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 16 matching rows.

Label, Generic name, Manufacturer table
LabelGeneric nameManufacturerSPL set IDEffective dateSafety fieldsMatch
LeflunomideLEFLUNOMIDEBurel Pharmaceuticals, LLCfc044417-cd9a-42f6-8a3d-a14e7c2f81a22026-05-01Boxed warning, Warnings, Adverse reactionsName/manufacturer search
Pantoprazole SodiumPANTOPRAZOLE SODIUMBurel Pharmaceuticals, LLC3cc5197e-6b39-4415-b963-d4bbeecd79532026-02-06Warnings, Adverse reactionsName/manufacturer search
Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate, and Amphetamine SulfateDEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE MONOHYDRATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATEBurel Pharmaceuticals, LLCbcdd2fe2-d0de-4a28-aced-40ac9ce5122d2025-12-16Boxed warning, Warnings, Adverse reactionsName/manufacturer search
Sodium Fluoride 1.1%SODIUM FLUORIDEBurel Pharmaceuticals LLC6e021467-08b3-40b3-9a39-2e9d9830085d2025-11-14Warnings, Adverse reactionsName/manufacturer search
MiloPheneCLOMIPHENE CITRATEBurel Pharmaceuticals, LLCb56131e5-efc7-43af-ac13-4a2ae918df4e2025-10-07Warnings, Adverse reactionsName/manufacturer search
Sodium Polystyrene SulfonateSODIUM POLYSTYRENE SULFONATEBurel Pharmaceuticals, LLC8bbeae67-a7ff-4fa6-b21e-fb8617cd91972025-05-01Warnings, Adverse reactionsName/manufacturer search
BETAMETHASONE DIPROPIONATEBETAMETHASONE DIPROPIONATEBurel Pharmaceuticals, LLCc8bda9a8-4dec-4084-84e5-4b4623390bd82024-12-04Warnings, Adverse reactionsName/manufacturer search
BUTALBITAL AND ACETAMINOPHENBUTALBITAL AND ACETAMINOPHENBurel Pharmaceuticals, LLC0a8a6a16-b23f-45d2-b5d4-540264e74d142024-10-18Boxed warning, Warnings, Adverse reactionsName/manufacturer search
PHENOXYBENZAMINE HYDROCHLORIDEPHENOXYBENZAMINE HYDROCHLORIDEBurel Pharmaceuticals, LLC609aa41e-4cb5-4cdf-9137-f429c21b4fab2024-08-09Warnings, Adverse reactionsName/manufacturer search
FinasterideFINASTERIDEBurel Pharmaceuticals, LLCc8516eaa-98d0-4eb1-bc65-aa765baea5db2024-04-25Warnings, Adverse reactionsName/manufacturer search
Benzoyl PeroxideBENZOYL PEROXIDEBurel Pharmaceuticals, LLC0617d42d-511d-4c1a-a919-b37abbc14efc2024-04-24WarningsName/manufacturer search
Carglumic acidCARGLUMIC ACIDBurel Pharmaceuticals, LLC2aee4281-402b-4cd6-9e6a-08945262e1a12024-03-19Adverse reactionsName/manufacturer search
NICARDIPINE HYDROCHLORIDENICARDIPINE HYDROCHLORIDEBurel Pharmaceuticals, LLCcb902af0-b5ad-4680-b2f2-007ef2196efe2023-09-07Warnings, Adverse reactionsName/manufacturer search
KETOCONAZOLEKETOCONAZOLEBurel Pharmaceuticals, LLC57e81e13-b395-4dbd-b660-3038de41a8382023-08-01Boxed warning, Warnings, Adverse reactionsName/manufacturer search
tadalafilTADALAFILBurel Pharmaceuticals, LLCa2e7f393-5cfc-45e5-b87d-9e8abc8e43552022-12-01Warnings, Adverse reactionsName/manufacturer search
LevalbuterolLEVALBUTEROL HYDROCHLORIDEBurel Pharmaceuticals, LLC737fe40b-798b-4d7f-bec9-7af952018ab52021-07-01Warnings, Adverse reactionsName/manufacturer search