NDA 217338, held by Reckitt Benckiser. Dextromethorphan Hydrobromide; Guaifenesin; Naproxen Sodium.
As of Nov 13, 2026, NDA 217338 (Mucinex 12hr Cold & Fever Multi-Symptom), held by Reckitt Benckiser, was first approved by FDA on Dec 22, 2025, with 0 approved supplements and 1 published complete response letter.
Uses ■ helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive ■ temporarily relieves: ■ cough due to minor throat and bronchial irritation as may occur with the common cold or inhaled irritants ■ the intensity of coughing ■ the impulse to cough to help you get to sleep ■ minor aches and pains due to headache and the common cold ■ temporarily reduces fever
| Date | Submission | Status | Documents |
|---|---|---|---|
| Dec 22, 2025 | Original applicationNew combination · Standard review | Approved |
| Letter | Product | Now |
|---|---|---|
| Jul 26, 2024 | NDA 217338Clinical | Unapproved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Mucinex 12hr Cold & Fever Multi-Symptom30MG;600MG;110MG · tablet, extended release;oral | Dextromethorphan Hydrobromide; Guaifenesin; Naproxen Sodium | OTCReference drug |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
