Dextromethorphan: clinical trials recruiting now
3
Recruiting trials
9
Conditions studied
3
US states with sites
5
Countries
FDA drug label
- FDA-approved
- Yes. Dextromethorphan appears in the FDA drug-label database. Marketed as Dextromethorphan HBr 15 mg.
FDA-approved use
Use temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
FDA recalls / enforcement
| Reason (FDA) | Classification | Status | Initiated |
|---|---|---|---|
| Labeling: Label Mix-Up; Bottles of Mucinex Fast-Max liquid are correctly labeled on the front of the label, however the back of the bottle where the Drug Facts labeling is, is missing certain Active Ingredients such as acetaminophen, phenylephrine, dextromethorphan, diphenhydramine, and/or guaifenes — Reckitt Benckiser LLC | Class I (FDA: reasonable probability of serious harm or death) | Terminated | 2015-04-15 |
| CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations. — Pharma-Natural Inc. | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2019-06-21 |
| Microbial Contamination of Non-Sterile Products — Efficient Laboratories, Inc. | Class II (FDA: may cause temporary or reversible harm) | Terminated | 2021-08-24 |
| Labeling: Incorrect Instructions; The product has been found to provide incorrect dosage information on its label due to a typographical error. The drug facts label incorrectly states children 6 to under 2 years of age, 1 teaspoonful every 4 hours, not to exceed 4 teaspoonfuls in 24 hours or directe — Novis PR, Inc. | Class I (FDA: reasonable probability of serious harm or death) | Terminated | 2019-05-28 |
| Product mix-up: incorrect product was found inside the G-Supress DX product carton. — Novis PR, LLC dba Kramer Novis | Class I (FDA: reasonable probability of serious harm or death) | Terminated | 2023-04-20 |
Phase breakdown
Early Phase 1 1
Phase 1 1
Phase 2 1
Conditions being studied
Recruiting trials involving Dextromethorphan
- An Early-Stage Study in Multiple Clinics of How Afimkibart May Affect the Body's Processing of Medicines That Rely on Cytochrome P450 Enzymes in Participants With Ulcerative Colitis
- Psilocybin-facilitated Treatment for Chronic Pain
- Study of Dextromethorphan in OCD and Related Disorders
Common questions
Is Dextromethorphan FDA-approved?
Yes, marketed as Dextromethorphan HBr 15 mg.
How many recruiting trials involve Dextromethorphan?
3 recruiting trials across 9 conditions.
Is this list of trials complete?
No. For the full record, search ClinicalTrials.gov.