{
"NDC": [
{
"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",
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},
{
"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",
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"Status": "Active",
"LastUpdate": "2025-10-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160401",
"SamplePackage": "N",
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},
{
"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",
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"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",
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"Status": "Active",
"LastUpdate": "2025-10-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160401",
"SamplePackage": "N",
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},
{
"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",
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"Status": "Active",
"LastUpdate": "2025-10-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160401",
"SamplePackage": "N",
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},
{
"NDCCode": "61500-5527-6",
"PackageDescription": "454 g in 1 BOTTLE (61500-5527-6) ",
"NDC11Code": "61500-5527-06",
"ProductNDC": "61500-5527",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Topricin",
"NonProprietaryName": "Aesculus Hippocastanum, Arnica Montana, Belladonna, Crotalus Horridus, Echinacea, Graphites, Heloderma, Lachesis Mutus, Naja Tripudians, Rhus Toxicodendron, Ruta Graveolens",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160401",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Topical BioMedics, Inc.",
"SubstanceName": "AESCULUS HIPPOCASTANUM FLOWER; ARNICA MONTANA; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA ANGUSTIFOLIA; GRAPHITE; HELODERMA HORRIDUM VENOM; LACHESIS MUTA VENOM; NAJA NAJA VENOM; RUTA GRAVEOLENS FLOWERING TOP; ATROPA BELLADONNA; TOXICODENDRON PUBESCENS LEAF",
"StrengthNumber": "6; 6; 8; 6; 6; 8; 8; 8; 6; 6; 6",
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"Status": "Active",
"LastUpdate": "2025-10-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160401",
"SamplePackage": "N",
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},
{
"NDCCode": "61500-5527-8",
"PackageDescription": "227 g in 1 BOTTLE (61500-5527-8) ",
"NDC11Code": "61500-5527-08",
"ProductNDC": "61500-5527",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Topricin",
"NonProprietaryName": "Aesculus Hippocastanum, Arnica Montana, Belladonna, Crotalus Horridus, Echinacea, Graphites, Heloderma, Lachesis Mutus, Naja Tripudians, Rhus Toxicodendron, Ruta Graveolens",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160401",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Topical BioMedics, Inc.",
"SubstanceName": "AESCULUS HIPPOCASTANUM FLOWER; ARNICA MONTANA; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA ANGUSTIFOLIA; GRAPHITE; HELODERMA HORRIDUM VENOM; LACHESIS MUTA VENOM; NAJA NAJA VENOM; RUTA GRAVEOLENS FLOWERING TOP; ATROPA BELLADONNA; TOXICODENDRON PUBESCENS LEAF",
"StrengthNumber": "6; 6; 8; 6; 6; 8; 8; 8; 6; 6; 6",
"StrengthUnit": "[hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g",
"Status": "Active",
"LastUpdate": "2025-10-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160401",
"SamplePackage": "N",
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},
{
"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",
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"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",
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"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": "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": "61500-5587-3",
"PackageDescription": "88 mL in 1 TUBE (61500-5587-3)",
"NDC11Code": "61500-5587-03",
"ProductNDC": "61500-5587",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "My Pain Away",
"NonProprietaryName": "Aesculus Hippocastanum, Arnica Montana, Belladonna, Crotalus Horridus, Echinacea, Graphites, Heloderma, Lachesis Mutus, Naja Tripudians, Rhus Toxicodendron, Ruta Graveolens",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20141001",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Topical BioMedics, Inc.",
"SubstanceName": "AESCULUS HIPPOCASTANUM FLOWER; ARNICA MONTANA; ATROPA BELLADONNA; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA ANGUSTIFOLIA; GRAPHITE; HELODERMA HORRIDUM VENOM; LACHESIS MUTA VENOM; NAJA NAJA VENOM; TOXICODENDRON PUBESCENS LEAF; RUTA GRAVEOLENS FLOWERING TOP",
"StrengthNumber": "6; 6; 6; 8; 6; 6; 8; 8; 8; 6; 6",
"StrengthUnit": "[hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL; [hp_X]/88mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231",
"IndicationAndUsage": "Rapid soothing relief of muscle pain at tender points or nerve pain associated with Fibromyalgia and Neuropathy."
},
{
"NDCCode": "0054-0115-13",
"PackageDescription": "30 TABLET in 1 BOTTLE (0054-0115-13)",
"NDC11Code": "00054-0115-13",
"ProductNDC": "0054-0115",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valacyclovir",
"NonProprietaryName": "Valacyclovir",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100524",
"EndMarketingDate": "20190130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078656",
"LabelerName": "West-Ward Pharmaceuticals Corp.",
"SubstanceName": "VALACYCLOVIR HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/1",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2019-01-30",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "0054-0115-27",
"PackageDescription": "250 TABLET in 1 BOTTLE (0054-0115-27)",
"NDC11Code": "00054-0115-27",
"ProductNDC": "0054-0115",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Valacyclovir",
"NonProprietaryName": "Valacyclovir",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20100524",
"EndMarketingDate": "20190130",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078656",
"LabelerName": "West-Ward Pharmaceuticals Corp.",
"SubstanceName": "VALACYCLOVIR HYDROCHLORIDE",
"StrengthNumber": "1",
"StrengthUnit": "g/1",
"Pharm_Classes": "DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient]",
"Status": "Deprecated",
"LastUpdate": "2019-01-30",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "0067-0115-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (0067-0115-01) / 237 mL in 1 BOTTLE",
"NDC11Code": "00067-0115-01",
"ProductNDC": "0067-0115",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Theraflu-d Flu Relief Max Strength Plus Nasal Decongestant",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hbr, Pseudoephedrine Hcl",
"DosageFormName": "SYRUP",
"RouteName": "ORAL",
"StartMarketingDate": "20240619",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M012",
"LabelerName": "Haleon US Holdings LLC",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE",
"StrengthNumber": "1000; 30; 60",
"StrengthUnit": "mg/30mL; mg/30mL; mg/30mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2024-06-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240619",
"SamplePackage": "N",
"IndicationAndUsage": "temporarily relieves these symptoms due to a common cold or flu: headacheminor aches and painsminor sore throat paincough due to minor throat and bronchial irritationnasal and sinus congestion. temporarily reduces fever."
},
{
"NDCCode": "0115-0511-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (0115-0511-01) ",
"NDC11Code": "00115-0511-01",
"ProductNDC": "0115-0511",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fenofibrate",
"NonProprietaryName": "Fenofibrate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100201",
"EndMarketingDate": "20231207",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075868",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "FENOFIBRATE",
"StrengthNumber": "67",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-12-08",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20100201",
"EndMarketingDatePackage": "20231207",
"SamplePackage": "N",
"IndicationAndUsage": "Treatment of Hypercholesterolemia. Fenofibrate capsules are indicated as adjunctive therapy to diet for the reduction of LDL-C, Total-C, Triglycerides and Apo B in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb). Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate (see National Cholesterol Education Program [NCEP] Treatment Guidelines, below). Treatment of Hypertriglyceridemia. Fenofibrate capsules are also indicated as adjunctive therapy to diet for treatment of adult patients with hypertriglyceridemia (Fredrickson Types IV and V hyperlipidemia). Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually reduce fasting triglycerides and eliminate chylomicronemia thereby obviating the need for pharmacologic intervention. Markedly elevated levels of serum triglycerides (e.g., > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been adequately studied. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV and V hyperlipoproteinemia2. The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcoholic intake may be important factors in hypertriglyceridemia and should be addressed prior to any drug therapy. Physical exercise can be an important ancillary measure. Diseases contributory to hyperlipidemia, such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy, like thiazide diuretics and beta-blockers, is sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of the specific etiologic agent may obviate the need for specific drug therapy of hypertriglyceridemia. The use of drugs should be considered only when reasonable attempts have been made to obtain satisfactory results with non-drug methods. If the decision is made to use drugs, the patient should be instructed that this does not reduce the importance of adhering to diet (see WARNINGS and PRECAUTIONS). Fredrickson Classification of Hyperlipoproteinemias. The NCEP Treatment Guidelines.",
"Description": "Fenofibrate capsules (micronized), is a lipid regulating agent available as capsules for oral administration. Each capsule contains 67 mg, 134 mg or 200 mg of micronized fenofibrate. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79° to 82°C. Fenofibrate is a white solid which is stable under ordinary conditions. Inactive Ingredients: The inactive ingredients in fenofibrate capsules include croscarmellose sodium, hypromellose type 2910/6 cP, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. The capsule shells contain gelatin and titanium dioxide. The 67 mg capsule shells also contain D&C Yellow No. 10 and FD&C Yellow No. 6. The 200 mg capsule shells also contain D&C Red No. 28, D&C Yellow No. 10, and FD&C Red No. 40. Additionally, the capsule imprint ink contains shellac glaze, ferrosoferric oxide, propylene glycol, FD&C Blue No. 2, FD&C Red No. 40, D&C Yellow No. 10 Aluminum Lake, and FD&C Blue No. 1."
},
{
"NDCCode": "0115-0522-01",
"PackageDescription": "100 CAPSULE in 1 BOTTLE (0115-0522-01) ",
"NDC11Code": "00115-0522-01",
"ProductNDC": "0115-0522",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fenofibrate",
"NonProprietaryName": "Fenofibrate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075868",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "FENOFIBRATE",
"StrengthNumber": "134",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20100201",
"SamplePackage": "N",
"IndicationAndUsage": "Treatment of Hypercholesterolemia. Fenofibrate capsules are indicated as adjunctive therapy to diet for the reduction of LDL-C, Total-C, Triglycerides and Apo B in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb). Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate (see National Cholesterol Education Program [NCEP] Treatment Guidelines, below). Treatment of Hypertriglyceridemia. Fenofibrate capsules are also indicated as adjunctive therapy to diet for treatment of adult patients with hypertriglyceridemia (Fredrickson Types IV and V hyperlipidemia). Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually reduce fasting triglycerides and eliminate chylomicronemia thereby obviating the need for pharmacologic intervention. Markedly elevated levels of serum triglycerides (e.g., > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been adequately studied. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV and V hyperlipoproteinemia2. The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcoholic intake may be important factors in hypertriglyceridemia and should be addressed prior to any drug therapy. Physical exercise can be an important ancillary measure. Diseases contributory to hyperlipidemia, such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy, like thiazide diuretics and beta-blockers, is sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of the specific etiologic agent may obviate the need for specific drug therapy of hypertriglyceridemia. The use of drugs should be considered only when reasonable attempts have been made to obtain satisfactory results with non-drug methods. If the decision is made to use drugs, the patient should be instructed that this does not reduce the importance of adhering to diet (see WARNINGS and PRECAUTIONS). Fredrickson Classification of Hyperlipoproteinemias. The NCEP Treatment Guidelines.",
"Description": "Fenofibrate capsules (micronized), is a lipid regulating agent available as capsules for oral administration. Each capsule contains 67 mg, 134 mg or 200 mg of micronized fenofibrate. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79° to 82°C. Fenofibrate is a white solid which is stable under ordinary conditions. Inactive Ingredients: The inactive ingredients in fenofibrate capsules include croscarmellose sodium, hypromellose type 2910/6 cP, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. The capsule shells contain gelatin and titanium dioxide. The 67 mg capsule shells also contain D&C Yellow No. 10 and FD&C Yellow No. 6. The 200 mg capsule shells also contain D&C Red No. 28, D&C Yellow No. 10, and FD&C Red No. 40. Additionally, the capsule imprint ink contains shellac glaze, ferrosoferric oxide, propylene glycol, FD&C Blue No. 2, FD&C Red No. 40, D&C Yellow No. 10 Aluminum Lake, and FD&C Blue No. 1."
},
{
"NDCCode": "0115-0522-02",
"PackageDescription": "500 CAPSULE in 1 BOTTLE (0115-0522-02) ",
"NDC11Code": "00115-0522-02",
"ProductNDC": "0115-0522",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Fenofibrate",
"NonProprietaryName": "Fenofibrate",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100201",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075868",
"LabelerName": "Amneal Pharmaceuticals of New York LLC",
"SubstanceName": "FENOFIBRATE",
"StrengthNumber": "134",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Peroxisome Proliferator Receptor alpha Agonist [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20100201",
"SamplePackage": "N",
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"IndicationAndUsage": "Treatment of Hypercholesterolemia. Fenofibrate capsules are indicated as adjunctive therapy to diet for the reduction of LDL-C, Total-C, Triglycerides and Apo B in adult patients with primary hypercholesterolemia or mixed dyslipidemia (Fredrickson Types IIa and IIb). Lipid-altering agents should be used in addition to a diet restricted in saturated fat and cholesterol when response to diet and non-pharmacological interventions alone has been inadequate (see National Cholesterol Education Program [NCEP] Treatment Guidelines, below). Treatment of Hypertriglyceridemia. Fenofibrate capsules are also indicated as adjunctive therapy to diet for treatment of adult patients with hypertriglyceridemia (Fredrickson Types IV and V hyperlipidemia). Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually reduce fasting triglycerides and eliminate chylomicronemia thereby obviating the need for pharmacologic intervention. Markedly elevated levels of serum triglycerides (e.g., > 2,000 mg/dL) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been adequately studied. Drug therapy is not indicated for patients with Type I hyperlipoproteinemia, who have elevations of chylomicrons and plasma triglycerides, but who have normal levels of very low density lipoprotein (VLDL). Inspection of plasma refrigerated for 14 hours is helpful in distinguishing Types I, IV and V hyperlipoproteinemia2. The initial treatment for dyslipidemia is dietary therapy specific for the type of lipoprotein abnormality. Excess body weight and excess alcoholic intake may be important factors in hypertriglyceridemia and should be addressed prior to any drug therapy. Physical exercise can be an important ancillary measure. Diseases contributory to hyperlipidemia, such as hypothyroidism or diabetes mellitus should be looked for and adequately treated. Estrogen therapy, like thiazide diuretics and beta-blockers, is sometimes associated with massive rises in plasma triglycerides, especially in subjects with familial hypertriglyceridemia. In such cases, discontinuation of the specific etiologic agent may obviate the need for specific drug therapy of hypertriglyceridemia. The use of drugs should be considered only when reasonable attempts have been made to obtain satisfactory results with non-drug methods. If the decision is made to use drugs, the patient should be instructed that this does not reduce the importance of adhering to diet (see WARNINGS and PRECAUTIONS). Fredrickson Classification of Hyperlipoproteinemias. The NCEP Treatment Guidelines.",
"Description": "Fenofibrate capsules (micronized), is a lipid regulating agent available as capsules for oral administration. Each capsule contains 67 mg, 134 mg or 200 mg of micronized fenofibrate. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79° to 82°C. Fenofibrate is a white solid which is stable under ordinary conditions. Inactive Ingredients: The inactive ingredients in fenofibrate capsules include croscarmellose sodium, hypromellose type 2910/6 cP, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. The capsule shells contain gelatin and titanium dioxide. The 67 mg capsule shells also contain D&C Yellow No. 10 and FD&C Yellow No. 6. The 200 mg capsule shells also contain D&C Red No. 28, D&C Yellow No. 10, and FD&C Red No. 40. Additionally, the capsule imprint ink contains shellac glaze, ferrosoferric oxide, propylene glycol, FD&C Blue No. 2, FD&C Red No. 40, D&C Yellow No. 10 Aluminum Lake, and FD&C Blue No. 1."
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"Description": "Fenofibrate capsules (micronized), is a lipid regulating agent available as capsules for oral administration. Each capsule contains 67 mg, 134 mg or 200 mg of micronized fenofibrate. The chemical name for fenofibrate is 2-[4-(4-chlorobenzoyl) phenoxy]-2-methyl-propanoic acid, 1-methylethyl ester with the following structural formula. The empirical formula is C20H21O4Cl and the molecular weight is 360.83; fenofibrate is insoluble in water. The melting point is 79° to 82°C. Fenofibrate is a white solid which is stable under ordinary conditions. Inactive Ingredients: The inactive ingredients in fenofibrate capsules include croscarmellose sodium, hypromellose type 2910/6 cP, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate. The capsule shells contain gelatin and titanium dioxide. The 67 mg capsule shells also contain D&C Yellow No. 10 and FD&C Yellow No. 6. The 200 mg capsule shells also contain D&C Red No. 28, D&C Yellow No. 10, and FD&C Red No. 40. Additionally, the capsule imprint ink contains shellac glaze, ferrosoferric oxide, propylene glycol, FD&C Blue No. 2, FD&C Red No. 40, D&C Yellow No. 10 Aluminum Lake, and FD&C Blue No. 1."
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"ProductNDC": "0115-0671",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"NonProprietaryName": "Zolmitriptan",
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"EndMarketingDate": "20190331",
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"LastUpdate": "2019-11-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
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"EndMarketingDatePackage": "20191031",
"SamplePackage": "N"
},
{
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"NDC11Code": "00115-0691-51",
"ProductNDC": "0115-0691",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zolmitriptan Orally Disintegrating",
"NonProprietaryName": "Zolmitriptan",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
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"Pharm_Classes": "Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]",
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"LastUpdate": "2020-09-01",
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"ProductNdcExcludeFlag": "N",
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"EndMarketingDatePackage": "20200831",
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{
"NDCCode": "0115-0692-50",
"PackageDescription": "1 BLISTER PACK in 1 CARTON (0115-0692-50) > 3 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK",
"NDC11Code": "00115-0692-50",
"ProductNDC": "0115-0692",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Zolmitriptan Orally Disintegrating",
"NonProprietaryName": "Zolmitriptan",
"DosageFormName": "TABLET, ORALLY DISINTEGRATING",
"RouteName": "ORAL",
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"ProductNdcExcludeFlag": "N",
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{
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"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
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"LabelerName": "Amneal Pharmaceuticals of New York LLC",
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"Description": "Baclofen, USP is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The structural formula is. C10H12ClNO2 M.W. 213.66. Baclofen, USP is a white to off-white, odorless, or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg, 10 mg or 20 mg baclofen, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate."
},
{
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"LabelerName": "Amneal Pharmaceuticals of New York LLC",
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"SamplePackage": "N",
"IndicationAndUsage": "Baclofen tablets are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson’s disease has not been established and, therefore, it is not recommended for these conditions.",
"Description": "Baclofen, USP is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The structural formula is. C10H12ClNO2 M.W. 213.66. Baclofen, USP is a white to off-white, odorless, or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg, 10 mg or 20 mg baclofen, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate."
}
]
}
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</NDC>
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<SamplePackage>N</SamplePackage>
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</NDC>
<NDC>
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<SamplePackage>N</SamplePackage>
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</NDC>
<NDC>
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</NDC>
<NDC>
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<SamplePackage>N</SamplePackage>
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</NDC>
<NDC>
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<LabelerName>Topical BioMedics, Inc.</LabelerName>
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<Status>Active</Status>
<LastUpdate>2025-10-22</LastUpdate>
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<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
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</NDC>
<NDC>
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<StartMarketingDate>20141001</StartMarketingDate>
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<LabelerName>Topical BioMedics, Inc.</LabelerName>
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<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>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20100524</StartMarketingDate>
<EndMarketingDate>20190130</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078656</ApplicationNumber>
<LabelerName>West-Ward Pharmaceuticals Corp.</LabelerName>
<SubstanceName>VALACYCLOVIR HYDROCHLORIDE</SubstanceName>
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<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-01-30</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
</NDC>
<NDC>
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<EndMarketingDate>20190130</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078656</ApplicationNumber>
<LabelerName>West-Ward Pharmaceuticals Corp.</LabelerName>
<SubstanceName>VALACYCLOVIR HYDROCHLORIDE</SubstanceName>
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<StrengthUnit>g/1</StrengthUnit>
<Pharm_Classes>DNA Polymerase Inhibitors [MoA],Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC],Nucleoside Analog [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-01-30</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
</NDC>
<NDC>
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<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Theraflu-d Flu Relief Max Strength Plus Nasal Decongestant</ProprietaryName>
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<DosageFormName>SYRUP</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240619</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M012</ApplicationNumber>
<LabelerName>Haleon US Holdings LLC</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE</SubstanceName>
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<StrengthUnit>mg/30mL; mg/30mL; mg/30mL</StrengthUnit>
<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-06-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240619</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>temporarily relieves these symptoms due to a common cold or flu: headacheminor aches and painsminor sore throat paincough due to minor throat and bronchial irritationnasal and sinus congestion. temporarily reduces fever.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0115-0511-01</NDCCode>
<PackageDescription>100 CAPSULE in 1 BOTTLE (0115-0511-01) </PackageDescription>
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<ProductNDC>0115-0511</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20100201</StartMarketingDate>
<EndMarketingDate>20231207</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075868</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
<SubstanceName>FENOFIBRATE</SubstanceName>
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<Pharm_Classes>Serotonin 1b Receptor Agonists [MoA],Serotonin 1d Receptor Agonists [MoA],Serotonin-1b and Serotonin-1d Receptor Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20130514</StartMarketingDatePackage>
<EndMarketingDatePackage>20190831</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0115-1010-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0115-1010-01) </PackageDescription>
<NDC11Code>00115-1010-01</NDC11Code>
<ProductNDC>0115-1010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Baclofen</ProprietaryName>
<NonProprietaryName>Baclofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20071027</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077971</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
<SubstanceName>BACLOFEN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20071027</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Baclofen tablets are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson’s disease has not been established and, therefore, it is not recommended for these conditions.</IndicationAndUsage>
<Description>Baclofen, USP is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The structural formula is. C10H12ClNO2 M.W. 213.66. Baclofen, USP is a white to off-white, odorless, or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg, 10 mg or 20 mg baclofen, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate.</Description>
</NDC>
<NDC>
<NDCCode>0115-1010-02</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (0115-1010-02) </PackageDescription>
<NDC11Code>00115-1010-02</NDC11Code>
<ProductNDC>0115-1010</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Baclofen</ProprietaryName>
<NonProprietaryName>Baclofen</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20071027</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077971</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals of New York LLC</LabelerName>
<SubstanceName>BACLOFEN</SubstanceName>
<StrengthNumber>10</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-01-15</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20071027</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Baclofen tablets are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson’s disease has not been established and, therefore, it is not recommended for these conditions.</IndicationAndUsage>
<Description>Baclofen, USP is a muscle relaxant and antispastic. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid. The structural formula is. C10H12ClNO2 M.W. 213.66. Baclofen, USP is a white to off-white, odorless, or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol and insoluble in chloroform. Each tablet, for oral administration, contains 5 mg, 10 mg or 20 mg baclofen, USP. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, sodium starch glycolate.</Description>
</NDC>
</NDCList>