EligibleTrials

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)ClassificationStatusInitiated
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

FDA label via openFDA

Phase breakdown

Early Phase 1 1 Phase 1 1 Phase 2 1

Conditions being studied

ConditionTrials
Active Ulcerative Colitis1
Anxiety1
Body Dysmorphic Disorders1
Fibromyalgia1
Fibromyalgia, Primary1
Illness Anxiety Disorder1
Obsessive-Compulsive Disorder1
Somatic Symptom Disorder1
Ulcerative colitis1

Recruiting trials involving Dextromethorphan

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.

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