Hydroxyzine
Sold as Neurax, Pharma-q hydroxyzine, Hydroxyzine equity, Aterax
2-[2-[4-[(4-Chlorophenyl)-phenylmethyl]piperazin-1-yl]ethoxy]ethanol
Drag to rotate. Structure from PubChem CID 3658.
Background
Registration
- Applicants
- 5
- Registrations
- 9
- Schedule source
- Consolidated Schedules 06 July 2026
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Unimed Healthcare (Pty) Ltd | Neurax | Not stated | 290003 | S5 | None |
| Pharma-q Holdings (Pty) Ltd | Pharma-q hydroxyzine | 100 mg/2 ml | 310070 | S5 | None |
| Equity Pharmaceutical (Pty) Ltd | Hydroxyzine equity | 25 | 560508 | S5 | None |
| Glaxosmithkline South Africa (Pty) Limited | Aterax | 100 mg/2 ml, syrup, 25 mg, 100 mg | B0784, B0785, B0787, B0788 | S5 | None |
| Ucb SA (Pty) Ltd | Aterax | 10MG, drops | B0786, B0797 | S5 | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Neurax EACH 2 ml SOLUTION CONTAINS HYDROXYZINE HYDROCHLORIDE 100 mg | Not listed | 29000329/2.6.3/0003 | Registered | S5 | None |
| Pharma-q hydroxyzine injection 100 mg/2 ML EACH 2 ml SOLUTION CONTAINS HYDROXYZINE HYDROCHLORIDE 100 mg | 100 mg/2 mlInjection | 31007031/2.6.3/0070 | Registered | S5 | None |
| Hydroxyzine 25 equity EACH TABLET CONTAINS HYDROXYZINE HYDROCHLORIDE 25,0 mg | 25 | 56050856/2.6.3/0508 | Registered | S5 | None |
| Aterax 100 mg/2 ML EACH 2,0 ml SOLUTION CONTAINS HYDROXYZINE HYDROCHLORIDE A 100,0 mg | 100 mg/2 ml | B0784 | Old Medicine | S5 | None |
| Aterax syrup EACH 5,0 ml SYRUP CONTAINS HYDROXYZINE HYDROCHLORIDE A 10,0 mg | Syrup | B0785 | Old Medicine | S5 | None |
| Aterax 10mg TABLET HYDROXYZINE HYDROCHLORIDE A 10 MG | 10MG | B0786 | Old Medicine | S5 | None |
| Aterax 25 MG EACH TABLET CONTAINS HYDROXYZINE HYDROCHLORIDE A 25,0 mg | 25 mg | B0787 | Old Medicine | S5 | None |
| Aterax 100 MG EACH TABLET CONTAINS HYDROXYZINE HYDROCHLORIDE A 100,0 mg | 100 mg | B0788 | Old Medicine | S5 | None |
| Aterax drops 1 ML HYDROXYZINE HYDROCHLORIDE A 7,48 MG | Drops | B0797 | Old Medicine | S5 | None |
Regulatory status
Where S5 sits on the scale
Prescription-only, with tighter controls on repeats.
Schedule 5 medicines need a prescription, and repeat dispensing is capped at six months in total; the prescriber must state upfront how many times, and at what intervals, it may be repeated. Extra limits apply to some uses: if it is being used for its anxiolytic, antidepressant, tranquillising or analgesic properties, it cannot be prescribed for longer than six months without a further consultation. 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 S5, matched to the Consolidated Schedules by ingredient, confidence high.
Who may supply: A pharmacist dispensing 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); manufacturers and wholesalers may supply people who may lawfully possess it.
Consolidated Schedules listings for Hydroxyzine hydrochloride
S5: Hydroxyzine
Consolidated Schedules 06 July 2026, line 9485
Pharmacological class: Diphenylmethane and its derivatives. (class 2.6.3)
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
SAHPRA has not published a professional information or patient information leaflet for this product.