FDA.reportPublic FDA data

NDC 53209-2001-01 - Motrin IB

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
53209-2001
Requested NDC
53209-2001-01
Package NDCs from labels
53209-2001-1, 53209-2001-2, 53209-2001-01
Manufacturer
Morning Star OTC
Effective date
2025-06-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Motrin IB - Morning Star OTCMorning Star OTC2025-06-19HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53209-2001-1Motrin IB2 in 1 BLISTER PACKTABLET, FILM COATED21
53209-2001-2Motrin IB25 in 1 POUCHTABLET, FILM COATED251

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 12 of 195 · 3,891 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENDISCOUNT DRUG MART, INC.aae40114-343e-12da-e053-2a95a90a92132026-06-23WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENBJWC0ca0b6cf-7d1f-4673-b9b9-48f78d80c00a2026-06-23WarningsExact identifier
unii: WK2XYI10QM
pain reliefIBUPROFENBionpharma Inc.2b4ecdd8-627a-445f-8ddc-f2b6c832c1e82026-06-23WarningsExact identifier
unii: WK2XYI10QM
dye-free pain reliefIBUPROFENBionpharma Inc.c46c9c36-8844-7b50-e053-2a95a90aa0e92026-06-23WarningsExact identifier
unii: WK2XYI10QM
dye-free pain reliefIBUPROFENBionpharma Inc.4227d0b7-846a-dcb0-e063-6294a90af7d72026-06-23WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENCHAIN DRUG MARKETING ASSOCIATION INC.3c1c1b65-f57f-62b0-e063-6294a90a10212026-06-23WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENChain Drug Marketing Association, Inc.3802982a-2373-9ca3-e063-6394a90a0ab72026-06-23WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENCHAIN DRUG MARKETING ASSOCIATION INC.4573753d-117b-a6f2-e063-6394a90ae2f92026-06-23WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENChain Drug Marketing Association, Inc.3ed7faff-fd48-0a83-e063-6394a90aab142026-06-23WarningsExact identifier
unii: WK2XYI10QM
Pain ReliefIBUPROFENAlbertsons Companiesf9deaeb7-efb3-4019-e053-6394a90a33d62026-06-23WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENMEIJER DISTRIBUTION INC.bc15fea8-0d86-4546-e053-2995a90abee32026-06-23WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENMEIJER DISTRIBUTION INC.a13ac87b-b395-685e-e053-2a95a90ab5d32026-06-23WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENWhole Foods Market, INC.32348505-744c-fbfd-e063-6394a90a82d72026-06-23WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAMERISOURCE BERGEN1afcf0c6-bd41-4621-9e44-d97b81221c122026-06-23WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAMERISOURCE BERGENa13cee82-1c4e-0cbe-e053-2a95a90a3ab82026-06-23WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENA-S Medication Solutions51de1183-d226-4869-a00a-f6c74e126a392026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENA-S Medication Solutions25a94943-9acc-49c8-a4da-7e07bb2c35eb2026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENTopco Associates, LLC59a88ca7-eb37-46de-9134-a5a6d330bd492026-06-23WarningsExact identifier
rxcui: 310965
unii: WK2XYI10QM
RYDEEN UV CLEARSUNSCREENGuangzhou Oupeng Cosmetics Co., Ltd.548000cd-1655-aeb3-e063-6294a90ad0042026-06-22WarningsExact identifier
unii: 15FIX9V2JP
Ibuprofen FamotidineIBUPROFEN FAMOTIDINEDirect_Rx54d9e1fc-507d-1859-e063-6394a90a8c6b2026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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