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 45 of 66 · 1,308 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens MotrinIBUPROFENKenvue Brands LLC152189e5-391c-42d3-a03b-c8364e2de6bf2024-11-08WarningsExact identifier
unii: WK2XYI10QM
Crane Safety Eye WashWATER SOLUTIONCrane Safety LLC96d8dda9-6cd6-3f68-e053-2995a90a0da22024-11-08WarningsExact identifier
unii: 059QF0KO0R
RUGBY EYE WASHWATER, PURIFIEDA-S Medication Solutions0773e558-2f46-494c-888a-3bc517202b652024-11-08WarningsExact identifier
unii: 059QF0KO0R
good sense ibuprofenIBUPROFENA-S Medication Solutions9ac095d2-ba19-4da1-acc9-85f7b4ae304d2024-11-04WarningsExact identifier
unii: WK2XYI10QM
Childrens MotrinIBUPROFENKenvue Brands LLC9e1cdef7-921f-4163-869c-6c062e31c5bb2024-11-01WarningsExact identifier
unii: WK2XYI10QM
Childrens MOTRINIBUPROFENKenvue Brands LLCf2609308-17bf-4bcb-84b2-d17f3fd359582024-11-01WarningsExact identifier
unii: WK2XYI10QM
GOOD REMEDIES ibuprofen 200 mgIBUPROFENStrive Pharmaceuticals Inc.24fb3741-65e0-898d-e063-6394a90af5692024-10-31WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen and Diphenhydramine CitrateIBUPROFEN AND DIPHENHYDRAMINE CITRATEBetter Living Brands, LLCfcfb044d-f6b9-5c43-e053-6394a90ac4172024-10-29WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENBryant Ranch Prepack7650f84b-92f2-4065-8ef2-f5de5bd7002b2024-10-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENBryant Ranch Prepack1361b6d6-0443-460a-8446-41f63a1e28df2024-10-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENRugby Laboratories, Inc.05c4e6c7-bf95-4e05-b7da-7a8778de342b2024-10-28WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENBETTER LIVING BRANDS, LLCeb619068-be71-7569-e053-2a95a90a4a6e2024-10-26WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen Pain Reliever/Fever ReducerIBUPROFENAmneal Pharmaceuticals LLC877440fc-3afb-4123-a2e6-5cb48c74413c2024-10-25WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen Pain Reliever/Fever ReducerIBUPROFENAmneal Pharmaceuticals LLC5f27dd3f-c735-417b-95e6-26dc5aae5a7a2024-10-25WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen and Pseudoephedrine HydrochlorideIBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDEAurohealth LLCc01116d3-32f8-41f0-8e31-c4142265ef562024-10-24WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENA-S Medication Solutions2d0c2d35-c212-4daa-b2c4-b407ca0b16ad2024-10-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENA-S Medication Solutions2b470e48-c23c-4f5c-916a-d38d8518896b2024-10-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
ChemtoxTRITICUM AESTIVUM, BERBERIS VULGARIS, GLYCYRRHIZA GLABRA, LAPPA MAJOR, RHAMNUS FRANGULA, RHAMNUS PURSHIANA, STILLINGIA SYLVATICA, TRIFOLIUM PRATENSE, XANTHOXYLUM FRAXINEUM, PHYTOLACCA DECANDRA, GLANDULA SUPRARENALIS SUIS, HEPAR SUIS, LYMPH NODE (SUIS), THYROIDINUM (SUIS), BELLADONNA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, NUX VOMICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, SALICYLICUM ACIDUM, CORTISONE ACETICUM, EUGENOL, STEARYL ALCOHOL, XYLITOL, FOLLICULINUM, BENZOICUM ACIDUM, CHLORINUM, POTASSIUM SORBATE,BioActive Nutritional, Inc.9aa060f1-f8f6-46e6-a7d0-bd46a73f26762024-10-17WarningsExact identifier
unii: 506T60A25R
EyS Eye WashWATEREyes-Plus LLC1443f6bf-3a77-4a19-8585-0ec58efe042f2024-10-15WarningsExact identifier
unii: 059QF0KO0R
kirkland signature ibuprofen ibIBUPROFENCostco Wholesale Company2fee0f32-0bc7-4d98-b5d4-5a7dad1c2a2c2024-10-14WarningsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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