Is Cetirizine + Pseudoephedrine 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 Cetirizine + Pseudoephedrine.

Is Cetirizine + Pseudoephedrine approved by the US FDA?

Drugs@FDA lists 7 application product lines for Cetirizine + Pseudoephedrine, including ZYRTEC-D 12 HOUR (Over-the-counter); CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (Over-the-counter); CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (Over-the-counter); CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (Over-the-counter); CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE (Over-the-counter).

Active substances

Cetirizine + Pseudoephedrine

SFDA 1
US FDA 7
Health Canada 1
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
CIRRUS 5-120MG PROLONG RELEASE F-C TABS.	120,5 mg,mg	Prolonged-release tablet · Oral use	14 Blister	SAR 19.90	NCE · OTC	Glaxo Saudi Arabia Ltd	Withdrawn by MAH · Not Marketed

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

Product	Strength	Form · route	Applicant	Status	First approved
ZYRTEC-D 12 HOUR	5MG;120MG	tablet, extended release · oral	KENVUE BRANDS	Over-the-counter	10 Aug 2001
CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	tablet, extended release · oral	IVAX SUB TEVA PHARMS	Over-the-counter	25 Feb 2008
CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	tablet, extended release · oral	PLD ACQUISITIONS	Over-the-counter	5 Mar 2008
CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	tablet, extended release · oral	SUN PHARM INDS LTD	Over-the-counter	28 Sep 2012
CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	tablet, extended release · oral	PPI-DAC	Over-the-counter	16 Nov 2018
CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	tablet, extended release · oral	AUROBINDO PHARMA LTD	Discontinued	8 Mar 2023
CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE	5MG;120MG	tablet, extended release · oral	UNICHEM	Discontinued	10 Sep 2024

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
REACTINE COMPLETE	02246162	5 MG; 120 MG	TABLET (EXTENDED-RELEASE) · ORAL	KENVUE CANADA INC.

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	CETIRIZINE-PSE ER 5-120 MG TAB	$0.56251	per EA	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.