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 53 of 195 · 3,891 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Publix Artificial Tears Eye DropsPOLYVINYL ALCOHOL, POVIDONEPublix Super Markets, Inc.f5d1394b-0fe8-c372-e053-2a95a90a1f782025-12-30WarningsExact identifier
unii: 532B59J990
Best Choice Artificial TearsPOLYVINYL ALCOHOL, POVIDONEBest Choicef5ba63f3-7966-81fe-e053-2995a90a342c2025-12-30WarningsExact identifier
unii: 532B59J990
Kroger Eye Drops Artificial TearsPOLYVINYL ALCOHOL, POVIDONEThe Kroger Companyf76f08c5-0111-8bc5-e053-6294a90a16ee2025-12-30WarningsExact identifier
unii: 532B59J990
CareOne Artificial Tears Eye Drops 15mLPOLYVINYL ALCOHOL, POVIDONERetail Business Services, LLC92fded6b-91fd-d82e-e053-2a95a90ab5232025-12-30WarningsExact identifier
unii: 532B59J990
Quality Choice Artificial Tears Lubricant Eye DropsPOLYVINYL ALCOHOL, POVIDONEChain Drug Marketing Association, Inc.1f669655-4bc7-0175-e063-6294a90a305a2025-12-30WarningsExact identifier
unii: 532B59J990
Equate Artificial TearsPOLYVINYL ALCOHOL, POVIDONEWalmart, Inc.ead9f271-0f15-1fff-e053-2a95a90a93ac2025-12-30WarningsExact identifier
unii: 532B59J990
IBUPROFENIBUPROFENTIME CAP LABORATORIES, INCe0a8315a-80a5-4be3-aad1-3d01f00df4942025-12-29WarningsExact identifier
unii: WK2XYI10QM
SPF 30 SunscreenZINC OXIDE, TITANIUM DIOXIDECLEUREf5512f34-08ee-b0f6-e053-2a95a90ab5bd2025-12-29WarningsExact identifier
unii: 15FIX9V2JP
RE-NUTRIV ULTRA RADIANCE MAKEUP BROAD SPECTRUM SPF 20OCTINOXATE AND TITANIUM DIOXIDEESTEE LAUDER INC897b8edb-f089-4a49-baca-e05806b0a0682025-12-29WarningsExact identifier
unii: 15FIX9V2JP
OI LIN SUNMILK SUNSCREEN SPF 30SUNSCREEN, TITANIUM DIOXIDESunrider Manufacturing L.P.26b57314-1616-4ca4-b65f-a363c525b4322025-12-29WarningsExact identifier
unii: 15FIX9V2JP
Medicated Cornstarch Baby PowderACTIVE CORN STARCHDavion, Inc.e39032d1-c8cd-4a41-af10-126970b8ad382025-12-29WarningsExact identifier
unii: O8232NY3SJ
Childrens Ibuprofen Oral Suspension Original Berry FlavorIBUPROFENPuro Pharma Inc.6b993b25-9c81-4d75-b332-6de3f6c3b4c92025-12-27WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENSun Pharmaceutical Industries, Inc.a8b46ae5-67bc-494d-850e-b4e4ed5a33b32025-12-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENNorthwind Health Company, LLCf2a08223-a73a-5461-e053-2995a90a3bce2025-12-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENNorthwind Health Company, LLCab074ae8-5696-5327-e053-2a95a90a7ce32025-12-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Childrens Ibuprofen Oral SuspensionIBUPROFENAptaPharma Inc.40936019-74ab-4b25-a502-7bbc6e12034a2025-12-26WarningsExact identifier
unii: WK2XYI10QM
Childrens Ibuprofen GrapeIBUPROFENAptaPharma Inc.7caca7e2-6652-45fc-9538-275b43a1594e2025-12-26WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENHumanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd46a9424c-fd7d-f88b-e063-6294a90abceb2025-12-24WarningsExact identifier
unii: WK2XYI10QM
StellaLife VEGA Oral CareSPRAYStellaLife, Inc.b8ba495e-2cfe-092c-e053-2995a90a3fd32025-12-24WarningsExact identifier
unii: ETJ7Z6XBU4
StellaLife VEGA Oral Care Recovery KitKITHomeocare Laboratories, Inc.b701234a-0bd2-16d3-e053-2995a90a5b132025-12-24WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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