TheraRadar
Data updated: May 26, 2026

PRILOCAINE HYDROCHLORIDE

Other Approved 2010-09-29

Prilocaine Hydrochloride helps patients undergoing dental procedures by providing local anesthesia. It is used during nerve blocks or infiltration techniques to numb specific areas of the mouth. This medication allows dental professionals to perform standard procedures while ensuring the patient remains comfortable in the targeted area.

Source: FDA Label • SEPTODONT INC

How PRILOCAINE HYDROCHLORIDE Works

This drug works by stabilizing the neuronal membrane to prevent the start and spread of nerve impulses. It achieves this by blocking the movement of ions that are necessary for the nerves to send signals. By stopping these electrical impulses, the medication effectively creates a local anesthetic effect.

Source: FDA Label
1
Indication
--
Phase 3 Trials
15
Years on Market

Details

Status
Prescription
First Approved
2010-09-29
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

Active Ingredient: PRILOCAINE HYDROCHLORIDE

PRILOCAINE HYDROCHLORIDE Approval History

2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
2 FDA actions from 2010 to 2018
Nov 2018 SUPPL
Label · Labeling
Sep 2010 ORIGINAL
Update

What PRILOCAINE HYDROCHLORIDE Treats

2 indications

PRILOCAINE HYDROCHLORIDE is approved for 2 conditions since its original approval in 2010. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Local anesthesia for dental procedures
  • Nerve block and infiltration in dentistry
Source: FDA Label

PRILOCAINE HYDROCHLORIDE Competitive Set

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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to PRILOCAINE HYDROCHLORIDE

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

CITANEST FORTE DENTAL
EPINEPHRINE BITARTRATE
2 shared
DENTSPLY PHARM
Shared indications:
Local anesthesia for dental proceduresNerve block and infiltration in dentistry
LIGNOSPAN FORTE
EPINEPHRINE BITARTRATE
1 shared
DEPROCO
Shared indications:
Local anesthesia for dental procedures
LIGNOSPAN STANDARD
EPINEPHRINE BITARTRATE
1 shared
DEPROCO
Shared indications:
Local anesthesia for dental procedures
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Active Pipeline

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

PRILOCAINE HYDROCHLORIDE FDA Label Details

Indications & Usage

PRILOCAINE HYDROCHLORIDE is indicated for the treatment of Local anesthesia for dental procedures; Nerve block and infiltration in dentistry.

Looking for the branded version?

CITANEST PLAIN DENTAL

Full clinical data, patents, trials, and competitive landscape for prilocaine hydrochloride.

See CITANEST PLAIN DENTAL

Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.