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 | PROMETHAZINE HYDROCHLORIDE | Chartwell Governmental & Specialty RX, LLC. | e5d2156d-1f66-4fdf-a3ae-5e1325218c8b | 2025-11-21 | Warnings, Adverse reactions | Name/manufacturer search |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | American Health Packaging | a8fe4bc5-961b-4441-b8e2-ef93e4e137b6 | 2025-11-13 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | American Health Packaging | 57b4bf23-c563-4357-9dcf-066cbc1280e4 | 2025-11-13 | Warnings, Adverse reactions | Name/manufacturer search |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Henry Schein, Inc. | d7675718-0a57-41ff-a771-79afc12150aa | 2025-11-07 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Henry Schein, Inc. | c525cb2c-9a01-4a9b-ad2c-08630719953d | 2025-11-07 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Cardinal Health 107, LLC | e16238dc-9292-49ac-b80f-8afeccb88bc5 | 2025-10-24 | Warnings, Adverse reactions | Name/manufacturer search |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 7d766cf7-a21c-4eaf-bbdc-00f2939ef19a | 2025-10-15 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | REMEDYREPACK INC. | 6728bb41-5d50-4abb-bb73-993dcc16ee66 | 2025-10-03 | 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 | PROMETHAZINE HYDROCHLORIDE | Major Pharmaceuticals | 4cee8622-7d59-4794-8e32-54f7aac1d923 | 2025-09-22 | Warnings, Adverse reactions | Name/manufacturer search |
| Promethazine Hydrochloride and Dextromethorphan Hydrobromide Oral Solution | PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE ORAL SOLUTION | Preferred Pharmaceuticals Inc. | 88137097-16b3-44b7-8e1f-26a8242d8179 | 2025-09-16 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Preferred Pharmaceuticals Inc. | 974208c8-4aad-4fb9-991b-cf3085034272 | 2025-09-16 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | BluePoint Laboratories | 44cd6d46-fbb9-4836-9426-d8ce2cb6d66d | 2025-09-12 | Boxed warning, 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 | PROMETHAZINE HYDROCHLORIDE | PAI Holdings, LLC dba PAI Pharma | 7a186bcd-ab8c-4695-8289-4cd33bb551cf | 2025-08-05 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | 13d9e59d-eadb-41d5-9f47-9c11a6efb31c | 2025-06-30 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Hikma Pharmaceuticals USA Inc. | d545105f-27dc-4820-b0b1-fcf17e0be0f0 | 2025-06-30 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Asclemed USA, Inc. | 1b1cee64-c0b5-4da6-92d0-1769350a5181 | 2025-06-07 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Promethazine Hydrochloride and Codeine Phosphate | PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE | ATLANTIC BIOLOGICALS CORP. | f8fb13e3-bc09-4004-a911-a38b6bbb0058 | 2025-06-04 | 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 |
| 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 | PROMETHAZINE HYDROCHLORIDE | Xttrium Laboratories, Inc. | 302bfea2-d403-d315-e063-6294a90a37dd | 2025-04-07 | 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 | PROMETHAZINE HYDROCHLORIDE | Kesin Pharma Corporation | 28793bd2-bd40-4571-e063-6394a90ae789 | 2025-03-13 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 74834e1b-0d90-0542-e053-2991aa0aa1ef | 2025-02-10 | Warnings, Adverse reactions | Name/manufacturer search |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Coupler LLC | 2d996287-9eed-265a-e063-6294a90a6969 | 2025-02-07 | Boxed warning, 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 | PROMETHAZINE HYDROCHLORIDE | PD-Rx Pharmaceuticals, Inc. | 12400c65-f93b-47a5-8167-1fb14337130b | 2025-01-07 | Warnings, Adverse reactions | Name/manufacturer search |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Advanced Rx Pharmacy of Tennessee, LLC | f4c23037-e415-7604-e053-2995a90a5bb6 | 2024-12-31 | Warnings, Adverse reactions | Name/manufacturer search |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Zydus Lifesciences Limited | 4eaa8291-9cde-4205-857b-925ea8d618ba | 2024-12-04 | Name/manufacturer search | |
| Promethazine Hydrochloride and Phenylephrine Hydrochloride | PROMETHAZINE AND PHENYLEPHRINE | Amneal Pharmaceuticals LLC | cf4ef7c0-2f4a-4b0f-9060-ad0b909d1ed4 | 2024-10-30 | 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 | PROMETHAZINE HYDROCHLORIDE | Amneal Pharmaceuticals LLC | 05907a49-537f-4bf2-8a5f-5e905f19fece | 2024-10-30 | Warnings, Adverse reactions | Name/manufacturer search |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | A-S Medication Solutions | 6aa6bfcc-024b-4ee2-a586-6c4ca879cea4 | 2024-10-21 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | A-S Medication Solutions | 69eea039-0098-4e2f-a832-152583b16f05 | 2024-10-21 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | A-S Medication Solutions | b7137912-d119-4899-9c93-09c1c625f290 | 2024-10-21 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | NuCare Pharmaceuticals,Inc. | 84899861-8fed-536d-e053-2991aa0a42b2 | 2024-09-26 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | NCS HealthCare of KY, LLC dba Vangard Labs | a4fbc2d8-19b3-4556-b0b9-6e7a14cd4c36 | 2024-09-13 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |
| Promethazine Hydrochloride | PROMETHAZINE HYDROCHLORIDE | Bryant Ranch Prepack | 07914b6e-c40f-44be-a1db-8724c70f99b6 | 2024-08-15 | Boxed warning, Warnings, Adverse reactions | Name/manufacturer search |