Prescription medicine
Mebendazole Brand names: Vermox
Mebendazole (Vermox) is a prescription medicine with an FDA approval on record since 1974. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the mebendazole FDA label on DailyMed (effective October 5, 2021, Janssen Pharmaceuticals, Inc.); the NDA 17481 record on Drugs@FDA; every mebendazole label on DailyMed.
Highlights of the record
FDA label of October 5, 2021; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageVERMOX™ CHEWABLE is indicated for the treatment of patients one year of age and older with gastrointestinal infections caused by Ascaris lumbricoides (roundworm) and Trichuris trichiura (whipworm).
Forms and strengths
- 500 mg
Chewable tablet.
On the market
- Earliest approval on file
- June 28, 1974 Vermox, Janssen Pharms; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 1 first January 4, 1995; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 784 through July 30, 2026
What is mebendazole used for?
From the label: indications and usageVERMOX™ CHEWABLE is indicated for the treatment of patients one year of age and older with gastrointestinal infections caused by Ascaris lumbricoides (roundworm) and Trichuris trichiura (whipworm). VERMOX™ CHEWABLE is an anthelmintic indicated for the treatment of patients one year of age and older with gastrointestinal infections caused by: Ascaris lumbricoides (roundworm) and Trichuris trichiura (whipworm) ( 1 ).
FDA pharmacologic class: Anthelmintic.
Source: FDA drug label (VERMOX), Janssen Pharmaceuticals, Inc., effective October 5, 2021 (SPL set a720c424-517a-461b-8e13-6c37caf8aa3f), via openFDA; the full label on DailyMed
Is there a generic for mebendazole (Vermox)?
The FDA approved the first generic mebendazole on January 4, 1995. 1 generic application is approved; 1 of it carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
- 1974 earliest approval on file
- 1995 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the mebendazole label say about other medicines?
The mebendazole label names 1 other medicine in its interaction, contraindication or warning sections. The labels of 2 other medicines name mebendazole. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Metronidazole | drug interactions | DRUG INTERACTIONS Concomitant use of mebendazole and metronidazole should be avoided [see Warnings and Precautions (5.3) ]. |
Other labels that name mebendazole
Source: FDA drug label (VERMOX), Janssen Pharmaceuticals, Inc., effective October 5, 2021 (SPL set a720c424-517a-461b-8e13-6c37caf8aa3f), via openFDA; the full label on DailyMed
What do FAERS reports show for mebendazole?
The FDA Adverse Event Reporting System holds 784 reports that list mebendazole among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 56 are coded as a death and 185 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other anthelmintics
- the pharmacologic class, with prices and generics
- Mebendazole side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other