Visine

NDA 20485, held by Kenvue Brands. Naphazoline Hydrochloride; Pheniramine Maleate.

As of Nov 13, 2026, NDA 20485 (Visine), held by Kenvue Brands, was first approved by FDA on Jan 31, 1996, with 13 approved supplements and 0 published complete response letters.

First approved: Jan 31, 1996
Review: Standard
Supplements approved: 13
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

Uses Temporarily relieves itchy, red eyes due to: pollen ragweed grass animal hair and dander

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 14 submissions below

Date	Submission	Status	Documents
Oct 17, 2018	Supplement 13Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jan 31, 1996	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Products

1 strengths and forms

Product	Active ingredient	Marketing
Visine0.025%;0.3% · solution/drops;ophthalmic	Naphazoline Hydrochloride; Pheniramine Maleate	OTCReference drug

All 14 submissions, including labeling and manufacturing supplements

Date	Submission	Status	Documents
Oct 22, 2025	Supplement 21Manufacturing	Approved	Letter Label
Oct 17, 2018	Supplement 13Efficacy (new indication or use) · Standard review	Approved	Label Letter
Jan 6, 2017	Supplement 12Manufacturing · Standard review	Approved	None posted
Aug 26, 2016	Supplement 11Labeling · Standard review	Approved	Label
Mar 10, 2016	Supplement 10Manufacturing · Standard review	Approved	None posted
Dec 18, 2012	Supplement 9Labeling · Standard review	Approved	Label Letter
Oct 15, 2004	Supplement 7Labeling · Standard review	Approved	Letter
Sep 15, 2003	Supplement 6Manufacturing · Standard review	Approved	Letter Label
Jun 14, 2002	Supplement 5Labeling · Standard review	Approved	Label Letter
Mar 11, 1999	Supplement 4Manufacturing · Standard review	Approved	None posted
Nov 19, 1998	Supplement 3Labeling · Standard review	Approved	None posted
Dec 26, 1996	Supplement 1Manufacturing · Standard review	Approved	None posted
Sep 26, 1996	Supplement 2Labeling · Standard review	Approved	None posted
Jan 31, 1996	Original applicationNew formulation or manufacturer · Standard review	Approved	None posted

Identifiers

Application: NDA 20485
Drugs@FDA: Overview at FDA
Company: Kenvue Brands

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