| Drug NDC: | 43857-0471 |
| 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: | Neurotox |
| 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: | Agaricus Muscarius, Coccus Cacti, Conium Maculatum, Lycopodium Clavatum, Phosphorus, Aluminium Metallicum, Antimonium Crudum, Argentum Metallicum, Arsenicum Album, Aurum Metallicum, Baryta Carbonica, Beryllium Metallicum, Bismuthum Metallicum, Boron, Bromium, Cadmium Metallicum Cerium Metallicum, Cesium Chloride, Chromium, Cobaltum Metallicum, Cuprum Metallicum, Dysprosium Metallicum, Erbium Metallicum, Europium Metallicum, Ferrum Metallicum, Gadolinium Metallicum, Germanium Sesquioxide, Holmium Metallicum |
| 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: | ALUMINUM - 12 [hp_X]/mL AMANITA MUSCARIA FRUITING BODY - 12 [hp_X]/mL ANTIMONY TRISULFIDE - 12 [hp_X]/mL ARSENIC TRIOXIDE - 12 [hp_X]/mL ASPARTAME - 30 [hp_X]/mL BARIUM CARBONATE - 12 [hp_X]/mL BENZALKONIUM CHLORIDE - 30 [hp_X]/mL BERYLLIUM - 12 [hp_X]/mL BISMUTH - 12 [hp_X]/mL BORON - 12 [hp_X]/mL Load more... BROMINE - 12 [hp_X]/mL CADMIUM - 12 [hp_X]/mL CERIUM - 12 [hp_X]/mL CESIUM CHLORIDE - 12 [hp_X]/mL CHROMIUM - 12 [hp_X]/mL CITHARACANTHUS SPINICRUS - 30 [hp_X]/mL CLOSTRIDIUM BOTULINUM - 30 [hp_X]/mL CLOSTRIDIUM PERFRINGENS - 15 [hp_C]/mL COBALT - 12 [hp_X]/mL CONIUM MACULATUM FLOWERING TOP - 12 [hp_X]/mL COPPER - 12 [hp_X]/mL DYSPROSIUM - 12 [hp_X]/mL ERBIUM - 12 [hp_X]/mL ESCHERICHIA COLI - 30 [hp_X]/mL EUROPIUM - 12 [hp_X]/mL FORMALDEHYDE - 30 [hp_X]/mL GADOLINIUM - 12 [hp_X]/mL GELSEMIUM SEMPERVIRENS ROOT - 30 [hp_X]/mL GERMANIUM SESQUIOXIDE - 12 [hp_X]/mL GOLD - 12 [hp_X]/mL HOLMIUM - 12 [hp_X]/mL HUMAN HERPESVIRUS 4 - 30 [hp_X]/mL INDIUM - 12 [hp_X]/mL INFLUENZA A VIRUS A/HONG KONG/4801/2014 X-263B (H3N2) ANTIGEN (PROPIOLACTONE INACTIVATED) - 30 [hp_X]/mL INFLUENZA A VIRUS A/SINGAPORE/GP1908/2015 IVR-180A (H1N1) ANTIGEN (PROPIOLACTONE INACTIVATED) - 30 [hp_X]/mL INFLUENZA B VIRUS B/BRISBANE/60/2008 ANTIGEN (PROPIOLACTONE INACTIVATED) - 30 [hp_X]/mL IRON - 12 [hp_X]/mL LANTHANUM - 14 [hp_C]/mL LATRODECTUS MACTANS - 30 [hp_X]/mL LEAD - 12 [hp_X]/mL LITHIUM CARBONATE - 12 [hp_X]/mL LYCOPODIUM CLAVATUM SPORE - 12 [hp_X]/mL MAGNESIUM - 12 [hp_X]/mL MANGANESE - 12 [hp_X]/mL MEASLES VIRUS - 30 [hp_X]/mL MERCURIUS SOLUBILIS - 12 [hp_X]/mL METHYLENE CHLORIDE - 30 [hp_X]/mL METHYLPARABEN - 30 [hp_X]/mL MOLYBDENUM - 12 [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 PHOSPHORUS - 12 [hp_X]/mL PLATINUM - 12 [hp_X]/mL POLIOVIRUS - 30 [hp_X]/mL PRASEODYMIUM - 12 [hp_X]/mL PROPYLPARABEN - 30 [hp_X]/mL PROTEUS VULGARIS - 30 [hp_X]/mL PROTORTONIA CACTI - 12 [hp_X]/mL PSEUDOMONAS AERUGINOSA - 30 [hp_X]/mL RHODIUM - 12 [hp_X]/mL RUBIDIUM NITRITE - 12 [hp_X]/mL SALMONELLA ENTERICA SUBSP. ENTERICA SEROVAR TYPHI - 33 [hp_X]/mL SAMARIUM - 12 [hp_X]/mL SELENIUM - 12 [hp_X]/mL SILVER - 12 [hp_X]/mL SODIUM BENZOATE - 30 [hp_X]/mL SODIUM CITRATE - 30 [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 TITANIUM DIOXIDE - 30 [hp_X]/mL TOXICODENDRON PUBESCENS LEAF - 30 [hp_X]/mL URANYL NITRATE HEXAHYDRATE - 12 [hp_X]/mL VANADIUM - 12 [hp_X]/mL YERSINIA ENTEROCOLITICA - 30 [hp_X]/mL YTTERBIUM OXIDE - 12 [hp_X]/mL ZINC - 12 [hp_X]/mL ZINC OXIDE - 30 [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: | 12 Mar, 2018 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 03 Apr, 2023 |
| 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: | 10 May, 2026 |
| 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: | N0000185508 N0000175629 N0000184306 M0000728 M0005152 N0000175831 N0000008595 N0000008924 N0000175830 N0000183893 N0000183364 M0011310 M0023305 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | CPD4NFA903 DIF093I037 F79059A38U S7V92P67HO Z0H242BBR1 6P669D8HQ8 F5UM2KM3W7 OW5102UV6N U015TT5I8H N9E3X5056Q Load more... SBV4XY874G 00BH33GNGH 30K4522N6T GNR9HML8BA 0R0008Q3JB 3Y5X6RT823 0296055VE0 OVP6XX033E 3G0H8C9362 Q28R5GF371 789U1901C5 1D4N45714Q 77B218D3YE 514B9K0L10 444W947O8O 1HG84L3525 AU0V1LM3JT 639KR60Q1Q 96WE91N25T 79Y1949PYO W1XX32SQN1 2A26YW7PNX 045A6V3VFX 3DZY3Q314E 9JWN7VDQ7N 293LSV29OL E1UOL152H7 6I3K30563S XJJ7QA858R 2P299V784P 2BMD2GNA4V C88X29Y479 I38ZP9992A 42Z2K6ZL8P HT3R7C012Q 324Y4038G2 588X2YUY0A A2I8C7HI9T 81AH48963U AYT3H319PN 7OV03QG267 05175J654G 2E7M255OPY 5TWQ1V240M 27YLU75U4W 49DFR088MY FZJ641678T NKN7EZA750 Z8IX2SC1OH 11T9HCO30O LZB7TFX1LT Y793W5V55N DMK383DSAC 93722E7JA1 760T5R8B3O 42OD65L39F H6241UJ22B 3M4G523W1G OJ245FE5EU 1Q73Q2JULR 41YPU4MMCA 6424HBN274 06SSF7P179 AD84R52XLF 387GMG9FH5 15FIX9V2JP 6IO182RP7A 3V057702FY 00J9J9XKDE AUL7Y5Z806 T66CZ53RP4 J41CSQ7QDS SOI2LOH54Z |
| 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: | Standardized Chemical Allergen [EPC] Copper-containing Intrauterine Device [EPC] Inactivated Influenza B Virus Vaccine [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] Actively Acquired Immunity [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] Copper [CS] Influenza Vaccines [CS] Vaccines, Inactivated [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: | Acidifying Activity [MoA] Actively Acquired Immunity [PE] Allergens [CS] Ammonium Ion Binding Activity [MoA] Anti-coagulant [EPC] Calcium Chelating Activity [MoA] Calculi Dissolution Agent [EPC] Cell-mediated Immunity [PE] Copper Absorption Inhibitor [EPC] Copper [CS] Copper-containing Intrauterine Device [EPC] Decreased Coagulation Factor Activity [PE] Decreased Copper Ion Absorption [PE] Decreased Embryonic Implantation [PE] Decreased Sperm Motility [PE] Inactivated Influenza B Virus Vaccine [EPC] Increased Histamine Release [PE] Influenza Vaccines [CS] Inhibit Ovum Fertilization [PE] Mood Stabilizer [EPC] Nitrogen Binding Agent [EPC] Standardized Chemical Allergen [EPC] Vaccines Inactivated [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 |
|---|---|---|---|---|
| 43857-0471-1 | 30 mL in 1 BOTTLE, DROPPER (43857-0471-1) | 12 Mar, 2018 | 03 Apr, 2023 | 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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