Orange Book product · Brand (NDA)
MUCINEX 12HR COLD & FEVER MULTI-SYMPTOM
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; NAPROXEN SODIUM
At a glance
Dec 22, 2025
Approved
Brand (NDA)
Application
Not listed
TE code
3
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Dec 22, 2025
6 mo ago
Today
Patent 11278506 expires
Listed drug product patent expiration.
Oct 11, 2036
in 10 yr 6 mo
Patent 12257218 expires
Listed drug product patent expiration.
Oct 11, 2036
in 10 yr 6 mo
Patent 12370189 expires
Listed drug product patent expiration.
Oct 11, 2036
in 10 yr 6 mo
Pharmaceutical detail
Active ingredient
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; NAPROXEN SODIUM
Strength
30MG;600MG;110MG
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
TE code
Not listed
Application
NDA 217338
Product number
001
Marketing status
OTC
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Listed patents (3)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11278506 | Oct 11, 2036 | in 10 yr 6 mo | Product |
| 12257218 | Oct 11, 2036 | in 10 yr 6 mo | Product |
| 12370189 | Oct 11, 2036 | in 10 yr 6 mo | Product |
