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 13 of 195 · 3,891 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Good Instincts Proper Sunscreen SPF 50ZINC OXIDE, TITANIUM DIOXIDEInhabit Brands, Inc82d2af99-7c42-4ce5-94e0-b2ac60b8db1b2026-06-22WarningsExact identifier
unii: 15FIX9V2JP
IbuprofenIBUPROFENCardinal Health 107, LLC8ea0e303-3967-4d71-8255-ac42a841ce282026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
ESPOIR BE VELVET COVER CUSHIONHOMOSALATE, TITANIUM DIOXIDEESPOIR Corporation54ce2420-4ac0-eb51-e063-6294a90a2de92026-06-21WarningsExact identifier
unii: 15FIX9V2JP
BABIES KIDSSUN PROTECTIONMINERAL SUNSCREENPANERGYTEK USA INC3a554118-b71d-a844-e063-6294a90a699f2026-06-20WarningsExact identifier
unii: 15FIX9V2JP
Creamy Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc548b7c90-ef97-38ab-e063-6394a90ac6092026-06-18WarningsExact identifier
unii: 15FIX9V2JP
Ibuprofen and FamotidineIBUPROFEN AND FAMOTIDINEAdvanced Rx of Tennessee, LLC548c705e-4094-fc6f-e063-6394a90a34262026-06-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENL.N.K. International, Inc.027ded51-aa01-6619-3938-c8162a421cf32026-06-18WarningsExact identifier
rxcui: 310965
unii: WK2XYI10QM
Ibuprofen and Pseudoephedrine HClIBUPROFEN AND PSEUDOEPHEDRINE HCLCARDINAL HEALTH 110, LLC. DBA LEADER06dd551b-6e13-425c-8d64-8d3177adc6bc2026-06-16WarningsExact identifier
unii: WK2XYI10QM
GlowBiotics Tinted Sunscreen SPF 30ZINC OXIDERum Brands, LLC544dba29-4785-4ab6-e063-6394a90a17b32026-06-16WarningsExact identifier
unii: 15FIX9V2JP
Societe Prime and DefendZINC OXIDE SUNSCREENSociete Clinical Skincare5439bd31-5ee1-9bca-e063-6394a90a748c2026-06-16WarningsExact identifier
unii: 15FIX9V2JP
Societe CoverShield Tinted SPFZINC OXIDESociete Clinical Skincare545efbc4-82d4-f126-e063-6294a90a97102026-06-16WarningsExact identifier
unii: 15FIX9V2JP
H-Scars FormulaCALENDULA OFFICINALLIS, SILICEAHealing Natural Oils LLC8433ff00-d815-45e0-b0ec-1448668dd8f82026-06-16WarningsExact identifier
unii: ETJ7Z6XBU4
Childrens Ibuprofen Bubblegum Dye FreeIBUPROFENCVS2cf2f35b-5d66-e3ff-e063-6294a90a9b452026-06-16WarningsExact identifier
unii: WK2XYI10QM
E-Z-GAS IIANTACID/ANTIFLATULENTE-Z-EM, INC.4e12e1cb-b033-076d-e054-00144ff8d46c2026-06-15WarningsExact identifier
unii: ETJ7Z6XBU4
Shield by HEALTHY SKIN LAB MD SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEHEALTHY SKIN LAB LIMITED6838b754-9915-48ff-af35-5338dbd06ac42026-06-15WarningsExact identifier
unii: 15FIX9V2JP
IBUPROFENIBUPROFENGranules India Limited97516b9f-219a-429d-850d-1fe9fd66646b2026-06-15WarningsExact identifier
rxcui: 310965
unii: WK2XYI10QM
BM BIO28 ALCOHOLCALC SULPH, CALC FLUOR, CALC PHOS, FERR PHOS, KALI MUR, KALI PHOS, KALI SULPH, MAG PHOS, NAT PHOS, NAT SULPH, NAT MUR, SILICEATotal Operations Management LLC DBA:Bestmade Natural Products Micro544b66c4-49df-556f-e063-6394a90af3ed2026-06-15WarningsExact identifier
unii: ETJ7Z6XBU4
Calamine, Pramoxind HClCALAMINE, PRAMOXIND HCLH E B4a7a0b09-d9bc-e752-e063-6394a90a9f2c2026-06-15Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Calamine, Zinc OxideCALAMINE, ZINC OXIDEH E B4a79259e-64ac-d187-e063-6294a90a78db2026-06-15Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
IbuprofenIBUPROFENCardinal Health 110, LLC. DBA Leadera41a0bc2-ef7a-44cd-a42e-aefab41323cc2026-06-15WarningsExact identifier
rxcui: 310965
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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