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 112 of 192 · 3,835 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENProficient Rx LPc5eaa3a9-5aa8-46b0-8cec-639bfb3274752025-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
profen ibIBUPROFENPublix Super Markets Incbee4b754-c476-4d0e-a1b4-4db8861af84a2025-05-01WarningsExact identifier
unii: WK2XYI10QM
EltaMD UV AOX ElementsZINC OXIDE, TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Incd01756c0-1f82-4e08-b956-8000ecaddfd12025-05-01WarningsExact identifier
unii: 15FIX9V2JP
Dye Free Childrens IbuprofenIBUPROFENCVS2cf2a4de-29d3-8af5-e063-6294a90a9cee2025-05-01WarningsExact identifier
unii: WK2XYI10QM
good sense ibuprofen childrensIBUPROFENL. Perrigo Company6127469c-143f-4dd2-bd37-6630291fcd5a2025-04-30WarningsExact identifier
unii: WK2XYI10QM
ibuprofen childrensIBUPROFENCVS Pharmacy4459298c-e0bf-4a10-b68c-6f83fefde7e92025-04-29WarningsExact identifier
unii: WK2XYI10QM
ibuprofenIBUPROFENH E Bbbcfea51-4c57-4a2c-a0ac-2a189c5ff38a2025-04-28WarningsExact identifier
unii: WK2XYI10QM
DG Health IbuprofenIBUPROFENDolgencorp Inc0c0cf516-b3e7-474d-885c-897574365be32025-04-28WarningsExact identifier
unii: WK2XYI10QM
ibuprofen childrensIBUPROFENMeijer Distribution Incc5e1d74d-99a3-4b3d-86c4-03f5c4c22f772025-04-27WarningsExact identifier
unii: WK2XYI10QM
No7 Lift and Luminate Triple Action Serum Foundation Sunscreen Broad Spectrum SPF 15 PorcelainOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SAS2fbf7f9d-dba7-48f9-b10e-63225e8f13992025-04-25WarningsExact identifier
unii: 15FIX9V2JP
DOCTRUST ONE S ToothSODIUM FLUORIDE, DENTAL TYPE SILICA, POTASSIUM NIRATEDOCSMEDI Co., Ltd.3382776a-a10e-1823-e063-6394a90a6f912025-04-24WarningsExact identifier
unii: ETJ7Z6XBU4
kirkland signature ibuprofenIBUPROFENCostco Wholesale Company65d8d650-9afc-44f7-9409-a3aa3014d4ab2025-04-24WarningsExact identifier
rxcui: 310965
unii: WK2XYI10QM
ibuprofenIBUPROFENA-S Medication Solutions504c7e5d-e721-4df8-865b-8ea17559831d2025-04-24WarningsExact identifier
rxcui: 310965
unii: WK2XYI10QM
KARYNG Complete SPF Sunscreen Light/MediumSUNSCREENKaryng LLC33596253-413d-fba3-e063-6394a90a39e42025-04-22WarningsExact identifier
unii: 15FIX9V2JP
KARYNG Complete SPF Sunscreen Medium/DarkSUNSCREENKaryng LLC335eee1e-ef1c-41da-e063-6294a90ac2732025-04-22WarningsExact identifier
unii: 15FIX9V2JP
AlgenistOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDESolazyme, Inc.4ece1847-1c94-4bf7-b936-109556a460a72025-04-22WarningsExact identifier
unii: 15FIX9V2JP
ibuprofen pmDIPHENHYDRAMINE CITRATE, IBUPROFENH E B2114b2a9-f9af-43b9-97ec-859a4afe7ec82025-04-21WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAphena Pharma Solutions - Tennessee, LLC334e40f3-6da4-ecbe-e063-6294a90a35bf2025-04-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Sulwhasoo Perfecting Cushion NO.17N1 VanillaOCTINOXATE, TITANIUM DIOXIDE, AND HOMOSALATEAmorepacific Corporation3350f28e-22b4-904c-e063-6394a90a1c812025-04-21WarningsExact identifier
unii: 15FIX9V2JP
ADVIL DUAL ACTION WITH ACETAMINOPHENIBUPROFEN, ACETAMINOPHENHaleon US Holdings LLCf5ea858e-76d9-4777-b3dc-5d614f66d4852025-04-21WarningsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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