Over-the-counter medicine
Benzocaine
Benzocaine is an over-the-counter medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
- Over the counter
Check it at the source: the benzocaine FDA label on DailyMed (effective January 17, 2025); every benzocaine label on DailyMed.
Highlights of the record
FDA label of January 17, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageFor oral mucosal use only, as directed by dentist.
Forms and strengths
- 15 mg
- 20 mg
- 200 mg
- 0.1 g/g
- 0.2 g/g
- 3 mg/100ml
- 4 g/100ml
- 5 g/100ml
- 5 g/100g
- 6.4 g/100g
- 7.5 g/100ml
- 7.5 g/100g
Gel; liquid; spray; cream; ointment.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 127 of which 0 under generic applications, 0 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)
- 0 since 2020 1 Class I among all firms' recalls; 13 more by firms not listed as its makers
- FAERS reports
- 1,036 through July 30, 2026
What is benzocaine used for?
From the label: indications and usageFor oral mucosal use only, as directed by dentist. For the temporary relief of pain due to minor dental procedures.
Conditions named in the indications of benzocaine's FDA labels, with every medicine labeled for each:
Source: FDA drug label (BENZOCAINE Raspberry), Darby Dental Supply, LLC, effective January 17, 2025 (SPL set dd805400-26c5-4c18-ade2-821298233f9b), via openFDA; the full label on DailyMed
Is there a generic for benzocaine?
No generic benzocaine is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has benzocaine been recalled?
The FDA's Enforcement Report lists 13 recalls naming benzocaine since 2020: 1 Class I (the most serious), 11 Class II, 1 Class III; 7 still ongoing. 13 of them are by firms that FDA's NDC Directory does not list as a maker of benzocaine and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| May 21, 2026 | Class II | Keystone Industries not a listed maker | Defective container:may contain bottles with incomplete seals |
| November 14, 2024 | Class II | Keystone Industries not a listed maker | CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of … |
| December 21, 2023 | Class I | Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare … not a listed maker | Chemical Contamination: presence of benzene |
| July 31, 2020 | Class III | The Mentholatum Company not a listed maker | Labeling; Not Elsewhere Classified: The Mentholatum Company is initiating a voluntary recall due to an error in the labeling of the cotton pellet box found … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the benzocaine label say about other medicines?
The benzocaine label names no other medicine on this site. The labels of 13 other medicines name benzocaine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
Other labels that name benzocaine
Source: FDA drug label (BENZOCAINE Raspberry), Darby Dental Supply, LLC, effective January 17, 2025 (SPL set dd805400-26c5-4c18-ade2-821298233f9b), via openFDA; the full label on DailyMed
What do FAERS reports show for benzocaine?
The FDA Adverse Event Reporting System holds 1,036 reports that list benzocaine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 78 are coded as a death and 390 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
How does benzocaine compare with medicines for the same use?
3 side-by-side pages set benzocaine beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Benzocaine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other