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 43 of 66 · 1,308 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENSpirit Pharmaceutical LLC59c77fd3-5e67-45ec-82ad-44585390c4f32024-12-30WarningsExact identifier
unii: WK2XYI10QM
IBUPROFENIBUPROFENSPIRIT PHARMACEUTICALS,LLC2810122e-3c89-49a2-8dac-db3714cb7b452024-12-30WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENSpirit Pharmaceutical LLCa96d012e-b132-4e99-b84b-ccd3a9a05cbb2024-12-30WarningsExact identifier
unii: WK2XYI10QM
Cabinet Pain Reliever and Fever ReducerIBUPROFENSpirit Pharmaceutical LLCe172a8d8-779d-4ad9-b6b0-08a198a580342024-12-30WarningsExact identifier
unii: WK2XYI10QM
ADVIL PM- diphenhydramine citrate and ibuprofen tablet, coatedADVIL PMLil Drug Store Products, Incd1138e15-8ae4-7b49-e053-2995a90a96072024-12-30WarningsExact identifier
unii: WK2XYI10QM
Advil Liqui-GelsIBUPROFEN CAPSULE, LIQUID-FILLEDLil' Drug Store Products, Inc.c459ea1e-dabf-bba6-e053-2995a90af40f2024-12-30WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAurohealth LLC09bd3935-526d-4ad1-898a-4f0d9499ebb92024-12-26WarningsExact identifier
unii: WK2XYI10QM
Aacetaminophen and IbuprofenACETAMINOPHEN AND IBUPROFENGRANULES USA, INC.1dd90684-6505-8e07-e063-6394a90afdf42024-12-26WarningsExact identifier
unii: WK2XYI10QM
Childrens Ibuprofen Oral SuspensionIBUPROFENChain Drug Marketing Association, Inc.f0959369-890e-403e-8a98-4eda340a07832024-12-23WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENSpirit Pharmaceutical LLC9a93d4a8-07a1-4ac5-9bd9-5d5e4e62c2af2024-12-20WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENDolgencorp, Inc.5398f5b7-a9a6-4f7e-a06c-e524b99395622024-12-19WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENNuCare Pharmaceuticals,Inc.fe939219-d752-63a0-e053-6394a90a0ab22024-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENQuality Care Products, LLC246b120e-3458-4721-bf95-82537feaa1312024-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENQuality Care Products, LLC56f1d6a9-6804-4235-a600-f7c8e458f6932024-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENNuCare Pharmaceuticals,Inc.f4d6372a-d560-0e14-e053-2a95a90a435a2024-12-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENSpirit Pharmaceuticals LLCe38d23e5-b455-41b5-86f6-c318b17bd3452024-12-13WarningsExact identifier
unii: WK2XYI10QM
VALUMEDS IBUPROFENIBUPROFENSPIRIT PHARMACEUTICALS LLCa6d4ceb0-2b79-496a-aa1e-27edd507ced02024-12-10WarningsExact identifier
unii: WK2XYI10QM
Fendall Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.afda6fc3-7615-b0be-e053-2995a90a62082024-12-10WarningsExact identifier
unii: 059QF0KO0R
Assured IbuprofenIBUPROFENSpirit Pharmaceuticals LLC119263b5-c3b7-46dc-a3bd-9893bfd246282024-12-10WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENAAA Pharmaceutical, Inc.39e55ec1-213f-4996-adca-68a5ffbc409b2024-12-06WarningsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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