Medicine
DycloPro 5 mg/mL topical solution
DycloPro 5 mg/mL topical solution is a prescription medicine containing Dyclonine for topical use, marketed by Septodont, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Subject to damage by freezing. Store at 20° to 25°C (68° to 77°F). Avoid…
Key facts
- Active ingredient (INN)
- Dyclonine
- Brand
- DycloPro
- Strength
- 5 mg/mL
- Dosage form
- Topical solution
- Route
- Topical
- Packs
- 1 bottle
- Marketing authorisation holder
- Septodont
- Manufacturer
- Septodont
- Origin register
- US FDA, United States
- Storage
- Subject to damage by freezing. Store at 20° to 25°C (68° to 77°F). Avoid excessive heat (temperatures above 40ºC [104ºF]).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- N01BX02 Dyclonine
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 1 September 2019
- Identifiers
- RxCUI 1048281, 2199132DailyMed set ID bfd9a2dd-7b40-40c0-b256-52f613395760NDC 0362-3971Application ANDA200480
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 bottle in 1 bottle / 30 mL in 1 bottle | 0362-3971-05 | Septodont | 1 September 2019 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | Approved | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Clinical summary
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
Read about DyclonineFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- DycloPro prescribing information (Septodont) · U.S. National Library of Medicine, DailyMed
Need DycloPro 5 mg/mL topical solution for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.