| Drug NDC: | 43857-0502 |
| 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: | Renotox |
| 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, Asparagus Officinalis, Berberis Vulgaris, Echinacea (angustifolia), Kali Muriaticum, Petroselinum Sativum, Sabal Serrulata, Solidago Virgaurea, Taraxacum Officinale, Uva-ursi, Barosma (betulina), Eupatorium Purpureum, Kidney (suis), Bryonia (alba), Mercurius Corrosivus, Aluminum Metallicum, Antimonium Crudum, Argentum Metallicum, Arsenicum Album, Aurum Metallicum, Baryta Carbonica, Beryllium Metallicum, Bismuthum Metallicum, Boron, Bromium, Cadmium Metallicum, Cerium 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: | AGATHOSMA BETULINA LEAF - 5 [hp_X]/mL ALUMINUM - 12 [hp_X]/mL ANTIMONY TRISULFIDE - 12 [hp_X]/mL ARCTOSTAPHYLOS UVA-URSI LEAF - 3 [hp_X]/mL ARSENIC TRIOXIDE - 12 [hp_X]/mL ASPARAGUS - 3 [hp_X]/mL BARIUM CARBONATE - 12 [hp_X]/mL BERBERIS VULGARIS ROOT BARK - 3 [hp_X]/mL BERYLLIUM - 12 [hp_X]/mL BISMUTH - 12 [hp_X]/mL Load more... BORON - 12 [hp_X]/mL BOTULINUM TOXIN TYPE A - 30 [hp_X]/mL BROMINE - 12 [hp_X]/mL BRYONIA ALBA ROOT - 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 CLOSTRIDIUM PERFRINGENS - 15 [hp_C]/mL COBALT - 12 [hp_X]/mL COPPER - 12 [hp_X]/mL DYSPROSIUM - 12 [hp_X]/mL ECHINACEA ANGUSTIFOLIA - 3 [hp_X]/mL ERBIUM - 12 [hp_X]/mL ESCHERICHIA COLI - 30 [hp_X]/mL EUROPIUM - 12 [hp_X]/mL EUTROCHIUM PURPUREUM ROOT - 6 [hp_X]/mL GADOLINIUM - 12 [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/SINGAPORE/GP1908/2015 IVR-180 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED) - 30 [hp_X]/mL INFLUENZA A VIRUS A/SINGAPORE/INFIMH-16-0019/2016 NIB-104 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED) - 30 [hp_X]/mL INFLUENZA B VIRUS B/MARYLAND/15/2016 ANTIGEN (FORMALDEHYDE INACTIVATED) - 30 [hp_X]/mL INFLUENZA B VIRUS B/PHUKET/3073/2013 ANTIGEN (FORMALDEHYDE INACTIVATED) - 30 [hp_X]/mL IRON - 12 [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 MEASLES VIRUS - 30 [hp_X]/mL MERCURIC CHLORIDE - 12 [hp_X]/mL MERCURIUS SOLUBILIS - 12 [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 PETROSELINUM CRISPUM - 3 [hp_X]/mL PLATINUM - 12 [hp_X]/mL POLIOVIRUS - 30 [hp_X]/mL PORK KIDNEY - 8 [hp_X]/mL POTASSIUM CHLORIDE - 3 [hp_X]/mL PRASEODYMIUM - 12 [hp_X]/mL PROTEUS VULGARIS - 30 [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 SAW PALMETTO - 3 [hp_X]/mL SELENIUM - 12 [hp_X]/mL SILVER - 12 [hp_X]/mL SOLIDAGO VIRGAUREA FLOWERING TOP - 3 [hp_X]/mL STRONTIUM CARBONATE - 12 [hp_X]/mL TANTALUM - 30 [hp_C]/mL TARAXACUM OFFICINALE - 3 [hp_X]/mL TERBIUM - 12 [hp_X]/mL THALLIUM - 12 [hp_X]/mL TIN - 12 [hp_X]/mL TRITICUM AESTIVUM WHOLE - 1 [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 |
| 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: | 08 Jan, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 25 Feb, 2024 |
| 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: | 09 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: | N0000185371 N0000175629 N0000184306 M0000728 M0006342 M0022575 N0000175771 N0000193962 N0000175731 N0000175770 N0000185508 M0005152 N0000175831 N0000008595 N0000008924 N0000175830 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | 369DDH39Z0 CPD4NFA903 F79059A38U 3M5V3D1X36 S7V92P67HO Z1EJP3037Z 6P669D8HQ8 1TH8Q20J0U OW5102UV6N U015TT5I8H Load more... N9E3X5056Q E211KPY694 SBV4XY874G T7J046YI2B 00BH33GNGH 30K4522N6T GNR9HML8BA 0R0008Q3JB OVP6XX033E 3G0H8C9362 789U1901C5 1D4N45714Q VB06AV5US8 77B218D3YE 514B9K0L10 444W947O8O 0VYG5PVN5Q AU0V1LM3JT 96WE91N25T 79Y1949PYO W1XX32SQN1 2A26YW7PNX 045A6V3VFX Q3P251C5MT 2ZSC17SIJ6 8V4458342X B93BQX9789 E1UOL152H7 6I3K30563S 2P299V784P 2BMD2GNA4V I38ZP9992A 42Z2K6ZL8P HT3R7C012Q 53GH7MZT1R 324Y4038G2 81AH48963U AYT3H319PN 7OV03QG267 05175J654G 2E7M255OPY 5TWQ1V240M 1WZA4Y92EX 49DFR088MY FZJ641678T X7BCI5P86H 660YQ98I10 NKN7EZA750 11T9HCO30O Y793W5V55N DMK383DSAC 93722E7JA1 760T5R8B3O 42OD65L39F J7WWH9M8QS H6241UJ22B 3M4G523W1G 5405K23S50 41YPU4MMCA 6424HBN274 39981FM375 06SSF7P179 AD84R52XLF 387GMG9FH5 3C3Y389JBU 3V057702FY 00J9J9XKDE AUL7Y5Z806 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 MOA: | Acetylcholine Release Inhibitors [MoA] |
| Mechanism of action of the drug—molecular, subcellular, or cellular functional activity—of the drug’s established pharmacologic class. Takes the form of the mechanism of action, followed by `[MoA]` (such as `Calcium Channel Antagonists [MoA]` or `Tumor Necrosis Factor Receptor Blocking Activity [MoA]`. | |
| Pharmacologic Class EPC: | Non-Standardized Food Allergenic Extract [EPC] Acetylcholine Release Inhibitor [EPC] Neuromuscular Blocker [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] Neuromuscular Blockade [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: | Acetylcholine Release Inhibitor [EPC] Acetylcholine Release Inhibitors [MoA] Allergens [CS] 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 Large Intestinal Motility [PE] Inhibit Ovum Fertilization [PE] Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] Mood Stabilizer [EPC] Neuromuscular Blockade [PE] Neuromuscular Blocker [EPC] Non-Standardized Food Allergenic Extract [EPC] Osmotic Activity [MoA] Osmotic Laxative [EPC] Potassium Compounds [CS] Potassium Salt [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 |
|---|---|---|---|---|
| 43857-0502-1 | 30 mL in 1 BOTTLE, DROPPER (43857-0502-1) | 08 Jan, 2019 | 25 Feb, 2024 | 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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