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FDA labels

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

Cross-check layer: openFDA label JSON supports search and identifier cross-checks. DailyMed SPL remains FDA.report’s canonical label presentation.

Label matches#

FDA label search results page 1 of 1 ยท 6 matching rows.

Label, Generic name, Manufacturer table
LabelGeneric nameManufacturerSPL set IDEffective dateSafety fieldsMatch
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