MedPath
FDA Approval

Allergy Relief

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

FDA Approval Summary

Company
Effective Date
April 9, 2025
Labeling Type
HUMAN OTC DRUG LABEL
Chlorpheniramine(4 mg in 1 1)

Manufacturing Establishments1

FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.

LNK International, Inc.

Strategic Sourcing Services LLC

117025878

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Allergy Relief

Product Details

NDC Product Code
70677-1016
Application Number
M012
Marketing Category
OTC Monograph Drug (C200263)
Route of Administration
ORAL
Effective Date
April 9, 2025
Code: V1Q0O9OJ9ZClass: ACTIBQuantity: 4 mg in 1 1
STARCH, CORNInactive
Code: O8232NY3SJClass: IACT
D&C YELLOW NO. 10 ALUMINUM LAKEInactive
Code: CQ3XH3DET6Class: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMKClass: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30Class: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61UClass: IACT
© Copyright 2025. All Rights Reserved by MedPath