Is Oxymetazoline registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 5 valid registrations of Oxymetazoline, including ClariSpray Menthol (0.5 mg/ml, Nasal spray, SAR 25.85); ClariSpray Original (0.5 mg/ml, Nasal spray, SAR 25.85); NASIVIN DROPS 0.025% (0.025 %, Nasal drops, SAR 4.40); NASIVIN DROPS 0.05% (0.05 %, Nasal drops, SAR 5.35); VICKS SINEX NASAL SPRAY. (0.05 %, Spray, SAR 3.60).

Is Oxymetazoline approved by the US FDA?

Drugs@FDA lists 5 application product lines for Oxymetazoline, including VISINE L.R. (Over-the-counter); RHOFADE (Prescription); UPNEEQ (Prescription); OXYMETAZOLINE HYDROCHLORIDE (Prescription); OCUCLEAR (Discontinued).

Are there safety signals or safety updates for Oxymetazoline?

US FDA: 2 entries; MHRA: 1 entry (latest 2026-04-30).

Active substance

Oxymetazoline

SFDA 8
US FDA 5
Health Canada 15
US price lines 1
Safety 3

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
ClariSpray Menthol	0.5 mg/ml	Nasal spray · Nasal use	1 Spray Pump	SAR 25.85	NCE · OTC	BAYER CONSUMER CARE AG	Valid
ClariSpray Original	0.5 mg/ml	Nasal spray · Nasal use	1 Spray Pump	SAR 25.85	NCE · OTC	BAYER CONSUMER CARE AG	Valid
NASIVIN DROPS 0.025%	0.025 %	Nasal drops · Nasal use	1 Dropper Container	SAR 4.40	Generic · OTC	Gulf Pharmaceutical Industries (Julphar)	Valid
NASIVIN DROPS 0.05%	0.05 %	Nasal drops · Nasal use	1 Dropper Container	SAR 5.35	Generic · OTC	Gulf Pharmaceutical Industries (Julphar)	Valid
VICKS SINEX NASAL SPRAY.	0.05 %	Spray · Nasal use	1 Spray Container	SAR 3.60	Generic · OTC	RICHARD SUN MRIL	Valid
ILIADIN	0.05 %	Nasal spray, solution · Nasal use	1 Spray Container	SAR 6.90	Generic · OTC	Merck Healthcare KGaA	Withdrawn by MAH · Not Marketed
ILIADIN ADULT	0.05 %	Nasal drops · Nasal use	1 Dropper Container	SAR 7.25	NCE · OTC	Merck Healthcare KGaA	Withdrawn by MAH · Not Marketed
ILIADIN INFANT	0.025 %	Nasal drops · Nasal use	1 Dropper Container	SAR 6.55	NCE · OTC	Merck Healthcare KGaA	Withdrawn by MAH · Not Marketed

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

Product	Strength	Form · route	Applicant	Status	First approved
VISINE L.R.	0.025%	solution/drops · ophthalmic	KENVUE BRANDS	Over-the-counter	31 Mar 1989
RHOFADE	1%	cream · topical	MAYNE PHARMA	Prescription	18 Jan 2017
UPNEEQ	0.1%	solution/drops · ophthalmic	RVL PHARMS	Prescription	8 Jul 2020
OXYMETAZOLINE HYDROCHLORIDE	1%	cream · topical	SUN PHARMA CANADA	Prescription	4 Oct 2021
OCUCLEAR	0.025%	solution/drops · ophthalmic	BAYER HEALTHCARE LLC	Discontinued	30 May 1986

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
CLARITIN ALLERGY DECONGESTANT	02243690	0.05 %	SOLUTION · NASAL	BAYER INC
DRIXORAL DECONGESTANT NASAL SPRAY	00740861	0.05 % / W/V	SOLUTION · NASAL	BAYER INC
DRIXORAL NASAL CONGESTION	02380129	0.05 %	SPRAY · NASAL	BAYER INC
DRIXORAL NO DRIP COOLING MENTHOL	02245580	0.05 % / W/V	SPRAY · NASAL	BAYER INC
DRIXORAL NO DRIP EXTRA MOISTURIZING	02245575	0.05 % / W/V	SPRAY · NASAL	BAYER INC
DRIXORAL NO DRIP NASAL CONGESTION	02498294	0.05 % / W/V	SPRAY · NASAL	BAYER INC
DRIXORAL NO DRIP NASAL CONGESTION WITH MENTHOL	02498308	0.05 % / W/V	SPRAY · NASAL	BAYER INC
DRIXORAL NO DRIP ORIGINAL UNSCENTED	02245578	0.05 % / W/V	SPRAY · NASAL	BAYER INC
EXTRA MOISTURIZING NASAL SPRAY	02460572	0.05 % / W/V	SPRAY (METERED-DOSE) · NASAL	LSL MEDPLUS INC
LONG LASTING DECONGESTANT NASAL SPRAY	02454351	0.05 % / W/V	SPRAY · NASAL	CRLS
LONG LASTING DRISTAN MENTHOLATED NASAL SPRAY	01929380	0.05 % / W/V	SPRAY · NASAL	FOUNDATION CONSUMER BRANDS, LLC
LONG LASTING DRISTAN NASAL MIST	01929372	0.05 % / W/V	SPRAY · NASAL	FOUNDATION CONSUMER BRANDS, LLC
NASAL CONGESTION SPRAY	02460599	0.05 % / W/V	SPRAY (METERED-DOSE) · NASAL	LSL MEDPLUS INC
SINEX CONGESTION MOISTURIZING	02563606	0.05 % / W/V	SOLUTION · NASAL	PROCTER & GAMBLE INC
SINEX CONGESTION ULTRA FINE MIST	02563614	0.05 % / W/V	SOLUTION · NASAL	PROCTER & GAMBLE INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	RHOFADE 1% CREAM	$23.47434	per GM	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.

Safety signals and safety-related labeling changes

MHRA 30 Apr 2026 Nasal decongestant sprays and drops containing xylometazoline hydrochloride / oxymetazoline hydrochloride: increased risk of rebound congestion, rhinitis medicamentosa, and tachyphylaxis with overuse
There have been reports of worsening nasal congestion (rebound congestion) when the effects of nasal decongestant sprays or drops containing xylometazoline hydrochloride and oxymetazoline hydrochloride, wear off.
US FDA 5 May 2021 UPNEEQ — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Patient Counseling Information / Patient Information / Medication Guide
US FDA 2 Nov 2018 KOVANAZE — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for oxymetazoline →

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.