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 48 of 66 · 1,308 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENAmneal Pharmaceuticals of New York LLCfaebc392-0fd9-4c71-8471-beba10dda0222024-07-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Ibuprofen PMIBUPROFEN AND DIPHENHYDRAMINE CITRATEKROGER COMPANY15e649c4-d75f-e8c1-e063-6294a90a77472024-07-26WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENActavis Pharma, Inc.3d156d13-25d8-4cfc-8285-5f7ebf48cf452024-07-24Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IBUIBUPROFENNuCare Pharmaceuticals,Inc.678e2d16-33f3-67a7-e053-2991aa0a11322024-07-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAmneal Pharmaceuticals of New York LLC75d963b9-3675-44ff-bc6b-83461bed1b672024-07-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAmneal Pharmaceuticals of New York LLC57cdd1df-a303-4265-a2d6-1d0b87105a282024-07-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAmneal Pharmaceuticals of New York LLC8df77ead-27eb-4f6f-95a9-f68d3e9cfa712024-07-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
AdvilIBUPROFEN TABLETS, COATEDLil' Drug Store Products, Inc.dd302e18-39e9-7e1a-e053-2a95a90a5f7c2024-07-17WarningsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENNuCare Pharmaceuticals,Inc.54b25106-5580-119d-e054-00144ff88e882024-07-17Exact identifier
unii: WK2XYI10QM
Ibuprofen and famotidineIBUPROFEN AND FAMOTIDINEAdvanced Rx of Tennessee, LLC1d625438-34dc-fbba-e063-6294a90afd2f2024-07-16Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Ibuprofen OralIBUPROFEN ORALNuCare Pharmaceuticals,Inc.84764eda-7446-5b16-e053-2991aa0abd7c2024-07-15WarningsExact identifier
unii: WK2XYI10QM
Thompson Safety EyewashWATERThompson Safety1d0e96cf-245b-cfb7-e063-6294a90a4ced2024-07-12WarningsExact identifier
unii: 059QF0KO0R
ibuprofenIBUPROFENBryant Ranch Prepack22cb2ccc-ba4d-4069-8334-f886f0e3e8022024-07-12WarningsExact identifier
unii: WK2XYI10QM
Foster and Thrive Infants IbuprofenIBUPROFENStrategic Sourcing Services LLCfe3092af-9a7b-4189-af89-31be8d6fed532024-07-12WarningsExact identifier
unii: WK2XYI10QM
IBUPROFEN AND FAMOTIDINEIBUPROFEN AND FAMOTIDINECamber Pharmaceuticals, Inc.7dc158a2-fdfa-4a5f-8c28-0ce5650991db2024-07-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENNuCare Pharmaceuticals,Inc.92efad86-31ae-78e5-e053-2995a90a0fda2024-07-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENNuCare Pharmaceuticals, Inc.3e3848f2-4922-39ea-e054-00144ff88e882024-06-25WarningsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENNuCare Pharmaceuticals,Inc.999aa615-72b2-9296-e053-2a95a90ac70b2024-06-20Exact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENNuCare Pharmaceuticals,Inc.9973bfa2-693a-1165-e053-2995a90a4b1d2024-06-20Exact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENNuCare Pharmaceuticals,Inc.99d7cf65-3ec2-24eb-e053-2a95a90acc5e2024-06-20Exact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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