FDA.reportPublic FDA data

NDC 59368-402 - 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
59368-402
Package NDCs from labels
59368-402-01
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 PRESCRIPTION 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 22 of 91 · 1,805 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENStrategic Sourcing Services, LLCdc469eb2-89cc-46c9-9304-f6cf119c05702026-01-29WarningsExact identifier
unii: WK2XYI10QM
OptaseGLYCERINScope Health Inc86c14327-ffc7-806e-e053-2991aa0aaf922026-01-29WarningsExact identifier
unii: PDC6A3C0OX
CaldolorIBUPROFENCumberland Pharmaceuticals Inc.1eaa7790-f1a1-4f51-b10a-cbbaf033f6842026-01-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Sodium Citrate and Citric AcidSODIUM CITRATE AND CITRIC ACID MONOHYDRATEAtlantic Biologicals Corp.42d837ae-2578-46df-92d2-24774964aaad2026-01-28Adverse reactionsExact identifier
unii: XF417D3PSL
Regener-Eyes Ophthalmic Solution PROFESSIONALGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, LLC49771efa-6682-51d0-e063-6294a90a18a52026-01-28WarningsExact identifier
unii: PDC6A3C0OX
Regener-Eyes Ophthalmic Solution LITEGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, LLC497763ee-dc70-bb48-e063-6294a90afb3d2026-01-28WarningsExact identifier
unii: PDC6A3C0OX
IBUPROFEN 200 MGIBUPROFEN 200 MGFarmacias De Similares TX LLC441f7920-5666-5a3e-e063-6294a90a55832026-01-28WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENSoftgel Healthcare Private Limited2b07ace6-6766-0a06-e063-6294a90ad1bd2026-01-27WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENMajor Pharmaceuticals847758ed-66fc-4db9-8fdb-78f3c3291a032026-01-26WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENCVS Pharmacy8d9f11a5-ca98-4280-9c6a-093d32e60ace2026-01-22WarningsExact identifier
unii: WK2XYI10QM
INSULIN DILUTING MEDIUM FOR KirstyWATERBiocon Biologics Inc.3db1d482-7e1f-aec6-79ef-3f305b4d82772026-01-20Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
equate ibuprofenIBUPROFENWal-Mart Stores Incb29034a6-657b-426f-a41a-5e64c4bc759d2026-01-20WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENPreferred Pharmaceuticals Inc.70e191ef-8fad-49eb-9850-fceea119e92f2026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENPreferred Pharmaceuticals Inc.b84ea215-e61d-4c00-8a34-d47c4080779b2026-01-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Lemon GlycerinGLYCERINJianerkang Medical Co., Ltdedee14da-13d8-4bc2-9c37-cfc353763d112026-01-16WarningsExact identifier
unii: PDC6A3C0OX
Hemorrhoidal CreamHEMORRHOIDAL CREAMWalgreens1ac2b2ae-c090-483b-ad2c-1374552add4a2026-01-15WarningsExact identifier
unii: PDC6A3C0OX
Walgreens Adult Glycerin LaxativeGLYCERIN SUPPOSITORYWalgreensf19c6cca-e763-4c38-a546-855f027d20c52026-01-15WarningsExact identifier
unii: PDC6A3C0OX
Walgreens Adult Glycerin LaxativeGLYCERIN SUPPOSITORYWalgreens1a00ff43-ba79-4339-a547-f9757872958b2026-01-15WarningsExact identifier
unii: PDC6A3C0OX
Hemorrhoidal CreamHEMORRHOIDAL CREAMWalgreens4276ddad-2363-462a-bb97-574f946ec3f02026-01-15WarningsExact identifier
unii: PDC6A3C0OX
Hemorrhoid and FissureGLYCERIN 6%,LIDOCAINE 4%,ECTOIN 0.12%FlexiGo Inc48697377-61c0-1b0a-e063-6294a90a32932026-01-15WarningsExact identifier
unii: PDC6A3C0OX

Reported adverse events (FAERS/openFDA)#

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