{
"NDC": [
{
"NDCCode": "81825-0011-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (81825-0011-1) ",
"NDC11Code": "81825-0011-01",
"ProductNDC": "81825-0011",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Stress Ii",
"NonProprietaryName": "Epinephrine, Thyroid, Unspecified, Bos Taurus Pituitary Gland, Posterior, Arsenic Trioxide, Oyster Shell Calcium Carbonate, Crude, Conium Maculatum Flowering Top, Cortisone Acetate, Crotalus Horridus Horridus Venom, Iron, Strychnos Nux-vomica Seed, Phosphoric Acid, Phosphorus, Selenium, Sepia Officinalis Juice, And Zanthoxylum Americanum Bark",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20250616",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Zorex",
"SubstanceName": "EPINEPHRINE; THYROID, UNSPECIFIED; BOS TAURUS PITUITARY GLAND, POSTERIOR; ARSENIC TRIOXIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CONIUM MACULATUM FLOWERING TOP; CORTISONE ACETATE; CROTALUS HORRIDUS HORRIDUS VENOM; IRON; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PHOSPHORUS; SELENIUM; SEPIA OFFICINALIS JUICE; ZANTHOXYLUM AMERICANUM BARK",
"StrengthNumber": "9; 9; 9; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Allergens [CS], Catecholamine [EPC], Catecholamines [CS], Cell-mediated Immunity [PE], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-06-28",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250616",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves symptoms of stress, fatigue and simple nervous tension.Claims based on traditional homeopathic practice, not accepted medical evidence. Not Food and Drug Administration evaluated."
},
{
"NDCCode": "81825-0001-2",
"PackageDescription": "60 mL in 1 BOTTLE, DROPPER (81825-0001-2) ",
"NDC11Code": "81825-0001-02",
"ProductNDC": "81825-0001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hydrate Ii",
"NonProprietaryName": "Berber Aqui, Beta Vulg, Boldo, Carduus Mar, Chelidonium Maj, Hordeum Vulgare, Iris Vers, Rosmarinus, Taraxacum, Avena, Eleutherococcus Senticosus, Xanthoxylum, Equisetum Hyem, Hypericum, Ulmus Fulv, Gettysburg Aqua, Glycyrrhiza, Wildbad Aqua, Carlsbad Aqua, Atp, Hydrogen, Nat Mur, Oxygen, Silicea, Wiesbaden Aqua",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20220216",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Zorex International",
"SubstanceName": "BERBERIS AQUIFOLIUM ROOT BARK; BETA VULGARIS WHOLE; PEUMUS BOLDUS LEAF; MILK THISTLE; CHELIDONIUM MAJUS WHOLE; HORDEUM VULGARE WHOLE; IRIS VERSICOLOR ROOT; SALVIA ROSMARINUS FLOWERING TOP; TARAXACUM OFFICINALE; AVENA SATIVA FLOWERING TOP; ELEUTHEROCOCCUS SENTICOSUS WHOLE; ZANTHOXYLUM AMERICANUM BARK; EQUISETUM HYEMALE WHOLE; HYPERICUM PERFORATUM WHOLE; ULMUS RUBRA BARK; GLYCYRRHIZA GLABRA; ADENOSINE TRIPHOSPHATE; HYDROGEN; SODIUM CHLORIDE; OXYGEN; SILICON DIOXIDE",
"StrengthNumber": "8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 12; 30; 34; 30; 30; 30",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]",
"Status": "Active",
"LastUpdate": "2023-04-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220216",
"SamplePackage": "N",
"IndicationAndUsage": "USES: Temporarily relieves low energy, circulatory disorders, digestive upset, &/or symptoms related to poor cellular hydration.**."
},
{
"NDCCode": "81825-0002-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (81825-0002-1) ",
"NDC11Code": "81825-0002-01",
"ProductNDC": "81825-0002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Mold Antigen",
"NonProprietaryName": "Alternaria Alternata, Aspergillus Fumigatus, Aspergillus Niger, Boletus Sat, Botrytis Cinerea, Cladosporium Metanigrum, Fusarium Oxysporum, Helminthosporium, Mucor Muecedo, Pullularia Pullulans, Rhizopus Nigricans, Ustilago Maydis, Arsenicum Alb, Candida Alb, Carbo An, Lachesis, Lycopodium, Merc Solub, Nitricum Ac, Phosphorus, Pulsatilla, Sepia, Silicea, Thuja Occ",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20211201",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Zorex International",
"SubstanceName": "ALTERNARIA ALTERNATA; ASPERGILLUS FUMIGATUS; ASPERGILLUS NIGER VAR. NIGER; BOLETUS SATANAS FRUITING BODY; BOTRYTIS CINEREA; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; FUSARIUM OXYSPORUM; COCHLIOBOLUS SATIVUS; RHIZOPUS STOLONIFER; USTILAGO MAYDIS; ARSENIC TRIOXIDE; CANDIDA ALBICANS; CARBO ANIMALIS; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; NITRIC ACID; PHOSPHORUS; PULSATILLA VULGARIS WHOLE; SEPIA OFFICINALIS JUICE; SILICON DIOXIDE; THUJA OCCIDENTALIS LEAFY TWIG",
"StrengthNumber": "200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2023-04-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211201",
"SamplePackage": "N",
"IndicationAndUsage": "USES: Temporarily relieves symptoms associated with allergies from mold.**."
},
{
"NDCCode": "81825-0003-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (81825-0003-1) ",
"NDC11Code": "81825-0003-01",
"ProductNDC": "81825-0003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "E.n.v.",
"NonProprietaryName": "Belladonna, Berberis Vulg, Carduus Mar, Chelidonium Maj, Colocynthis, Dioscorea, Hydrastis, Lycopodium, Nat Sulphuricum, Nux Vom, Phos, Pulsatilla, Veratrum Alb",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20211208",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Zorex International",
"SubstanceName": "ATROPA BELLADONNA; BERBERIS VULGARIS ROOT BARK; MILK THISTLE; CHELIDONIUM MAJUS WHOLE; CITRULLUS COLOCYNTHIS FRUIT PULP; DIOSCOREA VILLOSA TUBER; GOLDENSEAL; LYCOPODIUM CLAVATUM SPORE; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS WHOLE; VERATRUM ALBUM ROOT",
"StrengthNumber": "30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30",
"StrengthUnit": "[hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL",
"Pharm_Classes": "Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]",
"Status": "Active",
"LastUpdate": "2023-04-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211208",
"SamplePackage": "N",
"IndicationAndUsage": "USES: Temporarily relieves flatulence, constipation, and belching.**."
},
{
"NDCCode": "81825-0004-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (81825-0004-1) ",
"NDC11Code": "81825-0004-01",
"ProductNDC": "81825-0004",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Candida",
"NonProprietaryName": "Baptisia Tinctoria, Echinacea Purp, Glycyrrhiza Glabra, Astragalus, Candida Alb, Borax, Calc Carb, Kreosotum, Lycopodium, Nux Vom, Phosphoricum Ac, Pulsatilla, Sepia, Thuja Occ, Nat Phos, Nitricum Ac",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20211222",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Zorex International",
"SubstanceName": "BAPTISIA TINCTORIA WHOLE; ECHINACEA PURPUREA WHOLE; GLYCYRRHIZA GLABRA; ASTRAGALUS NUTTALLII LEAF; CANDIDA ALBICANS; SODIUM BORATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; WOOD CREOSOTE; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PULSATILLA VULGARIS WHOLE; SEPIA OFFICINALIS JUICE; THUJA OCCIDENTALIS LEAFY TWIG; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; NITRIC ACID",
"StrengthNumber": "4; 4; 4; 6; 200; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS]",
"Status": "Active",
"LastUpdate": "2023-04-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211222",
"SamplePackage": "N",
"IndicationAndUsage": "USES: Temporarily relieves symptoms associated with vaginal yeast.**."
},
{
"NDCCode": "81825-0005-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (81825-0005-1) ",
"NDC11Code": "81825-0005-01",
"ProductNDC": "81825-0005",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "H.m.d.",
"NonProprietaryName": "Allium Sat, Avena, Berber Vulg, Lappa, Phytolacca, Solidago, Alumina, Arg Nit, Baryta Carb, Beryllium, Cadmium Met, Curprum Met, Fluoricum Acidum, Indium, Iodium, Lithium Carb, Merc Solub, Niccolum Carb, Nitrogenum Oxygenatum, Plumb Met, Selenium, Strontium Carb, Titanium, Arsenicum Alb, Nat Mur, Nux Vom",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20211222",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Zorex International",
"SubstanceName": "GARLIC; AVENA SATIVA FLOWERING TOP; BERBERIS VULGARIS ROOT BARK; ARCTIUM LAPPA ROOT; PHYTOLACCA AMERICANA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; ALUMINUM OXIDE; SILVER NITRATE; BARIUM CARBONATE; BERYLLIUM; CADMIUM; COPPER; HYDROFLUORIC ACID; INDIUM; IODINE; LITHIUM CARBONATE; MERCURIUS SOLUBILIS; NICKEL CARBONATE HYDROXIDE TETRAHYDRATE; NITROUS OXIDE; LEAD; SELENIUM; STRONTIUM CARBONATE; TITANIUM; ARSENIC TRIOXIDE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED",
"StrengthNumber": "6; 6; 6; 6; 6; 6; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Inhibit Ovum Fertilization [PE], Mood Stabilizer [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS]",
"Status": "Active",
"LastUpdate": "2023-04-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211222",
"SamplePackage": "N",
"IndicationAndUsage": "USES: Temporarily relieves weakness and fatigue.**."
},
{
"NDCCode": "81825-0006-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (81825-0006-1) ",
"NDC11Code": "81825-0006-01",
"ProductNDC": "81825-0006",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Psoriasis",
"NonProprietaryName": "Arsenicum Album, Arsenicum Iodatum, Borax, Calcarea Carbonica, Graphites, Mezereum, Proteus, Natrum Muriaticum, Phytolacca Decandra, Sepia, Silicea, Sulphur, Thyroidinum",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20211201",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Zorex International",
"SubstanceName": "ARSENIC TRIOXIDE; SODIUM BORATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; GRAPHITE; DAPHNE MEZEREUM BARK; PROTEUS MORGANII; SODIUM CHLORIDE; PHYTOLACCA AMERICANA ROOT; SEPIA OFFICINALIS JUICE; SULFUR; THYROID, UNSPECIFIED; ARSENIC TRIIODIDE",
"StrengthNumber": "30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30",
"StrengthUnit": "[hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL",
"Status": "Active",
"LastUpdate": "2023-04-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20211201",
"SamplePackage": "N",
"IndicationAndUsage": "USES: Temporarily relieves rough skin, dry skin eruptions, rose-colored blotches, itchy skin, &/or other symptoms related to psoriasis.**."
},
{
"NDCCode": "81825-0007-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (81825-0007-1) ",
"NDC11Code": "81825-0007-01",
"ProductNDC": "81825-0007",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Allergy",
"NonProprietaryName": "Allium Cepa, Ambrosia, Arsenicum Alb, Carbo Veg, Euphrasia, Nux Vom, Phosphorus, Pulsatilla, Sulphur, Solidago",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20220216",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Zorex International",
"SubstanceName": "ONION; AMBROSIA ARTEMISIIFOLIA WHOLE; ACTIVATED CHARCOAL; EUPHRASIA STRICTA; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS WHOLE; SULFUR; SOLIDAGO VIRGAUREA FLOWERING TOP",
"StrengthNumber": "30; 30; 30; 30; 30; 30; 30; 30; 30",
"StrengthUnit": "[hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Vegetable Proteins [CS]",
"Status": "Active",
"LastUpdate": "2023-04-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220216",
"SamplePackage": "N",
"IndicationAndUsage": "USES: Temporarily relieves hay fever, coryza, itching and burning eyes, coughing and/or other symptoms associated with hay fever and allergies.**."
},
{
"NDCCode": "81825-0008-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (81825-0008-1) ",
"NDC11Code": "81825-0008-01",
"ProductNDC": "81825-0008",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Viral Hp",
"NonProprietaryName": "Arsenic Trioxide, Atropa Belladonna, Echinacea Angustifolia, Eupatorium Perfoliatum Flowering Top, Gelsemium Sempervirens Root, Lycopodium Clavatum Spore, Phosphoric Acid, Phosphorus, Rancid Beef, Toxicodendron Pubescens Leaf",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20220406",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Zorex International",
"SubstanceName": "ATROPA BELLADONNA; ECHINACEA ANGUSTIFOLIA; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; PHOSPHORUS; RANCID BEEF; TOXICODENDRON PUBESCENS LEAF; ARSENIC TRIOXIDE",
"StrengthNumber": "30; 30; 30; 30; 30; 30; 30; 30; 30; 30",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Active",
"LastUpdate": "2023-04-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220406",
"SamplePackage": "N",
"IndicationAndUsage": "USES: Temporarily relieves aches, fevers, restlessness.**."
},
{
"NDCCode": "81825-0009-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (81825-0009-1) ",
"NDC11Code": "81825-0009-01",
"ProductNDC": "81825-0009",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Flu",
"NonProprietaryName": "Aconitum Napellus, Arsenic Trioxide, Atropa Belladonna, Bryonia Alba Root, Eupatorium Perfoliatum Flowering Top, Ferrum Phosphoricum, Gelsemium Sempervirens Root",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20221003",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Zorex International",
"SubstanceName": "ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERRUM PHOSPHORICUM; GELSEMIUM SEMPERVIRENS ROOT",
"StrengthNumber": "30; 30; 30; 30; 30; 30; 30",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Active",
"LastUpdate": "2023-04-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20221003",
"SamplePackage": "N",
"IndicationAndUsage": "USES: Temporarily relieves flu-like symptoms.**."
},
{
"NDCCode": "81825-0010-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (81825-0010-1) ",
"NDC11Code": "81825-0010-01",
"ProductNDC": "81825-0010",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Stress",
"NonProprietaryName": "Aralia Quin, Passiflora, Scutellaria, Valeriana, Arsenicum Alb, Aur Met, Calc Carb, Coffea Cruda, Ignatia, Kali Phos, Lycopus, Phosphorus, Staphysagria",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20220922",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Zorex International",
"SubstanceName": "AMERICAN GINSENG; PASSIFLORA INCARNATA FLOWERING TOP; SCUTELLARIA LATERIFLORA WHOLE; VALERIAN; ARSENIC TRIOXIDE; GOLD; OYSTER SHELL CALCIUM CARBONATE, CRUDE; ARABICA COFFEE BEAN; STRYCHNOS IGNATII SEED; DIBASIC POTASSIUM PHOSPHATE; LYCOPUS VIRGINICUS WHOLE; PHOSPHORUS; DELPHINIUM STAPHISAGRIA SEED",
"StrengthNumber": "6; 6; 6; 6; 12; 12; 12; 12; 12; 12; 12; 12; 12",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Standardized Chemical Allergen [EPC]",
"Status": "Active",
"LastUpdate": "2023-04-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20220922",
"SamplePackage": "N",
"IndicationAndUsage": "USES: Temporarily relieves symptoms of simple nervous tension.**."
},
{
"NDCCode": "81825-0012-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (81825-0012-1) ",
"NDC11Code": "81825-0012-01",
"ProductNDC": "81825-0012",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Parasode",
"NonProprietaryName": "Artemisia Vulgaris Root, Chelidonium Majus Whole, Punica Granatum Root Bark, Spigelia Anthelmia Whole, Krameria Lappacea Root, Arsenic Trioxide, Iron, Oyster Shell Calcium Carbonate, Crude, Artemisia Cina Pre-flowering Top, Salmonella Enterica Enterica Serovar Enteritidis, Graphite, Calomel, Sodium Chloride, And Sodium Phosphate, Dibasic, Heptahydrate",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20250627",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Zorex",
"SubstanceName": "ARTEMISIA VULGARIS ROOT; CHELIDONIUM MAJUS WHOLE; PUNICA GRANATUM ROOT BARK; SPIGELIA ANTHELMIA WHOLE; KRAMERIA LAPPACEA ROOT; ARSENIC TRIOXIDE; IRON; OYSTER SHELL CALCIUM CARBONATE, CRUDE; ARTEMISIA CINA PRE-FLOWERING TOP; SALMONELLA ENTERICA ENTERICA SEROVAR ENTERITIDIS; GRAPHITE; CALOMEL; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE",
"StrengthNumber": "4; 4; 4; 4; 4; 6; 9; 12; 12; 12; 12; 12; 12; 12",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Status": "Active",
"LastUpdate": "2025-07-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250627",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves symptoms caused by pinworm infestation.Claims based on traditional homeopathic practice, not accepted medical evidence. Not Food and Drug Administration evaluated."
},
{
"NDCCode": "81825-0013-1",
"PackageDescription": "30 mL in 1 BOTTLE, DROPPER (81825-0013-1) ",
"NDC11Code": "81825-0013-01",
"ProductNDC": "81825-0013",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bac",
"NonProprietaryName": "Apis Mellifera, Arsenic Trioxide, Atropa Belladonna, Matricaria Chamomilla Flowering Top Oil, Lachesis Muta Venom, Mercurius Solubilis, Pulsatilla Vulgaris Whole, Toxicodendron Pubescens Leaf, And Silicon Dioxide",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20250626",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Zorex",
"SubstanceName": "APIS MELLIFERA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; MATRICARIA CHAMOMILLA FLOWERING TOP OIL; LACHESIS MUTA VENOM; MERCURIUS SOLUBILIS; PULSATILLA VULGARIS WHOLE; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE",
"StrengthNumber": "30; 30; 30; 30; 30; 30; 30; 30; 30",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC]",
"Status": "Active",
"LastUpdate": "2025-07-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20250626",
"SamplePackage": "N",
"IndicationAndUsage": "Temporarily relieves fever, chilliness with fever, headache.Claims based on traditional homeopathic practice, not accepted medical evidence. Not Food and Drug Administration evaluated."
},
{
"NDCCode": "0003-0011-01",
"PackageDescription": "28 TABLET in 1 BOTTLE (0003-0011-01) ",
"NDC11Code": "00003-0011-01",
"ProductNDC": "0003-0011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Daklinza",
"NonProprietaryName": "Daclatasvir",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20160518",
"EndMarketingDate": "20190430",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA206843",
"LabelerName": "E.R. Squibb & Sons, L.L.C.",
"SubstanceName": "DACLATASVIR DIHYDROCHLORIDE",
"StrengthNumber": "90",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Hepatitis C Virus NS5A Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-05-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20160518",
"EndMarketingDatePackage": "20190430",
"SamplePackage": "N"
},
{
"NDCCode": "0009-0011-04",
"PackageDescription": "25 VIAL, SINGLE-DOSE in 1 CARTON (0009-0011-04) / 2 mL in 1 VIAL, SINGLE-DOSE (0009-0011-03) ",
"NDC11Code": "00009-0011-04",
"ProductNDC": "0009-0011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Solu-cortef",
"NonProprietaryName": "Hydrocortisone Sodium Succinate",
"DosageFormName": "INJECTION, POWDER, FOR SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "19550427",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA009866",
"LabelerName": "Pharmacia & Upjohn Company LLC",
"SubstanceName": "HYDROCORTISONE SODIUM SUCCINATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/2mL",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2026-08-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "19550427",
"SamplePackage": "N",
"IndicationAndUsage": "When oral therapy is not feasible, and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intravenous or intramuscular use of SOLU-CORTEF Sterile Powder is indicated as follows. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, select cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous System: Cerebral edema associated with primary or metastatic brain tumor, or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome, or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus.",
"Description": "SOLU-CORTEF Sterile Powder is an anti-inflammatory glucocorticoid that contains hydrocortisone sodium succinate as the active ingredient. SOLU-CORTEF Sterile Powder is available in several packages for intravenous or intramuscular administration."
},
{
"NDCCode": "0054-0011-20",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (0054-0011-20) / 1 TABLET in 1 BLISTER PACK",
"NDC11Code": "00054-0011-20",
"ProductNDC": "0054-0011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Flecainide Acetate",
"NonProprietaryName": "Flecainide Acetate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20030114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076278",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "FLECAINIDE ACETATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20030114",
"SamplePackage": "N",
"IndicationAndUsage": "In patients without structural heart disease, flecainide acetate is indicated for the prevention of: 1 paroxysmal supraventricular tachycardias (PSVT), including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms, 2 paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms.",
"Description": "Flecainide Acetate Tablets, USP are an antiarrhythmic drug containing 50 mg, 100 mg or 150 mg of flecainide acetate, USP for oral administration. Flecainide acetate is N-(2-piperidylmethyl)-2,5-bis(2,2,2-trifluoroethoxy)benzamide monoacetate. The structural formula is given below. : 1 ."
},
{
"NDCCode": "0054-0011-21",
"PackageDescription": "60 TABLET in 1 BOTTLE (0054-0011-21) ",
"NDC11Code": "00054-0011-21",
"ProductNDC": "0054-0011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Flecainide Acetate",
"NonProprietaryName": "Flecainide Acetate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20030114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076278",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "FLECAINIDE ACETATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20030114",
"SamplePackage": "N",
"IndicationAndUsage": "In patients without structural heart disease, flecainide acetate is indicated for the prevention of: 1 paroxysmal supraventricular tachycardias (PSVT), including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms, 2 paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms.",
"Description": "Flecainide Acetate Tablets, USP are an antiarrhythmic drug containing 50 mg, 100 mg or 150 mg of flecainide acetate, USP for oral administration. Flecainide acetate is N-(2-piperidylmethyl)-2,5-bis(2,2,2-trifluoroethoxy)benzamide monoacetate. The structural formula is given below. : 1 ."
},
{
"NDCCode": "0054-0011-25",
"PackageDescription": "100 TABLET in 1 BOTTLE (0054-0011-25) ",
"NDC11Code": "00054-0011-25",
"ProductNDC": "0054-0011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Flecainide Acetate",
"NonProprietaryName": "Flecainide Acetate",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20030114",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076278",
"LabelerName": "Hikma Pharmaceuticals USA Inc.",
"SubstanceName": "FLECAINIDE ACETATE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antiarrhythmic [EPC]",
"Status": "Active",
"LastUpdate": "2024-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20030114",
"SamplePackage": "N",
"IndicationAndUsage": "In patients without structural heart disease, flecainide acetate is indicated for the prevention of: 1 paroxysmal supraventricular tachycardias (PSVT), including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms, 2 paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms.",
"Description": "Flecainide Acetate Tablets, USP are an antiarrhythmic drug containing 50 mg, 100 mg or 150 mg of flecainide acetate, USP for oral administration. Flecainide acetate is N-(2-piperidylmethyl)-2,5-bis(2,2,2-trifluoroethoxy)benzamide monoacetate. The structural formula is given below. : 1 ."
},
{
"NDCCode": "0068-0011-01",
"PackageDescription": "100 TABLET, SUGAR COATED in 1 BOTTLE (0068-0011-01)",
"NDC11Code": "00068-0011-01",
"ProductNDC": "0068-0011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Norpramin",
"NonProprietaryName": "Desipramine Hydrochloride",
"DosageFormName": "TABLET, SUGAR COATED",
"RouteName": "ORAL",
"StartMarketingDate": "19641120",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA014399",
"LabelerName": "sanofi-aventis U.S. LLC",
"SubstanceName": "DESIPRAMINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Tricyclic Antidepressant [EPC]",
"Status": "Deprecated",
"LastUpdate": "2019-03-05",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "0093-0011-98",
"PackageDescription": "90 TABLET, DELAYED RELEASE in 1 BOTTLE (0093-0011-98) ",
"NDC11Code": "00093-0011-98",
"ProductNDC": "0093-0011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pantoprazole Sodium",
"NonProprietaryName": "Pantoprazole Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20071221",
"EndMarketingDate": "20200531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077056",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "PANTOPRAZOLE SODIUM",
"StrengthNumber": "20",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20071221",
"EndMarketingDatePackage": "20200531",
"SamplePackage": "N"
},
{
"NDCCode": "0168-0011-04",
"PackageDescription": "1 TUBE in 1 CARTON (0168-0011-04) > 113.4 g in 1 TUBE",
"NDC11Code": "00168-0011-04",
"ProductNDC": "0168-0011",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bacitracin Zinc",
"NonProprietaryName": "Bacitracin Zinc",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100108",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333B",
"LabelerName": "E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc.",
"SubstanceName": "BACITRACIN ZINC",
"StrengthNumber": "500",
"StrengthUnit": "[USP'U]/g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "0168-0011-16",
"PackageDescription": "453.6 g in 1 JAR (0168-0011-16)",
"NDC11Code": "00168-0011-16",
"ProductNDC": "0168-0011",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bacitracin Zinc",
"NonProprietaryName": "Bacitracin Zinc",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100108",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333B",
"LabelerName": "E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc.",
"SubstanceName": "BACITRACIN ZINC",
"StrengthNumber": "500",
"StrengthUnit": "[USP'U]/g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "0168-0011-31",
"PackageDescription": "1 TUBE in 1 CARTON (0168-0011-31) > 28.35 g in 1 TUBE",
"NDC11Code": "00168-0011-31",
"ProductNDC": "0168-0011",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bacitracin Zinc",
"NonProprietaryName": "Bacitracin Zinc",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100108",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333B",
"LabelerName": "E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc.",
"SubstanceName": "BACITRACIN ZINC",
"StrengthNumber": "500",
"StrengthUnit": "[USP'U]/g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "0168-0011-35",
"PackageDescription": "1 TUBE in 1 CARTON (0168-0011-35) > 14.17 g in 1 TUBE",
"NDC11Code": "00168-0011-35",
"ProductNDC": "0168-0011",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Bacitracin Zinc",
"NonProprietaryName": "Bacitracin Zinc",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100108",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333B",
"LabelerName": "E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc.",
"SubstanceName": "BACITRACIN ZINC",
"StrengthNumber": "500",
"StrengthUnit": "[USP'U]/g",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231"
},
{
"NDCCode": "0187-0011-10",
"PackageDescription": "1 KIT in 1 PACKAGE (0187-0011-10) * 10 TRAY in 1 PACKAGE > 1 VIAL, SINGLE-DOSE in 1 TRAY > .5 mL in 1 VIAL, SINGLE-DOSE * .6 mL in 1 SYRINGE (0187-0012-01) ",
"NDC11Code": "00187-0011-10",
"ProductNDC": "0187-0011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Iprivask",
"NonProprietaryName": "Desirudin",
"DosageFormName": "KIT",
"StartMarketingDate": "20131231",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021271",
"LabelerName": "Valeant Pharmaceuticals North America LLC",
"Status": "Deprecated",
"LastUpdate": "2018-10-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20131231",
"SamplePackage": "N"
},
{
"NDCCode": "0220-0011-41",
"PackageDescription": "30 [hp_C] in 1 TUBE (0220-0011-41) ",
"NDC11Code": "00220-0011-41",
"ProductNDC": "0220-0011",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Abies Nigra",
"NonProprietaryName": "Picea Mariana Resin",
"DosageFormName": "PELLET",
"RouteName": "ORAL",
"StartMarketingDate": "19830303",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Boiron",
"SubstanceName": "PICEA MARIANA RESIN",
"StrengthNumber": "30",
"StrengthUnit": "[hp_C]/30[hp_C]",
"Status": "Active",
"LastUpdate": "2025-08-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19830303",
"SamplePackage": "N",
"IndicationAndUsage": "Relieves acid indigestion, sour stomach, heartburn *. Uses: See symptoms on front panel."
},
{
"NDCCode": "0268-0011-10",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (0268-0011-10)",
"NDC11Code": "00268-0011-10",
"ProductNDC": "0268-0011",
"ProductTypeName": "NON-STANDARDIZED ALLERGENIC",
"ProprietaryName": "House Dust",
"NonProprietaryName": "House Dust",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "SUBCUTANEOUS",
"StartMarketingDate": "19650101",
"MarketingCategoryName": "BLA",
"ApplicationNumber": "BLA103753",
"LabelerName": "ALK-Abello, Inc.",
"SubstanceName": "HOUSE DUST",
"StrengthNumber": "20000",
"StrengthUnit": "[PNU]/mL",
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},
{
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"LastUpdate": "2016-12-02"
},
{
"NDCCode": "0327-0011-05",
"PackageDescription": "500 mL in 1 BOTTLE (0327-0011-05) ",
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"LabelerName": "United-Guardian, Inc.",
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"StrengthUnit": "g/100mL; g/100mL; g/100mL",
"Pharm_Classes": "Calculi Dissolution Agent [EPC],Irrigation [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA]",
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"LastUpdate": "2018-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19910101",
"EndMarketingDatePackage": "20180601",
"SamplePackage": "N"
},
{
"NDCCode": "0360-0011-01",
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"ProductNDC": "0360-0011",
"ProductTypeName": "HUMAN OTC DRUG",
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"NonProprietaryName": "Argentum Nit.",
"DosageFormName": "TABLET",
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"StartMarketingDate": "19970217",
"EndMarketingDate": "20211231",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "STANDARD HOMEOPATHIC COMPANY",
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"LastUpdate": "2022-01-04",
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<NDCList>
<NDC>
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<Pharm_Classes>Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Allergens [CS], Catecholamine [EPC], Catecholamines [CS], Cell-mediated Immunity [PE], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-06-28</LastUpdate>
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<SamplePackage>N</SamplePackage>
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<PackageDescription>60 mL in 1 BOTTLE, DROPPER (81825-0001-2) </PackageDescription>
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<SubstanceName>BERBERIS AQUIFOLIUM ROOT BARK; BETA VULGARIS WHOLE; PEUMUS BOLDUS LEAF; MILK THISTLE; CHELIDONIUM MAJUS WHOLE; HORDEUM VULGARE WHOLE; IRIS VERSICOLOR ROOT; SALVIA ROSMARINUS FLOWERING TOP; TARAXACUM OFFICINALE; AVENA SATIVA FLOWERING TOP; ELEUTHEROCOCCUS SENTICOSUS WHOLE; ZANTHOXYLUM AMERICANUM BARK; EQUISETUM HYEMALE WHOLE; HYPERICUM PERFORATUM WHOLE; ULMUS RUBRA BARK; GLYCYRRHIZA GLABRA; ADENOSINE TRIPHOSPHATE; HYDROGEN; SODIUM CHLORIDE; OXYGEN; SILICON DIOXIDE</SubstanceName>
<StrengthNumber>8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 8; 12; 30; 34; 30; 30; 30</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-04-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
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<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: Temporarily relieves low energy, circulatory disorders, digestive upset, &/or symptoms related to poor cellular hydration.**.</IndicationAndUsage>
</NDC>
<NDC>
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<PackageDescription>30 mL in 1 BOTTLE, DROPPER (81825-0002-1) </PackageDescription>
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<ProductNDC>81825-0002</ProductNDC>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20211201</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Zorex International</LabelerName>
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<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-04-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: Temporarily relieves symptoms associated with allergies from mold.**.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>81825-0003-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (81825-0003-1) </PackageDescription>
<NDC11Code>81825-0003-01</NDC11Code>
<ProductNDC>81825-0003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>E.n.v.</ProprietaryName>
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<RouteName>ORAL</RouteName>
<StartMarketingDate>20211208</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Zorex International</LabelerName>
<SubstanceName>ATROPA BELLADONNA; BERBERIS VULGARIS ROOT BARK; MILK THISTLE; CHELIDONIUM MAJUS WHOLE; CITRULLUS COLOCYNTHIS FRUIT PULP; DIOSCOREA VILLOSA TUBER; GOLDENSEAL; LYCOPODIUM CLAVATUM SPORE; SODIUM SULFATE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS WHOLE; VERATRUM ALBUM ROOT</SubstanceName>
<StrengthNumber>30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30</StrengthNumber>
<StrengthUnit>[hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-04-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211208</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: Temporarily relieves flatulence, constipation, and belching.**.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>81825-0004-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (81825-0004-1) </PackageDescription>
<NDC11Code>81825-0004-01</NDC11Code>
<ProductNDC>81825-0004</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Candida</ProprietaryName>
<NonProprietaryName>Baptisia Tinctoria, Echinacea Purp, Glycyrrhiza Glabra, Astragalus, Candida Alb, Borax, Calc Carb, Kreosotum, Lycopodium, Nux Vom, Phosphoricum Ac, Pulsatilla, Sepia, Thuja Occ, Nat Phos, Nitricum Ac</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211222</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Zorex International</LabelerName>
<SubstanceName>BAPTISIA TINCTORIA WHOLE; ECHINACEA PURPUREA WHOLE; GLYCYRRHIZA GLABRA; ASTRAGALUS NUTTALLII LEAF; CANDIDA ALBICANS; SODIUM BORATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; WOOD CREOSOTE; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORIC ACID; PULSATILLA VULGARIS WHOLE; SEPIA OFFICINALIS JUICE; THUJA OCCIDENTALIS LEAFY TWIG; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; NITRIC ACID</SubstanceName>
<StrengthNumber>4; 4; 4; 6; 200; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-04-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: Temporarily relieves symptoms associated with vaginal yeast.**.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>81825-0005-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (81825-0005-1) </PackageDescription>
<NDC11Code>81825-0005-01</NDC11Code>
<ProductNDC>81825-0005</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>H.m.d.</ProprietaryName>
<NonProprietaryName>Allium Sat, Avena, Berber Vulg, Lappa, Phytolacca, Solidago, Alumina, Arg Nit, Baryta Carb, Beryllium, Cadmium Met, Curprum Met, Fluoricum Acidum, Indium, Iodium, Lithium Carb, Merc Solub, Niccolum Carb, Nitrogenum Oxygenatum, Plumb Met, Selenium, Strontium Carb, Titanium, Arsenicum Alb, Nat Mur, Nux Vom</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211222</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Zorex International</LabelerName>
<SubstanceName>GARLIC; AVENA SATIVA FLOWERING TOP; BERBERIS VULGARIS ROOT BARK; ARCTIUM LAPPA ROOT; PHYTOLACCA AMERICANA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; ALUMINUM OXIDE; SILVER NITRATE; BARIUM CARBONATE; BERYLLIUM; CADMIUM; COPPER; HYDROFLUORIC ACID; INDIUM; IODINE; LITHIUM CARBONATE; MERCURIUS SOLUBILIS; NICKEL CARBONATE HYDROXIDE TETRAHYDRATE; NITROUS OXIDE; LEAD; SELENIUM; STRONTIUM CARBONATE; TITANIUM; ARSENIC TRIOXIDE; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED</SubstanceName>
<StrengthNumber>6; 6; 6; 6; 6; 6; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Inhibit Ovum Fertilization [PE], Mood Stabilizer [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-04-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211222</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: Temporarily relieves weakness and fatigue.**.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>81825-0006-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (81825-0006-1) </PackageDescription>
<NDC11Code>81825-0006-01</NDC11Code>
<ProductNDC>81825-0006</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Psoriasis</ProprietaryName>
<NonProprietaryName>Arsenicum Album, Arsenicum Iodatum, Borax, Calcarea Carbonica, Graphites, Mezereum, Proteus, Natrum Muriaticum, Phytolacca Decandra, Sepia, Silicea, Sulphur, Thyroidinum</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211201</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Zorex International</LabelerName>
<SubstanceName>ARSENIC TRIOXIDE; SODIUM BORATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; GRAPHITE; DAPHNE MEZEREUM BARK; PROTEUS MORGANII; SODIUM CHLORIDE; PHYTOLACCA AMERICANA ROOT; SEPIA OFFICINALIS JUICE; SULFUR; THYROID, UNSPECIFIED; ARSENIC TRIIODIDE</SubstanceName>
<StrengthNumber>30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30</StrengthNumber>
<StrengthUnit>[hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-04-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20211201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: Temporarily relieves rough skin, dry skin eruptions, rose-colored blotches, itchy skin, &/or other symptoms related to psoriasis.**.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>81825-0007-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (81825-0007-1) </PackageDescription>
<NDC11Code>81825-0007-01</NDC11Code>
<ProductNDC>81825-0007</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Allergy</ProprietaryName>
<NonProprietaryName>Allium Cepa, Ambrosia, Arsenicum Alb, Carbo Veg, Euphrasia, Nux Vom, Phosphorus, Pulsatilla, Sulphur, Solidago</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220216</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Zorex International</LabelerName>
<SubstanceName>ONION; AMBROSIA ARTEMISIIFOLIA WHOLE; ACTIVATED CHARCOAL; EUPHRASIA STRICTA; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PULSATILLA VULGARIS WHOLE; SULFUR; SOLIDAGO VIRGAUREA FLOWERING TOP</SubstanceName>
<StrengthNumber>30; 30; 30; 30; 30; 30; 30; 30; 30</StrengthNumber>
<StrengthUnit>[hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-04-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220216</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: Temporarily relieves hay fever, coryza, itching and burning eyes, coughing and/or other symptoms associated with hay fever and allergies.**.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>81825-0008-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (81825-0008-1) </PackageDescription>
<NDC11Code>81825-0008-01</NDC11Code>
<ProductNDC>81825-0008</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Viral Hp</ProprietaryName>
<NonProprietaryName>Arsenic Trioxide, Atropa Belladonna, Echinacea Angustifolia, Eupatorium Perfoliatum Flowering Top, Gelsemium Sempervirens Root, Lycopodium Clavatum Spore, Phosphoric Acid, Phosphorus, Rancid Beef, Toxicodendron Pubescens Leaf</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220406</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Zorex International</LabelerName>
<SubstanceName>ATROPA BELLADONNA; ECHINACEA ANGUSTIFOLIA; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; LYCOPODIUM CLAVATUM SPORE; PHOSPHORIC ACID; PHOSPHORUS; RANCID BEEF; TOXICODENDRON PUBESCENS LEAF; ARSENIC TRIOXIDE</SubstanceName>
<StrengthNumber>30; 30; 30; 30; 30; 30; 30; 30; 30; 30</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-04-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220406</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: Temporarily relieves aches, fevers, restlessness.**.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>81825-0009-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (81825-0009-1) </PackageDescription>
<NDC11Code>81825-0009-01</NDC11Code>
<ProductNDC>81825-0009</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Flu</ProprietaryName>
<NonProprietaryName>Aconitum Napellus, Arsenic Trioxide, Atropa Belladonna, Bryonia Alba Root, Eupatorium Perfoliatum Flowering Top, Ferrum Phosphoricum, Gelsemium Sempervirens Root</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20221003</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Zorex International</LabelerName>
<SubstanceName>ACONITUM NAPELLUS; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BRYONIA ALBA ROOT; EUPATORIUM PERFOLIATUM FLOWERING TOP; FERRUM PHOSPHORICUM; GELSEMIUM SEMPERVIRENS ROOT</SubstanceName>
<StrengthNumber>30; 30; 30; 30; 30; 30; 30</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-04-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20221003</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: Temporarily relieves flu-like symptoms.**.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>81825-0010-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (81825-0010-1) </PackageDescription>
<NDC11Code>81825-0010-01</NDC11Code>
<ProductNDC>81825-0010</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Stress</ProprietaryName>
<NonProprietaryName>Aralia Quin, Passiflora, Scutellaria, Valeriana, Arsenicum Alb, Aur Met, Calc Carb, Coffea Cruda, Ignatia, Kali Phos, Lycopus, Phosphorus, Staphysagria</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220922</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Zorex International</LabelerName>
<SubstanceName>AMERICAN GINSENG; PASSIFLORA INCARNATA FLOWERING TOP; SCUTELLARIA LATERIFLORA WHOLE; VALERIAN; ARSENIC TRIOXIDE; GOLD; OYSTER SHELL CALCIUM CARBONATE, CRUDE; ARABICA COFFEE BEAN; STRYCHNOS IGNATII SEED; DIBASIC POTASSIUM PHOSPHATE; LYCOPUS VIRGINICUS WHOLE; PHOSPHORUS; DELPHINIUM STAPHISAGRIA SEED</SubstanceName>
<StrengthNumber>6; 6; 6; 6; 12; 12; 12; 12; 12; 12; 12; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Standardized Chemical Allergen [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-04-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220922</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: Temporarily relieves symptoms of simple nervous tension.**.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>81825-0012-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (81825-0012-1) </PackageDescription>
<NDC11Code>81825-0012-01</NDC11Code>
<ProductNDC>81825-0012</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Parasode</ProprietaryName>
<NonProprietaryName>Artemisia Vulgaris Root, Chelidonium Majus Whole, Punica Granatum Root Bark, Spigelia Anthelmia Whole, Krameria Lappacea Root, Arsenic Trioxide, Iron, Oyster Shell Calcium Carbonate, Crude, Artemisia Cina Pre-flowering Top, Salmonella Enterica Enterica Serovar Enteritidis, Graphite, Calomel, Sodium Chloride, And Sodium Phosphate, Dibasic, Heptahydrate</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250627</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Zorex</LabelerName>
<SubstanceName>ARTEMISIA VULGARIS ROOT; CHELIDONIUM MAJUS WHOLE; PUNICA GRANATUM ROOT BARK; SPIGELIA ANTHELMIA WHOLE; KRAMERIA LAPPACEA ROOT; ARSENIC TRIOXIDE; IRON; OYSTER SHELL CALCIUM CARBONATE, CRUDE; ARTEMISIA CINA PRE-FLOWERING TOP; SALMONELLA ENTERICA ENTERICA SEROVAR ENTERITIDIS; GRAPHITE; CALOMEL; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE</SubstanceName>
<StrengthNumber>4; 4; 4; 4; 4; 6; 9; 12; 12; 12; 12; 12; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-07-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250627</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves symptoms caused by pinworm infestation.Claims based on traditional homeopathic practice, not accepted medical evidence. Not Food and Drug Administration evaluated.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>81825-0013-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (81825-0013-1) </PackageDescription>
<NDC11Code>81825-0013-01</NDC11Code>
<ProductNDC>81825-0013</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bac</ProprietaryName>
<NonProprietaryName>Apis Mellifera, Arsenic Trioxide, Atropa Belladonna, Matricaria Chamomilla Flowering Top Oil, Lachesis Muta Venom, Mercurius Solubilis, Pulsatilla Vulgaris Whole, Toxicodendron Pubescens Leaf, And Silicon Dioxide</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250626</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Zorex</LabelerName>
<SubstanceName>APIS MELLIFERA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; MATRICARIA CHAMOMILLA FLOWERING TOP OIL; LACHESIS MUTA VENOM; MERCURIUS SOLUBILIS; PULSATILLA VULGARIS WHOLE; TOXICODENDRON PUBESCENS LEAF; SILICON DIOXIDE</SubstanceName>
<StrengthNumber>30; 30; 30; 30; 30; 30; 30; 30; 30</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Standardized Insect Venom Allergenic Extract [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-07-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250626</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporarily relieves fever, chilliness with fever, headache.Claims based on traditional homeopathic practice, not accepted medical evidence. Not Food and Drug Administration evaluated.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0003-0011-01</NDCCode>
<PackageDescription>28 TABLET in 1 BOTTLE (0003-0011-01) </PackageDescription>
<NDC11Code>00003-0011-01</NDC11Code>
<ProductNDC>0003-0011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Daklinza</ProprietaryName>
<NonProprietaryName>Daclatasvir</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160518</StartMarketingDate>
<EndMarketingDate>20190430</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA206843</ApplicationNumber>
<LabelerName>E.R. Squibb & Sons, L.L.C.</LabelerName>
<SubstanceName>DACLATASVIR DIHYDROCHLORIDE</SubstanceName>
<StrengthNumber>90</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Hepatitis C Virus NS5A Inhibitor [EPC],P-Glycoprotein Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA],Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA],Breast Cancer Resistance Protein Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-05-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20160518</StartMarketingDatePackage>
<EndMarketingDatePackage>20190430</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0009-0011-04</NDCCode>
<PackageDescription>25 VIAL, SINGLE-DOSE in 1 CARTON (0009-0011-04) / 2 mL in 1 VIAL, SINGLE-DOSE (0009-0011-03) </PackageDescription>
<NDC11Code>00009-0011-04</NDC11Code>
<ProductNDC>0009-0011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Solu-cortef</ProprietaryName>
<NonProprietaryName>Hydrocortisone Sodium Succinate</NonProprietaryName>
<DosageFormName>INJECTION, POWDER, FOR SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>19550427</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA009866</ApplicationNumber>
<LabelerName>Pharmacia & Upjohn Company LLC</LabelerName>
<SubstanceName>HYDROCORTISONE SODIUM SUCCINATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/2mL</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19550427</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>When oral therapy is not feasible, and the strength, dosage form, and route of administration of the drug reasonably lend the preparation to the treatment of the condition, the intravenous or intramuscular use of SOLU-CORTEF Sterile Powder is indicated as follows. Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis. Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis (systemic therapy) and ulcerative colitis. Hematologic disorders: Acquired (autoimmune) hemolytic anemia, congenital (erythroid) hypoplastic anemia (Diamond Blackfan anemia), idiopathic thrombocytopenic purpura in adults (intravenous administration only; intramuscular administration is contraindicated), pure red cell aplasia, select cases of secondary thrombocytopenia. Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy. Neoplastic diseases: For the palliative management of leukemias and lymphomas. Nervous System: Cerebral edema associated with primary or metastatic brain tumor, or craniotomy. Ophthalmic diseases: Sympathetic ophthalmia, uveitis and ocular inflammatory conditions unresponsive to topical corticosteroids. Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome, or that due to lupus erythematosus. Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis. Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, temporal arteritis, polymyositis, and systemic lupus erythematosus.</IndicationAndUsage>
<Description>SOLU-CORTEF Sterile Powder is an anti-inflammatory glucocorticoid that contains hydrocortisone sodium succinate as the active ingredient. SOLU-CORTEF Sterile Powder is available in several packages for intravenous or intramuscular administration.</Description>
</NDC>
<NDC>
<NDCCode>0054-0011-20</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (0054-0011-20) / 1 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00054-0011-20</NDC11Code>
<ProductNDC>0054-0011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Flecainide Acetate</ProprietaryName>
<NonProprietaryName>Flecainide Acetate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030114</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076278</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>FLECAINIDE ACETATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20030114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>In patients without structural heart disease, flecainide acetate is indicated for the prevention of: 1 paroxysmal supraventricular tachycardias (PSVT), including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms, 2 paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms.</IndicationAndUsage>
<Description>Flecainide Acetate Tablets, USP are an antiarrhythmic drug containing 50 mg, 100 mg or 150 mg of flecainide acetate, USP for oral administration. Flecainide acetate is N-(2-piperidylmethyl)-2,5-bis(2,2,2-trifluoroethoxy)benzamide monoacetate. The structural formula is given below. : 1 .</Description>
</NDC>
<NDC>
<NDCCode>0054-0011-21</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (0054-0011-21) </PackageDescription>
<NDC11Code>00054-0011-21</NDC11Code>
<ProductNDC>0054-0011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Flecainide Acetate</ProprietaryName>
<NonProprietaryName>Flecainide Acetate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030114</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076278</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>FLECAINIDE ACETATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20030114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>In patients without structural heart disease, flecainide acetate is indicated for the prevention of: 1 paroxysmal supraventricular tachycardias (PSVT), including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms, 2 paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms.</IndicationAndUsage>
<Description>Flecainide Acetate Tablets, USP are an antiarrhythmic drug containing 50 mg, 100 mg or 150 mg of flecainide acetate, USP for oral administration. Flecainide acetate is N-(2-piperidylmethyl)-2,5-bis(2,2,2-trifluoroethoxy)benzamide monoacetate. The structural formula is given below. : 1 .</Description>
</NDC>
<NDC>
<NDCCode>0054-0011-25</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0054-0011-25) </PackageDescription>
<NDC11Code>00054-0011-25</NDC11Code>
<ProductNDC>0054-0011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Flecainide Acetate</ProprietaryName>
<NonProprietaryName>Flecainide Acetate</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20030114</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076278</ApplicationNumber>
<LabelerName>Hikma Pharmaceuticals USA Inc.</LabelerName>
<SubstanceName>FLECAINIDE ACETATE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antiarrhythmic [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20030114</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>In patients without structural heart disease, flecainide acetate is indicated for the prevention of: 1 paroxysmal supraventricular tachycardias (PSVT), including atrioventricular nodal reentrant tachycardia, atrioventricular reentrant tachycardia and other supraventricular tachycardias of unspecified mechanism associated with disabling symptoms, 2 paroxysmal atrial fibrillation/flutter (PAF) associated with disabling symptoms.</IndicationAndUsage>
<Description>Flecainide Acetate Tablets, USP are an antiarrhythmic drug containing 50 mg, 100 mg or 150 mg of flecainide acetate, USP for oral administration. Flecainide acetate is N-(2-piperidylmethyl)-2,5-bis(2,2,2-trifluoroethoxy)benzamide monoacetate. The structural formula is given below. : 1 .</Description>
</NDC>
<NDC>
<NDCCode>0068-0011-01</NDCCode>
<PackageDescription>100 TABLET, SUGAR COATED in 1 BOTTLE (0068-0011-01)</PackageDescription>
<NDC11Code>00068-0011-01</NDC11Code>
<ProductNDC>0068-0011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Norpramin</ProprietaryName>
<NonProprietaryName>Desipramine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, SUGAR COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19641120</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA014399</ApplicationNumber>
<LabelerName>sanofi-aventis U.S. LLC</LabelerName>
<SubstanceName>DESIPRAMINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Tricyclic Antidepressant [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-03-05</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0093-0011-98</NDCCode>
<PackageDescription>90 TABLET, DELAYED RELEASE in 1 BOTTLE (0093-0011-98) </PackageDescription>
<NDC11Code>00093-0011-98</NDC11Code>
<ProductNDC>0093-0011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pantoprazole Sodium</ProprietaryName>
<NonProprietaryName>Pantoprazole Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20071221</StartMarketingDate>
<EndMarketingDate>20200531</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077056</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
<StrengthNumber>20</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2020-06-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20071221</StartMarketingDatePackage>
<EndMarketingDatePackage>20200531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0168-0011-04</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0168-0011-04) > 113.4 g in 1 TUBE</PackageDescription>
<NDC11Code>00168-0011-04</NDC11Code>
<ProductNDC>0168-0011</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bacitracin Zinc</ProprietaryName>
<NonProprietaryName>Bacitracin Zinc</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100108</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333B</ApplicationNumber>
<LabelerName>E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc.</LabelerName>
<SubstanceName>BACITRACIN ZINC</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>[USP'U]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0168-0011-16</NDCCode>
<PackageDescription>453.6 g in 1 JAR (0168-0011-16)</PackageDescription>
<NDC11Code>00168-0011-16</NDC11Code>
<ProductNDC>0168-0011</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bacitracin Zinc</ProprietaryName>
<NonProprietaryName>Bacitracin Zinc</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100108</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333B</ApplicationNumber>
<LabelerName>E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc.</LabelerName>
<SubstanceName>BACITRACIN ZINC</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>[USP'U]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0168-0011-31</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0168-0011-31) > 28.35 g in 1 TUBE</PackageDescription>
<NDC11Code>00168-0011-31</NDC11Code>
<ProductNDC>0168-0011</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bacitracin Zinc</ProprietaryName>
<NonProprietaryName>Bacitracin Zinc</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100108</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333B</ApplicationNumber>
<LabelerName>E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc.</LabelerName>
<SubstanceName>BACITRACIN ZINC</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>[USP'U]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0168-0011-35</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0168-0011-35) > 14.17 g in 1 TUBE</PackageDescription>
<NDC11Code>00168-0011-35</NDC11Code>
<ProductNDC>0168-0011</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Bacitracin Zinc</ProprietaryName>
<NonProprietaryName>Bacitracin Zinc</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100108</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333B</ApplicationNumber>
<LabelerName>E. FOUGERA & CO., A division of Fougera Pharmaceuticals Inc.</LabelerName>
<SubstanceName>BACITRACIN ZINC</SubstanceName>
<StrengthNumber>500</StrengthNumber>
<StrengthUnit>[USP'U]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0187-0011-10</NDCCode>
<PackageDescription>1 KIT in 1 PACKAGE (0187-0011-10) * 10 TRAY in 1 PACKAGE > 1 VIAL, SINGLE-DOSE in 1 TRAY > .5 mL in 1 VIAL, SINGLE-DOSE * .6 mL in 1 SYRINGE (0187-0012-01) </PackageDescription>
<NDC11Code>00187-0011-10</NDC11Code>
<ProductNDC>0187-0011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Iprivask</ProprietaryName>
<NonProprietaryName>Desirudin</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20131231</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021271</ApplicationNumber>
<LabelerName>Valeant Pharmaceuticals North America LLC</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2018-10-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131231</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0220-0011-41</NDCCode>
<PackageDescription>30 [hp_C] in 1 TUBE (0220-0011-41) </PackageDescription>
<NDC11Code>00220-0011-41</NDC11Code>
<ProductNDC>0220-0011</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Abies Nigra</ProprietaryName>
<NonProprietaryName>Picea Mariana Resin</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19830303</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Boiron</LabelerName>
<SubstanceName>PICEA MARIANA RESIN</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>[hp_C]/30[hp_C]</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2025-08-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19830303</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Relieves acid indigestion, sour stomach, heartburn *. Uses: See symptoms on front panel.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>0268-0011-10</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (0268-0011-10)</PackageDescription>
<NDC11Code>00268-0011-10</NDC11Code>
<ProductNDC>0268-0011</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>House Dust</ProprietaryName>
<NonProprietaryName>House Dust</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>19650101</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103753</ApplicationNumber>
<LabelerName>ALK-Abello, Inc.</LabelerName>
<SubstanceName>HOUSE DUST</SubstanceName>
<StrengthNumber>20000</StrengthNumber>
<StrengthUnit>[PNU]/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>0268-0011-50</NDCCode>
<PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (0268-0011-50)</PackageDescription>
<NDC11Code>00268-0011-50</NDC11Code>
<ProductNDC>0268-0011</ProductNDC>
<ProductTypeName>NON-STANDARDIZED ALLERGENIC</ProductTypeName>
<ProprietaryName>House Dust</ProprietaryName>
<NonProprietaryName>House Dust</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>SUBCUTANEOUS</RouteName>
<StartMarketingDate>19650101</StartMarketingDate>
<MarketingCategoryName>BLA</MarketingCategoryName>
<ApplicationNumber>BLA103753</ApplicationNumber>
<LabelerName>ALK-Abello, Inc.</LabelerName>
<SubstanceName>HOUSE DUST</SubstanceName>
<StrengthNumber>20000</StrengthNumber>
<StrengthUnit>[PNU]/mL</StrengthUnit>
<Pharm_Classes>Non-Standardized House Dust Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [Chemical/Ingredient],House Dust [Chemical/Ingredient]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2016-12-02</LastUpdate>
</NDC>
<NDC>
<NDCCode>0327-0011-05</NDCCode>
<PackageDescription>500 mL in 1 BOTTLE (0327-0011-05) </PackageDescription>
<NDC11Code>00327-0011-05</NDC11Code>
<ProductNDC>0327-0011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Renacidin</ProprietaryName>
<NonProprietaryName>Citric Acid, Gluconolactone And Magnesium Carbonate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>IRRIGATION</RouteName>
<StartMarketingDate>19910101</StartMarketingDate>
<EndMarketingDate>20180601</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019481</ApplicationNumber>
<LabelerName>United-Guardian, Inc.</LabelerName>
<SubstanceName>ANHYDROUS CITRIC ACID; GLUCONOLACTONE; MAGNESIUM CARBONATE</SubstanceName>
<StrengthNumber>6.6; .198; 3.376</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC],Irrigation [MoA],Acidifying Activity [MoA],Calculi Dissolution Agent [EPC],Anti-coagulant [EPC],Decreased Coagulation Factor Activity [PE],Calcium Chelating Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2018-06-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19910101</StartMarketingDatePackage>
<EndMarketingDatePackage>20180601</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0360-0011-01</NDCCode>
<PackageDescription>1 g in 1 BOTTLE, PLASTIC (0360-0011-01) </PackageDescription>
<NDC11Code>00360-0011-01</NDC11Code>
<ProductNDC>0360-0011</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Argentum</ProprietaryName>
<NonProprietaryName>Argentum Nit.</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>SUBLINGUAL</RouteName>
<StartMarketingDate>19970217</StartMarketingDate>
<EndMarketingDate>20211231</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>STANDARD HOMEOPATHIC COMPANY</LabelerName>
<SubstanceName>SILVER NITRATE</SubstanceName>
<StrengthNumber>6</StrengthNumber>
<StrengthUnit>[hp_X]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19970217</StartMarketingDatePackage>
<EndMarketingDatePackage>20211231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
</NDCList>