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 57 of 195 · 3,891 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
YOUR SKIN BUT BETTER CC COLOR CORRECTING FULL COVERAGE SPF 50 TANTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLC5cce7646-d9f5-454b-b7a8-a5a6b62a19162025-12-19WarningsExact identifier
unii: 15FIX9V2JP
YOUR SKIN BUT BETTER CC COLOR CORRECTING FULL COVERAGE SPF 50 RICHTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLC7da16dd7-c26c-4c4e-905f-3bbb878022cc2025-12-19WarningsExact identifier
unii: 15FIX9V2JP
YOUR SKIN BUT BETTER CC COLOR CORRECTING FULL COVERAGE SPF 50 MEDIUM-TANTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLC85f3dd47-4f1f-4fa3-a171-4f4b7707191c2025-12-19WarningsExact identifier
unii: 15FIX9V2JP
YOUR SKIN BUT BETTER CC ILLUMINATION FAIRTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLC4e5764f3-9d9e-460b-ab1e-36f280281dec2025-12-19WarningsExact identifier
unii: 15FIX9V2JP
Acetaminophen and IbuprofenACETAMINOPHEN AND IBUPROFENWAL-MART STORES INC.0aaddde9-4317-a828-e063-6294a90a26d52025-12-19WarningsExact identifier
unii: WK2XYI10QM
YOUR SKIN BUT BETTER CC COLOR CORRECTING FULL COVERAGE SPF 50 MEDIUMTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLCe700dc6e-e7ae-47ee-9974-430bfd045b4f2025-12-19WarningsExact identifier
unii: 15FIX9V2JP
YOUR SKIN BUT BETTER CC ILLUMINATION MEDIUM-TANTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLCc7924d60-03fb-4a4d-b718-e324f6f1f65f2025-12-19WarningsExact identifier
unii: 15FIX9V2JP
IbuprofenIBUPROFENRetail Business Services, LLC04115ec1-ef31-1746-e063-6394a90a0a522025-12-19WarningsExact identifier
rxcui: 310965
unii: WK2XYI10QM
IbuprofenIBUPROFENRETAIL BUSINESS SERVICES,LLC.a567dc6f-bd83-b9f5-e053-2995a90a05ee2025-12-19WarningsExact identifier
rxcui: 310965
unii: WK2XYI10QM
IbuprofenIBUPROFENRETAIL BUSINESS SERVICES,LLC.a568fd1e-9bf0-3c03-e053-2a95a90a45b72025-12-19WarningsExact identifier
rxcui: 310965
unii: WK2XYI10QM
IbuprofenIBUPROFENTOPCO ASSOCIATES LLC1a00c17f-9766-deaa-e063-6394a90a8d602025-12-19WarningsExact identifier
rxcui: 310965
unii: WK2XYI10QM
Acetaminophen and Ibuprofen (NSAID)ACETAMINOPHEN AND IBUPROFEN (NSAID)RETAIL BUSINESS SERVICES,LLCe7b7009a-89a4-720d-e053-2a95a90abff72025-12-19WarningsExact identifier
unii: WK2XYI10QM
AcetaminophenACETAMINOPHENRAONBIO CORPf6f5251d-db89-4b69-e053-6394a90a10282025-12-19WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENTOPCO ASSOCIATES LLC1a00c85b-2ba5-32c3-e063-6294a90af1482025-12-19WarningsExact identifier
rxcui: 310965
unii: WK2XYI10QM
Acetaminophen and IbuprofenACETAMINOPHEN AND IBUPROFENLEADER/ Cardinal Health 110, Inc.f1d69088-4d52-cbb5-e053-2995a90a3ec82025-12-19WarningsExact identifier
unii: WK2XYI10QM
Childrens Ibuprofen Oral SuspensionIBUPROFENMarc Glassman, Inc.0ef3f4b3-9af5-4243-8d45-dd68f72852292025-12-19WarningsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENWALGREENS CO.b8a77b7e-e161-b3ac-e053-2995a90af3e82025-12-19WarningsExact identifier
rxcui: 310965
unii: WK2XYI10QM
Acetaminophen and IbuprofenACETAMINOPHEN AND IBUPROFENRUGBY LABORATORIESed340993-04e6-b084-e053-2a95a90abf602025-12-19WarningsExact identifier
unii: WK2XYI10QM
Childrens Ibuprofen Oral SuspensionIBUPROFENDiscount Drug Mart7b7954b7-e4c8-4284-a649-31a4eb6ba73e2025-12-19WarningsExact identifier
unii: WK2XYI10QM
Acetaminophen and IbuprofenACETAMINOPHEN AND IBUPROFENWALGREENSe457af7c-0fa7-a47e-e053-2a95a90abf9c2025-12-19WarningsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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