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 | PROMETHAZINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 6bcaa89f-5f14-dc45-e053-2a91aa0aac54 | 2026-07-30 | Warnings, Adverse reactions | Name/manufacturer search |
| 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 | PROMETHAZINE HYDROCHLORIDE | Coupler LLC | 55f618d1-4466-3200-e063-6394a90a89a8 | 2026-07-06 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | REMEDYREPACK INC. | 9e4e57fa-4ce3-4b7b-be5a-381801ed0386 | 2026-07-03 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Sportpharm LLC | 4156e780-7ecf-bcae-e063-6394a90a2ae2 | 2026-07-02 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | ASCLEMED USA INC. | 4d30e587-6d59-4cf5-ab45-c7639f759df9 | 2026-07-02 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Unit Dose Solutions, Inc. | 5590f356-0904-58f6-e063-6294a90a6ad5 | 2026-07-01 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 804e2525-d61f-7bed-e053-2991aa0a5daa | 2026-06-30 | 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 | PROMETHAZINE HYDROCHLORIDE | Bryant Ranch Prepack | e6d940f8-fa1a-4a75-b4fc-2cbbaf7a0488 | 2026-06-05 | Warnings, Adverse reactions | Name/manufacturer search |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | Bryant Ranch Prepack | f9ff2bd5-6464-4c9e-b2ed-dcd2dbe83c47 | 2026-06-04 | Warnings, Adverse reactions | Name/manufacturer search |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 5ce082e9-13eb-4e63-a9e2-657d3ef0e9f8 | 2026-05-22 | Warnings, Adverse reactions | Name/manufacturer search |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | f93ca67d-362a-473f-8296-2952da77c074 | 2026-05-22 | Warnings, Adverse reactions | Name/manufacturer search |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | b0ba50da-9f70-4531-a9de-3dd3f8aa1f5d | 2026-05-22 | 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 | PROMETHAZINE HYDROCHLORIDE | Atlantic Biologicals Corp. | 4f99bbd5-02f7-2fed-e063-6394a90a6355 | 2026-04-16 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | A-S Medication Solutions | bf951b5b-6e38-44a9-895e-0d60c6b9d343 | 2026-03-27 | 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 | PROMETHAZINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 81fd29a9-c090-49ba-8b48-bd3656ca0c92 | 2026-03-19 | Warnings, Adverse reactions | Name/manufacturer search |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | KVK-Tech, Inc. | 7a137adf-39b7-4b14-80da-c3cac9ad562a | 2026-03-13 | Warnings, Adverse reactions | Name/manufacturer search |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | DIRECT RX | bae9c9c1-107f-0fcb-e053-2a95a90a75b2 | 2026-03-05 | Warnings, Adverse reactions | Name/manufacturer search |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | Henry Schein, Inc. | 7fa840ad-10e7-4faf-9325-451648604161 | 2026-03-05 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | REMEDYREPACK INC. | adb04635-584f-4fef-98ca-2574be312a73 | 2026-02-06 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | Chartwell RX, LLC | 2ca17cd4-460e-4d54-8c53-a58a2b80e5cb | 2026-01-30 | Warnings, Adverse reactions | Name/manufacturer search |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Cardinal Health 107, LLC | 7ce351d8-47be-4937-aad2-153208c93b53 | 2026-01-15 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Promethazine and Phenylephrine HCl, and Codeine Phosphate | PROMETHAZINE, PHENYLEPHRINE, CODEINE | Amneal Pharmaceuticals LLC | 5f23b254-872b-4e88-91be-710c3ea7687b | 2026-01-08 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Northwind Health Company, LLC | f6ca1097-1c75-c682-e053-6294a90a2bd6 | 2026-01-01 | Warnings, Adverse reactions | Name/manufacturer search |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | Northwind Health Company, LLC | d9cb1a44-d646-d9e9-e053-2995a90a24ff | 2026-01-01 | Warnings, Adverse reactions | Name/manufacturer search |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Northwind Health Company, LLC | 075f052e-7f38-7f75-e063-6394a90a512b | 2026-01-01 | Warnings, Adverse reactions | Name/manufacturer search |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Northwind Health Company, LLC | ba4ec2d8-1da4-473b-9ef8-57051cb2c0f7 | 2025-12-26 | Warnings, Adverse reactions | Name/manufacturer search |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Amneal Pharmaceuticals of New York LLC | 0b5734b8-6a52-44ff-ac29-9a91a4335394 | 2025-12-20 | Warnings, Adverse reactions | Name/manufacturer search |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | ProPharma Distribution | 38673af1-112e-9ddd-e063-6294a90af465 | 2025-12-18 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Promethazine Hydrochloride and Codeine Phosphate | PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE | Cosette Pharmaceuticals, Inc. | 3b02cda4-9b24-79c9-e063-6294a90af5b9 | 2025-12-18 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Promethazine Hydrochloride and Codeine Phosphate | PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE | Cranbury Pharmaceuticals, LLC | 785c605e-1907-4fac-8b69-d504a2076f8e | 2025-12-12 | 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 | PROMETHAZINE HYDROCHLORIDE | Cranbury Pharmaceuticals, LLC | d32ea9db-11d4-400d-b7ef-dd0ec01b796d | 2025-12-12 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| PROMETHAZINE HYDROCHLORIDE | PROMETHAZINE HYDROCHLORIDE | ProPharma Distribution | 45b09a50-dab2-e83d-e063-6394a90aa813 | 2025-12-11 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| promethazine hydrochloride | PROMETHAZINE HYDROCHLORIDE | ATLANTIC BIOLOGICALS CORP | 69934bbb-922c-4752-b253-f2f07340de8d | 2025-12-11 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | A-S Medication Solutions | 46b869e2-9305-43ae-bb15-919a6d09b6ff | 2025-12-04 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |