Childrens Allergy Relief
Leader 44-018
Approved
Approval ID
d2dab450-cf82-4be2-a4e2-630295fb59ab
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Apr 28, 2025
Manufacturers
FDA
Cardinal Health 110, LLC. DBA Leader
DUNS: 063997360
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Diphenhydramine HCl
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70000-0701
Application NumberM012
Product Classification
M
Marketing Category
C200263
G
Generic Name
Diphenhydramine HCl
Product Specifications
Route of AdministrationORAL
Effective DateApril 28, 2025
FDA Product Classification
INGREDIENTS (10)
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
TRISODIUM CITRATE DIHYDRATEInactive
Code: B22547B95K
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
DIPHENHYDRAMINE HYDROCHLORIDEActive
Quantity: 12.5 mg in 5 mL
Code: TC2D6JAD40
Classification: ACTIB