FDA Orange Book · active-ingredient family
Dextromethorphan hydrobromide; guaifenesin; naproxen sodium
Dextromethorphan hydrobromide; guaifenesin; naproxen sodium is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:MUCINEX 12HR COLD & FEVER MULTI-SYMPTOM · NDA 217338
1
Brand (NDA)
0
Generics (ANDA)
3
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MUCINEX 12HR COLD & FEVER MULTI-SYMPTOMRLD | RB HLTH | NDA 217338 | — | Dec 22, 2025 |
Listed patents (3)
| Patent | Expires | In | Type |
|---|---|---|---|
| 12257218 | Oct 11, 2036 | in 10 yr 6 mo | Product |
| 12370189 | Oct 11, 2036 | in 10 yr 6 mo | Product |
| 11278506 | Oct 11, 2036 | in 10 yr 6 mo | Product |
Dextromethorphan hydrobromide; guaifenesin; naproxen sodium — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
