{
"NDC": [
{
"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": "81825-0001-2",
"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": "81825-0011-1",
"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": "81825-0013-1",
"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": "0009-0012-01",
"PackageDescription": "50 TABLET in 1 BOTTLE (0009-0012-01) ",
"NDC11Code": "00009-0012-01",
"ProductNDC": "0009-0012",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cortef",
"NonProprietaryName": "Hydrocortisone",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "19521215",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA008697",
"LabelerName": "Pharmacia & Upjohn Company LLC",
"SubstanceName": "HYDROCORTISONE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]",
"Status": "Active",
"LastUpdate": "2025-02-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "19521215",
"SamplePackage": "N",
"IndicationAndUsage": "CORTEF Tablets are indicated in the following conditions.",
"Description": "CORTEF Tablets contain hydrocortisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Hydrocortisone USP is white to practically white, odorless, crystalline powder with a melting point of about 215° C. It is very slightly soluble in water and in ether; sparingly soluble in acetone and in alcohol; slightly soluble in chloroform. The chemical name for hydrocortisone is pregn-4-ene-3,20-dione,11,17,21-trihydroxy-, (11β)-. Its molecular weight is 362.46 and the structural formula is as outlined below. CORTEF Tablets are available for oral administration in three strengths: each tablet contains either 5 mg, 10 mg, or 20 mg of hydrocortisone. Inactive ingredients: calcium stearate, corn starch, lactose, mineral oil, sorbic acid, sucrose."
},
{
"NDCCode": "0054-0012-20",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (0054-0012-20) / 1 TABLET in 1 BLISTER PACK",
"NDC11Code": "00054-0012-20",
"ProductNDC": "0054-0012",
"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": "150",
"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": "0054-0012-21",
"PackageDescription": "60 TABLET in 1 BOTTLE (0054-0012-21) ",
"NDC11Code": "00054-0012-21",
"ProductNDC": "0054-0012",
"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": "150",
"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": "0054-0012-25",
"PackageDescription": "100 TABLET in 1 BOTTLE (0054-0012-25) ",
"NDC11Code": "00054-0012-25",
"ProductNDC": "0054-0012",
"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": "150",
"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": "0093-0012-98",
"PackageDescription": "90 TABLET, DELAYED RELEASE in 1 BOTTLE (0093-0012-98) ",
"NDC11Code": "00093-0012-98",
"ProductNDC": "0093-0012",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pantoprazole Sodium",
"NonProprietaryName": "Pantoprazole Sodium",
"DosageFormName": "TABLET, DELAYED RELEASE",
"RouteName": "ORAL",
"StartMarketingDate": "20071219",
"EndMarketingDate": "20200531",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077056",
"LabelerName": "Teva Pharmaceuticals USA, Inc.",
"SubstanceName": "PANTOPRAZOLE SODIUM",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2020-06-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20071219",
"EndMarketingDatePackage": "20200531",
"SamplePackage": "N"
},
{
"NDCCode": "0168-0012-09",
"PackageDescription": "144 PACKET in 1 CARTON (0168-0012-09) > .9 g in 1 PACKET",
"NDC11Code": "00168-0012-09",
"ProductNDC": "0168-0012",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Triple Antibiotic",
"NonProprietaryName": "Neomycin And Polymyxin B Sulfates And Bacitracin Zinc",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100106",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333B",
"LabelerName": "E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.",
"SubstanceName": "BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE",
"StrengthNumber": "400; 3.5; 5000",
"StrengthUnit": "[USP'U]/g; mg/g; [USP'U]/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0168-0012-31",
"PackageDescription": "1 TUBE in 1 CARTON (0168-0012-31) > 28.35 g in 1 TUBE",
"NDC11Code": "00168-0012-31",
"ProductNDC": "0168-0012",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Triple Antibiotic",
"NonProprietaryName": "Neomycin And Polymyxin B Sulfates And Bacitracin Zinc",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100106",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333B",
"LabelerName": "E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.",
"SubstanceName": "BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE",
"StrengthNumber": "400; 3.5; 5000",
"StrengthUnit": "[USP'U]/g; mg/g; [USP'U]/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0168-0012-35",
"PackageDescription": "1 TUBE in 1 CARTON (0168-0012-35) > 14.17 g in 1 TUBE",
"NDC11Code": "00168-0012-35",
"ProductNDC": "0168-0012",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Triple Antibiotic",
"NonProprietaryName": "Neomycin And Polymyxin B Sulfates And Bacitracin Zinc",
"DosageFormName": "OINTMENT",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100106",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part333B",
"LabelerName": "E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.",
"SubstanceName": "BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE",
"StrengthNumber": "400; 3.5; 5000",
"StrengthUnit": "[USP'U]/g; mg/g; [USP'U]/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"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": "0220-0012-11",
"PackageDescription": "30 mL in 1 BOTTLE, GLASS (0220-0012-11)",
"NDC11Code": "00220-0012-11",
"ProductNDC": "0220-0012",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Artemisia Abrotanum Flowering Top",
"DosageFormName": "PELLET",
"StartMarketingDate": "20170101",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Laboratoires Boiron",
"SubstanceName": "ARTEMISIA ABROTANUM FLOWERING TOP",
"StrengthNumber": "1",
"StrengthUnit": "[hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0220-0012-12",
"PackageDescription": "60 mL in 1 BOTTLE, GLASS (0220-0012-12)",
"NDC11Code": "00220-0012-12",
"ProductNDC": "0220-0012",
"ProductTypeName": "DRUG FOR FURTHER PROCESSING",
"NonProprietaryName": "Artemisia Abrotanum Flowering Top",
"DosageFormName": "PELLET",
"StartMarketingDate": "20170101",
"MarketingCategoryName": "DRUG FOR FURTHER PROCESSING",
"LabelerName": "Laboratoires Boiron",
"SubstanceName": "ARTEMISIA ABROTANUM FLOWERING TOP",
"StrengthNumber": "1",
"StrengthUnit": "[hp_X]/mL",
"Status": "Deprecated",
"LastUpdate": "2014-02-04",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "0245-0012-01",
"PackageDescription": "100 BLISTER PACK in 1 CARTON (0245-0012-01) / 1 TABLET in 1 BLISTER PACK (0245-0012-89) ",
"NDC11Code": "00245-0012-01",
"ProductNDC": "0245-0012",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sorine",
"NonProprietaryName": "Sotalol Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110215",
"EndMarketingDate": "20250131",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075500",
"LabelerName": "Upsher-Smith Laboratories, Inc.",
"SubstanceName": "SOTALOL HYDROCHLORIDE",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], Antiarrhythmic [EPC], Cardiac Rhythm Alteration [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20110215",
"EndMarketingDatePackage": "20240531",
"SamplePackage": "N",
"IndicationAndUsage": "SORINE (sotalol hydrochloride) is an antiarrhythmic indicated for: 1 the treatment of life-threatening ventricular arrhythmias (1.1), 2 the maintenance of normal sinus rhythm in patients with atrial fibrillation or flutter (AFIB/AFL) (1.2).",
"Description": "SORINE contains sotalol hydrochloride, USP an antiarrhythmic drug with Class II (beta-adrenoreceptor blocking) and Class III (cardiac action potential duration prolongation) properties. SORINE (sotalol hydrochloride, USP) is supplied as a white, capsule-shaped tablet for oral administration. Sotalol hydrochloride, USP is a white, crystalline solid with a molecular weight of 308.8. It is hydrophilic, soluble in water, propylene glycol and ethanol, but is only slightly soluble in chloroform. Chemically, sotalol hydrochloride, USP is d,l-N-[4-[1-hydroxy-2-[(1-methylethyl) amino]ethyl]phenyl]methane-sulfonamide monohydrochloride. The molecular formula is C12H20N2O3 S∙HCl and is represented by the following structural formula. SORINE Tablets contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, corn starch, stearic acid, magnesium stearate and silicon dioxide."
},
{
"NDCCode": "0245-0012-11",
"PackageDescription": "100 TABLET in 1 BOTTLE (0245-0012-11) ",
"NDC11Code": "00245-0012-11",
"ProductNDC": "0245-0012",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sorine",
"NonProprietaryName": "Sotalol Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110215",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA075500",
"LabelerName": "Upsher-Smith Laboratories, Inc.",
"SubstanceName": "SOTALOL HYDROCHLORIDE",
"StrengthNumber": "80",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Adrenergic beta-Antagonists [MoA], Antiarrhythmic [EPC], Cardiac Rhythm Alteration [PE]",
"Status": "Deprecated",
"LastUpdate": "2024-01-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20110215",
"SamplePackage": "N",
"IndicationAndUsage": "SORINE (sotalol hydrochloride) is an antiarrhythmic indicated for: 1 the treatment of life-threatening ventricular arrhythmias (1.1), 2 the maintenance of normal sinus rhythm in patients with atrial fibrillation or flutter (AFIB/AFL) (1.2).",
"Description": "SORINE contains sotalol hydrochloride, USP an antiarrhythmic drug with Class II (beta-adrenoreceptor blocking) and Class III (cardiac action potential duration prolongation) properties. SORINE (sotalol hydrochloride, USP) is supplied as a white, capsule-shaped tablet for oral administration. Sotalol hydrochloride, USP is a white, crystalline solid with a molecular weight of 308.8. It is hydrophilic, soluble in water, propylene glycol and ethanol, but is only slightly soluble in chloroform. Chemically, sotalol hydrochloride, USP is d,l-N-[4-[1-hydroxy-2-[(1-methylethyl) amino]ethyl]phenyl]methane-sulfonamide monohydrochloride. The molecular formula is C12H20N2O3 S∙HCl and is represented by the following structural formula. SORINE Tablets contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, corn starch, stearic acid, magnesium stearate and silicon dioxide."
},
{
"NDCCode": "0268-0012-10",
"PackageDescription": "10 mL in 1 VIAL, MULTI-DOSE (0268-0012-10)",
"NDC11Code": "00268-0012-10",
"ProductNDC": "0268-0012",
"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": ".1",
"StrengthUnit": "g/mL",
"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]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "0268-0012-50",
"PackageDescription": "50 mL in 1 VIAL, MULTI-DOSE (0268-0012-50)",
"NDC11Code": "00268-0012-50",
"ProductNDC": "0268-0012",
"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": ".1",
"StrengthUnit": "g/mL",
"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]",
"Status": "Deprecated",
"LastUpdate": "2016-12-02"
},
{
"NDCCode": "0327-0012-30",
"PackageDescription": "30 BOTTLE in 1 CARTON (0327-0012-30) > 30 mL in 1 BOTTLE",
"NDC11Code": "00327-0012-30",
"ProductNDC": "0327-0012",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Renacidin",
"NonProprietaryName": "Citric Acid, Gluconolactone And Magnesium Carbonate",
"DosageFormName": "SOLUTION",
"RouteName": "IRRIGATION",
"StartMarketingDate": "20160201",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA019481",
"LabelerName": "United-Guardian, Inc.",
"SubstanceName": "ANHYDROUS CITRIC ACID; GLUCONOLACTONE; MAGNESIUM CARBONATE",
"StrengthNumber": "6.602; .198; 3.268",
"StrengthUnit": "g/100mL; g/100mL; g/100mL",
"Pharm_Classes": "Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Irrigation [MoA]",
"Status": "Active",
"LastUpdate": "2020-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160201",
"SamplePackage": "N",
"IndicationAndUsage": "Renacidin is indicated for dissolution of bladder calculi of the struvite or apatite variety by local intermittent irrigation through a urethral catheter or cystostomy tube as an alternative or adjunct to surgical procedures. Renacidin is also indicated for use as an intermittent irrigating solution to prevent encrustations of indwelling urethral catheters and cystostomy tubes.",
"Description": "Renacidin® (Citric Acid, Glucono delta-lactone, and Magnesium Carbonate) is a sterile, non-pyrogenic irrigation solution for use within the lower urinary tract in the dissolution of bladder calculi of the struvite or apatite variety, and prevention of encrustations of urethral catheters and cystostomy tubes. Each 30 mL of Renacidin contains:. Active ingredients: Citric Acid (anhydrous), USP 1980.6 mg C6H8O7Glucono delta-lactone, USP 59.4 mg C6H10O6Magnesium Carbonate, USP 980.4 mg (MgCO3)4 · Mg(OH)2 · 5H2O. Citric Acid. Glucono delta-lactone. Magnesium Carbonate. (MgCO3)4 · Mg(OH)2 · 5H2O. Inert ingredients:Benzoic Acid, USP 6.9 mg Solution pH: 3.85 (3.5-4.2)."
},
{
"NDCCode": "0363-0012-90",
"PackageDescription": "90 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (0363-0012-90)",
"NDC11Code": "00363-0012-90",
"ProductNDC": "0363-0012",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Flavor Chews",
"NonProprietaryName": "Calcium Carbonate",
"DosageFormName": "TABLET, CHEWABLE",
"RouteName": "ORAL",
"StartMarketingDate": "20150316",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part331",
"LabelerName": "Walgreens",
"SubstanceName": "CALCIUM CARBONATE",
"StrengthNumber": "750",
"StrengthUnit": "mg/1",
"Status": "Deprecated",
"LastUpdate": "2018-11-10",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
}
]
}
{"NDC":[{"NDCCode":"81825-0012-1","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"},{"NDCCode":"81825-0001-2","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"},{"NDCCode":"81825-0002-1","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"},{"NDCCode":"81825-0003-1","ProprietaryName":"E.n.v.","NonProprietaryName":"Belladonna, Berberis Vulg, Carduus Mar, Chelidonium Maj, Colocynthis, Dioscorea, Hydrastis, Lycopodium, Nat Sulphuricum, Nux Vom, Phos, Pulsatilla, Veratrum Alb"},{"NDCCode":"81825-0004-1","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"},{"NDCCode":"81825-0005-1","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"},{"NDCCode":"81825-0006-1","ProprietaryName":"Psoriasis","NonProprietaryName":"Arsenicum Album, Arsenicum Iodatum, Borax, Calcarea Carbonica, Graphites, Mezereum, Proteus, Natrum Muriaticum, Phytolacca Decandra, Sepia, Silicea, Sulphur, Thyroidinum"},{"NDCCode":"81825-0007-1","ProprietaryName":"Allergy","NonProprietaryName":"Allium Cepa, Ambrosia, Arsenicum Alb, Carbo Veg, Euphrasia, Nux Vom, Phosphorus, Pulsatilla, Sulphur, Solidago"},{"NDCCode":"81825-0008-1","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"},{"NDCCode":"81825-0009-1","ProprietaryName":"Flu","NonProprietaryName":"Aconitum Napellus, Arsenic Trioxide, Atropa Belladonna, Bryonia Alba Root, Eupatorium Perfoliatum Flowering Top, Ferrum Phosphoricum, Gelsemium Sempervirens Root"},{"NDCCode":"81825-0010-1","ProprietaryName":"Stress","NonProprietaryName":"Aralia Quin, Passiflora, Scutellaria, Valeriana, Arsenicum Alb, Aur Met, Calc Carb, Coffea Cruda, Ignatia, Kali Phos, Lycopus, Phosphorus, Staphysagria"},{"NDCCode":"81825-0011-1","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"},{"NDCCode":"81825-0013-1","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"},{"NDCCode":"0009-0012-01","ProprietaryName":"Cortef","NonProprietaryName":"Hydrocortisone"},{"NDCCode":"0054-0012-20","ProprietaryName":"Flecainide Acetate","NonProprietaryName":"Flecainide Acetate"},{"NDCCode":"0054-0012-21","ProprietaryName":"Flecainide Acetate","NonProprietaryName":"Flecainide Acetate"},{"NDCCode":"0054-0012-25","ProprietaryName":"Flecainide Acetate","NonProprietaryName":"Flecainide Acetate"},{"NDCCode":"0093-0012-98","ProprietaryName":"Pantoprazole Sodium","NonProprietaryName":"Pantoprazole Sodium"},{"NDCCode":"0168-0012-09","ProprietaryName":"Triple Antibiotic","NonProprietaryName":"Neomycin And Polymyxin B Sulfates And Bacitracin Zinc"},{"NDCCode":"0168-0012-31","ProprietaryName":"Triple Antibiotic","NonProprietaryName":"Neomycin And Polymyxin B Sulfates And Bacitracin Zinc"},{"NDCCode":"0168-0012-35","ProprietaryName":"Triple Antibiotic","NonProprietaryName":"Neomycin And Polymyxin B Sulfates And Bacitracin Zinc"},{"NDCCode":"0187-0011-10","ProprietaryName":"Iprivask","NonProprietaryName":"Desirudin"},{"NDCCode":"0220-0012-11","NonProprietaryName":"Artemisia Abrotanum Flowering Top"},{"NDCCode":"0220-0012-12","NonProprietaryName":"Artemisia Abrotanum Flowering Top"},{"NDCCode":"0245-0012-01","ProprietaryName":"Sorine","NonProprietaryName":"Sotalol Hydrochloride"},{"NDCCode":"0245-0012-11","ProprietaryName":"Sorine","NonProprietaryName":"Sotalol Hydrochloride"},{"NDCCode":"0268-0012-10","ProprietaryName":"House Dust","NonProprietaryName":"House Dust"},{"NDCCode":"0268-0012-50","ProprietaryName":"House Dust","NonProprietaryName":"House Dust"},{"NDCCode":"0327-0012-30","ProprietaryName":"Renacidin","NonProprietaryName":"Citric Acid, Gluconolactone And Magnesium Carbonate"},{"NDCCode":"0363-0012-90","ProprietaryName":"Flavor Chews","NonProprietaryName":"Calcium Carbonate"}]}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<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>81825-0001-2</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE, DROPPER (81825-0001-2) </PackageDescription>
<NDC11Code>81825-0001-02</NDC11Code>
<ProductNDC>81825-0001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hydrate Ii</ProprietaryName>
<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</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20220216</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Zorex International</LabelerName>
<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>
<StartMarketingDatePackage>20220216</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USES: Temporarily relieves low energy, circulatory disorders, digestive upset, &/or symptoms related to poor cellular hydration.**.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>81825-0002-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (81825-0002-1) </PackageDescription>
<NDC11Code>81825-0002-01</NDC11Code>
<ProductNDC>81825-0002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Mold Antigen</ProprietaryName>
<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</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20211201</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Zorex International</LabelerName>
<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</SubstanceName>
<StrengthNumber>200; 200; 200; 200; 200; 200; 200; 200; 200; 200; 30; 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_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>
<NonProprietaryName>Belladonna, Berberis Vulg, Carduus Mar, Chelidonium Maj, Colocynthis, Dioscorea, Hydrastis, Lycopodium, Nat Sulphuricum, Nux Vom, Phos, Pulsatilla, Veratrum Alb</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<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>81825-0011-1</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, DROPPER (81825-0011-1) </PackageDescription>
<NDC11Code>81825-0011-01</NDC11Code>
<ProductNDC>81825-0011</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Stress Ii</ProprietaryName>
<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</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20250616</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Zorex</LabelerName>
<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</SubstanceName>
<StrengthNumber>9; 9; 9; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 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</StrengthUnit>
<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>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20250616</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<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.</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>0009-0012-01</NDCCode>
<PackageDescription>50 TABLET in 1 BOTTLE (0009-0012-01) </PackageDescription>
<NDC11Code>00009-0012-01</NDC11Code>
<ProductNDC>0009-0012</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cortef</ProprietaryName>
<NonProprietaryName>Hydrocortisone</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19521215</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA008697</ApplicationNumber>
<LabelerName>Pharmacia & Upjohn Company LLC</LabelerName>
<SubstanceName>HYDROCORTISONE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-02-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>19521215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CORTEF Tablets are indicated in the following conditions.</IndicationAndUsage>
<Description>CORTEF Tablets contain hydrocortisone which is a glucocorticoid. Glucocorticoids are adrenocortical steroids, both naturally occurring and synthetic, which are readily absorbed from the gastrointestinal tract. Hydrocortisone USP is white to practically white, odorless, crystalline powder with a melting point of about 215° C. It is very slightly soluble in water and in ether; sparingly soluble in acetone and in alcohol; slightly soluble in chloroform. The chemical name for hydrocortisone is pregn-4-ene-3,20-dione,11,17,21-trihydroxy-, (11β)-. Its molecular weight is 362.46 and the structural formula is as outlined below. CORTEF Tablets are available for oral administration in three strengths: each tablet contains either 5 mg, 10 mg, or 20 mg of hydrocortisone. Inactive ingredients: calcium stearate, corn starch, lactose, mineral oil, sorbic acid, sucrose.</Description>
</NDC>
<NDC>
<NDCCode>0054-0012-20</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (0054-0012-20) / 1 TABLET in 1 BLISTER PACK</PackageDescription>
<NDC11Code>00054-0012-20</NDC11Code>
<ProductNDC>0054-0012</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>150</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>0054-0012-21</NDCCode>
<PackageDescription>60 TABLET in 1 BOTTLE (0054-0012-21) </PackageDescription>
<NDC11Code>00054-0012-21</NDC11Code>
<ProductNDC>0054-0012</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>150</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>0054-0012-25</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0054-0012-25) </PackageDescription>
<NDC11Code>00054-0012-25</NDC11Code>
<ProductNDC>0054-0012</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>150</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>0093-0012-98</NDCCode>
<PackageDescription>90 TABLET, DELAYED RELEASE in 1 BOTTLE (0093-0012-98) </PackageDescription>
<NDC11Code>00093-0012-98</NDC11Code>
<ProductNDC>0093-0012</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pantoprazole Sodium</ProprietaryName>
<NonProprietaryName>Pantoprazole Sodium</NonProprietaryName>
<DosageFormName>TABLET, DELAYED RELEASE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20071219</StartMarketingDate>
<EndMarketingDate>20200531</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077056</ApplicationNumber>
<LabelerName>Teva Pharmaceuticals USA, Inc.</LabelerName>
<SubstanceName>PANTOPRAZOLE SODIUM</SubstanceName>
<StrengthNumber>40</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>20071219</StartMarketingDatePackage>
<EndMarketingDatePackage>20200531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>0168-0012-09</NDCCode>
<PackageDescription>144 PACKET in 1 CARTON (0168-0012-09) > .9 g in 1 PACKET</PackageDescription>
<NDC11Code>00168-0012-09</NDC11Code>
<ProductNDC>0168-0012</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Triple Antibiotic</ProprietaryName>
<NonProprietaryName>Neomycin And Polymyxin B Sulfates And Bacitracin Zinc</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100106</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333B</ApplicationNumber>
<LabelerName>E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.</LabelerName>
<SubstanceName>BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE</SubstanceName>
<StrengthNumber>400; 3.5; 5000</StrengthNumber>
<StrengthUnit>[USP'U]/g; mg/g; [USP'U]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0168-0012-31</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0168-0012-31) > 28.35 g in 1 TUBE</PackageDescription>
<NDC11Code>00168-0012-31</NDC11Code>
<ProductNDC>0168-0012</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Triple Antibiotic</ProprietaryName>
<NonProprietaryName>Neomycin And Polymyxin B Sulfates And Bacitracin Zinc</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100106</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333B</ApplicationNumber>
<LabelerName>E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.</LabelerName>
<SubstanceName>BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE</SubstanceName>
<StrengthNumber>400; 3.5; 5000</StrengthNumber>
<StrengthUnit>[USP'U]/g; mg/g; [USP'U]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0168-0012-35</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (0168-0012-35) > 14.17 g in 1 TUBE</PackageDescription>
<NDC11Code>00168-0012-35</NDC11Code>
<ProductNDC>0168-0012</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Triple Antibiotic</ProprietaryName>
<NonProprietaryName>Neomycin And Polymyxin B Sulfates And Bacitracin Zinc</NonProprietaryName>
<DosageFormName>OINTMENT</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100106</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part333B</ApplicationNumber>
<LabelerName>E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.</LabelerName>
<SubstanceName>BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE</SubstanceName>
<StrengthNumber>400; 3.5; 5000</StrengthNumber>
<StrengthUnit>[USP'U]/g; mg/g; [USP'U]/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</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>0220-0012-11</NDCCode>
<PackageDescription>30 mL in 1 BOTTLE, GLASS (0220-0012-11)</PackageDescription>
<NDC11Code>00220-0012-11</NDC11Code>
<ProductNDC>0220-0012</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Artemisia Abrotanum Flowering Top</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<StartMarketingDate>20170101</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Laboratoires Boiron</LabelerName>
<SubstanceName>ARTEMISIA ABROTANUM FLOWERING TOP</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0220-0012-12</NDCCode>
<PackageDescription>60 mL in 1 BOTTLE, GLASS (0220-0012-12)</PackageDescription>
<NDC11Code>00220-0012-12</NDC11Code>
<ProductNDC>0220-0012</ProductNDC>
<ProductTypeName>DRUG FOR FURTHER PROCESSING</ProductTypeName>
<NonProprietaryName>Artemisia Abrotanum Flowering Top</NonProprietaryName>
<DosageFormName>PELLET</DosageFormName>
<StartMarketingDate>20170101</StartMarketingDate>
<MarketingCategoryName>DRUG FOR FURTHER PROCESSING</MarketingCategoryName>
<LabelerName>Laboratoires Boiron</LabelerName>
<SubstanceName>ARTEMISIA ABROTANUM FLOWERING TOP</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>[hp_X]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2014-02-04</LastUpdate>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>0245-0012-01</NDCCode>
<PackageDescription>100 BLISTER PACK in 1 CARTON (0245-0012-01) / 1 TABLET in 1 BLISTER PACK (0245-0012-89) </PackageDescription>
<NDC11Code>00245-0012-01</NDC11Code>
<ProductNDC>0245-0012</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sorine</ProprietaryName>
<NonProprietaryName>Sotalol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110215</StartMarketingDate>
<EndMarketingDate>20250131</EndMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075500</ApplicationNumber>
<LabelerName>Upsher-Smith Laboratories, Inc.</LabelerName>
<SubstanceName>SOTALOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], Antiarrhythmic [EPC], Cardiac Rhythm Alteration [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-06-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20110215</StartMarketingDatePackage>
<EndMarketingDatePackage>20240531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SORINE (sotalol hydrochloride) is an antiarrhythmic indicated for: 1 the treatment of life-threatening ventricular arrhythmias (1.1), 2 the maintenance of normal sinus rhythm in patients with atrial fibrillation or flutter (AFIB/AFL) (1.2).</IndicationAndUsage>
<Description>SORINE contains sotalol hydrochloride, USP an antiarrhythmic drug with Class II (beta-adrenoreceptor blocking) and Class III (cardiac action potential duration prolongation) properties. SORINE (sotalol hydrochloride, USP) is supplied as a white, capsule-shaped tablet for oral administration. Sotalol hydrochloride, USP is a white, crystalline solid with a molecular weight of 308.8. It is hydrophilic, soluble in water, propylene glycol and ethanol, but is only slightly soluble in chloroform. Chemically, sotalol hydrochloride, USP is d,l-N-[4-[1-hydroxy-2-[(1-methylethyl) amino]ethyl]phenyl]methane-sulfonamide monohydrochloride. The molecular formula is C12H20N2O3 S∙HCl and is represented by the following structural formula. SORINE Tablets contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, corn starch, stearic acid, magnesium stearate and silicon dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0245-0012-11</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (0245-0012-11) </PackageDescription>
<NDC11Code>00245-0012-11</NDC11Code>
<ProductNDC>0245-0012</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sorine</ProprietaryName>
<NonProprietaryName>Sotalol Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110215</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA075500</ApplicationNumber>
<LabelerName>Upsher-Smith Laboratories, Inc.</LabelerName>
<SubstanceName>SOTALOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>80</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Antagonists [MoA], Antiarrhythmic [EPC], Cardiac Rhythm Alteration [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-01-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>SORINE (sotalol hydrochloride) is an antiarrhythmic indicated for: 1 the treatment of life-threatening ventricular arrhythmias (1.1), 2 the maintenance of normal sinus rhythm in patients with atrial fibrillation or flutter (AFIB/AFL) (1.2).</IndicationAndUsage>
<Description>SORINE contains sotalol hydrochloride, USP an antiarrhythmic drug with Class II (beta-adrenoreceptor blocking) and Class III (cardiac action potential duration prolongation) properties. SORINE (sotalol hydrochloride, USP) is supplied as a white, capsule-shaped tablet for oral administration. Sotalol hydrochloride, USP is a white, crystalline solid with a molecular weight of 308.8. It is hydrophilic, soluble in water, propylene glycol and ethanol, but is only slightly soluble in chloroform. Chemically, sotalol hydrochloride, USP is d,l-N-[4-[1-hydroxy-2-[(1-methylethyl) amino]ethyl]phenyl]methane-sulfonamide monohydrochloride. The molecular formula is C12H20N2O3 S∙HCl and is represented by the following structural formula. SORINE Tablets contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, corn starch, stearic acid, magnesium stearate and silicon dioxide.</Description>
</NDC>
<NDC>
<NDCCode>0268-0012-10</NDCCode>
<PackageDescription>10 mL in 1 VIAL, MULTI-DOSE (0268-0012-10)</PackageDescription>
<NDC11Code>00268-0012-10</NDC11Code>
<ProductNDC>0268-0012</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>.1</StrengthNumber>
<StrengthUnit>g/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>0268-0012-50</NDCCode>
<PackageDescription>50 mL in 1 VIAL, MULTI-DOSE (0268-0012-50)</PackageDescription>
<NDC11Code>00268-0012-50</NDC11Code>
<ProductNDC>0268-0012</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>.1</StrengthNumber>
<StrengthUnit>g/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>0327-0012-30</NDCCode>
<PackageDescription>30 BOTTLE in 1 CARTON (0327-0012-30) > 30 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>00327-0012-30</NDC11Code>
<ProductNDC>0327-0012</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Renacidin</ProprietaryName>
<NonProprietaryName>Citric Acid, Gluconolactone And Magnesium Carbonate</NonProprietaryName>
<DosageFormName>SOLUTION</DosageFormName>
<RouteName>IRRIGATION</RouteName>
<StartMarketingDate>20160201</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA019481</ApplicationNumber>
<LabelerName>United-Guardian, Inc.</LabelerName>
<SubstanceName>ANHYDROUS CITRIC ACID; GLUCONOLACTONE; MAGNESIUM CARBONATE</SubstanceName>
<StrengthNumber>6.602; .198; 3.268</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL</StrengthUnit>
<Pharm_Classes>Acidifying Activity [MoA], Anti-coagulant [EPC], Calcium Chelating Activity [MoA], Calculi Dissolution Agent [EPC], Calculi Dissolution Agent [EPC], Decreased Coagulation Factor Activity [PE], Irrigation [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2020-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160201</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Renacidin is indicated for dissolution of bladder calculi of the struvite or apatite variety by local intermittent irrigation through a urethral catheter or cystostomy tube as an alternative or adjunct to surgical procedures. Renacidin is also indicated for use as an intermittent irrigating solution to prevent encrustations of indwelling urethral catheters and cystostomy tubes.</IndicationAndUsage>
<Description>Renacidin® (Citric Acid, Glucono delta-lactone, and Magnesium Carbonate) is a sterile, non-pyrogenic irrigation solution for use within the lower urinary tract in the dissolution of bladder calculi of the struvite or apatite variety, and prevention of encrustations of urethral catheters and cystostomy tubes. Each 30 mL of Renacidin contains:. Active ingredients: Citric Acid (anhydrous), USP 1980.6 mg C6H8O7Glucono delta-lactone, USP 59.4 mg C6H10O6Magnesium Carbonate, USP 980.4 mg (MgCO3)4 · Mg(OH)2 · 5H2O. Citric Acid. Glucono delta-lactone. Magnesium Carbonate. (MgCO3)4 · Mg(OH)2 · 5H2O. Inert ingredients:Benzoic Acid, USP 6.9 mg Solution pH: 3.85 (3.5-4.2).</Description>
</NDC>
<NDC>
<NDCCode>0363-0012-90</NDCCode>
<PackageDescription>90 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (0363-0012-90)</PackageDescription>
<NDC11Code>00363-0012-90</NDC11Code>
<ProductNDC>0363-0012</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Flavor Chews</ProprietaryName>
<NonProprietaryName>Calcium Carbonate</NonProprietaryName>
<DosageFormName>TABLET, CHEWABLE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20150316</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part331</ApplicationNumber>
<LabelerName>Walgreens</LabelerName>
<SubstanceName>CALCIUM CARBONATE</SubstanceName>
<StrengthNumber>750</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-11-10</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
</NDCList>