NDC 43857-0626-01 — Allergen I Potassium Gluconate, Glandula

🆔 Identity & classification

FDA NDC (as labeled) 43857-0626-1

Product NDC 43857-0626

11-digit billing NDC 43857062601

UNII 12H3K5QKN9, M2776SWB29, P776JQ4R2F, S7V92P67HO, C88X29Y479, 269XH13919 +12 more

UPC 0210184340711

SPL Set ID 25e10444-a2cc-4f74-bf38-9852c273e5ca

Established class (EPC) Non-Standardized Plant Allergenic Extract; Non-Standardized Food Allergenic Extract

Physiologic effect Increased Histamine Release; Cell-mediated Immunity; Increased IgG Production

Chemical class Allergens; Plant Proteins; Seed Storage Proteins; Dietary Proteins; Vegetable Proteins; Milk Proteins; Egg Proteins, Dietary

DEA schedule Non-controlled

Marketing category UNAPPROVED HOMEOPATHIC

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2022-06-15

Route ORAL

Dosage form LIQUID

Substance POTASSIUM GLUCONATE; BOS TAURUS ADRENAL GLAND; HEPARIN, BOVINE; ARSENIC TRIOXIDE; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; PHOSPHORUS; PEANUT; BLACK WALNUT; ENGLISH WALNUT; BITTER ALMOND; CASHEW; COCONUT; PECAN; BRAZIL NUT; TOMATO; SOLANUM TU

Why two NDCs? The FDA registers this code as 43857-0626-1 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 43857-0626-01. Same drug, same package — only the format differs.

Where does this data come from?

Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏭 Manufacturer & labeler

LabelerBioActive Nutritional

Labeler code43857

First marketedJun 2022

Product typeHuman Otc Drug

Portfolio17 products on file

🔎 All NDCs from BioActive Nutritional

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).

Where does this data come from?

Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

🧪 What is this product?

This is an unapproved homeopathic liquid taken by mouth that contains multiple food and plant extracts along with mineral substances. Homeopathic practitioners traditionally use such preparations as allergen extracts, though homeopathic products are not evaluated by the FDA for effectiveness. The product lists numerous common allergens including tree nuts, shellfish, dairy, meats, and vegetables in homeopathic dilutions. Homeopathic products are marketed based on traditional homeopathic theory rather than modern clinical evidence.

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →

Where does this data come from?

Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

UNII 3K9958V90M
A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
UNII 059QF0KO0R
Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

2 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesDemineralized Water, 25% Ethanol

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?

Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.

Why might an inactive ingredient be missing?

Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.

Can inactive ingredients matter?

Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price system	Per mL	Per package
Retail pharmacies payNADAC · weekly	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo	No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly	No Part D plan price is available for this NDC in our data.

ℹ️

No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.

Where does this data come from?

NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Allergen I 6 [hp_X]/mL; 8 [hp_X]/mL; 8 [hp_X]/mL; 12 [hp_X]/mL; 12 [hp_X]/mL; 12 [hp_X]/mL; 12 [hp_X]/mL; 12 [hp_X]/mLthis 43857-0626-01	BioActive	30 ml	—	—	FDA listed	—

About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where available.

Where does this data come from?

Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️

2022

On the market since

Jun 2022

📍

2026

Currently FDA-listed

4 years listed

🔒

·

No generic listed yet

brand only

ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

Where does this data come from?

Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📦 Packaging — all sizes for this product

Package NDC	Description	Marketing start	Status
43857-0626-01 You're viewing this	30 mL in 1 BOTTLE, DROPPER (43857-0626-1)	2022-06-15	Active

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product Homeopathic listing

About homeopathic listings

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 Nigru 6 [hp_X]/mL; 8 [hp_X]/mL; 8 [hp_X]/mL; 12 [hp_X]/mL; 12 [hp_X]/mL; 12 [hp_X]/mL; 12 [hp_X]/mL; 12 [hp_X]/mL LIQUID is listed under the homeopathic marketing category. An NDC listing in this category does not by itself establish FDA approval, and FDA does not evaluate homeopathic products for effectiveness. This page reports the listing data as published.

What data is (and isn’t) available for this NDC — tap to expand

NDC identity (package / product / labeler codes)	✓ Available
Labeler	✓ Available
Product & package description	✓ Available
Marketing category & status	✓ Available
Active ingredient / dosage form / route	✓ Available
FDA label (SPL via DailyMed)	✓ Available
Package photos	✓ Available
Inactive ingredients (structured)	✓ Available
NADAC pharmacy acquisition price (CMS)	— Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data	— Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk	— Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD)	— Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.

“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is this NDC FDA-approved?

An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Unapproved Homeopathic". Products approved under an application carry an NDA, ANDA, or BLA number.

Why is there no price listed?

The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.

Is the NDC printed on the package the same as the 11-digit billing NDC?

Yes, they identify this exact package in different formats. The FDA registers it as 43857-0626-1, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 43857-0626-01, written without dashes as 43857062601. The Identity section at the top of this page lists every form of this code.

What do the three segments of this NDC mean?

In 43857-0626-01, the first segment (43857) is the labeler code FDA assigned to BioActive Nutritional; the middle segment (0626) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.

Is this package still being marketed?

Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by BioActive Nutritional. Listing status can change — the directory data on this page refreshes weekly.

Who lists this product with the FDA?

BioActive Nutritional is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.

Do I need a prescription for this product?

This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.

This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.

Where does this data come from?

Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.

🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose

🎯 Indications and Usage 32 words ▾

USES: For temporary relief of gastrointestinal dyspepsia with flatulence and bloating, loss of weight and intolerance of certain foods.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

⏱️ Dosage and Administration 32 words ▾

DIRECTIONS: • 10 drops orally, 3 times a day or as directed by a health care professional. • Consult a health care professional for use in children under 12 years of age.

⚠️ Warnings 50 words ▾

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.

🧪 Active Ingredient 154 words ▾

ACTIVE INGREDIENTS: Allium Cepa 12X, 30X, Amygdala Amara 12X, 30X, Apple 12X, 30X, Arsenicum Album 12X, Banana 12X, 30X, Beef 12X, 30X, Black Walnut 12X, 30X, Brazil Nut 12X, 30X, Cashew 12X, 30X, Cheese 12X, 30X, Chicken 12X, 30X, Coconut 12X, 30X, Cod 12X, 30X, Cortisone Aceticum 30X, Crab 12X, 30X, Egg 12X, 30X, Eggplant 12X, 30X, English Walnut 12X, 30X, Fragaria Vesca 12X, 30X, Glandula Suprarenalis Bovine 8X, Hepar Bovine 8X, Histaminum Hydrochloricum 30X, Hyaluronidase 30X, Interferon (Human) 30X, Lac Vaccinum 12X, 30X, Lamb 12X, 30X, Linum Usitatissimum 12X, 30X, Lycopodium Clavatum 12X, Nux Vomica 12X, Orange 12X, 30X, Oyster 12X, 30X, Peanut 12X, 30X, Pecan 12X, 30X, Phaseolus 12X, 30X, Phosphorus 12X, Piper Nigrum 12X, 30X, Pork 12X, 30X, Potassium Gluconate 6X, Rape Seed Oil 12X, 30X, Salmon 12X, 30X, Sesame Seed 12X, 30X, Serotonin 30X, Shrimp 12X, 30X, Solanum Tuberosum 12X, 30X, Tomato 12X, 30X, Tuna 12X, 30X, Wheat 12X, 30X.

🧪 Inactive Ingredients 6 words ▾

INACTIVE INGREDIENTS: Demineralized Water, 25% Ethanol

🎯 Purpose ~1 min read ▾

PURPOSE: Allium Cepa - flatulence,** Amygdala Amara – bloating, indigestion,** Apple – food intolerance,** Arsenicum Album – gastrointestinal disturbances,** Banana – food intolerance,** Beef - food intolerance,** Black Walnut - food intolerance,** Brazil Nut - food intolerance,** Cashew - food intolerance,** Cheese - food intolerance,** Chicken - food intolerance,** Coconut - food intolerance,** Cod - food intolerance,** Cortisone Aceticum – anti-inflammatory,** Crab - food intolerance,** Egg - food intolerance,** Eggplant - food intolerance,** English Walnut - food intolerance,** Fragaria Vesca - food intolerance,** Glandula Suprarenalis Bovine – stomach cramps,** Hepar Bovine – support of liver,** Histaminum Hydrochloricum - diarrhea,** Hyaluronidase – sensitivity to food,** Interferon (Human) – sensitivity to food,** Lac Vaccinum - food intolerance,** Lamb - food intolerance,** Linum Usitatissimum - food intolerance,** Lycopodium Clavatum - indigestion,** Nux Vomica – abdominal pain,** Orange - food intolerance,** Oyster - food intolerance,** Peanut - food intolerance,** Pecan - food intolerance,** Phaseolus - food intolerance,** Phosphorus – burning stomach pain,** Piper Nigrum - food intolerance,** Pork - food intolerance,** Potassium Gluconate – stomach cramps,** Rape Seed Oil – food intolerance,** Salmon - food intolerance,** Sesame Seed - food intolerance,** Serotonin – sensitivity to food,** Shrimp – food intolerance,** Solanum Tuberosum - food intolerance,** Tomato - food intolerance,** Tuna - food intolerance,** Wheat - food intolerance** **Claims based on traditional homeopathic practice, not accepted medical evidence.

Not FDA evaluated.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

🔗 Related NDC lookups

🧪 All 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 Nigru NDCsSame ingredient 🏭 All BioActive labeler NDCsLabeler code 43857