Is Loratadine + Pseudoephedrine registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 4 valid registrations of Loratadine + Pseudoephedrine, including CLARINASE TAB (120,5 mg,mg, Tablet, SAR 18.85); DEFONASE SYRUP (12,1 mg/ml,mg/ml, Syrup, SAR 21.00); Fedlora (12,1 mg/ml,mg/ml, Syrup, SAR 17.35); LORINASE SYRUP (12,1 mg/ml,mg/ml, Syrup, SAR 22.90).

Is Loratadine + Pseudoephedrine approved by the US FDA?

Drugs@FDA lists 9 application product lines for Loratadine + Pseudoephedrine, including CLARITIN-D (Over-the-counter); CLARITIN-D 24 HOUR (Over-the-counter); LORATADINE AND PSEUDOEPHEDRINE SULFATE (Over-the-counter); LORATADINE AND PSEUDOEPHEDRINE SULFATE (Over-the-counter); LORATADINE AND PSEUDOEPHEDRINE SULFATE (Over-the-counter).

Active substances

Loratadine + Pseudoephedrine

SFDA 8
US FDA 9
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
CLARINASE TAB	120,5 mg,mg	Tablet · Oral use	14 Blister	SAR 18.85	NCE · OTC	BAYER CONSUMER CARE AG	Valid
DEFONASE SYRUP	12,1 mg/ml,mg/ml	Syrup · Oral use	1 Bottle	SAR 21.00	Generic · OTC	DEEF PHARMACEUTICAL INDUSTRIES	Valid
Fedlora	12,1 mg/ml,mg/ml	Syrup · Oral use	1 Bottle	SAR 17.35	Generic · OTC	BATTERJEE PHARMACETICAL FACTORY	Valid
LORINASE SYRUP	12,1 mg/ml,mg/ml	Syrup · Oral use	1 Bottle	SAR 22.90	Generic · OTC	SPIMACO ADDWAEIH	Valid
CLARINASE 5MG+60MG-5ML SYRUP	12,1 mg/ml,mg/ml	Syrup · Oral use	1 Bottle	SAR 16.05	Generic · OTC	SCHERING-PLOUGH	Invalid · Not Marketed
CLARINASE TAB	5, 120 mg	Tablet · Oral use	14 Blister	SAR 21.20	NCE · OTC	SCHERING-PLOUGH	Withdrawn by MAH · Not Marketed
LORA S tablet	5, 120 mg	Tablet · Oral use	14 Blister	SAR 13.15	Generic · OTC	DAMMAM PHARMA	Suspended · Not Marketed
LORINASE TABLETS	5, 120 mg	Tablet · Oral use	14 Blister	SAR 14.60	Generic · OTC	SPIMACO ADDWAEIH	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

ALLERGIC RHINITIS

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

Product	Strength	Form · route	Applicant	Status	First approved
CLARITIN-D	5MG;120MG	tablet, extended release · oral	BAYER HEALTHCARE LLC	Over-the-counter	14 Nov 1994
CLARITIN-D 24 HOUR	10MG;240MG	tablet, extended release · oral	BAYER HEALTHCARE LLC	Over-the-counter	23 Aug 1996
LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	tablet, extended release · oral	PERRIGO PHARMA INTL	Over-the-counter	30 Jan 2003
LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	tablet, extended release · oral	P AND L	Over-the-counter	21 Feb 2003
LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	tablet, extended release · oral	PERRIGO PHARMA INTL	Over-the-counter	4 Mar 2004
LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	tablet, extended release · oral	SUN PHARM INDS LTD	Over-the-counter	22 Sep 2004
LORATADINE AND PSEUDOEPHEDRINE SULFATE	10MG;240MG	tablet, extended release · oral	BIONPHARMA	Over-the-counter	14 May 2024
LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	tablet, extended release · oral	DR REDDYS	Over-the-counter	6 Aug 2026
LORATADINE AND PSEUDOEPHEDRINE SULFATE	5MG;120MG	tablet, extended release · oral	HERITAGE PHARMA	Discontinued	28 Jan 2004

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
CLARITIN ALLERGY + SINUS	01945157	120 MG; 5 MG	TABLET (IMMEDIATE- AND EXTENDED-RELEASE) · ORAL	BAYER INC
CLARITIN ALLERGY + SINUS EXTRA STRENGTH	02260557	240 MG; 10 MG	TABLET (IMMEDIATE- AND 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.