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#
| Label | Generic name | Manufacturer | SPL set ID | Effective date | Safety fields | Match |
|---|---|---|---|---|---|---|
| PROMETHEGAN | PROMETHAZINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 6b72dcf9-a4a1-4cc1-b7c2-a0bc2740fe97 | 2025-10-20 | Boxed warning, Adverse reactions | Name/manufacturer search |
| PHENERGAN | PROMETHAZINE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | 6f7e47cc-f823-4336-8107-f980e3049617 | 2025-06-30 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| PHENERGAN | PROMETHAZINE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | 481866da-a712-48a5-853f-8e84aacaab6d | 2024-05-20 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| PROMETHEGAN | PROMETHAZINE HYDROCHLORIDE | Cosette Pharmaceuticals, Inc. | 5f079815-f48b-8b21-2130-7f791d967c9a | 2023-11-30 | Boxed warning, Adverse reactions | Name/manufacturer search |
| PROMETHEGAN | PROMETHAZINE HYDROCHLORIDE | Cosette Pharmaceuticals, Inc. | 636bb9bc-0cc5-4d6a-85be-6471acf01ffc | 2023-11-30 | Boxed warning, Adverse reactions | Name/manufacturer search |