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 65 of 66 · 1,308 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ibuprofen miniIBUPROFEN MINIHumanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd787cda64-c03e-462e-9590-6f04b68606102019-05-02WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENCHAIN DRUG MARKETING ASSOCIATION INCb234d42e-1333-48a1-8565-35d9759e80852019-03-29WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENTopco Associates LLC4aef9935-2e36-4779-a8a8-5288060573af2019-03-08WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAphena Pharma Solutions - Tennessee, LLC4a86a190-da5d-4b7a-a05f-e3e7ccbfa6032019-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Ibuprofen 200mgIBUPROFEN 200MGAllegiant Health51e95588-39af-40d6-9924-e98d42af15b92018-12-31WarningsExact identifier
unii: WK2XYI10QM
Dynamic Eyewash with EyecupWATERDynamic Safety International7d3af0f4-0e1f-9ea5-e053-2991aa0af7a22018-12-17WarningsExact identifier
unii: 059QF0KO0R
Ibuprofen and Diphenhydramine CitrateIBUPROFEN AND DIPHENHYDRAMINE CITRATEDr. Reddy's Laboratories Limited42c06daf-541a-7721-b875-ea18364501a42018-12-05WarningsExact identifier
unii: WK2XYI10QM
Care One ibuprofen childrensIBUPROFENAmerican Sales Company703869c9-7f12-4556-a2af-8e68942834f22018-11-26WarningsExact identifier
unii: WK2XYI10QM
IBUPROFEN, DIPHENHYDRAMINE HCLIBUPROFEN, DIPHENHYDRAMINE HCLBionpharma Inc.59a97c31-db90-48e1-ac1b-0f7026c8ec942018-11-09WarningsExact identifier
unii: WK2XYI10QM
ibuprofenIBUPROFENContract Pharmacal Corp.237bcb87-64a0-415b-bd53-e9d3b8bf33b62018-11-07WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLPremier Value Alliance LLC21afce91-afbe-4b38-a8a5-8775148835e82018-10-30WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENGeritrex LLCca9498ec-755d-4a09-9504-210dd48d6fed2018-10-12WarningsExact identifier
unii: WK2XYI10QM
Childrens IbuprofenIBUPROFENGuardian Drug Company694866ce-c419-4b4c-bfb2-4175703d89f12018-09-07WarningsExact identifier
unii: WK2XYI10QM
Bio Rock WaterROCK WATERBioActive Nutritional, Inc.178bd16d-0d4f-49d8-866b-8ab3a3c6889d2018-07-30WarningsExact identifier
unii: 059QF0KO0R
IBUPROFENIBUPROFEN 200MGADVANCED FIRST AID, INC.564e9910-b491-4129-a4f1-68216267623b2018-07-23WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen ChildrensIBUPROFENH E B0a9a54ce-572f-4a96-922f-cc136d2d4aad2018-06-07WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENBreeden Brothers, LLCe4314153-479d-4c0f-ba49-4d4efded304b2018-04-06WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen Fast relief medicine for painIBUPROFEN 200 MGAllegiant Healthdd63b011-0573-4374-9669-8d29146e5fc92017-11-17WarningsExact identifier
unii: WK2XYI10QM
Sound Body IbuprofenIBUPROFEN 200 MGAllegiant Health73af6385-3081-49cc-83de-f872a47c31dc2017-11-15WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen 200mgIBUPROFEN 200MGAthlete's Needs, Inc.2db10105-6fd3-420d-8889-7cfd6f396e5f2017-11-14WarningsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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