Naphcon-A

Relieves redness and itching of the eye(s). NDA 20226, held by Alcon. Naphazoline Hydrochloride; Pheniramine Maleate.

As of Nov 13, 2026, NDA 20226 (Naphcon-A), held by Alcon, was first approved by FDA on Jun 8, 1994, with 22 approved supplements and 0 published complete response letters.

First approved: Jun 8, 1994
Review: Standard
Supplements approved: 22
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Uses for the temporary relief of redness and itching of the eye(s) due to: ragweed pollen grass animal dander and hair

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 23 submissions below

Date	Submission	Status	Documents
Jun 8, 1994	Original applicationNew combination · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Naphcon-A0.025%;0.3% · solution/drops;ophthalmic	Naphazoline Hydrochloride; Pheniramine Maleate	OTCReference drug

All 23 submissions, including labeling and manufacturing supplements


Dec 19, 2022	Supplement 35Labeling · Standard review	Approved	Letter Label
Apr 11, 2019	Supplement 29Labeling · Standard review	Approved	Label Letter
Jul 31, 2015	Supplement 24Manufacturing · Standard review	Approved	None posted
Jun 23, 2014	Supplement 22Manufacturing · Standard review	Approved	None posted
Dec 4, 2002	Supplement 18Manufacturing · Standard review	Approved	None posted
Mar 16, 2001	Supplement 17Manufacturing · Standard review	Approved	None posted
Sep 22, 2000	Supplement 16Manufacturing · Standard review	Approved	None posted
Mar 17, 2000	Supplement 15Manufacturing · Standard review	Approved	None posted
Jan 21, 2000	Supplement 14Manufacturing · Standard review	Approved	None posted
Dec 16, 1999	Supplement 10Manufacturing · Standard review	Approved	None posted
Nov 19, 1999	Supplement 13Manufacturing · Standard review	Approved	None posted
Oct 4, 1999	Supplement 12Manufacturing · Standard review	Approved	None posted
Jun 14, 1999	Supplement 11Manufacturing · Standard review	Approved	None posted
Aug 20, 1998	Supplement 9Manufacturing · Standard review	Approved	None posted
Dec 23, 1997	Supplement 8Manufacturing · Standard review	Approved	None posted
Sep 26, 1996	Supplement 7Labeling · Standard review	Approved	None posted
Jul 30, 1996	Supplement 5Labeling · Standard review	Approved	None posted
Apr 16, 1996	Supplement 6Manufacturing · Standard review	Approved	None posted
Nov 1, 1995	Supplement 4Manufacturing · Standard review	Approved	None posted
Nov 1, 1995	Supplement 3Manufacturing · Standard review	Approved	None posted
Feb 23, 1995	Supplement 2Labeling · Standard review	Approved	None posted
Oct 4, 1994	Supplement 1Labeling · Standard review	Approved	None posted
Jun 8, 1994	Original applicationNew combination · Standard review	Approved	None posted

Identifiers

Application: NDA 20226
Drugs@FDA: Overview at FDA
Company: Alcon

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