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 173 of 191 · 3,812 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SiliceaSILICON DIOXIDEBoironce6a0710-7c28-11e6-86bf-424c583030312023-07-11Exact identifier
unii: ETJ7Z6XBU4
AluminaALUMINUM OXIDEBoiron84b4fd05-f2cc-3b45-e053-2991aa0ad5d92023-07-11Exact identifier
unii: LMI26O6933
AluminaALUMINAHahnemann Laboratories, INC.ffdbdb70-8666-f0c6-e053-6394a90a65962023-07-06Exact identifier
unii: LMI26O6933
Kidney DrainageSOLIDAGO VIRGAUREA, ASPARAGUS OFFICINALIS, JUNIPERUS COMMUNIS, SABAL SERRULATA, UVA-URSI, BERBERIS VULGARIS, EQUISETUM ARVENSE, URTICA DIOICA, RUBIA TINCTORUM, STAPHYSAGRIA, CANTHARIS, FAGUS SYLVATICA, FLOS, GLANDULA SUPRARENALIS SUIS, HEPAR SULPHURIS CALCAREUM, KIDNEY (SUIS), LARIX DECIDUA, FLOS, MANGANUM METALLICUM, MIMULUS GUTTATUS, FLOS, NITRICUM ACIDUM, RHUS AROMATICA, SILICEA, ULEX EUROPAEUS, FLOS, BENZOICUM ACIDUM, COBALTUM METALLICUMDeseret Biologicals, Inc.4f82e261-6101-48ab-b161-ded5aa41cd852023-06-27WarningsExact identifier
unii: ETJ7Z6XBU4
AluminaALUMINUM OXIDEBoirona9603cb0-7c3b-11e6-8197-424c583030312023-06-26Exact identifier
unii: LMI26O6933
IbuprofenIBUPROFENFamily Dollar (FAMILY WELLNESS)eaa0a286-a0f0-4979-8af3-c5f4194283fd2023-06-22WarningsExact identifier
rxcui: 310965
unii: WK2XYI10QM
CalciforceARNICA MONTANA, CHAMOMILLA, ECHINACEA (ANGUSTIFOLIA), BORON CITRATE, SYMPHYTUM OFFICINALE, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, HEKLA LAVA, LYCOPODIUM CLAVATUM, SILICEA, CALCAREA CARBONICABioActive Nutritional, Inc.1609ce3e-82c2-4597-86e6-847c944ddbe62023-06-07WarningsExact identifier
unii: ETJ7Z6XBU4
Rexall IbuprofenIBUPROFENDolgencorp, LLCd2dc2f71-c0cb-4e6d-85b9-fcf386e207a02023-06-06WarningsExact identifier
unii: WK2XYI10QM
Sheer Tint Mineral Sunscreen Broad Spectrum SPF 50 - Light/Medium ShadeSPF 50 SUNSCREEN BROAD SPECTRUM - LIGHT/MEDIUM SHADEAutumn Harpfd6807e1-c8c0-b361-e053-6294a90aea0c2023-06-05WarningsExact identifier
unii: 15FIX9V2JP
Silicea 6XSILICEA 6XTrue Botanica, LLCfd296871-c491-7d30-e053-6294a90ab64d2023-06-02WarningsExact identifier
unii: ETJ7Z6XBU4
IbuprofenIBUPROFENProficient Rx LPe4bb22bb-6df6-4016-a023-0b454df9fb0b2023-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
basic care ibuprofenIBUPROFENAmazon.com Services LLC3329f487-675d-440c-b7c5-d17a2b0242752023-05-31WarningsExact identifier
rxcui: 310965
unii: WK2XYI10QM
CHILDRENS IBUPROFENIBUPROFENBluePoint Laboratoriesd71acfe2-4643-f50b-e053-2a95a90add8b2023-05-31WarningsExact identifier
unii: WK2XYI10QM
Thinksport Mineral SPF 50ZINC OXIDE AND TITANIUM DIOXIDEthinkOperations,LLC77b63c0b-353b-4f5f-95c7-6f7eeab814712023-05-30WarningsExact identifier
unii: 15FIX9V2JP
Think Kids Mineral SPF 50ZINC OXIDE AND TITANIUM DIOXIDEthinkOperations,LLC25c59820-a08d-4abe-87ae-a787ac8b2ac22023-05-30WarningsExact identifier
unii: 15FIX9V2JP
DG health dual pain relieverACETAMINOPHEN, IBUPROFENDolgencorp Inc464d436a-79b0-45b4-8b5f-51dc2de2d8e42023-05-19WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENDolgencorp, Inc. (DOLLAR GENERAL & REXALL)7d544d8e-fa76-461f-9417-5f1873912eac2023-05-15WarningsExact identifier
unii: WK2XYI10QM
Equate IbuprofenIBUPROFENWal-Mart Stores Inc153bc4ac-427d-426a-9bb8-665487e4b1692023-04-27WarningsExact identifier
application number: ANDA077349
rxcui: 310965
unii: WK2XYI10QM
IbuprofenIBUPROFENP & L Development, LLC1889faea-24a3-45ea-92de-8dc76b9ed5b42023-04-25WarningsExact identifier
unii: WK2XYI10QM
Baby Nighttime Mucus Plus Cold ReliefCALCIUM SULFIDE,PHOSPHORUS,SULFUR,RUMEX CRISPUS ROOT,SODIUM CHLORIDE,ARABICA COFFEE BEAN,ANEMONE PULSATILLA,SILICON DIOXIDE, GOLDENSEAL,ONION,BRYONIA ALBA ROOT,EUPHRASIA STRICTA AND MATRICARIA CHAMOMILLAHyland's Inc.736b2487-e81d-d172-e053-2a91aa0ab0cf2023-04-17WarningsExact identifier
unii: ETJ7Z6XBU4

Reported adverse events (FAERS/openFDA)#

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