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 |
|---|---|---|---|---|---|---|
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution | PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE ORAL SOLUTION | ATLANTIC BIOLOGICALS CORP. | 3983d6d3-8bf4-4a88-962f-9bf72fd6e685 | 2026-07-10 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide | PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | Advagen Pharma Ltd | 8b60eff2-5759-4bc3-ac16-5ff80aa153a0 | 2026-06-26 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | Camber Pharmaceuticals, Inc. | 6a2cd2d6-6e0f-4b2d-be7a-8b99627f4453 | 2026-06-09 | Warnings, Adverse reactions | Name/manufacturer search |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide | PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | Atlantic Biologicals Corp. | 5022379d-05ef-63f2-e063-6294a90a2189 | 2026-04-23 | Warnings, Adverse reactions | Name/manufacturer search |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide | PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | Bryant Ranch Prepack | 709519cb-d124-4469-b329-b67e1bba214b | 2026-03-20 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide | PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | Cranbury Pharmaceuticals, LLC | a8b57027-a4b8-4149-93e8-aa3e7a6d6dc3 | 2025-12-12 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide | PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | Cosette Pharmaceuticals, Inc. | e7b336d9-b1df-4a08-9b67-754346d365f4 | 2025-09-23 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide | PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | A-S Medication Solutions | 87f9e9fb-5433-478b-9f23-e16883a9d2a9 | 2025-09-23 | Warnings, Adverse reactions | Name/manufacturer search |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide | PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | ANI Pharmaceuticals, Inc. | a52e210f-b99d-493e-b679-ec565c6ff72d | 2025-08-08 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide | PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | Asclemed USA, Inc. | 702eb7c0-db4c-4729-b69e-99f64c63c7bd | 2025-05-07 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide | PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | Xttrium Laboratories, Inc | 30c9d769-bc74-04d2-e063-6294a90a665a | 2025-04-07 | Warnings, Adverse reactions | Name/manufacturer search |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution | PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE ORAL SOLUTION | NuCare Pharmaceuticals,Inc. | 0b7bfbab-decb-970c-e063-6394a90a50ef | 2025-02-03 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide | PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | Amneal Pharmaceuticals LLC | 6081c216-0bed-40f0-8732-f999647003d5 | 2024-10-30 | Warnings, Adverse reactions | Name/manufacturer search |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide | PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | A-S Medication Solutions | e451cb8d-f856-479f-bee9-4cccab210b1e | 2024-02-12 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral | PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE ORAL | A-S Medication Solutions | 9c3e0e87-b2f5-4a09-9db8-6d088d2a5f25 | 2023-08-10 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide | PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | A-S Medication Solutions | ee227c52-2cd8-4a06-a2de-a257f1f4732a | 2023-07-11 | Warnings, Adverse reactions | Name/manufacturer search |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution | PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE ORAL SOLUTION | Proficient Rx LP | 68a4c521-6db0-4e94-9906-96e96e251301 | 2022-04-01 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Promethazine DM | PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | PAI Holdings, LLC dba PAI Pharma | 1d47280d-28c9-4701-8c5f-a6e6b524083b | 2025-05-31 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |