43857-0557 NDC - 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)

Drug Information

Product NDC: 43857-0557
Proprietary Name: Allergen
Non Proprietary Name: 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
Active Ingredient(s): 16 [hp_X]/mL AMBROSIA ARTEMISIIFOLIA WHOLE; 16 [hp_X]/mL ANTHOXANTHUM ODORATUM; 12 [hp_X]/mL ARSENIC TRIOXIDE; 8 [hp_X]/mL BEEF LIVER; 16 [hp_X]/mL CYNODON DACTYLON POLLEN; 16 [hp_X]/mL DACTYLIS GLOMERATA TOP; 8 [hp_X]/mL EPINEPHRINE; 30 [hp_X]/mL HISTAMINE DIHYDROCHLORIDE; 16 [hp_X]/mL LOLIUM PERENNE POLLEN; 16 [hp_X]/mL PASPALUM NOTATUM POLLEN; 16 [hp_X]/mL PHLEUM PRATENSE TOP; 12 [hp_X]/mL PHOSPHORUS; 16 [hp_X]/mL POA PRATENSIS TOP; 6 [hp_X]/mL POTASSIUM GLUCONATE; 12 [hp_X]/mL PULSATILLA PRATENSIS WHOLE; 16 [hp_X]/mL SORGHUM HALEPENSE POLLEN; 12 [hp_X]/mL SULFUR
Administration Route(s): ORAL
Dosage Form(s): LIQUID
Pharmacy Class(es): Adrenergic alpha-Agonists [MoA]; Adrenergic beta-Agonists [MoA]; Allergens [CS]; Allergens [CS]; Allergens [CS]; Allergens [CS]; Catecholamine [EPC]; Catecholamines [CS]; Cell-mediated Immunity [PE]; Cell-mediated Immunity [PE]; Cell-mediated Immunity [PE]; Cell-mediated Immunity [PE]; Dietary Proteins [CS]; Increased Histamine Release [PE]; Increased Histamine Release [PE]; Increased Histamine Release [PE]; Increased Histamine Release [PE]; Increased IgG Production [PE]; Increased IgG Production [PE]; Increased IgG Production [PE]; Increased Large Intestinal Motility [PE]; Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]; Meat Proteins [EXT]; Non-Standardized Food Allergenic Extract [EPC]; Non-Standardized Pollen Allergenic Extract [EPC]; Non-Standardized Pollen Allergenic Extract [EPC]; Osmotic Activity [MoA]; Osmotic Laxative [EPC]; Pollen [CS]; Pollen [CS]; Pollen [CS]; Potassium Compounds [CS]; Potassium Salt [EPC]; Standardized Pollen Allergenic Extract [EPC]; alpha-Adrenergic Agonist [EPC]; beta-Adrenergic Agonist [EPC]

Labeler Information

Field Name	Field Value
Labeler Name:	BioActive Nutritional, Inc.
Product Type:	HUMAN OTC DRUG
FDA Application Number:
Marketing Category:	UNAPPROVED HOMEOPATHIC
Start Marketing Date:	4/30/2020

Package Information

No.	Package Code	Package Description	Billing Unit
1	43857-0557-1	30 mL in 1 BOTTLE, DROPPER (43857-0557-1)

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	43857-0557	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	Allergen	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
PROPRIETARY NAME SUFFIX	II	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.
NON PROPRIETARY NAME	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	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	4/30/2020	This is the date that the labeler indicates was the start of its marketing of the drug product.
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	AMBROSIA ARTEMISIIFOLIA WHOLE; ANTHOXANTHUM ODORATUM; ARSENIC TRIOXIDE; BEEF LIVER; CYNODON DACTYLON POLLEN; DACTYLIS GLOMERATA TOP; EPINEPHRINE; HISTAMINE DIHYDROCHLORIDE; LOLIUM PERENNE POLLEN; PASPALUM NOTATUM POLLEN; PHLEUM PRATENSE TOP; PHOSPHORUS; POA PRATENSIS TOP; POTASSIUM GLUCONATE; PULSATILLA PRATENSIS WHOLE; SORGHUM HALEPENSE POLLEN; SULFUR	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	16; 16; 12; 8; 16; 16; 8; 30; 16; 16; 16; 12; 16; 6; 12; 16; 12
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_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; [hp_X]/mL
PHARM CLASSES	Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Catecholamine [EPC], Catecholamines [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Meat Proteins [EXT], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Non-Standardized Pollen Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Pollen [CS], Pollen [CS], Pollen [CS], Potassium Compounds [CS], Potassium Salt [EPC], Standardized Pollen Allergenic Extract [EPC], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]

Drug Information

Labeler Information

Package Information

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