Prescription and over-the-counter medicine
Dyclonine Brand names: Dyclopro
Dyclonine (Dyclopro) is a prescription and over-the-counter medicine. FDA's NDC Directory lists it from 1 generic labeler.
- Generic listed
Check it at the source: the dyclonine FDA label on DailyMed (effective November 28, 2024, Septodont Inc); every dyclonine label on DailyMed.
Highlights of the record
FDA label of November 28, 2024; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageDyclonine HCl Topical Solution, USP is indicated for anesthetizing accessible mucous membranes (e.g., the mouth, pharynx, larynx, trachea, esophagus, and urethra) prior to various endoscopic procedures.
Forms and strengths
- 5 mg/ml
Solution.
On the market
- Generic approvals
- 1 first November 20, 2018; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 1 of which 1 under generic applications, 0 under brand applications, repackagers included; 1 more under the over-the-counter monograph, without an application
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
- 95 through July 30, 2026
What is dyclonine used for?
From the label: indications and usageDyclonine HCl Topical Solution, USP is indicated for anesthetizing accessible mucous membranes (e.g., the mouth, pharynx, larynx, trachea, esophagus, and urethra) prior to various endoscopic procedures. Dyclonine HCl Topical Solution, USP, 0.5% topical anesthetic may also be used to block the gag reflex, to relieve the pain of oral ulcers or stomatitis and to relieve pain associated with ano-genital lesions.
Conditions named in the indications of dyclonine's FDA labels, with every medicine labeled for each:
Source: FDA drug label (DycloPro), Septodont Inc, effective November 28, 2024 (SPL set bfd9a2dd-7b40-40c0-b256-52f613395760), via openFDA; the full label on DailyMed
Is there a generic for dyclonine (Dyclopro)?
The FDA approved the first generic dyclonine on November 20, 2018. 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.
FDA's NDC Directory lists dyclonine from 1 labeler under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the dyclonine label say about other medicines?
The dyclonine label names no other medicine on this site. The labels of 1 other medicine name dyclonine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
Source: FDA drug label (DycloPro), Septodont Inc, effective November 28, 2024 (SPL set bfd9a2dd-7b40-40c0-b256-52f613395760), via openFDA; the full label on DailyMed
What do FAERS reports show for dyclonine?
The FDA Adverse Event Reporting System holds 95 reports that list dyclonine among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 0 are coded as a death and 53 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.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Dyclonine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other