Active substance
Prilocaine
- US FDA 4
- Health Canada 1
- Safety 4
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| PRILOCAINE HYDROCHLORIDE | 4% | injectable · injection | SEPTODONT INC | Prescription | 29 Sep 2010 |
| CITANEST | 3% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 2% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | injectable · injection | ASTRAZENECA | Discontinued | 18 Nov 1965 |
| CITANEST PLAIN | 4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | injectable · injection | ASTRAZENECA | Discontinued | 18 Nov 1965 |
| CITANEST PLAIN DENTAL | 4% | injectable · injection | DENTSPLY PHARM | Discontinued | 18 Nov 1965 |
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| 4% CITANEST PLAIN DENTAL | 02435276 | 40 MG / ML | SOLUTION · BLOCK/INFILTRATION | DENTSPLY CANADA LIMITED |
Safety signals and safety-related labeling changes
- US FDA 3 Nov 2021 CITANEST FORTE DENTAL — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide - US FDA 2 Nov 2018 CITANEST PLAIN DENTAL — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide - US FDA 2 Nov 2018 EMLA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide - US FDA 2 Nov 2018 ORAQIX — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide
Combinations containing Prilocaine
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.