{
"NDC": [
{
"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": "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": "61500-5547-8",
"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": "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": "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": "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": "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": "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": "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",
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"ProductNdcExcludeFlag": "N",
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"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."
},
{
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"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",
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},
{
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"PackageDescription": "88 mL in 1 TUBE (61500-5587-3)",
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"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",
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"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",
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"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."
},
{
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"PackageDescription": "1 BOTTLE, GLASS in 1 CARTON (62541-403-10) / 100 CAPSULE, DELAYED RELEASE in 1 BOTTLE, GLASS",
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"LabelerName": "VIVUS LLC",
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"StrengthNumber": "10500; 61500; 35500",
"StrengthUnit": "[USP'U]/1; [USP'U]/1; [USP'U]/1",
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"StartMarketingDatePackage": "20100412",
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"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."
},
{
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"ListingRecordCertifiedThrough": "20261231",
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{
"NDCCode": "0002-4178-31",
"PackageDescription": "1 BOTTLE in 1 CARTON (0002-4178-31) / 30 TABLET, FILM COATED in 1 BOTTLE (0002-4178-01) ",
"NDC11Code": "00002-4178-31",
"ProductNDC": "0002-4178",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"LabelerName": "Eli Lilly and Company",
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},
{
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"NDC11Code": "00002-4178-62",
"ProductNDC": "0002-4178",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"NonProprietaryName": "Orforglipron",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20260401",
"MarketingCategoryName": "NDA",
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"LabelerName": "Eli Lilly and Company",
"SubstanceName": "ORFORGLIPRON CALCIUM",
"StrengthNumber": ".8",
"StrengthUnit": "mg/1",
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"Status": "Active",
"LastUpdate": "2026-08-12",
"PackageNdcExcludeFlag": "N",
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"IndicationAndUsage": "FOUNDAYOTM is indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition.",
"Description": "FOUNDAYO contains orforglipron, a GLP-1 receptor agonist. The molecular formula for orforglipron calcium is C48H47F2N10O5.[0.5]Ca and the molecular weight is 902.0 g/mol. The chemical name is calcium bis{3-[(1S,2S)-1-({2-(4-fluoro-3,5-dimethylphenyl)-3-({3-[3-(4-fluoro-1-methyl-1H-indazol-5-yl)-2-oxo-2,3-dihydro-1H-imidazol-1-yl]-4-methyl-2,4,6,7-tetrahydro-5H-pyrazolo[4,3-c]pyridine-5-yl}carbonyl)-5-[(4S)-2,2-dimethyloxan-4-yl]-1H-indol-1-yl}-2-methylcyclopropyl]-5-oxo-1,2,4-oxadiazol-4(5H)-ide}. Orforglipron calcium has the following chemical structure:. Orforglipron calcium is a white to practically white to light brown solid that is hygroscopic. Orforglipron calcium is insoluble in water. FOUNDAYO tablets contain 0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg, or 17.2 mg of orforglipron (equivalent to 0.817 mg, 2.554 mg, 5.619 mg, 9.194 mg, 14.81 mg, and 17.57 mg of orforglipron calcium, respectively) as film-coated, debossed tablets for oral use. Each tablet contains the following inactive ingredients: copovidone, crospovidone, magnesium stearate, microcrystalline cellulose, and sodium carbonate anhydrous. The tablet film-coating material contains polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Additionally, the film coating of the: : 1 0.8 mg and 9 mg tablets contain ferric oxide red and ferric oxide yellow , 2 2.5 mg and 14.5 mg tablets contain ferric oxide yellow , 3 5.5 mg and 17.2 mg tablets contain ferrosoferric oxide and ferric oxide red. ."
}
]
}
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<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>
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<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>61500-5547-8</NDCCode>
<PackageDescription>454 g in 1 BOTTLE (61500-5547-8) </PackageDescription>
<NDC11Code>61500-5547-08</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>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>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>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>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>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>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>61500-5527-8</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>61500-5587-3</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>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>0002-1401-71</NDCCode>
<PackageDescription>9 TRAY in 1 BOX (0002-1401-71) / 160 SYRINGE in 1 TRAY / .5 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>00002-1401-71</NDC11Code>
<ProductNDC>0002-1401</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Dulaglutide</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<StartMarketingDate>20140922</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>DULAGLUTIDE</SubstanceName>
<StrengthNumber>.75</StrengthNumber>
<StrengthUnit>mg/.5mL</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-12-23</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>22-SEP-14</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>0002-1402-71</NDCCode>
<PackageDescription>9 TRAY in 1 BOX (0002-1402-71) / 160 SYRINGE in 1 TRAY / .5 mL in 1 SYRINGE</PackageDescription>
<NDC11Code>00002-1402-71</NDC11Code>
<ProductNDC>0002-1402</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Dulaglutide</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<StartMarketingDate>20140922</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>DULAGLUTIDE</SubstanceName>
<StrengthNumber>1.5</StrengthNumber>
<StrengthUnit>mg/.5mL</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-12-23</LastUpdate>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>22-SEP-14</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>0002-4178-31</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0002-4178-31) / 30 TABLET, FILM COATED in 1 BOTTLE (0002-4178-01) </PackageDescription>
<NDC11Code>00002-4178-31</NDC11Code>
<ProductNDC>0002-4178</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Foundayo</ProprietaryName>
<NonProprietaryName>Orforglipron</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260401</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA220934</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>ORFORGLIPRON CALCIUM</SubstanceName>
<StrengthNumber>.8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Gastric Motility [PE], GLP-1 Receptor Agonist [EPC], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA], Increased Gastric Muscle Tone [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>FOUNDAYOTM is indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition.</IndicationAndUsage>
<Description>FOUNDAYO contains orforglipron, a GLP-1 receptor agonist. The molecular formula for orforglipron calcium is C48H47F2N10O5.[0.5]Ca and the molecular weight is 902.0 g/mol. The chemical name is calcium bis{3-[(1S,2S)-1-({2-(4-fluoro-3,5-dimethylphenyl)-3-({3-[3-(4-fluoro-1-methyl-1H-indazol-5-yl)-2-oxo-2,3-dihydro-1H-imidazol-1-yl]-4-methyl-2,4,6,7-tetrahydro-5H-pyrazolo[4,3-c]pyridine-5-yl}carbonyl)-5-[(4S)-2,2-dimethyloxan-4-yl]-1H-indol-1-yl}-2-methylcyclopropyl]-5-oxo-1,2,4-oxadiazol-4(5H)-ide}. Orforglipron calcium has the following chemical structure:. Orforglipron calcium is a white to practically white to light brown solid that is hygroscopic. Orforglipron calcium is insoluble in water. FOUNDAYO tablets contain 0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg, or 17.2 mg of orforglipron (equivalent to 0.817 mg, 2.554 mg, 5.619 mg, 9.194 mg, 14.81 mg, and 17.57 mg of orforglipron calcium, respectively) as film-coated, debossed tablets for oral use. Each tablet contains the following inactive ingredients: copovidone, crospovidone, magnesium stearate, microcrystalline cellulose, and sodium carbonate anhydrous. The tablet film-coating material contains polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Additionally, the film coating of the: : 1 0.8 mg and 9 mg tablets contain ferric oxide red and ferric oxide yellow , 2 2.5 mg and 14.5 mg tablets contain ferric oxide yellow , 3 5.5 mg and 17.2 mg tablets contain ferrosoferric oxide and ferric oxide red. .</Description>
</NDC>
<NDC>
<NDCCode>0002-4178-62</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0002-4178-62) / 30 TABLET, FILM COATED in 1 BOTTLE</PackageDescription>
<NDC11Code>00002-4178-62</NDC11Code>
<ProductNDC>0002-4178</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Foundayo</ProprietaryName>
<NonProprietaryName>Orforglipron</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260401</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA220934</ApplicationNumber>
<LabelerName>Eli Lilly and Company</LabelerName>
<SubstanceName>ORFORGLIPRON CALCIUM</SubstanceName>
<StrengthNumber>.8</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Decreased Gastric Motility [PE], GLP-1 Receptor Agonist [EPC], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA], Increased Gastric Muscle Tone [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260401</StartMarketingDatePackage>
<SamplePackage>Y</SamplePackage>
<IndicationAndUsage>FOUNDAYOTM is indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults with obesity or adults with overweight in the presence of at least one weight-related comorbid condition.</IndicationAndUsage>
<Description>FOUNDAYO contains orforglipron, a GLP-1 receptor agonist. The molecular formula for orforglipron calcium is C48H47F2N10O5.[0.5]Ca and the molecular weight is 902.0 g/mol. The chemical name is calcium bis{3-[(1S,2S)-1-({2-(4-fluoro-3,5-dimethylphenyl)-3-({3-[3-(4-fluoro-1-methyl-1H-indazol-5-yl)-2-oxo-2,3-dihydro-1H-imidazol-1-yl]-4-methyl-2,4,6,7-tetrahydro-5H-pyrazolo[4,3-c]pyridine-5-yl}carbonyl)-5-[(4S)-2,2-dimethyloxan-4-yl]-1H-indol-1-yl}-2-methylcyclopropyl]-5-oxo-1,2,4-oxadiazol-4(5H)-ide}. Orforglipron calcium has the following chemical structure:. Orforglipron calcium is a white to practically white to light brown solid that is hygroscopic. Orforglipron calcium is insoluble in water. FOUNDAYO tablets contain 0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg, or 17.2 mg of orforglipron (equivalent to 0.817 mg, 2.554 mg, 5.619 mg, 9.194 mg, 14.81 mg, and 17.57 mg of orforglipron calcium, respectively) as film-coated, debossed tablets for oral use. Each tablet contains the following inactive ingredients: copovidone, crospovidone, magnesium stearate, microcrystalline cellulose, and sodium carbonate anhydrous. The tablet film-coating material contains polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. Additionally, the film coating of the: : 1 0.8 mg and 9 mg tablets contain ferric oxide red and ferric oxide yellow , 2 2.5 mg and 14.5 mg tablets contain ferric oxide yellow , 3 5.5 mg and 17.2 mg tablets contain ferrosoferric oxide and ferric oxide red. .</Description>
</NDC>
</NDCList>