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 5 matching rows.

Label, Generic name, Manufacturer table
LabelGeneric nameManufacturerSPL set IDEffective dateSafety fieldsMatch
Methylphenidate Extended-ReleaseMETHYLPHENIDATE EXTENDED-RELEASENeos Therapeutics, LPc2fec19b-6610-4ce0-8e60-f8218a11f62f2026-06-16Boxed warning, Warnings, Adverse reactionsName/manufacturer search
METHYLPHENIDATE HYDROCHLORIDE EXTENDED RELEASEMETHYLPHENIDATE HYDROCHLORIDE EXTENDED RELEASEKVK-Tech, Inc.be8580bc-0eb2-4eb6-a4cc-4ebbeb33424d2025-10-07Boxed warning, Warnings, Adverse reactionsName/manufacturer search
Methylphenidate Hydrochloride Extended-ReleaseMETHYLPHENIDATE HYDROCHLORIDESpecGx LLC9e11e093-4ff3-4bed-8fe9-3ee460b473032025-12-01Boxed warning, Warnings, Adverse reactionsName/manufacturer search
Methylphenidate Hydrochloride Extended-ReleaseMETHYLPHENIDATE HYDROCHLORIDESpecGx LLCb1b0f2ff-d9df-42ab-b471-226ecf97e0752024-09-01Boxed warning, Warnings, Adverse reactionsName/manufacturer search
JORNAY PM Extended-ReleaseMETHYLPHENIDATE HYDROCHLORIDEIronshore Pharmaceuticals Inc.d95dede0-b1ff-4489-8f91-3bbe122852bf2025-10-03Boxed warning, Warnings, Adverse reactionsName/manufacturer search