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 98 of 195 · 3,891 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dolce and Gabbana Everlast Foundation SPF 20 40C DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lcf4b6f45-d4ae-4665-87b4-c5af4910befa2025-09-03WarningsExact identifier
unii: 15FIX9V2JP
ibuprofenIBUPROFENWalgreen Company37c9b887-190a-4daf-8199-f406913132f02025-09-03WarningsExact identifier
rxcui: 310965
unii: WK2XYI10QM
IbuprofenIBUPROFENSam's West Inc6293a134-860d-4d12-9e4b-28490f8241082025-09-03WarningsExact identifier
rxcui: 310965
unii: WK2XYI10QM
CHILDRENS IBUPROFENIBUPROFENBetter Living Brands, LLCfab39a0a-882b-bf96-e053-6294a90a29322025-09-02WarningsExact identifier
unii: WK2XYI10QM
Pure6 ManiShield Hand ScreenZINC OXIDE, TITANIUM DIOXIDEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD3abcb6ba-1de8-55e7-e063-6294a90aecf12025-09-02WarningsExact identifier
unii: 15FIX9V2JP
CHILDRENS IBUPROFENIBUPROFENWALGREEN CO.fea3c4b2-cf96-2425-e053-6394a90ac6972025-09-02WarningsExact identifier
unii: WK2XYI10QM
CHILDRENS IBUPROFENIBUPROFEN7-Elevenaf0ec23c-cefc-40a9-ab9a-03b8528d4e132025-09-01WarningsExact identifier
unii: WK2XYI10QM
CHILDRENS IBUPROFENIBUPROFENAurohealth LLC0e1bcb06-be48-4efc-82e2-516582e023482025-09-01WarningsExact identifier
unii: WK2XYI10QM
CHILDRENS IBUPROFENIBUPROFENKROGER COMPANY15e72384-3a04-242d-e063-6294a90aa0fa2025-09-01WarningsExact identifier
unii: WK2XYI10QM
CHILDRENS IBUPROFENIBUPROFEN7-Elevencf7b38fc-0590-126a-e053-2a95a90a3e782025-09-01WarningsExact identifier
unii: WK2XYI10QM
toty Ilumina CC Creamy Compact 6NTITANIUM DIOXIDEChipican LLC3da732e7-19b0-3195-e063-6394a90a9a0c2025-09-01WarningsExact identifier
unii: 15FIX9V2JP
PHOFAY Matte Sunscreen Liquid Foundation SPF 30 4ENSULIZOLE ,HOMOSALATE,OCTINOXATE,TITANIUM DIOXIDEHangzhou Jingshen Trading Co., Ltd.3dba1360-f70f-e450-e063-6394a90a8c9f2025-09-01WarningsExact identifier
unii: 15FIX9V2JP
CHILDRENS IBUPROFENIBUPROFENChalkboard Healthc63eb5c6-adac-4d23-9661-1081ba4591ba2025-09-01WarningsExact identifier
unii: WK2XYI10QM
CHILDRENS IBUPROFENIBUPROFENRandob Labs., Ltd.50d6bf9d-ae37-4af3-bfeb-cc0abf8cb0942025-09-01WarningsExact identifier
unii: WK2XYI10QM
CHILDRENS IBUPROFENIBUPROFENAurohealth LLCad55d9b1-17b3-4a17-a4a3-d95ba29439592025-09-01WarningsExact identifier
unii: WK2XYI10QM
careone childrens ibuprofenIBUPROFENAmerican Sales Companybf88f91c-70ed-42be-b79c-ec60d4f0acda2025-08-30WarningsExact identifier
unii: WK2XYI10QM
Dolce and Gabbana Everlast Foundation SPF 20 33N DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Le249507c-d536-4c1d-a99d-857ca1e833d82025-08-29WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 32W Medium DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lba99edea-bf68-4118-8bb7-ea40322db46a2025-08-29WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 34W DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.L3a239897-9850-417f-8c00-e810a52540c12025-08-29WarningsExact identifier
unii: 15FIX9V2JP
Dolce and Gabbana Everlast Foundation SPF 20 36N DeepOCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEDolce & Gabbana Beauty S.R.Lc495afc3-6486-4652-b743-958f28eccaca2025-08-29WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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