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Opcon-A

Naphazoline hydrochloride and Pheniramine maleate · Solution/ Drops

Over-the-counter NDA RLD Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Opcon-A
Generic name
Naphazoline hydrochloride and Pheniramine maleate
Dosage form
Solution/ Drops
Route
Ophthalmic
Marketing category
NDA · NDA
Labeler
Bausch & Lomb Incorporated
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
2
Packages
4
Data completeness
76% 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
6

Regulatory status

Source: Drugs@FDANDC 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 20260320). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260320 HUMAN OTC DRUG · 20231214

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
24208-430-15 24208-430 Bausch & Lomb Incorporated 1 BOTTLE, DROPPER in 1 CARTON (24208-430-15) / 15 mL in 1 BOTTLE, DROPPER August 6, 1994
24208-430-45 24208-430 Bausch & Lomb Incorporated 2 BOTTLE, DROPPER in 1 CARTON (24208-430-45) / 15 mL in 1 BOTTLE, DROPPER July 1, 2015
24208-431-15 24208-431 Bausch & Lomb Incorporated 1 BOTTLE, DROPPER in 1 CARTON (24208-431-15) / 15 mL in 1 BOTTLE, DROPPER March 19, 2026
24208-431-45 24208-431 Bausch & Lomb Incorporated 2 BOTTLE, DROPPER in 1 CARTON (24208-431-45) / 15 mL in 1 BOTTLE, DROPPER March 19, 2026
24208-430 24208-430 Bausch & Lomb Incorporated — June 8, 1994
24208-431 24208-431 Bausch & Lomb Incorporated — March 19, 2026

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.