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
openFDA label cross-check#
Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Allergen 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 | BioActive Nutritional, Inc. | 2140b105-60d6-4b52-82f5-407211fd6933 | 2023-06-05 | Warnings | 43857-0557 |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Allergen
- Brand name suffix
- II
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| 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 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 12H3K5QKN9 | Internal UNII lookup |
| YKH834O4BH | Internal UNII lookup |
| W8N8R55022 | Internal UNII lookup |
| S7V92P67HO | Internal UNII lookup |
| 27YLU75U4W | Internal UNII lookup |
| 8E272251DI | Internal UNII lookup |
| 70FD1KFU70 | Internal UNII lookup |
| 9W34L2CQ9A | Internal UNII lookup |
| 7EA48700V9 | Internal UNII lookup |
| J41552QKAK | Internal UNII lookup |
| 175F461W10 | Internal UNII lookup |
| 577VA5B4HP | Internal UNII lookup |
| 4T81LB52R0 | Internal UNII lookup |
| YMW1K70E4Q | Internal UNII lookup |
| V003SHB7VK | Internal UNII lookup |
| S7PW24BX20 | Internal UNII lookup |
| 3POA0Q644U | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 2140b105-60d6-4b52-82f5-407211fd6933 | Available on FDA.report |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 43857-0557-1 | 2023-06-05 | C162847 | 48780-1 | f386c649-e281-0266-e053-dadaa90a7c1a | Drug Facts: |
| 43857-0557-1 | 2023-01-30 | C162847 | 48780-1 | f386c649-e281-0266-e053-dadaa90a7c1a | Drug Facts: |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 43857-0557-1 | AllergenII | 30 mL in 1 BOTTLE, DROPPER | LIQUID | 30 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 43857-0557 | ALLERGEN 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.] | 3 | Current NDC, Legacy NDC, 1 package rows | 20230607_2140b105-60d6-4b52-82f5-407211fd6933.zip |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 43857-0557-1 | 43857055701 | 30 mL in 1 BOTTLE, DROPPER (43857-0557-1) | 30 ml | 2020-04-30 | 0000-00-00 | No | No | Current |