Dye Free Childrens Ibuprofen
Children's Ibuprofen Oral Suspension Grape Dye Free
Approved
Approval ID
2cf2a4de-29d3-8af5-e063-6294a90a9cee
Product Type
HUMAN OTC DRUG LABEL
Effective Date
May 1, 2025
Manufacturers
FDA
CVS
DUNS: 062312574
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ibuprofen
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51316-914
Application NumberANDA210149
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ibuprofen
Product Specifications
Route of AdministrationORAL
Effective DateMay 1, 2025
FDA Product Classification
INGREDIENTS (9)
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
STARCH, PREGELATINIZED CORNInactive
Code: O8232NY3SJ
Classification: IACT
IBUPROFENActive
Quantity: 100 mg in 5 mL
Code: WK2XYI10QM
Classification: ACTIB
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT