Equaline Ibuprofen
SuperValu Inc. Children’s Ibuprofen Oral Suspension Drug Facts
Approved
Approval ID
5e860059-afc8-419e-9451-b1c2265f5ce6
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Apr 18, 2025
Manufacturers
FDA
United Natural Foods, Inc. dba UNFI
DUNS: 943556183
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 Code41163-685
Application NumberANDA074937
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ibuprofen
Product Specifications
Route of AdministrationORAL
Effective DateApril 18, 2025
FDA Product Classification
INGREDIENTS (10)
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
SORBITOL SOLUTIONInactive
Code: 8KW3E207O2
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
ANHYDROUS CITRIC ACIDInactive
Code: XF417D3PSL
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
HIGH FRUCTOSE CORN SYRUPInactive
Code: XY6UN3QB6S
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 4/18/2025
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 3/5/2013
OTC - ACTIVE INGREDIENT SECTION
LOINC: 55106-9Updated: 12/10/2017
OTC - PURPOSE SECTION
LOINC: 55105-1Updated: 1/8/2015
WARNINGS SECTION
LOINC: 34071-1Updated: 12/10/2017
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 12/10/2017
STORAGE AND HANDLING SECTION
LOINC: 44425-7Updated: 12/10/2017
INACTIVE INGREDIENT SECTION
LOINC: 51727-6Updated: 6/3/2009
OTC - QUESTIONS SECTION
LOINC: 53413-1Updated: 6/3/2009