Cetirizine
Sold as Zetop, Sinutab sinus allergy, Verlix, Texa allergy, Adco cetirizine, Ceticit, Allermine, Allecet, Acuzyrt, Seasoneze, Zelary, Aspen cetirizine, Atrizin, Austell cetirizine, Cetirizine austell, Zyncet, Reactyne, Gulf cetirizine, Sensahist, Cetirizine shanur, Zinallerg, AURO cetirizine, Trantrin, Allesoothe, Zialdel, Derasip, Cetriliqe, Cetirizine unimed, Zyrtec
2-[2-[4-[(4-Chlorophenyl)-phenylmethyl]piperazin-1-yl]ethoxy]acetic acid
Drag to rotate. Structure from PubChem CID 2678.
Background
Registration
- Applicants
- 23
- Registrations
- 42
- Schedule source
- SAHPRA documentation
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Pharma-q Holdings (Pty) Ltd | Zetop | Not stated | 320374 | Not determined | None |
| Ascendis Pharma (Pty) Ltd | Zetop | syrup | 330030 | Not determined | None |
| Johnson & Johnson (Pty) Ltd û East London1 of 4 cancelled | Sinutab sinus allergy, Reactyne | solution, effervescent | 350296, 350298, 410420, 410426 | Not determined | None |
| Ucb SA (Pty) LtdCancelled | Verlix | 10 mg/ML | 350297 | Not determined | None |
| Pharma Dynamics (Pty) Ltd | Texa allergy | tablets, syrup | 350314, 410086 | Not determined | None |
| Adcock ingram limited1 of 3 cancelled | Adco cetirizine, Ceticit | tablets, 1 mg/1 mL, 10mg | 360368, 360369, 420821 | Not determined | PIPIL |
| Trinity Pharma (Pty) Ltd | Allermine | 10 mg | 360388 | S2 | PIPIL |
| Cipla Medpro (Pty) LtdCertificate held by Cipla Medpro (Pty) Ltd.1 of 4 cancelled | Allecet, Acuzyrt | 10,0 mg, tablets, 1 mL | 370034, 370072, 370152, 370153 | S1 | PIPIL |
| Biotech Laboratories (Pty) Ltd | Seasoneze | 10 mg | 370086 | S1 | PIPIL |
| Austell Pharmaceuticals (Pty) LtdCertificate held by Austell Pharmaceuticals (Pty) Ltd, | Zelary, Austell cetirizine, Cetirizine austell | 5 mg, 10 mg | 370428, 370579, 370579, 370580 | S1 | PIPIL |
| Pharmacare limited û woodmeadCancelled | Aspen cetirizine | 1 mg/ml, 10 mg | 370490, 420143 | Not determined | None |
| Ipharma (Pty) Ltd | Atrizin | 10 mg | 370497 | S2 | PIPIL |
| Unichem SA (Pty) Ltd | Zyncet | 10 mg | 370651 | S1 | PIPIL |
| Unicorn Pharmaceuticals (Pty) Ltd | Zelary | syrup | 410085 | Not determined | None |
| Gulf Drug Company (Pty) Ltd | Gulf cetirizine | 10 | 410555 | Not determined | None |
| Oethmaan Biosims (Pty) Ltd | Sensahist, Zinallerg | Not stated | 420822, 430359 | Not determined | None |
| Shanur Healthcare (Pty) Ltd | Cetirizine shanur | 10 | 430358 | Not determined | None |
| Aurogen South Africa (Pty) LtdCertificate held by Aurogen Southafrica (Pty) Ltd | AURO cetirizine, Trantrin | 5 mg, 10 mg | 430643, 430644, 430645, 430646 | S2 | PIPIL |
| Forrester Pharma (Pty) Ltd | Allesoothe | 10 mg | 481197 | S2 | PIPIL |
| Hetero Drugs South Africa (Pty) Ltd | Zialdel, Derasip | 5 mg/5 ml | 530404, 530405.404 | Not determined | None |
| Pharmacorp (Pty) Ltd | Cetriliqe | Not stated | 580260 | Not determined | None |
| Unimed Healthcare (Pty) Ltd | Cetirizine unimed | oral solution, 10 | A390103, A390384 | Not determined | None |
| Glaxosmithkline South Africa (Pty) Limited | Zyrtec | 10 mg | W0148 | Not determined | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Zetop EACH TABLET CONTAINS CETIRIZINE DIHYDROCHLORIDE 10,0 mg | Not listed | 32037432/5.7.1/0374 | Registered | Not determined | None |
| Zetop syrup EACH 1,0 ml SYRUP CONTAINS CETIRIZINE DIHYDROCHLORIDE 1,0 mg | Syrup | 33003033/5.7.1/0030 | Registered | Not determined | None |
| Sinutab sinus allergy EACH TABLET CONTAINS CETIRIZINE DIHYDROCHLORIDE 10,0 mg | Not listed | 35029635/5.7.1/0296 | Registered | Not determined | None |
| Verlix oral drops 10 mg/ml EACH 1,0 ml SOLUTION CONTAINS CETIRIZINE DIHYDROCHLORIDE 10,0 mg | 10 mg/MLOral drops | 35029735/5.7.1/0297 | Cancelled | Not determined | None |
| Sinutab sinus allergy solution EACH 1,0 ml SOLUTION CONTAINS CETIRIZINE DIHYDROCHLORIDE 1,0 mg | Solution | 35029835/5.7.1/0298 | Registered | Not determined | None |
| Texa allergy tablets EACH TABLET CONTAINS CETIRIZINE HYDROCHLORIDE 10,0 mg | Tablets | 35031435/5.7.1/0314 | Registered | Not determined | None |
| Adco cetirizine tablets EACH TABLET CONTAINS CETIRIZINE DIHYDROCHLORIDE 10,0 mg | Tablets | 36036836/5.7.1/0368 | Cancelled | Not determined | None |
| Ceticit syrup EACH 1,0 ml SYRUP CONTAINS CETIRIZINE DIHYDROCHLORIDE 1,0 mg | 1 mg/1 mLOral syrup | 36036936/5.7.1/0369Approved 20 February 2024 | Registered | Not determined | PIPIL |
| Allermine tablets EACH TABLET CONTAINS CETIRIZINE DIHYDROCHLORIDE 10,0 mg | 10 mgTablet | 36038836/5.7.1/0388Approved 14 August 2025 | Registered | S2 | PIPIL |
| Allecet EACH TABLET CONTAINS CETIRIZINE DIHYDROCHLORIDE 10,0 mg | 10,0 mgFilm-coated tablets | 37003437/5.7.1/0034Approved 28 October 2024 | Registered | S1 | PIPIL |
| Acuzyrt tablets EACH TABLET CONTAINS CETIRIZINE DIHYDROCHLORIDE 10,0 mg | Tablets | 37007237/5.7.1/0072 | Cancelled | Not determined | None |
| Seasoneze EACH TABLET CONTAINS CETIRIZINE DIHYDROCHLORIDE 10,0 mg | 10 mgFilm-coated tablets. | 37008637/5.7.1/0086Approved 19 February 2025 | Registered | S1 | PIPIL |
| Acuzyrt syrup EACH 5,0 ml SYRUP CONTAINS CETIRIZINE DIHYDROCHLORIDE 5,0 mg | 1 mLSyrup | 37015237/5.7.1/0152Approved 28 February 2024 | Registered | S1 | PIPIL |
| Allecet syrup EACH 5,0 ml SYRUP CONTAINS CETIRIZINE DIHYDROCHLORIDE 5,0 mg | 1 mLSyrup | 37015337/5.7.1/0153Approved 28 February 2024 | Registered | S1 | PIPIL |
| Zelary 10 EACH TABLET CONTAINS CETIRIZINE DIHYDROCHLORIDE 10,0 mg | 10 mgFilm-coated tablets | 37042837/5.7.1/0428Approved 18 October 2024 | Registered | S1 | PIPIL |
| Aspen cetirizine 10 MG EACH TABLET CONTAINS CETIRIZINE DIHYDROCHLORIDE 10,0 mg | 10 mg | 37049037/5.7.1/0490 | Cancelled | Not determined | None |
| Atrizin 10 EACH TABLET CONTAINS CETIRIZINE DIHYDROCHLORIDE 10,0 mg | 10 mgTablets | 37049737/5.7.1/0497Approved 3 February 2021 | Registered | S2 | PIPIL |
| Austell cetirizine 5 MG EACH TABLET CONTAINS CETIRIZINE DIHYDROCHLORIDE 5,0 mg | 5 mg | 37057937/5.7.1/0579 | Registered | Not determined | None |
| Cetirizine 5 MG austell EACH TABLET CONTAINS: CETIRIZINE DIHYDROCHLORIDE 5,0 mg | 5 mg | 37057937/5.7.1/0579 | Registered | Not determined | None |
| Austell cetirizine 10 MG EACH TABLET CONTAINS :CETIRIZINE DIHYDROCHLORIDE 10,0 mg | 10 mg | 37058037/5.7.1/0580 | Registered | Not determined | None |
| Zyncet EACH TABLET CONTAINS CETIRIZINE DIHYDROCHLORIDE 10,0 mg | 10 mgFilm-coated tablets | 37065137/5.7.1/0651Approved 31 May 2024 | Registered | S1 | PIPIL |
| Zelary syrup EACH 1,0 ml SYRUP CONTAINS CETIRIZINE DIHYDROCHLORIDE 1,0 mg | Syrup | 41008541/7.5.1/0085 | Registered | Not determined | None |
| Texa allergy syrup EACH 1,0 ml SYRUP CONTAINS CETIRIZINE DIHYDROCHLORIDE 1,0 mg | Syrup | 41008641/5.7.1/0086 | Registered | Not determined | None |
| Sinutab sinus allergy effervescent EACH EFFERVESCENT TABLET CONTAINS CETIRIZINE DIHYDROCHLORIDE 10,0 mg | Effervescent | 41042041/5.7.1/0420 | Registered | Not determined | None |
| Reactyne effervescent EACH EFFERVESCENT TABLET CONTAINS CETIRIZINE DIHYDROCHLORIDE 10,0 mg | Effervescent | 41042641/5.7.1/0426 | Cancelled | Not determined | None |
| Gulf cetirizine 10 EACH TABLET CONTAINS CETIRIZINE DIHYDROCHLORIDE 10,0 mg | 10 | 41055541/5.7.1/0555 | Registered | Not determined | None |
| Aspen cetirizine 1 mg/ml EACH 1,0 ml SOLUTION CONTAINS CETIRIZINE DIHYDROCHLORIDE 1,0 mg | 1 mg/ml | 42014342/5.7.1/0143 | Cancelled | Not determined | None |
| Ceticit EACH TABLET CONTAINS CETIRIZINE DIHYDROCHLORIDE 10,0 mg | 10mgFilm-coated tablets | 42082142/5.7.1/0821Approved 20 February 2024 | Registered | Not determined | PIPIL |
| Sensahist EACH TABLET CONTAINS CETIRIZINE DIHYDROCHLORIDE 10,0 mg | Not listed | 42082242/5.7.1/0822 | Registered | Not determined | None |
| Cetirizine 10 shanur EACH TABLET CONTAINS :CETIRIZINE DIHYDROCHLORIDE 10,0 mg | 10 | 43035843/5.7.1/0358 | Registered | Not determined | None |
| Zinallerg EACH TABLET CONTAINS CETIRIZINE DIHYDROCHLORIDE 10,0 mg | Not listed | 43035943/5.7.1/0359 | Registered | Not determined | None |
| AURO cetirizine tablets 5 MG EACH TABLET CONTAINS CETIRIZINE DIHYDROCHLORIDE 5,0 mg | 5 mgFilm-coated tablet | 43064343/5.7.1/0643Approved 3 November 2022 | Registered | S2 | PIPIL |
| AURO cetirizine tablets 10 MG EACH TABLET CONTAINS CETIRIZINE DIHYDROCHLORIDE 10,0 mg | 10 mgFilm-coated tablet | 43064443/5.7.1/0644Approved 3 November 2022 | Registered | S2 | PIPIL |
| Trantrin tablets 5 MG EACH TABLET CONTAINS CETIRIZINE DIHYDROCHLORIDE 5,0 mg | 5 mgTablets | 43064543/5.7.1/0645 | Registered | Not determined | None |
| Trantrin tablets 10 MG EACH TABLET CONTAINS CETIRIZINE DIHYDROCHLORIDE 10,0 mg | 10 mgTablets | 43064643/5.7.1/0646 | Registered | Not determined | None |
| Allesoothe EACH TABLET CONTAINS CETIRIZINE DIHYDROCHLORIDE EQUIVALENT TO CETIRIZINE 10,0 mg | 10 mgFilm-coated tablets. | 48119748/5.7.1/1197Approved 27 February 2025 | Registered | S2 | PIPIL |
| Zialdel 5 mg/5 ML oral solution EACH 5,0 ml SOLUTION CONTAINS CETIRIZINE DIHYDROCHLORIDE 5,0 mg | 5 mg/5 mlOral solution | 53040453/5.7.1/0404 | Registered | Not determined | None |
| Derasip 5 mg/5 ML oral solution EACH 5,0 ml SOLUTION CONTAINS CETIRIZINE DIHYDROCHLORIDE 5,0 mg | 5 mg/5 mlOral solution | 530405.40453/5.7.1/0405.404 | Registered | Not determined | None |
| Cetriliqe EACH TABLET CONTAINS: CETIRIZINE HYDROCHLORIDE 10,0 mg | Not listed | 58026058/5.7.1/0260 | Registered | Not determined | None |
| Cetirizine oral solution unimed EACH 1,0 ml SOLUTION CONTAINS CETIRIZINE DIHYDROCHLORIDE 1,0 mg | Oral solution | A390103A39/5.7.1/0103 | Registered | Not determined | None |
| Cetirizine 10 unimed EACH TABLET CONTAINS CETIRIZINE DIHYDROCHLORIDE 10,0 mg | 10 | A390384A39/5.7.1/0384 | Registered | Not determined | None |
| Zyrtec tablet 10 MG EACH TABLET CONTAINS CETIRIZINE DIHYDROCHLORIDE 10 mg | 10 mgTablet | W0148W/5.7.1/148 | Registered | Not determined | None |
Regulatory status
Where S2 sits on the scale
A pharmacist can sell it directly, without a prescription.
Schedule 2 medicines sit behind the pharmacy counter. A pharmacist can decide to sell one of these directly, using their own professional judgement, without a doctor's prescription. It can also be dispensed against a prescription like the higher tiers, in which case the usual repeat limits apply. A child under 12 may only be sold a Schedule 2 substance on a prescription, or on a written order that names the purpose and carries a signature the seller recognises. Even though it cannot be advertised to the public in the ordinary sense, its price, name, pack size and strength can still be told to the public, as long as nothing links it to what it treats.
Schedule S2, read from the product's PI-PIL leaflet.
The Consolidated Schedules list this ingredient up to S1; the leaflet's S2 applies to this product.
Who may supply: Only a pharmacist, pharmacist intern or supervised pharmacist's assistant may sell it without a prescription. It may otherwise be dispensed by a pharmacist against a written or verbal prescription from an authorised prescriber; a veterinarian, who may also prescribe, compound or dispense it directly; a medical practitioner or dentist, who may prescribe it and may compound or dispense it directly only if licensed under section 22C(1)(a); and, for animal treatment, a person practising a para-veterinary profession, on a veterinarian's written or verbal instruction.
Consolidated Schedules listings for Cetirizine dihydrochloride
S1: Cetirizine
Consolidated Schedules 06 July 2026, line 318
Pharmacological class: Antihistaminics. (class 5.7.1)
5 of 11 approved products with this ingredient carry S2 on their leaflet.
This is an informational summary of the Medicines and Related Substances Act 101 of 1965 and its 2017 General Regulations. It is not medical advice and not legal advice. Always check the medicine's label, which carries the schedule number inside a square border, or ask a pharmacist if you are unsure.
SAHPRA documents
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.