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 12 of 66 · 1,308 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens Ibuprofen Oral Suspension Dye freeIBUPROFENAptaPharma Inc.bb995c57-a2cc-4bc7-9c7d-f885c425be642026-05-10WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENNuCare Pharmaceuticals,Inc.05ce8e8e-0b25-061e-e063-6394a90a2e922026-05-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
ibuprofen infantsIBUPROFENH E Be353bc69-c03e-4bae-a357-f7f3fab916952026-05-07WarningsExact identifier
unii: WK2XYI10QM
Sterile WaterWATERHospira, Inc.3a6422e1-feee-4095-8883-2b0837039e6e2026-05-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
ChemstatGLYCERINUM, TARAXACUM OFFICINALE, PHYTOLACCA DECANDRA, ARSENICUM ALBUM, NITRICUM ACIDUM, NUX VOMICA, PETROLEUM, PHOSPHORICUM ACIDUM, PHOSPHORUS, ACETYLSALICYLICUM ACIDUM, GLONOINUM, INSULINUM (HUMAN), LITHIUM CARBONICUM, THYROIDINUM (SUIS), ACETICUM ACIDUM, BENZOICUM ACIDUM, BENZYL ALCOHOL, BORICUM ACIDUM, CHLORINUM, CORTISONE ACETICUM, EUGENOL, FOLLICULINUM, ISOPROPYL PALMITATE, LACTICUM ACIDUM, PETROLEUM JELLY, PHENYL BUTAZONE, PLUMBUM METALLICUM, POTASSIUM SORBATE, RESORCINUM, SALICYLICUM ACIDUM,Energique, Inc.2831d28e-9cf1-4a72-9c6c-bb014d0595582026-05-06WarningsExact identifier
unii: 506T60A25R
IbuprofenIBUPROFENGranules Pharmaceuticals Inc.4aefcb3a-5dc8-b88e-e063-6294a90ac0442026-05-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENH E B4805977f-a30b-4f86-9ef5-e66ad6b8bd532026-05-06WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENARMY AND AIR FORCE EXCHANGE SERVICE4a0c744f-4ad8-445e-bab1-7ffee35bf8612026-05-06WarningsExact identifier
unii: WK2XYI10QM
Multi FlowerAESCULUS CARNEA, FLOS, AESCULUS HIPPOCASTANUM, FLOS, AGRIMONIA EUPATORIA, FLOS, BROMUS RAMOSUS, FLOS, CALLUNA VULGARIS, FLOS, CARPINUS BETULUS , FLOS, CASTANEA SATIVA, FLOS, CENTAURIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, CICHORIUM INTYBUS, FLOS, CLEMATIS VITALBA, FLOS, CLEMATIS VITALBA, FLOS, FAGUS SYLVATICA, FLOS, GENTIANELLA AMARELLA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, ILEX AQUIFOLIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, LARIX DECIDUA, FLOS, LONICERA CAPRIFOLIUM, FLOSEnergique, Inc.09c059e7-f748-402c-8447-af5b61169c582026-05-06WarningsExact identifier
unii: 059QF0KO0R
infants dye free ibuprofenIBUPROFENKroger Company6dc009c8-5b44-4d53-b053-eaed2223d9752026-05-05WarningsExact identifier
unii: WK2XYI10QM
pain relief pmIBUPROFEN AND DIPHENHYDRAMINE HCLBionpharma Inc.51037299-37dd-ca57-e063-6394a90a12c72026-05-04WarningsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENSt. Mary's Medical Park Pharmacy95830141-2439-9d45-e053-2995a90ae0842026-05-01Exact identifier
unii: WK2XYI10QM
Ibuprofen Dye FreeIBUPROFENCVS Pharmacy00653b7c-7099-487e-9a01-e89781c213232026-04-29WarningsExact identifier
unii: WK2XYI10QM
Acetaminophen and Ibuprofen Back PainACETAMINOPHEN AND IBUPROFENAurohealth LLC62d7ce90-63a4-4383-87c9-3a458eac29bf2026-04-28WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENCoupler LLC50766a3d-1a22-be14-e063-6294a90a0ed22026-04-27Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENMeijer Distribution Inc36f7227d-f3cb-44b7-a4c1-27611cd150522026-04-24WarningsExact identifier
unii: WK2XYI10QM
Medique at Home IprinIBUPROFENSportpharm LLC954d0436-b681-4bf5-80ec-0de9ddcab9942026-04-24WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen PMDIPHENHYDRAMINE CITRATE, IBUPROFENMeijer Distribution Inc47e71e23-da8a-4759-ac5a-1d48e0d9ab982026-04-22WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENCostco Wholesaleb4fa56d3-f4be-45b2-a3ac-40fe8d8bea072026-04-20WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen PMIBUPROFEN, DIPHENHYDRAMINE HCLMEIJER DISTRIBUTION INC.bb7701aa-f482-69e7-e053-2995a90a71b82026-04-17WarningsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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