Active substances
Epinephrine + Prilocaine
- US FDA 3
- Health Canada 2
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| CITANEST FORTE DENTAL | 0.005MG/ML;4% | injectable · injection | DENTSPLY PHARM | Prescription | 18 Nov 1965 |
| PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE | 0.005MG/ML;4% | injectable · injection | SEPTODONT INC | Prescription | 30 Aug 2011 |
| CITANEST FORTE | 0.005MG/ML;4% | injectable · injection | ASTRAZENECA | Discontinued | 18 Nov 1965 |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| 4% CITANEST FORTE DENTAL WITH EPINEPHRINE 1:200,000 | 02347695 | 40 MG / ML; 0.005 MG / ML | SOLUTION · BLOCK/INFILTRATION | DENTSPLY CANADA LIMITED |
| PRILOCAINE HCL 4% EPINEPH 1:200000INJ | 00393746 | 40 MG / ML; 0.005 MG / ML | SOLUTION · BLOCK/INFILTRATION | NOVOCOL PHARMACEUTICAL OF CANADA INC |
Components
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.