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FDA Approval

Childrens Allergy Relief

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

FDA Approval Summary

Company
Cardinal Health 110, LLC. DBA Leader
DUNS: 063997360
Effective Date
April 28, 2025
Labeling Type
HUMAN OTC DRUG LABEL
Diphenhydramine(12.5 mg in 5 mL)

Manufacturing Establishments1

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

LNK International, Inc.

Cardinal Health 110, LLC. DBA Leader

967626305

Products1

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

Childrens Allergy Relief

Product Details

NDC Product Code
70000-0701
Application Number
M012
Marketing Category
OTC Monograph Drug (C200263)
Route of Administration
ORAL
Effective Date
April 28, 2025
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSLClass: IACT
GLYCERINInactive
Code: PDC6A3C0OXClass: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3Class: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EUClass: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8XClass: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95KClass: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4Class: IACT
XANTHAN GUMInactive
Code: TTV12P4NEEClass: IACT
Code: TC2D6JAD40Class: ACTIBQuantity: 12.5 mg in 5 mL
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