| Drug NDC: | 43857-0384 |
| 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: | Lipotox |
| 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: | Squalene, Cholesterinum, Estradiol, Progesterone, Aspartame, Benzalkonium Chloride, Formalinum, Methylene Chloride, Methyl Paraben, Propyl Paraben, Sodium Benzoate, Sodium Citrate, Titanium Dioxide, Zincum Oxydatum, Arsenicum Album, Lycopodium Clavatum, Nux Vomica, Phosphoricum Acidum, Phosphorus, Aceticum Acidum, Adrenocorticotrophin, Benzoicum Acidum, Benzyl Alcohol, Boricum Acidum, Chlorinum, Cortisone Aceticum, Eugenol, Folliculinum, Isopropyl Palmitate, Lacticum Acidum, Petroleum Jelly |
| 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: | ACETIC ACID - 30 [hp_X]/mL ANHYDROUS TRISODIUM CITRATE - 30 [hp_X]/mL ARSENIC TRIOXIDE - 30 [hp_X]/mL ASPARTAME - 30 [hp_X]/mL BENZALKONIUM CHLORIDE - 30 [hp_X]/mL BENZOIC ACID - 30 [hp_X]/mL BENZYL ALCOHOL - 30 [hp_X]/mL BORIC ACID - 30 [hp_X]/mL CHLORINE - 30 [hp_X]/mL CHOLESTEROL - 12 [hp_X]/mL Load more... CORTICOTROPIN - 30 [hp_X]/mL CORTISONE ACETATE - 30 [hp_X]/mL ESTRADIOL - 12 [hp_X]/mL ESTRONE - 30 [hp_X]/mL EUGENOL - 30 [hp_X]/mL FORMALDEHYDE - 30 [hp_X]/mL ISOPROPYL ALCOHOL - 30 [hp_X]/mL LACTIC ACID, DL- - 30 [hp_X]/mL LEAD - 30 [hp_X]/mL LYCOPODIUM CLAVATUM SPORE - 30 [hp_X]/mL METHYLENE CHLORIDE - 30 [hp_X]/mL METHYLPARABEN - 30 [hp_X]/mL PETROLATUM - 30 [hp_X]/mL PHENYLBUTAZONE - 30 [hp_X]/mL PHOSPHORIC ACID - 30 [hp_X]/mL PHOSPHORUS - 30 [hp_X]/mL POTASSIUM SORBATE - 30 [hp_X]/mL PROGESTERONE - 12 [hp_X]/mL PROPYLPARABEN - 30 [hp_X]/mL RESORCINOL - 30 [hp_X]/mL SALICYLIC ACID - 30 [hp_X]/mL SODIUM BENZOATE - 30 [hp_X]/mL SORBITOL - 30 [hp_X]/mL SQUALENE - 8 [hp_X]/mL STEARYL ALCOHOL - 30 [hp_X]/mL STRYCHNOS NUX-VOMICA SEED - 30 [hp_X]/mL TITANIUM DIOXIDE - 30 [hp_X]/mL XYLITOL - 30 [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: | 11 Jan, 2016 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 09 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: | N0000175806 N0000175807 N0000181811 M0000499 N0000175941 M0447348 N0000175825 N0000000100 N0000185508 N0000175629 N0000184306 M0000728 M0017672 N0000175601 N0000185375 N0000185001 M0016962 M0516536 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | Q40Q9N063P RS7A450LGA S7V92P67HO Z0H242BBR1 F5UM2KM3W7 8SKN0B0MIM LKG8494WBH R57ZHV85D4 4R7X1O2820 97C5T2UQ7J Load more... K0U68Q2TXA 883WKN7W8X 4TI98Z838E 2DI9HA706A 3T8H1794QW 1HG84L3525 ND2M416302 3B8D35Y7S4 2P299V784P C88X29Y479 588X2YUY0A A2I8C7HI9T 4T6H12BN9U GN5P7K3T8S E4GA8884NN 27YLU75U4W 1VPU26JZZ4 4G7DS2Q64Y Z8IX2SC1OH YUL4LO94HK O414PZ4LPZ OJ245FE5EU 506T60A25R 7QWM220FJH 2KR89I4H1Y 269XH13919 15FIX9V2JP VCQ006KQ1E 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 MOA: | Ammonium Ion Binding Activity [MoA] Estrogen Receptor Agonists [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: | Nitrogen Binding Agent [EPC] Pediculicide [EPC] Adrenocorticotropic Hormone [EPC] Estrogen [EPC] Standardized Chemical Allergen [EPC] Progesterone [EPC] Non-Standardized Plant Allergenic Extract [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] Increased IgG Production [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: | Adrenocorticotropic Hormone [CS] Estradiol Congeners [CS] Allergens [CS] Progesterone [CS] Plant Proteins [CS] Seed Storage Proteins [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] Adrenocorticotropic Hormone [CS] Adrenocorticotropic Hormone [EPC] 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] Corticosteroid Hormone Receptor Agonists [MoA] Corticosteroid [EPC] Decreased Coagulation Factor Activity [PE] Decreased Copper Ion Absorption [PE] Estradiol Congeners [CS] Estrogen Receptor Agonists [MoA] Estrogen [EPC] Increased Histamine Release [PE] Increased IgG Production [PE] Nitrogen Binding Agent [EPC] Non-Standardized Plant Allergenic Extract [EPC] Pediculicide [EPC] Plant Proteins [CS] Progesterone [CS] Progesterone [EPC] Seed Storage Proteins [CS] Standardized Chemical Allergen [EPC] |
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. | |
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|---|---|---|---|
| 43857-0384-1 | 30 mL in 1 BOTTLE, DROPPER (43857-0384-1) | 11 Jan, 2016 | 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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