Eye Allergy Relief — Solution/ Drops

Overview

Brand name

Eye Allergy Relief

Generic name

Pheniramine Maleate and Naphazoline Hydrochloride

Dosage form

Solution/ Drops

Route

Ophthalmic

Marketing category

NDA · NDA

Labeler

CVS PHARMACY

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

2

NDC product codes

6

Packages

8

Data completeness

82% 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	.2675 mg/mL	1235200	View
Pheniramine Maleate	3.15 mg/mL	2286592	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Solution/ Drops

Route of administration

Ophthalmic

Presentations

14

Regulatory status

Source: Drugs@FDA NDC Directory

Application number

020065

Application type

NDA · New Drug Application

Approval date

June 8, 1994

Sponsor

BAUSCH AND LOMB

Products on application

1

Submissions recorded

17

Products approved under application 020065.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
020065-001	OPCON-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 020065.
Type	No.	Action	Status	Date	Review
Supplement	33	Labeling	Approved	September 23, 2022	Standard
Supplement	22	Manufacturing (CMC)	Approved	March 14, 2016	Standard
Supplement	21	Manufacturing (CMC)	Approved	September 18, 2015	Standard
Supplement	20	Manufacturing (CMC)	Approved	May 12, 2015	Standard
Supplement	17	Labeling	Approved	July 31, 2007	Standard
Supplement	10	Manufacturing (CMC)	Approved	April 20, 2005	Standard
Supplement	15	Manufacturing (CMC)	Approved	December 18, 1996	Standard
Supplement	14	Labeling	Approved	July 23, 1996	Standard
Supplement	13	Labeling	Approved	July 23, 1996	Standard
Supplement	11	Labeling	Approved	May 9, 1996	Standard
Supplement	8	Manufacturing (CMC)	Approved	April 11, 1996	Standard
Supplement	9	Manufacturing (CMC)	Approved	March 13, 1996	Standard
Supplement	5	Manufacturing (CMC)	Approved	May 11, 1995	Standard
Supplement	3	Manufacturing (CMC)	Approved	November 29, 1994	Standard
Supplement	2	Manufacturing (CMC)	Approved	November 29, 1994	Standard
Supplement	1	Manufacturing (CMC)	Approved	October 11, 1994	Standard
Original application	1	Type 5 - New Formulation or New Manufacturer	Approved	June 8, 1994	Standard

Review documents

0 · Supplement · October 5, 2022
0 · Supplement · September 26, 2022
0 · Supplement · August 2, 2007
0 · Supplement · August 2, 2007
0 · Supplement · April 28, 2005

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260114). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260114 HUMAN OTC DRUG · 20210405 HUMAN OTC DRUG · 20200127

Indications and Usage

openFDA Drug Labeling

Uses • temporarily relieves itching and redness caused by pollen, ragweed, grass, animal hair and dander.

Purpose

openFDA Drug Labeling

Purposes Redness reliever Antihistamine

Dosage and Administration

openFDA Drug Labeling

Directions • Adults and children 6 years of age and older: Instill 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 • if you are sensitive to any ingredient in this product • if solution changes color or becomes cloudy Ask a doctor before use if you have • heart disease • high blood pressure • trouble urinating due to an enlarged prostate gland • narrow angle glaucoma When using this product • overuse may cause more eye redness • pupils may become enlarged temporarily • do not touch tip of container to any surface to avoid contamination • you may feel a brief tingling after putting drops in eye • replace cap after use • remove contact lenses before using Stop use and ask a doctor if you experience • eye pain • changes in vision • redness or irritation of the eye that worsens or lasts more than 72 hours Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Accidental oral ingestion in infants and children may lead to coma and marked reduction in body temperature.

Do Not Use

openFDA Drug Labeling

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

Ask a Doctor

openFDA Drug Labeling

Ask a doctor before use if you have • heart disease • high blood pressure • trouble urinating due to an enlarged prostate gland • narrow angle glaucoma

Stop Use

openFDA Drug Labeling

Stop use and ask a doctor if you experience • eye pain • changes in vision • redness or irritation of the eye that worsens or lasts more than 72 hours

Active Ingredient

openFDA Drug Labeling

Active ingredients Naphazoline HCl (0.02675%) Pheniramine maleate (0.315%)

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.

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
69842-441-02	69842-441	CVS PHARMACY	2 BOTTLE, DROPPER in 1 CARTON (69842-441-02) / 15 mL in 1 BOTTLE, DROPPER	February 1, 2017
69842-441-15	69842-441	CVS PHARMACY	1 BOTTLE, DROPPER in 1 CARTON (69842-441-15) / 15 mL in 1 BOTTLE, DROPPER	February 1, 2017
55910-552-15	55910-552	DOLGENCORP, LLC	1 BOTTLE, DROPPER in 1 CARTON (55910-552-15) / 15 mL in 1 BOTTLE, DROPPER	July 1, 2015
11822-0552-1	11822-0552	Rite Aid Corporation	1 BOTTLE, DROPPER in 1 CARTON (11822-0552-1) / 15 mL in 1 BOTTLE, DROPPER	July 1, 2015
11822-0552-2	11822-0552	Rite Aid Corporation	2 BOTTLE, DROPPER in 1 CARTON (11822-0552-2) / 15 mL in 1 BOTTLE, DROPPER	July 1, 2015
11673-430-15	11673-430	Target Corporation	1 BOTTLE, DROPPER in 1 CARTON (11673-430-15) / 15 mL in 1 BOTTLE, DROPPER	August 31, 2010
49035-430-15	49035-430	Wal-Mart Stores Inc	1 BOTTLE, DROPPER in 1 CARTON (49035-430-15) / 15 mL in 1 BOTTLE, DROPPER	August 31, 2010
0363-0430-15	0363-0430	Walgreen Company	1 BOTTLE, DROPPER in 1 CARTON (0363-0430-15) / 15 mL in 1 BOTTLE, DROPPER	August 31, 2010
69842-441	69842-441	CVS PHARMACY	—	February 1, 2017
55910-552	55910-552	DOLGENCORP, LLC	—	July 1, 2015
11822-0552	11822-0552	Rite Aid Corporation	—	July 1, 2015
11673-430	11673-430	Target Corporation	—	August 31, 2010
49035-430	49035-430	Wal-Mart Stores Inc	—	August 31, 2010
0363-0430	0363-0430	Walgreen Company	—	August 31, 2010

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

Generated September 25, 2026 · 10 sections on this page.