Is Desloratadine + Pseudoephedrine registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 2 valid registrations of Desloratadine + Pseudoephedrine, including LORINASE-D (120,2.5 mg,mg, Tablet, SAR 24.60); Rina Extra (2.5,120 mg,mg, modified-release tablet, SAR 35.00).

Is Desloratadine + Pseudoephedrine approved by the US FDA?

Drugs@FDA lists 3 application product lines for Desloratadine + Pseudoephedrine, including CLARINEX-D 12 HOUR (Prescription); DESLORATADINE AND PSEUDOEPHEDRINE SULFATE 24 HOUR (Prescription); CLARINEX D 24 HOUR (Discontinued).

Active substances

Desloratadine + Pseudoephedrine

SFDA 2
US FDA 3
Health Canada 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
LORINASE-D	120,2.5 mg,mg	Tablet · Oral use	20 Blister	SAR 24.60	Generic · OTC	SPIMACO ADDWAEIH	Valid
Rina Extra	2.5,120 mg,mg	modified-release tablet · Oral use	30 Blister	SAR 35.00	Generic · OTC	DAR Al DAWA	Valid

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

Product	Strength	Form · route	Applicant	Status	First approved
CLARINEX-D 12 HOUR	2.5MG;120MG	tablet, extended release · oral	ORGANON LLC	Prescription	1 Feb 2006
DESLORATADINE AND PSEUDOEPHEDRINE SULFATE 24 HOUR	5MG;240MG	tablet, extended release · oral	DR REDDYS LABS LTD	Prescription	26 Apr 2011
CLARINEX D 24 HOUR	5MG;240MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet, extended release · oral	ORGANON	Discontinued	3 Mar 2005

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
AERIUS SINUS + ALLERGY	02309300	120 MG; 2.5 MG	TABLET (EXTENDED-RELEASE) · ORAL	BAYER INC

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.