United States· US:68400-355_0bf12bf6-737a-87c1-e063-6394a90aa1dd
Gelato Topical Anesthetic
A medicinal product containing benzocaine, registered in United States by Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc.
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
The record
At a glance
FDA National Drug Code directory (United States)- Active substance
- BENZOCAINE
- Manufacturer
- Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc
- Country
- United States (US)
- ATC code
- —
- Reimbursed
- Not published by this register
- Source register
- FDA National Drug Code directory (United States)
- Last checked
- September 27, 2026
Packs & prices · 2
- ndc1168400-355-30
- ndc11684003553030 g in 1 JAR (68400-355-30)
Regulatory notes
No shortage, Orange Book or US label notes for this record.
Same medicine, other countries
Benzocaine in 8 other countries
What each register calls a product with the same active substance — salts and hydrates count as the same.
- United KingdomAAA 1.5mg/dose sore throat sprayManx Healthcare Ltd
- SpainBENZOCAINA GOBENS 200 MG/ML SOLUCION PARA PULVERIZACION BUCALLaboratorios Normon S.A.
- Japanアミノ安息香酸エチル
- BelgiumHurricaïne Gel 200 mg/gVedefar
- NorwayTopicale Assorted FlavourPremier Research
- FinlandOtisynSanten Oy
- PolandPuder Płynny DermopurHerbapol - Poznańskie Zakłady Zielarskie S.A.
- GermanyBenzocain Smartpractice EuropeSmartpractice Europe Gmbh
Authorised across Europe · EMA
The same active substance is authorised in 6 EEA countries. Names it is sold under:
- Germany · Benzocain Smartpractice Europe
- Spain · Dentispray, Hurricaine
- United Kingdom (Northern Ireland) · Aaa Sore Throat, Benzocaine Prestige Brands (Uk)
- Malta · Topigel
- Poland · Puder Płynny Dermopur
- Portugal · Dentispray, Topigel,
Source: European Medicines Agency, Article 57 product data.
Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.
For developers
The same record over the API, and the raw payload
GET /v1/drugs/cf3a5016-75b6-487a-99a9-bcbb697f93ab GET /v1/drugs/cf3a5016-75b6-487a-99a9-bcbb697f93ab?format=fhir
Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.
{
"route": "DENTAL",
"source": "ndc",
"strength": "200",
"substance": "BENZOCAINE",
"productndc": "68400-355",
"dosage_form": "GEL",
"dea_schedule": null,
"strength_unit": "mg/g",
"application_number": "M022",
"marketing_category": "OTC MONOGRAPH DRUG"
}See everything about benzocaine.
This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.