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 35 of 66 · 1,308 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
basic care childrens ibuprofenIBUPROFENAmazon.com Services LLC9eafb61a-43bc-4845-b45a-72c7d5ac424e2025-06-05WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen 200IBUPROFENWalgreen Company62e8db95-aaef-4b0e-841e-64a0339f31902025-06-04WarningsExact identifier
unii: WK2XYI10QM
Good Sense Ibuprofen ChildrensIBUPROFENL. Perrigo Company321d6b3a-3dff-4334-b6ee-6ac801b9907c2025-06-03WarningsExact identifier
unii: WK2XYI10QM
Leader Childrens IbuprofenIBUPROFENCardinal Health 110, LLC. dba Leader2b0c3bb1-7667-403f-99e6-13c83755b1b52025-06-03WarningsExact identifier
unii: WK2XYI10QM
care one ibuprofenIBUPROFENAmerican Sales Company006adf23-21ab-4a4e-aae9-c4e5877771652025-06-03WarningsExact identifier
unii: WK2XYI10QM
up and up childrens ibuprofenIBUPROFENTarget Corporation834b7f5e-e636-4537-9bae-2d309fcc8eb32025-06-02WarningsExact identifier
unii: WK2XYI10QM
Sterile WaterWATERHenry Schein, Inc.88403fcf-a276-42c0-88b6-bd84a720b5642025-05-29Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Ibuprofen and FamotidineIBUPROFEN AND FAMOTIDINEZydus Lifesciences Limited24204938-0989-42ad-8ad8-89979e62d7002025-05-28Exact identifier
unii: WK2XYI10QM
Ibuprofen and FamotidineIBUPROFEN AND FAMOTIDINEViona Pharmaceuticals Inc66524c84-35bc-4e7f-897a-f63fa4bca4322025-05-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
equate ibuprofen childrensIBUPROFENWal-Mart Stores Inced9ee7b5-2d9a-4aaf-a245-aa13fcc6365a2025-05-23WarningsExact identifier
unii: WK2XYI10QM
ibuprofenIBUPROFENBryant Ranch Prepack92878aad-0bf9-4303-a1f8-4b9b23848a712025-05-21WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENNuCare Pharmaceuticals, Inc.2c3f8149-9b77-54cd-e063-6394a90a847e2025-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
childrens ibuprofenIBUPROFENCVS Pharmacy884d51d8-4774-4dde-b854-32abfb4b712d2025-05-20WarningsExact identifier
unii: WK2XYI10QM
Acetaminophen and IbuprofenACETAMINOPHEN AND IBUPROFENMeijer Distribution Inc2d916b1b-334f-15c7-e063-6294a90ae8b42025-05-19WarningsExact identifier
unii: WK2XYI10QM
equate dual back pain relieverACETAMINOPHEN, IBUPROFENWALMART INC.af7e6478-177f-473d-9d14-1e78610b1a6e2025-05-17WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen minisIBUPROFENP & L Development, LLC18b79fc5-57c8-46f1-81f3-2f9e189cdbcb2025-05-16WarningsExact identifier
unii: WK2XYI10QM
dg health ibuprofenIBUPROFENDolgencorp, LLCd6dcbdee-7c0d-4b5c-b0c1-1e8f357f7f592025-05-15WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENCHAIN DRUG MARKETING ASSOCIATION, INC.a60a6301-60b7-4f31-9ebe-872ccd8e9e762025-05-15WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENCHAIN DRUG MARKETING ASSOCIATION, INC.32f86bfb-67a6-49b5-a90a-5197f0d1baba2025-05-15WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENDISCOUNT DRUG MART9998b851-825b-a97d-e053-2a95a90affc62025-05-15WarningsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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