| PRODUCT NDC | 43857-0409 | 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. |
| PRODUCT TYPE NAME | HUMAN OTC DRUG | Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing. |
| PROPRIETARY NAME | Amoebatox | The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes. |
| NON PROPRIETARY NAME | Triticum Aestivum, Baptisia Tinctoria, Capsicum Annuum, Frasera Caroliniensis, Hamamelis Virginiana, Hydrastis Canadensis, Quassia Amara, Senna, Hydrastis Canadensis, Hepar Bovine, Pancreas Suis, Spleen (Bovine), Belladonna, Cinchona Officinalis, Lycopodium Clavatum, Nitricum Acidum, Nux Vomica, Entamoeba Histolytica, Giardia Lamblia30 | The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product. |
| DOSAGE FORM NAME | LIQUID | The translation of the dosage form Code submitted by the firm. |
| ROUTE NAME | ORAL | The translation of the route code submitted by the firm, indicating route of administration. |
| START MARKETING DATE | 8/18/2016 | This is the date that the labeler indicates was the start of its marketing of the drug product. |
| END MARKETING DATE | 2/18/2024 | 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. |
| MARKETING CATEGORY NAME | UNAPPROVED HOMEOPATHIC | Product types are broken down into several potential Marketing Categories, such as NDA/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. |
| LABELER NAME | BioActive Nutritional, Inc. | Name of Company corresponding to the labeler code segment of the Product NDC. |
| SUBSTANCE NAME | ALPINE STRAWBERRY; ATROPA BELLADONNA; BAPTISIA TINCTORIA ROOT; BEEF LIVER; BOS TAURUS SPLEEN; CAPSICUM; CINCHONA OFFICINALIS BARK; ENTAMOEBA HISTOLYTICA; FRASERA CAROLINIENSIS ROOT; GIARDIA LAMBLIA; GOLDENSEAL; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; QUASSIA AMARA WOOD; SENNA LEAF; STRYCHNOS NUX-VOMICA SEED; SUS SCROFA PANCREAS; TRITICUM AESTIVUM WHOLE | An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted. |
| ACTIVE NUMERATOR STRENGTH | 3; 12; 3; 8; 8; 3; 12; 15; 3; 15; 5; 3; 12; 12; 3; 3; 12; 8; 1 | |
| ACTIVE INGRED UNIT | [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL | |
| PHARM CLASSES | Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Meat Proteins [EXT], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS], Vegetable Proteins [CS] | |