FDA.reportPublic FDA data

NDC 59368-397 - Ibuprofen

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
59368-397
Package NDCs from labels
59368-397-01
Manufacturer
Praxis, LLC
Effective date
2023-01-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ibuprofen - Praxis, LLCPraxis, LLC2023-01-01HUMAN OTC DRUG LABEL

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 6 of 66 · 1,308 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ADVILIBUPROFENSelect Consumer Group3ca752d8-957c-21b4-e063-6294a90a52852026-07-03WarningsExact identifier
unii: WK2XYI10QM
Advil LiquigelIBUPROFENSelect Consumer Group3ca6bc9d-090f-e412-e063-6394a90a68762026-07-03WarningsExact identifier
unii: WK2XYI10QM
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Fendall 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Sterile Eyesaline EyewashSTERILE EYESALINE EYEWASHProtective Industrial Products, Inc.55a290e8-8310-8be4-e063-6394a90abdce2026-07-02WarningsExact identifier
unii: 059QF0KO0R
Eyesaline Emergency EyewashPURIFIED WATERProtective Industrial Products, Inc.55a261c2-725d-6765-e063-6294a90a32602026-07-02WarningsExact identifier
unii: 059QF0KO0R
RemodulinTREPROSTINILUnited Therapeutics Corporation6c80bb38-e8db-4138-9f0d-dbbf9c6731852026-07-02Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
IbuprofenIBUPROFENProficient Rx LP34a9b94f-93ba-4a7c-92eb-d0b4b530d8872026-07-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENDr. Reddy's Laboratories Inc.4d830b9b-b396-9581-7572-c7f19ff175972026-07-01WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENSt. Mary's Medical Park Pharmacy88dd304f-1c64-08e3-e053-2a95a90a596f2026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENAmazon.com Services LLCfaabb11a-6fa0-492d-85cc-74ff8175b0b32026-07-01WarningsExact identifier
unii: WK2XYI10QM
Infants MotrinIBUPROFENKenvue Brands LLCc2302bfe-b367-4867-b803-29f066a42dc72026-06-30WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENREMEDYREPACK INC.1e6f3ce7-e8a3-40e8-8437-523ef5277b2e2026-06-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENHAWAII REPACK, INC.6239818c-747d-4cbb-9b41-27ca8bbce41b2026-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENSportpharm LLCcef04ae4-e78a-454d-bb66-84b1d348c1062026-06-26Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Ibuprofen mini dye freeIBUPROFENCHAIN DRUG MARKETING ASSOCIATION INC.552d9018-cc7e-7e1a-e063-6294a90a33222026-06-26WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENTOP CARE (Topco Associates LLC)fb842f4d-1228-9a52-e053-6294a90adb412026-06-26WarningsExact identifier
unii: WK2XYI10QM
ibuprofenIBUPROFENUnit Dose Solutions, Inc.551535ce-eab0-bb13-e063-6294a90a20702026-06-25WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENUnit Dose Solutions, Inc.5515661b-6373-2191-e063-6294a90a17e02026-06-25Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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