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 53 of 66 · 1,308 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENAmneal Pharmaceuticals NY LLCe07d989d-1b0e-4cc1-abf2-93c8b208a29a2023-12-30Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Childrens Ibuprofen Oral SuspensionIBUPROFENDEMOULAS SUPERMARKETS INC.4ca54293-9e81-4b24-8112-734f28cd2c552023-12-29WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENBionpharma Inc.4bc6e8f2-ba95-4352-80ed-b44608fc49362023-12-27WarningsExact identifier
unii: WK2XYI10QM
Dye-Free IbuprofenIBUPROFENRITE AID CORPORATIONc1c58a2d-9ffd-69d0-e053-2a95a90a57182023-12-27WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLWALGREEN COMPANY3a193fdb-ab6e-464e-9f13-fda0fa8d50a82023-12-27WarningsExact identifier
unii: WK2XYI10QM
Leader Eye WashPURIFIED WATERCardinal Health8d3ad11f-1945-f838-e053-2995a90a7aa52023-12-23WarningsExact identifier
unii: 059QF0KO0R
Ibuprofen OralIBUPROFEN ORALA-S Medication Solutionsa8672e5a-61f2-46d8-9401-432a978d2fd32023-12-15WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENA-S Medication Solutionsf1f1e0ac-6944-4123-9e08-1df91582d4572023-12-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENA-S Medication Solutions8553e29a-7f6f-4ff8-9991-836e619c504d2023-12-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Childrens IbuprofenIBUPROFENAmerican Health Packagingbc69d88b-d9af-4010-8e8f-e761a9e295a92023-12-05WarningsExact identifier
unii: WK2XYI10QM
Eye WashWATERJiangxi Zhenmei Biological Technology Co.,Ltdc68795b8-bf68-0d01-e053-2a95a90abebb2023-12-04WarningsExact identifier
unii: 059QF0KO0R
IbuprofenIBUPROFENA-S Medication Solutions7152b6ce-6113-4003-bf80-aa263be693922023-11-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENA-S Medication Solutions400faee1-f662-470e-bcd6-7711dfaf9ba22023-11-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Childrens IbuprofenIBUPROFENChain Drug Marketing Association Inc.e210c707-2bae-44a5-93dc-459dd24fd9602023-11-20WarningsExact identifier
unii: WK2XYI10QM
Childrens IbuprofenIBUPROFENChain Drug Marketing Association Inc.c7e59784-a338-4922-a806-98c7505957cd2023-11-10WarningsExact identifier
unii: WK2XYI10QM
Concentrated ibuprofen infantsIBUPROFENChain Drug Marketing Association Inc.c9ae72d8-d205-4736-9bc4-2325cd77d36b2023-11-03WarningsExact identifier
unii: WK2XYI10QM
foster and thrive ibuprofen pmDIPHENHYDRAMINE CITRATE, IBUPROFENStrategic Sourcing Services LLC8691e397-e598-4e23-a389-2dbbb8f4496a2023-11-01WarningsExact identifier
unii: WK2XYI10QM
foster and thrive ibuprofenIBUPROFENStrategic Sourcing Services LLC68d67a25-e669-47c7-8410-9f304b914ff12023-10-31WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENGeri-Care Pharmaceutical Corp0744c3ca-4224-4f6a-a033-880949b544fd2023-10-30WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENTIME CAP LABORATORIES, INC.059cb22f-f6db-5d03-e063-6294a90a9ec12023-10-27WarningsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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