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 110 of 192 · 3,835 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ibuprofen minisIBUPROFENP & L Development, LLC18b79fc5-57c8-46f1-81f3-2f9e189cdbcb2025-05-16WarningsExact identifier
unii: WK2XYI10QM
dg health ibuprofenIBUPROFENDolgencorp, LLCd6dcbdee-7c0d-4b5c-b0c1-1e8f357f7f592025-05-15WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENCHAIN DRUG MARKETING ASSOCIATION, INC.a60a6301-60b7-4f31-9ebe-872ccd8e9e762025-05-15WarningsExact identifier
rxcui: 310965
unii: WK2XYI10QM
IbuprofenIBUPROFENCHAIN DRUG MARKETING ASSOCIATION, INC.32f86bfb-67a6-49b5-a90a-5197f0d1baba2025-05-15WarningsExact identifier
rxcui: 310965
unii: WK2XYI10QM
IbuprofenIBUPROFENDISCOUNT DRUG MART9998b851-825b-a97d-e053-2a95a90affc62025-05-15WarningsExact identifier
rxcui: 310965
unii: WK2XYI10QM
IbuprofenIBUPROFENDISCOUNT DRUG MART999902da-4850-68ab-e053-2a95a90a82ea2025-05-15WarningsExact identifier
rxcui: 310965
unii: WK2XYI10QM
Acetaminophen and IbuprofenACETAMINOPHEN AND IBUPROFENAMERISOURCE BERGEN04dc36e8-4d51-aabe-e063-6294a90a0d532025-05-15WarningsExact identifier
unii: WK2XYI10QM
Acetaminophen and IbuprofenACETAMINOPHEN AND IBUPROFENAMERISOURCE BERGEN353136b4-884d-baa2-e063-6394a90a89e92025-05-15WarningsExact identifier
unii: WK2XYI10QM
Vax SodeTHUJA OCCIDENTALIS, CALCAREA CARBONICA, SILICEA, SALMONELLA TYPHI NOSODE, SERUM ANGUILLAE, BACILLUS TETANI(CLOSTRIDIUM TETANI), MALANDRINUM, MORBILLINUM, PAROTIDINUM, RUBELLA NOSODE, YERSINIA ENTEROCOLITICA, SALMONELLA ENTERIDITISNutritional Specialties, Inc.6f8cfcad-4d23-44d3-9369-22b575b1e7e62025-05-15WarningsExact identifier
unii: ETJ7Z6XBU4
ApnetemPHOSPHORICUM ACIDUM, ALUMEN, PHOSPHORUS, SENEGA OFFICINALIS, ADENOSINUM CYCLOPHOSPHORICUM, ANTIMONIUM TARTARICUM, GRINDELIA, SABADILLA, ALUMINA, CUPRUM METALLICUM, SANGUINARINUM NITRICUM, SILICEA, LACHESIS MUTUS, RHEUM (PALMATUM), ZINCUM METALLICUM, LYCOPODIUM CLAVATUM, MANGANUM PHOSPHORICUM, ANTIPYRINUM, COENZYME ANucleic Products, LLCec5bc7e7-4be6-45a6-8cd9-62fdfa7fb4692025-05-14WarningsExact identifier
unii: LMI26O6933
unii: ETJ7Z6XBU4
IbuprofenIBUPROFENNuCare Pharmaceuticals, Inc.3520deb7-5e45-3d0f-e063-6394a90ab44b2025-05-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
profen ibIBUPROFENPublix Super Markets Inc51fbfd25-3c4d-4de1-8fa2-e5b4b24022f22025-05-13WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENATLANTIC BIOLOGICALS CORP.230914e6-fe0c-45be-8b2e-e066c71d004c2025-05-12WarningsExact identifier
unii: WK2XYI10QM
Bright Guard Sport SPFZINC SPFRENU LABORATORIES, LLCc9b48a9e-d69f-65a7-e053-2995a90a0baf2025-05-12WarningsExact identifier
unii: 15FIX9V2JP
Ibuprofen OralIBUPROFEN ORALBryant Ranch Prepack34f88afb-5c56-ca2c-e063-6394a90a90722025-05-12WarningsExact identifier
unii: WK2XYI10QM
good sense ibuprofen childrensIBUPROFENL. Perrigo Companyb8e3ad4f-3212-4674-bcdf-a60a6b23d7bb2025-05-12WarningsExact identifier
unii: WK2XYI10QM
Childrens IbuprofenIBUPROFENMeijer Distribution Inc3b15dc44-ae1d-43c6-b6c5-05fa31beb5542025-05-12WarningsExact identifier
unii: WK2XYI10QM
Up and Up childrens ibuprofenIBUPROFENTarget Corporation28911692-882b-4e30-ba1d-5c10f847be802025-05-12WarningsExact identifier
unii: WK2XYI10QM
Welly First Aid KitHYDROCORTISONE, BACITRACIN ZINC, NEOMYCIN SULFATE, POLYMYXIN B SULFATE, IBUPROFENWelly Health PBC11432329-12a1-4d73-b038-912175a49d092025-05-11WarningsExact identifier
rxcui: 310965
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Maui Medical Group, Inc34b6aa46-657b-2676-e063-6294a90abadd2025-05-09Exact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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