Data updated: May 26, 2026
GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE (dextromethorphan hydrobromide)
Respiratory
Approved 2015-08-31
6
Indications
--
Phase 3 Trials
10
Years on Market
Details
- Status
- Over-the-counter
- First Approved
- 2015-08-31
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE
Companies
Website: ↗
GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE Approval History
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
12 FDA actions from 2015 to 2023
Aug 2023 ORIGINAL
Update
Jul 2021 ORIGINAL
Update
Nov 2018 ORIGINAL
Update
What GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE Treats
6 FDA approvalsOriginally approved for its first indication in 2015 . Covers 6 distinct patient populations.
- Other (6)
Other
(6 approvals)- • Approved indication (Aug 2015)Letter
- • Approved indication (Mar 2017)
- • Approved indication (Mar 2018)
- • Approved indication (Nov 2018)
- • Approved indication (Jul 2021)
- • Approved indication (Aug 2023)
📋
Clinical Trial Registry
10 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02651116 CHPA DXM results posted | A6531002 CHPA DXM | Ph 4 | terminated | Dextromethorphan Pediatric Acute Cough Study |
| NCT01202279 Wait and See results posted | 2009-MUCD-001 | Ph 4 | completed | Safety and Efficacy Study of Guaifenesin and Pseudoephedrine for Symptomatic Therapy to Treat Acute RTI |
| 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 |
| NCT01364467 results posted | HM13538 | Ph 2 | completed | The Effect of Oral Guaifenesin on Pediatric Chronic Rhinitis: A Pilot Study |
| 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.
GUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDE FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.