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 |
|---|---|---|---|---|---|---|
| Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE | Prodose, Inc. | 3afc88c7-388a-dbd9-e063-6294a90a4faf | 2026-07-24 | Warnings | Name/manufacturer search |
| Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide | BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE | Sportpharm LLC | f3afca82-ba8f-4741-8332-b7939aa0ee5e | 2026-07-23 | 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 |
| Dextromethorphan Hydrobromide and Quinidine Sulphate | DEXTROMETHORPHAN HYDROBROMIDE AND QUINIDINE SULPHATE | Sun Pharmaceutical Industries, Inc. | 92b54ac4-594e-47b8-a4d3-394a29b425f3 | 2026-07-08 | 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 |
| Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide | BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE | Dr. Reddy's Labratories Inc. | 79be4527-73b4-93b2-5858-1e2a9819fd50 | 2026-06-22 | 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 |
| Acetominophen, Dextromethorphan hydrobromide | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE | Softgel Healthcare Private Limited | 5302bc6d-d947-31c3-e063-6294a90a09f3 | 2026-06-06 | Warnings | Name/manufacturer search |
| Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine Hydrochloride | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDE | Softgel Healthcare Pvt Ltd | 36ced59c-12dc-441f-e063-6294a90a3239 | 2026-04-27 | Warnings | Name/manufacturer search |
| Dextromethorphan Hydrobromide | DEXTROMETHORPHAN HYDROBROMIDE | Softgel Healthcare Pvt Ltd | 20f7c1a9-fc4d-1f51-e063-6394a90a8be3 | 2026-04-27 | Warnings | 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 |
| Guaifenesin and Dextromethorphan Hydrobromide | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | CVS PHARMACY, INC | dd00dfc0-e523-4dec-8fc0-50363eadec57 | 2026-04-20 | Warnings | 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 |
| Guaifenesin and Dextromethorphan Hydrobromide | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | Bryant Ranch Prepack | 9a77465c-6d3a-4399-9734-ad22e4b435db | 2026-03-18 | Warnings | Name/manufacturer search |
| Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide | BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE | Acella Pharmaceuticals, LLC | 1045e307-f60d-482d-8e06-40e72b84c651 | 2026-03-16 | Warnings, Adverse reactions | Name/manufacturer search |
| Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE | Softgel Healthcare Private Limited | 229d1939-84a9-f18e-e063-6394a90aba30 | 2026-01-28 | Warnings | Name/manufacturer search |
| Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine Hydrochloride | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDE | SOFTGEL HEALTHCARE PRIVATE LIMITED | 1fcbafaa-c871-db6d-e063-6394a90aab5e | 2026-01-28 | Warnings | Name/manufacturer search |
| Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE | SOFTGEL HEALTHCARE PRIVATE LIMITED | 1f7a6375-ab66-9782-e063-6394a90a99f3 | 2026-01-28 | Warnings | Name/manufacturer search |
| Acetaminophen, Dextromethorphan Hydrobromide and Phenylephrine Hydrochloride | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND PHENYLEPHRINE HYDROCHLORIDE | SOFTGEL HEALTHCARE PRIVATE LIMITED | 37e8ccd5-6be1-9aca-e063-6394a90a5263 | 2026-01-27 | Warnings | Name/manufacturer search |
| Acetaminophen, Dextromethorphan Hydrobromide and Doxylamine Succinate | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATE | SOFTGEL HEALTHCARE PRIVATE LIMITED | 2f7f078e-de04-9d53-e063-6394a90a409f | 2026-01-27 | Warnings | Name/manufacturer search |
| SEVERE COLD AND FLU DAYTIME NON DROWSY and NIGHTTIME | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE,GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE / ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE | Walgreens | 2dba2bec-e0e3-4910-89c5-ebc093e05bec | 2026-01-19 | Warnings | Name/manufacturer search |
| Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide | BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | REMEDYREPACK INC. | 35236e4a-6e98-4c4d-85bf-7551fd08d700 | 2026-01-13 | 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 |
| Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide | BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE | Chartwell Governmental & Specialty RX, LLC | a19b75d4-67de-4904-8487-1f9b3368c833 | 2025-11-25 | Warnings, Adverse reactions | Name/manufacturer search |
| Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide | BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | Bryant Ranch Prepack | 85b98fa3-376c-41a3-b3c1-0c739d903a22 | 2025-11-14 | Warnings, Adverse reactions | Name/manufacturer search |
| Guaifenesin and Dextromethorphan Hydrobromide | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | Method Pharmaceuticals | 1538bf63-d020-3ba2-e063-6294a90aecc5 | 2025-10-21 | Warnings | Name/manufacturer search |
| Guaifenesin and Dextromethorphan Hydrobromide | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | Method Pharmaceuticals | 389230e5-775e-5b0d-e054-00144ff88e88 | 2025-10-21 | Warnings | Name/manufacturer search |
| Brompheniramine Maleate, Pseudoephedrine Hydrochloride, Dextromethorphan Hydrobromide | BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE | Acella Pharmaceuticals, LLC | 0c403f27-0b9b-4da3-a66b-1040eff1b2bf | 2025-10-15 | Warnings, Adverse reactions | Name/manufacturer search |
| DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | OPMX LLC | 4139bfdc-792f-698a-e063-6394a90ad1af | 2025-10-15 | Warnings | Name/manufacturer search |
| Guaifenesin and Dextromethorphan Hydrobromide | GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE | InvaTech Pharma Solutions LLC | 40288ecf-043d-eb9e-e063-6394a90ac0a7 | 2025-10-02 | Warnings | Name/manufacturer search |
| Brompheniramine Maleate, Pseudoephedrine Hydrochloride, and Dextromethorphan Hydrobromide | BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE | BIONPHARMA INC. | 3ff18027-44fb-50a1-e063-6394a90a2390 | 2025-10-01 | Warnings, Adverse reactions | Name/manufacturer search |
| Acetaminophen 325 mg, Dextromethorphan Hydrobromide 10 mg, Phenlyephrine Hydrochloride 5 mg softgel (DAY-TIME) | ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE | Health Pharma USA LLC | a03befb4-d86d-43e4-8097-eda5c8bb25be | 2025-09-24 | Warnings | 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 |
| Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide | BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE | Padagis US LLC | 06db369d-09fe-4ca2-b98c-705356b7c403 | 2025-09-23 | 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 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 |
| Brompheniramine Maleate, Pseudoephedrine Hydrochloride and Dextromethorphan Hydrobromide | BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE, AND DEXTROMETHORPHAN HYDROBROMIDE | PAI Holdings, LLC dba PAI Pharma | 01ea6357-24dc-4056-9fd2-9e643650b91f | 2025-09-04 | 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 |
| DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | KJD Pharma Private Limited | b109249a-a0be-41bd-b6ce-ef621b588ddc | 2025-07-02 | Warnings | Name/manufacturer search |
| DEXTROMETHORPHAN HYDROBROMIDE and GUAIFENESIN | DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN | KJD Pharma Private Limited | 8877bb8d-479f-4968-8033-5c269d449a46 | 2025-06-10 | Warnings | Name/manufacturer search |