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 111 of 192 · 3,835 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Equaline IbuprofenIBUPROFENUnited Natural Foods, Inc. dba UNFIc611afc0-5cde-4f01-908a-de52cb61ab022025-05-08WarningsExact identifier
unii: WK2XYI10QM
Tinted Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEScottsdale Skin Boutique and Dermatology Pllc34a5a99f-9e22-52ab-e063-6294a90a93232025-05-08Exact identifier
unii: 15FIX9V2JP
IbuprofenIBUPROFENAAFES/Your Military Exchanges773b0230-a3a3-44e0-a22b-d143796ca3652025-05-08WarningsExact identifier
unii: WK2XYI10QM
Equaline ibuprofen childrensIBUPROFENUnited Natural Foods, Inc. dba UNFI811d4360-7468-4ef8-a60e-6e9a6e169de02025-05-08WarningsExact identifier
unii: WK2XYI10QM
Good Sense Childrens IbuprofenIBUPROFENL. Perrigo Companya8fc1b0c-dd69-4567-8eea-de4d9b0c77402025-05-07WarningsExact identifier
unii: WK2XYI10QM
PowderTITANIUM DIOXIDEOxygen Development LLC08b7eeeb-09ae-ffe6-e063-6294a90aba902025-05-07WarningsExact identifier
unii: 15FIX9V2JP
unii: 1K09F3G675
foster and thrive childrens ibuprofen ibIBUPROFENStrategic Sourcing Services LLC37adf659-9a92-428b-ac99-5718f242a4e92025-05-07WarningsExact identifier
unii: WK2XYI10QM
up and up ibuprofenIBUPROFENTarget Corporation6e0330ac-a111-4574-9197-d7aab33b86082025-05-07WarningsExact identifier
unii: WK2XYI10QM
ibuprofenIBUPROFENMeijer Distribution Inc66b19ed1-6cf9-4705-82cd-02f23c6379e72025-05-06WarningsExact identifier
rxcui: 310965
unii: WK2XYI10QM
equaline ibuprofen childrensIBUPROFENUnited Natural Foods, Inc. dba UNFI835c3bc8-fb55-4b7e-98ad-3d84d089c8cb2025-05-06WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAphena Pharma Solutions - Tennessee, LLC34673d3b-41cd-f4c9-e063-6394a90a85102025-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAphena Pharma Solutions - Tennessee, LLC3467b45b-c432-2923-e063-6394a90a10442025-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Vivier Sheer SPF 30 Mineral TintedTITANIUM DIOXIDE, ZINC OXIDEVivier Pharma, Inc.e12e3bcb-4c3d-41be-8e2b-12a817c8b3672025-05-05WarningsExact identifier
unii: 15FIX9V2JP
ibuprofenIBUPROFENMajor Pharmaceuticalsb4962985-47e6-4389-874f-76742b086e2f2025-05-03WarningsExact identifier
unii: WK2XYI10QM
Topcare Infants IbuprofenIBUPROFENTopco Associates LLC00d33273-e8c7-4d40-8e6f-a980f746fff22025-05-03WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.3732defa-67c2-4b84-8a84-4bbc27b6cb242025-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.689dbbe8-4f85-48fe-8efc-fda81b60d37f2025-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.09621787-9a5c-4abf-9ccd-d6f8d581738f2025-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.42b92fd7-468c-4fb8-9ff0-31296735df4c2025-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENPD-Rx Pharmaceuticals, Inc.7942cc53-1268-4e5f-8db0-f0b3524bb7442025-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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