Regional Allergies Great Lakes U.S.

Product NDC
57955-2807
11-digit product format
579552807
Labeler code
57955
Product ID
57955-2807_59b78c88-6319-4d4a-976d-eff6129dcc03
Type
HUMAN OTC DRUG
Nonproprietary name
Adenosinum cyclophosphoricum, Adrenalinum, Adrenocorticotrophin, Allium cepa, Ambrosia artemisiaefolia, Arum triphyllum, Arundo mauritanica, Chelidonium majus, Chenopodium vulvaria, Cichorium intybus, Cortisone aceticum, Euphrasia officinalis, Galphimia glauca, Hedera helix, Histaminum hydrochloricum, Juglans cinerea, Kali muriaticum, Natrum muriaticum, Pulsatilla, RNA, Sabadilla, Teucrium scorodonia.
Dosage form
LIQUID
Route
ORAL
Labeler
King Bio Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2022-04-14
Marketing end
0000-00-00
Substance
ADENOSINE CYCLIC PHOSPHATE; AMBROSIA ARTEMISIIFOLIA WHOLE; ARISAEMA TRIPHYLLUM ROOT; ARUNDO PLINIANA ROOT; CHELIDONIUM MAJUS WHOLE; CHENOPODIUM VULVARIA WHOLE; CHICORY ROOT; CORTICOTROPIN; CORTISONE ACETATE; EPINEPHRINE; EUPHRASIA STRICTA; GALPHIMIA GLAUCA FLOWERING TOP; HEDERA HELIX FLOWERING TWIG; HISTAMINE DIHYDROCHLORIDE; JUGLANS CINEREA BRANCH BARK/ROOT BARK; ONION; POTASSIUM CHLORIDE; PULSATILLA VULGARIS WHOLE; SACCHAROMYCES CEREVISIAE RNA; SCHOENOCAULON OFFICINALE SEED; SODIUM CHLORIDE; TEUCRIUM SCORODONIA FLOWERING TOP
Active strength
12 [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL; [hp_X]/59mL
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], Adrenergic beta-Agonists [MoA], Adrenocorticotropic Hormone [CS], Adrenocorticotropic Hormone [EPC], Allergens [CS], Catecholamine [EPC], Catecholamines [CS], Cell-mediated Immunity [PE], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Non-Standardized Food Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Vegetable Proteins [CS], alpha-Adrenergic Agonist [EPC], beta-Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct57955-2807DDiscontinued by firm2026-09-14
excluded packagepackage57955-280757955-2807-2DDiscontinued by firm2026-09-14

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage57955-2807-2d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage57955-2807-2f5e01cc5f278…a2eaf40c39c3…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
57955-2807-2579552807021 BOTTLE, SPRAY in 1 CARTON (57955-2807-2) > 59 mL in 1 BOTTLE, SPRAY2022-04-140000-00-00NoNoCurrent