FDA.reportPublic FDA data

NDC 0121-4774-05 - IBUPROFEN

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0121-4774
Requested NDC
0121-4774-05
Package NDCs from labels
0121-4774-05, 0121-4774-40, 0121-4774-10
Manufacturer
Pharmaceutical Associates, Inc. | L. Perrigo Company
Effective date
2018-01-04
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
HIGH FRUCTOSE CORN SYRUP - Pharmaceutical Associates, Inc. | L. Perrigo CompanyPharmaceutical Associates, Inc. | L. Perrigo Company2018-01-04HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
0121-4774-102022-12-02Ibuprofen Oral Suspension USP 100 mg/5 mL
0121-4774-402022-12-02Ibuprofen Oral Suspension USP 100 mg/5 mL
0121-4774-102022-01-28Ibuprofen Oral Suspension USP 100 mg/5 mL
0121-4774-402022-01-28Ibuprofen Oral Suspension USP 100 mg/5 mL

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-4774-05ML - Milliliter0121-4774446c11c7-3098-421f-ae42-cfcb84e0253712013-10-17
0121-4774-40ML - Milliliter0121-477451d33980-495c-4a75-80de-c133e735f93212018-02-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IBUPROFENACTIVE INGREDIENTWK2XYI10QMIBUPROFEN SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]2
IBUPROFENACTIVE MOIETYWK2XYI10QMIBUPROFEN SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]2
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8IBUPROFEN SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPIBUPROFEN SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]2
CORN SYRUPINACTIVE INGREDIENT9G5L16BK6NIBUPROFEN SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]2
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LIBUPROFEN SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8IBUPROFEN SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXIBUPROFEN SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOIBUPROFEN SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]2
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HIBUPROFEN SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3IBUPROFEN SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]2
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUIBUPROFEN SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]2
SORBITOLINACTIVE INGREDIENT506T60A25RIBUPROFEN SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0RIBUPROFEN SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEIBUPROFEN SUSPENSION [PHARMACEUTICAL ASSOCIATES, INC.]2

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 92 · 1,837 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
dual actionACETAMINOPHEN, IBUPROFENRite Aid Corporation54b08d24-d5e9-4111-9d97-329896e8309d2026-09-09WarningsExact identifier
unii: WK2XYI10QM
Leader Eye Drops Redness ReliefGLYCERIN, NAPHAZOLINE HYDROCHLORIDECardinal Healthaee4bbe2-4f11-4c54-be8b-df48b3ba4f3a2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
IbuprofenIBUPROFENLidl US LLC0ca02f8b-4413-4e7c-a67b-8c67c53e13432026-09-09WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENGOODSENSE596a1007-08ea-00ec-e063-6394a90a5eb22026-09-09WarningsExact identifier
unii: WK2XYI10QM
ibuprofen childrensIBUPROFENRite Aid Corporationc6e68886-edcb-414d-9cba-0d97772ef8b62026-09-09WarningsExact identifier
rxcui: 197803
unii: WK2XYI10QM
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMRite Aid Corporation407c78ca-6fee-4ed6-b61b-711ec049c86e2026-09-09WarningsExact identifier
unii: PDC6A3C0OX
Ibuprofen minisIBUPROFENThe Kroger Co.15709fa7-114b-453c-b63d-f1c4f28f0f952026-09-08WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENREMEDYREPACK INC.2144eff0-d7ab-486d-b116-a4ff3ae2afe22026-09-08Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Clear Eyes NighttimeGLYCERINPrestige Brands Holdings, Inc.af75e2f7-81dd-43e0-a390-b52bbfbebf622026-09-08WarningsExact identifier
unii: PDC6A3C0OX
IbuprofenIBUPROFENThe Kroger Co.a7789f7f-3356-463b-9fd7-2d7f7eba27992026-09-08WarningsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENAmazon.com Services LLC90659e83-d989-46a5-9680-3a4f616125112026-09-04WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENDirect_Rx40071818-5bf0-095b-e063-6294a90ad58a2026-09-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMCVS Pharmacy3167c918-a7d3-46a1-a85b-64f9c22916f22026-09-04WarningsExact identifier
unii: PDC6A3C0OX
IbuprofenIBUPROFENChain Drug Marketing Association, Inc.8d518a08-486a-4d11-b042-27fc1e6060c92026-09-03WarningsExact identifier
unii: WK2XYI10QM
IBUPROFEN Immediate ReleaseIBUPROFENStrides Pharma Inca5dd275f-f388-44ec-8297-74430a742d522026-09-02Boxed warning, WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.0fa4cd66-66ad-4ec9-b38c-6b5840df39df2026-09-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Ibuprofen Immediate ReleaseIBUPROFENStrides Pharma Incebcc4da3-d0f6-4e40-99b5-e88310ea4a5b2026-09-02Boxed warning, WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENREMEDYREPACK INC.99730c4a-d2ee-46f5-91f4-a15cbaace40d2026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.3a38add6-a114-4e18-836c-3bfc727db2312026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENREMEDYREPACK INC.404df13d-4ada-4324-9eed-e21f5d5043a42026-09-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.