Is Tetrahydrozoline registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 0 valid registrations of Tetrahydrozoline.

Is Tetrahydrozoline approved by the US FDA?

Drugs@FDA lists 2 application product lines for Tetrahydrozoline, including TYZINE (Prescription); TYZINE (Prescription).

Active substance

Tetrahydrozoline

SFDA 1
US FDA 2
Health Canada 2

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
VISINE EYE DROPS 0.05%	0.05 %	Eye drops · Ocular use	1 Dropper Container	SAR 6.15	NCE · Prescription	PFIZER	Withdrawn by MAH · Not Marketed

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

Product	Strength	Form · route	Applicant	Status	First approved
TYZINE	0.1%; 0.05%	solution · nasal	FOUGERA PHARMS	Prescription	30 Nov 1979
TYZINE	0.1%	spray · nasal	FOUGERA PHARMS	Prescription	30 Nov 1979

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ORIGINAL EYE DROPS	02273446	0.05 % / W/V	SOLUTION · OPHTHALMIC	JUNO OTC INC
VISINE ORIGINAL	01942425	0.05 %	DROPS · OPHTHALMIC	JOHNSON & JOHNSON INC

Combinations containing Tetrahydrozoline

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.