| Drug NDC: | 43857-0481 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. | |
| Proprietary Name: | Free Radical |
| Also known as the trade name. It is the name of the product chosen by the labeler. | |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. | |
| Non Proprietary Name: | Triticum Aestivum, Alfalfa, Fucus Vesiculosus, Laminaria Digitata, Nasturtium Aquaticum, Oryza Sativa, Raphanus Sativus, Symphytum Officinale, Hordeum Vulgare, Asparagus Officinalis, Manganese Gluconate, Ferrum Phosphoricum, Arnica Montana, Cuprum Metallicum, Ubidecarenonum, Alpha-ketoglutaricum Acidum, Glyoxal Trimer Dihydrate, Aluminum Metallicum, Antimonium Crudum, Argentum Metallicum, Arsenicum Album, Aurum Metallicum, Baryta Carbonica, Beryllium Metallicum, Bismuthum Metallicum, Boron, Bromium |
| Also known as the generic name, this is usually the active ingredient(s) of the product. | |
| Labeler Name: | Bioactive Nutritional, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. | |
| Dosage Form: | Liquid |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. | |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. | |
| Substance Name: | .ALPHA.-KETOGLUTARIC ACID - 30 [hp_X]/mL ALFALFA - 3 [hp_X]/mL ALUMINUM - 12 [hp_X]/mL ANTIMONY TRISULFIDE - 12 [hp_X]/mL ARNICA MONTANA - 12 [hp_X]/mL ARSENIC TRIOXIDE - 12 [hp_X]/mL ASPARAGUS - 6 [hp_X]/mL BARIUM CARBONATE - 12 [hp_X]/mL BERYLLIUM - 12 [hp_X]/mL BISMUTH - 12 [hp_X]/mL Load more... BORON - 12 [hp_X]/mL BROMINE - 12 [hp_X]/mL BROWN RICE - 3 [hp_X]/mL CADMIUM - 12 [hp_X]/mL CERIUM - 12 [hp_X]/mL CESIUM CHLORIDE - 12 [hp_X]/mL CHROMIUM - 12 [hp_X]/mL COBALT - 12 [hp_X]/mL COMFREY ROOT - 6 [hp_X]/mL COPPER - 12 [hp_X]/mL DYSPROSIUM - 12 [hp_X]/mL ERBIUM - 12 [hp_X]/mL EUROPIUM - 12 [hp_X]/mL FERROSOFERRIC PHOSPHATE - 8 [hp_X]/mL FUCUS VESICULOSUS - 3 [hp_X]/mL GADOLINIUM - 12 [hp_X]/mL GERMANIUM SESQUIOXIDE - 12 [hp_X]/mL GLYOXAL TRIMER DIHYDRATE - 30 [hp_X]/mL GOLD - 12 [hp_X]/mL HOLMIUM - 12 [hp_X]/mL HORDEUM VULGARE TOP - 3 [hp_X]/mL INDIUM - 12 [hp_X]/mL IRON - 12 [hp_X]/mL LAMINARIA DIGITATA - 3 [hp_X]/mL LANTHANUM - 14 [hp_C]/mL LEAD - 12 [hp_X]/mL LITHIUM CARBONATE - 12 [hp_X]/mL MAGNESIUM - 12 [hp_X]/mL MANGANESE - 12 [hp_X]/mL MANGANESE GLUCONATE - 6 [hp_X]/mL MERCURIUS SOLUBILIS - 12 [hp_X]/mL MOLYBDENUM - 12 [hp_X]/mL NASTURTIUM OFFICINALE - 3 [hp_X]/mL NEODYMIUM OXIDE - 12 [hp_X]/mL NICKEL - 12 [hp_X]/mL NIOBIUM - 30 [hp_C]/mL OSMIUM - 12 [hp_X]/mL PALLADIUM - 12 [hp_X]/mL PLATINUM - 12 [hp_X]/mL PRASEODYMIUM - 12 [hp_X]/mL RADISH - 3 [hp_X]/mL RHODIUM - 12 [hp_X]/mL RUBIDIUM NITRITE - 12 [hp_X]/mL SAMARIUM - 12 [hp_X]/mL SELENIUM - 12 [hp_X]/mL SILVER - 12 [hp_X]/mL STRONTIUM CARBONATE - 12 [hp_X]/mL TANTALUM - 30 [hp_C]/mL TERBIUM - 12 [hp_X]/mL THALLIUM - 12 [hp_X]/mL TIN - 12 [hp_X]/mL TRITICUM AESTIVUM WHOLE - 1 [hp_X]/mL UBIDECARENONE - 12 [hp_X]/mL URANYL NITRATE HEXAHYDRATE - 12 [hp_X]/mL VANADIUM - 12 [hp_X]/mL YTTERBIUM OXIDE - 12 [hp_X]/mL ZINC - 12 [hp_X]/mL |
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. | |
| Route Details: | ORAL |
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. | |
| Marketing Category: | UNAPPROVED HOMEOPATHIC |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. | |
| Marketing Start Date: | 22 May, 2018 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 03 May, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. | |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. | |
| Manufacturer Name: | BioActive Nutritional, Inc. |
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. | |
| Original Packager: | Yes |
| Whether or not the drug has been repackaged for distribution. | |
| NUI: | N0000185371 N0000175629 N0000184306 M0000728 M0006342 M0022575 N0000185016 N0000185508 M0005152 N0000175831 N0000008595 N0000008924 N0000175830 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | 8ID597Z82X DJO934BRBD CPD4NFA903 F79059A38U O80TY208ZW S7V92P67HO Z1EJP3037Z 6P669D8HQ8 OW5102UV6N U015TT5I8H Load more... N9E3X5056Q SBV4XY874G 659G217HPG 00BH33GNGH 30K4522N6T GNR9HML8BA 0R0008Q3JB 3G0H8C9362 M9VVZ08EKQ 789U1901C5 1D4N45714Q 77B218D3YE 444W947O8O 91GQH8I5F7 535G2ABX9M AU0V1LM3JT 96WE91N25T R6GJS0F9NZ 79Y1949PYO W1XX32SQN1 86507VZR9K 045A6V3VFX E1UOL152H7 15E7C67EE8 6I3K30563S 2P299V784P 2BMD2GNA4V I38ZP9992A 42Z2K6ZL8P 9YY2F980SV 324Y4038G2 81AH48963U YH89GMV676 AYT3H319PN 7OV03QG267 05175J654G 2E7M255OPY 5TWQ1V240M 49DFR088MY NKN7EZA750 EM5RP35463 DMK383DSAC 93722E7JA1 42OD65L39F H6241UJ22B 3M4G523W1G 41YPU4MMCA 6424HBN274 06SSF7P179 AD84R52XLF 387GMG9FH5 3C3Y389JBU EJ27X76M46 3V057702FY 00J9J9XKDE T66CZ53RP4 J41CSQ7QDS |
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. | |
| Pharmacologic Class EPC: | Non-Standardized Food Allergenic Extract [EPC] Standardized Chemical Allergen [EPC] Copper-containing Intrauterine Device [EPC] |
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. | |
| Pharmacologic Class PE: | Increased Histamine Release [PE] Cell-mediated Immunity [PE] Decreased Embryonic Implantation [PE] Decreased Sperm Motility [PE] Inhibit Ovum Fertilization [PE] |
| Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`. | |
| Pharmacologic Class CS: | Allergens [CS] Dietary Proteins [CS] Vegetable Proteins [CS] Copper [CS] |
| Chemical structure classification of the drug product’s pharmacologic class. Takes the form of the classification, followed by `[Chemical/Ingredient]` (such as `Thiazides [Chemical/Ingredient]` or `Antibodies, Monoclonal [Chemical/Ingredient]. | |
| Pharmacologic Class: | Allergens [CS] Cell-mediated Immunity [PE] Copper [CS] Copper-containing Intrauterine Device [EPC] Decreased Embryonic Implantation [PE] Decreased Sperm Motility [PE] Dietary Proteins [CS] Grain Proteins [EXT] Increased Histamine Release [PE] Inhibit Ovum Fertilization [PE] Magnetic Resonance Contrast Activity [MoA] Mood Stabilizer [EPC] Non-Standardized Food Allergenic Extract [EPC] Paramagnetic Contrast Agent [EPC] Standardized Chemical Allergen [EPC] Vegetable Proteins [CS] |
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. | |
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|---|---|---|---|
| 43857-0481-1 | 30 mL in 1 BOTTLE, DROPPER (43857-0481-1) | 22 May, 2018 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. | ||||
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