| Drug NDC: | 43857-0405 |
| 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: | Pneumotox |
| 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, Arnica Montana, Asclepias Tuberosa, Chamomilla, Echinacea (angustifolia), Eucalyptus Globulus, Fucus Vesiculosus, Hordeum Vulgare, Laminaria Digitata, Nasturtium Aquaticum, Plantago Major, Raphanus Sativus, Trifolium Pratense, Trigonella Foenum-graecum, Symphytum Officinale, Lung (suis), Oryza Sativa, Silicea, Acetone, Sodium Tripolyphosphate, Propylene Glycol, Sodium Benzene Sulfonate, Ammonium Muriaticum, Sodium Lauryl Sulfate, Terebinthina, Arsenicum Album |
| 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: | ACETONE - 9 [hp_X]/mL ALFALFA - 3 [hp_X]/mL AMMONIUM CHLORIDE - 9 [hp_X]/mL AMMONIUM THIOGLYCOLATE - 30 [hp_X]/mL ANHYDROUS CITRIC ACID - 30 [hp_X]/mL ANTHRAQUINONE - 30 [hp_X]/mL ARNICA MONTANA - 3 [hp_X]/mL ARSENIC TRIOXIDE - 12 [hp_X]/mL ASCLEPIAS TUBEROSA ROOT - 3 [hp_X]/mL DIMETHICONE - 30 [hp_X]/mL Load more... ECHINACEA ANGUSTIFOLIA - 3 [hp_X]/mL ETHYLENE GLYCOL - 30 [hp_X]/mL EUCALYPTUS GLOBULUS LEAF - 3 [hp_X]/mL FUCUS VESICULOSUS - 3 [hp_X]/mL GLUTARAL - 30 [hp_X]/mL GLYCOLIC ACID - 30 [hp_X]/mL HORDEUM VULGARE TOP - 3 [hp_X]/mL HYDROGEN PEROXIDE - 30 [hp_X]/mL LAMINARIA DIGITATA - 3 [hp_X]/mL MATRICARIA RECUTITA - 3 [hp_X]/mL METHYL METHACRYLATE - 30 [hp_X]/mL MONOETHANOLAMINE - 30 [hp_X]/mL NASTURTIUM OFFICINALE - 3 [hp_X]/mL NITRIC ACID - 12 [hp_X]/mL OENANTHE AQUATICA FRUIT - 12 [hp_X]/mL ORYZA SATIVA WHOLE - 8 [hp_X]/mL P-AMINOPHENOL - 30 [hp_X]/mL PALMITIC ACID - 30 [hp_X]/mL PARAFFIN - 30 [hp_X]/mL PHOSPHORIC ACID - 12 [hp_X]/mL PHOSPHORUS - 12 [hp_X]/mL PLANTAGO MAJOR - 3 [hp_X]/mL POLYACRYLIC ACID (8000 MW) - 30 1/mL PROPYL ALCOHOL - 30 [hp_X]/mL PROPYLENE GLYCOL - 9 [hp_X]/mL PULSATILLA VULGARIS - 12 [hp_X]/mL RAPHANUS SATIVUS - 3 [hp_X]/mL SILICON DIOXIDE - 8 [hp_X]/mL SODIUM BENZENESULFONATE - 9 [hp_X]/mL SODIUM CARBONATE - 30 [hp_X]/mL SODIUM CHLORIDE - 12 [hp_X]/mL SODIUM LAURYL SULFATE - 9 [hp_X]/mL SODIUM TRIPOLYPHOSPHATE - 9 [hp_X]/mL SUS SCROFA LUNG - 8 [hp_X]/mL SYMPHYTUM OFFICINALE WHOLE - 6 [hp_X]/mL TARTARIC ACID - 30 [hp_X]/mL TOLUENE-2,5-DIAMINE - 30 [hp_X]/mL TOXICODENDRON PUBESCENS LEAF - 12 [hp_X]/mL TRIFOLIUM PRATENSE FLOWER - 3 [hp_X]/mL TRIGONELLA FOENUM-GRAECUM WHOLE - 3 [hp_X]/mL TRITICUM AESTIVUM WHOLE - 1 [hp_X]/mL TURPENTINE OIL - 9 [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: | 03 Aug, 2016 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 29 Jun, 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: | N0000175833 N0000175835 N0000175980 N0000008556 N0000175089 N0000010282 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | 1364PS73AF DJO934BRBD 01Q9PC255D 6P9E788VZZ XF417D3PSL 030MS0JBDO O80TY208ZW S7V92P67HO 1ZL82U5D18 92RU3N3Y1O Load more... VB06AV5US8 FC72KVT52F S546YLW6E6 535G2ABX9M T3C89M417N 0WT12SX38S 86507VZR9K BBX060AN9V 15E7C67EE8 G0R4UBI2ZZ 196OC77688 5KV86114PT YH89GMV676 411VRN1TV4 N4LEE4Z93J 84IVV0906Z R7P8FRP05V 2V16EO95H1 I9O0E3H2ZE E4GA8884NN 27YLU75U4W W2469WNO6U 73861X4K5F 96F264O9SV 6DC9Q167V3 I76KB35JEV 86R5J6D01D ETJ7Z6XBU4 K5RM14AZHX 45P3261C7T 451W47IQ8X 368GB5141J 5HK03SA80J 7GL3G1COB3 H8FJJ6KX5Y W4888I119H 24JO8Z0RJU 6IO182RP7A 4JS0838828 5610HF69OB 3C3Y389JBU C5H0QJ6V7F |
| 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: | Acidifying Activity [MoA] Calcium Chelating Activity [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: | Calculi Dissolution Agent [EPC] Anti-coagulant [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: | Decreased Coagulation Factor Activity [PE] Skin Barrier Activity [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: | Acidifying Activity [MoA] Anti-coagulant [EPC] Calcium Chelating Activity [MoA] Calculi Dissolution Agent [EPC] Decreased Coagulation Factor Activity [PE] Sclerosing Activity [MoA] Sclerosing Agent [EPC] Skin Barrier Activity [PE] Vascular Sclerosing Activity [PE] |
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. | |
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|---|---|---|---|
| 43857-0405-1 | 30 mL in 1 BOTTLE, DROPPER (43857-0405-1) | 03 Aug, 2016 | 29 Jun, 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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