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 |
| Daytime Nighttime | ACETAMINOPHEN DEXTROMETHORPHAN HBR, ACETAMINOPHEN DEXTROMETHORPHAN HBR TRIPROLIDINE HCL | WALGREENS | 47f1d92f-cb4b-1635-e063-6294a90a2c71 | 2026-06-09 | Warnings | 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 |
| Daytime Nighttime | ACETAMINOPHEN DEXTROMETHORPHAN HBR, ACETAMINOPHEN DEXTROMETHORPHAN HBR TRIPROLIDINE HCL | TARGET CORPORATION | 4779288a-9850-8490-e063-6394a90abe51 | 2026-06-05 | Warnings | Name/manufacturer search |
| Delsym (Dextromethorphan) | DEXTROMETHORPHAN | Reckitt Benckiser LLC | bb0116d0-93e4-44e2-b0e4-c0b773eced6f | 2026-05-20 | Warnings | Name/manufacturer search |
| DEXTROMETHORPHAN POLISTIREX | DEXTROMETHORPHAN POLISTIREX | Aurohealth LLC | fc328034-ad2a-4f7d-81cf-f4da4e64f5d7 | 2026-05-13 | Warnings | Name/manufacturer search |
| DEXTROMETHORPHAN POLISTIREX | DEXTROMETHORPHAN POLISTIREX | Aurohealth LLC | 0fb8cdfc-3fa0-4773-813a-04c82b003bdf | 2026-05-13 | Warnings | Name/manufacturer search |
| Delsym (Dextromethorphan) | DEXTROMETHORPHAN | Reckitt Benckiser LLC | ce4b477c-430e-40a3-b247-b3914ef17793 | 2026-05-13 | Warnings | Name/manufacturer search |
| DEXTROMETHORPHAN POLISTIREX | DEXTROMETHORPHAN POLISTIREX | Aurohealth LLC | 4fde00af-3824-44f1-8a5f-d88518e0a8c8 | 2026-05-04 | Warnings | Name/manufacturer search |
| DEXTROMETHORPHAN POLISTIREX | DEXTROMETHORPHAN POLISTIREX | Aurohealth LLC | 759acdcd-d8d0-41d0-8b80-7f81fe196a9f | 2026-05-04 | Warnings | Name/manufacturer search |
| Guaifenesin,Dextromethorphan Hbr | GUAIFENESIN,DEXTROMETHORPHAN HBR | Softgel Healthcare Pvt Ltd | 3e5d978f-cc70-60a5-e063-6394a90a67d3 | 2026-04-27 | 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 |
| Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mg | ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCL | Softgel Healthcare Private Limited | 30ab39f3-27cc-5728-e063-6394a90a9cbe | 2026-04-27 | Warnings | Name/manufacturer search |
| Acetaminophen, Dextromethorphan HBr and Doxylamine Succinate | ACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATE | Softgel Healthcare Private Limited | 353f71f7-81e0-08c2-e063-6294a90acb49 | 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 |
| Acetaminophen, Dextromethorphan HBr ,Guaifenesin | ACETAMINOPHEN, DEXTROMETHORPHAN HBR ,GUAIFENESIN | Softgel Healthcare Pvt Ltd | 353ef34f-760d-ae92-e063-6294a90a5b4a | 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 HBR | GUAIFENESIN AND DEXTROMETHORPHAN HBR | TOPCO ASSOCIATES LLC | 3a9737c0-e413-dfd1-e063-6294a90aaebd | 2026-04-23 | Warnings | Name/manufacturer search |
| Guaifenesin and Dextromethorphan HBr | GUAIFENESIN AND DEXTROMETHORPHAN HBR | OHM LABORATORIES INC | f2eb5494-2672-444f-afa3-d1ef8ed1eaa1 | 2026-04-22 | Warnings | 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 |
| Guaifenesin and Dextromethorphan HBr | GUAIFENESIN AND DEXTROMETHORPHAN HBR | OHM LABORATORIES INC | 07b9854d-1ec6-4c8a-983e-96ed1e2de1c2 | 2026-04-20 | Warnings | Name/manufacturer search |
| Goodmeds Cough Relief Dextromethorphan HBr | DEXTROMETHORPHAN HYDROBROMIDE | Cabinet Health P.B.C. | aeb26c0e-4efe-4099-9b68-47824f4506c0 | 2026-04-20 | Warnings | Name/manufacturer search |
| Guaifenesin and Dextromethorphan HBr | GUAIFENESIN AND DEXTROMETHORPHAN HBR | VESPYR BRANDS LLC | 1c8fbf40-17c1-4ee9-a2b9-ca4a08e08293 | 2026-04-13 | Warnings | Name/manufacturer search |
| MAXIMUM STRENGTH DAYTIME NIGHTTIME SINUS RELIEF | ACETAMINOPHEN DEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCL AND ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE PHENYLEPHRINE HCL | CVS Pharmacy, Inc. | c17d5ba7-3302-7931-e053-2a95a90a5a6c | 2026-03-26 | Warnings | Name/manufacturer search |
| MAXIMUM STRENGTH DAYTIME NIGHTTIME COLD AND FLU | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | CVS Pharmacy, Inc. | c17b8f17-95f6-37e4-e053-2995a90a411a | 2026-03-26 | Warnings | Name/manufacturer search |
| Theraflu Flu Relief Max Strength Daytime Nighttime Value Pack | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR | Haleon US Holdings LLC | 3618ccf0-1f30-42e0-bb50-bfa45cf2b583 | 2026-03-26 | 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 |
| Daytime Nighttime Cold and Flu | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCI, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | Grocery Outlet, Inc. | 447a8753-96bd-676a-e063-6394a90a48f2 | 2026-03-06 | Warnings | Name/manufacturer search |
| Daytime Nighttime Ultra Concentrated | DAYTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND NIGHTTIME - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE | CVS HEALTH CORP | 4584d701-5a4e-e54e-e063-6394a90a38d6 | 2026-03-03 | Warnings | Name/manufacturer search |
| Severe Cold and Flu Daytime and Nighttime | ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL | Kroger | 49a98411-aa5a-6de3-e063-6294a90a148f | 2026-02-27 | Warnings | Name/manufacturer search |
| Guaifenesin and Dextromethorphan HBr | GUAIFENESIN AND DEXTROMETHORPHAN HBR | Sportpharm LLC | 2f170b35-03a8-4d2e-a4ea-21cccf693d9e | 2026-02-18 | Warnings | Name/manufacturer search |
| Guaifenesin and Dextromethorphan HBr | GUAIFENESIN AND DEXTROMETHORPHAN HBR | Sportpharm LLC | 3b5c5617-8499-7fc8-e063-6394a90aa86c | 2026-02-06 | Warnings | Name/manufacturer search |