Regulatory PathRegulatory requirements compared

Active substance

Cetirizine

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
ARTIZ 10 MG F.C TABLET10 mgFilm-coated tablet · Oral use10 BlisterSAR 9.75Generic · OTCTabuk Pharmaceutical Manufacturing CompanyValid
ARTIZ 10 MG F.C TABLET10 mgFilm-coated tablet · Oral use30 BlisterSAR 29.25Generic · OTCTabuk Pharmaceutical Manufacturing CompanyValid
CETRALON 10 MG TAB10 mgFilm-coated tablet · Oral use10 BlisterSAR 10.25Generic · OTCGulf Pharmaceutical Industries (Julphar)Valid
CETRALON 5MG-5ML SYRUP1 mg/mlSyrup · Oral use1 BottleSAR 10.10Generic · OTCGulf Pharmaceutical Industries (Julphar)Valid
CITRIN 5MG-5ML SYRUP1 mg/mlSyrup · Oral use1 BottleSAR 11.80Generic · OTCDEEF PHARMACEUTICAL INDUSTRIESValid
FINALLERG10 mgFilm-coated tablet · Oral use30 BlisterSAR 22.35Generic · OTCPHARMA INTERNATIONAL COValid
FINALLERG10 mgFilm-coated tablet · Oral use30 BlisterSAR 22.35Generic · OTCPHARMA INTERNATIONAL COValid
FINALLERG 10MG F.C TABLET10 mgFilm-coated tablet · Oral use10 BlisterSAR 7.45Generic · OTCPharma International Co.Valid
FINALLERG 1MG-1ML ORAL SOLUTION1 mg/mlOral solution · Oral use1 BottleSAR 6.60Generic · OTCPharma International Co.Valid
OMCET 10MG F.C. TABS10 mgFilm-coated tablet · Oral use10 BlisterSAR 6.75Generic · OTCNational Pharmaceutical Industries Co. (SAOG)Valid
OMCET 5MG-5ML SYRUP1 mg/mlSyrup · Oral use1 BottleSAR 5.95Generic · OTCNational Pharmaceutical Industries Co. (SAOG)Valid
Omcet10 mgFilm-coated tablet · Oral use840 BlisterSAR 512.00Generic · PrescriptionNational Pharmaceutical Industries Co. (SAOG)Valid
RIZINO 5MG/5ML SYRUP1 mg/mlSyrup · Oral use1 BottleSAR 11.80Generic · OTCBATTERJEE PHARMACETICAL FACTORYValid
ZERTAZINE10 mgFilm-coated tablet · Oral use20 BlisterSAR 18.50Generic · OTCRIYADH PHARMAValid
ZERTAZINE10 mgFilm-coated tablet · Oral use10 BlisterSAR 9.25Generic · OTCRIYADH PHARMAValid
ZERTAZINE 5MG\5ML SYRUP1 mg/mlSyrup · Oral use1 BottleSAR 8.15Generic · OTCRIYADH PHARMAValid
ZYRTEC 0.1% ORAL SOLN.1 mg/mlOral solution · Oral use1 BottleSAR 19.35NCE · OTCGlaxo Saudi Arabia LtdValid
ZYRTEC 10MG F.C.TAB10 mgFilm-coated tablet · Oral use10 BlisterSAR 16.20NCE · OTCGlaxo Saudi Arabia LtdValid
Zyrtec10 mgFilm-coated tablet · Oral use20 BlisterSAR 32.40NCE · OTCGLAXO SAUDI ARABIAValid
CETRO 10MG F.C TAB10 mgFilm-coated tablet · Oral use10 BlisterSAR 8.30Generic · PrescriptionCOOPER PHARMAWithdrawn by MAH · Not Marketed
CETRO 10MG F.C TAB10 mgFilm-coated tablet · Oral use10 BlisterSAR 8.30Generic · OTCSPIMACO ADDWAEIHWithdrawn by MAH · Not Marketed
CETRO 5MG\5ML SYRUP1 mg/mlSyrup · Oral use1 BottleSAR 9.10Generic · PrescriptionCOOPER PHARMAWithdrawn by MAH · Not Marketed
CETRO 5MG\5ML SYRUP1 mg/mlSyrup · Oral use1 BottleSAR 9.10Generic · OTCSPIMACO ADDWAEIHWithdrawn by MAH · Not Marketed
GLOTRIZINE 5MG-5ML SYRUP1 mg/mlSyrup · Oral use1 BottleSAR 7.35Generic · OTCGLOBAL PHARMAWithdrawn by MAH · Not Marketed
NOHIST 10MG TAB10 mgTablet · Oral use10 BlisterSAR 8.90Generic · OTCAPMWithdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

ALLERGIC CONJUCTIVITIS (AC); ALLERGIC RHINITIS; ANAPHYLACTIC SHOCK; HUMAN IMMUNODEFICIENCY VIRUS; POLYCYTHEMIA VERA - PRURITUS; PROGRESSIVE FAMILIAL INTRAHEPATIC CHOLESTASIS - PRURITUS; T-CELL LYMPHOMA; TUBERCULOSIS-SUPPORTIVE CARE; URTICARIA

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

ProductStrengthForm · routeApplicantStatusFirst approved
ZYRTEC ALLERGY5MG; 10MGtablet · oralKENVUE BRANDSOver-the-counter8 Dec 1995
CHILDREN'S ZYRTEC ALLERGY10MG; 2.5MGtablet, chewable · oralKENVUE BRANDSOver-the-counter16 Mar 2004
CHILDREN'S ZYRTEC HIVES5MG/5MLsolution · oralKENVUE BRANDSOver-the-counter16 Nov 2007
CHILDREN'S ZYRTEC ALLERGY5MG/5MLsolution · oralKENVUE BRANDSOver-the-counter16 Nov 2007
CETIRIZINE HYDROCHLORIDE ALLERGY5MG; 10MGtablet · oralCONTRACT PHARMACALOver-the-counter27 Dec 2007
CETIRIZINE HYDROCHLORIDE ALLERGY5MG; 10MGtablet · oralMYLANOver-the-counter27 Dec 2007
CETIRIZINE HYDROCHLORIDE HIVES10MG; 5MGtablet · oralMYLANOver-the-counter27 Dec 2007
CETIRIZINE HYDROCHLORIDE ALLERGY5MG; 10MGtablet · oralSUN PHARM INDS LTDOver-the-counter27 Dec 2007
CETIRIZINE HYDROCHLORIDE HIVES5MG; 10MGtablet · oralSUN PHARM INDS LTDOver-the-counter27 Dec 2007
CETIRIZINE HYDROCHLORIDE ALLERGY5MG; 10MGtablet · oralPLD ACQUISITIONSOver-the-counter27 Dec 2007
CETIRIZINE HYDROCHLORIDE ALLERGY5MG; 10MGtablet · oralAPOTEX INCOver-the-counter27 Dec 2007
CETIRIZINE HYDROCHLORIDE ALLERGY5MG; 10MGtablet · oralPERRIGO R AND DOver-the-counter27 Dec 2007
CETIRIZINE HYDROCHLORIDE HIVES5MG; 10MGtablet · oralPERRIGO R AND DOver-the-counter27 Dec 2007
CETIRIZINE HYDROCHLORIDE ALLERGY5MG; 10MGtablet · oralGLENMARK PHARMSOver-the-counter28 Dec 2007
CETIRIZINE HYDROCHLORIDE HIVES5MG; 10MGtablet · oralDR REDDYS LABS LTDOver-the-counter15 Jan 2008
CETIRIZINE HYDROCHLORIDE ALLERGY10MG; 5MGtablet · oralDR REDDYS LABS LTDOver-the-counter15 Jan 2008
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG; 10MGtablet, chewable · oralSANDOZOver-the-counter14 Feb 2008
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLsolution · oralPERRIGO R AND DOver-the-counter9 Apr 2008
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLsolution · oralPERRIGO R AND DOver-the-counter9 Apr 2008
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF5MG/5MLsolution · oralTAROOver-the-counter22 Apr 2008
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY5MG/5MLsolution · oralTAROOver-the-counter22 Apr 2008
CETIRIZINE HYDROCHLORIDE5MG/5MLsolution · oralPADAGIS USPrescription17 Jun 2008
CETIRIZINE HYDROCHLORIDE5MG/5MLsolution · oralPHARM ASSOCPrescription18 Jun 2008
CETIRIZINE HYDROCHLORIDE5MG/5MLsolution · oralTAROPrescription20 Jun 2008
CETIRIZINE HYDROCHLORIDE5MG/5MLsolution · oralBIONPHARMAPrescription6 Oct 2008

83 more — full table

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
ALLERGY RELIEF0224026610 MGTABLET · ORALAPOTEX INC
ALLERGY RELIEF LIQUID GELS0252873810 MGCAPSULE · ORALJUNO OTC INC
APO-CETIRIZINE0223160310 MGTABLET · ORALAPOTEX INC
APO-CETIRIZINE0245336320 MGTABLET · ORALAPOTEX INC
BIO-CETIRIZINE0251003020 MGTABLET · ORALBIOMED PHARMA
CETIRIZINE0251569520 MGTABLET · ORALSANIS HEALTH INC
CETIRIZINE0253412620 MGTABLET · ORALSIVEM PHARMACEUTICALS ULC
EXTRA STRENGTH ALLERGY RELIEF0231595510 MGTABLET · ORALPHARMASCIENCE INC
EXTRA STRENGTH ALLERGY RELIEF0254049510 MGTABLET · ORALVITA HEALTH PRODUCTS INC
JAMP-CETIRIZINE0245177810 MGTABLET · ORALJAMP PHARMA CORPORATION
JAMP-CETIRIZINE0246617120 MGTABLET · ORALJAMP PHARMA CORPORATION
M-CETIRIZINE0251202520 MGTABLET · ORALMANTRA PHARMA INC
MAR-CETIRIZINE0242714120 MGTABLET · ORALMARCAN PHARMACEUTICALS INC
NAT-CETIRIZINE0249646110 MGTABLET · ORALNATCO PHARMA (CANADA) INC
NAT-CETIRIZINE0249648820 MGTABLET · ORALNATCO PHARMA (CANADA) INC
NRA-CETIRIZINE TABLETS0253023620 MGTABLET · ORALNORA PHARMA INC
PMS-CETIRIZINE0231596320 MGTABLET · ORALPHARMASCIENCE INC
PRO-CETIRIZINE0245052620 MGTABLET · ORALPRO DOC LIMITEE
REACTINE022235465 MGTABLET · ORALKENVUE CANADA INC.
REACTINE0222355410 MGTABLET · ORALKENVUE CANADA INC.
REACTINE022383375 MG / 5 MLSYRUP · ORALKENVUE CANADA INC.
REACTINE 20 MG TABLET0190097820 MGTABLET · ORALKENVUE CANADA INC.
REACTINE ALLERGY024869545 MG / 5 MLSYRUP · ORALKENVUE CANADA INC.
REACTINE ALLERGY LIQUID GELS0236806410 MGCAPSULE (IMMEDIATE-RELEASE) · ORALKENVUE CANADA INC.
REACTINE FAST MELT JUNIOR0235835210 MGTABLET (ORALLY-DISINTEGRATING) · ORALKENVUE CANADA INC.

2 more — full table

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACALLERGY RELIEF 10 MG TABLET$0.05294per EA23 Sep 2026
US NADACALLERGY RELIEF 12.5 MG/5 ML$0.01744per ML23 Sep 2026
US NADACALLERGY RELIEF 180 MG TABLET$0.2302per EA23 Sep 2026
US NADACALLERGY RELIEF 25 MG CAPSULE$0.05336per EA23 Sep 2026
US NADACALLERGY RELIEF 25 MG SOFTGEL$0.05336per EA23 Sep 2026
US NADACALLERGY RELIEF 25 MG TABLET$0.03697per EA23 Sep 2026
US NADACALLERGY RELIEF 4 MG TABLET$0.01772per EA23 Sep 2026
US NADACALLERGY RELIEF 5 MG/5 ML SOLN$0.04139per ML23 Sep 2026
US NADACALLERGY RELIEF 50 MCG SPRAY$0.89591per ML23 Sep 2026
US NADACCETIRIZINE HCL 1 MG/ML SOLN$0.02231per ML23 Sep 2026
US NADACCETIRIZINE HCL 1 MG/ML SOLN$0.11989per ML23 Sep 2026
US NADACCETIRIZINE HCL 1 MG/ML SOLN$0.3318per ML18 Mar 2026
NHS Drug TariffCetirizine 10mg tablets£0.8130 tablet1 Oct 2026
NHS Drug TariffCetirizine 1mg/ml oral solution sugar free£2.83200 ml1 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.

WHO WHO Model List of Essential Medicines (2025)

  • 3. Antiallergics and medicines used in anaphylaxis · core
    Therapeutic equivalent to loratadine for Allergic or hypersensitivity conditions of unspecified type

Safety signals and safety-related labeling changes

All safety entries for cetirizine →

Combinations containing Cetirizine

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.