FDA labels
Search the openFDA drug-label export by label identifier, NDC, application, RxCUI, UNII, product name, or manufacturer.
Cross-check layer: openFDA label JSON supports search and identifier cross-checks. DailyMed SPL remains FDA.report’s canonical label presentation.
Label matches#
| Label | Generic name | Manufacturer | SPL set ID | Effective date | Safety fields | Match |
|---|---|---|---|---|---|---|
| Promethazine Hydrochloride and Phenylephrine Hydrochloride | PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE | Genus Lifesciences Inc. | 7f8ebc9c-c4e6-4344-95a5-ec25b8c99bc1 | 2024-07-22 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| 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 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 |