Allergen Liquid
NDC Package 43857-0557-1
Package Information
Allergen (potassium gluconate, adrenalinum, hepar bovine, arsenicum album, phosphorus, pulsatilla (pratensis), sulphur, ambrosia artemisiaefolia, kentucky bluegrass, orchard grass, bermuda grass, johnson grass, rye grass, vernal grass, bahia grass, timothy grass, histaminum hydrochloricum) liquids is for temporary relief of sinus congestion, symptoms due to hay fever & allergic rhinitis. This formulation utilizes a liquid delivery system. Marketed by Bioactive Nutritional, Inc., this product is identified by NDC 43857-0557.
Identification & Billing
Clinical Specifications
- POTASSIUM GLUCONATE 16 [hp_X]/mL
- EPINEPHRINE 16 [hp_X]/mL
- BEEF LIVER 12 [hp_X]/mL
- ARSENIC TRIOXIDE 8 [hp_X]/mL
- PHOSPHORUS 16 [hp_X]/mL
- PULSATILLA PRATENSIS WHOLE 16 [hp_X]/mL
- SULFUR 8 [hp_X]/mL
- AMBROSIA ARTEMISIIFOLIA WHOLE 30 [hp_X]/mL
- POA PRATENSIS TOP 16 [hp_X]/mL
- DACTYLIS GLOMERATA TOP 16 [hp_X]/mL
- CYNODON DACTYLON POLLEN 16 [hp_X]/mL
- SORGHUM HALEPENSE POLLEN 12 [hp_X]/mL
- LOLIUM PERENNE POLLEN 16 [hp_X]/mL
- ANTHOXANTHUM ODORATUM 6 [hp_X]/mL
- PASPALUM NOTATUM POLLEN 12 [hp_X]/mL
- PHLEUM PRATENSE TOP 16 [hp_X]/mL
- HISTAMINE DIHYDROCHLORIDE 12 [hp_X]/mL
- Adrenergic alpha-Agonists - [MoA] (Mechanism of Action)
- Adrenergic beta-Agonists - [MoA] (Mechanism of Action)
- Allergens - [CS]
- Catecholamine - [EPC] (Established Pharmacologic Class)
- Catecholamines - [CS]
- Cell-mediated Immunity - [PE] (Physiologic Effect)
- Dietary Proteins - [CS]
- Increased Histamine Release - [PE] (Physiologic Effect)
- Increased IgG Production - [PE] (Physiologic Effect)
- Increased Large Intestinal Motility - [PE] (Physiologic Effect)
- Inhibition Large Intestine Fluid/Electrolyte Absorption - [PE] (Physiologic Effect)
- Meat Proteins - [EXT]
- Non-Standardized Food Allergenic Extract - [EPC] (Established Pharmacologic Class)
- Non-Standardized Pollen Allergenic Extract - [EPC] (Established Pharmacologic Class)
- Osmotic Activity - [MoA] (Mechanism of Action)
- Osmotic Laxative - [EPC] (Established Pharmacologic Class)
- Pollen - [CS]
- Potassium Compounds - [CS]
- Potassium Salt - [EPC] (Established Pharmacologic Class)
- Standardized Pollen Allergenic Extract - [EPC] (Established Pharmacologic Class)
- alpha-Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
- beta-Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
Regulatory & Marketing
Hierarchy Structure
- 43857 - Bioactive Nutritional, Inc.
- 43857-0557 - Allergen
- 43857-0557-1 - 30 mL in 1 BOTTLE, DROPPER
- 43857-0557 - Allergen
The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.
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Frequently Asked Questions
What is the distribution configuration for this product package?
The code 43857-0557-1 identifies a specific commercial package of 30 ml in 1 bottle, dropper of Allergen II, a human over the counter drug labeled by Bioactive Nutritional, Inc.. This liquid is formulated for oral use and contains potassium gluconate; epinephrine; beef liver; arsenic trioxide; phosphorus; pulsatilla pratensis whole; sulfur; ambrosia artemisiifolia whole; poa pratensis top; dactylis glomerata top; cynodon dactylon pollen; sorghum halepense pollen; lolium perenne pollen; anthoxanthum odoratum; paspalum notatum pollen; phleum pratense top; histamine dihydrochloride as the active substance.
Is this product currently listed with the FDA?
Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Bioactive Nutritional, Inc. on April 30, 2020. The current certification is valid through December 31, 2026.
How is this Bioactive Nutritional, Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 43857055701. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.
11-Digit Code Conversion
Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:
Note: The zero is added to the Package segment to maintain the 5-4-2 structure.