Allergen I

Potassium Gluconate, Glandula Suprarenalis Bovine, Hepar Bovine, Arsenicum Album, Lycopodium Clavatum, Nux Vomica, Phosphorus, Peanut, Black Walnut, English Walnut, Amygdala Amara, Cashew, Coconut, Pecan, Brazil Nut, Tomato, Solanum Tuberosum, Piper Nigrum, Eggplant (solanum Melongena), Rape Seed Oil, Linum Usitatissimum, Sesame Seed, Cheese (stilton), Lac Vaccinum, Beef, Lamb, Pork, Chicken, Egg (whole), Phaseolus, Allium Cepa, Apple, Wheat, Banana, Strawberry, Cod (gadus Morhua), Tuna (thunnus Thynnus),

Bioactive Nutritional
Human Otc Drug
NDC 43857-0626

Allergen I also known as Potassium Gluconate, Glandula Suprarenalis Bovine, Hepar Bovine, Arsenicum Album, Lycopodium Clavatum, Nux Vomica, Phosphorus, Peanut, Black Walnut, English Walnut, Amygdala Amara, Cashew, Coconut, Pecan, Brazil Nut, Tomato, Solanum Tuberosum, Piper Nigrum, Eggplant (solanum Melongena), Rape Seed Oil, Linum Usitatissimum, Sesame Seed, Cheese (stilton), Lac Vaccinum, Beef, Lamb, Pork, Chicken, Egg (whole), Phaseolus, Allium Cepa, Apple, Wheat, Banana, Strawberry, Cod (gadus Morhua), Tuna (thunnus Thynnus), is a human otc drug labeled by 'Bioactive Nutritional'. National Drug Code (NDC) number for Allergen I is 43857-0626. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Allergen I drug includes Apple - 12 [hp_X]/mL Arsenic Trioxide - 12 [hp_X]/mL Atlantic Cod - 12 [hp_X]/mL Atlantic Salmon - 12 [hp_X]/mL Banana - 12 [hp_X]/mL Beef - 12 [hp_X]/mL Bitter Almond - 12 [hp_X]/mL Black Walnut - 12 [hp_X]/mL Bos Taurus Adrenal Gland - 8 [hp_X]/mL Brazil Nut - 12 [hp_X]/mL and more. The currest status of Allergen I drug is Active.

Drug Information:

Drug NDC:	43857-0626
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, English Walnut, Amygdala Amara, Cashew, Coconut, Pecan, Brazil Nut, Tomato, Solanum Tuberosum, Piper Nigrum, Eggplant (solanum Melongena), Rape Seed Oil, Linum Usitatissimum, Sesame Seed, Cheese (stilton), Lac Vaccinum, Beef, Lamb, Pork, Chicken, Egg (whole), Phaseolus, Allium Cepa, Apple, Wheat, Banana, Strawberry, Cod (gadus Morhua), Tuna (thunnus Thynnus),
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:	APPLE - 12 [hp_X]/mL ARSENIC TRIOXIDE - 12 [hp_X]/mL ATLANTIC COD - 12 [hp_X]/mL ATLANTIC SALMON - 12 [hp_X]/mL BANANA - 12 [hp_X]/mL BEEF - 12 [hp_X]/mL BITTER ALMOND - 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... CANOLA OIL - 12 [hp_X]/mL CASEIN, LACTOCOCCUS LACTIS CULTURED, PENICILLIUM ROQUEFORTI CULTURED, AGED - 12 [hp_X]/mL CASHEW - 12 [hp_X]/mL CHICKEN - 12 [hp_X]/mL COCONUT - 12 [hp_X]/mL CORTISONE ACETATE - 30 [hp_X]/mL COW MILK - 12 [hp_X]/mL CRANGON SHRIMP - 12 [hp_X]/mL EDIBLE ROCK CRAB - 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 FRAGARIA VESCA FRUIT - 12 [hp_X]/mL GREEN PEPPERCORN - 12 [hp_X]/mL HEPARIN, BOVINE - 8 [hp_X]/mL HISTAMINE DIHYDROCHLORIDE - 30 [hp_X]/mL HYALURONIDASE (BOVINE) - 30 [hp_X]/mL INTERLEUKIN-1 .BETA. HUMAN - 30 [hp_X]/mL KIDNEY BEAN - 12 [hp_X]/mL LAMB - 12 [hp_X]/mL LYCOPODIUM CLAVATUM SPORE - 12 [hp_X]/mL NORTHERN BLUEFIN TUNA - 12 [hp_X]/mL ONION - 12 [hp_X]/mL ORANGE - 12 [hp_X]/mL PACIFIC OYSTER - 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 SEROTONIN HYDROCHLORIDE - 30 [hp_X]/mL SESAME SEED - 12 [hp_X]/mL SOLANUM TUBEROSUM WHOLE - 12 [hp_X]/mL STRYCHNOS NUX-VOMICA SEED - 12 [hp_X]/mL TOMATO - 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 Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

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:	15 Jun, 2022
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date:	15 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.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.

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 M0000728 M0006342 N0000185015 N0000184306 N0000185014 N0000185017 N0000185019 N0000185018 M0013890 M0023708 N0000185375 M0016962 M0022575 N0000185001 M0516536 N0000185016
Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT).
UNII:	B423VGH5S9 S7V92P67HO RPX7J99EXW 7062I37LB3 4AJZ4765R9 4PIB2155QP O65SFW8R9A 02WM57RXZJ M2776SWB29 XKR79OET1K Load more... 331KBJ17RK IYI0G2057S 3H5U5CX7KO 0X8Q245Y7B 3RT3536DHY 883WKN7W8X 917J3173FT G1ZD4XB2AH RLE491K17W 291P45F896 W5K7RAS4VK 1V3SHR7QB7 4110YT348C CG6IX3GCMU 6G53L8ESRK P776JQ4R2F 3POA0Q644U 8KOG53Z5EM X62226112J M98C8416QO FOF26T73HA C88X29Y479 816CLQ4017 492225Q21H 5EVU04N5QU FX2S0D3781 QE1QX6B99R F14P91GB5F 27YLU75U4W O138UB266J 12H3K5QKN9 GKN429M9VS 7Y1255HVXR 2A8I57T4MX 269XH13919 Z4KHF2C175 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]
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] Milk Proteins [CS] Egg Proteins, Dietary [CS] Plant Proteins [CS] Vegetable 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:	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.

Packaging Information:

Package NDC	Description	Marketing Start Date	Marketing End Date	Sample Available
43857-0626-1	30 mL in 1 BOTTLE, DROPPER (43857-0626-1)	15 Jun, 2022	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.

Other medicines with the same generic name

Allergen I

Potassium Gluconate & more..

Liquid
BioActive Nutritional
NDC: 43857-0626

Purpose:

Indications: for temporary relief of gastrointestinal dyspepsia with flatulence and bloating, loss of weight and intolerance of certain foods.

Product Elements:

Allergen i potassium gluconate, glandula suprarenalis bovine, hepar bovine, arsenicum album, lycopodium clavatum, nux vomica, phosphorus, peanut, black walnut, english walnut, amygdala amara, cashew, coconut, pecan, brazil nut, tomato, solanum tuberosum, piper nigrum, eggplant (solanum melongena), rape seed oil, linum usitatissimum, sesame seed, cheese (stilton), lac vaccinum, beef, lamb, pork, chicken, egg (whole), phaseolus, allium cepa, apple, wheat, banana, strawberry, cod (gadus morhua), tuna (thunnus thynnus), potassium gluconate potassium cation bos taurus adrenal gland bos taurus adrenal gland heparin, bovine heparin, bovine arsenic trioxide arsenic cation (3+) lycopodium clavatum spore lycopodium clavatum spore strychnos nux-vomica seed strychnos nux-vomica seed phosphorus phosphorus peanut peanut black walnut black walnut english walnut english walnut bitter almond bitter almond cashew cashew coconut coconut pecan pecan brazil nut brazil nut tomato tomato solanum tuberosum whole solanum tuberosum whole green peppercorn green peppercorn eggplant eggplant canola oil canola oil flax seed flax seed sesame seed sesame seed casein, lactococcus lactis cultured, penicillium roqueforti cultured, aged casein, lactococcus lactis cultured, penicillium roqueforti cultured, aged cow milk cow milk beef beef lamb lamb pork pork chicken chicken egg egg kidney bean kidney bean onion onion apple apple wheat wheat banana banana fragaria vesca fruit alpine strawberry orange orange atlantic cod atlantic cod northern bluefin tuna northern bluefin tuna atlantic salmon atlantic salmon edible rock crab edible rock crab pacific oyster pacific oyster crangon shrimp crangon shrimp cortisone acetate cortisone histamine dihydrochloride histamine hyaluronidase (bovine) hyaluronidase (bovine) interleukin-1 .beta. human interleukin-1 .beta. human serotonin hydrochloride serotonin water alcohol

Indications and Usage:

Indications: for temporary relief of gastrointestinal dyspepsia with flatulence and bloating, loss of weight and intolerance of certain foods.

Warnings:

Warnings: if pregnant or breast-feeding, ask a health care professional before use. keep out of reach of children. in case of overdose, get medical help or contact a poison control center right away. do not use if tamper evident seal is broken or missing. store in a cool, dry place.

Dosage and Administration:

Directions: 10 drops orally, 3 times a day. consult a physician for use in children under 12 years of age.

Package Label Principal Display Panel:

Package label display: bio active nutritional allergen i homeopathic 1 fl oz (30 ml) allergen i

Further Questions:

Questions: distributed by: bioactive nutritional, inc. 1803 n. wickham rd. melbourne, fl 32935 bioactivenutritional.com

Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.