Is Naphazoline + Pheniramine registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Naphazoline + Pheniramine, including NAPHCON-A EYE DROPS (3,0.025 %,%, Eye drops, SAR 17.25).

Is Naphazoline + Pheniramine approved by the US FDA?

Drugs@FDA lists 5 application product lines for Naphazoline + Pheniramine, including OPCON-A (Over-the-counter); NAPHCON-A (Over-the-counter); VISINE (Over-the-counter); NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE (Over-the-counter); NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE (Over-the-counter).

Active substances

Naphazoline + Pheniramine

SFDA 1
US FDA 5
Health Canada 3
US price lines 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
NAPHCON-A EYE DROPS	3,0.025 %,%	Eye drops · Ophthalmic use	1 Dropper Container	SAR 17.25	NCE · OTC	ALCON N.V.	Valid

Indications — CHI Daman Drug Formulary

ALLERGIC CONJUCTIVITIS (AC); ALLERGIC RHINITIS; ALLERGIC RHINITIS-ALLERGIC RHINO-CONJUNCTIVITIS; VIRAL CONJUNCTIVITS, HERPESVIRAL KERATITIS, HERPESVIRAL CONJUNCTIVITIS, VARICELLA KERATITIS, ZOSTER CONJUNCTIVITIS, ZOSTER KERATITIS, MEASLES KERATITIS AND KERATOCONJUNCTIVITIS, VIRAL CONJUNCTIVITIS, KERATITIS

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
OPCON-A	0.02675%;0.315%	solution/drops · ophthalmic	BAUSCH AND LOMB	Over-the-counter	8 Jun 1994
NAPHCON-A	0.025%;0.3%	solution/drops · ophthalmic	ALCON	Over-the-counter	8 Jun 1994
VISINE	0.025%;0.3%	solution/drops · ophthalmic	KENVUE BRANDS	Over-the-counter	31 Jan 1996
NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.02675%;0.315%	solution/drops · ophthalmic	ALTAIRE PHARMS INC	Over-the-counter	27 Sep 2010
NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE	0.025%;0.3%	solution/drops · ophthalmic	RISING	Over-the-counter	24 Jan 2013

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
NAPHCON A	00481408	0.025 %; 0.3 %	SOLUTION · OPHTHALMIC	ALCON CANADA INC
SOOTHE ALLERGY	00750794	0.315 % / W/V; 0.02675 % / W/V	DROPS · OPHTHALMIC	BAUSCH & LOMB INC
VISINE FOR ALLERGY WITH ANTIHISTAMINE	02242764	0.025 % / W/V; 0.3 % / W/V	DROPS · OPHTHALMIC	JOHNSON & JOHNSON INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	NAPHCON-A EYE DROPS	$0.55744	per ML	23 Sep 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Components

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.