Data updated: May 26, 2026
MUCINEX 12HR COLD & FEVER MULTI-SYMPTOM (dextromethorphan hydrobromide)
Respiratory
Approved 2025-12-22
1
Indication
--
Phase 3 Trials
0
Years on Market
Details
- Status
- Over-the-counter
- First Approved
- 2025-12-22
- Patent Cliff
- 2036
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE
Companies
Website: ↗
MUCINEX 12HR COLD & FEVER MULTI-SYMPTOM Approval History
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2025 to 2025
What MUCINEX 12HR COLD & FEVER MULTI-SYMPTOM Treats
1 FDA approvalsOriginally approved for its first indication in 2025 .
- Other (1)
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Clinical Trial Registry
8 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02651116 CHPA DXM results posted | A6531002 CHPA DXM | Ph 4 | terminated | Dextromethorphan Pediatric Acute Cough Study |
| NCT03480009 DexMab results posted | STUDY19020221 | Ph 3 | completed | Dextromethorphan as a Novel Non-opioid Adjunctive Agent for Pain Control in Medication Abortion |
| NCT01441102 MiDME2 results posted | 110244 11-EI-0244 | Ph 1, Ph 2 | completed | Dextromethorphan for Diabetic Macular Edema |
| NCT02860962 | Pro00052508 | Ph 1 | completed | A Trial of Dextromethorphan for Treatment of Major Depressive Disorder |
| NCT01218620 | NCI-2012-02916 NCI-2012-02916, CDR0000685426 | Ph 1 | completed | Gamma-Secretase/Notch Signalling Pathway Inhibitor RO4929097 in Treating Patients With Advanced Solid Tumors |
| NCT02182336 | 1220.32 | Ph 1 | completed | Effects of BI 201335 NA on Cytochrome P450 and P-glycoprotein Activity Using a Probe Drug Cocktail in Healthy Volunteers |
| NCT01017939 | CR017128 COU-AA-015 | Ph 1 | completed | A Drug-Drug Interaction Study of Abiraterone Acetate Plus Prednisone With Dextromethorphan and Theophylline in Patients With Metastatic Castration-Resistant Prostate Cancer |
| NCT01441986 DXM/AMT | 0533-DXM | Ph 2 | completed | Dextromethorphan, Amantadine and Glucose Homeostasis in Diabetes Subjects |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
MUCINEX 12HR COLD & FEVER MULTI-SYMPTOM FDA Label Details
MUCINEX 12HR COLD & FEVER MULTI-SYMPTOM Patents & Exclusivity
Latest Patent: Oct 2036
Patents (3 active)
Source: FDA Orange Book
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Revenue Insights
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Patent Timeline
- • Cliff: 2036
- • 3 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.