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Molecule

Dyclonine

Also known as dyclonine hydrochloride
Available on requestPain and anaesthesia
Presentations
1
Brands
1
Manufacturers
1
Available from stock
0

Dyclonine is a prescription medicine indicated for anesthetizing accessible mucous membranes (e.g., the mouth, pharynx, larynx, trachea, esophagus, and urethra) prior to various endoscopic procedures. It is available as topical solution. MedsAcross supplies Dyclonine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

ATC classification
N01BX02 Dyclonine · Local anesthetic, subgroup N01BXR02AD04 Dyclonine · Throat preparations, subgroup R02A, subgroup R02AD
US FDA first approval
Approved
EU status
Not recorded
Orphan designation
Not recorded
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Topical
Dosage forms
Topical solution
Identifiers
UNII 078A24Q30ORxCUI 23744CAS 586-60-7DrugBank DB00645Q425386

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

Dyclonine 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.

Source: US FDA prescribing information

Dosing overview

As with all local anesthetics, the dosage varies and depends upon the area to be anesthetized, vascularity of the tissues, individual tolerance and the technique of anesthesia. The lowest dosage needed to provide effective anesthesia should be administered. A maximum dose of 30 mL of Dyclonine HCl Topical Solution, USP 1% topical anesthetic (300 mg of dyclonine HCl) may be used, although satisfactory anesthesia is usually produced within the range of 4 to 20 mL. For specific techniques and procedures refer to standard textbooks. Although as much as 300 mg of Dyclonine HCl Topical Solution USP (as a 1% solution) have been tolerated, this dosage as a 0.5% solution has not been administered primarily because satisfactory anesthesia in endoscopic procedures can usually be produced by lesser amounts. For specific techniques for endoscopic procedures refer to standard textbooks.

Source: US FDA prescribing information

Contraindications

Dyclonine HCl Topical Solution, USP is contraindicated in patients known to be hypersensitive (allergic) to the local anesthetic or to other components of Dyclonine HCl Topical Solution, USP.

Source: US FDA prescribing information

Warnings and precautions

IN ORDER TO MANAGE POSSIBLE ADVERSE REACTIONS, RESUSCITATIVE EQUIPMENT, OXYGEN AND OTHER RESUSCITATIVE DRUGS SHOULD BE IMMEDIATELY AVAILABLE WHENEVER LOCAL ANESTHETIC AGENTS, SUCH AS DYCLONINE, ARE ADMINISTERED TO MUCOUS MEMBRANES. Dyclonine HCl Topical Solution, USP should not be injected into tissue or used in the eyes because of highly irritant properties. Dyclonine HCl Topical Solution, USP should be used with extreme caution in the presence of sepsis or severely traumatized mucosa in the area of application since under such conditions there is the potential for rapid systemic absorption.

Source: US FDA prescribing information

Side effects

Adverse experiences following the administration of dyclonine are similar in nature to those observed with other local anesthetic agents. These adverse experiences are, in general, dose-related and may result from high plasma levels caused by excessive dosage or rapid absorption, or may result from a hypersensitivity, idiosyncrasy or diminished tolerance on the part of the patient. Serious adverse experiences are generally systemic in nature. The following types are those most commonly reported: Central nervous system: CNS manifestations are excitatory and/or depressant and may be characterized by lightheadedness, nervousness, apprehension, euphoria, confusion, dizziness, drowsiness, tinnitus, blurred or double vision, vomiting, sensations of heat, cold or numbness, twitching, tremors, convulsions, unconsciousness, respiratory depression and arrest.

Source: US FDA prescribing information

Storage

Store at 20° to 25°C (68° to 77°F). Avoid excessive heat (temperatures above 40ºC [104ºF]). Subject to damage by freezing.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

1 presentations of Dyclonine, sorted by availability.

MedicineManufacturerRegisterAvailability
DycloPro 5 mg/mL topical solutionTopicalSeptodontUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAApprovedDrugs@FDA
EU (EMA)Not recorded—
India (CDSCO)Not yet confirmed against CDSCO approval lists—
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Conditions

Conditions linked to Dyclonine in public data. This is not a list of approved uses, see the clinical information.

Questions and answers

Is Dyclonine available for export from India?

Yes, on request. MedsAcross lists 1 presentations of Dyclonine and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Dyclonine have?

The catalogue lists 1 brand names for Dyclonine, including DycloPro.

Does Dyclonine need cold chain shipping?

No listed presentation of Dyclonine is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

Which ATC class is Dyclonine in?

Dyclonine is classified under ATC code N01BX02 (Dyclonine).

References

  1. DycloPro prescribing information (Septodont). U.S. National Library of Medicine, DailyMed. Retrieved 28 November 2024

Request Dyclonine for export supply

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