| Drug NDC: | 43857-0241 |
| 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: | Allergen I |
| Also known as the trade name. It is the name of the product chosen by the labeler. | |
| Proprietary Name Base: | Allergen |
| The base of the Brand/Proprietary name excluding its suffix. | |
| Proprietary Name Suffix: | I |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. | |
| 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: | Potassium Gluconate, Glandula Suprarenalis Bovine, Hepar Bovine, Arsenicum Album, Lycopodium Clavatum, Nux Vomica, Phosphorus, Peanut, Black Walnut, Juglans Regia, Almond, Cashew, Coconut, Pecan, Brazil Nut, Lycopersicum Esculentum, Potato, Black Pepper, Eggplant, Gossypium Herbaceum, Flax, Parmesan Cheese, Milk, Beef, Lamb, Pork, Chicken, Egg, Beans, Allium Cepa, Malus Pumila, Flos, Triticum Aestivum, Banana, Fragaria Vesca, Citrus Sinensis, Cod, Tuna, Salmon, Limulus, Oyster, Shrimp, Cortisone Aceticum |
| Also known as the generic name, this is usually the active ingredient(s) of the product. | |
| Labeler Name: | Bioactive Nutritional |
| 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: | ALMOND - 12 [hp_X]/mL ALPINE STRAWBERRY - 12 [hp_X]/mL ARSENIC TRIOXIDE - 12 [hp_X]/mL BANANA - 12 [hp_X]/mL BEEF - 12 [hp_X]/mL BEEF LIVER - 8 [hp_X]/mL BLACK PEPPER - 12 [hp_X]/mL BLACK WALNUT - 12 [hp_X]/mL BOS TAURUS ADRENAL GLAND - 8 [hp_X]/mL BRAZIL NUT - 12 [hp_X]/mL Load more... CASEIN, LACTOCOCCUS LACTIS CULTURED - 12 [hp_X]/mL CASHEW - 12 [hp_X]/mL CHICKEN - 12 [hp_X]/mL COCONUT - 12 [hp_X]/mL COD, UNSPECIFIED - 12 [hp_X]/mL CORTISONE ACETATE - 30 [hp_X]/mL COW MILK - 12 [hp_X]/mL EGG - 12 [hp_X]/mL EGGPLANT - 12 [hp_X]/mL ENGLISH WALNUT - 12 [hp_X]/mL FLAX SEED - 12 [hp_X]/mL HISTAMINE DIHYDROCHLORIDE - 30 [hp_X]/mL HYALURONIDASE - 30 [hp_X]/mL INTERFERON .GAMMA. PORCINE RECOMBINANT - 30 [hp_X]/mL KIDNEY BEAN - 12 [hp_X]/mL LAMB - 12 [hp_X]/mL LEVANT COTTON SEED - 12 [hp_X]/mL LIMULUS POLYPHEMUS - 12 [hp_X]/mL LYCOPODIUM CLAVATUM SPORE - 12 [hp_X]/mL MALUS PUMILA FLOWER - 12 [hp_X]/mL ONION - 12 [hp_X]/mL ORANGE - 12 [hp_X]/mL OYSTER, UNSPECIFIED - 12 [hp_X]/mL PEANUT - 12 [hp_X]/mL PECAN - 12 [hp_X]/mL PHOSPHORUS - 12 [hp_X]/mL PORK - 12 [hp_X]/mL POTASSIUM GLUCONATE - 6 [hp_X]/mL POTATO - 12 [hp_X]/mL SALMON, UNSPECIFIED - 12 [hp_X]/mL SEROTONIN HYDROCHLORIDE - 30 [hp_X]/mL SESAME SEED - 12 [hp_X]/mL SHRIMP, UNSPECIFIED - 12 [hp_X]/mL SOLANUM LYCOPERSICUM - 12 [hp_X]/mL STRYCHNOS NUX-VOMICA SEED - 12 [hp_X]/mL TUNA, UNSPECIFIED - 12 [hp_X]/mL WHEAT - 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: | 26 Sep, 2013 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. | |
| Marketing End Date: | 16 Nov, 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: | 12 Jun, 2026 |
| This is the date when the listing record will expire if not updated or certified by the firm. | |
| Manufacturer Name: | BioActive Nutritional |
| 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 N0000185019 N0000185015 N0000185017 M0022575 N0000185018 N0000185014 M0013890 M0023708 N0000185375 M0016962 N0000185001 M0516536 N0000175531 M0009499 N0000185020 N0000185016 |
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). | |
| UNII: | 3Z252A2K9G CG6IX3GCMU S7V92P67HO 4AJZ4765R9 4PIB2155QP W8N8R55022 KM66971LVF 02WM57RXZJ M2776SWB29 XKR79OET1K Load more... 489F5JNV5B 3H5U5CX7KO 0X8Q245Y7B 3RT3536DHY 8D6Q5LNG3D 883WKN7W8X 917J3173FT 291P45F896 W5K7RAS4VK 1V3SHR7QB7 4110YT348C 3POA0Q644U 8KOG53Z5EM 69404B0LO7 M98C8416QO FOF26T73HA 550E4N439V 3R8874KEYH C88X29Y479 EF626V855K 492225Q21H 5EVU04N5QU S614XWR17V QE1QX6B99R F14P91GB5F 27YLU75U4W O138UB266J 12H3K5QKN9 CFE1S8DYWD 6122W2M0GB GKN429M9VS 7Y1255HVXR 1891LE191T 0243Q4990L 269XH13919 V2T3IHT3E2 4J2I0SN84Y |
| 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: | Non-Standardized Food Allergenic Extract [EPC] Non-Standardized Plant Allergenic Extract [EPC] Endoglycosidase [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: | Allergens [CS] Dietary Proteins [CS] Vegetable Proteins [CS] Milk Proteins [CS] Egg Proteins, Dietary [CS] Plant Proteins [CS] Seed Storage Proteins [CS] Glycoside Hydrolases [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: | Allergens [CS] Cell-mediated Immunity [PE] Corticosteroid Hormone Receptor Agonists [MoA] Corticosteroid [EPC] Dietary Proteins [CS] Egg Proteins Dietary [CS] Endoglycosidase [EPC] Fish Proteins Dietary [EXT] Fruit Proteins [EXT] Glycoside Hydrolases [CS] Grain Proteins [EXT] Increased Histamine Release [PE] Increased IgG Production [PE] Increased Large Intestinal Motility [PE] Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] Meat Proteins [EXT] Milk Proteins [CS] Non-Standardized Food Allergenic Extract [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 |
|---|---|---|---|---|
| 43857-0241-1 | 30 mL in 1 BOTTLE, DROPPER (43857-0241-1) | 30 Mar, 2017 | 16 Nov, 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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