Childrens Zyrtec
Children's Zyrtec Chewable Tablets 10mg
Approved
Approval ID
0fe77356-d945-46a0-882e-b3bbab784556
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Apr 7, 2025
Manufacturers
FDA
Kenvue Brands LLC
DUNS: 118772437
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Cetirizine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50580-791
Application NumberNDA021621
Product Classification
M
Marketing Category
C73594
G
Generic Name
Cetirizine hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 7, 2025
FDA Product Classification
INGREDIENTS (7)
BETADEXInactive
Code: JV039JZZ3A
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
CETIRIZINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: 64O047KTOA
Classification: ACTIB