Mucinex 12Hr Cold & Fever Multi-Symptom (dextromethorphan hydrobromide, guaifenesin, naproxen sodium)
New combination
- Region
- 🇺🇸 US
- Active substance
- dextromethorphan hydrobromide, guaifenesin, naproxen sodium
- Company
- Reckitt Benckiser
- Status
- Approved
- FDA approval
- Mon 22 Dec 2025
- Designations
- New combination
- Application
- NDA217338
- Official record
- www.accessdata.fda.gov
Regulatory milestones
Mon 22 Dec 2025🇺🇸 FDA approval
FDA approves Mucinex 12Hr Cold & Fever Multi-Symptom (dextromethorphan hydrobromide, guaifenesin, naproxen sodium): new combination
Reckitt Benckiser; NDA217338; New combination; tablet, extended release · source
Same substance in other markets
- 🇪🇺 Nuedexta Withdrawn · Jenson Pharmaceutical Services Limited
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.