Oraqix

NDA 21451, held by Dentsply Pharm. Lidocaine; Prilocaine.

As of Nov 14, 2026, NDA 21451 (Oraqix), held by Dentsply Pharm, was first approved by FDA on Dec 19, 2003, with 5 approved supplements and 0 published complete response letters.

First approved: Dec 19, 2003
Review: Standard
Supplements approved: 5
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Oraqix is an amide local anesthetic indicated for adults who require localized anesthesia in periodontal pockets during scaling and/or root planing.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 6 submissions below

Date	Submission	Status	Documents
Dec 19, 2003	Original applicationNew combination · Standard review	Approved	Review Label Letter

Products

1 strengths and forms

Product	Active ingredient	Marketing
Oraqix2.5%;2.5% · gel;periodontal	Lidocaine; Prilocaine	RxReference drug

All 6 submissions, including labeling and manufacturing supplements


Mar 2, 2022	Supplement 13Labeling · Standard review	Approved	None posted
Nov 2, 2018	Supplement 14Labeling · Standard review	Approved	Letter Label
Aug 8, 2012	Supplement 8Labeling · Standard review	Approved	Letter Label
Sep 27, 2010	Supplement 7Labeling · Standard review	Approved	Letter Label
Apr 13, 2010	Supplement 5Labeling · Standard review	Approved	Letter Label
Dec 19, 2003	Original applicationNew combination · Standard review	Approved	Review Label Letter

Identifiers

Application: NDA 21451
Drugs@FDA: Overview at FDA
Company: Dentsply Pharmaceutical

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters