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 174 of 191 · 3,812 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RadialginCITRUS LIMONUM, FUCUS VESICULOSUS, HYDRANGEA ARBORESCENS, SODIUM ALGINATE, NATRUM MURIATICUM, PHOSPHORUS, AGATE, RADIUM BROMATUM, X RAYNutritional Specialties, Inc.f1414ae2-4068-4076-bf11-b57a34ba5df22023-04-12WarningsExact identifier
unii: ETJ7Z6XBU4
IbuprofenIBUPROFENRITE AID CORPORATIONde158883-1175-18fc-e053-2995a90a3c962023-04-12WarningsExact identifier
unii: WK2XYI10QM
AluminaALUMINUM OXIDEBoiron8426bd35-372c-4417-e053-2a91aa0a79032023-04-11Exact identifier
unii: LMI26O6933
Ferrum OxydatumFERRUM OXYDATUMHahnemann Laboratories, INC.f8b52d3f-3fe2-a850-e053-6394a90a5d9f2023-04-06Exact identifier
unii: 1K09F3G675
IbuprofenIBUPROFENMARKSANS PHARMA LIMITED403ec259-3be1-4e0b-ab7b-fee213b7eabe2023-04-03WarningsExact identifier
unii: WK2XYI10QM
ibuprofenIBUPROFENProficient Rx LP4ee828df-873d-4379-9a17-a805d97dfe042023-04-01WarningsExact identifier
rxcui: 310965
unii: WK2XYI10QM
AluminaALUMINUM OXIDEBoiron84274737-2fed-d542-e053-2a91aa0a1ead2023-03-28Exact identifier
unii: LMI26O6933
AluminaALUMINUM OXIDEBoiron84270ebe-2cd9-7fb5-e053-2a91aa0ab7d52023-03-27Exact identifier
unii: LMI26O6933
SiliceaSILICON DIOXIDEBoiron86d34721-7dfc-bf91-e053-2991aa0a70ae2023-03-27Exact identifier
unii: ETJ7Z6XBU4
equate pain relieverACETAMINOPHEN, IBUPROFENWALMART INC.8e0aaae0-a97d-4b9d-b326-44ef45f3fa0c2023-03-17WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENDolgencorp, Inc. (DOLLAR GENERAL & REXALL)759e5cf4-641f-4b3c-bc06-9ee0b4d010fc2023-03-16WarningsExact identifier
unii: WK2XYI10QM
Motrin IBIBUPROFENNavajo Manufacturing Company Inc.f70c1b68-61c8-b333-e053-6294a90aadaa2023-03-16WarningsExact identifier
rxcui: 201126
rxcui: 310965
unii: WK2XYI10QM
IBUPROFEN AND FAMOTIDINEIBUPROFEN AND FAMOTIDINEAscent Pharmaceuticals, Inc.03733e49-7db4-4d98-b363-d0d23686ec722023-03-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Advil LiquigelsIBUPROFENNavajo Manufacturing Company Inc.e2c09216-fd63-4d50-9878-62b36236b2e72023-03-15WarningsExact identifier
unii: WK2XYI10QM
NS SupportBERBERIS VULGARIS, CIMICIFUGA RACEMOSA, CINCHONA OFFICINALIS, COLOCYNTHIS, LEDUM PALUSTRE, RANUNCULUS BULBOSUS, AESCULUS HIPPOCASTANUM, CUPRUM ACETICUM, NADIDUM, NATRUM OXALACETICUM, NICOTINAMIDUM, PYRIDOXINUM HYDROCHLORICUM, RIBOFLAVINUM, THIAMINUM HYDROCHLORICUM, ALPHA-LIPOICUM ACIDUM, AMMONIUM MURIATICUM, CARTILAGO SUIS, DISCUS INTERVERTEBRALIS SUIS, PICRICUM ACIDUM, SILICEA, ARGENTUM METALLICUM, CALCAREA PHOSPHORICA, FUNICULUS UMBILICALIS SUIS, GLANDULA SUPRARENALIS SUIS, GNAPHALIUM POLYCEPHALUM,Dr. Donna Restivo DC807fd9cf-13d1-4173-a6da-180f89b67cf22023-03-15WarningsExact identifier
unii: ETJ7Z6XBU4
IbuprofenIBUPROFENBETTER LIVING BRANDS LLC.a3fadcc0-97f5-9f9b-e053-2a95a90aeb542023-03-15WarningsExact identifier
rxcui: 310965
unii: WK2XYI10QM
Advil Allergy and Congestion ReliefCHLORPHENIRAMINE MALEATE, IBUPROFEN, PHENYLEPHRINE HYDROCHLORIDENavajo Manufacturing Company Inc.d40bf078-ee6f-4c64-9c74-e4e770c150bf2023-03-15WarningsExact identifier
unii: WK2XYI10QM
Advil Sinus Congestion and Pain ReliefIBUPROFEN, PHENYLEPHRINE HYDROCHLORIDENavajo Manufacturing Company Inc.531abadc-37fd-4953-95bc-a211a2ba69142023-03-15WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENCardinal Health (Leader) 70000e751cb66-5fa5-4171-b061-da34aa10de6c2023-03-10WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen minisIBUPROFENEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)c3f1b721-2bb0-4297-bfc6-7faaf9ba84192023-03-09WarningsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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