# MUCINEX 12HR COLD & FEVER MULTI-SYMPTOM
> **NDA217338** · New Drug Application · Sponsor: RB HLTH · Approved 2025-12-22
## Drug
- **FDA Application Number:** NDA217338
- **Application type:** New Drug Application
- **Brand name:** MUCINEX 12HR COLD & FEVER MULTI-SYMPTOM
- **Generic name:** Dextromethorphan Hydrobromide
- **Active ingredients:** DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; NAPROXEN SODIUM
- **Dosage form:** TABLET, EXTENDED RELEASE
- **Route:** ORAL
- **Marketing status:** Over-the-counter
- **Sponsor:** RB HLTH
- **First approval:** 2025-12-22
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=217338)
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