Lidocaine

Relieves pain associated with minor burns, including sunburn, abrasions of the skin, and…. ANDA 40911, held by Septodont Inc. Lidocaine.

As of Nov 15, 2026, ANDA 40911 (Lidocaine), held by Septodont Inc, was first approved by FDA on May 23, 2011, with 2 approved supplements and 0 published complete response letters.

First approved: May 23, 2011
Supplements approved: 2
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

INDICATIONS AND USAGE Lidocaine Ointment 5% is indicated for production of anesthesia of accessible mucous membranes of the oropharynx. It is also useful as an anesthetic lubricant for intubation and for the temporary relief of pain associated with minor burns, including sunburn, abrasions of the skin, and insect bites.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 3 submissions below

Date	Submission	Status	Documents
May 23, 2011	Original application	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Lidocaine5% · ointment;topical	Lidocaine	Rx

All 3 submissions, including labeling and manufacturing supplements


Nov 2, 2018	Supplement 7Labeling · Standard review	Approved	None posted
Nov 1, 2018	Supplement 5Labeling · Standard review	Approved	None posted
May 23, 2011	Original application	Approved	None posted

Identifiers

Application: ANDA 40911
Drugs@FDA: Overview at FDA
Company: Septodont

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