{
"NDC": [
{
"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": "61500-5527-6",
"PackageDescription": "454 g in 1 BOTTLE (61500-5527-6) ",
"NDC11Code": "61500-5527-06",
"ProductNDC": "61500-5527",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Topricin",
"NonProprietaryName": "Aesculus Hippocastanum, Arnica Montana, Belladonna, Crotalus Horridus, Echinacea, Graphites, Heloderma, Lachesis Mutus, Naja Tripudians, Rhus Toxicodendron, Ruta Graveolens",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160401",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Topical BioMedics, Inc.",
"SubstanceName": "AESCULUS HIPPOCASTANUM FLOWER; ARNICA MONTANA; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA ANGUSTIFOLIA; GRAPHITE; HELODERMA HORRIDUM VENOM; LACHESIS MUTA VENOM; NAJA NAJA VENOM; RUTA GRAVEOLENS FLOWERING TOP; ATROPA BELLADONNA; TOXICODENDRON PUBESCENS LEAF",
"StrengthNumber": "6; 6; 8; 6; 6; 8; 8; 8; 6; 6; 6",
"StrengthUnit": "[hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g",
"Status": "Active",
"LastUpdate": "2025-10-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160401",
"SamplePackage": "N",
"IndicationAndUsage": "Rapid, soothing relief of pain, stiffness, tingling, or burning nerve pain associated with. Arthritis and other joint pain and discomfort. Fibromyalgia. Carpal Tunnel Syndrome and other types of nerve pain. Pains & muscle cramps of the back, neck, shoulder, legs, hands & feet. Sports injuries (muscle pulls & soreness, impact, sprains, dislocations). Repetitive motion injuries, such as bursitis, tendonitis and sciatica. First Aid for simple trauma (bruises, minor burns, cuts, scrapes & strains."
},
{
"NDCCode": "51552-1501-6",
"PackageDescription": "1000 g in 1 CONTAINER (51552-1501-6)",
"NDC11Code": "51552-1501-06",
"ProductNDC": "51552-1501",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Ketoprofen Ultra",
"DosageFormName": "POWDER",
"StartMarketingDate": "20160915",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Fagron Inc",
"SubstanceName": "KETOPROFEN",
"StrengthNumber": "1",
"StrengthUnit": "g/g",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "63629-1501-6",
"PackageDescription": "112 CAPSULE in 1 BOTTLE (63629-1501-6)",
"NDC11Code": "63629-1501-06",
"ProductNDC": "63629-1501",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tetracycline Hydrochloride",
"NonProprietaryName": "Tetracycline Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100323",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA060704",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "TETRACYCLINE HYDROCHLORIDE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Antimicrobial [EPC],Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "63629-1501-7",
"PackageDescription": "6 CAPSULE in 1 BOTTLE (63629-1501-7)",
"NDC11Code": "63629-1501-07",
"ProductNDC": "63629-1501",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Tetracycline Hydrochloride",
"NonProprietaryName": "Tetracycline Hydrochloride",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20100323",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA060704",
"LabelerName": "Bryant Ranch Prepack",
"SubstanceName": "TETRACYCLINE HYDROCHLORIDE",
"StrengthNumber": "250",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Antimicrobial [EPC],Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "67510-1501-6",
"PackageDescription": "177 mL in 1 BOTTLE (67510-1501-6)",
"NDC11Code": "67510-1501-06",
"ProductNDC": "67510-1501",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Night Time Cold/flu Relief Original",
"NonProprietaryName": "Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20120730",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part341",
"LabelerName": "Kareway Product, Inc.",
"SubstanceName": "ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE",
"StrengthNumber": "650; 30; 12.5",
"StrengthUnit": "mg/30mL; mg/30mL; mg/30mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "69238-1501-6",
"PackageDescription": "60 TABLET in 1 BOTTLE (69238-1501-6) ",
"NDC11Code": "69238-1501-06",
"ProductNDC": "69238-1501",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Doxycycline Hyclate",
"NonProprietaryName": "Doxycycline",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20171009",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209372",
"LabelerName": "Amneal Pharmaceuticals NY LLC",
"SubstanceName": "DOXYCYCLINE",
"StrengthNumber": "150",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tetracycline-class Drug [EPC], Tetracyclines [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-12-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20171009",
"SamplePackage": "N",
"Description": "Doxycycline hyclate tablets, USP contain doxycycline hyclate, USP a tetracycline class drug synthetically derived from oxytetracycline, in an immediate release formulation for oral administration. The molecular formula of doxycycline hyclate is (C22H24N2O8 HCl)2 C2H6OH2O and the molecular weight of doxycycline hyclate is 1025.87. The chemical name for doxycycline hyclate is. 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. The structural formula for doxycycline hyclate is. Figure 1: Structure of Doxycycline Hyclate. Doxycycline hyclate, USP is a yellow crystalline powder soluble in water and in solutions of alkali hydroxides and carbonates. Doxycycline hyclate tablets, USP:Doxycycline hyclate tablets, USP is available as 75 mg and 150 mg tablets. Each 75 mg tablet contains 86.6 mg of doxycycline hyclate, USP equivalent to 75 mg of doxycycline, USP. Each 150 mg tablet contains 173.2 mg of doxycycline hyclate, USP equivalent to 150 mg of doxycycline, USP. Inactive ingredients in the tablet formulation are: croscarmellose sodium, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. Film-coating contains: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, FD&C Blue #1 aluminum lake (75 mg Tablet), FD&C Yellow #6 aluminum lake (75 mg Tablet), FD&C Blue #2 (150 mg Tablet) and iron oxide yellow (150 mg Tablet). Doxycycline hyclate tablets, 75 mg contain 0.13 mg (0.0056 mEq) of sodium. Doxycycline hyclate tablets, 150 mg contain 0.26 mg (0.0113 mEq) of sodium."
},
{
"NDCCode": "70274-1501-6",
"PackageDescription": "60 mL in 1 BOTTLE, SPRAY (70274-1501-6)",
"NDC11Code": "70274-1501-06",
"ProductNDC": "70274-1501",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mhs Dit Da Jow",
"NonProprietaryName": "Menthol Liniment",
"DosageFormName": "LINIMENT",
"RouteName": "PERCUTANEOUS; TRANSDERMAL",
"StartMarketingDate": "20151123",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part348",
"LabelerName": "Modern Herb Shop, Inc.",
"SubstanceName": "MENTHOL",
"StrengthNumber": "1",
"StrengthUnit": "g/3500mL",
"Status": "Deprecated",
"LastUpdate": "2017-05-31"
},
{
"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": "61500-5527-1",
"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": "61500-5527-8",
"PackageDescription": "227 g in 1 BOTTLE (61500-5527-8) ",
"NDC11Code": "61500-5527-08",
"ProductNDC": "61500-5527",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Topricin",
"NonProprietaryName": "Aesculus Hippocastanum, Arnica Montana, Belladonna, Crotalus Horridus, Echinacea, Graphites, Heloderma, Lachesis Mutus, Naja Tripudians, Rhus Toxicodendron, Ruta Graveolens",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160401",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Topical BioMedics, Inc.",
"SubstanceName": "AESCULUS HIPPOCASTANUM FLOWER; ARNICA MONTANA; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA ANGUSTIFOLIA; GRAPHITE; HELODERMA HORRIDUM VENOM; LACHESIS MUTA VENOM; NAJA NAJA VENOM; RUTA GRAVEOLENS FLOWERING TOP; ATROPA BELLADONNA; TOXICODENDRON PUBESCENS LEAF",
"StrengthNumber": "6; 6; 8; 6; 6; 8; 8; 8; 6; 6; 6",
"StrengthUnit": "[hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g",
"Status": "Active",
"LastUpdate": "2025-10-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160401",
"SamplePackage": "N",
"IndicationAndUsage": "Rapid, soothing relief of pain, stiffness, tingling, or burning nerve pain associated with. Arthritis and other joint pain and discomfort. Fibromyalgia. Carpal Tunnel Syndrome and other types of nerve pain. Pains & muscle cramps of the back, neck, shoulder, legs, hands & feet. Sports injuries (muscle pulls & soreness, impact, sprains, dislocations). Repetitive motion injuries, such as bursitis, tendonitis and sciatica. First Aid for simple trauma (bruises, minor burns, cuts, scrapes & strains."
},
{
"NDCCode": "61500-5547-0",
"PackageDescription": "2 g in 1 PACKET (61500-5547-0) ",
"NDC11Code": "61500-5547-00",
"ProductNDC": "61500-5547",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Topricin",
"NonProprietaryName": "Aesculus Hippocastanum, Arnica Montana, Belladonna, Calendula Officinalis, Crotalus Horridus, Echinacea, Graphites, Heloderma Horridum, Lachesis Mutus, Naja Tripudians, Phosphorus, Rhus Toxicodendron, Ruta Graveolens, Sulfur",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160401",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Topical BioMedics, Inc.",
"SubstanceName": "PHOSPHORUS; ARNICA MONTANA; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA ANGUSTIFOLIA; GRAPHITE; HELODERMA HORRIDUM VENOM; LACHESIS MUTA VENOM; NAJA NAJA VENOM; RUTA GRAVEOLENS FLOWERING TOP; AESCULUS HIPPOCASTANUM FLOWER; ATROPA BELLADONNA; TOXICODENDRON PUBESCENS LEAF; CALENDULA OFFICINALIS FLOWERING TOP; SULFUR",
"StrengthNumber": "9; 6; 8; 4; 6; 8; 8; 8; 6; 6; 6; 8; 4; 8",
"StrengthUnit": "[hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g",
"Status": "Active",
"LastUpdate": "2025-10-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160401",
"SamplePackage": "N",
"IndicationAndUsage": "Rapid, moisturizing healing pain relief from trauma injuries of the foot, ankle and lower extremity. Reduces swelling, numbness and burning pain associated with. Joint pain in the toes, feet and ankles. Heel pain/soreness (heel spurs). Bunions pain/soreness (big toe). Nerve pain (burning pain in feet). Gout (pain in big toe). Relieves arch pain, soft tissue pain, and ball of the foot. Relieves nerve pain between toes. Sports injuries, shin splints, ankle sprain, Achilles tendonitis, Plantar Fasciitis. Tired aching feet, Tarsal Tunnel Syndrome."
},
{
"NDCCode": "61500-5547-1",
"PackageDescription": "21 g in 1 TUBE (61500-5547-1) ",
"NDC11Code": "61500-5547-01",
"ProductNDC": "61500-5547",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Topricin",
"NonProprietaryName": "Aesculus Hippocastanum, Arnica Montana, Belladonna, Calendula Officinalis, Crotalus Horridus, Echinacea, Graphites, Heloderma Horridum, Lachesis Mutus, Naja Tripudians, Phosphorus, Rhus Toxicodendron, Ruta Graveolens, Sulfur",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160401",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Topical BioMedics, Inc.",
"SubstanceName": "PHOSPHORUS; ARNICA MONTANA; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA ANGUSTIFOLIA; GRAPHITE; HELODERMA HORRIDUM VENOM; LACHESIS MUTA VENOM; NAJA NAJA VENOM; RUTA GRAVEOLENS FLOWERING TOP; AESCULUS HIPPOCASTANUM FLOWER; ATROPA BELLADONNA; TOXICODENDRON PUBESCENS LEAF; CALENDULA OFFICINALIS FLOWERING TOP; SULFUR",
"StrengthNumber": "9; 6; 8; 4; 6; 8; 8; 8; 6; 6; 6; 8; 4; 8",
"StrengthUnit": "[hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g",
"Status": "Active",
"LastUpdate": "2025-10-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160401",
"SamplePackage": "N",
"IndicationAndUsage": "Rapid, moisturizing healing pain relief from trauma injuries of the foot, ankle and lower extremity. Reduces swelling, numbness and burning pain associated with. Joint pain in the toes, feet and ankles. Heel pain/soreness (heel spurs). Bunions pain/soreness (big toe). Nerve pain (burning pain in feet). Gout (pain in big toe). Relieves arch pain, soft tissue pain, and ball of the foot. Relieves nerve pain between toes. Sports injuries, shin splints, ankle sprain, Achilles tendonitis, Plantar Fasciitis. Tired aching feet, Tarsal Tunnel Syndrome."
},
{
"NDCCode": "61500-5547-2",
"PackageDescription": "57 g in 1 TUBE (61500-5547-2) ",
"NDC11Code": "61500-5547-02",
"ProductNDC": "61500-5547",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Topricin",
"NonProprietaryName": "Aesculus Hippocastanum, Arnica Montana, Belladonna, Calendula Officinalis, Crotalus Horridus, Echinacea, Graphites, Heloderma Horridum, Lachesis Mutus, Naja Tripudians, Phosphorus, Rhus Toxicodendron, Ruta Graveolens, Sulfur",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160401",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Topical BioMedics, Inc.",
"SubstanceName": "PHOSPHORUS; ARNICA MONTANA; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA ANGUSTIFOLIA; GRAPHITE; HELODERMA HORRIDUM VENOM; LACHESIS MUTA VENOM; NAJA NAJA VENOM; RUTA GRAVEOLENS FLOWERING TOP; AESCULUS HIPPOCASTANUM FLOWER; ATROPA BELLADONNA; TOXICODENDRON PUBESCENS LEAF; CALENDULA OFFICINALIS FLOWERING TOP; SULFUR",
"StrengthNumber": "9; 6; 8; 4; 6; 8; 8; 8; 6; 6; 6; 8; 4; 8",
"StrengthUnit": "[hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g",
"Status": "Active",
"LastUpdate": "2025-10-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160401",
"SamplePackage": "N",
"IndicationAndUsage": "Rapid, moisturizing healing pain relief from trauma injuries of the foot, ankle and lower extremity. Reduces swelling, numbness and burning pain associated with. Joint pain in the toes, feet and ankles. Heel pain/soreness (heel spurs). Bunions pain/soreness (big toe). Nerve pain (burning pain in feet). Gout (pain in big toe). Relieves arch pain, soft tissue pain, and ball of the foot. Relieves nerve pain between toes. Sports injuries, shin splints, ankle sprain, Achilles tendonitis, Plantar Fasciitis. Tired aching feet, Tarsal Tunnel Syndrome."
},
{
"NDCCode": "61500-5547-4",
"PackageDescription": "113 g in 1 JAR (61500-5547-4) ",
"NDC11Code": "61500-5547-04",
"ProductNDC": "61500-5547",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Topricin",
"NonProprietaryName": "Aesculus Hippocastanum, Arnica Montana, Belladonna, Calendula Officinalis, Crotalus Horridus, Echinacea, Graphites, Heloderma Horridum, Lachesis Mutus, Naja Tripudians, Phosphorus, Rhus Toxicodendron, Ruta Graveolens, Sulfur",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20160401",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Topical BioMedics, Inc.",
"SubstanceName": "PHOSPHORUS; ARNICA MONTANA; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA ANGUSTIFOLIA; GRAPHITE; HELODERMA HORRIDUM VENOM; LACHESIS MUTA VENOM; NAJA NAJA VENOM; RUTA GRAVEOLENS FLOWERING TOP; AESCULUS HIPPOCASTANUM FLOWER; ATROPA BELLADONNA; TOXICODENDRON PUBESCENS LEAF; CALENDULA OFFICINALIS FLOWERING TOP; SULFUR",
"StrengthNumber": "9; 6; 8; 4; 6; 8; 8; 8; 6; 6; 6; 8; 4; 8",
"StrengthUnit": "[hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g",
"Status": "Active",
"LastUpdate": "2025-10-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160401",
"SamplePackage": "N",
"IndicationAndUsage": "Rapid, moisturizing healing pain relief from trauma injuries of the foot, ankle and lower extremity. Reduces swelling, numbness and burning pain associated with. Joint pain in the toes, feet and ankles. Heel pain/soreness (heel spurs). Bunions pain/soreness (big toe). Nerve pain (burning pain in feet). Gout (pain in big toe). Relieves arch pain, soft tissue pain, and ball of the foot. Relieves nerve pain between toes. Sports injuries, shin splints, ankle sprain, Achilles tendonitis, Plantar Fasciitis. Tired aching feet, Tarsal Tunnel Syndrome."
},
{
"NDCCode": "61500-5547-8",
"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": "0069-1501-30",
"PackageDescription": "1 BOTTLE in 1 CARTON (0069-1501-30) / 30 CAPSULE in 1 BOTTLE",
"NDC11Code": "00069-1501-30",
"ProductNDC": "0069-1501",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Talzenna",
"NonProprietaryName": "Talazoparib",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20220131",
"EndMarketingDate": "20270331",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA211651",
"LabelerName": "Pfizer Laboratories Div Pfizer Inc",
"SubstanceName": "TALAZOPARIB TOSYLATE",
"StrengthNumber": ".5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Poly(ADP-Ribose) Polymerase Inhibitor [EPC], Poly(ADP-Ribose) Polymerase Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2025-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20220131",
"EndMarketingDatePackage": "20270331",
"SamplePackage": "N",
"Description": "Talazoparib is an inhibitor of mammalian polyadenosine 5'-diphosphoribose (ADP-ribose) polymerase (PARP) enzymes. The chemical name of talazoparib tosylate is (8S,9R)-5-Fluoro-8-(4-fluorophenyl)-9-(1-methyl-1H-1,2,4-triazol-5-yl)-2,7,8,9-tetrahydro-3H-pyrido[4,3,2-de]phthalazin-3-one 4-methylbenzenesulfonate (1:1). The chemical formula of talazoparib tosylate is C26H22F2N6O4S, and the relative molecular mass is 552.56 Daltons. The chemical structure of talazoparib tosylate is shown below. Talazoparib tosylate is a white to yellow solid. TALZENNA capsules for oral use are available as: 1 0.1 mg hard hypromellose (HPMC) capsule that contains 0.145 mg talazoparib tosylate equivalent to 0.1 mg talazoparib free base, or , 2 0.25 mg HPMC capsule that contains 0.363 mg talazoparib tosylate equivalent to 0.25 mg talazoparib free base, or, 3 0.35 mg HPMC capsule that contains 0.509 mg talazoparib tosylate equivalent to 0.35 mg talazoparib free base, or, 4 0.5 mg HPMC capsule that contains 0.727 mg talazoparib tosylate equivalent to 0.5 mg talazoparib free base, or, 5 0.75 mg HPMC capsule that contains 1.09 mg talazoparib tosylate equivalent to 0.75 mg talazoparib free base, or, 6 1 mg HPMC capsule that contains 1.453 mg talazoparib tosylate equivalent to 1 mg talazoparib free base."
},
{
"NDCCode": "0145-1501-03",
"PackageDescription": "71 g in 1 BOTTLE (0145-1501-03) ",
"NDC11Code": "00145-1501-03",
"ProductNDC": "0145-1501",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Zeasorb",
"NonProprietaryName": "Miconazole Nitrate",
"DosageFormName": "POWDER",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110314",
"EndMarketingDate": "20200531",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333C",
"LabelerName": "Stiefel Laboratories Inc",
"SubstanceName": "MICONAZOLE NITRATE",
"StrengthNumber": "20.6",
"StrengthUnit": "mg/g",
"Status": "Deprecated",
"LastUpdate": "2020-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20110314",
"EndMarketingDatePackage": "20200531",
"SamplePackage": "N"
},
{
"NDCCode": "0527-1501-37",
"PackageDescription": "100 TABLET in 1 BOTTLE (0527-1501-37) ",
"NDC11Code": "00527-1501-37",
"ProductNDC": "0527-1501",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate",
"NonProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20181212",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211352",
"LabelerName": "Lannett Company, Inc.",
"SubstanceName": "AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE",
"StrengthNumber": "1.875; 1.875; 1.875; 1.875",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2025-02-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20181212",
"SamplePackage": "N",
"IndicationAndUsage": "Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy.",
"Description": "A single-entity amphetamine product combining the neutral sulfate salts of dextroamphetamine and amphetamine, with the dextro isomer of amphetamine saccharate and d, l-amphetamine aspartate monohydrate. Inactive Ingredients: compressible sugar, magnesium stearate, maltodextrin, microcrystalline cellulose, sodium saccharin, and pregelatinized starch. Colors: Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets 5 mg, 7.5 mg and 10 mg contain FD&C Blue #1 Aluminum Lake. Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets 12.5 mg, 15 mg, 20 mg and 30 mg contain FD&C Yellow #6 Aluminum Lake as a color additive."
},
{
"NDCCode": "0527-1501-41",
"PackageDescription": "500 TABLET in 1 BOTTLE (0527-1501-41) ",
"NDC11Code": "00527-1501-41",
"ProductNDC": "0527-1501",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate",
"NonProprietaryName": "Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20181212",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA211352",
"LabelerName": "Lannett Company, Inc.",
"SubstanceName": "AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE",
"StrengthNumber": "1.875; 1.875; 1.875; 1.875",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]",
"DEASchedule": "CII",
"Status": "Deprecated",
"LastUpdate": "2025-02-12",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20181212",
"SamplePackage": "N",
"IndicationAndUsage": "Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy.",
"Description": "A single-entity amphetamine product combining the neutral sulfate salts of dextroamphetamine and amphetamine, with the dextro isomer of amphetamine saccharate and d, l-amphetamine aspartate monohydrate. Inactive Ingredients: compressible sugar, magnesium stearate, maltodextrin, microcrystalline cellulose, sodium saccharin, and pregelatinized starch. Colors: Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets 5 mg, 7.5 mg and 10 mg contain FD&C Blue #1 Aluminum Lake. Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets 12.5 mg, 15 mg, 20 mg and 30 mg contain FD&C Yellow #6 Aluminum Lake as a color additive."
},
{
"NDCCode": "22840-1501-1",
"PackageDescription": "5 mL in 1 VIAL, MULTI-DOSE (22840-1501-1) ",
"NDC11Code": "22840-1501-01",
"ProductNDC": "22840-1501",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "Dandelion",
"NonProprietaryName": "Taraxacum Officinale",
"DosageFormName": "SOLUTION",
"RouteName": "INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS",
"StartMarketingDate": "19810915",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA101833",
"LabelerName": "Greer Laboratories, Inc.",
"SubstanceName": "TARAXACUM OFFICINALE POLLEN",
"StrengthNumber": "1000",
"StrengthUnit": "[PNU]/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]",
"Status": "Active",
"LastUpdate": "2025-06-05",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19810915",
"SamplePackage": "N",
"IndicationAndUsage": "Non-Standardized Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergies to one or more of the specific non-standardized allergens., 2 Immunotherapy for the reduction of allergen-induced allergic symptoms confirmed by appropriate positive skin tests or by in vitro testing for allergen-specific IgE antibodies. .",
"Description": "Non-Standardized Allergenic Extracts are sterile solutions used for percutaneous testing, intradermal testing, or subcutaneous immunotherapy. Aqueous extracts contain the soluble extractants of the source material in water for injection, 0.5% sodium chloride, 0.54% sodium bicarbonate, and 0.4% phenol. Glycerinated extracts contain the soluable extractants of the source material in water for injection and 50% glycerin, 0.25% sodium chloride, 0.27% sodium bicarbonate, and 0.2% phenol. The pH of the extracts range from 6 to 9. Certain food extracts (Barley, Oat, Pineapple, Rye, Spinach, and Wheat), labeled “For Diagnostic Use Only”, contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Source materials used in the manufacture of allergenic extracts are collected from natural sources or from laboratory cultures. Non-Standardized Allergenic Extracts appear as clear and colorless to dark brown solutions that should be free of particulate matter. Extracts are labeled either as weight-to-volume based on the weight of the source material to the volume of the extracting fluid, or as PNU/milliliter with one PNU representing 0.00001 mg of protein nitrogen per milliliter."
},
{
"NDCCode": "53645-1501-2",
"PackageDescription": "23 g in 1 BOTTLE (53645-1501-2) ",
"NDC11Code": "53645-1501-02",
"ProductNDC": "53645-1501",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hyoscyamus Niger",
"NonProprietaryName": "Hyoscymus Niger",
"DosageFormName": "GLOBULE",
"RouteName": "ORAL",
"StartMarketingDate": "20140203",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "True Botanica, LLC",
"SubstanceName": "HYOSCYAMUS NIGER",
"StrengthNumber": "6",
"StrengthUnit": "[hp_X]/23g",
"Status": "Active",
"LastUpdate": "2023-05-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20140203",
"SamplePackage": "N",
"IndicationAndUsage": "For temporary relief of muscular and nervous twitches. Helps increase alertness and creativity. May also be used for standard homeopathic indications or as directed by your physician."
},
{
"NDCCode": "57520-1501-4",
"PackageDescription": "48000 mL in 1 CONTAINER (57520-1501-4) ",
"NDC11Code": "57520-1501-04",
"ProductNDC": "57520-1501",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Avena Sativa, Dna, Elaeis Guineensis, Glandula Suprarenalis Suis, Hamamelis Virginiana, Hepar Suis, Kali Sulphuricum, Natrum Muriaticum, Nicotinamidum, Phosphoricum Acidum, Pituitarum Posterium (bovine), Riboflavinum, Thiaminum Hydrochloricum, Thuja Occidentalis, Thyroidinum (bovine), Urtica Urens",
"DosageFormName": "LIQUID",
"StartMarketingDate": "20240501",
"EndMarketingDate": "20280428",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Apotheca Company",
"SubstanceName": "AVENA SATIVA FLOWERING TOP; BOS TAURUS PITUITARY GLAND, POSTERIOR; ELAEIS GUINEENSIS FRUIT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HERRING SPERM DNA; NIACINAMIDE; PHOSPHORIC ACID; PORK LIVER; POTASSIUM SULFATE; RIBOFLAVIN; SODIUM CHLORIDE; SUS SCROFA ADRENAL GLAND; THIAMINE HYDROCHLORIDE; THUJA OCCIDENTALIS LEAFY TWIG; THYROID, BOVINE; URTICA URENS WHOLE",
"StrengthNumber": "4; 10; 15; 4; 12; 6; 4; 6; 30; 8; 200; 30; 6; 200; 30; 4",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL",
"Status": "Unfinished",
"LastUpdate": "2025-01-11",
"StartMarketingDatePackage": "01-MAY-24",
"EndMarketingDatePackage": "28-APR-28"
},
{
"NDCCode": "58668-1501-1",
"PackageDescription": "50 mL in 1 BOTTLE (58668-1501-1)",
"NDC11Code": "58668-1501-01",
"ProductNDC": "58668-1501",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Clarins Hydraquench Tinted Moisturizer Broad Spectrum Spf 6 01 Naturel",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "EMULSION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20121025",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Laboratoires Clarins S.A.",
"SubstanceName": "TITANIUM DIOXIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/mL",
"Status": "Deprecated",
"LastUpdate": "2018-02-08",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
}
]
}
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<NDCList>
<NDC>
<NDCCode>61500-1501-6</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (61500-1501-6) > 1 [hp_X] in 1 TUBE</PackageDescription>
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<ProductNDC>61500-1501</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
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<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>
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<RouteName>TOPICAL</RouteName>
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<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>
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<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>
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<PackageDescription>454 g in 1 BOTTLE (61500-5527-6) </PackageDescription>
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<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>51552-1501-6</NDCCode>
<PackageDescription>1000 g in 1 CONTAINER (51552-1501-6)</PackageDescription>
<NDC11Code>51552-1501-06</NDC11Code>
<ProductNDC>51552-1501</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Ketoprofen Ultra</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20160915</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Fagron Inc</LabelerName>
<SubstanceName>KETOPROFEN</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>63629-1501-6</NDCCode>
<PackageDescription>112 CAPSULE in 1 BOTTLE (63629-1501-6)</PackageDescription>
<NDC11Code>63629-1501-06</NDC11Code>
<ProductNDC>63629-1501</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tetracycline Hydrochloride</ProprietaryName>
<NonProprietaryName>Tetracycline Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100323</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA060704</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>TETRACYCLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Antimicrobial [EPC],Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>63629-1501-7</NDCCode>
<PackageDescription>6 CAPSULE in 1 BOTTLE (63629-1501-7)</PackageDescription>
<NDC11Code>63629-1501-07</NDC11Code>
<ProductNDC>63629-1501</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Tetracycline Hydrochloride</ProprietaryName>
<NonProprietaryName>Tetracycline Hydrochloride</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100323</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA060704</ApplicationNumber>
<LabelerName>Bryant Ranch Prepack</LabelerName>
<SubstanceName>TETRACYCLINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>250</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Antimicrobial [EPC],Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>67510-1501-6</NDCCode>
<PackageDescription>177 mL in 1 BOTTLE (67510-1501-6)</PackageDescription>
<NDC11Code>67510-1501-06</NDC11Code>
<ProductNDC>67510-1501</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Night Time Cold/flu Relief Original</ProprietaryName>
<NonProprietaryName>Acetaminophen, Dextromethorphan Hbr, Doxylamine Succinate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120730</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part341</ApplicationNumber>
<LabelerName>Kareway Product, Inc.</LabelerName>
<SubstanceName>ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE</SubstanceName>
<StrengthNumber>650; 30; 12.5</StrengthNumber>
<StrengthUnit>mg/30mL; mg/30mL; mg/30mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>69238-1501-6</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (69238-1501-6) </PackageDescription>
<NDC11Code>69238-1501-06</NDC11Code>
<ProductNDC>69238-1501</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Doxycycline Hyclate</ProprietaryName>
<NonProprietaryName>Doxycycline</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20171009</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209372</ApplicationNumber>
<LabelerName>Amneal Pharmaceuticals NY LLC</LabelerName>
<SubstanceName>DOXYCYCLINE</SubstanceName>
<StrengthNumber>150</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tetracycline-class Drug [EPC], Tetracyclines [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20171009</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Doxycycline hyclate tablets, USP contain doxycycline hyclate, USP a tetracycline class drug synthetically derived from oxytetracycline, in an immediate release formulation for oral administration. The molecular formula of doxycycline hyclate is (C22H24N2O8 HCl)2 C2H6OH2O and the molecular weight of doxycycline hyclate is 1025.87. The chemical name for doxycycline hyclate is. 4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-naphthacenecarboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate. The structural formula for doxycycline hyclate is. Figure 1: Structure of Doxycycline Hyclate. Doxycycline hyclate, USP is a yellow crystalline powder soluble in water and in solutions of alkali hydroxides and carbonates. Doxycycline hyclate tablets, USP:Doxycycline hyclate tablets, USP is available as 75 mg and 150 mg tablets. Each 75 mg tablet contains 86.6 mg of doxycycline hyclate, USP equivalent to 75 mg of doxycycline, USP. Each 150 mg tablet contains 173.2 mg of doxycycline hyclate, USP equivalent to 150 mg of doxycycline, USP. Inactive ingredients in the tablet formulation are: croscarmellose sodium, magnesium stearate, microcrystalline cellulose and sodium lauryl sulfate. Film-coating contains: polyvinyl alcohol, polyethylene glycol, talc, titanium dioxide, FD&C Blue #1 aluminum lake (75 mg Tablet), FD&C Yellow #6 aluminum lake (75 mg Tablet), FD&C Blue #2 (150 mg Tablet) and iron oxide yellow (150 mg Tablet). Doxycycline hyclate tablets, 75 mg contain 0.13 mg (0.0056 mEq) of sodium. Doxycycline hyclate tablets, 150 mg contain 0.26 mg (0.0113 mEq) of sodium.</Description>
</NDC>
<NDC>
<NDCCode>70274-1501-6</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE, SPRAY (70274-1501-6)</PackageDescription>
<NDC11Code>70274-1501-06</NDC11Code>
<ProductNDC>70274-1501</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mhs Dit Da Jow</ProprietaryName>
<NonProprietaryName>Menthol Liniment</NonProprietaryName>
<DosageFormName>LINIMENT</DosageFormName>
<RouteName>PERCUTANEOUS; TRANSDERMAL</RouteName>
<StartMarketingDate>20151123</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part348</ApplicationNumber>
<LabelerName>Modern Herb Shop, Inc.</LabelerName>
<SubstanceName>MENTHOL</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>g/3500mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2017-05-31</LastUpdate>
</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>61500-5527-1</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>61500-5527-8</NDCCode>
<PackageDescription>227 g in 1 BOTTLE (61500-5527-8) </PackageDescription>
<NDC11Code>61500-5527-08</NDC11Code>
<ProductNDC>61500-5527</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Topricin</ProprietaryName>
<NonProprietaryName>Aesculus Hippocastanum, Arnica Montana, Belladonna, Crotalus Horridus, Echinacea, Graphites, Heloderma, Lachesis Mutus, Naja Tripudians, Rhus Toxicodendron, Ruta Graveolens</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160401</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Topical BioMedics, Inc.</LabelerName>
<SubstanceName>AESCULUS HIPPOCASTANUM FLOWER; ARNICA MONTANA; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA ANGUSTIFOLIA; GRAPHITE; HELODERMA HORRIDUM VENOM; LACHESIS MUTA VENOM; NAJA NAJA VENOM; RUTA GRAVEOLENS FLOWERING TOP; ATROPA BELLADONNA; TOXICODENDRON PUBESCENS LEAF</SubstanceName>
<StrengthNumber>6; 6; 8; 6; 6; 8; 8; 8; 6; 6; 6</StrengthNumber>
<StrengthUnit>[hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g; [hp_X]/170g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-10-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rapid, soothing relief of pain, stiffness, tingling, or burning nerve pain associated with. Arthritis and other joint pain and discomfort. Fibromyalgia. Carpal Tunnel Syndrome and other types of nerve pain. Pains & muscle cramps of the back, neck, shoulder, legs, hands & feet. Sports injuries (muscle pulls & soreness, impact, sprains, dislocations). Repetitive motion injuries, such as bursitis, tendonitis and sciatica. First Aid for simple trauma (bruises, minor burns, cuts, scrapes & strains.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61500-5547-0</NDCCode>
<PackageDescription>2 g in 1 PACKET (61500-5547-0) </PackageDescription>
<NDC11Code>61500-5547-00</NDC11Code>
<ProductNDC>61500-5547</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Topricin</ProprietaryName>
<NonProprietaryName>Aesculus Hippocastanum, Arnica Montana, Belladonna, Calendula Officinalis, Crotalus Horridus, Echinacea, Graphites, Heloderma Horridum, Lachesis Mutus, Naja Tripudians, Phosphorus, Rhus Toxicodendron, Ruta Graveolens, Sulfur</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160401</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Topical BioMedics, Inc.</LabelerName>
<SubstanceName>PHOSPHORUS; ARNICA MONTANA; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA ANGUSTIFOLIA; GRAPHITE; HELODERMA HORRIDUM VENOM; LACHESIS MUTA VENOM; NAJA NAJA VENOM; RUTA GRAVEOLENS FLOWERING TOP; AESCULUS HIPPOCASTANUM FLOWER; ATROPA BELLADONNA; TOXICODENDRON PUBESCENS LEAF; CALENDULA OFFICINALIS FLOWERING TOP; SULFUR</SubstanceName>
<StrengthNumber>9; 6; 8; 4; 6; 8; 8; 8; 6; 6; 6; 8; 4; 8</StrengthNumber>
<StrengthUnit>[hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-10-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rapid, moisturizing healing pain relief from trauma injuries of the foot, ankle and lower extremity. Reduces swelling, numbness and burning pain associated with. Joint pain in the toes, feet and ankles. Heel pain/soreness (heel spurs). Bunions pain/soreness (big toe). Nerve pain (burning pain in feet). Gout (pain in big toe). Relieves arch pain, soft tissue pain, and ball of the foot. Relieves nerve pain between toes. Sports injuries, shin splints, ankle sprain, Achilles tendonitis, Plantar Fasciitis. Tired aching feet, Tarsal Tunnel Syndrome.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61500-5547-1</NDCCode>
<PackageDescription>21 g in 1 TUBE (61500-5547-1) </PackageDescription>
<NDC11Code>61500-5547-01</NDC11Code>
<ProductNDC>61500-5547</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Topricin</ProprietaryName>
<NonProprietaryName>Aesculus Hippocastanum, Arnica Montana, Belladonna, Calendula Officinalis, Crotalus Horridus, Echinacea, Graphites, Heloderma Horridum, Lachesis Mutus, Naja Tripudians, Phosphorus, Rhus Toxicodendron, Ruta Graveolens, Sulfur</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160401</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Topical BioMedics, Inc.</LabelerName>
<SubstanceName>PHOSPHORUS; ARNICA MONTANA; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA ANGUSTIFOLIA; GRAPHITE; HELODERMA HORRIDUM VENOM; LACHESIS MUTA VENOM; NAJA NAJA VENOM; RUTA GRAVEOLENS FLOWERING TOP; AESCULUS HIPPOCASTANUM FLOWER; ATROPA BELLADONNA; TOXICODENDRON PUBESCENS LEAF; CALENDULA OFFICINALIS FLOWERING TOP; SULFUR</SubstanceName>
<StrengthNumber>9; 6; 8; 4; 6; 8; 8; 8; 6; 6; 6; 8; 4; 8</StrengthNumber>
<StrengthUnit>[hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-10-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rapid, moisturizing healing pain relief from trauma injuries of the foot, ankle and lower extremity. Reduces swelling, numbness and burning pain associated with. Joint pain in the toes, feet and ankles. Heel pain/soreness (heel spurs). Bunions pain/soreness (big toe). Nerve pain (burning pain in feet). Gout (pain in big toe). Relieves arch pain, soft tissue pain, and ball of the foot. Relieves nerve pain between toes. Sports injuries, shin splints, ankle sprain, Achilles tendonitis, Plantar Fasciitis. Tired aching feet, Tarsal Tunnel Syndrome.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61500-5547-2</NDCCode>
<PackageDescription>57 g in 1 TUBE (61500-5547-2) </PackageDescription>
<NDC11Code>61500-5547-02</NDC11Code>
<ProductNDC>61500-5547</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Topricin</ProprietaryName>
<NonProprietaryName>Aesculus Hippocastanum, Arnica Montana, Belladonna, Calendula Officinalis, Crotalus Horridus, Echinacea, Graphites, Heloderma Horridum, Lachesis Mutus, Naja Tripudians, Phosphorus, Rhus Toxicodendron, Ruta Graveolens, Sulfur</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160401</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Topical BioMedics, Inc.</LabelerName>
<SubstanceName>PHOSPHORUS; ARNICA MONTANA; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA ANGUSTIFOLIA; GRAPHITE; HELODERMA HORRIDUM VENOM; LACHESIS MUTA VENOM; NAJA NAJA VENOM; RUTA GRAVEOLENS FLOWERING TOP; AESCULUS HIPPOCASTANUM FLOWER; ATROPA BELLADONNA; TOXICODENDRON PUBESCENS LEAF; CALENDULA OFFICINALIS FLOWERING TOP; SULFUR</SubstanceName>
<StrengthNumber>9; 6; 8; 4; 6; 8; 8; 8; 6; 6; 6; 8; 4; 8</StrengthNumber>
<StrengthUnit>[hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-10-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rapid, moisturizing healing pain relief from trauma injuries of the foot, ankle and lower extremity. Reduces swelling, numbness and burning pain associated with. Joint pain in the toes, feet and ankles. Heel pain/soreness (heel spurs). Bunions pain/soreness (big toe). Nerve pain (burning pain in feet). Gout (pain in big toe). Relieves arch pain, soft tissue pain, and ball of the foot. Relieves nerve pain between toes. Sports injuries, shin splints, ankle sprain, Achilles tendonitis, Plantar Fasciitis. Tired aching feet, Tarsal Tunnel Syndrome.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61500-5547-4</NDCCode>
<PackageDescription>113 g in 1 JAR (61500-5547-4) </PackageDescription>
<NDC11Code>61500-5547-04</NDC11Code>
<ProductNDC>61500-5547</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Topricin</ProprietaryName>
<NonProprietaryName>Aesculus Hippocastanum, Arnica Montana, Belladonna, Calendula Officinalis, Crotalus Horridus, Echinacea, Graphites, Heloderma Horridum, Lachesis Mutus, Naja Tripudians, Phosphorus, Rhus Toxicodendron, Ruta Graveolens, Sulfur</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160401</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Topical BioMedics, Inc.</LabelerName>
<SubstanceName>PHOSPHORUS; ARNICA MONTANA; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA ANGUSTIFOLIA; GRAPHITE; HELODERMA HORRIDUM VENOM; LACHESIS MUTA VENOM; NAJA NAJA VENOM; RUTA GRAVEOLENS FLOWERING TOP; AESCULUS HIPPOCASTANUM FLOWER; ATROPA BELLADONNA; TOXICODENDRON PUBESCENS LEAF; CALENDULA OFFICINALIS FLOWERING TOP; SULFUR</SubstanceName>
<StrengthNumber>9; 6; 8; 4; 6; 8; 8; 8; 6; 6; 6; 8; 4; 8</StrengthNumber>
<StrengthUnit>[hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-10-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rapid, moisturizing healing pain relief from trauma injuries of the foot, ankle and lower extremity. Reduces swelling, numbness and burning pain associated with. Joint pain in the toes, feet and ankles. Heel pain/soreness (heel spurs). Bunions pain/soreness (big toe). Nerve pain (burning pain in feet). Gout (pain in big toe). Relieves arch pain, soft tissue pain, and ball of the foot. Relieves nerve pain between toes. Sports injuries, shin splints, ankle sprain, Achilles tendonitis, Plantar Fasciitis. Tired aching feet, Tarsal Tunnel Syndrome.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>61500-5547-8</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>61500-5547-9</NDCCode>
<PackageDescription>227 g in 1 BOTTLE (61500-5547-9) </PackageDescription>
<NDC11Code>61500-5547-09</NDC11Code>
<ProductNDC>61500-5547</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Topricin</ProprietaryName>
<NonProprietaryName>Aesculus Hippocastanum, Arnica Montana, Belladonna, Calendula Officinalis, Crotalus Horridus, Echinacea, Graphites, Heloderma Horridum, Lachesis Mutus, Naja Tripudians, Phosphorus, Rhus Toxicodendron, Ruta Graveolens, Sulfur</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20160401</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Topical BioMedics, Inc.</LabelerName>
<SubstanceName>PHOSPHORUS; ARNICA MONTANA; CROTALUS HORRIDUS HORRIDUS VENOM; ECHINACEA ANGUSTIFOLIA; GRAPHITE; HELODERMA HORRIDUM VENOM; LACHESIS MUTA VENOM; NAJA NAJA VENOM; RUTA GRAVEOLENS FLOWERING TOP; AESCULUS HIPPOCASTANUM FLOWER; ATROPA BELLADONNA; TOXICODENDRON PUBESCENS LEAF; CALENDULA OFFICINALIS FLOWERING TOP; SULFUR</SubstanceName>
<StrengthNumber>9; 6; 8; 4; 6; 8; 8; 8; 6; 6; 6; 8; 4; 8</StrengthNumber>
<StrengthUnit>[hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g; [hp_X]/227g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-10-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Rapid, moisturizing healing pain relief from trauma injuries of the foot, ankle and lower extremity. Reduces swelling, numbness and burning pain associated with. Joint pain in the toes, feet and ankles. Heel pain/soreness (heel spurs). Bunions pain/soreness (big toe). Nerve pain (burning pain in feet). Gout (pain in big toe). Relieves arch pain, soft tissue pain, and ball of the foot. Relieves nerve pain between toes. Sports injuries, shin splints, ankle sprain, Achilles tendonitis, Plantar Fasciitis. Tired aching feet, Tarsal Tunnel Syndrome.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>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>0069-1501-30</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (0069-1501-30) / 30 CAPSULE in 1 BOTTLE</PackageDescription>
<NDC11Code>00069-1501-30</NDC11Code>
<ProductNDC>0069-1501</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Talzenna</ProprietaryName>
<NonProprietaryName>Talazoparib</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220131</StartMarketingDate>
<EndMarketingDate>20270331</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA211651</ApplicationNumber>
<LabelerName>Pfizer Laboratories Div Pfizer Inc</LabelerName>
<SubstanceName>TALAZOPARIB TOSYLATE</SubstanceName>
<StrengthNumber>.5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Poly(ADP-Ribose) Polymerase Inhibitor [EPC], Poly(ADP-Ribose) Polymerase Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20220131</StartMarketingDatePackage>
<EndMarketingDatePackage>20270331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<Description>Talazoparib is an inhibitor of mammalian polyadenosine 5'-diphosphoribose (ADP-ribose) polymerase (PARP) enzymes. The chemical name of talazoparib tosylate is (8S,9R)-5-Fluoro-8-(4-fluorophenyl)-9-(1-methyl-1H-1,2,4-triazol-5-yl)-2,7,8,9-tetrahydro-3H-pyrido[4,3,2-de]phthalazin-3-one 4-methylbenzenesulfonate (1:1). The chemical formula of talazoparib tosylate is C26H22F2N6O4S, and the relative molecular mass is 552.56 Daltons. The chemical structure of talazoparib tosylate is shown below. Talazoparib tosylate is a white to yellow solid. TALZENNA capsules for oral use are available as: 1 0.1 mg hard hypromellose (HPMC) capsule that contains 0.145 mg talazoparib tosylate equivalent to 0.1 mg talazoparib free base, or , 2 0.25 mg HPMC capsule that contains 0.363 mg talazoparib tosylate equivalent to 0.25 mg talazoparib free base, or, 3 0.35 mg HPMC capsule that contains 0.509 mg talazoparib tosylate equivalent to 0.35 mg talazoparib free base, or, 4 0.5 mg HPMC capsule that contains 0.727 mg talazoparib tosylate equivalent to 0.5 mg talazoparib free base, or, 5 0.75 mg HPMC capsule that contains 1.09 mg talazoparib tosylate equivalent to 0.75 mg talazoparib free base, or, 6 1 mg HPMC capsule that contains 1.453 mg talazoparib tosylate equivalent to 1 mg talazoparib free base.</Description>
</NDC>
<NDC>
<NDCCode>0145-1501-03</NDCCode>
<PackageDescription>71 g in 1 BOTTLE (0145-1501-03) </PackageDescription>
<NDC11Code>00145-1501-03</NDC11Code>
<ProductNDC>0145-1501</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Zeasorb</ProprietaryName>
<NonProprietaryName>Miconazole Nitrate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110314</StartMarketingDate>
<EndMarketingDate>20200531</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333C</ApplicationNumber>
<LabelerName>Stiefel Laboratories Inc</LabelerName>
<SubstanceName>MICONAZOLE NITRATE</SubstanceName>
<StrengthNumber>20.6</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20110314</StartMarketingDatePackage>
<EndMarketingDatePackage>20200531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0527-1501-37</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0527-1501-37) </PackageDescription>
<NDC11Code>00527-1501-37</NDC11Code>
<ProductNDC>0527-1501</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate</ProprietaryName>
<NonProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181212</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211352</ApplicationNumber>
<LabelerName>Lannett Company, Inc.</LabelerName>
<SubstanceName>AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE</SubstanceName>
<StrengthNumber>1.875; 1.875; 1.875; 1.875</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-02-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181212</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy.</IndicationAndUsage>
<Description>A single-entity amphetamine product combining the neutral sulfate salts of dextroamphetamine and amphetamine, with the dextro isomer of amphetamine saccharate and d, l-amphetamine aspartate monohydrate. Inactive Ingredients: compressible sugar, magnesium stearate, maltodextrin, microcrystalline cellulose, sodium saccharin, and pregelatinized starch. Colors: Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets 5 mg, 7.5 mg and 10 mg contain FD&C Blue #1 Aluminum Lake. Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets 12.5 mg, 15 mg, 20 mg and 30 mg contain FD&C Yellow #6 Aluminum Lake as a color additive.</Description>
</NDC>
<NDC>
<NDCCode>0527-1501-41</NDCCode>
<PackageDescription>500 TABLET in 1 BOTTLE (0527-1501-41) </PackageDescription>
<NDC11Code>00527-1501-41</NDC11Code>
<ProductNDC>0527-1501</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate</ProprietaryName>
<NonProprietaryName>Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20181212</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA211352</ApplicationNumber>
<LabelerName>Lannett Company, Inc.</LabelerName>
<SubstanceName>AMPHETAMINE ASPARTATE MONOHYDRATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE</SubstanceName>
<StrengthNumber>1.875; 1.875; 1.875; 1.875</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE], Central Nervous System Stimulation [PE]</Pharm_Classes>
<DEASchedule>CII</DEASchedule>
<Status>Deprecated</Status>
<LastUpdate>2025-02-12</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181212</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate and amphetamine sulfate tablets is indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) and Narcolepsy.</IndicationAndUsage>
<Description>A single-entity amphetamine product combining the neutral sulfate salts of dextroamphetamine and amphetamine, with the dextro isomer of amphetamine saccharate and d, l-amphetamine aspartate monohydrate. Inactive Ingredients: compressible sugar, magnesium stearate, maltodextrin, microcrystalline cellulose, sodium saccharin, and pregelatinized starch. Colors: Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets 5 mg, 7.5 mg and 10 mg contain FD&C Blue #1 Aluminum Lake. Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets 12.5 mg, 15 mg, 20 mg and 30 mg contain FD&C Yellow #6 Aluminum Lake as a color additive.</Description>
</NDC>
<NDC>
<NDCCode>22840-1501-1</NDCCode>
<PackageDescription>5 mL in 1 VIAL, MULTI-DOSE (22840-1501-1) </PackageDescription>
<NDC11Code>22840-1501-01</NDC11Code>
<ProductNDC>22840-1501</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>Dandelion</ProprietaryName>
<NonProprietaryName>Taraxacum Officinale</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS</RouteName>
<StartMarketingDate>19810915</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA101833</ApplicationNumber>
<LabelerName>Greer Laboratories, Inc.</LabelerName>
<SubstanceName>TARAXACUM OFFICINALE POLLEN</SubstanceName>
<StrengthNumber>1000</StrengthNumber>
<StrengthUnit>[PNU]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Pollen Allergenic Extract [EPC], Pollen [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-05</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19810915</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Non-Standardized Allergenic Extracts are indicated for. : 1 Skin test diagnosis of patients with a clinical history of allergies to one or more of the specific non-standardized allergens., 2 Immunotherapy for the reduction of allergen-induced allergic symptoms confirmed by appropriate positive skin tests or by in vitro testing for allergen-specific IgE antibodies. .</IndicationAndUsage>
<Description>Non-Standardized Allergenic Extracts are sterile solutions used for percutaneous testing, intradermal testing, or subcutaneous immunotherapy. Aqueous extracts contain the soluble extractants of the source material in water for injection, 0.5% sodium chloride, 0.54% sodium bicarbonate, and 0.4% phenol. Glycerinated extracts contain the soluable extractants of the source material in water for injection and 50% glycerin, 0.25% sodium chloride, 0.27% sodium bicarbonate, and 0.2% phenol. The pH of the extracts range from 6 to 9. Certain food extracts (Barley, Oat, Pineapple, Rye, Spinach, and Wheat), labeled “For Diagnostic Use Only”, contain 0.1% sodium formaldehyde sulfoxylate as an antioxidant. Source materials used in the manufacture of allergenic extracts are collected from natural sources or from laboratory cultures. Non-Standardized Allergenic Extracts appear as clear and colorless to dark brown solutions that should be free of particulate matter. Extracts are labeled either as weight-to-volume based on the weight of the source material to the volume of the extracting fluid, or as PNU/milliliter with one PNU representing 0.00001 mg of protein nitrogen per milliliter.</Description>
</NDC>
<NDC>
<NDCCode>53645-1501-2</NDCCode>
<PackageDescription>23 g in 1 BOTTLE (53645-1501-2) </PackageDescription>
<NDC11Code>53645-1501-02</NDC11Code>
<ProductNDC>53645-1501</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hyoscyamus Niger</ProprietaryName>
<NonProprietaryName>Hyoscymus Niger</NonProprietaryName>
<DosageFormName>GLOBULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20140203</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>True Botanica, LLC</LabelerName>
<SubstanceName>HYOSCYAMUS NIGER</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_X]/23g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-05-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20140203</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For temporary relief of muscular and nervous twitches. Helps increase alertness and creativity. May also be used for standard homeopathic indications or as directed by your physician.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>57520-1501-4</NDCCode>
<PackageDescription>48000 mL in 1 CONTAINER (57520-1501-4) </PackageDescription>
<NDC11Code>57520-1501-04</NDC11Code>
<ProductNDC>57520-1501</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Avena Sativa, Dna, Elaeis Guineensis, Glandula Suprarenalis Suis, Hamamelis Virginiana, Hepar Suis, Kali Sulphuricum, Natrum Muriaticum, Nicotinamidum, Phosphoricum Acidum, Pituitarum Posterium (bovine), Riboflavinum, Thiaminum Hydrochloricum, Thuja Occidentalis, Thyroidinum (bovine), Urtica Urens</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<StartMarketingDate>20240501</StartMarketingDate>
<EndMarketingDate>20280428</EndMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Apotheca Company</LabelerName>
<SubstanceName>AVENA SATIVA FLOWERING TOP; BOS TAURUS PITUITARY GLAND, POSTERIOR; ELAEIS GUINEENSIS FRUIT; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HERRING SPERM DNA; NIACINAMIDE; PHOSPHORIC ACID; PORK LIVER; POTASSIUM SULFATE; RIBOFLAVIN; SODIUM CHLORIDE; SUS SCROFA ADRENAL GLAND; THIAMINE HYDROCHLORIDE; THUJA OCCIDENTALIS LEAFY TWIG; THYROID, BOVINE; URTICA URENS WHOLE</SubstanceName>
<StrengthNumber>4; 10; 15; 4; 12; 6; 4; 6; 30; 8; 200; 30; 6; 200; 30; 4</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2025-01-11</LastUpdate>
<StartMarketingDatePackage>01-MAY-24</StartMarketingDatePackage>
<EndMarketingDatePackage>28-APR-28</EndMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>58668-1501-1</NDCCode>
<PackageDescription>50 mL in 1 BOTTLE (58668-1501-1)</PackageDescription>
<NDC11Code>58668-1501-01</NDC11Code>
<ProductNDC>58668-1501</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Clarins Hydraquench Tinted Moisturizer Broad Spectrum Spf 6 01 Naturel</ProprietaryName>
<NonProprietaryName>Titanium Dioxide</NonProprietaryName>
<DosageFormName>EMULSION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20121025</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Laboratoires Clarins S.A.</LabelerName>
<SubstanceName>TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-02-08</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
</NDCList>