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 26 of 66 · 1,308 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
careone childrens ibuprofenIBUPROFENAmerican Sales Companybca90b40-7973-4f22-8647-44cce5a6036e2025-10-28WarningsExact identifier
unii: WK2XYI10QM
Bacteriostatic WaterWATERHenry Schein, Inc.a833502e-a622-4e81-8c58-cef6ccb6c4c92025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
IbuprofenIBUPROFENA-S Medication Solutions8d5f7d2a-af48-4d47-8bf5-48f01c092d242025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENA-S Medication Solutions4b75bd6f-5455-4237-991c-eacc0fdcf7092025-10-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
childrens ibuprofen 100IBUPROFENWalgreen Company9b748f51-1d09-46ca-9dba-fec226c027e02025-10-26WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENCVS Pharmacy93f8101c-1cf7-4cb0-9c00-c57c9f9023c82025-10-26WarningsExact identifier
unii: WK2XYI10QM
Up and Up Childrens IbuprofenIBUPROFENTarget Corporationeead7d57-dfd3-4007-a620-74afebc3d3652025-10-26WarningsExact identifier
unii: WK2XYI10QM
ibuprofen pmDIPHENHYDRAMINE CITRATE AND IBUPROFENCVS Pharmacy44e4e54b-cb40-4b7c-a141-181bde62a69f2025-10-24WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENFamily Dollar (FAMILY WELLNESS)3a02af7e-7e69-45a6-97d7-ddc7d92b28b32025-10-22WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen PMDIPHENHYDRAMINE CITRATE, IBUPROFENFamily Dollar (FAMILY WELLNESS)e01be0d7-e16d-44f1-9a0c-251ff9a65d282025-10-22WarningsExact identifier
unii: WK2XYI10QM
Sterile WaterWATERBecton Dickinson and Companycab03cda-4660-4020-a3be-bf86242ff6642025-10-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Foster and Thrive IbuprofenIBUPROFENStrategic Sourcing Services LLCbcfa45ac-63d6-49a7-aa1c-b9f1d6c571f32025-10-22WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen MinisIBUPROFENFamily Dollar (FAMILY WELLNESS)72f933d8-cf01-4bb6-a552-e3cdb297038b2025-10-21WarningsExact identifier
unii: WK2XYI10QM
IBUPROFEN AND FAMOTIDINEIBUPROFEN AND FAMOTIDINEPHOENIX RX LLC3ff33400-30e8-87fa-e063-6394a90a7f5c2025-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAdvanced Rx of Tennessee, LLC41351cc0-5ec6-2f4d-e063-6294a90a733a2025-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
childrens ibuprofenIBUPROFENSafeway6dbf5acc-46a1-4d5b-a9a6-9b77f106d7112025-10-14WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENDirect_rx1be33b4f-4987-580f-e063-6294a90a31032025-10-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENCoupler LLC410f7320-4caa-8f88-e063-6394a90acf932025-10-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENPreferred Pharmaceuticals Inc.a85080d7-50b4-461b-9d77-d6fbab971c032025-10-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENRite Aid Corporation1dba3cb7-2e3d-4378-93cf-92db8f24f41f2025-10-09WarningsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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