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 60 of 66 · 1,308 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Circle K IbuprofenIBUPROFENLil Drug Store Products, Inc791a7375-34b2-449b-9284-3c49a27046192022-10-11WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENPharmPak, Inc.b493bf76-1e8b-4e72-bef6-aca4efc69cbe2022-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENPharmPak, Inc.4d95bccd-8280-4d03-a574-927669c7cda02022-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENPharmPak, Inc.bb6d0547-c113-42f9-8bf2-c227a55ab7582022-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Bach Original Flower Remedies Rock WaterWATERNelson Bach USA Limitedea242559-1618-3354-e053-2a95a90a1a952022-10-03WarningsExact identifier
unii: 059QF0KO0R
Circle K IbuprofenIBUPROFENLil Drug Store Products, Inc805d9d80-7de7-49d9-afdb-3a645059fe352022-09-21WarningsExact identifier
unii: WK2XYI10QM
Sterile WaterWATERMedical Purchasing Solutions, LLCe90b47e3-9636-b9ee-e053-2a95a90ad48c2022-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
IbuprofenIBUPROFENAurohealth LLCe1b49257-d226-457f-8f2d-9a757a65bbcb2022-09-06WarningsExact identifier
unii: WK2XYI10QM
Childrens Ibuprofen Oral SuspensionIBUPROFENPharmaceutical Associates, Inc.7a6832f2-2d80-483c-bde3-e6cacb7c318a2022-08-31WarningsExact identifier
unii: WK2XYI10QM
betr pain reliefIBUPROFENLive Betr LLC1b709dce-5c71-45e6-b516-d510a0a8c25d2022-08-24WarningsExact identifier
unii: WK2XYI10QM
Diphenhydramine HCl and IbuprofenDIPHENHYDRAMINE HCL AND IBUPROFENAurohealth LLC2c7c5349-06c9-401a-88e9-8f91ddb7f91a2022-08-19WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen OralIBUPROFEN ORALStrategic Sourcing Servicesa3062142-db0e-4758-a762-2b2bb05670b12022-08-10WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFEN TABLET, FILM-COATEDLil' Drug Store Products, Inc.e5bf5e09-7d42-6314-e053-2a95a90a23252022-08-08WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENDOLGENCORP, INC.df321783-73cb-55bf-e053-2a95a90a4ce22022-07-07WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENProficient Rx LPb7565aac-a928-4116-b9af-cf636da4537c2022-07-01WarningsExact identifier
unii: WK2XYI10QM
Sterile WaterWATERFresenius Kabi USA, LLCf42ac50f-0ec5-4713-a4c8-99d972d90bed2022-06-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
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

Reported adverse events (FAERS/openFDA)#

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