FDA.reportPublic FDA data

FDA labels

Search the openFDA drug-label export by label identifier, NDC, application, RxCUI, UNII, product name, or manufacturer.

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report.

Label matches#

FDA label search results page 1 of 1 ยท 3 matching rows.

Label, Generic name, Manufacturer table
LabelGeneric nameManufacturerSPL set IDEffective dateSafety fieldsMatch
Fluoxetine HCLFLUOXETINE HCLDirect_rx48705e4f-c3ee-af78-e063-6394a90ad0522026-06-17Boxed warning, Warnings, Adverse reactionsName/manufacturer search
FLUOXETINE HCLFLUOXETINE HCLStrides Pharma Science Limitedd09a5026-b3eb-403f-bf31-d5991a81a8ce2025-12-16Boxed warning, Warnings, Adverse reactionsName/manufacturer search
Fluoxetine HCLFLUOXETINE HCLDirect_Rx0259db51-e1ff-6e7a-e063-6394a90abace2025-01-22Boxed warning, Warnings, Adverse reactionsName/manufacturer search