Is Levocetirizine registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 19 valid registrations of Levocetirizine, including ALLERTEC 5 mg film-coated tablet (5 mg, Film-coated tablet, SAR 23.10); GLOZAL 5 mg film-coated tablet (5 mg, Film-coated tablet, SAR 15.95); L-CET (0.5 mg/ml, Oral solution, SAR 11.55); L-CET 5 mg film-coated tablet (5 mg, Film-coated tablet, SAR 19.40); LAYAL (5 mg, Tablet, SAR 23.90).

Is Levocetirizine approved by the US FDA?

Drugs@FDA lists 28 application product lines for Levocetirizine, including LEVOCETIRIZINE DIHYDROCHLORIDE (Prescription); LEVOCETIRIZINE DIHYDROCHLORIDE (Prescription); LEVOCETIRIZINE DIHYDROCHLORIDE (Prescription); LEVOCETIRIZINE DIHYDROCHLORIDE (Prescription); LEVOCETIRIZINE DIHYDROCHLORIDE (Prescription).

Are there safety signals or safety updates for Levocetirizine?

US FDA: 3 entries (latest 2026-05-20).

Active substance

Levocetirizine

SFDA 21
US FDA 28
US price lines 3
NHS prices 2
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
ALLERTEC 5 mg film-coated tablet	5 mg	Film-coated tablet · Oral use	30 Blister	SAR 23.10	Generic · OTC	KRKA D D NOVO MESTO	Valid
GLOZAL 5 mg film-coated tablet	5 mg	Film-coated tablet · Oral use	20 Blister	SAR 15.95	Generic · OTC	GLOBAL PHARMA	Valid
GLOZAL 5 mg film-coated tablet	5 mg	Film-coated tablet · Oral use	30 Blister	SAR 23.90	Generic · OTC	GLOBAL PHARMA	Valid
L-CET	0.5 mg/ml	Oral solution · Oral use	1 Bottle	SAR 11.55	Generic · OTC	OMAN PHARMACEUTICAL PRODUCTS	Valid
L-CET 5 mg film-coated tablet	5 mg	Film-coated tablet · Oral use	20 Blister	SAR 19.40	Generic · OTC	OMAN PHARMACEUTICAL PRODUCTS	Valid
LAYAL	5 mg	Tablet · Oral use	30 Blister	SAR 23.90	Generic · OTC	Jordan Sweden Medical and Sterilization Co.	Valid
LAYAL 5 mg film-coated tablet	5 mg	Tablet · Oral use	10 Blister	SAR 7.95	Generic · OTC	Jordan Sweden Medical and Sterilization Co.	Valid
LAYAL Syrup	0.5 mg/ml	Syrup · Oral use	1 Bottle	SAR 11.55	Generic · OTC	Jordan Sweden Medical and Sterilization Co.	Valid
LEVOZAL 0.5 mg/ml Syrup	0.5 mg	Syrup · Oral use	1 Bottle	SAR 14.25	Generic · OTC	Jamjoom Pharmaceuticals Factory Company	Valid
LEVOZAL 5 MG FILM COATED TABLET	5 mg	Film-coated tablet · Oral use	20 Blister	SAR 20.50	Generic · OTC	Jamjoom Pharmaceuticals Factory Company	Valid
LEVOZIN 5 mg film-coated tablet	5 mg	Film-coated tablet · Oral use	20 Blister	SAR 15.95	Generic · OTC	SAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL CO	Valid
LEZAL	0.5 mg/ml	Oral solution · Oral use	1 Bottle	SAR 17.30	Generic · OTC	SPIMACO ADDWAEIH	Valid
Levar	5 mg	Film-coated tablet · Oral use	30 Blister	SAR 22.80	Generic · OTC	Al-Taqaddom pharmaceutical Industries	Valid
Levar	5 mg	Film-coated tablet · Oral use	10 Blister	SAR 7.60	Generic · OTC	Al-Taqaddom pharmaceutical Industries	Valid
Levozal	0.5 mg/ml	Syrup · Oral use	1 Bottle	SAR 28.50	Generic · OTC	Jamjoom Pharmaceuticals Factory Company	Valid
Levozyrt	5 mg	Film-coated tablet · Oral use	30 Blister	SAR 23.90	Generic · OTC	Saudi Amarox	Valid
XYZAL 5MG F.C.TABLET	5 mg	Film-coated tablet · Oral use	20 Blister	SAR 21.60	NCE · OTC	Glaxo Saudi Arabia Ltd	Valid
ZOLIX 0.5 mg/ml Oral Solution	0.5 mg/ml	Oral solution · Oral use	1 Bottle	SAR 25.65	Generic · OTC	Tabuk Pharmaceutical Manufacturing Company	Valid
ZOLIX 5 mg film-coated tablet	5 mg	Film-coated tablet · Oral use	20 Blister	SAR 17.75	Generic · OTC	Tabuk Pharmaceutical Manufacturing Company	Valid
ALLERCET 5MG F.C.TABLET	5 mg	Film-coated tablet · Oral use	30 Blister	SAR 23.90	Generic · OTC	NEOPHARMA	Suspended
ALLERCET 5MG F.C.TABLET	5 mg	Film-coated tablet · Oral use	10 Blister	SAR 7.95	Generic · OTC	NEOPHARMA	Suspended

Indications — CHI Daman Drug Formulary

ALLERGIC CONJUCTIVITIS (AC); ALLERGIC RHINITIS; HUMAN IMMUNODEFICIENCY VIRUS; PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS - PRURITUS; TUBERCULOSIS-SUPPORTIVE CARE; URTICARIA

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

Product	Strength	Form · route	Applicant	Status	First approved
LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	tablet · oral	SYNTHON BV	Prescription	26 Nov 2010
LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	tablet · oral	GLENMARK PHARMS LTD	Prescription	24 Feb 2011
LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	tablet · oral	DR REDDYS LABS LTD	Prescription	24 Feb 2011
LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	tablet · oral	TEVA PHARMS	Prescription	22 Aug 2011
LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	solution · oral	PADAGIS US	Prescription	7 Nov 2011
LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	tablet · oral	HETERO LABS LTD III	Prescription	29 Jun 2012
LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	tablet · oral	SUN PHARM	Prescription	31 Jan 2013
LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	tablet · oral	MICRO LABS LTD INDIA	Prescription	17 Sep 2013
LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	tablet · oral	SCIEGEN PHARMS	Prescription	9 Sep 2014
LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	tablet · oral	MACLEODS PHARMS	Prescription	11 Jan 2016
XYZAL ALLERGY 24HR	5MG	tablet · oral	CHATTEM SANOFI	Over-the-counter	31 Jan 2017
XYZAL ALLERGY 24HR	2.5MG/5ML	solution · oral	CHATTEM SANOFI	Over-the-counter	31 Jan 2017
LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	solution · oral	CHARTWELL MOLECULAR	Prescription	15 May 2017
LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	tablet · oral	DR REDDYS	Over-the-counter	19 Jan 2018
LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	tablet · oral	SANKALP LIFECARE	Over-the-counter	20 Nov 2018
LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	tablet · oral	PERRIGO R AND D	Over-the-counter	28 Mar 2019
LEVOCETIRIZINE HYDROCHLORIDE	2.5MG/5ML	solution · oral	HETERO LABS LTD III	Prescription	1 Apr 2019
LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	tablet · oral	HETERO LABS LTD III	Over-the-counter	29 Apr 2020
XYZAL	5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet · oral	CHATTEM SANOFI	Discontinued	25 May 2007
XYZAL	2.5MG/5ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	solution · oral	CHATTEM SANOFI	Discontinued	28 Jan 2008
LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	tablet · oral	GRANULES	Discontinued	26 Mar 2013
LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	solution · oral	TARO	Discontinued	26 Jul 2013
LEVOCETIRIZINE DIHYDROCHLORIDE	2.5MG/5ML	solution · oral	APOTEX	Discontinued	21 Aug 2014
LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	tablet · oral	APOTEX	Discontinued	13 Feb 2015
LEVOCETIRIZINE DIHYDROCHLORIDE	5MG	tablet · oral	SUN PHARM INDS LTD	Discontinued	26 Jun 2015

3 more — full table

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	LEVOCETIRIZINE 2.5 MG/5 ML SOL	$0.16588	per ML	23 Sep 2026
US NADAC	LEVOCETIRIZINE 5 MG TABLET	$0.0511	per EA	23 Sep 2026
US NADAC	LEVOCETIRIZINE 5 MG TABLET	$0.21834	per EA	23 Sep 2026
NHS Drug Tariff	Levocetirizine 500micrograms/ml oral solution sugar free	£6.00	200 ml	1 Oct 2026
NHS Drug Tariff	Levocetirizine 5mg tablets	£2.89	30 tablet	1 Oct 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

US FDA 20 May 2026 XYZAL ALLERGY 24HR — safety-related labeling change
Labeling sections changed: Warnings and Precautions
US FDA 11 Jul 2025 XYZAL — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 11 Jul 2025 XYZAL — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for levocetirizine →

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.