Naphcon A — Solution/ Drops

Overview

Brand name

Naphcon A

Generic name

naphazoline hydrochloride and pheniramine maleate

Dosage form

Solution/ Drops

Route

Ophthalmic

Marketing category

NDA · NDA

Labeler

A-S Medication Solutions

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

2

NDC product codes

2

Packages

2

Data completeness

77% of corroborating sources present

Active ingredients

Source: NDC Directory

Active ingredients and strengths as listed in the NDC Directory.
Ingredient	Strength	RxCUI	Monograph
Naphazoline Hydrochloride	.25 mg/mL	1235200	View
Pheniramine Maleate	3 mg/mL	2286592	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Solution/ Drops

Route of administration

Ophthalmic

Presentations

4

Regulatory status

Source: Drugs@FDA NDC Directory

Application number

020226

Application type

NDA · New Drug Application

Approval date

June 8, 1994

Sponsor

ALCON

Products on application

1

Submissions recorded

23

Products approved under application 020226.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
020226-001	NAPHCON-A	SOLUTION/DROPS		NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE	Over-the-counter	—	RLD RS

Therapeutic equivalence

Source: Orange Book

TE code

—

Reference Listed Drug

Yes

Reference Standard

Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Approval history

Source: Drugs@FDA

Most recent submissions on application 020226.
Type	No.	Action	Status	Date	Review
Supplement	35	Labeling	Approved	December 19, 2022	Standard
Supplement	29	Labeling	Approved	April 11, 2019	Standard
Supplement	24	Manufacturing (CMC)	Approved	July 31, 2015	Standard
Supplement	22	Manufacturing (CMC)	Approved	June 23, 2014	Standard
Supplement	18	Manufacturing (CMC)	Approved	December 4, 2002	Standard
Supplement	17	Manufacturing (CMC)	Approved	March 16, 2001	Standard
Supplement	16	Manufacturing (CMC)	Approved	September 22, 2000	Standard
Supplement	15	Manufacturing (CMC)	Approved	March 17, 2000	Standard
Supplement	14	Manufacturing (CMC)	Approved	January 21, 2000	Standard
Supplement	10	Manufacturing (CMC)	Approved	December 16, 1999	Standard
Supplement	13	Manufacturing (CMC)	Approved	November 19, 1999	Standard
Supplement	12	Manufacturing (CMC)	Approved	October 4, 1999	Standard
Supplement	11	Manufacturing (CMC)	Approved	June 14, 1999	Standard
Supplement	9	Manufacturing (CMC)	Approved	August 20, 1998	Standard
Supplement	8	Manufacturing (CMC)	Approved	December 23, 1997	Standard
Supplement	7	Labeling	Approved	September 26, 1996	Standard
Supplement	5	Labeling	Approved	July 30, 1996	Standard
Supplement	6	Manufacturing (CMC)	Approved	April 16, 1996	Standard
Supplement	4	Manufacturing (CMC)	Approved	November 1, 1995	Standard
Supplement	3	Manufacturing (CMC)	Approved	November 1, 1995	Standard
Supplement	2	Labeling	Approved	February 23, 1995	Standard
Supplement	1	Labeling	Approved	October 4, 1994	Standard
Original application	1	Type 4 - New Combination	Approved	June 8, 1994	Standard

Review documents

0 · Supplement · December 21, 2022
0 · Supplement · December 20, 2022
0 · Supplement · April 15, 2019
0 · Supplement · April 12, 2019

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20240327). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20240327 HUMAN OTC DRUG · 20231025

Indications and Usage

openFDA Drug Labeling

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

Purpose

openFDA Drug Labeling

Active ingredients Purpose Naphazoline hydrochloride 0.025% Redness reliever Pheniramine maleate 0.3% Antihistamine

Dosage and Administration

openFDA Drug Labeling

Directions adults and children 6 years and over: put 1 or 2 drops in the affected eye(s) up to 4 times daily children under 6 years: ask a doctor

Warnings

openFDA Drug Labeling

Warnings For external use only

Do Not Use

openFDA Drug Labeling

Do not use if you are sensitive to any ingredient in this product if this solution changes color or becomes cloudy

Ask a Doctor

openFDA Drug Labeling

Ask a doctor before use if you have narrow angle glaucoma heart disease high blood pressure trouble urinating

Stop Use

openFDA Drug Labeling

Stop use and ask a doctor if you feel eye pain changes in vision occur redness or irritation of the eye(s) gets worse or lasts more than 72 hours

Active Ingredient

openFDA Drug Labeling

Active ingredients Purpose Naphazoline hydrochloride 0.025% Redness reliever Pheniramine maleate 0.3% Antihistamine

How Supplied / Storage and Handling

openFDA Drug Labeling

HOW SUPPLIED Product: 50090-0185 NDC: 50090-0185-0 15 mL in a BOTTLE / 1 in a CARTON

Adverse event reports

Source: openFDA FAERS

2,257

FAERS reports mentioning this drug

as of 2026-09-25T03:42:24+00:00

A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: NAPHAZOLINE HYDROCHLORIDE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Recalls

Source: FDA Enforcement

Drug recall enforcement reports associated with this product.
Classification	Reported	Firm	Reason	Status
Class II	August 17, 2022	Mckesson Medical-Surgical Inc. Corporate Office	CGMP Deviations: products were stored outside the drug label specifications.	Terminated

Packaging and NDCs

Source: NDC Directory

Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC	Product NDC	Labeler	Description	Marketing start
50090-0185-0	50090-0185	A-S Medication Solutions	1 BOTTLE in 1 CARTON (50090-0185-0) / 15 mL in 1 BOTTLE	November 28, 2014
0065-0085-15	0065-0085	Alcon Laboratories, Inc.	1 BOTTLE in 1 CARTON (0065-0085-15) / 15 mL in 1 BOTTLE	January 3, 1995
50090-0185	50090-0185	A-S Medication Solutions	—	June 8, 1994
0065-0085	0065-0085	Alcon Laboratories, Inc.	—	June 8, 1994

Sources for this page

Every dataset that contributed a fact to this page.
Dataset	Agency	Used for
NDC Directory	FDA	Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA	FDA	Application, sponsor, submissions, review documents, marketing status
Drug Labeling	FDA / NLM	Prescribing information reproduced above
FAERS	FDA	Adverse event report counts
Enforcement	FDA	Recall records

Generated September 25, 2026 · 11 sections on this page.