Data updated: Jun 28, 2026
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE (dextromethorphan hydrobromide)
Respiratory
Approved 1957-12-03
Promethazine hydrochloride and dextromethorphan hydrobromide oral solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.
Source: FDA Label • HETERO LABS LTD III
8
Indications
--
Phase 3 Trials
68
Years on Market
Details
- Status
- Prescription
- First Approved
- 1957-12-03
- Routes
- ORAL
- Dosage Forms
- SYRUP
Companies
Website: ↗
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE Approval History
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Original
New Indication
New Form
Label Update
23 FDA actions from 1957 to 2026 · 1 indication expansions
Jun 2026 ORIGINAL
Update
Mar 2026 ORIGINAL
Update
Jun 2012 ORIGINAL
Update · Not Applicable
Feb 2011 ORIGINAL
Update
Dec 2005 SUPPL
Label
Feb 2001 SUPPL
Label
May 1998 SUPPL
Mfg
Jul 1996 ORIGINAL
Update
Feb 1996 SUPPL
Label
Mar 1992 SUPPL
Mfg
Nov 1989 SUPPL
Mfg
Aug 1988 SUPPL
Efficacy
Jun 1988 SUPPL
Mfg
May 1986 SUPPL
Mfg
Sep 1985 SUPPL
Label
Jul 1985 SUPPL
Mfg
Apr 1984 SUPPL
Label
Apr 1984 SUPPL
Mfg
Dec 1957 ORIGINAL
New Combo
What PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE Treats
8 FDA approvalsOriginally approved for its first indication in 1957 . Covers 8 distinct patient populations.
- Other (8)
Other
(8 approvals)- • Approved indication (Dec 1957)
- • Approved indication (Apr 1984)
- • Approved indication (Aug 1988)
- • Approved indication (Jul 1996)
- • Approved indication (Feb 2011)
- • Approved indication (Jun 2012)
- • Approved indication (Mar 2026) New
- • Approved indication (Jun 2026) New
📋
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 |
🔬
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.
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE FDA Label Details
Indications & Usage
FDA Label (PDF)Promethazine hydrochloride and dextromethorphan hydrobromide oral solution is indicated for the temporary relief of coughs and upper respiratory symptoms associated with allergy or the common cold.
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Data Sources
FDA Approval: ANDA218264 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →
Data sourced from official FDA and NIH databases. Click links to verify on original sources.