MedPath

Onion

Generic Name
Onion
Drug Type
Biotech
Unique Ingredient Identifier
492225Q21H

Overview

Onion allergenic extract is used in allergenic testing.

Indication

No indication information available.

Associated Conditions

No associated conditions information available.

Research Report

Published: Jun 24, 2025

A Comprehensive Report on Onion Allergenic Extract (DB10548) and the Investigational Anesthetic ABP-700 (DB15411)

Part I: Onion (Allium cepa) Allergenic Extract (DB10548): A Diagnostic and Immunological Profile

1.0 Introduction to Onion as a Food Allergen

1.1 Overview

Onion (Allium cepa), a species within the Allium genus, is a vegetable cultivated and consumed globally, serving as a foundational ingredient in a vast array of culinary traditions.[1] Despite its ubiquity in the human diet, it is also a source of allergic reactions, which, while rare, can be severe.[1] The immunological response to onion is complex, capable of inducing both immediate (Type I) and delayed hypersensitivity reactions through various routes of exposure, including ingestion, direct skin contact, and inhalation of vapors during food preparation.[2]

To diagnose these allergic sensitivities, standardized allergenic extracts are employed in clinical settings. Onion Allergenic Extract (DrugBank ID: DB10548) is a non-standardized food allergenic extract derived from onion bulb tissue.[7] It is formulated for diagnostic use in skin testing to identify the presence of onion-specific immunoglobulin E (IgE) antibodies in sensitized individuals.[7] The extract is typically supplied in a phenol-preserved saline or glycerin-based solution for percutaneous or intradermal administration.[8] The diagnostic principle relies on the interaction between the allergenic proteins in the extract and IgE antibodies fixed to the surface of cutaneous mast cells. This interaction triggers mast cell degranulation, releasing histamine and other chemical mediators that produce a characteristic wheal-and-flare reaction, indicative of a positive test.[8]

1.2 Epidemiology and Prevalence

Continue reading the full research report

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Nutritional Specialties, Inc.
83027-0052
ORAL
1 [hp_X] in 1 mL
5/15/2025
Bestmade Natural Products
82969-5004
ORAL
30 [hp_C] in 30 [hp_C]
5/27/2025
Deseret Biologicals, Inc.
43742-2108
ORAL
6 [hp_X] in 1 mL
5/27/2025
Boiron
0220-9303
ORAL
5 [hp_C] in 1 1
5/12/2025
Allergy Laboratories, Inc.
54575-422
PERCUTANEOUS, SUBCUTANEOUS
1 g in 20 mL
3/15/2011
Nelco Laboratories, Inc.
36987-1474
INTRADERMAL, SUBCUTANEOUS
0.05 g in 1 mL
12/9/2009
Nelco Laboratories, Inc.
36987-1477
INTRADERMAL, SUBCUTANEOUS
0.1 g in 1 mL
12/9/2009
Deseret Biologicals, Inc.
43742-2178
ORAL
6 [hp_X] in 1 mL
4/22/2025
King Bio Inc.
57955-0762
ORAL
12 [hp_X] in 59 mL
5/20/2025
King Bio Inc.
57955-4809
ORAL
12 [hp_X] in 118 mL
5/2/2025

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.

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