{
"NDC": [
{
"NDCCode": "55146-011-01",
"PackageDescription": "120 mL in 1 BOTTLE (55146-011-01) ",
"NDC11Code": "55146-0011-01",
"ProductNDC": "55146-011",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "1 Detoxification",
"NonProprietaryName": "Trifolium Pratense, Capsicum Annuum, Phytolacca Decandra, Aluminum Metallicum, Antimonium Crudum, Argentum Metallicum, Arsenicum Album, Aurum Metallicum, Baryta Carbonica, Beryllium Metallicum, Bismuthum Metallicum, Boron, Bromium, Cadmium Metallicum, Cerium Metallicum, Cesium Chloride, Chromium, Cobaltum Metallicum, Cuprum Metallicum, Dysprosium Metallicum, Erbium Metallicum, Europium Oxydatum, Ferrum Metallicum, Gadolinium Metallicum, Germanium Sesquioxide, Holmium Metallicum, Indium Metallicum,",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20200505",
"EndMarketingDate": "20250625",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Biotics Research Corporation",
"SubstanceName": "ACTIVATED CHARCOAL; ALCOHOL, X-RAY EXPOSED (1000 RAD); ALLYLTHIOUREA; ALUMINUM; ANGUILLA ROSTRATA BLOOD SERUM; ANTIMONY TRISULFIDE; APIS MELLIFERA; ARSENIC TRIOXIDE; BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; BARIUM CARBONATE; BERYLLIUM; BISMUTH; BORON; BROMINE; CADMIUM; CAPSICUM; CARBO ANIMALIS; CERIUM; CESIUM CHLORIDE; CHROMIUM; CLAVICEPS PURPUREA SCLEROTIUM; COBALT; CONIUM MACULATUM FLOWERING TOP; COPPER; CORTICOTROPIN; DYSPROSIUM; ERBIUM; EUROPIUM; GADOLINIUM; GELSEMIUM SEMPERVIRENS ROOT; GERMANIUM SESQUIOXIDE; GOLD; HOLMIUM; HUMAN BREAST TUMOR CELL; INDIUM; IRON; LACHESIS MUTA VENOM; LANTHANUM; LEAD; LITHIUM CARBONATE; MAGNESIUM; MANGANESE; MERCURIUS SOLUBILIS; MOLYBDENUM; NEODYMIUM OXIDE; NICKEL; NIOBIUM; OSMIUM; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PALLADIUM; PHOSPHORIC ACID; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PLATINUM; POTASSIUM DICHROMATE; PRASEODYMIUM; RANCID BEEF; RHODIUM; RUBIDIUM NITRITE; SAMARIUM; SELENIUM; SILVER; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; STRONTIUM CARBONATE; STRYCHNOS WALLICHIANA BARK; SULFURIC ACID; SUS SCROFA PITUITARY GLAND; TANTALUM; TARTARIC ACID; TERBIUM; THALLIUM; THERIDION CURASSAVICUM; THUJA OCCIDENTALIS LEAFY TWIG; THYROID; TIN; TRIFOLIUM PRATENSE FLOWER; URANYL NITRATE HEXAHYDRATE; VANADIUM; VERATRUM ALBUM ROOT; YTTERBIUM OXIDE; ZINC",
"StrengthNumber": "30; 30; 30; 12; 30; 12; 30; 12; 30; 12; 12; 12; 12; 12; 12; 3; 30; 12; 12; 12; 30; 12; 30; 12; 30; 12; 12; 12; 12; 30; 12; 12; 12; 30; 12; 12; 30; 14; 12; 12; 12; 12; 12; 12; 12; 12; 30; 12; 30; 12; 30; 30; 4; 12; 30; 12; 30; 12; 12; 12; 12; 12; 30; 12; 30; 30; 30; 30; 30; 12; 12; 30; 30; 30; 12; 3; 12; 12; 30; 12; 12",
"StrengthUnit": "[hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/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_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/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_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Adrenocorticotropic Hormone [CS], Adrenocorticotropic Hormone [EPC], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Bee Venoms [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], 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 Histamine Release [PE], Increased Histamine Release [PE], 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], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Standardized Insect Venom Allergenic Extract [EPC], Vegetable Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200505",
"EndMarketingDatePackage": "20250625",
"SamplePackage": "N",
"IndicationAndUsage": "For temporary relief of gastrointestinal dyspepsia (indigestion) with flatulence, bloating and intolerance of certain foods. Remedy #1 supports detoxification and cellular repair."
},
{
"NDCCode": "55146-001-01",
"PackageDescription": "120 mL in 1 BOTTLE (55146-001-01) ",
"NDC11Code": "55146-0001-01",
"ProductNDC": "55146-001",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "1 Detoxification",
"NonProprietaryName": "Capsicum Annuum, Phytolacca Decandra, Trifolium Pratense, Aluminum Metallicum, Antimonium Crudum, Argentum Metallicum, Arsenicum Album, Aurum Metallicum, Baryta Carbonica, Beryllium Metallicum, Bismuthum Metallicum, Boron, Bromium, Cadmium Metallicum, Cerium Metallicum, Cesium Chloride, Chromium Metallicum, Cobaltum Metallicum, Cuprum Metallicum, Dysprosium Metallicum, Erbium Metallicum, Europium Oxydatum, Ferrum Metallicum, Gadolinium Oxydatum, Germanium Sesquioxide, Holmium,",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20190610",
"EndMarketingDate": "20250625",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Biotics Research Corporation",
"SubstanceName": "ACTIVATED CHARCOAL; ALCOHOL, X-RAY EXPOSED (1000 RAD); ALLYLTHIOUREA; ALUMINUM; ANGUILLA ROSTRATA BLOOD SERUM; ANTIMONY TRISULFIDE; APIS MELLIFERA; ARSENIC TRIOXIDE; BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; BARIUM CARBONATE; BERYLLIUM; BISMUTH; BORON; BROMINE; CADMIUM; CAPSICUM; CARBO ANIMALIS; CERIUM; CESIUM CHLORIDE; CHROMIUM; CLAVICEPS PURPUREA SCLEROTIUM; COBALT; CONIUM MACULATUM FLOWERING TOP; COPPER; CORTICOTROPIN; DYSPROSIUM; ERBIUM; EUROPIUM; GADOLINIUM; GELSEMIUM SEMPERVIRENS ROOT; GERMANIUM SESQUIOXIDE; GOLD; HOLMIUM; HUMAN BREAST TUMOR CELL; INDIUM; IRON; LACHESIS MUTA VENOM; LANTHANUM; LEAD; LITHIUM CARBONATE; MAGNESIUM; MANGANESE; MERCURIUS SOLUBILIS; MOLYBDENUM; NEODYMIUM OXIDE; NICKEL; NIOBIUM; OSMIUM; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PALLADIUM; PHOSPHORIC ACID; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PLATINUM; POTASSIUM DICHROMATE; PRASEODYMIUM; RANCID BEEF; RHODIUM; RUBIDIUM NITRITE; SAMARIUM; SELENIUM; SILVER; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; STRONTIUM CARBONATE; STRYCHNOS WALLICHIANA BARK; SULFURIC ACID; SUS SCROFA PITUITARY GLAND; TANTALUM; TARTARIC ACID; TERBIUM; THALLIUM; THERIDION CURASSAVICUM; THUJA OCCIDENTALIS LEAFY TWIG; THYROID; TIN; TRIFOLIUM PRATENSE FLOWER; URANYL NITRATE HEXAHYDRATE; VANADIUM; VERATRUM ALBUM ROOT; YTTERBIUM OXIDE; ZINC",
"StrengthNumber": "30; 30; 30; 12; 30; 12; 30; 12; 30; 12; 12; 12; 12; 30; 12; 3; 30; 12; 12; 12; 30; 12; 30; 12; 30; 12; 12; 12; 12; 30; 12; 12; 12; 30; 12; 12; 30; 14; 12; 12; 12; 12; 12; 12; 12; 12; 30; 12; 30; 12; 30; 30; 4; 12; 30; 12; 30; 12; 12; 12; 12; 12; 30; 12; 30; 30; 30; 30; 30; 12; 12; 30; 30; 30; 12; 3; 12; 12; 30; 12; 12",
"StrengthUnit": "[hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/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_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Adrenocorticotropic Hormone [CS], Adrenocorticotropic Hormone [EPC], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Bee Venoms [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], 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 Histamine Release [PE], Increased Histamine Release [PE], 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], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Standardized Insect Venom Allergenic Extract [EPC], Vegetable Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2025-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190610",
"EndMarketingDatePackage": "20250625",
"SamplePackage": "N",
"IndicationAndUsage": "For temporary relief of gastrointestinal dyspepsia (indigestion) with flatulence, bloating and intolerance of certain foods. Remedy #1 supports detoxification and cellular repair."
},
{
"NDCCode": "55146-002-01",
"PackageDescription": "120 mL in 1 BOTTLE, PLASTIC (55146-002-01) ",
"NDC11Code": "55146-0002-01",
"ProductNDC": "55146-002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "2 Lymphatic Drainage",
"NonProprietaryName": "Berberis Vulgaris, Carduus Marianus, Chelidonium Majus, Collinsonia Canadensis, Solidago Virgaurea, Hydrastis Canadensis, Fel Tauri, Apis Mellifica, Baryta Muriatica, Ceanothus Americanus, Chininum Sulphuricum, Conium Maculatum, Iodium, Lachesis Mutus, Mercurius Solubilis, Nux Vomica, Phosphorus, Silicea",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20190611",
"EndMarketingDate": "20250821",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Biotics Research Corporation",
"SubstanceName": "APIS MELLIFERA; BARIUM CHLORIDE DIHYDRATE; BERBERIS VULGARIS ROOT BARK; BOS TAURUS BILE; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; COLLINSONIA CANADENSIS ROOT; CONIUM MACULATUM FLOWERING TOP; GOLDENSEAL; IODINE; LACHESIS MUTA VENOM; MERCURIUS SOLUBILIS; MILK THISTLE; PHOSPHORUS; QUININE SULFATE; SILICON DIOXIDE; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED",
"StrengthNumber": "30; 30; 3; 6; 30; 3; 3; 30; 5; 30; 30; 30; 3; 30; 30; 30; 3; 30",
"StrengthUnit": "[hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Antimalarial [EPC], Bee Venoms [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Standardized Insect Venom Allergenic Extract [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-08-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190611",
"EndMarketingDatePackage": "20250821",
"SamplePackage": "N",
"IndicationAndUsage": "For temporary relief of fever, sore throat and acute irritation of the bladder. Remedy #2 supports the clearing of organs allowing for lymphatic drainage and detoxification of any stored toxins that have been released during the cleansing."
},
{
"NDCCode": "55146-003-01",
"PackageDescription": "120 mL in 1 BOTTLE, PLASTIC (55146-003-01) ",
"NDC11Code": "55146-0003-01",
"ProductNDC": "55146-003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "3 Acute Stress",
"NonProprietaryName": "Arnica Montana, Bellis Perennis, Passiflora Incarnata, Valeriana Officinalis, Arsenicum Album, Apis Mellifica, Carcinosin, Cistus Canadensis, Clematis Erecta, Coffea Cruda, Ignatia Amara, Lachesis Mutus, Magnesia Phosphorica, Natrum Muriaticum, Natrum Sulphuricum, Ornithogalum Umbellatum, Phosphoricum Acidum, Salix Nigra, Staphysagria",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20190611",
"EndMarketingDate": "20250716",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Biotics Research Corporation",
"SubstanceName": "APIS MELLIFERA; ARABICA COFFEE BEAN; ARNICA MONTANA WHOLE; ARSENIC TRIOXIDE; BELLIS PERENNIS WHOLE; CLEMATIS RECTA FLOWERING TOP; DELPHINIUM STAPHISAGRIA SEED; HELIANTHEMUM CANADENSE; HUMAN BREAST TUMOR CELL; LACHESIS MUTA VENOM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; ORNITHOGALUM UMBELLATUM WHOLE; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORIC ACID; SALIX NIGRA BARK; SODIUM CHLORIDE; SODIUM SULFATE; STRYCHNOS IGNATII SEED; VALERIAN",
"StrengthNumber": "30; 30; 3; 6; 3; 30; 30; 30; 30; 30; 30; 30; 3; 30; 30; 30; 30; 30; 3",
"StrengthUnit": "[hp_C]/mL; [hp_C]/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_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Bee Venoms [CS], Calculi Dissolution Agent [EPC], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Standardized Insect Venom Allergenic Extract [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-07-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190611",
"EndMarketingDatePackage": "20250716",
"SamplePackage": "N",
"IndicationAndUsage": "For temporary relief of acute stress due to emotional strain, anxiety, sleeplessness, apprehension or fear."
},
{
"NDCCode": "55146-004-01",
"PackageDescription": "120 mL in 1 BOTTLE, PLASTIC (55146-004-01) ",
"NDC11Code": "55146-0004-01",
"ProductNDC": "55146-004",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "4 Detox-virus",
"NonProprietaryName": "Astragalus Membranaceus, Baptisia Tinctoria, Echinacea (echinacea), Phytolacca Decandra, Hydrastis Canadensis, Apis Mellifica, Aranea Diadema, Belladonna, Eupatorium Perfoliatum, Gelsemium Sempervirens, Lachesis Mutus, Phosphoricum Acidum, Silicea, Thuja Occidentalis, Vaccinium Myrtillus",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20190611",
"EndMarketingDate": "20250625",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Biotics Research Corporation",
"SubstanceName": "APIS MELLIFERA; ARANEUS DIADEMATUS; ARSENIC TRIOXIDE; ASTRAGALUS PROPINQUUS ROOT; ATROPA BELLADONNA; BAPTISIA TINCTORIA; BILBERRY; ECHINACEA ANGUSTIFOLIA WHOLE; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; LACHESIS MUTA VENOM; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; RANCID BEEF; SILICON DIOXIDE; THUJA OCCIDENTALIS LEAFY TWIG",
"StrengthNumber": "30; 30; 30; 3; 30; 3; 30; 3; 30; 30; 5; 30; 30; 4; 30; 30; 30",
"StrengthUnit": "[hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/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": "Deprecated",
"LastUpdate": "2025-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190611",
"EndMarketingDatePackage": "20250625",
"SamplePackage": "N",
"IndicationAndUsage": "For temporary relief of skin irritation, dry cough, eczema or fever. Remedy #4 supports detoxification of residual toxins left from a viral infection."
},
{
"NDCCode": "55146-005-01",
"PackageDescription": "120 mL in 1 BOTTLE, PLASTIC (55146-005-01) ",
"NDC11Code": "55146-0005-01",
"ProductNDC": "55146-005",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "5 Chronic Stress",
"NonProprietaryName": "Aralia Quinquefolia, Fucus Vesiculosus, Solidago Virgaurea, Taraxacum Officinale, Trifolium Pratense, Hydrastis Canadensis, Arsenicum Album, Calcarea Carbonica, Carbo Vegetabilis, Ceanothus Americanus, Cyclamen Europaeum, Hepar Sulphuris Calcareum, Natrum Muriaticum, Nux Vomica, Petroleum, Phosphorus",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20190611",
"EndMarketingDate": "20250701",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Biotics Research Corporation",
"SubstanceName": "ACTIVATED CHARCOAL; AMERICAN GINSENG; ARSENIC TRIOXIDE; CEANOTHUS AMERICANUS LEAF; CYCLAMEN PURPURASCENS TUBER; FUCUS VESICULOSUS; GOLDENSEAL; KEROSENE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; SODIUM CHLORIDE; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE; TRIFOLIUM PRATENSE FLOWER",
"StrengthNumber": "30; 3; 30; 30; 30; 3; 5; 30; 30; 30; 30; 3; 30; 3; 3",
"StrengthUnit": "[hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/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": "Deprecated",
"LastUpdate": "2025-07-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190611",
"EndMarketingDatePackage": "20250701",
"SamplePackage": "N",
"IndicationAndUsage": "For temporary relief of debility or exhaustion after slight exertion, or exhaustion following dysentery. Remedy #5 supports the easing of chronic stress produced by natural substances called adaptogens."
},
{
"NDCCode": "55146-006-01",
"PackageDescription": "120 mL in 1 BOTTLE, PLASTIC (55146-006-01) ",
"NDC11Code": "55146-0006-01",
"ProductNDC": "55146-006",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "6 Environmental Detox",
"NonProprietaryName": "Baptisia Tinctoria, Phytolacca Decandra, Spigelia Anthelmia, Adrenocorticotrophin, Aluminum Metallicum, Apis Mellifica, Argentum Nitricum, Arsenicum Album, Benzoicum Acidum, Calcarea Carbonica, Carbo Vegetabilis, Kali Phosphoricum, Magnesia Sulphurica, Mercurius Solubilis, Nitricum Acidum, Nux Vomica, Phosphorus, Silicea",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20190611",
"EndMarketingDate": "20251211",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Biotics Research Corporation",
"SubstanceName": "ACTIVATED CHARCOAL; ALUMINUM; APIS MELLIFERA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BENZOIC ACID; CORTICOTROPIN; MAGNESIUM SULFATE HEPTAHYDRATE; MERCURIUS SOLUBILIS; NITRIC ACID; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; POTASSIUM PHOSPHATE, DIBASIC; SILICON DIOXIDE; SILVER NITRATE; SPIGELIA ANTHELMIA WHOLE; STRYCHNOS NUX-VOMICA SEED",
"StrengthNumber": "30; 30; 30; 30; 3; 30; 30; 30; 30; 30; 30; 30; 4; 30; 30; 30; 6; 30",
"StrengthUnit": "[hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/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_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL",
"Pharm_Classes": "Adrenocorticotropic Hormone [CS], Adrenocorticotropic Hormone [EPC], Allergens [CS], Allergens [CS], Ammonium Ion Binding Activity [MoA], Bee Venoms [CS], Calculi Dissolution Agent [EPC], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Nitrogen Binding Agent [EPC], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Standardized Insect Venom Allergenic Extract [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-12-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190611",
"EndMarketingDatePackage": "20251211",
"SamplePackage": "N",
"IndicationAndUsage": "For temporary relief of cough, rattling in chest, hoarseness, sore throat, skin irritation and vomiting upon environmental exposure. Remedy # 6 supports detoxification of insecticides, environmental and industrial pollutants."
},
{
"NDCCode": "55146-007-01",
"PackageDescription": "120 mL in 1 BOTTLE, PLASTIC (55146-007-01) ",
"NDC11Code": "55146-0007-01",
"ProductNDC": "55146-007",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "7 Heavy Metal Detox",
"NonProprietaryName": "Allium Sativum, Aluminum Metallicum, Antimonium Crudum, Argentum Metallicum, Arsenicum Album, Aurum Metallicum, Baryta Carbonica, Beryllium Metallicum, Bismuthum Metallicum, Boron, Bromium, Cadmium Metallicum, Cerium Metallicum, Cesium Chloride, Chromium, Cobaltum Metallicum, Cuprum Metallicum, Dysprosium Metallicum, Erbium Metallicum, Europium Metallicum, Ferrum Metallicum, Gadolinium Metallicum, Germanium Sesquioxide, Holmium Metallicum, Indium Metallicum, Lithium Carbonicum, Magnesium Metallicum,",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20190611",
"EndMarketingDate": "20250625",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Biotics Research Corporation",
"SubstanceName": "ALUMINUM; ANTIMONY TRISULFIDE; APIS MELLIFERA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BARIUM CARBONATE; BERBERIS VULGARIS ROOT BARK; BERYLLIUM; BISMUTH; BORON; BROMINE; CADMIUM; CALCIUM SULFIDE; CAUSTICUM; CERIUM; CESIUM CHLORIDE; CHROMIUM; COBALT; CONIUM MACULATUM FLOWERING TOP; COPPER; DYSPROSIUM; ERBIUM; EUROPIUM OXIDE; GADOLINIUM; GARLIC; GERMANIUM SESQUIOXIDE; GOLD; HOLMIUM; HYPERICUM PERFORATUM; INDIUM; IPECAC; IRON; LANTHANUM; LEAD; LITHIUM CARBONATE; MAGNESIUM; MANGANESE; MERCURIUS SOLUBILIS; MOLYBDENUM; NEODYMIUM OXIDE; NICKEL; NIOBIUM; OSMIUM; PALLADIUM; PLATINUM; PRASEODYMIUM; RHODIUM; RUBIDIUM NITRITE; SAMARIUM; SELENIUM; SILVER; STRONTIUM CARBONATE; TANTALUM; TERBIUM; THALLIUM; TIN; URANYL NITRATE HEXAHYDRATE; VANADIUM; VERATRUM ALBUM ROOT; YTTERBIUM OXIDE; ZINC",
"StrengthNumber": "12; 12; 30; 12; 30; 12; 30; 12; 12; 12; 12; 12; 30; 30; 12; 12; 12; 12; 30; 12; 12; 12; 12; 12; 4; 12; 12; 12; 30; 12; 30; 12; 14; 12; 12; 12; 12; 12; 12; 12; 12; 30; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30; 12; 12; 12; 12; 12; 30; 12; 12",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/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_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/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_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_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Bee Venoms [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], 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 Histamine Release [PE], Increased Histamine Release [PE], 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], Plant Proteins [CS], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Standardized Insect Venom Allergenic Extract [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190611",
"EndMarketingDatePackage": "20250625",
"SamplePackage": "N",
"IndicationAndUsage": "Temporary relief of neurological disorders, vomiting, prostration and metallic aftertaste. Remedy #7 supports detoxification of environmental pollutants."
},
{
"NDCCode": "55146-008-01",
"PackageDescription": "120 mL in 1 BOTTLE, PLASTIC (55146-008-01) ",
"NDC11Code": "55146-0008-01",
"ProductNDC": "55146-008",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "8 Fungal Yeast Infection",
"NonProprietaryName": "Astragalus Membranaceus, Berberis Vulgaris, Echinacea (angustifolia), Gentiana Lutea, Phytolacca Decandra, Hydrastis Canadensis, Candida Albicans, Apis Mellifica, Calcarea Carbonica, Lycopodium Clavatum, Mercurius Solubilis, Pulsatilla (vulgaris) Sepia, Thuja Occidentalis",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20190611",
"EndMarketingDate": "20230413",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Biotics Research Corporation",
"SubstanceName": "APIS MELLIFERA; ASTRAGALUS PROPINQUUS ROOT; BERBERIS VULGARIS ROOT BARK; CANDIDA ALBICANS; ECHINACEA ANGUSTIFOLIA; GENTIANA LUTEA ROOT; GOLDENSEAL; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; THUJA OCCIDENTALIS LEAF",
"StrengthNumber": "30; 3; 3; 12; 3; 3; 5; 30; 30; 30; 4; 30; 30; 30",
"StrengthUnit": "[hp_C]/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_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC], Standardized Insect Venom Allergenic Extract [EPC]",
"Status": "Deprecated",
"LastUpdate": "2023-04-14",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190611",
"EndMarketingDatePackage": "20230413",
"SamplePackage": "N"
},
{
"NDCCode": "55146-009-01",
"PackageDescription": "120 mL in 1 BOTTLE, PLASTIC (55146-009-01) ",
"NDC11Code": "55146-0009-01",
"ProductNDC": "55146-009",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "9 Bacterial Detox",
"NonProprietaryName": "Baptisia Tinctoria, Dulcamara, Echinacea (angustifolia), Allium Sativum, Phytolacca Decandra, Apis Mellifica, Arsenicum Album, Belladonna, Chamomilla, Ferrum Phosphoricum, Gelsemium Sempervirens, Lachesis Mutus, Mercurius Solubilis, Pyrogenium",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20190611",
"EndMarketingDate": "20250625",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Biotics Research Corporation",
"SubstanceName": "APIS MELLIFERA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BAPTISIA TINCTORIA ROOT; ECHINACEA ANGUSTIFOLIA WHOLE; FERROSOFERRIC PHOSPHATE; GARLIC; GELSEMIUM SEMPERVIRENS ROOT; LACHESIS MUTA VENOM; MATRICARIA CHAMOMILLA WHOLE; MERCURIUS SOLUBILIS; PHYTOLACCA AMERICANA ROOT; RANCID BEEF; SOLANUM DULCAMARA TOP",
"StrengthNumber": "30; 30; 30; 3; 3; 30; 4; 30; 30; 30; 30; 4; 30; 3",
"StrengthUnit": "[hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL",
"Pharm_Classes": "Allergens [CS], Allergens [CS], Bee Venoms [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], Plant Proteins [CS], Standardized Insect Venom Allergenic Extract [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190611",
"EndMarketingDatePackage": "20250625",
"SamplePackage": "N",
"IndicationAndUsage": "For temporary relief of fever, sore throat and acute irritation of the bladder. Remedy #9 supports detoxification of toxins that remain after a bacterial infection."
},
{
"NDCCode": "55146-010-01",
"PackageDescription": "120 mL in 1 BOTTLE, PLASTIC (55146-010-01) ",
"NDC11Code": "55146-0010-01",
"ProductNDC": "55146-010",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "10 Parasite Detox",
"NonProprietaryName": "Carduus Marianus, Chelidonium Majus, Cina, Sabadilla, Teucrium Marum, Terebinthina, Thyroidinum (suis), Spigelia Anthelmia, Apis Mellifica, Baryta Carbonica, Calcarea Carbonica, Ferrum Muriaticum, Natrum Muriaticum, Silicea, Sulphur",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20190611",
"EndMarketingDate": "20250625",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "Biotics Research Corporation",
"SubstanceName": "APIS MELLIFERA; ARTEMISIA CINA PRE-FLOWERING TOP; BARIUM CARBONATE; CHELIDONIUM MAJUS WHOLE; FERRIC CHLORIDE HEXAHYDRATE; MILK THISTLE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SCHOENOCAULON OFFICINALE SEED; SILICON DIOXIDE; SODIUM CHLORIDE; SPIGELIA ANTHELMIA WHOLE; SULFUR; TEUCRIUM MARUM WHOLE; THYROID; TURPENTINE OIL",
"StrengthNumber": "30; 3; 30; 3; 30; 3; 30; 3; 30; 30; 6; 30; 3; 6; 5",
"StrengthUnit": "[hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/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], Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Standardized Insect Venom Allergenic Extract [EPC]",
"Status": "Deprecated",
"LastUpdate": "2025-06-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20190611",
"EndMarketingDatePackage": "20250625",
"SamplePackage": "N",
"IndicationAndUsage": "For temporary relief of fever, joint pain, cough, stiffness and gastric upset. Remedy #10 supports detoxification of toxins that remain following a parasitic infection."
},
{
"NDCCode": "10006-011-01",
"PackageDescription": "6032 L in 1 CYLINDER (10006-011-01)",
"NDC11Code": "10006-0011-01",
"ProductNDC": "10006-011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Heliox",
"NonProprietaryName": "Heliox",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19360101",
"MarketingCategoryName": "UNAPPROVED MEDICAL GAS",
"LabelerName": "Acetylene Oxygen Company",
"SubstanceName": "OXYGEN",
"StrengthNumber": "30",
"StrengthUnit": "L/100L",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "10348-011-01",
"PackageDescription": "1 TUBE in 1 CARTON (10348-011-01) > 3.5 mL in 1 TUBE",
"NDC11Code": "10348-0011-01",
"ProductNDC": "10348-011",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Camera Ready Bb Eyes Bs Spf 15",
"NonProprietaryName": "Octinoxate, Titanium Dioxide, And Zinc Oxide",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20130920",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "SMASHBOX BEAUTY COSMETICS, INC",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": ".04592; .01568; .0168",
"StrengthUnit": "g/100mL; g/100mL; g/100mL",
"Status": "Deprecated",
"LastUpdate": "2020-11-19",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20130920",
"SamplePackage": "N"
},
{
"NDCCode": "10678-011-01",
"PackageDescription": "3539 L in 1 CYLINDER (10678-011-01)",
"NDC11Code": "10678-0011-01",
"ProductNDC": "10678-011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Helium Oxygen Mix 80/20",
"NonProprietaryName": "Helium Oxygen Mix 80/20",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "19470523",
"MarketingCategoryName": "UNAPPROVED MEDICAL GAS",
"LabelerName": "Airgas-West, Inc.",
"SubstanceName": "HELIUM; OXYGEN",
"StrengthNumber": "800; 200",
"StrengthUnit": "mL/L; mL/L",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "10702-011-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (10702-011-01) ",
"NDC11Code": "10702-0011-01",
"ProductNDC": "10702-011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Hydroxyzine Hydrochloride",
"NonProprietaryName": "Hydroxyzine Hydrochloride",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20120724",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040786",
"LabelerName": "KVK-Tech, Inc.",
"SubstanceName": "HYDROXYZINE DIHYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Antihistamine [EPC], Histamine Receptor Antagonists [MoA]",
"Status": "Active",
"LastUpdate": "2023-01-26",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20120724",
"SamplePackage": "N",
"IndicationAndUsage": "For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses and in histamine-mediated pruritus. As a sedative when used as a premedication and following general anesthesia, hydroxyzine may potentiate meperidine and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. The effectiveness of hydroxyzine as an antianxiety agent for long term use, that is more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.",
"Description": "Hydroxyzine hydrochloride has the chemical name of 2-[2-[4-( p-Chloro- α-phenylbenzyl)-1-piperazinyl] ethoxy] ethanol dihydrochloride. Hydroxyzine hydrochloride occurs as a white, odorless powder which is very soluble in water. Each tablet for oral administration contains 10 mg, 25 mg or 50 mg hydroxyzine hydrochloride. Inactive ingredients include colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol/macrogol and titanium dioxide. This product complies with USP dissolution test 2."
},
{
"NDCCode": "10736-011-01",
"PackageDescription": "5974.9 L in 1 CYLINDER (10736-011-01)",
"NDC11Code": "10736-0011-01",
"ProductNDC": "10736-011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Compressed Gas N.o.s.",
"NonProprietaryName": "Oxygen, Nitrogen, Carbon Dioxide",
"DosageFormName": "GAS",
"RouteName": "RESPIRATORY (INHALATION)",
"StartMarketingDate": "20120529",
"MarketingCategoryName": "UNAPPROVED MEDICAL GAS",
"LabelerName": "Medical-Technical Gases, Inc.",
"SubstanceName": "OXYGEN; NITROGEN; CARBON DIOXIDE",
"StrengthNumber": "19.95; 75.05; 5",
"StrengthUnit": "mL/L; mL/L; mL/L",
"Pharm_Classes": "Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "10812-011-01",
"PackageDescription": "1 TUBE in 1 BLISTER PACK (10812-011-01) > 4.2 g in 1 TUBE",
"NDC11Code": "10812-0011-01",
"ProductNDC": "10812-011",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Neutrogena Revitalizing Lip Balm",
"ProprietaryNameSuffix": "Spf 20 - Healthy Blush 20",
"NonProprietaryName": "Octinoxate And Oxybenzone",
"DosageFormName": "LIPSTICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20101201",
"EndMarketingDate": "20181201",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Johnson & Johnson Consumer Inc.",
"SubstanceName": "OCTINOXATE; OXYBENZONE",
"StrengthNumber": "75; 50",
"StrengthUnit": "mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2018-12-04",
"ProductNdcExcludeFlag": "N"
},
{
"NDCCode": "10858-011-05",
"PackageDescription": "5 VIAL in 1 CARTON (10858-011-05) > 2 mL in 1 VIAL (10858-011-01) ",
"NDC11Code": "10858-0011-05",
"ProductNDC": "10858-011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Benztropine Mesylate",
"NonProprietaryName": "Benztropine Mesylate",
"DosageFormName": "INJECTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20201126",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA091525",
"LabelerName": "Wintac Limited",
"SubstanceName": "BENZTROPINE MESYLATE",
"StrengthNumber": "1",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA]",
"Status": "Deprecated",
"LastUpdate": "2022-01-04",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20201126",
"SamplePackage": "N"
},
{
"NDCCode": "11086-011-01",
"PackageDescription": "118 mL in 1 BOTTLE (11086-011-01) ",
"NDC11Code": "11086-0011-01",
"ProductNDC": "11086-011",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tarsum Professional",
"NonProprietaryName": "Coal Tar",
"DosageFormName": "SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "20131030",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M032",
"LabelerName": "Summers Laboratories Inc",
"SubstanceName": "COAL TAR",
"StrengthNumber": "2",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2025-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20131030",
"SamplePackage": "N",
"IndicationAndUsage": "USE: 1 CONTROLS ITCHING, FLAKING AND REDNESS DUE TO PSORIASIS, SEBORRHEIC DERMATITIS AND DANDRUFF."
},
{
"NDCCode": "11086-011-11",
"PackageDescription": "1 BOTTLE in 1 BOX (11086-011-11) > 118 mL in 1 BOTTLE (11086-011-01)",
"NDC11Code": "11086-0011-11",
"ProductNDC": "11086-011",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Tarsum Professional",
"NonProprietaryName": "Coal Tar",
"DosageFormName": "SHAMPOO",
"RouteName": "TOPICAL",
"StartMarketingDate": "20131030",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part358H",
"LabelerName": "Summers Laboratories Inc",
"SubstanceName": "COAL TAR",
"StrengthNumber": "2",
"StrengthUnit": "g/100mL",
"Status": "Deprecated",
"LastUpdate": "2018-11-22",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "11559-011-01",
"PackageDescription": "1 JAR in 1 CARTON (11559-011-01) > 50 mL in 1 JAR (11559-011-02)",
"NDC11Code": "11559-0011-01",
"ProductNDC": "11559-011",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Resilience Lift",
"ProprietaryNameSuffix": "Firming Sculpting Face And Neck Creme Spf 15 Nml Combo",
"NonProprietaryName": "Octinoxate, Octisalate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110201",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "ESTEE LAUDER INC",
"SubstanceName": "OCTINOXATE; OCTISALATE",
"StrengthNumber": "7.5; 3.5",
"StrengthUnit": "mL/100mL; mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "11788-011-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (11788-011-01) ",
"NDC11Code": "11788-0011-01",
"ProductNDC": "11788-011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Methimazole",
"NonProprietaryName": "Methimazole",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20260401",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA040547",
"LabelerName": "AiPing Pharmaceutical, Inc.",
"SubstanceName": "METHIMAZOLE",
"StrengthNumber": "5",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Thyroid Hormone Synthesis Inhibitor [EPC], Thyroid Hormone Synthesis Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-08-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20260401",
"SamplePackage": "N",
"IndicationAndUsage": "Methimazole tablets are indicated: 1 In patients with Graves’ disease with hyperthyroidism or toxic multinodular goiter for whom surgery or radioactive iodine therapy is not an appropriate treatment option., 2 To ameliorate symptoms of hyperthyroidism in preparation for thyroidectomy or radioactive iodine therapy.",
"Description": "Methimazole, USP (1-methylimidazole-2-thiol) is a white, crystalline substance that is freely soluble in water. It differs chemically from the drugs of the thiouracil series primarily because it has a 5- instead of a 6-membered ring. Methimazole tablet, USP contains 5 or 10 mg methimazole, an orally administered antithyroid drug. Each tablet also contains lactose monohydrate, magnesium stearate, potato starch and talc. The molecular weight is 114.17, and the molecular formula is C4H6N2S. The structural formula is as follows."
},
{
"NDCCode": "11994-011-01",
"PackageDescription": "1 VIAL, GLASS in 1 CARTON (11994-011-01) / 1.5 mL in 1 VIAL, GLASS",
"NDC11Code": "11994-0011-01",
"ProductNDC": "11994-011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Definity",
"NonProprietaryName": "Perflutren",
"DosageFormName": "INJECTION, SUSPENSION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20010731",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021064",
"LabelerName": "Lantheus Medical Imaging, Inc.",
"SubstanceName": "PERFLUTREN",
"StrengthNumber": "6.52",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Contrast Agent for Ultrasound Imaging [EPC], Ultrasound Contrast Activity [MoA]",
"Status": "Active",
"LastUpdate": "2024-03-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20010731",
"SamplePackage": "N",
"IndicationAndUsage": "DEFINITY is indicated, after activation, for use in adult and pediatric patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.",
"Description": "DEFINITY (perflutren lipid microsphere) injectable suspension is, after activation an ultrasound contrast agent for intravenous use. The perflutren lipid microspheres are composed of perflutren encapsulated in an outer lipid shell consisting of (R) – hexadecanoic acid, 1-[(phosphonoxy)methyl]-1,2-ethanediyl ester, monosodium salt (abbreviated DPPA); (R) - 4-hydroxy-N,N,N-trimethyl-10-oxo-7-[(1-oxohexadecyl)oxy]-3,4,9-trioxa-4-phosphapentacosan-1-aminium, 4-oxide, inner salt (abbreviated DPPC); and (R)-∝-[6-hydroxy-6-oxido-9-[(1-oxohexadecyl)oxy]-5,7,11-trioxa-2-aza-6-phosphahexacos-1-yl]- ω-methoxypoly(ox-1,2-ethanediyl), monosodium salt; commonly called N-(methoxypolyethylene glycol 5000 carbamoyl)-1,2-dipalmitoyl-sn-glycero-3- phosphatidylethanolamine, monosodium salt (abbreviated MPEG5000 DPPE). Perflutren is chemically characterized as 1,1,1,2,2,3,3,3-octafluoropropane. It has a molecular weight of 188, empirical formula of C3F8 and has the following structural formula. DPPA has a molecular weight of 670, empirical formula of C35H68O8PNa, and following structural formula. DPPC has a molecular weight of 734, empirical formula of C40H80NO8P, and following structural formula. MPEG5000 DPPE has an approximate molecular weight of 5750 represented by empirical formula C265H527NO123PNa, contains <100ppm Ca2+ and Mg2+ and the following structural formula. Prior to activation, perflutren is in the headspace of the vial with a concentration of 6.52 mg/mL which is confirmed by positive IR spectroscopic testing in every vial. The lipid blend is in the clear, colorless, hypertonic, sterile liquid. Each mL of the liquid contains 0.75 mg lipid blend (consisting of 0.045 mg DPPA, 0.401 mg DPPC, and 0.304 mg MPEG5000 DPPE) and the following inactive ingredients: 103.5 mg propylene glycol, 126.2 mg glycerin, 2.34 mg sodium phosphate monobasic monohydrate, 2.16 mg sodium phosphate dibasic heptahydrate, and 4.87 mg sodium chloride in water for injection. The pH is 6.2 to 6.8. DEFINITY does not contain bacterial preservative. After activation with the aid of the VIALMIX or VIALMIX RFID, each mL of the activated DEFINITY as homogenous milky white suspension contains a maximum of 1.2 × 1010 perflutren lipid microspheres, and about 150 microL/mL (1.1 mg/mL) perflutren. The microsphere particle size parameters are listed in Table 2 below."
},
{
"NDCCode": "13107-011-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (13107-011-01)",
"NDC11Code": "13107-0011-01",
"ProductNDC": "13107-011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sertraline Hydrochloride",
"NonProprietaryName": "Sertraline Hydrochloride",
"DosageFormName": "TABLET",
"RouteName": "ORAL",
"StartMarketingDate": "20110315",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA077206",
"LabelerName": "Aurolife Pharma LLC",
"SubstanceName": "SERTRALINE HYDROCHLORIDE",
"StrengthNumber": "25",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Major Depressive Disorder. Sertraline hydrochloride tablets are indicated for the treatment of major depressive disorder in adults. The efficacy of sertraline hydrochloride tablets in the treatment of a major depressive episode was established in six to eight week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III category of major depressive disorder (see Clinical Trials under CLINICAL PHARMACOLOGY). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The antidepressant action of sertraline hydrochloride tablets in hospitalized depressed patients has not been adequately studied. The efficacy of sertraline hydrochloride tablets in maintaining an antidepressant response for up to 44 weeks following 8 weeks of open-label acute treatment (52 weeks total) was demonstrated in a placebo-controlled trial. The usefulness of the drug in patients receiving sertraline hydrochloride tablets for extended periods should be reevaluated periodically (see Clinical Trials under CLINICAL PHARMACOLOGY). Obsessive-Compulsive Disorder. Sertraline hydrochloride tablets are indicated for the treatment of obsessions and compulsions in patients with obsessive-compulsive disorder (OCD), as defined in the DSM-III-R; i.e., the obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning. The efficacy of sertraline hydrochloride tablets were established in 12-week trials with obsessive-compulsive outpatients having diagnoses of obsessive-compulsive disorder as defined according to DSM-III or DSM-III-R criteria (see Clinical Trials under CLINICAL PHARMACOLOGY). Obsessive-compulsive disorder is characterized by recurrent and persistent ideas, thoughts, impulses, or images (obsessions) that are ego-dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable. The efficacy of sertraline hydrochloride tablets in maintaining a response, in patients with OCD who responded during a 52-week treatment phase while taking sertraline hydrochloride tablets and were then observed for relapse during a period of up to 28 weeks, was demonstrated in a placebo-controlled trial (see Clinical Trials under CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use sertraline hydrochloride tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Panic Disorder. Sertraline hydrochloride tablets are indicated for the treatment of panic disorder in adults, with or without agoraphobia, as defined in DSM-IV. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks. The efficacy of sertraline hydrochloride tablets were established in three 10 to 12 week trials in adult panic disorder patients whose diagnoses corresponded to the DSM-III-R category of panic disorder (see Clinical Trials under CLINICAL PHARMACOLOGY). Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart, or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded, or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. The efficacy of sertraline hydrochloride tablets in maintaining a response, in adult patients with panic disorder who responded during a 52-week treatment phase while taking sertraline hydrochloride tablets and were then observed for relapse during a period of up to 28 weeks, was demonstrated in a placebo-controlled trial (see Clinical Trials under CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use sertraline hydrochloride tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Posttraumatic Stress Disorder (PTSD). Sertraline hydrochloride tablets are indicated for the treatment of posttraumatic stress disorder in adults. The efficacy of sertraline hydrochloride tablets in the treatment of PTSD was established in two 12-week placebo-controlled trials of adult outpatients whose diagnosis met criteria for the DSM-III-R category of PTSD (see Clinical Trials under CLINICAL PHARMACOLOGY). PTSD, as defined by DSM-III-R/IV, requires exposure to a traumatic event that involved actual or threatened death or serious injury, or threat to the physical integrity of self or others, and a response which involves intense fear, helplessness, or horror. Symptoms that occur as a result of exposure to the traumatic event include reexperiencing of the event in the form of intrusive thoughts, flashbacks or dreams, and intense psychological distress and physiological reactivity on exposure to cues to the event; avoidance of situations reminiscent of the traumatic event, inability to recall details of the event, and/or numbing of general responsiveness manifested as diminished interest in significant activities, estrangement from others, restricted range of affect, or sense of foreshortened future; and symptoms of autonomic arousal including hypervigilance, exaggerated startle response, sleep disturbance, impaired concentration, and irritability or outbursts of anger. A PTSD diagnosis requires that the symptoms are present for at least a month and that they cause clinically significant distress or impairment in social, occupational, or other important areas of functioning. The efficacy of sertraline hydrochloride tablets in maintaining a response in adult patients with PTSD for up to 28 weeks following 24 weeks of open-label treatment was demonstrated in a placebo-controlled trial. Nevertheless, the physician who elects to use sertraline hydrochloride tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Premenstrual Dysphoric Disorder (PMDD). Sertraline hydrochloride tablets are indicated for the treatment of premenstrual dysphoric disorder (PMDD) in adults. The efficacy of sertraline hydrochloride tablets in the treatment of PMDD was established in 2 placebo-controlled trials of female adult outpatients treated for 3 menstrual cycles who met criteria for the DSM-III-R/IV category of PMDD (see Clinical Trials under CLINICAL PHARMACOLOGY). The essential features of PMDD include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. Other features include decreased interest in activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating and weight gain. These symptoms occur regularly during the luteal phase and remit within a few days following onset of menses; the disturbance markedly interferes with work or school or with usual social activities and relationships with others. In making the diagnosis, care should be taken to rule out other cyclical mood disorders that may be exacerbated by treatment with an antidepressant. The effectiveness of sertraline hydrochloride tablets in long-term use, that is, for more than 3 menstrual cycles, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use sertraline hydrochloride tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Social Anxiety Disorder. Sertraline hydrochloride tablets are indicated for the treatment of social anxiety disorder, also known as social phobia in adults. The efficacy of sertraline hydrochloride tablets in the treatment of social anxiety disorder was established in two placebo-controlled trials of adult outpatients with a diagnosis of social anxiety disorder as defined by DSM-IV criteria (see Clinical Trials under CLINICAL PHARMACOLOGY). Social anxiety disorder, as defined by DSM-IV, is characterized by marked and persistent fear of social or performance situations involving exposure to unfamiliar people or possible scrutiny by others and by fears of acting in a humiliating or embarrassing way. Exposure to the feared social situation almost always provokes anxiety and feared social or performance situations are avoided or else are endured with intense anxiety or distress. In addition, patients recognize that the fear is excessive or unreasonable and the avoidance and anticipatory anxiety of the feared situation is associated with functional impairment or marked distress. The efficacy of sertraline hydrochloride tablets in maintaining a response in adult patients with social anxiety disorder for up to 24 weeks following 20 weeks of sertraline hydrochloride tablets treatment was demonstrated in a placebo-controlled trial. Physicians who prescribe sertraline hydrochloride tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see Clinical Trials under CLINICAL PHARMACOLOGY)."
},
{
"NDCCode": "13668-011-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (13668-011-01) ",
"NDC11Code": "13668-0011-01",
"ProductNDC": "13668-011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Citalopram",
"NonProprietaryName": "Citalopram",
"DosageFormName": "TABLET, FILM COATED",
"RouteName": "ORAL",
"StartMarketingDate": "20071018",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA078216",
"LabelerName": "Torrent Pharmaceuticals Limited",
"SubstanceName": "CITALOPRAM HYDROBROMIDE",
"StrengthNumber": "40",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]",
"Status": "Active",
"LastUpdate": "2026-02-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20271231",
"StartMarketingDatePackage": "20071018",
"SamplePackage": "N",
"IndicationAndUsage": "Citalopram tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)] .",
"Description": "Citalopram tablets, USP contain citalopram, a selective serotonin reuptake inhibitor (SSRI). Citalopram hydrobromide is a racemic bicyclic phthalane structure and is designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3dihydroisobenzofuran-5-carbonitrile hydrobromide with the following structural formula. The molecular formula is C 20H 22BrFN 2O and its molecular weight is 405.35. Citalopram hydrobromide, USP occurs as a fine, white to off-white powder. Citalopram hydrobromide is sparingly soluble in water and soluble in ethanol. Citalopram, USP 10 mg tablets are film-coated, round shaped tablets containing citalopram hydrobromide in strengths equivalent to 10 mg citalopram base. Citalopram hydrobromide, USP 20 mg and 40 mg tablets are film-coated, oval shaped, scored tablets containing citalopram hydrobromide, in strengths equivalent to 20 mg or 40 mg citalopram base. The tablets also contain the following inactive ingredients: copovidone, corn starch, croscarmellose sodium, ferric oxide red, ferric oxide yellow, glycerin, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide."
},
{
"NDCCode": "13733-011-01",
"PackageDescription": "50 mL in 1 CARTON (13733-011-01)",
"NDC11Code": "13733-0011-01",
"ProductNDC": "13733-011",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Misa Cho Bo Yang Bb",
"ProprietaryNameSuffix": "Spf30 Pa Plus Plus No.1 Natural Beige",
"NonProprietaryName": "Titanium Dioxide",
"DosageFormName": "CREAM",
"RouteName": "CUTANEOUS",
"StartMarketingDate": "20110601",
"MarketingCategoryName": "OTC MONOGRAPH FINAL",
"ApplicationNumber": "part352",
"LabelerName": "ABLE C&C CO., LTD.",
"SubstanceName": "TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": "5.2; .7",
"StrengthUnit": "mL/50mL; mL/50mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "INDICATION AND USAGE:After basic skin care, apply an appropriate amount along the skin texture and finish with powder."
},
{
"NDCCode": "13913-011-19",
"PackageDescription": "9 PACKET in 1 CARTON (13913-011-19) > 1 POWDER, FOR SOLUTION in 1 PACKET (13913-011-01) ",
"NDC11Code": "13913-0011-19",
"ProductNDC": "13913-011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cambia",
"NonProprietaryName": "Diclofenac Potassium",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20100420",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022165",
"LabelerName": "Assertio Therapeutics, Inc.",
"SubstanceName": "DICLOFENAC POTASSIUM",
"StrengthNumber": "50",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-12-06",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20100420",
"SamplePackage": "N",
"IndicationAndUsage": "CAMBIA is a non-steroidal anti-inflammatory (NSAID) drug indicated for the acute treatment of migraine attacks with or without aura in adults 18 years of age or older (1.1). Important Limitations (1.2): 1 CAMBIA is not indicated for the prophylactic therapy of migraine, 2 Safety and effectiveness of CAMBIA not established for cluster headache, which is present in an older, predominantly male population.",
"Description": "CAMBIA (Diclofenac Potassium for Oral Solution) is a benzeneacetic acid derivative NSAID. CAMBIA is available as a buffered soluble powder, designed to be mixed with water prior to oral administration. CAMBIA is a white to off-white, buffered, flavored powder for oral solution packaged in individual unit dose packets [see How Supplied/Storage and Handling (16)]. The chemical name for diclofenac potassium is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid monopotassium salt. The molecular weight of diclofenac potassium is 334.25. Its molecular formula is C14H10Cl2NKO2, and it has the following structural formula. The inactive ingredients in CAMBIA include: aspartame (equivalent to 25 mg phenylalanine), flavoring agents (anise and mint), glycerol behenate, mannitol, potassium bicarbonate, and saccharin sodium."
},
{
"NDCCode": "14141-011-01",
"PackageDescription": "1 CASE in 1 BOX (14141-011-01) > 9 g in 1 CASE",
"NDC11Code": "14141-0011-01",
"ProductNDC": "14141-011",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel Clarite Makeup Foundation For A Clearer Appearance Spf 30 270-c",
"NonProprietaryName": "Octinoxate, Zinc Oxide",
"DosageFormName": "PASTE",
"RouteName": "TOPICAL",
"StartMarketingDate": "20220101",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Bel Star S.A.",
"SubstanceName": "OCTINOXATE; ZINC OXIDE",
"StrengthNumber": "75; 78.4",
"StrengthUnit": "mg/g; mg/g",
"Status": "Deprecated",
"LastUpdate": "2023-12-20",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20231231",
"StartMarketingDatePackage": "20220101",
"SamplePackage": "N"
},
{
"NDCCode": "14445-011-01",
"PackageDescription": "5 kg in 1 DRUM (14445-011-01) ",
"NDC11Code": "14445-0011-01",
"ProductNDC": "14445-011",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Febuxostat",
"DosageFormName": "POWDER",
"StartMarketingDate": "20160305",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Indoco Remedies Limited",
"SubstanceName": "FEBUXOSTAT",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2024-03-12",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "05-MAR-16"
},
{
"NDCCode": "14789-011-01",
"PackageDescription": "10 VIAL, SINGLE-DOSE in 1 CARTON (14789-011-01) / 1 mL in 1 VIAL, SINGLE-DOSE",
"NDC11Code": "14789-0011-01",
"ProductNDC": "14789-011",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Isoproterenol Hydrochloride",
"NonProprietaryName": "Isoproterenol Hydrochloride",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAMUSCULAR; INTRAVENOUS",
"StartMarketingDate": "20170803",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA206961",
"LabelerName": "Nexus Pharmaceuticals LLC",
"SubstanceName": "ISOPROTERENOL HYDROCHLORIDE",
"StrengthNumber": ".2",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Adrenergic beta-Agonists [MoA], beta-Adrenergic Agonist [EPC]",
"Status": "Active",
"LastUpdate": "2025-09-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20170803",
"SamplePackage": "N",
"IndicationAndUsage": "Isoproterenol hydrochloride is indicated: 1 To improve hemodynamic status in patients in distributive shock and shock due to reduced cardiac output, 2 For bronchospasm occurring during anesthesia.",
"Description": "Isoproterenol hydrochloride is 3,4-Dihydroxy-α-[(isopropylamino)methyl] benzyl alcohol hydrochloride, a beta-adrenergic agonist and a synthetic sympathomimetic amine that is structur ally related to epinephrine. The molecular formula is C 11H 17NO 3· HCl. It has a molecular weight of 247.72 and the following structural formula:. Isoproterenol hydrochloride is a racemic compound. The pH is adjusted between 3.5 and 4.5 with hydrochloric acid and/or sodium hydroxide. The sterile solution is nonpyrogenic and can be administered by the intravenous route."
}
]
}
{"NDC":[{"NDCCode":"55146-011-01","ProprietaryName":"1 Detoxification","NonProprietaryName":"Trifolium Pratense, Capsicum Annuum, Phytolacca Decandra, Aluminum Metallicum, Antimonium Crudum, Argentum Metallicum, Arsenicum Album, Aurum Metallicum, Baryta Carbonica, Beryllium Metallicum, Bismuthum Metallicum, Boron, Bromium, Cadmium Metallicum, Cerium Metallicum, Cesium Chloride, Chromium, Cobaltum Metallicum, Cuprum Metallicum, Dysprosium Metallicum, Erbium Metallicum, Europium Oxydatum, Ferrum Metallicum, Gadolinium Metallicum, Germanium Sesquioxide, Holmium Metallicum, Indium Metallicum,"},{"NDCCode":"55146-001-01","ProprietaryName":"1 Detoxification","NonProprietaryName":"Capsicum Annuum, Phytolacca Decandra, Trifolium Pratense, Aluminum Metallicum, Antimonium Crudum, Argentum Metallicum, Arsenicum Album, Aurum Metallicum, Baryta Carbonica, Beryllium Metallicum, Bismuthum Metallicum, Boron, Bromium, Cadmium Metallicum, Cerium Metallicum, Cesium Chloride, Chromium Metallicum, Cobaltum Metallicum, Cuprum Metallicum, Dysprosium Metallicum, Erbium Metallicum, Europium Oxydatum, Ferrum Metallicum, Gadolinium Oxydatum, Germanium Sesquioxide, Holmium,"},{"NDCCode":"55146-002-01","ProprietaryName":"2 Lymphatic Drainage","NonProprietaryName":"Berberis Vulgaris, Carduus Marianus, Chelidonium Majus, Collinsonia Canadensis, Solidago Virgaurea, Hydrastis Canadensis, Fel Tauri, Apis Mellifica, Baryta Muriatica, Ceanothus Americanus, Chininum Sulphuricum, Conium Maculatum, Iodium, Lachesis Mutus, Mercurius Solubilis, Nux Vomica, Phosphorus, Silicea"},{"NDCCode":"55146-003-01","ProprietaryName":"3 Acute Stress","NonProprietaryName":"Arnica Montana, Bellis Perennis, Passiflora Incarnata, Valeriana Officinalis, Arsenicum Album, Apis Mellifica, Carcinosin, Cistus Canadensis, Clematis Erecta, Coffea Cruda, Ignatia Amara, Lachesis Mutus, Magnesia Phosphorica, Natrum Muriaticum, Natrum Sulphuricum, Ornithogalum Umbellatum, Phosphoricum Acidum, Salix Nigra, Staphysagria"},{"NDCCode":"55146-004-01","ProprietaryName":"4 Detox-virus","NonProprietaryName":"Astragalus Membranaceus, Baptisia Tinctoria, Echinacea (echinacea), Phytolacca Decandra, Hydrastis Canadensis, Apis Mellifica, Aranea Diadema, Belladonna, Eupatorium Perfoliatum, Gelsemium Sempervirens, Lachesis Mutus, Phosphoricum Acidum, Silicea, Thuja Occidentalis, Vaccinium Myrtillus"},{"NDCCode":"55146-005-01","ProprietaryName":"5 Chronic Stress","NonProprietaryName":"Aralia Quinquefolia, Fucus Vesiculosus, Solidago Virgaurea, Taraxacum Officinale, Trifolium Pratense, Hydrastis Canadensis, Arsenicum Album, Calcarea Carbonica, Carbo Vegetabilis, Ceanothus Americanus, Cyclamen Europaeum, Hepar Sulphuris Calcareum, Natrum Muriaticum, Nux Vomica, Petroleum, Phosphorus"},{"NDCCode":"55146-006-01","ProprietaryName":"6 Environmental Detox","NonProprietaryName":"Baptisia Tinctoria, Phytolacca Decandra, Spigelia Anthelmia, Adrenocorticotrophin, Aluminum Metallicum, Apis Mellifica, Argentum Nitricum, Arsenicum Album, Benzoicum Acidum, Calcarea Carbonica, Carbo Vegetabilis, Kali Phosphoricum, Magnesia Sulphurica, Mercurius Solubilis, Nitricum Acidum, Nux Vomica, Phosphorus, Silicea"},{"NDCCode":"55146-007-01","ProprietaryName":"7 Heavy Metal Detox","NonProprietaryName":"Allium Sativum, Aluminum Metallicum, Antimonium Crudum, Argentum Metallicum, Arsenicum Album, Aurum Metallicum, Baryta Carbonica, Beryllium Metallicum, Bismuthum Metallicum, Boron, Bromium, Cadmium Metallicum, Cerium Metallicum, Cesium Chloride, Chromium, Cobaltum Metallicum, Cuprum Metallicum, Dysprosium Metallicum, Erbium Metallicum, Europium Metallicum, Ferrum Metallicum, Gadolinium Metallicum, Germanium Sesquioxide, Holmium Metallicum, Indium Metallicum, Lithium Carbonicum, Magnesium Metallicum,"},{"NDCCode":"55146-008-01","ProprietaryName":"8 Fungal Yeast Infection","NonProprietaryName":"Astragalus Membranaceus, Berberis Vulgaris, Echinacea (angustifolia), Gentiana Lutea, Phytolacca Decandra, Hydrastis Canadensis, Candida Albicans, Apis Mellifica, Calcarea Carbonica, Lycopodium Clavatum, Mercurius Solubilis, Pulsatilla (vulgaris) Sepia, Thuja Occidentalis"},{"NDCCode":"55146-009-01","ProprietaryName":"9 Bacterial Detox","NonProprietaryName":"Baptisia Tinctoria, Dulcamara, Echinacea (angustifolia), Allium Sativum, Phytolacca Decandra, Apis Mellifica, Arsenicum Album, Belladonna, Chamomilla, Ferrum Phosphoricum, Gelsemium Sempervirens, Lachesis Mutus, Mercurius Solubilis, Pyrogenium"},{"NDCCode":"55146-010-01","ProprietaryName":"10 Parasite Detox","NonProprietaryName":"Carduus Marianus, Chelidonium Majus, Cina, Sabadilla, Teucrium Marum, Terebinthina, Thyroidinum (suis), Spigelia Anthelmia, Apis Mellifica, Baryta Carbonica, Calcarea Carbonica, Ferrum Muriaticum, Natrum Muriaticum, Silicea, Sulphur"},{"NDCCode":"10006-011-01","ProprietaryName":"Heliox","NonProprietaryName":"Heliox"},{"NDCCode":"10348-011-01","ProprietaryName":"Camera Ready Bb Eyes Bs Spf 15","NonProprietaryName":"Octinoxate, Titanium Dioxide, And Zinc Oxide"},{"NDCCode":"10678-011-01","ProprietaryName":"Helium Oxygen Mix 80/20","NonProprietaryName":"Helium Oxygen Mix 80/20"},{"NDCCode":"10702-011-01","ProprietaryName":"Hydroxyzine Hydrochloride","NonProprietaryName":"Hydroxyzine Hydrochloride"},{"NDCCode":"10736-011-01","ProprietaryName":"Compressed Gas N.o.s.","NonProprietaryName":"Oxygen, Nitrogen, Carbon Dioxide"},{"NDCCode":"10812-011-01","ProprietaryName":"Neutrogena Revitalizing Lip Balm","NonProprietaryName":"Octinoxate And Oxybenzone"},{"NDCCode":"10858-011-05","ProprietaryName":"Benztropine Mesylate","NonProprietaryName":"Benztropine Mesylate"},{"NDCCode":"11086-011-01","ProprietaryName":"Tarsum Professional","NonProprietaryName":"Coal Tar"},{"NDCCode":"11086-011-11","ProprietaryName":"Tarsum Professional","NonProprietaryName":"Coal Tar"},{"NDCCode":"11559-011-01","ProprietaryName":"Resilience Lift","NonProprietaryName":"Octinoxate, Octisalate"},{"NDCCode":"11788-011-01","ProprietaryName":"Methimazole","NonProprietaryName":"Methimazole"},{"NDCCode":"11994-011-01","ProprietaryName":"Definity","NonProprietaryName":"Perflutren"},{"NDCCode":"13107-011-01","ProprietaryName":"Sertraline Hydrochloride","NonProprietaryName":"Sertraline Hydrochloride"},{"NDCCode":"13668-011-01","ProprietaryName":"Citalopram","NonProprietaryName":"Citalopram"},{"NDCCode":"13733-011-01","ProprietaryName":"Misa Cho Bo Yang Bb","NonProprietaryName":"Titanium Dioxide"},{"NDCCode":"13913-011-19","ProprietaryName":"Cambia","NonProprietaryName":"Diclofenac Potassium"},{"NDCCode":"14141-011-01","ProprietaryName":"Lbel Clarite Makeup Foundation For A Clearer Appearance Spf 30 270-c","NonProprietaryName":"Octinoxate, Zinc Oxide"},{"NDCCode":"14445-011-01","NonProprietaryName":"Febuxostat"},{"NDCCode":"14789-011-01","ProprietaryName":"Isoproterenol Hydrochloride","NonProprietaryName":"Isoproterenol Hydrochloride"}]}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>55146-011-01</NDCCode>
<PackageDescription>120 mL in 1 BOTTLE (55146-011-01) </PackageDescription>
<NDC11Code>55146-0011-01</NDC11Code>
<ProductNDC>55146-011</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>1 Detoxification</ProprietaryName>
<NonProprietaryName>Trifolium Pratense, Capsicum Annuum, Phytolacca Decandra, Aluminum Metallicum, Antimonium Crudum, Argentum Metallicum, Arsenicum Album, Aurum Metallicum, Baryta Carbonica, Beryllium Metallicum, Bismuthum Metallicum, Boron, Bromium, Cadmium Metallicum, Cerium Metallicum, Cesium Chloride, Chromium, Cobaltum Metallicum, Cuprum Metallicum, Dysprosium Metallicum, Erbium Metallicum, Europium Oxydatum, Ferrum Metallicum, Gadolinium Metallicum, Germanium Sesquioxide, Holmium Metallicum, Indium Metallicum,</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20200505</StartMarketingDate>
<EndMarketingDate>20250625</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Biotics Research Corporation</LabelerName>
<SubstanceName>ACTIVATED CHARCOAL; ALCOHOL, X-RAY EXPOSED (1000 RAD); ALLYLTHIOUREA; ALUMINUM; ANGUILLA ROSTRATA BLOOD SERUM; ANTIMONY TRISULFIDE; APIS MELLIFERA; ARSENIC TRIOXIDE; BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; BARIUM CARBONATE; BERYLLIUM; BISMUTH; BORON; BROMINE; CADMIUM; CAPSICUM; CARBO ANIMALIS; CERIUM; CESIUM CHLORIDE; CHROMIUM; CLAVICEPS PURPUREA SCLEROTIUM; COBALT; CONIUM MACULATUM FLOWERING TOP; COPPER; CORTICOTROPIN; DYSPROSIUM; ERBIUM; EUROPIUM; GADOLINIUM; GELSEMIUM SEMPERVIRENS ROOT; GERMANIUM SESQUIOXIDE; GOLD; HOLMIUM; HUMAN BREAST TUMOR CELL; INDIUM; IRON; LACHESIS MUTA VENOM; LANTHANUM; LEAD; LITHIUM CARBONATE; MAGNESIUM; MANGANESE; MERCURIUS SOLUBILIS; MOLYBDENUM; NEODYMIUM OXIDE; NICKEL; NIOBIUM; OSMIUM; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PALLADIUM; PHOSPHORIC ACID; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PLATINUM; POTASSIUM DICHROMATE; PRASEODYMIUM; RANCID BEEF; RHODIUM; RUBIDIUM NITRITE; SAMARIUM; SELENIUM; SILVER; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; STRONTIUM CARBONATE; STRYCHNOS WALLICHIANA BARK; SULFURIC ACID; SUS SCROFA PITUITARY GLAND; TANTALUM; TARTARIC ACID; TERBIUM; THALLIUM; THERIDION CURASSAVICUM; THUJA OCCIDENTALIS LEAFY TWIG; THYROID; TIN; TRIFOLIUM PRATENSE FLOWER; URANYL NITRATE HEXAHYDRATE; VANADIUM; VERATRUM ALBUM ROOT; YTTERBIUM OXIDE; ZINC</SubstanceName>
<StrengthNumber>30; 30; 30; 12; 30; 12; 30; 12; 30; 12; 12; 12; 12; 12; 12; 3; 30; 12; 12; 12; 30; 12; 30; 12; 30; 12; 12; 12; 12; 30; 12; 12; 12; 30; 12; 12; 30; 14; 12; 12; 12; 12; 12; 12; 12; 12; 30; 12; 30; 12; 30; 30; 4; 12; 30; 12; 30; 12; 12; 12; 12; 12; 30; 12; 30; 30; 30; 30; 30; 12; 12; 30; 30; 30; 12; 3; 12; 12; 30; 12; 12</StrengthNumber>
<StrengthUnit>[hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/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_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/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_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Adrenocorticotropic Hormone [CS], Adrenocorticotropic Hormone [EPC], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Bee Venoms [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], 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 Histamine Release [PE], Increased Histamine Release [PE], 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], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Standardized Insect Venom Allergenic Extract [EPC], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200505</StartMarketingDatePackage>
<EndMarketingDatePackage>20250625</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For temporary relief of gastrointestinal dyspepsia (indigestion) with flatulence, bloating and intolerance of certain foods. Remedy #1 supports detoxification and cellular repair.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55146-001-01</NDCCode>
<PackageDescription>120 mL in 1 BOTTLE (55146-001-01) </PackageDescription>
<NDC11Code>55146-0001-01</NDC11Code>
<ProductNDC>55146-001</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>1 Detoxification</ProprietaryName>
<NonProprietaryName>Capsicum Annuum, Phytolacca Decandra, Trifolium Pratense, Aluminum Metallicum, Antimonium Crudum, Argentum Metallicum, Arsenicum Album, Aurum Metallicum, Baryta Carbonica, Beryllium Metallicum, Bismuthum Metallicum, Boron, Bromium, Cadmium Metallicum, Cerium Metallicum, Cesium Chloride, Chromium Metallicum, Cobaltum Metallicum, Cuprum Metallicum, Dysprosium Metallicum, Erbium Metallicum, Europium Oxydatum, Ferrum Metallicum, Gadolinium Oxydatum, Germanium Sesquioxide, Holmium,</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190610</StartMarketingDate>
<EndMarketingDate>20250625</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Biotics Research Corporation</LabelerName>
<SubstanceName>ACTIVATED CHARCOAL; ALCOHOL, X-RAY EXPOSED (1000 RAD); ALLYLTHIOUREA; ALUMINUM; ANGUILLA ROSTRATA BLOOD SERUM; ANTIMONY TRISULFIDE; APIS MELLIFERA; ARSENIC TRIOXIDE; BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; BARIUM CARBONATE; BERYLLIUM; BISMUTH; BORON; BROMINE; CADMIUM; CAPSICUM; CARBO ANIMALIS; CERIUM; CESIUM CHLORIDE; CHROMIUM; CLAVICEPS PURPUREA SCLEROTIUM; COBALT; CONIUM MACULATUM FLOWERING TOP; COPPER; CORTICOTROPIN; DYSPROSIUM; ERBIUM; EUROPIUM; GADOLINIUM; GELSEMIUM SEMPERVIRENS ROOT; GERMANIUM SESQUIOXIDE; GOLD; HOLMIUM; HUMAN BREAST TUMOR CELL; INDIUM; IRON; LACHESIS MUTA VENOM; LANTHANUM; LEAD; LITHIUM CARBONATE; MAGNESIUM; MANGANESE; MERCURIUS SOLUBILIS; MOLYBDENUM; NEODYMIUM OXIDE; NICKEL; NIOBIUM; OSMIUM; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PALLADIUM; PHOSPHORIC ACID; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; PLATINUM; POTASSIUM DICHROMATE; PRASEODYMIUM; RANCID BEEF; RHODIUM; RUBIDIUM NITRITE; SAMARIUM; SELENIUM; SILVER; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; STRONTIUM CARBONATE; STRYCHNOS WALLICHIANA BARK; SULFURIC ACID; SUS SCROFA PITUITARY GLAND; TANTALUM; TARTARIC ACID; TERBIUM; THALLIUM; THERIDION CURASSAVICUM; THUJA OCCIDENTALIS LEAFY TWIG; THYROID; TIN; TRIFOLIUM PRATENSE FLOWER; URANYL NITRATE HEXAHYDRATE; VANADIUM; VERATRUM ALBUM ROOT; YTTERBIUM OXIDE; ZINC</SubstanceName>
<StrengthNumber>30; 30; 30; 12; 30; 12; 30; 12; 30; 12; 12; 12; 12; 30; 12; 3; 30; 12; 12; 12; 30; 12; 30; 12; 30; 12; 12; 12; 12; 30; 12; 12; 12; 30; 12; 12; 30; 14; 12; 12; 12; 12; 12; 12; 12; 12; 30; 12; 30; 12; 30; 30; 4; 12; 30; 12; 30; 12; 12; 12; 12; 12; 30; 12; 30; 30; 30; 30; 30; 12; 12; 30; 30; 30; 12; 3; 12; 12; 30; 12; 12</StrengthNumber>
<StrengthUnit>[hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/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_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Adrenocorticotropic Hormone [CS], Adrenocorticotropic Hormone [EPC], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Bee Venoms [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], 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 Histamine Release [PE], Increased Histamine Release [PE], 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], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Standardized Insect Venom Allergenic Extract [EPC], Vegetable Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190610</StartMarketingDatePackage>
<EndMarketingDatePackage>20250625</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For temporary relief of gastrointestinal dyspepsia (indigestion) with flatulence, bloating and intolerance of certain foods. Remedy #1 supports detoxification and cellular repair.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55146-002-01</NDCCode>
<PackageDescription>120 mL in 1 BOTTLE, PLASTIC (55146-002-01) </PackageDescription>
<NDC11Code>55146-0002-01</NDC11Code>
<ProductNDC>55146-002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>2 Lymphatic Drainage</ProprietaryName>
<NonProprietaryName>Berberis Vulgaris, Carduus Marianus, Chelidonium Majus, Collinsonia Canadensis, Solidago Virgaurea, Hydrastis Canadensis, Fel Tauri, Apis Mellifica, Baryta Muriatica, Ceanothus Americanus, Chininum Sulphuricum, Conium Maculatum, Iodium, Lachesis Mutus, Mercurius Solubilis, Nux Vomica, Phosphorus, Silicea</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190611</StartMarketingDate>
<EndMarketingDate>20250821</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Biotics Research Corporation</LabelerName>
<SubstanceName>APIS MELLIFERA; BARIUM CHLORIDE DIHYDRATE; BERBERIS VULGARIS ROOT BARK; BOS TAURUS BILE; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; COLLINSONIA CANADENSIS ROOT; CONIUM MACULATUM FLOWERING TOP; GOLDENSEAL; IODINE; LACHESIS MUTA VENOM; MERCURIUS SOLUBILIS; MILK THISTLE; PHOSPHORUS; QUININE SULFATE; SILICON DIOXIDE; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED</SubstanceName>
<StrengthNumber>30; 30; 3; 6; 30; 3; 3; 30; 5; 30; 30; 30; 3; 30; 30; 30; 3; 30</StrengthNumber>
<StrengthUnit>[hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Antimalarial [EPC], Bee Venoms [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Standardized Insect Venom Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-08-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190611</StartMarketingDatePackage>
<EndMarketingDatePackage>20250821</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For temporary relief of fever, sore throat and acute irritation of the bladder. Remedy #2 supports the clearing of organs allowing for lymphatic drainage and detoxification of any stored toxins that have been released during the cleansing.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55146-003-01</NDCCode>
<PackageDescription>120 mL in 1 BOTTLE, PLASTIC (55146-003-01) </PackageDescription>
<NDC11Code>55146-0003-01</NDC11Code>
<ProductNDC>55146-003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>3 Acute Stress</ProprietaryName>
<NonProprietaryName>Arnica Montana, Bellis Perennis, Passiflora Incarnata, Valeriana Officinalis, Arsenicum Album, Apis Mellifica, Carcinosin, Cistus Canadensis, Clematis Erecta, Coffea Cruda, Ignatia Amara, Lachesis Mutus, Magnesia Phosphorica, Natrum Muriaticum, Natrum Sulphuricum, Ornithogalum Umbellatum, Phosphoricum Acidum, Salix Nigra, Staphysagria</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190611</StartMarketingDate>
<EndMarketingDate>20250716</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Biotics Research Corporation</LabelerName>
<SubstanceName>APIS MELLIFERA; ARABICA COFFEE BEAN; ARNICA MONTANA WHOLE; ARSENIC TRIOXIDE; BELLIS PERENNIS WHOLE; CLEMATIS RECTA FLOWERING TOP; DELPHINIUM STAPHISAGRIA SEED; HELIANTHEMUM CANADENSE; HUMAN BREAST TUMOR CELL; LACHESIS MUTA VENOM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; ORNITHOGALUM UMBELLATUM WHOLE; PASSIFLORA INCARNATA FLOWERING TOP; PHOSPHORIC ACID; SALIX NIGRA BARK; SODIUM CHLORIDE; SODIUM SULFATE; STRYCHNOS IGNATII SEED; VALERIAN</SubstanceName>
<StrengthNumber>30; 30; 3; 6; 3; 30; 30; 30; 30; 30; 30; 30; 3; 30; 30; 30; 30; 30; 3</StrengthNumber>
<StrengthUnit>[hp_C]/mL; [hp_C]/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_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Bee Venoms [CS], Calculi Dissolution Agent [EPC], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Standardized Insect Venom Allergenic Extract [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-07-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190611</StartMarketingDatePackage>
<EndMarketingDatePackage>20250716</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For temporary relief of acute stress due to emotional strain, anxiety, sleeplessness, apprehension or fear.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55146-004-01</NDCCode>
<PackageDescription>120 mL in 1 BOTTLE, PLASTIC (55146-004-01) </PackageDescription>
<NDC11Code>55146-0004-01</NDC11Code>
<ProductNDC>55146-004</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>4 Detox-virus</ProprietaryName>
<NonProprietaryName>Astragalus Membranaceus, Baptisia Tinctoria, Echinacea (echinacea), Phytolacca Decandra, Hydrastis Canadensis, Apis Mellifica, Aranea Diadema, Belladonna, Eupatorium Perfoliatum, Gelsemium Sempervirens, Lachesis Mutus, Phosphoricum Acidum, Silicea, Thuja Occidentalis, Vaccinium Myrtillus</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190611</StartMarketingDate>
<EndMarketingDate>20250625</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Biotics Research Corporation</LabelerName>
<SubstanceName>APIS MELLIFERA; ARANEUS DIADEMATUS; ARSENIC TRIOXIDE; ASTRAGALUS PROPINQUUS ROOT; ATROPA BELLADONNA; BAPTISIA TINCTORIA; BILBERRY; ECHINACEA ANGUSTIFOLIA WHOLE; EUPATORIUM PERFOLIATUM FLOWERING TOP; GELSEMIUM SEMPERVIRENS ROOT; GOLDENSEAL; LACHESIS MUTA VENOM; PHOSPHORIC ACID; PHYTOLACCA AMERICANA ROOT; RANCID BEEF; SILICON DIOXIDE; THUJA OCCIDENTALIS LEAFY TWIG</SubstanceName>
<StrengthNumber>30; 30; 30; 3; 30; 3; 30; 3; 30; 30; 5; 30; 30; 4; 30; 30; 30</StrengthNumber>
<StrengthUnit>[hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/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>Deprecated</Status>
<LastUpdate>2025-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190611</StartMarketingDatePackage>
<EndMarketingDatePackage>20250625</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For temporary relief of skin irritation, dry cough, eczema or fever. Remedy #4 supports detoxification of residual toxins left from a viral infection.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55146-005-01</NDCCode>
<PackageDescription>120 mL in 1 BOTTLE, PLASTIC (55146-005-01) </PackageDescription>
<NDC11Code>55146-0005-01</NDC11Code>
<ProductNDC>55146-005</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>5 Chronic Stress</ProprietaryName>
<NonProprietaryName>Aralia Quinquefolia, Fucus Vesiculosus, Solidago Virgaurea, Taraxacum Officinale, Trifolium Pratense, Hydrastis Canadensis, Arsenicum Album, Calcarea Carbonica, Carbo Vegetabilis, Ceanothus Americanus, Cyclamen Europaeum, Hepar Sulphuris Calcareum, Natrum Muriaticum, Nux Vomica, Petroleum, Phosphorus</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190611</StartMarketingDate>
<EndMarketingDate>20250701</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Biotics Research Corporation</LabelerName>
<SubstanceName>ACTIVATED CHARCOAL; AMERICAN GINSENG; ARSENIC TRIOXIDE; CEANOTHUS AMERICANUS LEAF; CYCLAMEN PURPURASCENS TUBER; FUCUS VESICULOSUS; GOLDENSEAL; KEROSENE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; SODIUM CHLORIDE; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; TARAXACUM OFFICINALE; TRIFOLIUM PRATENSE FLOWER</SubstanceName>
<StrengthNumber>30; 3; 30; 30; 30; 3; 5; 30; 30; 30; 30; 3; 30; 3; 3</StrengthNumber>
<StrengthUnit>[hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/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>Deprecated</Status>
<LastUpdate>2025-07-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190611</StartMarketingDatePackage>
<EndMarketingDatePackage>20250701</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For temporary relief of debility or exhaustion after slight exertion, or exhaustion following dysentery. Remedy #5 supports the easing of chronic stress produced by natural substances called adaptogens.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55146-006-01</NDCCode>
<PackageDescription>120 mL in 1 BOTTLE, PLASTIC (55146-006-01) </PackageDescription>
<NDC11Code>55146-0006-01</NDC11Code>
<ProductNDC>55146-006</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>6 Environmental Detox</ProprietaryName>
<NonProprietaryName>Baptisia Tinctoria, Phytolacca Decandra, Spigelia Anthelmia, Adrenocorticotrophin, Aluminum Metallicum, Apis Mellifica, Argentum Nitricum, Arsenicum Album, Benzoicum Acidum, Calcarea Carbonica, Carbo Vegetabilis, Kali Phosphoricum, Magnesia Sulphurica, Mercurius Solubilis, Nitricum Acidum, Nux Vomica, Phosphorus, Silicea</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190611</StartMarketingDate>
<EndMarketingDate>20251211</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Biotics Research Corporation</LabelerName>
<SubstanceName>ACTIVATED CHARCOAL; ALUMINUM; APIS MELLIFERA; ARSENIC TRIOXIDE; BAPTISIA TINCTORIA ROOT; BENZOIC ACID; CORTICOTROPIN; MAGNESIUM SULFATE HEPTAHYDRATE; MERCURIUS SOLUBILIS; NITRIC ACID; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; POTASSIUM PHOSPHATE, DIBASIC; SILICON DIOXIDE; SILVER NITRATE; SPIGELIA ANTHELMIA WHOLE; STRYCHNOS NUX-VOMICA SEED</SubstanceName>
<StrengthNumber>30; 30; 30; 30; 3; 30; 30; 30; 30; 30; 30; 30; 4; 30; 30; 30; 6; 30</StrengthNumber>
<StrengthUnit>[hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/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_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL</StrengthUnit>
<Pharm_Classes>Adrenocorticotropic Hormone [CS], Adrenocorticotropic Hormone [EPC], Allergens [CS], Allergens [CS], Ammonium Ion Binding Activity [MoA], Bee Venoms [CS], Calculi Dissolution Agent [EPC], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Nitrogen Binding Agent [EPC], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Standardized Insect Venom Allergenic Extract [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-12-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190611</StartMarketingDatePackage>
<EndMarketingDatePackage>20251211</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For temporary relief of cough, rattling in chest, hoarseness, sore throat, skin irritation and vomiting upon environmental exposure. Remedy # 6 supports detoxification of insecticides, environmental and industrial pollutants.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55146-007-01</NDCCode>
<PackageDescription>120 mL in 1 BOTTLE, PLASTIC (55146-007-01) </PackageDescription>
<NDC11Code>55146-0007-01</NDC11Code>
<ProductNDC>55146-007</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>7 Heavy Metal Detox</ProprietaryName>
<NonProprietaryName>Allium Sativum, Aluminum Metallicum, Antimonium Crudum, Argentum Metallicum, Arsenicum Album, Aurum Metallicum, Baryta Carbonica, Beryllium Metallicum, Bismuthum Metallicum, Boron, Bromium, Cadmium Metallicum, Cerium Metallicum, Cesium Chloride, Chromium, Cobaltum Metallicum, Cuprum Metallicum, Dysprosium Metallicum, Erbium Metallicum, Europium Metallicum, Ferrum Metallicum, Gadolinium Metallicum, Germanium Sesquioxide, Holmium Metallicum, Indium Metallicum, Lithium Carbonicum, Magnesium Metallicum,</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190611</StartMarketingDate>
<EndMarketingDate>20250625</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Biotics Research Corporation</LabelerName>
<SubstanceName>ALUMINUM; ANTIMONY TRISULFIDE; APIS MELLIFERA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BARIUM CARBONATE; BERBERIS VULGARIS ROOT BARK; BERYLLIUM; BISMUTH; BORON; BROMINE; CADMIUM; CALCIUM SULFIDE; CAUSTICUM; CERIUM; CESIUM CHLORIDE; CHROMIUM; COBALT; CONIUM MACULATUM FLOWERING TOP; COPPER; DYSPROSIUM; ERBIUM; EUROPIUM OXIDE; GADOLINIUM; GARLIC; GERMANIUM SESQUIOXIDE; GOLD; HOLMIUM; HYPERICUM PERFORATUM; INDIUM; IPECAC; IRON; LANTHANUM; LEAD; LITHIUM CARBONATE; MAGNESIUM; MANGANESE; MERCURIUS SOLUBILIS; MOLYBDENUM; NEODYMIUM OXIDE; NICKEL; NIOBIUM; OSMIUM; PALLADIUM; PLATINUM; PRASEODYMIUM; RHODIUM; RUBIDIUM NITRITE; SAMARIUM; SELENIUM; SILVER; STRONTIUM CARBONATE; TANTALUM; TERBIUM; THALLIUM; TIN; URANYL NITRATE HEXAHYDRATE; VANADIUM; VERATRUM ALBUM ROOT; YTTERBIUM OXIDE; ZINC</SubstanceName>
<StrengthNumber>12; 12; 30; 12; 30; 12; 30; 12; 12; 12; 12; 12; 30; 30; 12; 12; 12; 12; 30; 12; 12; 12; 12; 12; 4; 12; 12; 12; 30; 12; 30; 12; 14; 12; 12; 12; 12; 12; 12; 12; 12; 30; 12; 12; 12; 12; 12; 12; 12; 12; 12; 12; 30; 12; 12; 12; 12; 12; 30; 12; 12</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/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_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/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_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_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Bee Venoms [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], 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 Histamine Release [PE], Increased Histamine Release [PE], 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], Plant Proteins [CS], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Standardized Chemical Allergen [EPC], Standardized Insect Venom Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190611</StartMarketingDatePackage>
<EndMarketingDatePackage>20250625</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temporary relief of neurological disorders, vomiting, prostration and metallic aftertaste. Remedy #7 supports detoxification of environmental pollutants.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55146-008-01</NDCCode>
<PackageDescription>120 mL in 1 BOTTLE, PLASTIC (55146-008-01) </PackageDescription>
<NDC11Code>55146-0008-01</NDC11Code>
<ProductNDC>55146-008</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>8 Fungal Yeast Infection</ProprietaryName>
<NonProprietaryName>Astragalus Membranaceus, Berberis Vulgaris, Echinacea (angustifolia), Gentiana Lutea, Phytolacca Decandra, Hydrastis Canadensis, Candida Albicans, Apis Mellifica, Calcarea Carbonica, Lycopodium Clavatum, Mercurius Solubilis, Pulsatilla (vulgaris) Sepia, Thuja Occidentalis</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190611</StartMarketingDate>
<EndMarketingDate>20230413</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Biotics Research Corporation</LabelerName>
<SubstanceName>APIS MELLIFERA; ASTRAGALUS PROPINQUUS ROOT; BERBERIS VULGARIS ROOT BARK; CANDIDA ALBICANS; ECHINACEA ANGUSTIFOLIA; GENTIANA LUTEA ROOT; GOLDENSEAL; LYCOPODIUM CLAVATUM SPORE; MERCURIUS SOLUBILIS; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PHYTOLACCA AMERICANA ROOT; PULSATILLA VULGARIS; SEPIA OFFICINALIS JUICE; THUJA OCCIDENTALIS LEAF</SubstanceName>
<StrengthNumber>30; 3; 3; 12; 3; 3; 5; 30; 30; 30; 4; 30; 30; 30</StrengthNumber>
<StrengthUnit>[hp_C]/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_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC], Standardized Insect Venom Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2023-04-14</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190611</StartMarketingDatePackage>
<EndMarketingDatePackage>20230413</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>55146-009-01</NDCCode>
<PackageDescription>120 mL in 1 BOTTLE, PLASTIC (55146-009-01) </PackageDescription>
<NDC11Code>55146-0009-01</NDC11Code>
<ProductNDC>55146-009</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>9 Bacterial Detox</ProprietaryName>
<NonProprietaryName>Baptisia Tinctoria, Dulcamara, Echinacea (angustifolia), Allium Sativum, Phytolacca Decandra, Apis Mellifica, Arsenicum Album, Belladonna, Chamomilla, Ferrum Phosphoricum, Gelsemium Sempervirens, Lachesis Mutus, Mercurius Solubilis, Pyrogenium</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190611</StartMarketingDate>
<EndMarketingDate>20250625</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Biotics Research Corporation</LabelerName>
<SubstanceName>APIS MELLIFERA; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BAPTISIA TINCTORIA ROOT; ECHINACEA ANGUSTIFOLIA WHOLE; FERROSOFERRIC PHOSPHATE; GARLIC; GELSEMIUM SEMPERVIRENS ROOT; LACHESIS MUTA VENOM; MATRICARIA CHAMOMILLA WHOLE; MERCURIUS SOLUBILIS; PHYTOLACCA AMERICANA ROOT; RANCID BEEF; SOLANUM DULCAMARA TOP</SubstanceName>
<StrengthNumber>30; 30; 30; 3; 3; 30; 4; 30; 30; 30; 30; 4; 30; 3</StrengthNumber>
<StrengthUnit>[hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL</StrengthUnit>
<Pharm_Classes>Allergens [CS], Allergens [CS], Bee Venoms [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], Plant Proteins [CS], Standardized Insect Venom Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190611</StartMarketingDatePackage>
<EndMarketingDatePackage>20250625</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For temporary relief of fever, sore throat and acute irritation of the bladder. Remedy #9 supports detoxification of toxins that remain after a bacterial infection.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>55146-010-01</NDCCode>
<PackageDescription>120 mL in 1 BOTTLE, PLASTIC (55146-010-01) </PackageDescription>
<NDC11Code>55146-0010-01</NDC11Code>
<ProductNDC>55146-010</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>10 Parasite Detox</ProprietaryName>
<NonProprietaryName>Carduus Marianus, Chelidonium Majus, Cina, Sabadilla, Teucrium Marum, Terebinthina, Thyroidinum (suis), Spigelia Anthelmia, Apis Mellifica, Baryta Carbonica, Calcarea Carbonica, Ferrum Muriaticum, Natrum Muriaticum, Silicea, Sulphur</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20190611</StartMarketingDate>
<EndMarketingDate>20250625</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>Biotics Research Corporation</LabelerName>
<SubstanceName>APIS MELLIFERA; ARTEMISIA CINA PRE-FLOWERING TOP; BARIUM CARBONATE; CHELIDONIUM MAJUS WHOLE; FERRIC CHLORIDE HEXAHYDRATE; MILK THISTLE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SCHOENOCAULON OFFICINALE SEED; SILICON DIOXIDE; SODIUM CHLORIDE; SPIGELIA ANTHELMIA WHOLE; SULFUR; TEUCRIUM MARUM WHOLE; THYROID; TURPENTINE OIL</SubstanceName>
<StrengthNumber>30; 3; 30; 3; 30; 3; 30; 3; 30; 30; 6; 30; 3; 6; 5</StrengthNumber>
<StrengthUnit>[hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/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], Iron [CS], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Standardized Insect Venom Allergenic Extract [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-06-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20190611</StartMarketingDatePackage>
<EndMarketingDatePackage>20250625</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For temporary relief of fever, joint pain, cough, stiffness and gastric upset. Remedy #10 supports detoxification of toxins that remain following a parasitic infection.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>10006-011-01</NDCCode>
<PackageDescription>6032 L in 1 CYLINDER (10006-011-01)</PackageDescription>
<NDC11Code>10006-0011-01</NDC11Code>
<ProductNDC>10006-011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Heliox</ProprietaryName>
<NonProprietaryName>Heliox</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19360101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED MEDICAL GAS</MarketingCategoryName>
<LabelerName>Acetylene Oxygen Company</LabelerName>
<SubstanceName>OXYGEN</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>L/100L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>10348-011-01</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (10348-011-01) > 3.5 mL in 1 TUBE</PackageDescription>
<NDC11Code>10348-0011-01</NDC11Code>
<ProductNDC>10348-011</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Camera Ready Bb Eyes Bs Spf 15</ProprietaryName>
<NonProprietaryName>Octinoxate, Titanium Dioxide, And Zinc Oxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20130920</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>SMASHBOX BEAUTY COSMETICS, INC</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>.04592; .01568; .0168</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-11-19</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20130920</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>10678-011-01</NDCCode>
<PackageDescription>3539 L in 1 CYLINDER (10678-011-01)</PackageDescription>
<NDC11Code>10678-0011-01</NDC11Code>
<ProductNDC>10678-011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Helium Oxygen Mix 80/20</ProprietaryName>
<NonProprietaryName>Helium Oxygen Mix 80/20</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>19470523</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED MEDICAL GAS</MarketingCategoryName>
<LabelerName>Airgas-West, Inc.</LabelerName>
<SubstanceName>HELIUM; OXYGEN</SubstanceName>
<StrengthNumber>800; 200</StrengthNumber>
<StrengthUnit>mL/L; mL/L</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>10702-011-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (10702-011-01) </PackageDescription>
<NDC11Code>10702-0011-01</NDC11Code>
<ProductNDC>10702-011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Hydroxyzine Hydrochloride</ProprietaryName>
<NonProprietaryName>Hydroxyzine Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20120724</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040786</ApplicationNumber>
<LabelerName>KVK-Tech, Inc.</LabelerName>
<SubstanceName>HYDROXYZINE DIHYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Antihistamine [EPC], Histamine Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2023-01-26</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20120724</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For symptomatic relief of anxiety and tension associated with psychoneurosis and as an adjunct in organic disease states in which anxiety is manifested. Useful in the management of pruritus due to allergic conditions such as chronic urticaria and atopic and contact dermatoses and in histamine-mediated pruritus. As a sedative when used as a premedication and following general anesthesia, hydroxyzine may potentiate meperidine and barbiturates, so their use in pre-anesthetic adjunctive therapy should be modified on an individual basis. Atropine and other belladonna alkaloids are not affected by the drug. Hydroxyzine is not known to interfere with the action of digitalis in any way and it may be used concurrently with this agent. The effectiveness of hydroxyzine as an antianxiety agent for long term use, that is more than 4 months, has not been assessed by systematic clinical studies. The physician should reassess periodically the usefulness of the drug for the individual patient.</IndicationAndUsage>
<Description>Hydroxyzine hydrochloride has the chemical name of 2-[2-[4-( p-Chloro- α-phenylbenzyl)-1-piperazinyl] ethoxy] ethanol dihydrochloride. Hydroxyzine hydrochloride occurs as a white, odorless powder which is very soluble in water. Each tablet for oral administration contains 10 mg, 25 mg or 50 mg hydroxyzine hydrochloride. Inactive ingredients include colloidal silicon dioxide, crospovidone, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol/macrogol and titanium dioxide. This product complies with USP dissolution test 2.</Description>
</NDC>
<NDC>
<NDCCode>10736-011-01</NDCCode>
<PackageDescription>5974.9 L in 1 CYLINDER (10736-011-01)</PackageDescription>
<NDC11Code>10736-0011-01</NDC11Code>
<ProductNDC>10736-011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Compressed Gas N.o.s.</ProprietaryName>
<NonProprietaryName>Oxygen, Nitrogen, Carbon Dioxide</NonProprietaryName>
<DosageFormName>GAS</DosageFormName>
<RouteName>RESPIRATORY (INHALATION)</RouteName>
<StartMarketingDate>20120529</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED MEDICAL GAS</MarketingCategoryName>
<LabelerName>Medical-Technical Gases, Inc.</LabelerName>
<SubstanceName>OXYGEN; NITROGEN; CARBON DIOXIDE</SubstanceName>
<StrengthNumber>19.95; 75.05; 5</StrengthNumber>
<StrengthUnit>mL/L; mL/L; mL/L</StrengthUnit>
<Pharm_Classes>Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>10812-011-01</NDCCode>
<PackageDescription>1 TUBE in 1 BLISTER PACK (10812-011-01) > 4.2 g in 1 TUBE</PackageDescription>
<NDC11Code>10812-0011-01</NDC11Code>
<ProductNDC>10812-011</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Neutrogena Revitalizing Lip Balm</ProprietaryName>
<ProprietaryNameSuffix>Spf 20 - Healthy Blush 20</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Oxybenzone</NonProprietaryName>
<DosageFormName>LIPSTICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20101201</StartMarketingDate>
<EndMarketingDate>20181201</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Johnson & Johnson Consumer Inc.</LabelerName>
<SubstanceName>OCTINOXATE; OXYBENZONE</SubstanceName>
<StrengthNumber>75; 50</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-12-04</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
</NDC>
<NDC>
<NDCCode>10858-011-05</NDCCode>
<PackageDescription>5 VIAL in 1 CARTON (10858-011-05) > 2 mL in 1 VIAL (10858-011-01) </PackageDescription>
<NDC11Code>10858-0011-05</NDC11Code>
<ProductNDC>10858-011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Benztropine Mesylate</ProprietaryName>
<NonProprietaryName>Benztropine Mesylate</NonProprietaryName>
<DosageFormName>INJECTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20201126</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA091525</ApplicationNumber>
<LabelerName>Wintac Limited</LabelerName>
<SubstanceName>BENZTROPINE MESYLATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Anticholinergic [EPC],Antihistamine [EPC],Cholinergic Antagonists [MoA],Histamine Receptor Antagonists [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2022-01-04</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20201126</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>11086-011-01</NDCCode>
<PackageDescription>118 mL in 1 BOTTLE (11086-011-01) </PackageDescription>
<NDC11Code>11086-0011-01</NDC11Code>
<ProductNDC>11086-011</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tarsum Professional</ProprietaryName>
<NonProprietaryName>Coal Tar</NonProprietaryName>
<DosageFormName>SHAMPOO</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20131030</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M032</ApplicationNumber>
<LabelerName>Summers Laboratories Inc</LabelerName>
<SubstanceName>COAL TAR</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2025-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20131030</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>USE: 1 CONTROLS ITCHING, FLAKING AND REDNESS DUE TO PSORIASIS, SEBORRHEIC DERMATITIS AND DANDRUFF.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>11086-011-11</NDCCode>
<PackageDescription>1 BOTTLE in 1 BOX (11086-011-11) > 118 mL in 1 BOTTLE (11086-011-01)</PackageDescription>
<NDC11Code>11086-0011-11</NDC11Code>
<ProductNDC>11086-011</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Tarsum Professional</ProprietaryName>
<NonProprietaryName>Coal Tar</NonProprietaryName>
<DosageFormName>SHAMPOO</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20131030</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part358H</ApplicationNumber>
<LabelerName>Summers Laboratories Inc</LabelerName>
<SubstanceName>COAL TAR</SubstanceName>
<StrengthNumber>2</StrengthNumber>
<StrengthUnit>g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2018-11-22</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>11559-011-01</NDCCode>
<PackageDescription>1 JAR in 1 CARTON (11559-011-01) > 50 mL in 1 JAR (11559-011-02)</PackageDescription>
<NDC11Code>11559-0011-01</NDC11Code>
<ProductNDC>11559-011</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Resilience Lift</ProprietaryName>
<ProprietaryNameSuffix>Firming Sculpting Face And Neck Creme Spf 15 Nml Combo</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate, Octisalate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110201</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>ESTEE LAUDER INC</LabelerName>
<SubstanceName>OCTINOXATE; OCTISALATE</SubstanceName>
<StrengthNumber>7.5; 3.5</StrengthNumber>
<StrengthUnit>mL/100mL; mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>11788-011-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (11788-011-01) </PackageDescription>
<NDC11Code>11788-0011-01</NDC11Code>
<ProductNDC>11788-011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Methimazole</ProprietaryName>
<NonProprietaryName>Methimazole</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20260401</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA040547</ApplicationNumber>
<LabelerName>AiPing Pharmaceutical, Inc.</LabelerName>
<SubstanceName>METHIMAZOLE</SubstanceName>
<StrengthNumber>5</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Thyroid Hormone Synthesis Inhibitor [EPC], Thyroid Hormone Synthesis Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-08-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20260401</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Methimazole tablets are indicated: 1 In patients with Graves’ disease with hyperthyroidism or toxic multinodular goiter for whom surgery or radioactive iodine therapy is not an appropriate treatment option., 2 To ameliorate symptoms of hyperthyroidism in preparation for thyroidectomy or radioactive iodine therapy.</IndicationAndUsage>
<Description>Methimazole, USP (1-methylimidazole-2-thiol) is a white, crystalline substance that is freely soluble in water. It differs chemically from the drugs of the thiouracil series primarily because it has a 5- instead of a 6-membered ring. Methimazole tablet, USP contains 5 or 10 mg methimazole, an orally administered antithyroid drug. Each tablet also contains lactose monohydrate, magnesium stearate, potato starch and talc. The molecular weight is 114.17, and the molecular formula is C4H6N2S. The structural formula is as follows.</Description>
</NDC>
<NDC>
<NDCCode>11994-011-01</NDCCode>
<PackageDescription>1 VIAL, GLASS in 1 CARTON (11994-011-01) / 1.5 mL in 1 VIAL, GLASS</PackageDescription>
<NDC11Code>11994-0011-01</NDC11Code>
<ProductNDC>11994-011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Definity</ProprietaryName>
<NonProprietaryName>Perflutren</NonProprietaryName>
<DosageFormName>INJECTION, SUSPENSION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20010731</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021064</ApplicationNumber>
<LabelerName>Lantheus Medical Imaging, Inc.</LabelerName>
<SubstanceName>PERFLUTREN</SubstanceName>
<StrengthNumber>6.52</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Contrast Agent for Ultrasound Imaging [EPC], Ultrasound Contrast Activity [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-03-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20010731</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>DEFINITY is indicated, after activation, for use in adult and pediatric patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.</IndicationAndUsage>
<Description>DEFINITY (perflutren lipid microsphere) injectable suspension is, after activation an ultrasound contrast agent for intravenous use. The perflutren lipid microspheres are composed of perflutren encapsulated in an outer lipid shell consisting of (R) – hexadecanoic acid, 1-[(phosphonoxy)methyl]-1,2-ethanediyl ester, monosodium salt (abbreviated DPPA); (R) - 4-hydroxy-N,N,N-trimethyl-10-oxo-7-[(1-oxohexadecyl)oxy]-3,4,9-trioxa-4-phosphapentacosan-1-aminium, 4-oxide, inner salt (abbreviated DPPC); and (R)-∝-[6-hydroxy-6-oxido-9-[(1-oxohexadecyl)oxy]-5,7,11-trioxa-2-aza-6-phosphahexacos-1-yl]- ω-methoxypoly(ox-1,2-ethanediyl), monosodium salt; commonly called N-(methoxypolyethylene glycol 5000 carbamoyl)-1,2-dipalmitoyl-sn-glycero-3- phosphatidylethanolamine, monosodium salt (abbreviated MPEG5000 DPPE). Perflutren is chemically characterized as 1,1,1,2,2,3,3,3-octafluoropropane. It has a molecular weight of 188, empirical formula of C3F8 and has the following structural formula. DPPA has a molecular weight of 670, empirical formula of C35H68O8PNa, and following structural formula. DPPC has a molecular weight of 734, empirical formula of C40H80NO8P, and following structural formula. MPEG5000 DPPE has an approximate molecular weight of 5750 represented by empirical formula C265H527NO123PNa, contains <100ppm Ca2+ and Mg2+ and the following structural formula. Prior to activation, perflutren is in the headspace of the vial with a concentration of 6.52 mg/mL which is confirmed by positive IR spectroscopic testing in every vial. The lipid blend is in the clear, colorless, hypertonic, sterile liquid. Each mL of the liquid contains 0.75 mg lipid blend (consisting of 0.045 mg DPPA, 0.401 mg DPPC, and 0.304 mg MPEG5000 DPPE) and the following inactive ingredients: 103.5 mg propylene glycol, 126.2 mg glycerin, 2.34 mg sodium phosphate monobasic monohydrate, 2.16 mg sodium phosphate dibasic heptahydrate, and 4.87 mg sodium chloride in water for injection. The pH is 6.2 to 6.8. DEFINITY does not contain bacterial preservative. After activation with the aid of the VIALMIX or VIALMIX RFID, each mL of the activated DEFINITY as homogenous milky white suspension contains a maximum of 1.2 × 1010 perflutren lipid microspheres, and about 150 microL/mL (1.1 mg/mL) perflutren. The microsphere particle size parameters are listed in Table 2 below.</Description>
</NDC>
<NDC>
<NDCCode>13107-011-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (13107-011-01)</PackageDescription>
<NDC11Code>13107-0011-01</NDC11Code>
<ProductNDC>13107-011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sertraline Hydrochloride</ProprietaryName>
<NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName>
<DosageFormName>TABLET</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110315</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA077206</ApplicationNumber>
<LabelerName>Aurolife Pharma LLC</LabelerName>
<SubstanceName>SERTRALINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>25</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Major Depressive Disorder. Sertraline hydrochloride tablets are indicated for the treatment of major depressive disorder in adults. The efficacy of sertraline hydrochloride tablets in the treatment of a major depressive episode was established in six to eight week controlled trials of adult outpatients whose diagnoses corresponded most closely to the DSM-III category of major depressive disorder (see Clinical Trials under CLINICAL PHARMACOLOGY). A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks); it should include at least 4 of the following 8 symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and a suicide attempt or suicidal ideation. The antidepressant action of sertraline hydrochloride tablets in hospitalized depressed patients has not been adequately studied. The efficacy of sertraline hydrochloride tablets in maintaining an antidepressant response for up to 44 weeks following 8 weeks of open-label acute treatment (52 weeks total) was demonstrated in a placebo-controlled trial. The usefulness of the drug in patients receiving sertraline hydrochloride tablets for extended periods should be reevaluated periodically (see Clinical Trials under CLINICAL PHARMACOLOGY). Obsessive-Compulsive Disorder. Sertraline hydrochloride tablets are indicated for the treatment of obsessions and compulsions in patients with obsessive-compulsive disorder (OCD), as defined in the DSM-III-R; i.e., the obsessions or compulsions cause marked distress, are time-consuming, or significantly interfere with social or occupational functioning. The efficacy of sertraline hydrochloride tablets were established in 12-week trials with obsessive-compulsive outpatients having diagnoses of obsessive-compulsive disorder as defined according to DSM-III or DSM-III-R criteria (see Clinical Trials under CLINICAL PHARMACOLOGY). Obsessive-compulsive disorder is characterized by recurrent and persistent ideas, thoughts, impulses, or images (obsessions) that are ego-dystonic and/or repetitive, purposeful, and intentional behaviors (compulsions) that are recognized by the person as excessive or unreasonable. The efficacy of sertraline hydrochloride tablets in maintaining a response, in patients with OCD who responded during a 52-week treatment phase while taking sertraline hydrochloride tablets and were then observed for relapse during a period of up to 28 weeks, was demonstrated in a placebo-controlled trial (see Clinical Trials under CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use sertraline hydrochloride tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Panic Disorder. Sertraline hydrochloride tablets are indicated for the treatment of panic disorder in adults, with or without agoraphobia, as defined in DSM-IV. Panic disorder is characterized by the occurrence of unexpected panic attacks and associated concern about having additional attacks, worry about the implications or consequences of the attacks, and/or a significant change in behavior related to the attacks. The efficacy of sertraline hydrochloride tablets were established in three 10 to 12 week trials in adult panic disorder patients whose diagnoses corresponded to the DSM-III-R category of panic disorder (see Clinical Trials under CLINICAL PHARMACOLOGY). Panic disorder (DSM-IV) is characterized by recurrent unexpected panic attacks, i.e., a discrete period of intense fear or discomfort in which four (or more) of the following symptoms develop abruptly and reach a peak within 10 minutes: (1) palpitations, pounding heart, or accelerated heart rate; (2) sweating; (3) trembling or shaking; (4) sensations of shortness of breath or smothering; (5) feeling of choking; (6) chest pain or discomfort; (7) nausea or abdominal distress; (8) feeling dizzy, unsteady, lightheaded, or faint; (9) derealization (feelings of unreality) or depersonalization (being detached from oneself); (10) fear of losing control; (11) fear of dying; (12) paresthesias (numbness or tingling sensations); (13) chills or hot flushes. The efficacy of sertraline hydrochloride tablets in maintaining a response, in adult patients with panic disorder who responded during a 52-week treatment phase while taking sertraline hydrochloride tablets and were then observed for relapse during a period of up to 28 weeks, was demonstrated in a placebo-controlled trial (see Clinical Trials under CLINICAL PHARMACOLOGY). Nevertheless, the physician who elects to use sertraline hydrochloride tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Posttraumatic Stress Disorder (PTSD). Sertraline hydrochloride tablets are indicated for the treatment of posttraumatic stress disorder in adults. The efficacy of sertraline hydrochloride tablets in the treatment of PTSD was established in two 12-week placebo-controlled trials of adult outpatients whose diagnosis met criteria for the DSM-III-R category of PTSD (see Clinical Trials under CLINICAL PHARMACOLOGY). PTSD, as defined by DSM-III-R/IV, requires exposure to a traumatic event that involved actual or threatened death or serious injury, or threat to the physical integrity of self or others, and a response which involves intense fear, helplessness, or horror. Symptoms that occur as a result of exposure to the traumatic event include reexperiencing of the event in the form of intrusive thoughts, flashbacks or dreams, and intense psychological distress and physiological reactivity on exposure to cues to the event; avoidance of situations reminiscent of the traumatic event, inability to recall details of the event, and/or numbing of general responsiveness manifested as diminished interest in significant activities, estrangement from others, restricted range of affect, or sense of foreshortened future; and symptoms of autonomic arousal including hypervigilance, exaggerated startle response, sleep disturbance, impaired concentration, and irritability or outbursts of anger. A PTSD diagnosis requires that the symptoms are present for at least a month and that they cause clinically significant distress or impairment in social, occupational, or other important areas of functioning. The efficacy of sertraline hydrochloride tablets in maintaining a response in adult patients with PTSD for up to 28 weeks following 24 weeks of open-label treatment was demonstrated in a placebo-controlled trial. Nevertheless, the physician who elects to use sertraline hydrochloride tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Premenstrual Dysphoric Disorder (PMDD). Sertraline hydrochloride tablets are indicated for the treatment of premenstrual dysphoric disorder (PMDD) in adults. The efficacy of sertraline hydrochloride tablets in the treatment of PMDD was established in 2 placebo-controlled trials of female adult outpatients treated for 3 menstrual cycles who met criteria for the DSM-III-R/IV category of PMDD (see Clinical Trials under CLINICAL PHARMACOLOGY). The essential features of PMDD include markedly depressed mood, anxiety or tension, affective lability, and persistent anger or irritability. Other features include decreased interest in activities, difficulty concentrating, lack of energy, change in appetite or sleep, and feeling out of control. Physical symptoms associated with PMDD include breast tenderness, headache, joint and muscle pain, bloating and weight gain. These symptoms occur regularly during the luteal phase and remit within a few days following onset of menses; the disturbance markedly interferes with work or school or with usual social activities and relationships with others. In making the diagnosis, care should be taken to rule out other cyclical mood disorders that may be exacerbated by treatment with an antidepressant. The effectiveness of sertraline hydrochloride tablets in long-term use, that is, for more than 3 menstrual cycles, has not been systematically evaluated in controlled trials. Therefore, the physician who elects to use sertraline hydrochloride tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION). Social Anxiety Disorder. Sertraline hydrochloride tablets are indicated for the treatment of social anxiety disorder, also known as social phobia in adults. The efficacy of sertraline hydrochloride tablets in the treatment of social anxiety disorder was established in two placebo-controlled trials of adult outpatients with a diagnosis of social anxiety disorder as defined by DSM-IV criteria (see Clinical Trials under CLINICAL PHARMACOLOGY). Social anxiety disorder, as defined by DSM-IV, is characterized by marked and persistent fear of social or performance situations involving exposure to unfamiliar people or possible scrutiny by others and by fears of acting in a humiliating or embarrassing way. Exposure to the feared social situation almost always provokes anxiety and feared social or performance situations are avoided or else are endured with intense anxiety or distress. In addition, patients recognize that the fear is excessive or unreasonable and the avoidance and anticipatory anxiety of the feared situation is associated with functional impairment or marked distress. The efficacy of sertraline hydrochloride tablets in maintaining a response in adult patients with social anxiety disorder for up to 24 weeks following 20 weeks of sertraline hydrochloride tablets treatment was demonstrated in a placebo-controlled trial. Physicians who prescribe sertraline hydrochloride tablets for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient (see Clinical Trials under CLINICAL PHARMACOLOGY).</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>13668-011-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (13668-011-01) </PackageDescription>
<NDC11Code>13668-0011-01</NDC11Code>
<ProductNDC>13668-011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Citalopram</ProprietaryName>
<NonProprietaryName>Citalopram</NonProprietaryName>
<DosageFormName>TABLET, FILM COATED</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20071018</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA078216</ApplicationNumber>
<LabelerName>Torrent Pharmaceuticals Limited</LabelerName>
<SubstanceName>CITALOPRAM HYDROBROMIDE</SubstanceName>
<StrengthNumber>40</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-02-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20271231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20071018</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Citalopram tablets are indicated for the treatment of major depressive disorder (MDD) in adults [see Clinical Studies (14)] .</IndicationAndUsage>
<Description>Citalopram tablets, USP contain citalopram, a selective serotonin reuptake inhibitor (SSRI). Citalopram hydrobromide is a racemic bicyclic phthalane structure and is designated (±)-1-(3-dimethylaminopropyl)-1-(4-fluorophenyl)-1,3dihydroisobenzofuran-5-carbonitrile hydrobromide with the following structural formula. The molecular formula is C 20H 22BrFN 2O and its molecular weight is 405.35. Citalopram hydrobromide, USP occurs as a fine, white to off-white powder. Citalopram hydrobromide is sparingly soluble in water and soluble in ethanol. Citalopram, USP 10 mg tablets are film-coated, round shaped tablets containing citalopram hydrobromide in strengths equivalent to 10 mg citalopram base. Citalopram hydrobromide, USP 20 mg and 40 mg tablets are film-coated, oval shaped, scored tablets containing citalopram hydrobromide, in strengths equivalent to 20 mg or 40 mg citalopram base. The tablets also contain the following inactive ingredients: copovidone, corn starch, croscarmellose sodium, ferric oxide red, ferric oxide yellow, glycerin, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>13733-011-01</NDCCode>
<PackageDescription>50 mL in 1 CARTON (13733-011-01)</PackageDescription>
<NDC11Code>13733-0011-01</NDC11Code>
<ProductNDC>13733-011</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Misa Cho Bo Yang Bb</ProprietaryName>
<ProprietaryNameSuffix>Spf30 Pa Plus Plus No.1 Natural Beige</ProprietaryNameSuffix>
<NonProprietaryName>Titanium Dioxide</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>CUTANEOUS</RouteName>
<StartMarketingDate>20110601</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>ABLE C&C CO., LTD.</LabelerName>
<SubstanceName>TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>5.2; .7</StrengthNumber>
<StrengthUnit>mL/50mL; mL/50mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>INDICATION AND USAGE:After basic skin care, apply an appropriate amount along the skin texture and finish with powder.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>13913-011-19</NDCCode>
<PackageDescription>9 PACKET in 1 CARTON (13913-011-19) > 1 POWDER, FOR SOLUTION in 1 PACKET (13913-011-01) </PackageDescription>
<NDC11Code>13913-0011-19</NDC11Code>
<ProductNDC>13913-011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cambia</ProprietaryName>
<NonProprietaryName>Diclofenac Potassium</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100420</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022165</ApplicationNumber>
<LabelerName>Assertio Therapeutics, Inc.</LabelerName>
<SubstanceName>DICLOFENAC POTASSIUM</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-12-06</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20100420</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CAMBIA is a non-steroidal anti-inflammatory (NSAID) drug indicated for the acute treatment of migraine attacks with or without aura in adults 18 years of age or older (1.1). Important Limitations (1.2): 1 CAMBIA is not indicated for the prophylactic therapy of migraine, 2 Safety and effectiveness of CAMBIA not established for cluster headache, which is present in an older, predominantly male population.</IndicationAndUsage>
<Description>CAMBIA (Diclofenac Potassium for Oral Solution) is a benzeneacetic acid derivative NSAID. CAMBIA is available as a buffered soluble powder, designed to be mixed with water prior to oral administration. CAMBIA is a white to off-white, buffered, flavored powder for oral solution packaged in individual unit dose packets [see How Supplied/Storage and Handling (16)]. The chemical name for diclofenac potassium is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid monopotassium salt. The molecular weight of diclofenac potassium is 334.25. Its molecular formula is C14H10Cl2NKO2, and it has the following structural formula. The inactive ingredients in CAMBIA include: aspartame (equivalent to 25 mg phenylalanine), flavoring agents (anise and mint), glycerol behenate, mannitol, potassium bicarbonate, and saccharin sodium.</Description>
</NDC>
<NDC>
<NDCCode>14141-011-01</NDCCode>
<PackageDescription>1 CASE in 1 BOX (14141-011-01) > 9 g in 1 CASE</PackageDescription>
<NDC11Code>14141-0011-01</NDC11Code>
<ProductNDC>14141-011</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lbel Clarite Makeup Foundation For A Clearer Appearance Spf 30 270-c</ProprietaryName>
<NonProprietaryName>Octinoxate, Zinc Oxide</NonProprietaryName>
<DosageFormName>PASTE</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20220101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Bel Star S.A.</LabelerName>
<SubstanceName>OCTINOXATE; ZINC OXIDE</SubstanceName>
<StrengthNumber>75; 78.4</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2023-12-20</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20231231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20220101</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>14445-011-01</NDCCode>
<PackageDescription>5 kg in 1 DRUM (14445-011-01) </PackageDescription>
<NDC11Code>14445-0011-01</NDC11Code>
<ProductNDC>14445-011</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Febuxostat</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20160305</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Indoco Remedies Limited</LabelerName>
<SubstanceName>FEBUXOSTAT</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-03-12</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>05-MAR-16</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>14789-011-01</NDCCode>
<PackageDescription>10 VIAL, SINGLE-DOSE in 1 CARTON (14789-011-01) / 1 mL in 1 VIAL, SINGLE-DOSE</PackageDescription>
<NDC11Code>14789-0011-01</NDC11Code>
<ProductNDC>14789-011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Isoproterenol Hydrochloride</ProprietaryName>
<NonProprietaryName>Isoproterenol Hydrochloride</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAMUSCULAR; INTRAVENOUS</RouteName>
<StartMarketingDate>20170803</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA206961</ApplicationNumber>
<LabelerName>Nexus Pharmaceuticals LLC</LabelerName>
<SubstanceName>ISOPROTERENOL HYDROCHLORIDE</SubstanceName>
<StrengthNumber>.2</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Adrenergic beta-Agonists [MoA], beta-Adrenergic Agonist [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-09-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20170803</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Isoproterenol hydrochloride is indicated: 1 To improve hemodynamic status in patients in distributive shock and shock due to reduced cardiac output, 2 For bronchospasm occurring during anesthesia.</IndicationAndUsage>
<Description>Isoproterenol hydrochloride is 3,4-Dihydroxy-α-[(isopropylamino)methyl] benzyl alcohol hydrochloride, a beta-adrenergic agonist and a synthetic sympathomimetic amine that is structur ally related to epinephrine. The molecular formula is C 11H 17NO 3· HCl. It has a molecular weight of 247.72 and the following structural formula:. Isoproterenol hydrochloride is a racemic compound. The pH is adjusted between 3.5 and 4.5 with hydrochloric acid and/or sodium hydroxide. The sterile solution is nonpyrogenic and can be administered by the intravenous route.</Description>
</NDC>
</NDCList>