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 3 of 4 · 125 matching rows.

Label, Generic name, Manufacturer table
LabelGeneric nameManufacturerSPL set IDEffective dateSafety fieldsMatch
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEBryant Ranch Prepackea490539-007b-47b1-bef9-22de02ae7c642024-08-08Boxed warning, Warnings, Adverse reactionsName/manufacturer search
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEBryant Ranch Prepacka4b3da5b-1129-43c2-bf22-3a29c3fae1162024-07-30Boxed warning, Warnings, Adverse reactionsName/manufacturer search
Promethazine Hydrochloride and Phenylephrine HydrochloridePROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDEGenus Lifesciences Inc.7f8ebc9c-c4e6-4344-95a5-ec25b8c99bc12024-07-22Boxed warning, Warnings, Adverse reactionsName/manufacturer search
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.8749824b-6d66-430d-e053-2995a90a2db82024-06-14Boxed warning, Warnings, Adverse reactionsName/manufacturer search
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDENuCare Pharmaceuticals,Inc.7e5715cf-056f-4095-e053-2991aa0ad3e52024-06-12Warnings, Adverse reactionsName/manufacturer search
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.4bf3912c-8339-401e-9711-dad6acf15f112024-06-05Boxed warning, Warnings, Adverse reactionsName/manufacturer search
Promethazine Hydrochloride and Codeine PhosphatePROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATEBryant Ranch Prepackdf2c24ba-1c88-4ec3-b2a1-801358ec645c2024-04-16Boxed warning, Warnings, Adverse reactionsName/manufacturer search
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.b0d5abba-6fae-4f3c-b990-dd9c83c7b5a92024-04-10Boxed warning, Warnings, Adverse reactionsName/manufacturer search
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEHikma Pharmaceuticals USA Inc.365138a6-28d8-4881-a3e9-02c80aaf83e82024-04-10Boxed warning, Warnings, Adverse reactionsName/manufacturer search
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEBryant Ranch Prepackda246971-20b8-b46e-8366-9700d3604cf12024-04-02Boxed warning, Warnings, Adverse reactionsName/manufacturer search
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEAsclemed USA, Inc.b4985d9d-1aa0-4b36-bc98-6a5410ad9bad2024-02-26Boxed warning, Warnings, Adverse reactionsName/manufacturer search
PROMETHAZINE HCIPROMETHAZINE HCIHF Acquisition Co. LLC, DBA HealthFirst744bcc7b-a1b3-1b72-e053-2a91aa0a7c3a2024-02-22Boxed warning, Warnings, Adverse reactionsName/manufacturer search
PROMETHAZINE HCIPROMETHAZINE HCIHF Acquisition Co. LLC, DBA HealthFirst7447e8c6-c198-cd2d-e053-2a91aa0a38952024-02-22Boxed warning, Warnings, Adverse reactionsName/manufacturer search
Promethazine Hydrochloride and Dextromethorphan HydrobromidePROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEA-S Medication Solutionse451cb8d-f856-479f-bee9-4cccab210b1e2024-02-12Boxed warning, Warnings, Adverse reactionsName/manufacturer search
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEXGen Pharmaceuticals DJB, Inc.b6f6698f-f23c-452a-9b38-bbb96ab88ae42024-01-09Boxed warning, Warnings, Adverse reactionsName/manufacturer search
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEXGen Pharmaceuticals DJB, Inc.1d02d52b-84bb-4e81-b352-125029eb39f62024-01-05Boxed warning, Warnings, Adverse reactionsName/manufacturer search
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEA-S Medication Solutionsa7b1e8b2-6f20-4096-87c7-cf349ed4f7b92023-12-15Warnings, Adverse reactionsName/manufacturer search
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEA-S Medication Solutionsb54439a3-1d01-4c5f-8508-731790ae215b2023-12-15Warnings, Adverse reactionsName/manufacturer search
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEZydus Pharmaceuticals USA Inc.c0c0d4f0-8396-485b-a585-71df01491f6f2023-11-07Boxed warning, Warnings, Adverse reactionsName/manufacturer search
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEA-S Medication Solutionsb96904e7-cc67-4abc-b946-8423f3f897ff2023-10-24Warnings, Adverse reactionsName/manufacturer search
promethazine hydrochloridePROMETHAZINE HYDROCHLORIDEA-S Medication Solutionsc0a68671-407b-4840-9662-04f168cff1cb2023-09-10Boxed warning, Warnings, Adverse reactionsName/manufacturer search
Promethazine Hydrochloride and Dextromethorphan Hydrobromide OralPROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE ORALA-S Medication Solutions9c3e0e87-b2f5-4a09-9db8-6d088d2a5f252023-08-10Boxed warning, Warnings, Adverse reactionsName/manufacturer search
Promethazine Hydrochloride and Dextromethorphan HydrobromidePROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDEA-S Medication Solutionsee227c52-2cd8-4a06-a2de-a257f1f4732a2023-07-11Warnings, Adverse reactionsName/manufacturer search
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEPadagis Israel Pharmaceuticals Ltd047b9a7c-586b-4635-a63e-2c7ce9ec34e72023-06-30Boxed warning, Warnings, Adverse reactionsName/manufacturer search
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEMedical Purchasing Solutions, LLC677b5fc5-94be-638b-e053-2991aa0a7f972023-05-23Boxed warning, Warnings, Adverse reactionsName/manufacturer search
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEA-S Medication Solutions2c9a4767-23c4-4a1c-bb4c-2bad1351c2702023-05-08Warnings, Adverse reactionsName/manufacturer search
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEMedical Purchasing Solutions, LLCdc8b50de-e4f6-607f-e053-2995a90a29022023-05-02Boxed warning, Warnings, Adverse reactionsName/manufacturer search
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEProficient Rx LPdcb1694a-8451-403c-b848-edb89ba170202023-05-01Boxed warning, Warnings, Adverse reactionsName/manufacturer search
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEQUAGEN PHARMACEUTICALS LLC32022e66-6f76-430a-8ad2-1e9e2872fee12023-02-15Boxed warning, Warnings, Adverse reactionsName/manufacturer search
Promethazine Hydrochloride and Codeine PhosphatePROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATEQUAGEN PHARMACEUTICALS LLC9aca56ec-28f8-4679-9f90-ec3e82deb9ac2023-02-15Boxed warning, Warnings, Adverse reactionsName/manufacturer search
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEA-S Medication Solutions87429921-00d2-42c7-9e99-600e8075b8ce2023-02-06Boxed warning, Warnings, Adverse reactionsName/manufacturer search
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEA-S Medication Solutionsc930985b-bba3-4f3a-a1ae-1d808670efde2023-02-04Boxed warning, Warnings, Adverse reactionsName/manufacturer search
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEProficient Rx LP59b906c6-2ccc-416e-b3ee-db09bf5531462023-01-01Boxed warning, Warnings, Adverse reactionsName/manufacturer search
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDECamber Pharmaceuticals, Inc.ba7d9e82-9b13-4607-b2f9-25e575b8c73b2022-11-05Warnings, Adverse reactionsName/manufacturer search
PromethazinePROMETHAZINEPharmPak, Inc.4f681538-7ac4-484c-9e6d-b571d73b9e0b2022-10-08Warnings, Adverse reactionsName/manufacturer search
Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral SolutionPROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE ORAL SOLUTIONProficient Rx LP68a4c521-6db0-4e94-9906-96e96e2513012022-04-01Boxed warning, Warnings, Adverse reactionsName/manufacturer search
PROMETHAZINE HYDROCHLORIDEPROMETHAZINE HYDROCHLORIDEProficient Rx LP29a8b172-1bad-40db-8d73-1fe7fb309cff2022-04-01Warnings, Adverse reactionsName/manufacturer search
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEProficient Rx LP08bf9fbf-cc21-41a0-9e81-ec498aa641702019-11-01Warnings, Adverse reactionsName/manufacturer search
Promethazine HydrochloridePROMETHAZINE HYDROCHLORIDEActavis Pharma, Inc.a32255f0-0077-489e-bdc6-869aca8cd4342016-12-01Warnings, Adverse reactionsName/manufacturer search
PhenerganPROMETHAZINE HCLDirect_Rxeec705f7-123a-7926-e053-2a95a90af46d2026-03-05Warnings, Adverse reactionsName/manufacturer search