{
"NDC": [
{
"NDCCode": "63972-012-01",
"PackageDescription": "120 mL in 1 BOTTLE (63972-012-01) ",
"NDC11Code": "63972-0012-01",
"ProductNDC": "63972-012",
"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,",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20151109",
"EndMarketingDate": "20230131",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "21st Century Homeopathics",
"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": "2023-02-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20151109",
"EndMarketingDatePackage": "20230131",
"SamplePackage": "N"
},
{
"NDCCode": "63972-002-01",
"PackageDescription": "120 mL in 1 BOTTLE (63972-002-01)",
"NDC11Code": "63972-0002-01",
"ProductNDC": "63972-002",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Century 21 Lymphatic Drainage",
"NonProprietaryName": "Strychnos Nux-vomica Seed, Barium Chloride Dihydrate, Lachesis Muta Venom, Conium Maculatum Flowering Top, Goldenseal, Iodine, Silicon Dioxide, Phosphorus, Quinine Sulfate, Silybum Marianum Seed, Chelidonium Majus, Berberis Vulgaris Root Bark, Sonia Canadensis Root, Mercurius Solubilis, Ceanothus Americanus Leaf, Solidago Virgaurea Flowering Top, Bos Taurus Bile, Apis Mellifera",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19750101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "21st Century Homeopathics, Inc",
"SubstanceName": "STRYCHNOS NUX-VOMICA SEED; BARIUM CHLORIDE DIHYDRATE; LACHESIS MUTA VENOM; CONIUM MACULATUM FLOWERING TOP; GOLDENSEAL; IODINE; SILICON DIOXIDE; PHOSPHORUS; QUININE SULFATE; SILYBUM MARIANUM SEED; CHELIDONIUM MAJUS; BERBERIS VULGARIS ROOT BARK; COLLINSONIA CANADENSIS ROOT; MERCURIUS SOLUBILIS; CEANOTHUS AMERICANUS LEAF; SOLIDAGO VIRGAUREA FLOWERING TOP; BOS TAURUS BILE; APIS MELLIFERA",
"StrengthNumber": "30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 6; 30",
"StrengthUnit": "[hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Indications: 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": "63972-003-01",
"PackageDescription": "120 mL in 1 BOTTLE (63972-003-01)",
"NDC11Code": "63972-0003-01",
"ProductNDC": "63972-003",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Century 21 Acute Stress",
"NonProprietaryName": "Arnica Montana, Arsenic Trioxide, Bellis Perennis, Passiflora Incarnata Flowering Top, Valerian, Apis Mellifera, Human Breast Tumor Cell, Helianthemum Canadense, Clematis Recta Flowering Top, Arabica Coffee Bean, Strychnos Ignatii Seed, Lachesis Muta Venom, Magnesium Phosphate, Dibasic Trihydrate, Sodium Chloride, Sodium Sulfate, Ornithogalum Umbellatum, Phosphoric Acid, Salix Nigra Bark, Delphinium Staphisagria Seed",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19750101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "21st Century Homeopathics, Inc",
"SubstanceName": "ARNICA MONTANA; ARSENIC TRIOXIDE; BELLIS PERENNIS; PASSIFLORA INCARNATA FLOWERING TOP; VALERIAN; APIS MELLIFERA; HUMAN BREAST TUMOR CELL; HELIANTHEMUM CANADENSE; CLEMATIS RECTA FLOWERING TOP; ARABICA COFFEE BEAN; STRYCHNOS IGNATII SEED; LACHESIS MUTA VENOM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM CHLORIDE; SODIUM SULFATE; ORNITHOGALUM UMBELLATUM; PHOSPHORIC ACID; SALIX NIGRA BARK; DELPHINIUM STAPHISAGRIA SEED",
"StrengthNumber": "30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30",
"StrengthUnit": "[hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Indications: For temporary relief of acute stress due to emotional strain, anxiety, sleeplessness, apprehension or fear."
},
{
"NDCCode": "63972-004-01",
"PackageDescription": "120 mL in 1 BOTTLE (63972-004-01)",
"NDC11Code": "63972-0004-01",
"ProductNDC": "63972-004",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Century 21 Detox-virus",
"NonProprietaryName": "Araneus Diadematus, Rancid Beef, Phytolacca Americana Root, Echinacea Angustifolia, Astragalus Propinquus Root, Baptisia Tinctoria Root, Goldenseal, Lachesis Muta Venom, Gelsemium Sempervirens Root, Atropa Belladonna, Eupatorium Perfoliatum Flowering Top, Arsenic Trioxide, Silicon Dioxide, Thuja Occidentalis Leafy Twig, Bilberry, Apis Mellifera",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19750101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "21st Century Homeopathics, Inc",
"SubstanceName": "ARANEUS DIADEMATUS; RANCID BEEF; PHYTOLACCA AMERICANA ROOT; ECHINACEA ANGUSTIFOLIA; ASTRAGALUS PROPINQUUS ROOT; BAPTISIA TINCTORIA ROOT; GOLDENSEAL; LACHESIS MUTA VENOM; GELSEMIUM SEMPERVIRENS ROOT; ATROPA BELLADONNA; EUPATORIUM PERFOLIATUM FLOWERING TOP; ARSENIC TRIOXIDE; PHOSPHORIC ACID; SILICON DIOXIDE; THUJA OCCIDENTALIS LEAFY TWIG; BILBERRY; APIS MELLIFERA",
"StrengthNumber": "30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30",
"StrengthUnit": "[hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Indications: For relief of skin irritation, dry cough, eczema or fever. Remedy # 4 supports detoxification of residual toxins left from a viral infection."
},
{
"NDCCode": "63972-005-01",
"PackageDescription": "120 mL in 1 BOTTLE (63972-005-01) ",
"NDC11Code": "63972-0005-01",
"ProductNDC": "63972-005",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "5 Chronic Stress",
"NonProprietaryName": "Aralia Quinquefolia, Fucus Vesiculosus, Hydrastis Canadensis, Solidago Virgaurea, Taraxacum Officinale, Trifolium Pratense, Arsenicum Album, Calcarea Carbonica, Carbo Vegetabilis, Ceanothus Americanus, Cyclamen Europaeum, Hepar Sulphuris Calcareum, Natrum Muriaticum, Nux Vomica, Petroleum, Phosphorus",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19750101",
"EndMarketingDate": "20210715",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "21st Century Homeopathics, Inc",
"SubstanceName": "AMERICAN GINSENG; FUCUS VESICULOSUS; GOLDENSEAL; SOLIDAGO VIRGAUREA FLOWERING TOP; TARAXACUM OFFICINALE; TRIFOLIUM PRATENSE FLOWER; ARSENIC TRIOXIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; ACTIVATED CHARCOAL; CEANOTHUS AMERICANUS LEAF; CYCLAMEN PURPURASCENS TUBER; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; KEROSENE; PHOSPHORUS",
"StrengthNumber": "30; 3; 30; 3; 3; 3; 30; 30; 30; 30; 30; 30; 30; 30; 30",
"StrengthUnit": "[hp_C]/mL; [hp_X]/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_C]/mL; [hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2021-07-16",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19750101",
"EndMarketingDatePackage": "20210715",
"SamplePackage": "N"
},
{
"NDCCode": "63972-006-01",
"PackageDescription": "120 mL in 1 BOTTLE (63972-006-01)",
"NDC11Code": "63972-0006-01",
"ProductNDC": "63972-006",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "6 Environmental Detox",
"NonProprietaryName": "Acth, Calcarea Carbonica, Magnesia Sulphurica, Kali Phosphoricum, Nitricum Acidum, Benzoicum Acidum, Silicea, Arsenicum Album, Mercuris Solubilis, Phosphorus, Carbo Vegetabilis, Nux Vomica, Aluminum Metallicum, Phytolacca Decandra, Baptisia Tinctoria, Argentum Nitricum, Spigelia Anthelmia, Apis Mellifica",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19750101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "21st Century Homeopathics, Inc",
"SubstanceName": "BAPTISIA TINCTORIA ROOT; PHYTOLACCA AMERICANA ROOT; SPIGELIA ANTHELMIA; CORTICOTROPIN; ALUMINUM; APIS MELLIFERA; SILVER NITRATE; ARSENIC TRIOXIDE; BENZOIC ACID; OYSTER SHELL CALCIUM CARBONATE, CRUDE; ACTIVATED CHARCOAL; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM SULFATE HEPTAHYDRATE; MERCURIUS SOLUBILIS; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; SILICON DIOXIDE",
"StrengthNumber": "3; 3; 3; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30",
"StrengthUnit": "[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2020-01-01",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"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": "63972-007-01",
"PackageDescription": "120 mL in 1 BOTTLE (63972-007-01)",
"NDC11Code": "63972-0007-01",
"ProductNDC": "63972-007",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Century 21 Heavy Metal Detox",
"NonProprietaryName": "Garlic, Gold, Atropa Belladonna, Berberis Vulgaris Root Bark, Causticum, Conium Maculatum Flowering Top, Calcium Sulfide, Hypericum Perforatum, Ipecac, Aluminum, Silver, Arsenic, Barium Carbonate, Beryllium, Boron, Bromine, Cadmium, D And C Black No. 2, Cerium, Cesium, Chromium, Cobalt, Copper, Dysprosium, Erbium, Europium, Iron, Fluorine, Gadolinium, Gallium, Germanium, Holmium, Hydrogen, Indium, Iodine, Lanthanum, Lithium Carbonate, Manganese, Mercurius Solubilis, Molybdenum, Neodymium, Nickel",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19750101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "21st Century Homeopathics, Inc",
"SubstanceName": "GARLIC; GOLD; ATROPA BELLADONNA; BERBERIS VULGARIS ROOT BARK; CAUSTICUM; CONIUM MACULATUM FLOWERING TOP; CALCIUM SULFIDE; HYPERICUM PERFORATUM; IPECAC; ALUMINUM; SILVER; ARSENIC; BARIUM CARBONATE; BERYLLIUM; BORON; BROMINE; CADMIUM; D&C BLACK NO. 2; CERIUM; CESIUM; CHROMIUM; COBALT; COPPER; DYSPROSIUM; ERBIUM; EUROPIUM; IRON; FLUORINE; GADOLINIUM; GALLIUM; GERMANIUM; HOLMIUM; HYDROGEN; INDIUM; IODINE; LANTHANUM; LITHIUM CARBONATE; MANGANESE; MERCURIUS SOLUBILIS; MOLYBDENUM; NEODYMIUM; NICKEL; NIOBIUM; NITROUS OXIDE; OXYGEN; LEAD; PRASEODYMIUM; RUBIDIUM; SAMARIUM; SCANDIUM; SELENIUM; SILICON DIOXIDE; TIN; STRONTIUM CARBONATE; TANTALUM; TERBIUM; THULIUM; TITANIUM; VANADIUM; YTTERBIUM; ZINC; VERATRUM ALBUM ROOT; APIS MELLIFERA",
"StrengthNumber": "30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30",
"StrengthUnit": "[hp_C]/5mL; [hp_X]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_C]/5mL; [hp_C]/5mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Indications: Temporary relief of neurological disorders, vomiting, prostration and metallic aftertaste. Remedy #7 supports detoxification of environmental pollutants."
},
{
"NDCCode": "63972-008-01",
"PackageDescription": "120 mL in 1 BOTTLE (63972-008-01)",
"NDC11Code": "63972-0008-01",
"ProductNDC": "63972-008",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Century 21 Fungal Yeast Infection",
"NonProprietaryName": "Candida Albicans, Sepia Officinalis Juice, Echinacea, Unspecified, Lycopodium Clavatum Spore, Pulsatilla Vulgaris, Thuja Occidentalis Leafy Twig, Oyster Shell Calcium Carbonate, Crude, Astragalus Propinquus Root, Mercurius Solubilis, Goldenseal, Phytolacca Americana Root, Berberis Vulgaris Root Bark, Gentiana Lutea Root, Apis Mellifera",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19750101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "21st Century Homeopathics, Inc",
"SubstanceName": "CANDIDA ALBICANS; SEPIA OFFICINALIS JUICE; ECHINACEA, UNSPECIFIED; LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS; THUJA OCCIDENTALIS LEAFY TWIG; OYSTER SHELL CALCIUM CARBONATE, CRUDE; ASTRAGALUS PROPINQUUS ROOT; MERCURIUS SOLUBILIS; GOLDENSEAL; PHYTOLACCA AMERICANA ROOT; BERBERIS VULGARIS ROOT BARK; GENTIANA LUTEA ROOT; APIS MELLIFERA",
"StrengthNumber": "30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30",
"StrengthUnit": "[hp_X]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Indications: For temporary relief of flatulence, bloating and rhinitis. Remedy #8 supports detoxification due to mycotic infections."
},
{
"NDCCode": "63972-009-01",
"PackageDescription": "120 mL in 1 BOTTLE (63972-009-01)",
"NDC11Code": "63972-0009-01",
"ProductNDC": "63972-009",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Century 21 Bacterial Detox",
"NonProprietaryName": "Echinacea Angustifolia, Baptisia Tinctoria Root, Phytolacca Americana Root, Ferrosoferric Phosphate, Arsenic Trioxide, Atropa Belladonna, Matricaria Recutita, Mercurius Solubilis, Gelsemium Sempervirens Root, Lachesis Muta Venom, Solanum Dulcamara Top, Rancid Beef, Garlic, Apis Mellifera",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19750101",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "21st Century Homeopathics, Inc",
"SubstanceName": "ECHINACEA ANGUSTIFOLIA; BAPTISIA TINCTORIA ROOT; PHYTOLACCA AMERICANA ROOT; FERROSOFERRIC PHOSPHATE; ARSENIC TRIOXIDE; ATROPA BELLADONNA; MATRICARIA RECUTITA; MERCURIUS SOLUBILIS; GELSEMIUM SEMPERVIRENS ROOT; LACHESIS MUTA VENOM; SOLANUM DULCAMARA TOP; RANCID BEEF; GARLIC; APIS MELLIFERA",
"StrengthNumber": "30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30",
"StrengthUnit": "[hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Indications: For relief of fever, sore throat and acute irritation of the bladder. Remedy # 9 supports detoxification of toxins that remain after a bacterial infection."
},
{
"NDCCode": "63972-010-01",
"PackageDescription": "120 mL in 1 BOTTLE (63972-010-01) ",
"NDC11Code": "63972-0010-01",
"ProductNDC": "63972-010",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "10 Parasite Detox",
"NonProprietaryName": "Carduus Marianus, Chelidonium Majus, Cina, Sabadilla, Spigelia Anthelmia, Teucrium Marum, Terebinthina, Thyroidinum (suis), Apis Mellifica, Baryta Carbonica, Calcarea Carbonica, Ferrum Muriaticum, Natrum Muriaticum, Silicea, Sulphur",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "19750101",
"EndMarketingDate": "20211230",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "21st Century Homeopathics",
"SubstanceName": "BARIUM CARBONATE; SILYBUM MARIANUM SEED; CHELIDONIUM MAJUS; ARTEMISIA MARITIMA FLOWER; FERRIC CHLORIDE HEXAHYDRATE; SODIUM CHLORIDE; SCHOENOCAULON OFFICINALE SEED; SILICON DIOXIDE; SPIGELIA ANTHELMIA; SULFUR; THYROID, UNSPECIFIED; APIS MELLIFERA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TURPENTINE OIL; TEUCRIUM MARUM",
"StrengthNumber": "30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 6; 30; 30; 5; 30",
"StrengthUnit": "[hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL",
"Status": "Deprecated",
"LastUpdate": "2021-12-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "19750101",
"EndMarketingDatePackage": "20211230",
"SamplePackage": "N"
},
{
"NDCCode": "63972-011-01",
"PackageDescription": "120 mL in 1 BOTTLE (63972-011-01) ",
"NDC11Code": "63972-0011-01",
"ProductNDC": "63972-011",
"ProductTypeName": "HUMAN PRESCRIPTION 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": "20151106",
"EndMarketingDate": "20211229",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "21st Century Homeopathics",
"SubstanceName": "ARNICA MONTANA; BELLIS PERENNIS; PASSIFLORA INCARNATA FLOWERING TOP; VALERIAN; ARSENIC TRIOXIDE; APIS MELLIFERA; HUMAN BREAST TUMOR CELL; HELIANTHEMUM CANADENSE; CLEMATIS RECTA FLOWERING TOP; ARABICA COFFEE BEAN; STRYCHNOS IGNATII SEED; LACHESIS MUTA VENOM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM CHLORIDE; SODIUM SULFATE; ORNITHOGALUM UMBELLATUM; PHOSPHORIC ACID; SALIX NIGRA BARK; DELPHINIUM STAPHISAGRIA SEED",
"StrengthNumber": "3; 3; 3; 3; 6; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30",
"StrengthUnit": "[hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL",
"Pharm_Classes": "Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Bee Venoms [CS],Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Seed Storage Proteins [CS]",
"Status": "Deprecated",
"LastUpdate": "2021-12-30",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20151106",
"EndMarketingDatePackage": "20211229",
"SamplePackage": "N"
},
{
"NDCCode": "63972-013-01",
"PackageDescription": "120 mL in 1 BOTTLE (63972-013-01) ",
"NDC11Code": "63972-0013-01",
"ProductNDC": "63972-013",
"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": "20151109",
"EndMarketingDate": "20221129",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "21st Century Homeopathics",
"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 OXIDE; 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; SUS SCROFA THYROID; TANTALUM; TARTARIC ACID; TERBIUM; THALLIUM; THERIDION CURASSAVICUM; THUJA OCCIDENTALIS LEAFY TWIG; 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; 3; 12; 30; 12; 30; 12; 12; 12; 12; 12; 30; 12; 30; 30; 30; 30; 30; 30; 12; 12; 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_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_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], Gadolinium-based Contrast Agent [EPC], 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], Magnetic Resonance Contrast Activity [MoA], 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": "2022-11-29",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20151109",
"EndMarketingDatePackage": "20221129",
"SamplePackage": "N"
},
{
"NDCCode": "63972-014-01",
"PackageDescription": "120 mL in 1 BOTTLE (63972-014-01) ",
"NDC11Code": "63972-0014-01",
"ProductNDC": "63972-014",
"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": "20170113",
"EndMarketingDate": "20221023",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "21st Century Homeopathics, Inc",
"SubstanceName": "APIS MELLIFERA; BARIUM CHLORIDE DIHYDRATE; BERBERIS VULGARIS ROOT BARK; BOS TAURUS BILE; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; COLLINSONIA CANADENSIS ROOT; 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; 5; 30; 30; 30; 3; 30; 30; 30; 3; 30",
"StrengthUnit": "[hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_Q]/mL; [hp_C]/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; [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": "2022-10-25",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170113",
"EndMarketingDatePackage": "20221023",
"SamplePackage": "N"
},
{
"NDCCode": "63972-015-01",
"PackageDescription": "120 mL in 1 BOTTLE (63972-015-01) ",
"NDC11Code": "63972-0015-01",
"ProductNDC": "63972-015",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "8 Fungal Yeast Infection",
"NonProprietaryName": "Astragalus Membranaceus, Berberis Vulgaris, Echinacea (angustifolia), Gentiana Lutea, Hydrastis Canadensis, Phytolacca Decandra, Candida Albicans, Apis Mellifica, Calcarea Carbonica, Lycopodium Clavatum, Mercurius Solubilis, Pulsatilla (vulgaris) Sepia, Thuja Occidentalis",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20170116",
"EndMarketingDate": "20230413",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "21st Century Homeopathics, Inc",
"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; 3; 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": "20170116",
"EndMarketingDatePackage": "20230413",
"SamplePackage": "N"
},
{
"NDCCode": "63972-016-01",
"PackageDescription": "120 mL in 1 BOTTLE, PLASTIC (63972-016-01) ",
"NDC11Code": "63972-0016-01",
"ProductNDC": "63972-016",
"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": "20170929",
"EndMarketingDate": "20230409",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "21st Century Homeopathics",
"SubstanceName": "APIS MELLIFERA; ARANEUS DIADEMATUS; ARSENIC TRIOXIDE; ASTRAGALUS PROPINQUUS ROOT; ATROPA BELLADONNA WHOLE; BAPTISIA TINCTORIA; BILBERRY; ECHINACEA ANGUSTIFOLIA; 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; 3; 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": "2023-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20170929",
"EndMarketingDatePackage": "20230409",
"SamplePackage": "N"
},
{
"NDCCode": "63972-017-01",
"PackageDescription": "120 mL in 1 BOTTLE, DROPPER (63972-017-01) ",
"NDC11Code": "63972-0017-01",
"ProductNDC": "63972-017",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "10 Parasite Detox",
"NonProprietaryName": "Carduus Marianus, Chelidonium Majus, Cina, Sabadilla, Spigelia Anthelmia, Teucrium Marum, Terebinthina, Thyroidinum (suis), Spigelia Anthelmia, Apis Mellifica, Baryta Carbonica, Calcarea Carbonica, Ferrum Muriaticum, Natrum Muriaticum, Silicea, Sulphur",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20171229",
"EndMarketingDate": "20230410",
"MarketingCategoryName": "UNAPPROVED HOMEOPATHIC",
"LabelerName": "21st Century Homeopathics",
"SubstanceName": "APIS MELLIFERA; ARTEMISIA CINA PRE-FLOWERING TOP; BARIUM CARBONATE; CHELIDONIUM MAJUS; FERRIC CHLORIDE HEXAHYDRATE; MILK THISTLE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SCHOENOCAULON OFFICINALE SEED; SILICON DIOXIDE; SODIUM CHLORIDE; SPIGELIA ANTHELMIA; SULFUR; SUS SCROFA THYROID; TEUCRIUM MARUM; TURPENTINE OIL",
"StrengthNumber": "30; 3; 30; 3; 30; 3; 30; 3; 30; 30; 6; 30; 6; 3; 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": "2023-04-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20171229",
"EndMarketingDatePackage": "20230410",
"SamplePackage": "N"
},
{
"NDCCode": "10348-012-01",
"PackageDescription": "1 BOTTLE in 1 CARTON (10348-012-01) > 30 mL in 1 BOTTLE",
"NDC11Code": "10348-0012-01",
"ProductNDC": "10348-012",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Camera Ready Bb Water Broad Spectrum Spf 30",
"NonProprietaryName": "Octinoxate, Titanium Dioxide, And Zinc Oxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20150406",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "SMASHBOX BEAUTY COSMETICS, INC",
"SubstanceName": "OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE",
"StrengthNumber": ".056; .03472; .02352",
"StrengthUnit": "g/100mL; g/100mL; g/100mL",
"Status": "Deprecated",
"LastUpdate": "2020-11-18",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20201231",
"StartMarketingDatePackage": "20150406",
"SamplePackage": "N"
},
{
"NDCCode": "10572-012-01",
"PackageDescription": "2 BOTTLE, PLASTIC in 1 CARTON (10572-012-01) / 177.4 mL in 1 BOTTLE, PLASTIC",
"NDC11Code": "10572-0012-01",
"ProductNDC": "10572-012",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Sodium Sulfate, Potassium Sulfate And Magnesium Sulfate",
"NonProprietaryName": "Sodium Sulfate, Potassium Sulfate, Magnesium Sulfate",
"DosageFormName": "SOLUTION, CONCENTRATE",
"RouteName": "ORAL",
"StartMarketingDate": "20100805",
"EndMarketingDate": "20280331",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA022372",
"LabelerName": "Affordable Pharmaceuticals, LLC",
"SubstanceName": "SODIUM SULFATE; POTASSIUM SULFATE; MAGNESIUM SULFATE, UNSPECIFIED FORM",
"StrengthNumber": "17.5; 3.13; 1.6",
"StrengthUnit": "g/mL; g/mL; g/mL",
"Pharm_Classes": "Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]",
"Status": "Active",
"LastUpdate": "2026-10-10",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20100805",
"EndMarketingDatePackage": "20280331",
"SamplePackage": "N"
},
{
"NDCCode": "10702-012-01",
"PackageDescription": "100 TABLET, FILM COATED in 1 BOTTLE (10702-012-01) ",
"NDC11Code": "10702-0012-01",
"ProductNDC": "10702-012",
"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": "50",
"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": "10812-012-01",
"PackageDescription": "1 TUBE in 1 BLISTER PACK (10812-012-01) > 4.2 g in 1 TUBE",
"NDC11Code": "10812-0012-01",
"ProductNDC": "10812-012",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Neutrogena Revitalizing Lip Balm",
"ProprietaryNameSuffix": "Spf 20 - Sunny Berry 30",
"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": "11517-012-01",
"PackageDescription": "23 kg in 1 DRUM (11517-012-01) ",
"NDC11Code": "11517-0012-01",
"ProductNDC": "11517-012",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Albuterol Sulfate",
"DosageFormName": "POWDER",
"StartMarketingDate": "20150430",
"MarketingCategoryName": "BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING",
"LabelerName": "Kindeva Drug Delivery Limited",
"SubstanceName": "ALBUTEROL SULFATE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"Status": "Unfinished",
"LastUpdate": "2024-12-28",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "30-APR-15"
},
{
"NDCCode": "11559-012-01",
"PackageDescription": "1 JAR in 1 CARTON (11559-012-01) > 50 mL in 1 JAR (11559-012-02)",
"NDC11Code": "11559-0012-01",
"ProductNDC": "11559-012",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Resilience Lift",
"ProprietaryNameSuffix": "Firming Sculpting Face And Neck Spf15 For Dry Skin",
"NonProprietaryName": "Ocinoxate",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20100901",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "ESTEE LAUDER INC",
"SubstanceName": "OCTINOXATE",
"StrengthNumber": "7.5",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "11788-012-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (11788-012-01) ",
"NDC11Code": "11788-0012-01",
"ProductNDC": "11788-012",
"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": "10",
"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": "11994-012-01",
"PackageDescription": "10 VIAL in 1 BOX (11994-012-01) > 10 mL in 1 VIAL",
"NDC11Code": "11994-0012-01",
"ProductNDC": "11994-012",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Ablavar",
"NonProprietaryName": "Gadofosveset Trisodium",
"DosageFormName": "INJECTION, SOLUTION",
"RouteName": "INTRAVENOUS",
"StartMarketingDate": "20081212",
"MarketingCategoryName": "NDA",
"ApplicationNumber": "NDA021711",
"LabelerName": "Lantheus Medical Imaging, Inc.",
"SubstanceName": "GADOFOSVESET TRISODIUM",
"StrengthNumber": "244",
"StrengthUnit": "mg/mL",
"Pharm_Classes": "Gadolinium-based Contrast Agent [EPC],Magnetic Resonance Contrast Activity [MoA]",
"Status": "Deprecated",
"LastUpdate": "2017-01-13"
},
{
"NDCCode": "13107-012-01",
"PackageDescription": "100 TABLET in 1 BOTTLE (13107-012-01)",
"NDC11Code": "13107-0012-01",
"ProductNDC": "13107-012",
"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": "50",
"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": "13733-012-01",
"PackageDescription": "20 g in 1 CARTON (13733-012-01)",
"NDC11Code": "13733-0012-01",
"ProductNDC": "13733-012",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Missha M Swirl Bb Sun Balm",
"ProprietaryNameSuffix": "Spf50 Plus Pa Plus Plus Plus No.21",
"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": "4.46; 1.44",
"StrengthUnit": "g/20g; g/20g",
"Status": "Deprecated",
"LastUpdate": "2019-01-08",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231"
},
{
"NDCCode": "13913-012-03",
"PackageDescription": "9 PACKET in 1 CARTON (13913-012-03) / 1 POWDER, FOR SOLUTION in 1 PACKET (13913-012-01) ",
"NDC11Code": "13913-0012-03",
"ProductNDC": "13913-012",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Cambia",
"NonProprietaryName": "Diclofenac Potassium",
"DosageFormName": "POWDER, FOR SOLUTION",
"RouteName": "ORAL",
"StartMarketingDate": "20160310",
"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": "Active",
"LastUpdate": "2024-12-13",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160310",
"SamplePackage": "N",
"IndicationAndUsage": "CAMBIA is indicated for the acute treatment of migraine attacks with or without aura in adults (18 years of age or older). Limitations of Use: 1 CAMBIA is not indicated for the prophylactic therapy of migraine., 2 The safety and effectiveness of CAMBIA have not been established for cluster headache, which is present in an older, predominantly male population.",
"Description": "CAMBIA (diclofenac potassium) for oral solution is a nonsteroidal anti-inflammatory drug, 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. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid monopotassium salt. The molecular weight is 334.25. Its molecular formula is C14H10Cl2NKO2, and it has the following structure. The inactive ingredients in CAMBIA include: flavoring agents (anise and mint), glycerol behenate, mannitol, potassium bicarbonate, and sucralose."
},
{
"NDCCode": "14141-012-01",
"PackageDescription": "1 CASE in 1 BOX (14141-012-01) > 9 g in 1 CASE",
"NDC11Code": "14141-0012-01",
"ProductNDC": "14141-012",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel Clarite Makeup Foundation For A Clearer Appearance Spf 30 280-f",
"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": "14445-012-01",
"PackageDescription": ".5 kg in 1 DRUM (14445-012-01) ",
"NDC11Code": "14445-0012-01",
"ProductNDC": "14445-012",
"ProductTypeName": "BULK INGREDIENT",
"NonProprietaryName": "Lacosamide",
"DosageFormName": "POWDER",
"StartMarketingDate": "20160218",
"MarketingCategoryName": "BULK INGREDIENT",
"LabelerName": "Indoco Remedies Limited",
"SubstanceName": "LACOSAMIDE",
"StrengthNumber": "1",
"StrengthUnit": "kg/kg",
"DEASchedule": "CV",
"Status": "Unfinished",
"LastUpdate": "2024-03-08",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "18-FEB-16"
},
{
"NDCCode": "14783-012-02",
"PackageDescription": "1 TUBE in 1 BOX (14783-012-02) > 4 g in 1 TUBE (14783-012-01)",
"NDC11Code": "14783-0012-02",
"ProductNDC": "14783-012",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Lbel Couleur Luxe Amplifier Xp",
"ProprietaryNameSuffix": "Amplifying Spf 15",
"NonProprietaryName": "Octinoxate And Oxybenzone",
"DosageFormName": "LIPSTICK",
"RouteName": "TOPICAL",
"StartMarketingDate": "20120914",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "Ventura International LTD.",
"SubstanceName": "OCTINOXATE; OXYBENZONE",
"StrengthNumber": ".047; .009",
"StrengthUnit": "g/g; g/g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "Helps prevent sunburn."
}
]
}
{"NDC":[{"NDCCode":"63972-012-01","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,"},{"NDCCode":"63972-002-01","ProprietaryName":"Century 21 Lymphatic Drainage","NonProprietaryName":"Strychnos Nux-vomica Seed, Barium Chloride Dihydrate, Lachesis Muta Venom, Conium Maculatum Flowering Top, Goldenseal, Iodine, Silicon Dioxide, Phosphorus, Quinine Sulfate, Silybum Marianum Seed, Chelidonium Majus, Berberis Vulgaris Root Bark, Sonia Canadensis Root, Mercurius Solubilis, Ceanothus Americanus Leaf, Solidago Virgaurea Flowering Top, Bos Taurus Bile, Apis Mellifera"},{"NDCCode":"63972-003-01","ProprietaryName":"Century 21 Acute Stress","NonProprietaryName":"Arnica Montana, Arsenic Trioxide, Bellis Perennis, Passiflora Incarnata Flowering Top, Valerian, Apis Mellifera, Human Breast Tumor Cell, Helianthemum Canadense, Clematis Recta Flowering Top, Arabica Coffee Bean, Strychnos Ignatii Seed, Lachesis Muta Venom, Magnesium Phosphate, Dibasic Trihydrate, Sodium Chloride, Sodium Sulfate, Ornithogalum Umbellatum, Phosphoric Acid, Salix Nigra Bark, Delphinium Staphisagria Seed"},{"NDCCode":"63972-004-01","ProprietaryName":"Century 21 Detox-virus","NonProprietaryName":"Araneus Diadematus, Rancid Beef, Phytolacca Americana Root, Echinacea Angustifolia, Astragalus Propinquus Root, Baptisia Tinctoria Root, Goldenseal, Lachesis Muta Venom, Gelsemium Sempervirens Root, Atropa Belladonna, Eupatorium Perfoliatum Flowering Top, Arsenic Trioxide, Silicon Dioxide, Thuja Occidentalis Leafy Twig, Bilberry, Apis 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<NDCList>
<NDC>
<NDCCode>63972-012-01</NDCCode>
<PackageDescription>120 mL in 1 BOTTLE (63972-012-01) </PackageDescription>
<NDC11Code>63972-0012-01</NDC11Code>
<ProductNDC>63972-012</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>7 Heavy Metal Detox</ProprietaryName>
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<EndMarketingDate>20230131</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>21st Century Homeopathics</LabelerName>
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<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>2023-02-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20151109</StartMarketingDatePackage>
<EndMarketingDatePackage>20230131</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63972-002-01</NDCCode>
<PackageDescription>120 mL in 1 BOTTLE (63972-002-01)</PackageDescription>
<NDC11Code>63972-0002-01</NDC11Code>
<ProductNDC>63972-002</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Century 21 Lymphatic Drainage</ProprietaryName>
<NonProprietaryName>Strychnos Nux-vomica Seed, Barium Chloride Dihydrate, Lachesis Muta Venom, Conium Maculatum Flowering Top, Goldenseal, Iodine, Silicon Dioxide, Phosphorus, Quinine Sulfate, Silybum Marianum Seed, Chelidonium Majus, Berberis Vulgaris Root Bark, Sonia Canadensis Root, Mercurius Solubilis, Ceanothus Americanus Leaf, Solidago Virgaurea Flowering Top, Bos Taurus Bile, Apis Mellifera</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19750101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>21st Century Homeopathics, Inc</LabelerName>
<SubstanceName>STRYCHNOS NUX-VOMICA SEED; BARIUM CHLORIDE DIHYDRATE; LACHESIS MUTA VENOM; CONIUM MACULATUM FLOWERING TOP; GOLDENSEAL; IODINE; SILICON DIOXIDE; PHOSPHORUS; QUININE SULFATE; SILYBUM MARIANUM SEED; CHELIDONIUM MAJUS; BERBERIS VULGARIS ROOT BARK; COLLINSONIA CANADENSIS ROOT; MERCURIUS SOLUBILIS; CEANOTHUS AMERICANUS LEAF; SOLIDAGO VIRGAUREA FLOWERING TOP; BOS TAURUS BILE; APIS MELLIFERA</SubstanceName>
<StrengthNumber>30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 6; 30</StrengthNumber>
<StrengthUnit>[hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Indications: 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>63972-003-01</NDCCode>
<PackageDescription>120 mL in 1 BOTTLE (63972-003-01)</PackageDescription>
<NDC11Code>63972-0003-01</NDC11Code>
<ProductNDC>63972-003</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Century 21 Acute Stress</ProprietaryName>
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<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19750101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>21st Century Homeopathics, Inc</LabelerName>
<SubstanceName>ARNICA MONTANA; ARSENIC TRIOXIDE; BELLIS PERENNIS; PASSIFLORA INCARNATA FLOWERING TOP; VALERIAN; APIS MELLIFERA; HUMAN BREAST TUMOR CELL; HELIANTHEMUM CANADENSE; CLEMATIS RECTA FLOWERING TOP; ARABICA COFFEE BEAN; STRYCHNOS IGNATII SEED; LACHESIS MUTA VENOM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM CHLORIDE; SODIUM SULFATE; ORNITHOGALUM UMBELLATUM; PHOSPHORIC ACID; SALIX NIGRA BARK; DELPHINIUM STAPHISAGRIA SEED</SubstanceName>
<StrengthNumber>30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30</StrengthNumber>
<StrengthUnit>[hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Indications: For temporary relief of acute stress due to emotional strain, anxiety, sleeplessness, apprehension or fear.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63972-004-01</NDCCode>
<PackageDescription>120 mL in 1 BOTTLE (63972-004-01)</PackageDescription>
<NDC11Code>63972-0004-01</NDC11Code>
<ProductNDC>63972-004</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Century 21 Detox-virus</ProprietaryName>
<NonProprietaryName>Araneus Diadematus, Rancid Beef, Phytolacca Americana Root, Echinacea Angustifolia, Astragalus Propinquus Root, Baptisia Tinctoria Root, Goldenseal, Lachesis Muta Venom, Gelsemium Sempervirens Root, Atropa Belladonna, Eupatorium Perfoliatum Flowering Top, Arsenic Trioxide, Silicon Dioxide, Thuja Occidentalis Leafy Twig, Bilberry, Apis Mellifera</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19750101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>21st Century Homeopathics, Inc</LabelerName>
<SubstanceName>ARANEUS DIADEMATUS; RANCID BEEF; PHYTOLACCA AMERICANA ROOT; ECHINACEA ANGUSTIFOLIA; ASTRAGALUS PROPINQUUS ROOT; BAPTISIA TINCTORIA ROOT; GOLDENSEAL; LACHESIS MUTA VENOM; GELSEMIUM SEMPERVIRENS ROOT; ATROPA BELLADONNA; EUPATORIUM PERFOLIATUM FLOWERING TOP; ARSENIC TRIOXIDE; PHOSPHORIC ACID; SILICON DIOXIDE; THUJA OCCIDENTALIS LEAFY TWIG; BILBERRY; APIS MELLIFERA</SubstanceName>
<StrengthNumber>30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30</StrengthNumber>
<StrengthUnit>[hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Indications: For 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>63972-005-01</NDCCode>
<PackageDescription>120 mL in 1 BOTTLE (63972-005-01) </PackageDescription>
<NDC11Code>63972-0005-01</NDC11Code>
<ProductNDC>63972-005</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>5 Chronic Stress</ProprietaryName>
<NonProprietaryName>Aralia Quinquefolia, Fucus Vesiculosus, Hydrastis Canadensis, Solidago Virgaurea, Taraxacum Officinale, Trifolium Pratense, 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>19750101</StartMarketingDate>
<EndMarketingDate>20210715</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>21st Century Homeopathics, Inc</LabelerName>
<SubstanceName>AMERICAN GINSENG; FUCUS VESICULOSUS; GOLDENSEAL; SOLIDAGO VIRGAUREA FLOWERING TOP; TARAXACUM OFFICINALE; TRIFOLIUM PRATENSE FLOWER; ARSENIC TRIOXIDE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; ACTIVATED CHARCOAL; CEANOTHUS AMERICANUS LEAF; CYCLAMEN PURPURASCENS TUBER; SODIUM CHLORIDE; STRYCHNOS NUX-VOMICA SEED; KEROSENE; PHOSPHORUS</SubstanceName>
<StrengthNumber>30; 3; 30; 3; 3; 3; 30; 30; 30; 30; 30; 30; 30; 30; 30</StrengthNumber>
<StrengthUnit>[hp_C]/mL; [hp_X]/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_C]/mL; [hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-07-16</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19750101</StartMarketingDatePackage>
<EndMarketingDatePackage>20210715</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63972-006-01</NDCCode>
<PackageDescription>120 mL in 1 BOTTLE (63972-006-01)</PackageDescription>
<NDC11Code>63972-0006-01</NDC11Code>
<ProductNDC>63972-006</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>6 Environmental Detox</ProprietaryName>
<NonProprietaryName>Acth, Calcarea Carbonica, Magnesia Sulphurica, Kali Phosphoricum, Nitricum Acidum, Benzoicum Acidum, Silicea, Arsenicum Album, Mercuris Solubilis, Phosphorus, Carbo Vegetabilis, Nux Vomica, Aluminum Metallicum, Phytolacca Decandra, Baptisia Tinctoria, Argentum Nitricum, Spigelia Anthelmia, Apis Mellifica</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19750101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>21st Century Homeopathics, Inc</LabelerName>
<SubstanceName>BAPTISIA TINCTORIA ROOT; PHYTOLACCA AMERICANA ROOT; SPIGELIA ANTHELMIA; CORTICOTROPIN; ALUMINUM; APIS MELLIFERA; SILVER NITRATE; ARSENIC TRIOXIDE; BENZOIC ACID; OYSTER SHELL CALCIUM CARBONATE, CRUDE; ACTIVATED CHARCOAL; POTASSIUM PHOSPHATE, DIBASIC; MAGNESIUM SULFATE HEPTAHYDRATE; MERCURIUS SOLUBILIS; NITRIC ACID; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; SILICON DIOXIDE</SubstanceName>
<StrengthNumber>3; 3; 3; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30</StrengthNumber>
<StrengthUnit>[hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-01-01</LastUpdate>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<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>63972-007-01</NDCCode>
<PackageDescription>120 mL in 1 BOTTLE (63972-007-01)</PackageDescription>
<NDC11Code>63972-0007-01</NDC11Code>
<ProductNDC>63972-007</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Century 21 Heavy Metal Detox</ProprietaryName>
<NonProprietaryName>Garlic, Gold, Atropa Belladonna, Berberis Vulgaris Root Bark, Causticum, Conium Maculatum Flowering Top, Calcium Sulfide, Hypericum Perforatum, Ipecac, Aluminum, Silver, Arsenic, Barium Carbonate, Beryllium, Boron, Bromine, Cadmium, D And C Black No. 2, Cerium, Cesium, Chromium, Cobalt, Copper, Dysprosium, Erbium, Europium, Iron, Fluorine, Gadolinium, Gallium, Germanium, Holmium, Hydrogen, Indium, Iodine, Lanthanum, Lithium Carbonate, Manganese, Mercurius Solubilis, Molybdenum, Neodymium, Nickel</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19750101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>21st Century Homeopathics, Inc</LabelerName>
<SubstanceName>GARLIC; GOLD; ATROPA BELLADONNA; BERBERIS VULGARIS ROOT BARK; CAUSTICUM; CONIUM MACULATUM FLOWERING TOP; CALCIUM SULFIDE; HYPERICUM PERFORATUM; IPECAC; ALUMINUM; SILVER; ARSENIC; BARIUM CARBONATE; BERYLLIUM; BORON; BROMINE; CADMIUM; D&C BLACK NO. 2; CERIUM; CESIUM; CHROMIUM; COBALT; COPPER; DYSPROSIUM; ERBIUM; EUROPIUM; IRON; FLUORINE; GADOLINIUM; GALLIUM; GERMANIUM; HOLMIUM; HYDROGEN; INDIUM; IODINE; LANTHANUM; LITHIUM CARBONATE; MANGANESE; MERCURIUS SOLUBILIS; MOLYBDENUM; NEODYMIUM; NICKEL; NIOBIUM; NITROUS OXIDE; OXYGEN; LEAD; PRASEODYMIUM; RUBIDIUM; SAMARIUM; SCANDIUM; SELENIUM; SILICON DIOXIDE; TIN; STRONTIUM CARBONATE; TANTALUM; TERBIUM; THULIUM; TITANIUM; VANADIUM; YTTERBIUM; ZINC; VERATRUM ALBUM ROOT; APIS MELLIFERA</SubstanceName>
<StrengthNumber>30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30</StrengthNumber>
<StrengthUnit>[hp_C]/5mL; [hp_X]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_X]/5mL; [hp_C]/5mL; [hp_C]/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Indications: Temporary relief of neurological disorders, vomiting, prostration and metallic aftertaste. Remedy #7 supports detoxification of environmental pollutants.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63972-008-01</NDCCode>
<PackageDescription>120 mL in 1 BOTTLE (63972-008-01)</PackageDescription>
<NDC11Code>63972-0008-01</NDC11Code>
<ProductNDC>63972-008</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Century 21 Fungal Yeast Infection</ProprietaryName>
<NonProprietaryName>Candida Albicans, Sepia Officinalis Juice, Echinacea, Unspecified, Lycopodium Clavatum Spore, Pulsatilla Vulgaris, Thuja Occidentalis Leafy Twig, Oyster Shell Calcium Carbonate, Crude, Astragalus Propinquus Root, Mercurius Solubilis, Goldenseal, Phytolacca Americana Root, Berberis Vulgaris Root Bark, Gentiana Lutea Root, Apis Mellifera</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19750101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>21st Century Homeopathics, Inc</LabelerName>
<SubstanceName>CANDIDA ALBICANS; SEPIA OFFICINALIS JUICE; ECHINACEA, UNSPECIFIED; LYCOPODIUM CLAVATUM SPORE; PULSATILLA VULGARIS; THUJA OCCIDENTALIS LEAFY TWIG; OYSTER SHELL CALCIUM CARBONATE, CRUDE; ASTRAGALUS PROPINQUUS ROOT; MERCURIUS SOLUBILIS; GOLDENSEAL; PHYTOLACCA AMERICANA ROOT; BERBERIS VULGARIS ROOT BARK; GENTIANA LUTEA ROOT; APIS MELLIFERA</SubstanceName>
<StrengthNumber>30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30</StrengthNumber>
<StrengthUnit>[hp_X]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Indications: For temporary relief of flatulence, bloating and rhinitis. Remedy #8 supports detoxification due to mycotic infections.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>63972-009-01</NDCCode>
<PackageDescription>120 mL in 1 BOTTLE (63972-009-01)</PackageDescription>
<NDC11Code>63972-0009-01</NDC11Code>
<ProductNDC>63972-009</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Century 21 Bacterial Detox</ProprietaryName>
<NonProprietaryName>Echinacea Angustifolia, Baptisia Tinctoria Root, Phytolacca Americana Root, Ferrosoferric Phosphate, Arsenic Trioxide, Atropa Belladonna, Matricaria Recutita, Mercurius Solubilis, Gelsemium Sempervirens Root, Lachesis Muta Venom, Solanum Dulcamara Top, Rancid Beef, Garlic, Apis Mellifera</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19750101</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>21st Century Homeopathics, Inc</LabelerName>
<SubstanceName>ECHINACEA ANGUSTIFOLIA; BAPTISIA TINCTORIA ROOT; PHYTOLACCA AMERICANA ROOT; FERROSOFERRIC PHOSPHATE; ARSENIC TRIOXIDE; ATROPA BELLADONNA; MATRICARIA RECUTITA; MERCURIUS SOLUBILIS; GELSEMIUM SEMPERVIRENS ROOT; LACHESIS MUTA VENOM; SOLANUM DULCAMARA TOP; RANCID BEEF; GARLIC; APIS MELLIFERA</SubstanceName>
<StrengthNumber>30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30</StrengthNumber>
<StrengthUnit>[hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL; [hp_C]/5mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Indications: For 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>63972-010-01</NDCCode>
<PackageDescription>120 mL in 1 BOTTLE (63972-010-01) </PackageDescription>
<NDC11Code>63972-0010-01</NDC11Code>
<ProductNDC>63972-010</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>10 Parasite Detox</ProprietaryName>
<NonProprietaryName>Carduus Marianus, Chelidonium Majus, Cina, Sabadilla, Spigelia Anthelmia, Teucrium Marum, Terebinthina, Thyroidinum (suis), Apis Mellifica, Baryta Carbonica, Calcarea Carbonica, Ferrum Muriaticum, Natrum Muriaticum, Silicea, Sulphur</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>19750101</StartMarketingDate>
<EndMarketingDate>20211230</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>21st Century Homeopathics</LabelerName>
<SubstanceName>BARIUM CARBONATE; SILYBUM MARIANUM SEED; CHELIDONIUM MAJUS; ARTEMISIA MARITIMA FLOWER; FERRIC CHLORIDE HEXAHYDRATE; SODIUM CHLORIDE; SCHOENOCAULON OFFICINALE SEED; SILICON DIOXIDE; SPIGELIA ANTHELMIA; SULFUR; THYROID, UNSPECIFIED; APIS MELLIFERA; OYSTER SHELL CALCIUM CARBONATE, CRUDE; TURPENTINE OIL; TEUCRIUM MARUM</SubstanceName>
<StrengthNumber>30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 6; 30; 30; 5; 30</StrengthNumber>
<StrengthUnit>[hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-12-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>19750101</StartMarketingDatePackage>
<EndMarketingDatePackage>20211230</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63972-011-01</NDCCode>
<PackageDescription>120 mL in 1 BOTTLE (63972-011-01) </PackageDescription>
<NDC11Code>63972-0011-01</NDC11Code>
<ProductNDC>63972-011</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION 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>20151106</StartMarketingDate>
<EndMarketingDate>20211229</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>21st Century Homeopathics</LabelerName>
<SubstanceName>ARNICA MONTANA; BELLIS PERENNIS; PASSIFLORA INCARNATA FLOWERING TOP; VALERIAN; ARSENIC TRIOXIDE; APIS MELLIFERA; HUMAN BREAST TUMOR CELL; HELIANTHEMUM CANADENSE; CLEMATIS RECTA FLOWERING TOP; ARABICA COFFEE BEAN; STRYCHNOS IGNATII SEED; LACHESIS MUTA VENOM; MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE; SODIUM CHLORIDE; SODIUM SULFATE; ORNITHOGALUM UMBELLATUM; PHOSPHORIC ACID; SALIX NIGRA BARK; DELPHINIUM STAPHISAGRIA SEED</SubstanceName>
<StrengthNumber>3; 3; 3; 3; 6; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30; 30</StrengthNumber>
<StrengthUnit>[hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Standardized Insect Venom Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Allergens [CS],Bee Venoms [CS],Non-Standardized Food Allergenic Extract [EPC],Non-Standardized Plant Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS],Dietary Proteins [CS],Plant Proteins [CS],Seed Storage Proteins [CS]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2021-12-30</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20151106</StartMarketingDatePackage>
<EndMarketingDatePackage>20211229</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63972-013-01</NDCCode>
<PackageDescription>120 mL in 1 BOTTLE (63972-013-01) </PackageDescription>
<NDC11Code>63972-0013-01</NDC11Code>
<ProductNDC>63972-013</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>20151109</StartMarketingDate>
<EndMarketingDate>20221129</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>21st Century Homeopathics</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 OXIDE; 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; SUS SCROFA THYROID; TANTALUM; TARTARIC ACID; TERBIUM; THALLIUM; THERIDION CURASSAVICUM; THUJA OCCIDENTALIS LEAFY TWIG; 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; 3; 12; 30; 12; 30; 12; 12; 12; 12; 12; 30; 12; 30; 30; 30; 30; 30; 30; 12; 12; 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_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_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], Gadolinium-based Contrast Agent [EPC], 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], Magnetic Resonance Contrast Activity [MoA], 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>2022-11-29</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20151109</StartMarketingDatePackage>
<EndMarketingDatePackage>20221129</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63972-014-01</NDCCode>
<PackageDescription>120 mL in 1 BOTTLE (63972-014-01) </PackageDescription>
<NDC11Code>63972-0014-01</NDC11Code>
<ProductNDC>63972-014</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>20170113</StartMarketingDate>
<EndMarketingDate>20221023</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>21st Century Homeopathics, Inc</LabelerName>
<SubstanceName>APIS MELLIFERA; BARIUM CHLORIDE DIHYDRATE; BERBERIS VULGARIS ROOT BARK; BOS TAURUS BILE; CEANOTHUS AMERICANUS LEAF; CHELIDONIUM MAJUS; COLLINSONIA CANADENSIS ROOT; 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; 5; 30; 30; 30; 3; 30; 30; 30; 3; 30</StrengthNumber>
<StrengthUnit>[hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_Q]/mL; [hp_C]/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; [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>2022-10-25</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170113</StartMarketingDatePackage>
<EndMarketingDatePackage>20221023</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63972-015-01</NDCCode>
<PackageDescription>120 mL in 1 BOTTLE (63972-015-01) </PackageDescription>
<NDC11Code>63972-0015-01</NDC11Code>
<ProductNDC>63972-015</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>8 Fungal Yeast Infection</ProprietaryName>
<NonProprietaryName>Astragalus Membranaceus, Berberis Vulgaris, Echinacea (angustifolia), Gentiana Lutea, Hydrastis Canadensis, Phytolacca Decandra, Candida Albicans, Apis Mellifica, Calcarea Carbonica, Lycopodium Clavatum, Mercurius Solubilis, Pulsatilla (vulgaris) Sepia, Thuja Occidentalis</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20170116</StartMarketingDate>
<EndMarketingDate>20230413</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>21st Century Homeopathics, Inc</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; 3; 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>20170116</StartMarketingDatePackage>
<EndMarketingDatePackage>20230413</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63972-016-01</NDCCode>
<PackageDescription>120 mL in 1 BOTTLE, PLASTIC (63972-016-01) </PackageDescription>
<NDC11Code>63972-0016-01</NDC11Code>
<ProductNDC>63972-016</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>20170929</StartMarketingDate>
<EndMarketingDate>20230409</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>21st Century Homeopathics</LabelerName>
<SubstanceName>APIS MELLIFERA; ARANEUS DIADEMATUS; ARSENIC TRIOXIDE; ASTRAGALUS PROPINQUUS ROOT; ATROPA BELLADONNA WHOLE; BAPTISIA TINCTORIA; BILBERRY; ECHINACEA ANGUSTIFOLIA; 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; 3; 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>2023-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20170929</StartMarketingDatePackage>
<EndMarketingDatePackage>20230409</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>63972-017-01</NDCCode>
<PackageDescription>120 mL in 1 BOTTLE, DROPPER (63972-017-01) </PackageDescription>
<NDC11Code>63972-0017-01</NDC11Code>
<ProductNDC>63972-017</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>10 Parasite Detox</ProprietaryName>
<NonProprietaryName>Carduus Marianus, Chelidonium Majus, Cina, Sabadilla, Spigelia Anthelmia, 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>20171229</StartMarketingDate>
<EndMarketingDate>20230410</EndMarketingDate>
<MarketingCategoryName>UNAPPROVED HOMEOPATHIC</MarketingCategoryName>
<LabelerName>21st Century Homeopathics</LabelerName>
<SubstanceName>APIS MELLIFERA; ARTEMISIA CINA PRE-FLOWERING TOP; BARIUM CARBONATE; CHELIDONIUM MAJUS; FERRIC CHLORIDE HEXAHYDRATE; MILK THISTLE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; SCHOENOCAULON OFFICINALE SEED; SILICON DIOXIDE; SODIUM CHLORIDE; SPIGELIA ANTHELMIA; SULFUR; SUS SCROFA THYROID; TEUCRIUM MARUM; TURPENTINE OIL</SubstanceName>
<StrengthNumber>30; 3; 30; 3; 30; 3; 30; 3; 30; 30; 6; 30; 6; 3; 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>2023-04-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20171229</StartMarketingDatePackage>
<EndMarketingDatePackage>20230410</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>10348-012-01</NDCCode>
<PackageDescription>1 BOTTLE in 1 CARTON (10348-012-01) > 30 mL in 1 BOTTLE</PackageDescription>
<NDC11Code>10348-0012-01</NDC11Code>
<ProductNDC>10348-012</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Camera Ready Bb Water Broad Spectrum Spf 30</ProprietaryName>
<NonProprietaryName>Octinoxate, Titanium Dioxide, And Zinc Oxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20150406</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>SMASHBOX BEAUTY COSMETICS, INC</LabelerName>
<SubstanceName>OCTINOXATE; TITANIUM DIOXIDE; ZINC OXIDE</SubstanceName>
<StrengthNumber>.056; .03472; .02352</StrengthNumber>
<StrengthUnit>g/100mL; g/100mL; g/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-11-18</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20201231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20150406</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>10572-012-01</NDCCode>
<PackageDescription>2 BOTTLE, PLASTIC in 1 CARTON (10572-012-01) / 177.4 mL in 1 BOTTLE, PLASTIC</PackageDescription>
<NDC11Code>10572-0012-01</NDC11Code>
<ProductNDC>10572-012</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Sodium Sulfate, Potassium Sulfate And Magnesium Sulfate</ProprietaryName>
<NonProprietaryName>Sodium Sulfate, Potassium Sulfate, Magnesium Sulfate</NonProprietaryName>
<DosageFormName>SOLUTION, CONCENTRATE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20100805</StartMarketingDate>
<EndMarketingDate>20280331</EndMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA022372</ApplicationNumber>
<LabelerName>Affordable Pharmaceuticals, LLC</LabelerName>
<SubstanceName>SODIUM SULFATE; POTASSIUM SULFATE; MAGNESIUM SULFATE, UNSPECIFIED FORM</SubstanceName>
<StrengthNumber>17.5; 3.13; 1.6</StrengthNumber>
<StrengthUnit>g/mL; g/mL; g/mL</StrengthUnit>
<Pharm_Classes>Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2026-10-10</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20100805</StartMarketingDatePackage>
<EndMarketingDatePackage>20280331</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>10702-012-01</NDCCode>
<PackageDescription>100 TABLET, FILM COATED in 1 BOTTLE (10702-012-01) </PackageDescription>
<NDC11Code>10702-0012-01</NDC11Code>
<ProductNDC>10702-012</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>50</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>10812-012-01</NDCCode>
<PackageDescription>1 TUBE in 1 BLISTER PACK (10812-012-01) > 4.2 g in 1 TUBE</PackageDescription>
<NDC11Code>10812-0012-01</NDC11Code>
<ProductNDC>10812-012</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Neutrogena Revitalizing Lip Balm</ProprietaryName>
<ProprietaryNameSuffix>Spf 20 - Sunny Berry 30</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>11517-012-01</NDCCode>
<PackageDescription>23 kg in 1 DRUM (11517-012-01) </PackageDescription>
<NDC11Code>11517-0012-01</NDC11Code>
<ProductNDC>11517-012</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Albuterol Sulfate</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20150430</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT FOR HUMAN PRESCRIPTION COMPOUNDING</MarketingCategoryName>
<LabelerName>Kindeva Drug Delivery Limited</LabelerName>
<SubstanceName>ALBUTEROL SULFATE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<Status>Unfinished</Status>
<LastUpdate>2024-12-28</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>30-APR-15</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>11559-012-01</NDCCode>
<PackageDescription>1 JAR in 1 CARTON (11559-012-01) > 50 mL in 1 JAR (11559-012-02)</PackageDescription>
<NDC11Code>11559-0012-01</NDC11Code>
<ProductNDC>11559-012</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Resilience Lift</ProprietaryName>
<ProprietaryNameSuffix>Firming Sculpting Face And Neck Spf15 For Dry Skin</ProprietaryNameSuffix>
<NonProprietaryName>Ocinoxate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20100901</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>ESTEE LAUDER INC</LabelerName>
<SubstanceName>OCTINOXATE</SubstanceName>
<StrengthNumber>7.5</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>11788-012-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (11788-012-01) </PackageDescription>
<NDC11Code>11788-0012-01</NDC11Code>
<ProductNDC>11788-012</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>10</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>11994-012-01</NDCCode>
<PackageDescription>10 VIAL in 1 BOX (11994-012-01) > 10 mL in 1 VIAL</PackageDescription>
<NDC11Code>11994-0012-01</NDC11Code>
<ProductNDC>11994-012</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Ablavar</ProprietaryName>
<NonProprietaryName>Gadofosveset Trisodium</NonProprietaryName>
<DosageFormName>INJECTION, SOLUTION</DosageFormName>
<RouteName>INTRAVENOUS</RouteName>
<StartMarketingDate>20081212</StartMarketingDate>
<MarketingCategoryName>NDA</MarketingCategoryName>
<ApplicationNumber>NDA021711</ApplicationNumber>
<LabelerName>Lantheus Medical Imaging, Inc.</LabelerName>
<SubstanceName>GADOFOSVESET TRISODIUM</SubstanceName>
<StrengthNumber>244</StrengthNumber>
<StrengthUnit>mg/mL</StrengthUnit>
<Pharm_Classes>Gadolinium-based Contrast Agent [EPC],Magnetic Resonance Contrast Activity [MoA]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2017-01-13</LastUpdate>
</NDC>
<NDC>
<NDCCode>13107-012-01</NDCCode>
<PackageDescription>100 TABLET in 1 BOTTLE (13107-012-01)</PackageDescription>
<NDC11Code>13107-0012-01</NDC11Code>
<ProductNDC>13107-012</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>50</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>13733-012-01</NDCCode>
<PackageDescription>20 g in 1 CARTON (13733-012-01)</PackageDescription>
<NDC11Code>13733-0012-01</NDC11Code>
<ProductNDC>13733-012</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Missha M Swirl Bb Sun Balm</ProprietaryName>
<ProprietaryNameSuffix>Spf50 Plus Pa Plus Plus Plus No.21</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>4.46; 1.44</StrengthNumber>
<StrengthUnit>g/20g; g/20g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-01-08</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>13913-012-03</NDCCode>
<PackageDescription>9 PACKET in 1 CARTON (13913-012-03) / 1 POWDER, FOR SOLUTION in 1 PACKET (13913-012-01) </PackageDescription>
<NDC11Code>13913-0012-03</NDC11Code>
<ProductNDC>13913-012</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Cambia</ProprietaryName>
<NonProprietaryName>Diclofenac Potassium</NonProprietaryName>
<DosageFormName>POWDER, FOR SOLUTION</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20160310</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>Active</Status>
<LastUpdate>2024-12-13</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160310</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>CAMBIA is indicated for the acute treatment of migraine attacks with or without aura in adults (18 years of age or older). Limitations of Use: 1 CAMBIA is not indicated for the prophylactic therapy of migraine., 2 The safety and effectiveness of CAMBIA have not been established for cluster headache, which is present in an older, predominantly male population.</IndicationAndUsage>
<Description>CAMBIA (diclofenac potassium) for oral solution is a nonsteroidal anti-inflammatory drug, 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. The chemical name is 2-[(2,6-dichlorophenyl)amino] benzeneacetic acid monopotassium salt. The molecular weight is 334.25. Its molecular formula is C14H10Cl2NKO2, and it has the following structure. The inactive ingredients in CAMBIA include: flavoring agents (anise and mint), glycerol behenate, mannitol, potassium bicarbonate, and sucralose.</Description>
</NDC>
<NDC>
<NDCCode>14141-012-01</NDCCode>
<PackageDescription>1 CASE in 1 BOX (14141-012-01) > 9 g in 1 CASE</PackageDescription>
<NDC11Code>14141-0012-01</NDC11Code>
<ProductNDC>14141-012</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lbel Clarite Makeup Foundation For A Clearer Appearance Spf 30 280-f</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>14445-012-01</NDCCode>
<PackageDescription>.5 kg in 1 DRUM (14445-012-01) </PackageDescription>
<NDC11Code>14445-0012-01</NDC11Code>
<ProductNDC>14445-012</ProductNDC>
<ProductTypeName>BULK INGREDIENT</ProductTypeName>
<NonProprietaryName>Lacosamide</NonProprietaryName>
<DosageFormName>POWDER</DosageFormName>
<StartMarketingDate>20160218</StartMarketingDate>
<MarketingCategoryName>BULK INGREDIENT</MarketingCategoryName>
<LabelerName>Indoco Remedies Limited</LabelerName>
<SubstanceName>LACOSAMIDE</SubstanceName>
<StrengthNumber>1</StrengthNumber>
<StrengthUnit>kg/kg</StrengthUnit>
<DEASchedule>CV</DEASchedule>
<Status>Unfinished</Status>
<LastUpdate>2024-03-08</LastUpdate>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>18-FEB-16</StartMarketingDatePackage>
</NDC>
<NDC>
<NDCCode>14783-012-02</NDCCode>
<PackageDescription>1 TUBE in 1 BOX (14783-012-02) > 4 g in 1 TUBE (14783-012-01)</PackageDescription>
<NDC11Code>14783-0012-02</NDC11Code>
<ProductNDC>14783-012</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Lbel Couleur Luxe Amplifier Xp</ProprietaryName>
<ProprietaryNameSuffix>Amplifying Spf 15</ProprietaryNameSuffix>
<NonProprietaryName>Octinoxate And Oxybenzone</NonProprietaryName>
<DosageFormName>LIPSTICK</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20120914</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>Ventura International LTD.</LabelerName>
<SubstanceName>OCTINOXATE; OXYBENZONE</SubstanceName>
<StrengthNumber>.047; .009</StrengthNumber>
<StrengthUnit>g/g; g/g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>Helps prevent sunburn.</IndicationAndUsage>
</NDC>
</NDCList>
<NDCList><NDC><NDCCode>63972-012-01</NDCCode><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,</NonProprietaryName></NDC><NDC><NDCCode>63972-002-01</NDCCode><ProprietaryName>Century 21 Lymphatic Drainage</ProprietaryName><NonProprietaryName>Strychnos Nux-vomica Seed, Barium Chloride Dihydrate, Lachesis Muta Venom, Conium Maculatum Flowering Top, Goldenseal, Iodine, Silicon Dioxide, Phosphorus, Quinine Sulfate, Silybum Marianum Seed, Chelidonium Majus, Berberis Vulgaris Root Bark, Sonia Canadensis Root, Mercurius Solubilis, Ceanothus Americanus Leaf, Solidago Virgaurea Flowering Top, Bos Taurus Bile, Apis Mellifera</NonProprietaryName></NDC><NDC><NDCCode>63972-003-01</NDCCode><ProprietaryName>Century 21 Acute Stress</ProprietaryName><NonProprietaryName>Arnica Montana, Arsenic Trioxide, Bellis Perennis, Passiflora Incarnata Flowering Top, Valerian, Apis Mellifera, Human Breast Tumor Cell, Helianthemum Canadense, Clematis Recta Flowering Top, Arabica Coffee Bean, Strychnos Ignatii Seed, Lachesis Muta Venom, Magnesium Phosphate, Dibasic Trihydrate, Sodium Chloride, Sodium Sulfate, Ornithogalum Umbellatum, Phosphoric Acid, Salix Nigra Bark, Delphinium Staphisagria Seed</NonProprietaryName></NDC><NDC><NDCCode>63972-004-01</NDCCode><ProprietaryName>Century 21 Detox-virus</ProprietaryName><NonProprietaryName>Araneus Diadematus, Rancid Beef, Phytolacca Americana Root, Echinacea Angustifolia, Astragalus Propinquus Root, Baptisia Tinctoria Root, Goldenseal, Lachesis Muta Venom, Gelsemium Sempervirens Root, Atropa Belladonna, Eupatorium Perfoliatum Flowering Top, Arsenic Trioxide, Silicon Dioxide, Thuja Occidentalis Leafy Twig, Bilberry, Apis Mellifera</NonProprietaryName></NDC><NDC><NDCCode>63972-005-01</NDCCode><ProprietaryName>5 Chronic Stress</ProprietaryName><NonProprietaryName>Aralia Quinquefolia, Fucus Vesiculosus, Hydrastis Canadensis, Solidago Virgaurea, Taraxacum Officinale, Trifolium Pratense, Arsenicum Album, Calcarea Carbonica, Carbo Vegetabilis, Ceanothus Americanus, Cyclamen Europaeum, Hepar Sulphuris Calcareum, Natrum Muriaticum, Nux Vomica, Petroleum, Phosphorus</NonProprietaryName></NDC><NDC><NDCCode>63972-006-01</NDCCode><ProprietaryName>6 Environmental Detox</ProprietaryName><NonProprietaryName>Acth, Calcarea Carbonica, Magnesia Sulphurica, Kali Phosphoricum, Nitricum Acidum, Benzoicum Acidum, Silicea, Arsenicum Album, Mercuris Solubilis, Phosphorus, Carbo Vegetabilis, Nux Vomica, Aluminum Metallicum, Phytolacca Decandra, Baptisia Tinctoria, Argentum Nitricum, Spigelia Anthelmia, Apis Mellifica</NonProprietaryName></NDC><NDC><NDCCode>63972-007-01</NDCCode><ProprietaryName>Century 21 Heavy Metal Detox</ProprietaryName><NonProprietaryName>Garlic, Gold, Atropa Belladonna, Berberis Vulgaris Root Bark, Causticum, Conium Maculatum Flowering Top, Calcium Sulfide, Hypericum Perforatum, Ipecac, Aluminum, Silver, Arsenic, Barium Carbonate, Beryllium, Boron, Bromine, Cadmium, D And C Black No. 2, Cerium, Cesium, Chromium, Cobalt, Copper, Dysprosium, Erbium, Europium, Iron, Fluorine, Gadolinium, Gallium, Germanium, Holmium, Hydrogen, Indium, Iodine, Lanthanum, Lithium Carbonate, Manganese, Mercurius Solubilis, Molybdenum, Neodymium, Nickel</NonProprietaryName></NDC><NDC><NDCCode>63972-008-01</NDCCode><ProprietaryName>Century 21 Fungal Yeast Infection</ProprietaryName><NonProprietaryName>Candida Albicans, Sepia Officinalis Juice, Echinacea, Unspecified, Lycopodium Clavatum Spore, Pulsatilla Vulgaris, Thuja Occidentalis Leafy Twig, Oyster Shell Calcium Carbonate, Crude, Astragalus Propinquus Root, Mercurius Solubilis, Goldenseal, Phytolacca Americana Root, Berberis Vulgaris Root Bark, Gentiana Lutea Root, Apis Mellifera</NonProprietaryName></NDC><NDC><NDCCode>63972-009-01</NDCCode><ProprietaryName>Century 21 Bacterial Detox</ProprietaryName><NonProprietaryName>Echinacea Angustifolia, Baptisia Tinctoria Root, Phytolacca Americana Root, Ferrosoferric Phosphate, Arsenic Trioxide, Atropa Belladonna, Matricaria Recutita, Mercurius Solubilis, Gelsemium Sempervirens Root, Lachesis Muta Venom, Solanum Dulcamara Top, Rancid Beef, Garlic, Apis Mellifera</NonProprietaryName></NDC><NDC><NDCCode>63972-010-01</NDCCode><ProprietaryName>10 Parasite Detox</ProprietaryName><NonProprietaryName>Carduus Marianus, Chelidonium Majus, Cina, Sabadilla, Spigelia Anthelmia, Teucrium Marum, Terebinthina, Thyroidinum (suis), Apis Mellifica, Baryta Carbonica, Calcarea Carbonica, Ferrum Muriaticum, Natrum Muriaticum, Silicea, Sulphur</NonProprietaryName></NDC><NDC><NDCCode>63972-011-01</NDCCode><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></NDC><NDC><NDCCode>63972-013-01</NDCCode><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></NDC><NDC><NDCCode>63972-014-01</NDCCode><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></NDC><NDC><NDCCode>63972-015-01</NDCCode><ProprietaryName>8 Fungal Yeast Infection</ProprietaryName><NonProprietaryName>Astragalus Membranaceus, Berberis Vulgaris, Echinacea (angustifolia), Gentiana Lutea, Hydrastis Canadensis, Phytolacca Decandra, Candida Albicans, Apis Mellifica, Calcarea Carbonica, Lycopodium Clavatum, Mercurius Solubilis, Pulsatilla (vulgaris) Sepia, Thuja Occidentalis</NonProprietaryName></NDC><NDC><NDCCode>63972-016-01</NDCCode><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></NDC><NDC><NDCCode>63972-017-01</NDCCode><ProprietaryName>10 Parasite Detox</ProprietaryName><NonProprietaryName>Carduus Marianus, Chelidonium Majus, Cina, Sabadilla, Spigelia Anthelmia, Teucrium Marum, Terebinthina, Thyroidinum (suis), Spigelia Anthelmia, Apis Mellifica, Baryta Carbonica, Calcarea Carbonica, Ferrum Muriaticum, Natrum Muriaticum, Silicea, Sulphur</NonProprietaryName></NDC><NDC><NDCCode>10348-012-01</NDCCode><ProprietaryName>Camera Ready Bb Water Broad Spectrum Spf 30</ProprietaryName><NonProprietaryName>Octinoxate, Titanium Dioxide, And Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>10572-012-01</NDCCode><ProprietaryName>Sodium Sulfate, Potassium Sulfate And Magnesium Sulfate</ProprietaryName><NonProprietaryName>Sodium Sulfate, Potassium Sulfate, Magnesium Sulfate</NonProprietaryName></NDC><NDC><NDCCode>10702-012-01</NDCCode><ProprietaryName>Hydroxyzine Hydrochloride</ProprietaryName><NonProprietaryName>Hydroxyzine Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>10812-012-01</NDCCode><ProprietaryName>Neutrogena Revitalizing Lip Balm</ProprietaryName><NonProprietaryName>Octinoxate And Oxybenzone</NonProprietaryName></NDC><NDC><NDCCode>11517-012-01</NDCCode><NonProprietaryName>Albuterol Sulfate</NonProprietaryName></NDC><NDC><NDCCode>11559-012-01</NDCCode><ProprietaryName>Resilience Lift</ProprietaryName><NonProprietaryName>Ocinoxate</NonProprietaryName></NDC><NDC><NDCCode>11788-012-01</NDCCode><ProprietaryName>Methimazole</ProprietaryName><NonProprietaryName>Methimazole</NonProprietaryName></NDC><NDC><NDCCode>11994-012-01</NDCCode><ProprietaryName>Ablavar</ProprietaryName><NonProprietaryName>Gadofosveset Trisodium</NonProprietaryName></NDC><NDC><NDCCode>13107-012-01</NDCCode><ProprietaryName>Sertraline Hydrochloride</ProprietaryName><NonProprietaryName>Sertraline Hydrochloride</NonProprietaryName></NDC><NDC><NDCCode>13733-012-01</NDCCode><ProprietaryName>Missha M Swirl Bb Sun Balm</ProprietaryName><NonProprietaryName>Titanium Dioxide</NonProprietaryName></NDC><NDC><NDCCode>13913-012-03</NDCCode><ProprietaryName>Cambia</ProprietaryName><NonProprietaryName>Diclofenac Potassium</NonProprietaryName></NDC><NDC><NDCCode>14141-012-01</NDCCode><ProprietaryName>Lbel Clarite Makeup Foundation For A Clearer Appearance Spf 30 280-f</ProprietaryName><NonProprietaryName>Octinoxate, Zinc Oxide</NonProprietaryName></NDC><NDC><NDCCode>14445-012-01</NDCCode><NonProprietaryName>Lacosamide</NonProprietaryName></NDC><NDC><NDCCode>14783-012-02</NDCCode><ProprietaryName>Lbel Couleur Luxe Amplifier Xp</ProprietaryName><NonProprietaryName>Octinoxate And Oxybenzone</NonProprietaryName></NDC></NDCList>