Allergen

Product NDC
43857-0557
11-digit product format
438570557
Labeler code
43857
Product ID
43857-0557_d46c8440-f512-4247-9eb0-8a7b4f165bb3
Type
HUMAN OTC DRUG
Nonproprietary 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
Dosage form
LIQUID
Route
ORAL
Labeler
BioActive Nutritional, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2020-04-30
Substance
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
Active strength
16; 16; 12; 8; 16; 16; 8; 30; 16; 16; 16; 12; 16; 6; 12; 16; 12 [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
Pharmacologic 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]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Allergen
Brand name suffix
II
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMBROSIA ARTEMISIIFOLIA WHOLE16 [hp_X]/mL
ANTHOXANTHUM ODORATUM16 [hp_X]/mL
ARSENIC TRIOXIDE12 [hp_X]/mL
BEEF LIVER8 [hp_X]/mL
CYNODON DACTYLON POLLEN16 [hp_X]/mL
DACTYLIS GLOMERATA TOP16 [hp_X]/mL
EPINEPHRINE8 [hp_X]/mL
HISTAMINE DIHYDROCHLORIDE30 [hp_X]/mL
LOLIUM PERENNE POLLEN16 [hp_X]/mL
PASPALUM NOTATUM POLLEN16 [hp_X]/mL
PHLEUM PRATENSE TOP16 [hp_X]/mL
PHOSPHORUS12 [hp_X]/mL
POA PRATENSIS TOP16 [hp_X]/mL
POTASSIUM GLUCONATE6 [hp_X]/mL
PULSATILLA PRATENSIS WHOLE12 [hp_X]/mL
SORGHUM HALEPENSE POLLEN16 [hp_X]/mL
SULFUR12 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9W34L2CQ9A, YMW1K70E4Q, S7V92P67HO, W8N8R55022, 175F461W10, J41552QKAK, YKH834O4BH, 3POA0Q644U, 4T81LB52R0, V003SHB7VK, S7PW24BX20, 27YLU75U4W, 7EA48700V9, 12H3K5QKN9, 8E272251DI, 577VA5B4HP, 70FD1KFU70

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43857-0557-12023-06-05C16284748780-1f386c649-e281-0266-e053-dadaa90a7c1aDrug Facts:
43857-0557-12023-01-30C16284748780-1f386c649-e281-0266-e053-dadaa90a7c1aDrug Facts:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43857-0557-1AllergenII30 mL in 1 BOTTLE, DROPPERLIQUID303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43857-0557ALLERGEN II (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) LIQUID [BIOACTIVE NUTRITIONAL, INC.]3Current NDC, Legacy NDC, 1 package rows20230607_2140b105-60d6-4b52-82f5-407211fd6933.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43857-0557-14385705570130 mL in 1 BOTTLE, DROPPER (43857-0557-1) 30 ml2020-04-300000-00-00NoNoCurrent