FDA.reportPublic FDA data

NDC 59368-397-01 - 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
Requested NDC
59368-397-01
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 60 of 65 · 1,292 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERFresenius Kabi USA, LLCe71c6c83-d518-496c-b2ab-efd5987e47832022-06-09Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Ibuprofen and Diphenhydramine CitrateIBUPROFEN AND DIPHENHYDRAMINE CITRATEAurohealth LLC21c1f5c5-19fa-4a59-bad3-ea85fd37471b2022-06-03WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENCARDINAL HEALTHdfbbde4f-633d-6d57-e053-2a95a90ad82f2022-05-24WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAurohealth LLC7779c369-50bf-4cde-9015-ff3fb35e128e2022-05-16WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENProficient Rx LPd2c7f045-e70c-4e2b-b2e0-d81a271d0a042022-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Motrin IBIBUPROFENJones Healthcare Group - Packaging Services, Inc6419cc78-27d4-7713-e053-2a91aa0a5a102022-04-29WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENProficient Rx LP2dc3108f-d917-40c6-865d-c900cf055d1c2022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
ibuprofenIBUPROFENProficient Rx LP798d33b0-5d7a-4445-8a51-2a3d336f744a2022-04-01WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENProficient Rx LP444b2ea0-ec42-4bcf-b8d2-38b4b297ada02022-04-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAurohealth LLC1100648c-6b9f-49c9-94d0-c40f24fe5c272022-03-23WarningsExact identifier
unii: WK2XYI10QM
basic care ibuprofenIBUPROFENAmazon.com Services LLC9bbbedb3-e0b2-4645-8105-98800096cfed2022-03-09WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAurohealth LLC3b0e77a1-b49d-4c67-81dd-66450dabcf3b2022-03-04WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAurohealth LLC0ade8ee2-7c74-4b05-925e-d92742fc2b902022-03-03WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAurohealth LLCcf6fbf3b-a0f3-4e08-a981-d183fa2857582022-03-03WarningsExact identifier
unii: WK2XYI10QM
Diphenhydramine HCl and IbuprofenDIPHENHYDRAMINE HCL AND IBUPROFENAurohealth LLCa656f8b0-8cb4-4802-b8d3-7b95c0265d562022-02-21WarningsExact identifier
unii: WK2XYI10QM
Sterile WaterWATERAmerican Regent, Inc.78b35864-4bbc-4759-a5c1-7e4f25e229322022-01-31Boxed warningExact identifier
unii: 059QF0KO0R
IbuprofenIBUPROFENAphena Pharma Solutions - Tennessee, LLC91723661-d0bb-4498-ac59-59bbdc3342302022-01-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Ibuprofen and Pseudoephedrine HClIBUPROFEN AND PSEUDOEPHEDRINE HCLAurohealth LLC6adf9292-b4af-4cb4-99f3-dda03734570a2022-01-21WarningsExact identifier
unii: WK2XYI10QM
Pain Relief - Ibuprofen 200 mgIBUPROFENHealth Pharma USA LLCd60a6a11-8c06-cede-e053-2a95a90af7f92022-01-20WarningsExact identifier
unii: WK2XYI10QM
Concentrated ibuprofen infantsIBUPROFENWal-Mart Stores, Inc.00b7fc71-8cf0-4c12-a479-146408f7f91b2022-01-11WarningsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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