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 7 matching rows.

Label, Generic name, Manufacturer table
LabelGeneric nameManufacturerSPL set IDEffective dateSafety fieldsMatch
Tapentadol HydrochlorideTAPENTADOL HYDROCHLORIDENovadoz Pharmaceuticals LLCd4c5938a-68f0-46d2-9bad-8988d5724b092026-09-03Boxed warning, Warnings, Adverse reactionsName/manufacturer search
Tapentadol HydrochlorideTAPENTADOL HYDROCHLORIDEANI Pharmaceuticals, Inc.e0ecb809-6a55-4afe-b981-b8f174e5c3442026-07-27Boxed warning, Warnings, Adverse reactionsName/manufacturer search
TAPENTADOLTAPENTADOL HYDROCHLORIDEHikma Pharmaceuticals USA Inc.863f3fd3-1e8d-41b0-855f-8f9a29237cda2026-02-26Boxed warning, Warnings, Adverse reactionsName/manufacturer search
TAPENTADOLTAPENTADOL HYDROCHLORIDEHikma Pharmaceuticals USA Inc.38de863e-56ff-4c43-9ab8-9b3e1ba828582026-02-26Boxed warning, Warnings, Adverse reactionsName/manufacturer search
Tapentadol HydrochlorideTAPENTADOL HYDROCHLORIDEEPIC PHARMA LLCfecd2104-5bf3-47ed-a6f0-5c6ebb0a17b42026-01-28Boxed warning, Warnings, Adverse reactionsName/manufacturer search
Nucynta ERTAPENTADOL HYDROCHLORIDECollegium Pharmaceutical, Inc.c3d04d70-0155-4147-9ce4-a3b1fad4b3732025-12-30Boxed warning, Warnings, Adverse reactionsName/manufacturer search
NucyntaTAPENTADOL HYDROCHLORIDECollegium Pharmaceutical, Inc.80938c30-9fe3-4c7d-9d9c-5476638cfb2d2025-12-30Boxed warning, Warnings, Adverse reactionsName/manufacturer search