FDA.reportPublic FDA data

NDC 51672-1385-08 - 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
51672-1385
Requested NDC
51672-1385-08
Package NDCs from labels
51672-1385-8, 51672-1385-9, 51672-1385-08
Manufacturer
REMEDYREPACK INC.
Effective date
2026-03-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ibuprofen Oral Suspension USP, 100 mg/5 mLREMEDYREPACK INC.2026-03-24HUMAN PRESCRIPTION DRUG LABEL
Ibuprofen Oral Suspension USP, 100 mg/5 mLSun Pharmaceutical Industries, Inc. | Sun Pharma Canada Inc.2025-12-27HUMAN PRESCRIPTION DRUG LABEL
Ibuprofen Oral Suspension USP, 100 mg/5 mLPharmaceutical Associates, Inc.2024-11-21HUMAN PRESCRIPTION DRUG LABEL
Ibuprofen Oral Suspension USP, 100 mg/5 mLPreferred Pharmaceuticals Inc.2020-06-11HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-1385-8Ibuprofen1 in 1 CARTONSUSPENSION18
51672-1385-8Ibuprofen118 mL in 1 BOTTLESUSPENSION1188
51672-1385-9Ibuprofen473 mL in 1 BOTTLESUSPENSION4738

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1385IBUPROFEN SUSPENSION [SUN PHARMACEUTICAL INDUSTRIES, INC.]6Current NDC, Legacy NDC, 3 package rows20250406_a8b46ae5-67bc-494d-850e-b4e4ed5a33b3.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1385-8ML - Milliliter51672-138513a2a3e8-f834-4d2d-a6b8-b343115b264c12017-10-13
51672-1385-9ML - Milliliter51672-13857c8f4189-f5ee-4e29-8c05-9539e9dfe33f12017-10-13

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 90 · 1,783 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.