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 114 of 192 · 3,835 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ibuprofenIBUPROFENMajor Pharmaceuticals14f43c32-0895-4ef2-aa54-52b952d058fd2025-04-08WarningsExact identifier
rxcui: 310965
unii: WK2XYI10QM
parents choice infants ibuprofenIBUPROFENWal-Mart Stores Inca826d6cc-f582-4508-897d-0d637de0666c2025-04-07WarningsExact identifier
unii: WK2XYI10QM
leader infants ibuprofenIBUPROFENCardinal Health 110, LLC. dba Leaderb72fdf65-8112-4d8b-b86f-8e17a40ee8e62025-04-07WarningsExact identifier
unii: WK2XYI10QM
equaline ibuprofenIBUPROFENUnited Natural Foods, Inc. dba UNFIea2ba726-0199-42ae-9c60-4b068df35e642025-04-07WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAphena Pharma Solutions - Tennessee, LLC31f59d10-d821-2291-e063-6294a90ac5182025-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAphena Pharma Solutions - Tennessee, LLC31f61d5c-a3a3-3d47-e063-6394a90afb622025-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Acetaminophen 250 mg and Ibuprofen 125 mgACETAMINOPHEN AND IBUPROFENDr. Reddy's Labortories Inc3e65c8a3-498e-1a2a-bb76-18e28ae2c73c2025-04-04WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAphena Pharma Solutions - Tennessee, LLC31e6005b-492e-7936-e063-6394a90ad8012025-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAphena Pharma Solutions - Tennessee, LLC31e6ac7a-fa3e-4dd4-e063-6294a90a29af2025-04-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Childrens IbuprofenIBUPROFENBryant Ranch Prepackb303b554-c457-4f2b-9931-48f30943178b2025-04-03WarningsExact identifier
unii: WK2XYI10QM
Childrens IbuprofenIBUPROFENBryant Ranch Prepack87c9f15f-1196-477c-b5d2-3b875bea61d02025-04-03WarningsExact identifier
unii: WK2XYI10QM
dg health ibuprofenIBUPROFENDolgencorp Inc74f46147-b4c2-4bb3-bd0a-220c0a5403a62025-04-01WarningsExact identifier
unii: WK2XYI10QM
good sense ibuprofenIBUPROFENL. Perrigo Company0cb4b0ef-5cdd-4c79-8718-4fb157a2c9482025-03-29WarningsExact identifier
unii: WK2XYI10QM
ALEX MD PHD Sheer Mineral SunscreenZINC OXIDE, TITANIUM DIOXIDEPHYSICIAN LABORATORIES INC8f64c4fa-92ee-4af0-ab1b-6c3673f9a6222025-03-28WarningsExact identifier
unii: 15FIX9V2JP
ALEX MD PHD Tinted Mineral SunscreenZINC OXIDE, TITANIUM DIOXIDEPHYSICIAN LABORATORIES INC93873c34-5c72-43c8-b6c2-c65b596191d72025-03-28WarningsExact identifier
unii: 15FIX9V2JP
City Skin Age Defense Broad Spectrum SPF 50TITANIUM DIOXIDE AND ZINC OXIDEMurad, LLCf8c572a2-b4bc-49e9-95df-359f05bd69b72025-03-28WarningsExact identifier
unii: 15FIX9V2JP
Bestmade Natural Products BM238SANTONINE, CINA, SILICEA, INDIGO, AMBROSIA, CUCCURBITA CIT, CUCCURBITA PEPBestmade Natural Products298fb9e2-3f98-01e6-e063-6294a90a7aaf2025-03-26WarningsExact identifier
unii: ETJ7Z6XBU4
IbuprofenIBUPROFENAphena Pharma Solutions - Tennessee, LLC3140a614-c7ae-3062-e063-6394a90ad3d72025-03-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
it cosmetics Your Skin But Better CC Plus Color Correcting Broad Spectrum SPF 50 Plus Sunscreen Full Coverage Deep FairLight Neutral Tan Rich Honey LightMedium and Neutral MediumTITANIUM DIOXIDE AND ZINC OXIDEIT COSMETICS, LLCe17dc640-30e9-441b-a212-ef1508af79442025-03-25WarningsExact identifier
unii: 15FIX9V2JP
good sense ibuprofenIBUPROFENL. Perrigo Company3b78c004-e4fe-449c-86e9-52e8ccf127852025-03-25WarningsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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