric patients (aged 5–12 years) diagnosed with asthma, mean peak inspiratory flow rate in the 5- to 8-year-old subgroup was >50 L/min (minimum of 46 L/min) and for the 9- to 12-year-old subgroup was >60 L/min (minimum of 48 L/min)."
},
{
"NDCCode": "54868-5547-2",
"PackageDescription": "1 POUCH in 1 CARTON (54868-5547-2) > 1 INHALER in 1 POUCH > 14 INHALANT in 1 INHALER",
"NDC11Code": "54868-5547-02",
"ProductNDC": "54868-5547",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Asmanex",
"NonProprietaryName": "Mometasone Furoate",
"DosageFormName": "INHALANT",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20060309",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021067",
"LabelerName": "Physicians Total Care, Inc.",
"SubstanceName": "MOMETASONE FUROATE",
"StrengthNumber": "220",
"StrengthUnit": "ug/1",
"Pharm_Classes": "Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2018-07-24",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "ASMANEX TWISTHALER is a corticosteroid indicated for: 1 Maintenance treatment of asthma as prophylactic therapy in patients 4 years of age and older. (1.1).",
"Description": "Mometasone furoate, the active component of the ASMANEX TWISTHALER product, is a corticosteroid with the chemical name 9,21-dichloro-11(Beta),17-dihydroxy-16(alpha)-methylpregna-1,4-diene-3,20-dione 17-(2-furoate) and the following chemical structure. Mometasone furoate is a white powder with an empirical formula of C27H30Cl2O6, and molecular weight of 521.44 Daltons. The ASMANEX TWISTHALER 110 mcg and 220 mcg products are cap-activated, inhalation-driven, multidose dry powder inhalers containing mometasone furoate and anhydrous lactose (which contains trace amounts of milk proteins). Each actuation of the ASMANEX TWISTHALER 110 mcg or 220 mcg inhaler provides a measured dose of approximately 0.75 or 1.5 mg mometasone furoate inhalation powder, containing 110 or 220 mcg of mometasone furoate, respectively. This results in delivery of 100 or 200 mcg mometasone furoate from the mouthpiece, respectively, based on in vitro testing at flow rates of 30 L/min and 60 L/min with constant volume of 2 L. The amount of mometasone furoate emitted from the inhaler in vitro does not differ significantly for flow rates ranging from 28.3 L/min to 70 L/min at a constant volume of 2 L. However, the amount of drug delivered to the lung will depend on patient factors such as inspiratory flow and peak inspiratory flow through the device. In adult and adolescent patients (aged ≥12 years) with varied asthma severity, mean peak inspiratory flow rate through the device was 69 L/min (range: 54–77 L/min). In pediatric patients (aged 5–12 years) diagnosed with asthma, mean peak inspiratory flow rate in the 5- to 8-year-old subgroup was >50 L/min (minimum of 46 L/min) and for the 9- to 12-year-old subgroup was >60 L/min (minimum of 48 L/min)."
},
{
"NDCCode": "61500-0115-1",
"PackageDescription": "176 mL in 1 TUBE (61500-0115-1)",
"NDC11Code": "61500-0115-01",
"ProductNDC": "61500-0115",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "My Pain Away After Burn Cream",
"NonProprietaryName": "Aesculus Hippocastanum, Arnica Montana, Belladonna, Crotalus Horridus, Echinacea, Graphites, Heloderma, Lachesis Mutus, Naja Tripudians, Rhus Toxicodendron, Ruta Graveolens",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160801",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Topical BioMedics, Inc.",
"SubstanceName": "ARNICA MONTANA; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA ANGUSTIFOLIA; GRAPHITE; BELLIS PERENNIS; LACHESIS MUTA VENOM; NAJA NAJA VENOM; RUTA GRAVEOLENS FLOWERING TOP; AESCULUS HIPPOCASTANUM FLOWER; ATROPA BELLADONNA; TOXICODENDRON PUBESCENS LEAF; CALENDULA OFFICINALIS FLOWERING TOP; SULFUR; HYPERICUM PERFORATUM",
"StrengthNumber": "6; 8; 6; 6; 6; 8; 8; 6; 6; 6; 12; 4; 8; 6",
"StrengthUnit": "[hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231"
},
{
"NDCCode": "61500-1501-6",
"PackageDescription": "1 TUBE in 1 CARTON (61500-1501-6) > 1 [hp_X] in 1 TUBE",
"NDC11Code": "61500-1501-06",
"ProductNDC": "61500-1501",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mypainaway Sports Cream",
"NonProprietaryName": "Aesculus Hippocastanum, Arnica Montana, Bellis Perennis, Calendula Officinalis, Capsicum Annum, Crotalus Horridus, Echinacea, Gelsemium Sempervirens, Graphites, Hypericum Perforatum, Kali Carbonicum, Lachesis Mutus, Magnesium Phosphorica, Naja Tripudians, Rhus Tox, Ruta Graveolens, Sulphur",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160401",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Topical BioMedics, Inc.",
"SubstanceName": "AESCULUS HIPPOCASTANUM BARK; ARNICA MONTANA; BELLIS PERENNIS; CALENDULA OFFICINALIS WHOLE; SULFUR; CAPSICUM ANNUUM WHOLE; CROTALUS HORRIDUS HORRIDUS WHOLE; ECHINACEA, UNSPECIFIED; GRAPHITE; GELSEMIUM SEMPERVIRENS WHOLE; HYPERICUM PERFORATUM; LACHESIS MUTA WHOLE; POTASSIUM CARBONATE; MAGNESIUM PHOSPHATE, MONOBASIC, UNSPECIFIED; NAJA NAJA WHOLE; RHUS SPP. WHOLE; RUTA GRAVEOLENS WHOLE",
"StrengthNumber": "6; 6; 6; 6; 8; 10; 8; 6; 6; 8; 6; 8; 8; 6; 8; 12; 6",
"StrengthUnit": "[hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"IndicationAndUsage": "Uses: Rapid, soothing relief of pain stiffness tingling or burning nerve pain Sports injuries muscle pulls and soreness impact injuries sprains dislocations repetitive motion injuries: bursitis tendonitis sciatica."
},
{
"NDCCode": "61500-5527-1",
"PackageDescription": "21 g in 1 TUBE (61500-5527-1) ",
"NDC11Code": "61500-5527-01",
"ProductNDC": "61500-5527",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Topricin",
"NonProprietaryName": "Aesculus Hippocastanum, Arnica Montana, Belladonna, Crotalus Horridus, Echinacea, Graphites, Heloderma, Lachesis Mutus, Naja Tripudians, Rhus Toxicodendron, Ruta Graveolens",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160401",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Topical BioMedics, Inc.",
"SubstanceName": "AESCULUS HIPPOCASTANUM FLOWER; ARNICA MONTANA; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA ANGUSTIFOLIA; GRAPHITE; HELODERMA HORRIDUM VENOM; LACHESIS MUTA VENOM; NAJA NAJA VENOM; RUTA GRAVEOLENS FLOWERING TOP; ATROPA BELLADONNA; TOXICODENDRON PUBESCENS LEAF",
"StrengthNumber": "6; 6; 8; 6; 6; 8; 8; 8; 6; 6; 6",
"StrengthUnit": "[hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g",
"Status": "Active",
"LastUpdate": "2025-10-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160405",
"SamplePackage": "N",
"IndicationAndUsage": "Rapid, soothing relief of pain, stiffness, tingling, or burning nerve pain associated with. Arthritis and other joint pain and discomfort. Fibromyalgia. Carpal Tunnel Syndrome and other types of nerve pain. Pains & muscle cramps of the back, neck, shoulder, legs, hands & feet. Sports injuries (muscle pulls & soreness, impact, sprains, dislocations). Repetitive motion injuries, such as bursitis, tendonitis and sciatica. First Aid for simple trauma (bruises, minor burns, cuts, scrapes & strains."
},
{
"NDCCode": "61500-5527-2",
"PackageDescription": "57 g in 1 TUBE (61500-5527-2) ",
"NDC11Code": "61500-5527-02",
"ProductNDC": "61500-5527",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Topricin",
"NonProprietaryName": "Aesculus Hippocastanum, Arnica Montana, Belladonna, Crotalus Horridus, Echinacea, Graphites, Heloderma, Lachesis Mutus, Naja Tripudians, Rhus Toxicodendron, Ruta Graveolens",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160401",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Topical BioMedics, Inc.",
"SubstanceName": "AESCULUS HIPPOCASTANUM FLOWER; ARNICA MONTANA; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA ANGUSTIFOLIA; GRAPHITE; HELODERMA HORRIDUM VENOM; LACHESIS MUTA VENOM; NAJA NAJA VENOM; RUTA GRAVEOLENS FLOWERING TOP; ATROPA BELLADONNA; TOXICODENDRON PUBESCENS LEAF",
"StrengthNumber": "6; 6; 8; 6; 6; 8; 8; 8; 6; 6; 6",
"StrengthUnit": "[hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g",
"Status": "Active",
"LastUpdate": "2025-10-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160401",
"SamplePackage": "N",
"IndicationAndUsage": "Rapid, soothing relief of pain, stiffness, tingling, or burning nerve pain associated with. Arthritis and other joint pain and discomfort. Fibromyalgia. Carpal Tunnel Syndrome and other types of nerve pain. Pains & muscle cramps of the back, neck, shoulder, legs, hands & feet. Sports injuries (muscle pulls & soreness, impact, sprains, dislocations). Repetitive motion injuries, such as bursitis, tendonitis and sciatica. First Aid for simple trauma (bruises, minor burns, cuts, scrapes & strains."
},
{
"NDCCode": "61500-5527-3",
"PackageDescription": "907 g in 1 BOTTLE, PUMP (61500-5527-3) ",
"NDC11Code": "61500-5527-03",
"ProductNDC": "61500-5527",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Topricin",
"NonProprietaryName": "Aesculus Hippocastanum, Arnica Montana, Belladonna, Crotalus Horridus, Echinacea, Graphites, Heloderma, Lachesis Mutus, Naja Tripudians, Rhus Toxicodendron, Ruta Graveolens",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160401",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Topical BioMedics, Inc.",
"SubstanceName": "AESCULUS HIPPOCASTANUM FLOWER; ARNICA MONTANA; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA ANGUSTIFOLIA; GRAPHITE; HELODERMA HORRIDUM VENOM; LACHESIS MUTA VENOM; NAJA NAJA VENOM; RUTA GRAVEOLENS FLOWERING TOP; ATROPA BELLADONNA; TOXICODENDRON PUBESCENS LEAF",
"StrengthNumber": "6; 6; 8; 6; 6; 8; 8; 8; 6; 6; 6",
"StrengthUnit": "[hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g",
"Status": "Active",
"LastUpdate": "2025-10-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160401",
"SamplePackage": "N",
"IndicationAndUsage": "Rapid, soothing relief of pain, stiffness, tingling, or burning nerve pain associated with. Arthritis and other joint pain and discomfort. Fibromyalgia. Carpal Tunnel Syndrome and other types of nerve pain. Pains & muscle cramps of the back, neck, shoulder, legs, hands & feet. Sports injuries (muscle pulls & soreness, impact, sprains, dislocations). Repetitive motion injuries, such as bursitis, tendonitis and sciatica. First Aid for simple trauma (bruises, minor burns, cuts, scrapes & strains."
},
{
"NDCCode": "61500-5527-4",
"PackageDescription": "113 g in 1 JAR (61500-5527-4) ",
"NDC11Code": "61500-5527-04",
"ProductNDC": "61500-5527",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Topricin",
"NonProprietaryName": "Aesculus Hippocastanum, Arnica Montana, Belladonna, Crotalus Horridus, Echinacea, Graphites, Heloderma, Lachesis Mutus, Naja Tripudians, Rhus Toxicodendron, Ruta Graveolens",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160401",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Topical BioMedics, Inc.",
"SubstanceName": "AESCULUS HIPPOCASTANUM FLOWER; ARNICA MONTANA; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA ANGUSTIFOLIA; GRAPHITE; HELODERMA HORRIDUM VENOM; LACHESIS MUTA VENOM; NAJA NAJA VENOM; RUTA GRAVEOLENS FLOWERING TOP; ATROPA BELLADONNA; TOXICODENDRON PUBESCENS LEAF",
"StrengthNumber": "6; 6; 8; 6; 6; 8; 8; 8; 6; 6; 6",
"StrengthUnit": "[hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g",
"Status": "Active",
"LastUpdate": "2025-10-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160401",
"SamplePackage": "N",
"IndicationAndUsage": "Rapid, soothing relief of pain, stiffness, tingling, or burning nerve pain associated with. Arthritis and other joint pain and discomfort. Fibromyalgia. Carpal Tunnel Syndrome and other types of nerve pain. Pains & muscle cramps of the back, neck, shoulder, legs, hands & feet. Sports injuries (muscle pulls & soreness, impact, sprains, dislocations). Repetitive motion injuries, such as bursitis, tendonitis and sciatica. First Aid for simple trauma (bruises, minor burns, cuts, scrapes & strains."
},
{
"NDCCode": "61500-5527-5",
"PackageDescription": "170 g in 1 TUBE (61500-5527-5) ",
"NDC11Code": "61500-5527-05",
"ProductNDC": "61500-5527",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Topricin",
"NonProprietaryName": "Aesculus Hippocastanum, Arnica Montana, Belladonna, Crotalus Horridus, Echinacea, Graphites, Heloderma, Lachesis Mutus, Naja Tripudians, Rhus Toxicodendron, Ruta Graveolens",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160401",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Topical BioMedics, Inc.",
"SubstanceName": "AESCULUS HIPPOCASTANUM FLOWER; ARNICA MONTANA; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA ANGUSTIFOLIA; GRAPHITE; HELODERMA HORRIDUM VENOM; LACHESIS MUTA VENOM; NAJA NAJA VENOM; RUTA GRAVEOLENS FLOWERING TOP; ATROPA BELLADONNA; TOXICODENDRON PUBESCENS LEAF",
"StrengthNumber": "6; 6; 8; 6; 6; 8; 8; 8; 6; 6; 6",
"StrengthUnit": "[hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g",
"Status": "Active",
"LastUpdate": "2025-10-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160401",
"SamplePackage": "N",
"IndicationAndUsage": "Rapid, soothing relief of pain, stiffness, tingling, or burning nerve pain associated with. Arthritis and other joint pain and discomfort. Fibromyalgia. Carpal Tunnel Syndrome and other types of nerve pain. Pains & muscle cramps of the back, neck, shoulder, legs, hands & feet. Sports injuries (muscle pulls & soreness, impact, sprains, dislocations). Repetitive motion injuries, such as bursitis, tendonitis and sciatica. First Aid for simple trauma (bruises, minor burns, cuts, scrapes & strains."
},
{
"NDCCode": "61500-5527-6",
"PackageDescription": "454 g in 1 BOTTLE (61500-5527-6) ",
"NDC11Code": "61500-5527-06",
"ProductNDC": "61500-5527",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Topricin",
"NonProprietaryName": "Aesculus Hippocastanum, Arnica Montana, Belladonna, Crotalus Horridus, Echinacea, Graphites, Heloderma, Lachesis Mutus, Naja Tripudians, Rhus Toxicodendron, Ruta Graveolens",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160401",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Topical BioMedics, Inc.",
"SubstanceName": "AESCULUS HIPPOCASTANUM FLOWER; ARNICA MONTANA; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA ANGUSTIFOLIA; GRAPHITE; HELODERMA HORRIDUM VENOM; LACHESIS MUTA VENOM; NAJA NAJA VENOM; RUTA GRAVEOLENS FLOWERING TOP; ATROPA BELLADONNA; TOXICODENDRON PUBESCENS LEAF",
"StrengthNumber": "6; 6; 8; 6; 6; 8; 8; 8; 6; 6; 6",
"StrengthUnit": "[hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g",
"Status": "Active",
"LastUpdate": "2025-10-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160401",
"SamplePackage": "N",
"IndicationAndUsage": "Rapid, soothing relief of pain, stiffness, tingling, or burning nerve pain associated with. Arthritis and other joint pain and discomfort. Fibromyalgia. Carpal Tunnel Syndrome and other types of nerve pain. Pains & muscle cramps of the back, neck, shoulder, legs, hands & feet. Sports injuries (muscle pulls & soreness, impact, sprains, dislocations). Repetitive motion injuries, such as bursitis, tendonitis and sciatica. First Aid for simple trauma (bruises, minor burns, cuts, scrapes & strains."
},
{
"NDCCode": "61500-5587-3",
"PackageDescription": "88 mL in 1 TUBE (61500-5587-3)",
"NDC11Code": "61500-5587-03",
"ProductNDC": "61500-5587",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "My Pain Away",
"NonProprietaryName": "Aesculus Hippocastanum, Arnica Montana, Belladonna, Crotalus Horridus, Echinacea, Graphites, Heloderma, Lachesis Mutus, Naja Tripudians, Rhus Toxicodendron, Ruta Graveolens",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20141001",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Topical BioMedics, Inc.",
"SubstanceName": "AESCULUS HIPPOCASTANUM FLOWER; ARNICA MONTANA; ATROPA BELLADONNA; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA ANGUSTIFOLIA; GRAPHITE; HELODERMA HORRIDUM VENOM; LACHESIS MUTA VENOM; NAJA NAJA VENOM; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP",
"StrengthNumber": "6; 6; 6; 8; 6; 6; 8; 8; 8; 6; 6",
"StrengthUnit": "[hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Rapid soothing relief of muscle pain at tender points or nerve pain associated with Fibromyalgia and Neuropathy."
},
{
"NDCCode": "41595-5547-1",
"PackageDescription": "73 g in 1 CANISTER (41595-5547-1) ",
"NDC11Code": "41595-5547-01",
"ProductNDC": "41595-5547",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Sure Invisible Solid Nourishing Coconut",
"NonProprietaryName": "Aluminum Zirconium Tricholorohydrex Gly",
"DosageFormName": "STICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20190101",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part350",
"LabelerName": "Idelle Labs, Ltd",
"SubstanceName": "ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY",
"StrengthNumber": "19",
"StrengthUnit": "g/100g",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20190101",
"SamplePackage": "N",
"IndicationAndUsage": "Reduces underarm wetness."
},
{
"NDCCode": "58420-007-04",
"PackageDescription": "5547 L in 1 CYLINDER (58420-007-04)",
"NDC11Code": "58420-0007-04",
"ProductNDC": "58420-007",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Helium Oxygen Mixture",
"NonProprietaryName": "Helium Oxygen Mixture",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19980101",
"MarketingCategoryName": "UNAPPROVED MEDICAL GAS",
"LabelerName": "Airgas Intermountain Inc",
"SubstanceName": "HELIUM; OXYGEN",
"StrengthNumber": "800; 200",
"StrengthUnit": "mL/L; mL/L",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "62670-5547-0",
"PackageDescription": "29 mL in 1 BOTTLE (62670-5547-0) ",
"NDC11Code": "62670-5547-00",
"ProductNDC": "62670-5547",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Anti-bacterial Hand",
"ProprietaryNameSuffix": "Merry Cookie",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20181206",
"EndMarketingDate": "20190606",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333E",
"LabelerName": "Bath & Body Works, Inc.",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "68",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-06-07",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20181206",
"EndMarketingDatePackage": "20190606",
"SamplePackage": "N"
},
{
"NDCCode": "50458-342-60",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (50458-342-60) > 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE, GLASS",
"NDC11Code": "50458-0342-60",
"ProductNDC": "50458-342",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pancreaze",
"NonProprietaryName": "Pancrelipase",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20100412",
"EndMarketingDate": "20190831",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022523",
"LabelerName": "Janssen Pharmaceuticals, Inc.",
"SubstanceName": "PANCRELIPASE LIPASE; PANCRELIPASE AMYLASE; PANCRELIPASE PROTEASE",
"StrengthNumber": "10500; 61500; 35500",
"StrengthUnit": "[USP'U]/1; [USP'U]/1; [USP'U]/1",
"Status": "Deprecated",
"LastUpdate": "2019-09-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20100412",
"EndMarketingDatePackage": "20190831",
"SamplePackage": "N"
},
{
"NDCCode": "62541-403-10",
"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (62541-403-10) / 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE, GLASS",
"NDC11Code": "62541-0403-10",
"ProductNDC": "62541-403",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pancreaze",
"NonProprietaryName": "Pancrelipase Lipase, Pancrelipase Amylase, And Pancrelipase Protease",
"DosageFormName": "CAPSULE, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20100412",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA022523",
"LabelerName": "VIVUS LLC",
"SubstanceName": "PANCRELIPASE LIPASE; PANCRELIPASE AMYLASE; PANCRELIPASE PROTEASE",
"StrengthNumber": "10500; 61500; 35500",
"StrengthUnit": "[USP'U]/1; [USP'U]/1; [USP'U]/1",
"Status": "Active",
"LastUpdate": "2025-06-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20100412",
"SamplePackage": "N",
"IndicationAndUsage": "PANCREAZE is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients.",
"Description": "Pancrelipase is a pancreatic enzyme product consisting of a mixture of enzymes including lipases, proteases, and amylases and is an extract derived from porcine pancreatic glands. The enteric-coated microtablets in PANCREAZE are formulated to release pancreatic enzymes at an approximate pH of 5.5 or greater. PANCREAZE (pancrelipase) delayed-release capsules are for oral administration and include a two-piece shell containing enteric-coated microtablets that are each approximately 2 mm in diameter and are available as follows."
},
{
"NDCCode": "0002-0213-01",
"PackageDescription": "1 VIAL, MULTI-DOSE in 1 CARTON (0002-0213-01) / 3 mL in 1 VIAL, MULTI-DOSE",
"NDC11Code": "00002-0213-01",
"ProductNDC": "0002-0213",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Humulin",
"ProprietaryNameSuffix": "R",
"NonProprietaryName": "Insulin Human",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "PARENTERAL",
"StartMarketingDate": "19830627",
"EndMarketingDate": "20261215",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA018780",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "INSULIN HUMAN",
"StrengthNumber": "100",
"StrengthUnit": "[iU]/mL",
"Pharm_Classes": "Insulin [CS], Insulin [EPC]",
"Status": "Active",
"LastUpdate": "2026-09-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20230620",
"EndMarketingDatePackage": "20261215",
"SamplePackage": "N",
"IndicationAndUsage": "HUMULIN R is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.",
"Description": "Insulin human is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli and has the empirical formula C257H383N65O77S6 with a molecular weight of 5.808 kDa. HUMULIN R (insulin human) injection is a short-acting human insulin for subcutaneous or intravenous use. HUMULIN R is a sterile, aqueous, clear, and colorless solution. HUMULIN R contains 100 units of insulin human in each milliliter. Each milliliter of HUMULIN R also contains glycerin (16 mg), metacresol (2.5 mg), endogenous zinc (approximately 0.015 mg/100 units,) and Water for Injection. Sodium hydroxide and hydrochloric acid may be added during manufacture to adjust the pH. The pH is 7.0 to 7.8."
},
{
"NDCCode": "0002-0485-01",
"PackageDescription": "8 BOTTLE in 1 CONTAINER (0002-0485-01) > 2000 g in 1 BOTTLE",
"NDC11Code": "00002-0485-01",
"ProductNDC": "0002-0485",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Insulin Human",
"DosageFormName": "CRYSTAL",
"StartMarketingDate": "20150401",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "INSULIN HUMAN",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0002-0535-01",
"PackageDescription": "8 BOTTLE in 1 CONTAINER (0002-0535-01) > 2000 g in 1 BOTTLE",
"NDC11Code": "00002-0535-01",
"ProductNDC": "0002-0535",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Insulin Lispro",
"DosageFormName": "CRYSTAL",
"StartMarketingDate": "20140131",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "INSULIN LISPRO",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0002-0800-01",
"PackageDescription": "1 VIAL in 1 CARTON (0002-0800-01) / 10 mL in 1 VIAL",
"NDC11Code": "00002-0800-01",
"ProductNDC": "0002-0800",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sterile Diluent",
"NonProprietaryName": "Diluent",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "19870710",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA020563",
"LabelerName": "Eli Lilly and Company",
"SubstanceName": "WATER",
"StrengthNumber": "1",
"StrengthUnit": "mL/mL",
"Status": "Active",
"LastUpdate": "2026-08-11",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19870710",
"SamplePackage": "N",
"IndicationAndUsage": "HUMALOG is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.",
"Description": "Insulin lispro is a rapid-acting human insulin analog produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli. Insulin lispro differs from human insulin in that the amino acid proline at position B28 is replaced by lysine and the lysine in position B29 is replaced by proline. Chemically, it is Lys(B28), Pro(B29) human insulin analog and has the empirical formula C257H383N65O77S6 and a molecular weight of 5.808 kDa, both identical to that of human insulin. Insulin lispro has the following primary structure:. HUMALOG (insulin lispro) injection is a sterile, clear, and colorless solution for subcutaneous or intravenous use. Each mL of HUMALOG U-100 contains 100 units of insulin lispro, and the inactive ingredients: dibasic sodium phosphate (1.0 mg), glycerin (16 mg), metacresol (3.15 mg), trace amounts of phenol, zinc oxide (content adjusted to provide 0.0197 mg zinc ion), and Water for Injection, USP. Each mL of HUMALOG U-200 contains 200 units of insulin lispro, and the inactive ingredients: glycerin (16 mg), metacresol (3.15 mg), trace amounts of phenol, tromethamine (5 mg), zinc oxide (content adjusted to provide 0.046 mg zinc ion), and Water for Injection, USP. HUMALOG has a pH of 7.0 to 7.8. Hydrochloric acid 10% and/or sodium hydroxide 10% is added to adjust the pH."
}
]
}
{"NDC":[{"NDCCode":"61500-5547-8","ProprietaryName":"Topricin","NonProprietaryName":"Aesculus Hippocastanum, Arnica Montana, Belladonna, Calendula Officinalis, Crotalus Horridus, Echinacea, Graphites, Heloderma Horridum, Lachesis Mutus, Naja Tripudians, Phosphorus, Rhus Toxicodendron, Ruta Graveolens, Sulfur"},{"NDCCode":"61500-5527-8","ProprietaryName":"Topricin","NonProprietaryName":"Aesculus Hippocastanum, Arnica Montana, Belladonna, Crotalus Horridus, Echinacea, Graphites, Heloderma, Lachesis Mutus, Naja Tripudians, Rhus Toxicodendron, Ruta Graveolens"},{"NDCCode":"61500-5547-0","ProprietaryName":"Topricin","NonProprietaryName":"Aesculus Hippocastanum, Arnica Montana, Belladonna, Calendula Officinalis, Crotalus Horridus, Echinacea, Graphites, Heloderma Horridum, Lachesis Mutus, Naja Tripudians, Phosphorus, Rhus Toxicodendron, Ruta Graveolens, Sulfur"},{"NDCCode":"61500-5547-1","ProprietaryName":"Topricin","NonProprietaryName":"Aesculus Hippocastanum, Arnica Montana, Belladonna, 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Lachesis Mutus, Naja Tripudians, Phosphorus, Rhus Toxicodendron, Ruta Graveolens, Sulfur"},{"NDCCode":"0409-5547-10","ProprietaryName":"Cisatracurium Besylate","NonProprietaryName":"Cisatracurium Besylate"},{"NDCCode":"50090-5547-0","ProprietaryName":"Januvia","NonProprietaryName":"Sitagliptin"},{"NDCCode":"54868-5547-0","ProprietaryName":"Asmanex","NonProprietaryName":"Mometasone Furoate"},{"NDCCode":"54868-5547-1","ProprietaryName":"Asmanex","NonProprietaryName":"Mometasone Furoate"},{"NDCCode":"54868-5547-2","ProprietaryName":"Asmanex","NonProprietaryName":"Mometasone Furoate"},{"NDCCode":"61500-0115-1","ProprietaryName":"My Pain Away After Burn Cream","NonProprietaryName":"Aesculus Hippocastanum, Arnica Montana, Belladonna, Crotalus Horridus, Echinacea, Graphites, Heloderma, Lachesis Mutus, Naja Tripudians, Rhus Toxicodendron, Ruta Graveolens"},{"NDCCode":"61500-1501-6","ProprietaryName":"Mypainaway Sports Cream","NonProprietaryName":"Aesculus Hippocastanum, Arnica Montana, Bellis Perennis, Calendula Officinalis, Capsicum Annum, Crotalus Horridus, Echinacea, Gelsemium Sempervirens, Graphites, Hypericum Perforatum, Kali Carbonicum, Lachesis Mutus, Magnesium Phosphorica, Naja Tripudians, Rhus Tox, Ruta Graveolens, Sulphur"},{"NDCCode":"61500-5527-1","ProprietaryName":"Topricin","NonProprietaryName":"Aesculus Hippocastanum, Arnica Montana, Belladonna, Crotalus Horridus, Echinacea, Graphites, Heloderma, Lachesis Mutus, Naja Tripudians, Rhus Toxicodendron, Ruta Graveolens"},{"NDCCode":"61500-5527-2","ProprietaryName":"Topricin","NonProprietaryName":"Aesculus Hippocastanum, Arnica Montana, Belladonna, Crotalus Horridus, Echinacea, Graphites, Heloderma, Lachesis Mutus, Naja Tripudians, Rhus Toxicodendron, Ruta Graveolens"},{"NDCCode":"61500-5527-3","ProprietaryName":"Topricin","NonProprietaryName":"Aesculus Hippocastanum, Arnica Montana, Belladonna, Crotalus Horridus, Echinacea, Graphites, Heloderma, Lachesis Mutus, Naja Tripudians, Rhus Toxicodendron, Ruta 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<NDCList>
<NDC>
<NDCCode>61500-5547-8</NDCCode>
<PackageDescription>454 g in 1 BOTTLE (61500-5547-8) </PackageDescription>
<NDC11Code>61500-5547-08</NDC11Code>
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<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160401</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Topical BioMedics, Inc.</LabelerName>
<SubstanceName>PHOSPHORUS; ARNICA MONTANA; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA ANGUSTIFOLIA; GRAPHITE; HELODERMA HORRIDUM VENOM; LACHESIS MUTA VENOM; NAJA NAJA VENOM; RUTA GRAVEOLENS FLOWERING TOP; AESCULUS HIPPOCASTANUM FLOWER; ATROPA BELLADONNA; TOXICODENDRON PUBESCENS LEAF; CALENDULA OFFICINALIS FLOWERING TOP; SULFUR</SubstanceName>
<StrengthNumber>9; 6; 8; 4; 6; 8; 8; 8; 6; 6; 6; 8; 4; 8</StrengthNumber>
<StrengthUnit>[hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-10-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rapid, moisturizing healing pain relief from trauma injuries of the foot, ankle and lower extremity. Reduces swelling, numbness and burning pain associated with. Joint pain in the toes, feet and ankles. Heel pain/soreness (heel spurs). Bunions pain/soreness (big toe). Nerve pain (burning pain in feet). Gout (pain in big toe). Relieves arch pain, soft tissue pain, and ball of the foot. Relieves nerve pain between toes. Sports injuries, shin splints, ankle sprain, Achilles tendonitis, Plantar Fasciitis. Tired aching feet, Tarsal Tunnel Syndrome.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61500-5527-8</NDCCode>
<PackageDescription>227 g in 1 BOTTLE (61500-5527-8) </PackageDescription>
<NDC11Code>61500-5527-08</NDC11Code>
<ProductNDC>61500-5527</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Topricin</ProprietaryName>
<NonProprietaryName>Aesculus Hippocastanum, Arnica Montana, Belladonna, Crotalus Horridus, Echinacea, Graphites, Heloderma, Lachesis Mutus, Naja Tripudians, Rhus Toxicodendron, Ruta Graveolens</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160401</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Topical BioMedics, Inc.</LabelerName>
<SubstanceName>AESCULUS HIPPOCASTANUM FLOWER; ARNICA MONTANA; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA ANGUSTIFOLIA; GRAPHITE; HELODERMA HORRIDUM VENOM; LACHESIS MUTA VENOM; NAJA NAJA VENOM; RUTA GRAVEOLENS FLOWERING TOP; ATROPA BELLADONNA; TOXICODENDRON PUBESCENS LEAF</SubstanceName>
<StrengthNumber>6; 6; 8; 6; 6; 8; 8; 8; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-10-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rapid, soothing relief of pain, stiffness, tingling, or burning nerve pain associated with. Arthritis and other joint pain and discomfort. Fibromyalgia. Carpal Tunnel Syndrome and other types of nerve pain. Pains & muscle cramps of the back, neck, shoulder, legs, hands & feet. Sports injuries (muscle pulls & soreness, impact, sprains, dislocations). Repetitive motion injuries, such as bursitis, tendonitis and sciatica. First Aid for simple trauma (bruises, minor burns, cuts, scrapes & strains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61500-5547-0</NDCCode>
<PackageDescription>2 g in 1 PACKET (61500-5547-0) </PackageDescription>
<NDC11Code>61500-5547-00</NDC11Code>
<ProductNDC>61500-5547</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Topricin</ProprietaryName>
<NonProprietaryName>Aesculus Hippocastanum, Arnica Montana, Belladonna, Calendula Officinalis, Crotalus Horridus, Echinacea, Graphites, Heloderma Horridum, Lachesis Mutus, Naja Tripudians, Phosphorus, Rhus Toxicodendron, Ruta Graveolens, Sulfur</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160401</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Topical BioMedics, Inc.</LabelerName>
<SubstanceName>PHOSPHORUS; ARNICA MONTANA; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA ANGUSTIFOLIA; GRAPHITE; HELODERMA HORRIDUM VENOM; LACHESIS MUTA VENOM; NAJA NAJA VENOM; RUTA GRAVEOLENS FLOWERING TOP; AESCULUS HIPPOCASTANUM FLOWER; ATROPA BELLADONNA; TOXICODENDRON PUBESCENS LEAF; CALENDULA OFFICINALIS FLOWERING TOP; SULFUR</SubstanceName>
<StrengthNumber>9; 6; 8; 4; 6; 8; 8; 8; 6; 6; 6; 8; 4; 8</StrengthNumber>
<StrengthUnit>[hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-10-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rapid, moisturizing healing pain relief from trauma injuries of the foot, ankle and lower extremity. Reduces swelling, numbness and burning pain associated with. Joint pain in the toes, feet and ankles. Heel pain/soreness (heel spurs). Bunions pain/soreness (big toe). Nerve pain (burning pain in feet). Gout (pain in big toe). Relieves arch pain, soft tissue pain, and ball of the foot. Relieves nerve pain between toes. Sports injuries, shin splints, ankle sprain, Achilles tendonitis, Plantar Fasciitis. Tired aching feet, Tarsal Tunnel Syndrome.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61500-5547-1</NDCCode>
<PackageDescription>21 g in 1 TUBE (61500-5547-1) </PackageDescription>
<NDC11Code>61500-5547-01</NDC11Code>
<ProductNDC>61500-5547</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Topricin</ProprietaryName>
<NonProprietaryName>Aesculus Hippocastanum, Arnica Montana, Belladonna, Calendula Officinalis, Crotalus Horridus, Echinacea, Graphites, Heloderma Horridum, Lachesis Mutus, Naja Tripudians, Phosphorus, Rhus Toxicodendron, Ruta Graveolens, Sulfur</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160401</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Topical BioMedics, Inc.</LabelerName>
<SubstanceName>PHOSPHORUS; ARNICA MONTANA; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA ANGUSTIFOLIA; GRAPHITE; HELODERMA HORRIDUM VENOM; LACHESIS MUTA VENOM; NAJA NAJA VENOM; RUTA GRAVEOLENS FLOWERING TOP; AESCULUS HIPPOCASTANUM FLOWER; ATROPA BELLADONNA; TOXICODENDRON PUBESCENS LEAF; CALENDULA OFFICINALIS FLOWERING TOP; SULFUR</SubstanceName>
<StrengthNumber>9; 6; 8; 4; 6; 8; 8; 8; 6; 6; 6; 8; 4; 8</StrengthNumber>
<StrengthUnit>[hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-10-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rapid, moisturizing healing pain relief from trauma injuries of the foot, ankle and lower extremity. Reduces swelling, numbness and burning pain associated with. Joint pain in the toes, feet and ankles. Heel pain/soreness (heel spurs). Bunions pain/soreness (big toe). Nerve pain (burning pain in feet). Gout (pain in big toe). Relieves arch pain, soft tissue pain, and ball of the foot. Relieves nerve pain between toes. Sports injuries, shin splints, ankle sprain, Achilles tendonitis, Plantar Fasciitis. Tired aching feet, Tarsal Tunnel Syndrome.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61500-5547-2</NDCCode>
<PackageDescription>57 g in 1 TUBE (61500-5547-2) </PackageDescription>
<NDC11Code>61500-5547-02</NDC11Code>
<ProductNDC>61500-5547</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Topricin</ProprietaryName>
<NonProprietaryName>Aesculus Hippocastanum, Arnica Montana, Belladonna, Calendula Officinalis, Crotalus Horridus, Echinacea, Graphites, Heloderma Horridum, Lachesis Mutus, Naja Tripudians, Phosphorus, Rhus Toxicodendron, Ruta Graveolens, Sulfur</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160401</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Topical BioMedics, Inc.</LabelerName>
<SubstanceName>PHOSPHORUS; ARNICA MONTANA; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA ANGUSTIFOLIA; GRAPHITE; HELODERMA HORRIDUM VENOM; LACHESIS MUTA VENOM; NAJA NAJA VENOM; RUTA GRAVEOLENS FLOWERING TOP; AESCULUS HIPPOCASTANUM FLOWER; ATROPA BELLADONNA; TOXICODENDRON PUBESCENS LEAF; CALENDULA OFFICINALIS FLOWERING TOP; SULFUR</SubstanceName>
<StrengthNumber>9; 6; 8; 4; 6; 8; 8; 8; 6; 6; 6; 8; 4; 8</StrengthNumber>
<StrengthUnit>[hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-10-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rapid, moisturizing healing pain relief from trauma injuries of the foot, ankle and lower extremity. Reduces swelling, numbness and burning pain associated with. Joint pain in the toes, feet and ankles. Heel pain/soreness (heel spurs). Bunions pain/soreness (big toe). Nerve pain (burning pain in feet). Gout (pain in big toe). Relieves arch pain, soft tissue pain, and ball of the foot. Relieves nerve pain between toes. Sports injuries, shin splints, ankle sprain, Achilles tendonitis, Plantar Fasciitis. Tired aching feet, Tarsal Tunnel Syndrome.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61500-5547-4</NDCCode>
<PackageDescription>113 g in 1 JAR (61500-5547-4) </PackageDescription>
<NDC11Code>61500-5547-04</NDC11Code>
<ProductNDC>61500-5547</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Topricin</ProprietaryName>
<NonProprietaryName>Aesculus Hippocastanum, Arnica Montana, Belladonna, Calendula Officinalis, Crotalus Horridus, Echinacea, Graphites, Heloderma Horridum, Lachesis Mutus, Naja Tripudians, Phosphorus, Rhus Toxicodendron, Ruta Graveolens, Sulfur</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160401</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Topical BioMedics, Inc.</LabelerName>
<SubstanceName>PHOSPHORUS; ARNICA MONTANA; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA ANGUSTIFOLIA; GRAPHITE; HELODERMA HORRIDUM VENOM; LACHESIS MUTA VENOM; NAJA NAJA VENOM; RUTA GRAVEOLENS FLOWERING TOP; AESCULUS HIPPOCASTANUM FLOWER; ATROPA BELLADONNA; TOXICODENDRON PUBESCENS LEAF; CALENDULA OFFICINALIS FLOWERING TOP; SULFUR</SubstanceName>
<StrengthNumber>9; 6; 8; 4; 6; 8; 8; 8; 6; 6; 6; 8; 4; 8</StrengthNumber>
<StrengthUnit>[hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-10-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rapid, moisturizing healing pain relief from trauma injuries of the foot, ankle and lower extremity. Reduces swelling, numbness and burning pain associated with. Joint pain in the toes, feet and ankles. Heel pain/soreness (heel spurs). Bunions pain/soreness (big toe). Nerve pain (burning pain in feet). Gout (pain in big toe). Relieves arch pain, soft tissue pain, and ball of the foot. Relieves nerve pain between toes. Sports injuries, shin splints, ankle sprain, Achilles tendonitis, Plantar Fasciitis. Tired aching feet, Tarsal Tunnel Syndrome.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61500-5547-9</NDCCode>
<PackageDescription>227 g in 1 BOTTLE (61500-5547-9) </PackageDescription>
<NDC11Code>61500-5547-09</NDC11Code>
<ProductNDC>61500-5547</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Topricin</ProprietaryName>
<NonProprietaryName>Aesculus Hippocastanum, Arnica Montana, Belladonna, Calendula Officinalis, Crotalus Horridus, Echinacea, Graphites, Heloderma Horridum, Lachesis Mutus, Naja Tripudians, Phosphorus, Rhus Toxicodendron, Ruta Graveolens, Sulfur</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160401</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Topical BioMedics, Inc.</LabelerName>
<SubstanceName>PHOSPHORUS; ARNICA MONTANA; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA ANGUSTIFOLIA; GRAPHITE; HELODERMA HORRIDUM VENOM; LACHESIS MUTA VENOM; NAJA NAJA VENOM; RUTA GRAVEOLENS FLOWERING TOP; AESCULUS HIPPOCASTANUM FLOWER; ATROPA BELLADONNA; TOXICODENDRON PUBESCENS LEAF; CALENDULA OFFICINALIS FLOWERING TOP; SULFUR</SubstanceName>
<StrengthNumber>9; 6; 8; 4; 6; 8; 8; 8; 6; 6; 6; 8; 4; 8</StrengthNumber>
<StrengthUnit>[hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-10-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rapid, moisturizing healing pain relief from trauma injuries of the foot, ankle and lower extremity. Reduces swelling, numbness and burning pain associated with. Joint pain in the toes, feet and ankles. Heel pain/soreness (heel spurs). Bunions pain/soreness (big toe). Nerve pain (burning pain in feet). Gout (pain in big toe). Relieves arch pain, soft tissue pain, and ball of the foot. Relieves nerve pain between toes. Sports injuries, shin splints, ankle sprain, Achilles tendonitis, Plantar Fasciitis. Tired aching feet, Tarsal Tunnel Syndrome.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0409-5547-10</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (0409-5547-10) / 5 mL in 1 VIAL, SINGLE-DOSE (0409-5547-01) </PackageDescription>
<NDC11Code>00409-5547-10</NDC11Code>
<ProductNDC>0409-5547</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cisatracurium Besylate</ProprietaryName>
<NonProprietaryName>Cisatracurium Besylate</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20210601</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA203236</ApplicationNumber>
<LabelerName>Hospira, Inc.</LabelerName>
<SubstanceName>CISATRACURIUM BESYLATE</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Neuromuscular Nondepolarizing Blockade [PE], Nondepolarizing Neuromuscular Blocker [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-11-21</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210601</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Cisatracurium Besylate Injection is indicated: 1 as an adjunct to general anesthesia to facilitate tracheal intubation in adults and in pediatric patients 1 month to 12 years of age, 2 to provide skeletal muscle relaxation in adults during surgical procedures or during mechanical ventilation in the ICU, 3 to provide skeletal muscle relaxation during surgical procedures via infusion in pediatric patients 2 years and older.</IndicationAndUsage>
<Description>Cisatracurium besylate is a nondepolarizing skeletal neuromuscular blocker for intravenous administration. Compared to other neuromuscular blockers, it is intermediate in its onset and duration of action. Cisatracurium besylate is one of 10 isomers of atracurium besylate and constitutes approximately 15% of that mixture. Cisatracurium besylate is [1R-[1α,2α(1'R*,2'R*)]]-2,2'-[1,5-pentanediylbis[oxy(3-oxo-3,1-propanediyl)]]bis[1-[(3,4-dimethoxyphenyl)methyl]-1,2,3,4-tetrahydro-6,7-dimethoxy-2-methylisoquinolinium] dibenzenesulfonate. The molecular formula of the cisatracurium parent bis-cation is C53H72N2O12 and the molecular weight is 929.2. The molecular formula of cisatracurium as the besylate salt is C65H82N2O18S2 and the molecular weight is 1243.5. The structural formula of cisatracurium besylate is. The log of the partition coefficient of cisatracurium besylate is -2.12 in a 1-octanol/distilled water system at 25°C. Cisatracurium Besylate Injection, USP is a sterile, non-pyrogenic aqueous solution provided in 5 mL, 10 mL, and 20 mL vials. The pH is adjusted to 3.0 to 3.8 with benzenesulfonic acid. : 1 The 5 mL single-dose vials contain 2 mg/mL cisatracurium, equivalent to 2.68 mg/mL cisatracurium besylate., 2 The 10 mL multiple-dose vials contain 2 mg/mL cisatracurium, equivalent to 2.68 mg/mL cisatracurium besylate, and 0.9% benzyl alcohol as a preservative., 3 The 20 mL single-dose vials contain 10 mg/mL cisatracurium, equivalent to 13.38 mg/mL cisatracurium besylate.</Description>
</NDC>
<NDC>
<NDCCode>50090-5547-0</NDCCode>
<PackageDescription>30 TABLET, FILM COATED in 1 BOTTLE (50090-5547-0) </PackageDescription>
<NDC11Code>50090-5547-00</NDC11Code>
<ProductNDC>50090-5547</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Januvia</ProprietaryName>
<NonProprietaryName>Sitagliptin</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20061016</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021995</ApplicationNumber>
<LabelerName>A-S Medication Solutions</LabelerName>
<SubstanceName>SITAGLIPTIN PHOSPHATE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Dipeptidyl Peptidase 4 Inhibitor [EPC], Dipeptidyl Peptidase 4 Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-07-09</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20210520</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>JANUVIA® is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.</IndicationAndUsage>
<Description>JANUVIA Tablets contain sitagliptin phosphate, an orally-active inhibitor of the dipeptidyl peptidase-4 (DPP-4) enzyme. Sitagliptin phosphate monohydrate is described chemically as 7-[(3R)-3-amino-1-oxo-4-(2,4,5-trifluorophenyl)butyl]-5,6,7,8-tetrahydro-3-(trifluoromethyl)-1,2,4-triazolo[4,3-a]pyrazine phosphate (1:1) monohydrate. The empirical formula is C16H15F6N5OH3PO4H2O and the molecular weight is 523.32. The structural formula is:. Sitagliptin phosphate monohydrate is a white to off-white, crystalline, non-hygroscopic powder. It is soluble in water and N,N-dimethyl formamide; slightly soluble in methanol; very slightly soluble in ethanol, acetone, and acetonitrile; and insoluble in isopropanol and isopropyl acetate. Each film-coated tablet of JANUVIA contains 32.13, 64.25, or 128.5 mg of sitagliptin phosphate monohydrate, which is equivalent to 25, 50, or 100 mg, respectively, of free base and the following inactive ingredients: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, and sodium stearyl fumarate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, red iron oxide, and yellow iron oxide.</Description>
</NDC>
<NDC>
<NDCCode>54868-5547-0</NDCCode>
<PackageDescription>1 POUCH in 1 CARTON (54868-5547-0) > 1 INHALER in 1 POUCH > 60 INHALANT in 1 INHALER</PackageDescription>
<NDC11Code>54868-5547-00</NDC11Code>
<ProductNDC>54868-5547</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Asmanex</ProprietaryName>
<NonProprietaryName>Mometasone Furoate</NonProprietaryName>
<DosageFormName>INHALANT</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20060309</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021067</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>MOMETASONE FUROATE</SubstanceName>
<StrengthNumber>220</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>ASMANEX TWISTHALER is a corticosteroid indicated for: 1 Maintenance treatment of asthma as prophylactic therapy in patients 4 years of age and older. (1.1).</IndicationAndUsage>
<Description>Mometasone furoate, the active component of the ASMANEX TWISTHALER product, is a corticosteroid with the chemical name 9,21-dichloro-11(Beta),17-dihydroxy-16(alpha)-methylpregna-1,4-diene-3,20-dione 17-(2-furoate) and the following chemical structure. Mometasone furoate is a white powder with an empirical formula of C27H30Cl2O6, and molecular weight of 521.44 Daltons. The ASMANEX TWISTHALER 110 mcg and 220 mcg products are cap-activated, inhalation-driven, multidose dry powder inhalers containing mometasone furoate and anhydrous lactose (which contains trace amounts of milk proteins). Each actuation of the ASMANEX TWISTHALER 110 mcg or 220 mcg inhaler provides a measured dose of approximately 0.75 or 1.5 mg mometasone furoate inhalation powder, containing 110 or 220 mcg of mometasone furoate, respectively. This results in delivery of 100 or 200 mcg mometasone furoate from the mouthpiece, respectively, based on in vitro testing at flow rates of 30 L/min and 60 L/min with constant volume of 2 L. The amount of mometasone furoate emitted from the inhaler in vitro does not differ significantly for flow rates ranging from 28.3 L/min to 70 L/min at a constant volume of 2 L. However, the amount of drug delivered to the lung will depend on patient factors such as inspiratory flow and peak inspiratory flow through the device. In adult and adolescent patients (aged ≥12 years) with varied asthma severity, mean peak inspiratory flow rate through the device was 69 L/min (range: 54–77 L/min). In pediatric patients (aged 5–12 years) diagnosed with asthma, mean peak inspiratory flow rate in the 5- to 8-year-old subgroup was >50 L/min (minimum of 46 L/min) and for the 9- to 12-year-old subgroup was >60 L/min (minimum of 48 L/min).</Description>
</NDC>
<NDC>
<NDCCode>54868-5547-1</NDCCode>
<PackageDescription>1 POUCH in 1 CARTON (54868-5547-1) > 1 INHALER in 1 POUCH > 30 INHALANT in 1 INHALER</PackageDescription>
<NDC11Code>54868-5547-01</NDC11Code>
<ProductNDC>54868-5547</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Asmanex</ProprietaryName>
<NonProprietaryName>Mometasone Furoate</NonProprietaryName>
<DosageFormName>INHALANT</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20060309</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021067</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>MOMETASONE FUROATE</SubstanceName>
<StrengthNumber>220</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>ASMANEX TWISTHALER is a corticosteroid indicated for: 1 Maintenance treatment of asthma as prophylactic therapy in patients 4 years of age and older. (1.1).</IndicationAndUsage>
<Description>Mometasone furoate, the active component of the ASMANEX TWISTHALER product, is a corticosteroid with the chemical name 9,21-dichloro-11(Beta),17-dihydroxy-16(alpha)-methylpregna-1,4-diene-3,20-dione 17-(2-furoate) and the following chemical structure. Mometasone furoate is a white powder with an empirical formula of C27H30Cl2O6, and molecular weight of 521.44 Daltons. The ASMANEX TWISTHALER 110 mcg and 220 mcg products are cap-activated, inhalation-driven, multidose dry powder inhalers containing mometasone furoate and anhydrous lactose (which contains trace amounts of milk proteins). Each actuation of the ASMANEX TWISTHALER 110 mcg or 220 mcg inhaler provides a measured dose of approximately 0.75 or 1.5 mg mometasone furoate inhalation powder, containing 110 or 220 mcg of mometasone furoate, respectively. This results in delivery of 100 or 200 mcg mometasone furoate from the mouthpiece, respectively, based on in vitro testing at flow rates of 30 L/min and 60 L/min with constant volume of 2 L. The amount of mometasone furoate emitted from the inhaler in vitro does not differ significantly for flow rates ranging from 28.3 L/min to 70 L/min at a constant volume of 2 L. However, the amount of drug delivered to the lung will depend on patient factors such as inspiratory flow and peak inspiratory flow through the device. In adult and adolescent patients (aged ≥12 years) with varied asthma severity, mean peak inspiratory flow rate through the device was 69 L/min (range: 54–77 L/min). In pediatric patients (aged 5–12 years) diagnosed with asthma, mean peak inspiratory flow rate in the 5- to 8-year-old subgroup was >50 L/min (minimum of 46 L/min) and for the 9- to 12-year-old subgroup was >60 L/min (minimum of 48 L/min).</Description>
</NDC>
<NDC>
<NDCCode>54868-5547-2</NDCCode>
<PackageDescription>1 POUCH in 1 CARTON (54868-5547-2) > 1 INHALER in 1 POUCH > 14 INHALANT in 1 INHALER</PackageDescription>
<NDC11Code>54868-5547-02</NDC11Code>
<ProductNDC>54868-5547</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Asmanex</ProprietaryName>
<NonProprietaryName>Mometasone Furoate</NonProprietaryName>
<DosageFormName>INHALANT</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20060309</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021067</ApplicationNumber>
<LabelerName>Physicians Total Care, Inc.</LabelerName>
<SubstanceName>MOMETASONE FUROATE</SubstanceName>
<StrengthNumber>220</StrengthNumber>
<StrengthUnit>ug/1</StrengthUnit>
<Pharm_Classes>Corticosteroid [EPC],Corticosteroid Hormone Receptor Agonists [MoA],Corticosteroid Hormone Receptor Agonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-07-24</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>ASMANEX TWISTHALER is a corticosteroid indicated for: 1 Maintenance treatment of asthma as prophylactic therapy in patients 4 years of age and older. (1.1).</IndicationAndUsage>
<Description>Mometasone furoate, the active component of the ASMANEX TWISTHALER product, is a corticosteroid with the chemical name 9,21-dichloro-11(Beta),17-dihydroxy-16(alpha)-methylpregna-1,4-diene-3,20-dione 17-(2-furoate) and the following chemical structure. Mometasone furoate is a white powder with an empirical formula of C27H30Cl2O6, and molecular weight of 521.44 Daltons. The ASMANEX TWISTHALER 110 mcg and 220 mcg products are cap-activated, inhalation-driven, multidose dry powder inhalers containing mometasone furoate and anhydrous lactose (which contains trace amounts of milk proteins). Each actuation of the ASMANEX TWISTHALER 110 mcg or 220 mcg inhaler provides a measured dose of approximately 0.75 or 1.5 mg mometasone furoate inhalation powder, containing 110 or 220 mcg of mometasone furoate, respectively. This results in delivery of 100 or 200 mcg mometasone furoate from the mouthpiece, respectively, based on in vitro testing at flow rates of 30 L/min and 60 L/min with constant volume of 2 L. The amount of mometasone furoate emitted from the inhaler in vitro does not differ significantly for flow rates ranging from 28.3 L/min to 70 L/min at a constant volume of 2 L. However, the amount of drug delivered to the lung will depend on patient factors such as inspiratory flow and peak inspiratory flow through the device. In adult and adolescent patients (aged ≥12 years) with varied asthma severity, mean peak inspiratory flow rate through the device was 69 L/min (range: 54–77 L/min). In pediatric patients (aged 5–12 years) diagnosed with asthma, mean peak inspiratory flow rate in the 5- to 8-year-old subgroup was >50 L/min (minimum of 46 L/min) and for the 9- to 12-year-old subgroup was >60 L/min (minimum of 48 L/min).</Description>
</NDC>
<NDC>
<NDCCode>61500-0115-1</NDCCode>
<PackageDescription>176 mL in 1 TUBE (61500-0115-1)</PackageDescription>
<NDC11Code>61500-0115-01</NDC11Code>
<ProductNDC>61500-0115</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>My Pain Away After Burn Cream</ProprietaryName>
<NonProprietaryName>Aesculus Hippocastanum, Arnica Montana, Belladonna, Crotalus Horridus, Echinacea, Graphites, Heloderma, Lachesis Mutus, Naja Tripudians, Rhus Toxicodendron, Ruta Graveolens</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160801</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Topical BioMedics, Inc.</LabelerName>
<SubstanceName>ARNICA MONTANA; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA ANGUSTIFOLIA; GRAPHITE; BELLIS PERENNIS; LACHESIS MUTA VENOM; NAJA NAJA VENOM; RUTA GRAVEOLENS FLOWERING TOP; AESCULUS HIPPOCASTANUM FLOWER; ATROPA BELLADONNA; TOXICODENDRON PUBESCENS LEAF; CALENDULA OFFICINALIS FLOWERING TOP; SULFUR; HYPERICUM PERFORATUM</SubstanceName>
<StrengthNumber>6; 8; 6; 6; 6; 8; 8; 6; 6; 6; 12; 4; 8; 6</StrengthNumber>
<StrengthUnit>[hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>61500-1501-6</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (61500-1501-6) > 1 [hp_X] in 1 TUBE</PackageDescription>
<NDC11Code>61500-1501-06</NDC11Code>
<ProductNDC>61500-1501</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mypainaway Sports Cream</ProprietaryName>
<NonProprietaryName>Aesculus Hippocastanum, Arnica Montana, Bellis Perennis, Calendula Officinalis, Capsicum Annum, Crotalus Horridus, Echinacea, Gelsemium Sempervirens, Graphites, Hypericum Perforatum, Kali Carbonicum, Lachesis Mutus, Magnesium Phosphorica, Naja Tripudians, Rhus Tox, Ruta Graveolens, Sulphur</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160401</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Topical BioMedics, Inc.</LabelerName>
<SubstanceName>AESCULUS HIPPOCASTANUM BARK; ARNICA MONTANA; BELLIS PERENNIS; CALENDULA OFFICINALIS WHOLE; SULFUR; CAPSICUM ANNUUM WHOLE; CROTALUS HORRIDUS HORRIDUS WHOLE; ECHINACEA, UNSPECIFIED; GRAPHITE; GELSEMIUM SEMPERVIRENS WHOLE; HYPERICUM PERFORATUM; LACHESIS MUTA WHOLE; POTASSIUM CARBONATE; MAGNESIUM PHOSPHATE, MONOBASIC, UNSPECIFIED; NAJA NAJA WHOLE; RHUS SPP. WHOLE; RUTA GRAVEOLENS WHOLE</SubstanceName>
<StrengthNumber>6; 6; 6; 6; 8; 10; 8; 6; 6; 8; 6; 8; 8; 6; 8; 12; 6</StrengthNumber>
<StrengthUnit>[hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]; [hp_X]/[hp_X]</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Uses: Rapid, soothing relief of pain stiffness tingling or burning nerve pain Sports injuries muscle pulls and soreness impact injuries sprains dislocations repetitive motion injuries: bursitis tendonitis sciatica.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61500-5527-1</NDCCode>
<PackageDescription>21 g in 1 TUBE (61500-5527-1) </PackageDescription>
<NDC11Code>61500-5527-01</NDC11Code>
<ProductNDC>61500-5527</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Topricin</ProprietaryName>
<NonProprietaryName>Aesculus Hippocastanum, Arnica Montana, Belladonna, Crotalus Horridus, Echinacea, Graphites, Heloderma, Lachesis Mutus, Naja Tripudians, Rhus Toxicodendron, Ruta Graveolens</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160401</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Topical BioMedics, Inc.</LabelerName>
<SubstanceName>AESCULUS HIPPOCASTANUM FLOWER; ARNICA MONTANA; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA ANGUSTIFOLIA; GRAPHITE; HELODERMA HORRIDUM VENOM; LACHESIS MUTA VENOM; NAJA NAJA VENOM; RUTA GRAVEOLENS FLOWERING TOP; ATROPA BELLADONNA; TOXICODENDRON PUBESCENS LEAF</SubstanceName>
<StrengthNumber>6; 6; 8; 6; 6; 8; 8; 8; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-10-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160405</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rapid, soothing relief of pain, stiffness, tingling, or burning nerve pain associated with. Arthritis and other joint pain and discomfort. Fibromyalgia. Carpal Tunnel Syndrome and other types of nerve pain. Pains & muscle cramps of the back, neck, shoulder, legs, hands & feet. Sports injuries (muscle pulls & soreness, impact, sprains, dislocations). Repetitive motion injuries, such as bursitis, tendonitis and sciatica. First Aid for simple trauma (bruises, minor burns, cuts, scrapes & strains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61500-5527-2</NDCCode>
<PackageDescription>57 g in 1 TUBE (61500-5527-2) </PackageDescription>
<NDC11Code>61500-5527-02</NDC11Code>
<ProductNDC>61500-5527</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Topricin</ProprietaryName>
<NonProprietaryName>Aesculus Hippocastanum, Arnica Montana, Belladonna, Crotalus Horridus, Echinacea, Graphites, Heloderma, Lachesis Mutus, Naja Tripudians, Rhus Toxicodendron, Ruta Graveolens</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160401</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Topical BioMedics, Inc.</LabelerName>
<SubstanceName>AESCULUS HIPPOCASTANUM FLOWER; ARNICA MONTANA; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA ANGUSTIFOLIA; GRAPHITE; HELODERMA HORRIDUM VENOM; LACHESIS MUTA VENOM; NAJA NAJA VENOM; RUTA GRAVEOLENS FLOWERING TOP; ATROPA BELLADONNA; TOXICODENDRON PUBESCENS LEAF</SubstanceName>
<StrengthNumber>6; 6; 8; 6; 6; 8; 8; 8; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-10-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rapid, soothing relief of pain, stiffness, tingling, or burning nerve pain associated with. Arthritis and other joint pain and discomfort. Fibromyalgia. Carpal Tunnel Syndrome and other types of nerve pain. Pains & muscle cramps of the back, neck, shoulder, legs, hands & feet. Sports injuries (muscle pulls & soreness, impact, sprains, dislocations). Repetitive motion injuries, such as bursitis, tendonitis and sciatica. First Aid for simple trauma (bruises, minor burns, cuts, scrapes & strains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61500-5527-3</NDCCode>
<PackageDescription>907 g in 1 BOTTLE, PUMP (61500-5527-3) </PackageDescription>
<NDC11Code>61500-5527-03</NDC11Code>
<ProductNDC>61500-5527</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Topricin</ProprietaryName>
<NonProprietaryName>Aesculus Hippocastanum, Arnica Montana, Belladonna, Crotalus Horridus, Echinacea, Graphites, Heloderma, Lachesis Mutus, Naja Tripudians, Rhus Toxicodendron, Ruta Graveolens</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160401</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Topical BioMedics, Inc.</LabelerName>
<SubstanceName>AESCULUS HIPPOCASTANUM FLOWER; ARNICA MONTANA; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA ANGUSTIFOLIA; GRAPHITE; HELODERMA HORRIDUM VENOM; LACHESIS MUTA VENOM; NAJA NAJA VENOM; RUTA GRAVEOLENS FLOWERING TOP; ATROPA BELLADONNA; TOXICODENDRON PUBESCENS LEAF</SubstanceName>
<StrengthNumber>6; 6; 8; 6; 6; 8; 8; 8; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-10-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rapid, soothing relief of pain, stiffness, tingling, or burning nerve pain associated with. Arthritis and other joint pain and discomfort. Fibromyalgia. Carpal Tunnel Syndrome and other types of nerve pain. Pains & muscle cramps of the back, neck, shoulder, legs, hands & feet. Sports injuries (muscle pulls & soreness, impact, sprains, dislocations). Repetitive motion injuries, such as bursitis, tendonitis and sciatica. First Aid for simple trauma (bruises, minor burns, cuts, scrapes & strains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61500-5527-4</NDCCode>
<PackageDescription>113 g in 1 JAR (61500-5527-4) </PackageDescription>
<NDC11Code>61500-5527-04</NDC11Code>
<ProductNDC>61500-5527</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Topricin</ProprietaryName>
<NonProprietaryName>Aesculus Hippocastanum, Arnica Montana, Belladonna, Crotalus Horridus, Echinacea, Graphites, Heloderma, Lachesis Mutus, Naja Tripudians, Rhus Toxicodendron, Ruta Graveolens</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160401</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Topical BioMedics, Inc.</LabelerName>
<SubstanceName>AESCULUS HIPPOCASTANUM FLOWER; ARNICA MONTANA; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA ANGUSTIFOLIA; GRAPHITE; HELODERMA HORRIDUM VENOM; LACHESIS MUTA VENOM; NAJA NAJA VENOM; RUTA GRAVEOLENS FLOWERING TOP; ATROPA BELLADONNA; TOXICODENDRON PUBESCENS LEAF</SubstanceName>
<StrengthNumber>6; 6; 8; 6; 6; 8; 8; 8; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-10-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rapid, soothing relief of pain, stiffness, tingling, or burning nerve pain associated with. Arthritis and other joint pain and discomfort. Fibromyalgia. Carpal Tunnel Syndrome and other types of nerve pain. Pains & muscle cramps of the back, neck, shoulder, legs, hands & feet. Sports injuries (muscle pulls & soreness, impact, sprains, dislocations). Repetitive motion injuries, such as bursitis, tendonitis and sciatica. First Aid for simple trauma (bruises, minor burns, cuts, scrapes & strains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61500-5527-5</NDCCode>
<PackageDescription>170 g in 1 TUBE (61500-5527-5) </PackageDescription>
<NDC11Code>61500-5527-05</NDC11Code>
<ProductNDC>61500-5527</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Topricin</ProprietaryName>
<NonProprietaryName>Aesculus Hippocastanum, Arnica Montana, Belladonna, Crotalus Horridus, Echinacea, Graphites, Heloderma, Lachesis Mutus, Naja Tripudians, Rhus Toxicodendron, Ruta Graveolens</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160401</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Topical BioMedics, Inc.</LabelerName>
<SubstanceName>AESCULUS HIPPOCASTANUM FLOWER; ARNICA MONTANA; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA ANGUSTIFOLIA; GRAPHITE; HELODERMA HORRIDUM VENOM; LACHESIS MUTA VENOM; NAJA NAJA VENOM; RUTA GRAVEOLENS FLOWERING TOP; ATROPA BELLADONNA; TOXICODENDRON PUBESCENS LEAF</SubstanceName>
<StrengthNumber>6; 6; 8; 6; 6; 8; 8; 8; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-10-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rapid, soothing relief of pain, stiffness, tingling, or burning nerve pain associated with. Arthritis and other joint pain and discomfort. Fibromyalgia. Carpal Tunnel Syndrome and other types of nerve pain. Pains & muscle cramps of the back, neck, shoulder, legs, hands & feet. Sports injuries (muscle pulls & soreness, impact, sprains, dislocations). Repetitive motion injuries, such as bursitis, tendonitis and sciatica. First Aid for simple trauma (bruises, minor burns, cuts, scrapes & strains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61500-5527-6</NDCCode>
<PackageDescription>454 g in 1 BOTTLE (61500-5527-6) </PackageDescription>
<NDC11Code>61500-5527-06</NDC11Code>
<ProductNDC>61500-5527</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Topricin</ProprietaryName>
<NonProprietaryName>Aesculus Hippocastanum, Arnica Montana, Belladonna, Crotalus Horridus, Echinacea, Graphites, Heloderma, Lachesis Mutus, Naja Tripudians, Rhus Toxicodendron, Ruta Graveolens</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160401</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Topical BioMedics, Inc.</LabelerName>
<SubstanceName>AESCULUS HIPPOCASTANUM FLOWER; ARNICA MONTANA; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA ANGUSTIFOLIA; GRAPHITE; HELODERMA HORRIDUM VENOM; LACHESIS MUTA VENOM; NAJA NAJA VENOM; RUTA GRAVEOLENS FLOWERING TOP; ATROPA BELLADONNA; TOXICODENDRON PUBESCENS LEAF</SubstanceName>
<StrengthNumber>6; 6; 8; 6; 6; 8; 8; 8; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-10-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rapid, soothing relief of pain, stiffness, tingling, or burning nerve pain associated with. Arthritis and other joint pain and discomfort. Fibromyalgia. Carpal Tunnel Syndrome and other types of nerve pain. Pains & muscle cramps of the back, neck, shoulder, legs, hands & feet. Sports injuries (muscle pulls & soreness, impact, sprains, dislocations). Repetitive motion injuries, such as bursitis, tendonitis and sciatica. First Aid for simple trauma (bruises, minor burns, cuts, scrapes & strains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61500-5587-3</NDCCode>
<PackageDescription>88 mL in 1 TUBE (61500-5587-3)</PackageDescription>
<NDC11Code>61500-5587-03</NDC11Code>
<ProductNDC>61500-5587</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>My Pain Away</ProprietaryName>
<NonProprietaryName>Aesculus Hippocastanum, Arnica Montana, Belladonna, Crotalus Horridus, Echinacea, Graphites, Heloderma, Lachesis Mutus, Naja Tripudians, Rhus Toxicodendron, Ruta Graveolens</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20141001</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Topical BioMedics, Inc.</LabelerName>
<SubstanceName>AESCULUS HIPPOCASTANUM FLOWER; ARNICA MONTANA; ATROPA BELLADONNA; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA ANGUSTIFOLIA; GRAPHITE; HELODERMA HORRIDUM VENOM; LACHESIS MUTA VENOM; NAJA NAJA VENOM; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP</SubstanceName>
<StrengthNumber>6; 6; 6; 8; 6; 6; 8; 8; 8; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Rapid soothing relief of muscle pain at tender points or nerve pain associated with Fibromyalgia and Neuropathy.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>41595-5547-1</NDCCode>
<PackageDescription>73 g in 1 CANISTER (41595-5547-1) </PackageDescription>
<NDC11Code>41595-5547-01</NDC11Code>
<ProductNDC>41595-5547</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Sure Invisible Solid Nourishing Coconut</ProprietaryName>
<NonProprietaryName>Aluminum Zirconium Tricholorohydrex Gly</NonProprietaryName>
<DosageFormName>STICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20190101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part350</ApplicationNumber>
<LabelerName>Idelle Labs, Ltd</LabelerName>
<SubstanceName>ALUMINUM ZIRCONIUM TRICHLOROHYDREX GLY</SubstanceName>
<StrengthNumber>19</StrengthNumber>
<StrengthUnit>g/100g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20190101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Reduces underarm wetness.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>58420-007-04</NDCCode>
<PackageDescription>5547 L in 1 CYLINDER (58420-007-04)</PackageDescription>
<NDC11Code>58420-0007-04</NDC11Code>
<ProductNDC>58420-007</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Helium Oxygen Mixture</ProprietaryName>
<NonProprietaryName>Helium Oxygen Mixture</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19980101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED MEDICAL GAS</MarketingCategoryName>
<LabelerName>Airgas Intermountain Inc</LabelerName>
<SubstanceName>HELIUM; OXYGEN</SubstanceName>
<StrengthNumber>800; 200</StrengthNumber>
<StrengthUnit>mL/L; mL/L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>62670-5547-0</NDCCode>
<PackageDescription>29 mL in 1 BOTTLE (62670-5547-0) </PackageDescription>
<NDC11Code>62670-5547-00</NDC11Code>
<ProductNDC>62670-5547</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Anti-bacterial Hand</ProprietaryName>
<ProprietaryNameSuffix>Merry Cookie</ProprietaryNameSuffix>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20181206</StartMarketingDate>
<EndMarketingDate>20190606</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333E</ApplicationNumber>
<LabelerName>Bath & Body Works, Inc.</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>68</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-06-07</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20181206</StartMarketingDatePackage>
<EndMarketingDatePackage>20190606</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>50458-342-60</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (50458-342-60) > 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>50458-0342-60</NDC11Code>
<ProductNDC>50458-342</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pancreaze</ProprietaryName>
<NonProprietaryName>Pancrelipase</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100412</StartMarketingDate>
<EndMarketingDate>20190831</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022523</ApplicationNumber>
<LabelerName>Janssen Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>PANCRELIPASE LIPASE; PANCRELIPASE AMYLASE; PANCRELIPASE PROTEASE</SubstanceName>
<StrengthNumber>10500; 61500; 35500</StrengthNumber>
<StrengthUnit>[USP'U]/1; [USP'U]/1; [USP'U]/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20100412</StartMarketingDatePackage>
<EndMarketingDatePackage>20190831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>62541-403-10</NDCCode>
<PackageDescription>1 BOTTLE, GLASS in 1 CARTON (62541-403-10) / 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE, GLASS</PackageDescription>
<NDC11Code>62541-0403-10</NDC11Code>
<ProductNDC>62541-403</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pancreaze</ProprietaryName>
<NonProprietaryName>Pancrelipase Lipase, Pancrelipase Amylase, And Pancrelipase Protease</NonProprietaryName>
<DosageFormName>CAPSULE, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100412</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA022523</ApplicationNumber>
<LabelerName>VIVUS LLC</LabelerName>
<SubstanceName>PANCRELIPASE LIPASE; PANCRELIPASE AMYLASE; PANCRELIPASE PROTEASE</SubstanceName>
<StrengthNumber>10500; 61500; 35500</StrengthNumber>
<StrengthUnit>[USP'U]/1; [USP'U]/1; [USP'U]/1</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-06-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100412</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>PANCREAZE is indicated for the treatment of exocrine pancreatic insufficiency in adult and pediatric patients.</IndicationAndUsage>
<Description>Pancrelipase is a pancreatic enzyme product consisting of a mixture of enzymes including lipases, proteases, and amylases and is an extract derived from porcine pancreatic glands. The enteric-coated microtablets in PANCREAZE are formulated to release pancreatic enzymes at an approximate pH of 5.5 or greater. PANCREAZE (pancrelipase) delayed-release capsules are for oral administration and include a two-piece shell containing enteric-coated microtablets that are each approximately 2 mm in diameter and are available as follows.</Description>
</NDC>
<NDC>
<NDCCode>0002-0213-01</NDCCode>
<PackageDescription>1 VIAL, MULTI-DOSE in 1 CARTON (0002-0213-01) / 3 mL in 1 VIAL, MULTI-DOSE</PackageDescription>
<NDC11Code>00002-0213-01</NDC11Code>
<ProductNDC>0002-0213</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Humulin</ProprietaryName>
<ProprietaryNameSuffix>R</ProprietaryNameSuffix>
<NonProprietaryName>Insulin Human</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>PARENTERAL</RouteName>
<StartMarketingDate>19830627</StartMarketingDate>
<EndMarketingDate>20261215</EndMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA018780</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>INSULIN HUMAN</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>[iU]/mL</StrengthUnit>
<Pharm_Classes>Insulin [CS], Insulin [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-09-08</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20230620</StartMarketingDatePackage>
<EndMarketingDatePackage>20261215</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>HUMULIN R is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.</IndicationAndUsage>
<Description>Insulin human is produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli and has the empirical formula C257H383N65O77S6 with a molecular weight of 5.808 kDa. HUMULIN R (insulin human) injection is a short-acting human insulin for subcutaneous or intravenous use. HUMULIN R is a sterile, aqueous, clear, and colorless solution. HUMULIN R contains 100 units of insulin human in each milliliter. Each milliliter of HUMULIN R also contains glycerin (16 mg), metacresol (2.5 mg), endogenous zinc (approximately 0.015 mg/100 units,) and Water for Injection. Sodium hydroxide and hydrochloric acid may be added during manufacture to adjust the pH. The pH is 7.0 to 7.8.</Description>
</NDC>
<NDC>
<NDCCode>0002-0485-01</NDCCode>
<PackageDescription>8 BOTTLE in 1 CONTAINER (0002-0485-01) > 2000 g in 1 BOTTLE</PackageDescription>
<NDC11Code>00002-0485-01</NDC11Code>
<ProductNDC>0002-0485</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Insulin Human</NonProprietaryName>
<DosageFormName>CRYSTAL</DosageFormName>
<StartMarketingDate>20150401</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>INSULIN HUMAN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0002-0535-01</NDCCode>
<PackageDescription>8 BOTTLE in 1 CONTAINER (0002-0535-01) > 2000 g in 1 BOTTLE</PackageDescription>
<NDC11Code>00002-0535-01</NDC11Code>
<ProductNDC>0002-0535</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Insulin Lispro</NonProprietaryName>
<DosageFormName>CRYSTAL</DosageFormName>
<StartMarketingDate>20140131</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>INSULIN LISPRO</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0002-0800-01</NDCCode>
<PackageDescription>1 VIAL in 1 CARTON (0002-0800-01) / 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>00002-0800-01</NDC11Code>
<ProductNDC>0002-0800</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sterile Diluent</ProprietaryName>
<NonProprietaryName>Diluent</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>19870710</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA020563</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>WATER</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mL/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2026-08-11</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19870710</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>HUMALOG is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus.</IndicationAndUsage>
<Description>Insulin lispro is a rapid-acting human insulin analog produced by recombinant DNA technology utilizing a non-pathogenic laboratory strain of Escherichia coli. Insulin lispro differs from human insulin in that the amino acid proline at position B28 is replaced by lysine and the lysine in position B29 is replaced by proline. Chemically, it is Lys(B28), Pro(B29) human insulin analog and has the empirical formula C257H383N65O77S6 and a molecular weight of 5.808 kDa, both identical to that of human insulin. Insulin lispro has the following primary structure:. HUMALOG (insulin lispro) injection is a sterile, clear, and colorless solution for subcutaneous or intravenous use. Each mL of HUMALOG U-100 contains 100 units of insulin lispro, and the inactive ingredients: dibasic sodium phosphate (1.0 mg), glycerin (16 mg), metacresol (3.15 mg), trace amounts of phenol, zinc oxide (content adjusted to provide 0.0197 mg zinc ion), and Water for Injection, USP. Each mL of HUMALOG U-200 contains 200 units of insulin lispro, and the inactive ingredients: glycerin (16 mg), metacresol (3.15 mg), trace amounts of phenol, tromethamine (5 mg), zinc oxide (content adjusted to provide 0.046 mg zinc ion), and Water for Injection, USP. HUMALOG has a pH of 7.0 to 7.8. Hydrochloric acid 10% and/or sodium hydroxide 10% is added to adjust the pH.</Description>
</NDC>
</NDCList>