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 51 of 66 · 1,308 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENEXELAN PHARMACEUTICALS, INC.362f934a-4382-43bc-bedd-65081286f1c92024-03-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENWALGREENS746f79aa-3036-1b9b-e053-2a91aa0a1db62024-03-18WarningsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENWALGREENS76f4cc25-a77e-6245-e053-2a91aa0af7ae2024-03-18WarningsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENWALGREENS3ce5b71b-f841-444f-bf66-023e4bd9aa162024-03-15WarningsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENWALGREENS76f15be2-4682-5015-e053-2991aa0af0d22024-03-15WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen OralIBUPROFEN ORALBryant Ranch Prepackcf22da7e-fcf1-49da-8314-277d31199c1c2024-03-13WarningsExact identifier
unii: WK2XYI10QM
basic care ibuprofenIBUPROFENAmazon.com Services LLC5ada3dbe-af87-49db-a6b0-0a1c02111cbf2024-03-11WarningsExact identifier
unii: WK2XYI10QM
ChemtoxBERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, HEPAR SUIS, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, THYROIDINUM (SUIS), ARSENICUM ALBUM, ASARUM CANADENSE, CARBOLICUM ACIDUM, CARBONEUM SULPHURATUM, IRIDIUM METALLICUM, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORUS, SELENIUM METALLICUM, SULPHURICUM ACIDUM, CHLORINUM, BUTYLBENZENE, PETROLEUM, SORBITOLDeseret Biologicals, Inc.91f52c95-f36d-4754-8570-f81ed8d361802024-03-06WarningsExact identifier
unii: 506T60A25R
GI DrainageCINNAMOMUM, GENTIANA LUTEA, SYZYGIUM JAMBOLANUM, ARGENTUM NITRICUM, COLCHICUM AUTUMNALE, COLOSTRUM (BOVINE), COPPER GLUCONATE, LAPPA MAJOR, LYCOPODIUM CLAVATUM, MAGNESIUM GLUCONICUM, MANGANESE GLUCONATE, PANCREAS SUIS, POTASSIUM GLUCONATE, RUMEX CRISPUS, STOMACH (SUIS), AURUM METALLICUM, CALCAREA CARBONICA, CARBO VEGETABILIS, INTESTINE (SUIS), MALUS PUMILA, FLOS, NITRICUM ACIDUM, PRUNUS CERASIFERA, FLOS, ROCK WATER, SCHROPHULARIA NODOSA, FAGUS SYLVATICA, FLOSDeseret Biologicals, Inc.ff81e3ca-2f88-4daf-a734-083107269d3a2024-02-21WarningsExact identifier
unii: 059QF0KO0R
Basic Care Dual ActionACETAMINOPHEN, IBUPROFENAmazon.com Services LLC7e27f5cb-8728-400f-82c5-0984276aa5dd2024-02-20WarningsExact identifier
unii: WK2XYI10QM
CHILDRENS ADVILIBUPROFENHaleon US Holdings LLC3079d932-afb2-94fe-f4ba-a3d8b5198fce2024-02-08WarningsExact identifier
unii: WK2XYI10QM
CHILDRENS ADVILIBUPROFENHaleon US Holdings LLC4eba2795-e826-480d-afdc-d62004e95f362024-02-08WarningsExact identifier
unii: WK2XYI10QM
pain reliefIBUPROFENMeijer, Inc.1f965703-3262-4dd1-b4f8-6341786553b12024-02-07WarningsExact identifier
unii: WK2XYI10QM
Topcare Dual Action Back PainACETAMINOPHEN, IBUPROFENTopco Associates LLCe40ec21c-6c44-4219-a94f-8b93a4853aa52024-02-06WarningsExact identifier
unii: WK2XYI10QM
Sterile WaterSTERILE WATERChartwell RX, LLC3681eeaa-807a-47ca-9fbc-61c2b682800a2024-02-01Exact identifier
unii: 059QF0KO0R
signature care ibuprofenIBUPROFENSafeway95904b21-752d-48b4-a882-8d81d2384e1f2024-02-01WarningsExact identifier
unii: WK2XYI10QM
Sterile WaterWATERA-S Medication Solutionsdba87371-31d2-47c2-ab83-89aabce4b1842024-01-31Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Childrens FLANAX ORALIBUPROFENBelmora LLC9b9318cb-3bc7-40ca-bf8a-7495d93869b32024-01-30WarningsExact identifier
unii: WK2XYI10QM
good sense ibuprofenIBUPROFENA-S Medication Solutions57af05fc-30b9-4487-9a37-fb35dac4acf72024-01-29WarningsExact identifier
unii: WK2XYI10QM
PROPRINALIBUPROFEN CAPSULES 200 MGA-S Medication Solutions4723dd14-5d20-4a9a-b127-4237d5db59562024-01-29WarningsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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