Xylometazoline
Sold as Otrivin menthol, Sinutab adult nasal, Sinutab children's nasal, Nazovin adult metered-dose, Nazovin adult nasal, Nazovin paediatric nasal, Zylovin, Xykleer, Nasylo, Otrivin paed, Otrivin adult, Sine-off hour, Sinutab nasal
2-[(4-tert-Butyl-2,6-dimethylphenyl)methyl]-4,5-dihydro-1H-imidazole
Drag to rotate. Structure from PubChem CID 5709.
Background
Registration
- Applicants
- 7
- Registrations
- 13
- Schedule source
- SAHPRA documentation
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Haleon South Africa (Pty) Ltd | Otrivin menthol, Otrivin paed, Otrivin adult | Not stated | 310319, H1381, H1382 | Not determined | None |
| Johnson & Johnson (Pty) Ltd û East London | Sinutab adult nasal, Sinutab children's nasal, Sinutab nasal | spray | 460127, 460128, P0184 | Not determined | None |
| Cipla Medpro (Pty) Ltd | Nazovin adult metered-dose, Nazovin paediatric nasal | spray, drops | 460311, 460854 | Not determined | None |
| Actor Pharma (Pty) Ltd - ApplicantCancelled | Nazovin adult nasal | drops | 460853 | Not determined | None |
| Lamar International (Pty) Ltd | Zylovin, Nasylo | 1 mg/mL | 510735, 600542 | S1 | PIPIL |
| Pharma Dynamics (Pty) Ltd | Xykleer | Not stated | 590513 | Not determined | None |
| Pharmacare limited û woodmeadCancelled | Sine-off hour | 12 | L0174 | Not determined | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Otrivin menthol EACH 1 ml CONTAINS: XYLOMETAZOLINE HYDROCHLORIDE 1,0 mg | Not listed | 31031931/16.1/0319 | Registered | Not determined | None |
| Sinutab adult nasal spray EACH 1,0 ml SOLUTION CONTAINS XYLOMETAZOLINE HYDROCHLORIDE 1,0 mg | Spray | 46012746/16.1/0127 | Registered | Not determined | None |
| Sinutab children's nasal spray EACH 1,0 ml SOLUTION CONTAINS XYLOMETAZOLINE HYDROCHLORIDE 0,5 mg | Spray | 46012846/16.1/0128 | Registered | Not determined | None |
| Nazovin adult metered-dose spray EACH 1,0 ml SOLUTION CONTAINS :XYLOMETAZOLINE HYDROCHLORIDE 1,0 mg | Spray | 46031146/16.1/0311 | Registered | Not determined | None |
| Nazovin adult nasal drops EACH 1,0 ml SOLUTION CONTAINS : XYLOMETAZOLINE HYDROCHLORIDE 1,0 mg | Drops | 46085346/16.1/0853 | Cancelled | Not determined | None |
| Nazovin paediatric nasal drops EACH 1,0 ml SOLUTION CONTAINS :XYLOMETAZOLINE HYDROCHLORIDE 0,5 mg | Drops | 46085446/16.1/0854 | Registered | Not determined | None |
| Zylovin Each 1 ml contains XYLOMETAZOLINE HYDROCHLORIDE EQUIVALENT TO XYLOMETAZOLINE 1,0 mg | 1 mg/mLNasal spray | 51073551/16.1/0735Approved 19 July 2022 | Registered | S1 | PIPIL |
| Xykleer EACH 1,0 ml SOLUTION CONTAINS: XYLOMETAZOLINE HYDROCHLORIDE 1,0 mg | Not listed | 59051359/16.1/0513 | Registered | Not determined | None |
| Nasylo EACH 1,0 ml VIAL CONTAINS XYLOMETAZOLINE HYDROCHLORIDE EQUIVALENT TO XYLOMETAZOLINE 1,0 mg | Not listed | 60054260/16.1/0542 | Registered | Not determined | None |
| Otrivin paed EACH 1 ml CONTAINS: XYLOMETAZOLINE HYDROCHLORIDE 0,5 mg | Not listed | H1381H/16.1/1381 | Registered | Not determined | None |
| Otrivin adult EACH 1 ml CONTAINS: XYLOMETAZOLINE HYDROCHLORIDE 1,0 mg | Not listed | H1382H/16.1/1382 | Registered | Not determined | None |
| Sine-off 12 hour spray EACH 30 ml CONTAINS XYLOMETAZOLINE HYDROCHLORIDE 30 mg | 12Spray | L0174L/16.1/174 | Cancelled | Not determined | None |
| Sinutab nasal spray EACH 1 ml SOLUTION CONTAINS XYLOMETAZOLINE HYDROCHLORIDE 1 mg | Spray | P0184P/16.1/184 | Registered | Not determined | None |
Regulatory status
Where S1 sits on the scale
Sold by a pharmacist, no doctor's prescription needed.
Schedule 1 medicines are normally sold by a pharmacist, or by a supervised pharmacist intern or assistant, without a doctor's visit; a veterinarian, or a licensed dispensing doctor, dentist or nurse prescriber, may also supply them. A nurse or other non-doctor prescriber may only prescribe the specific substances the Schedule names for that purpose, and may only dispense them if licensed to do so. A child under 12 may only be sold one of these medicines on a prescription, or on a written order that names the purpose and carries a signature the seller recognises.
Schedule S1, read from the product's PI-PIL leaflet.
The Consolidated Schedules list this ingredient up to S2; the leaflet's S1 applies to this product.
Who may supply: A pharmacist, or a supervised pharmacist intern or assistant; manufacturers and wholesalers supplying people who may lawfully possess it; a veterinarian, who may prescribe, compound or dispense it; a medical practitioner or dentist, who may prescribe it, and may compound or dispense it only if licensed under section 22C(1)(a); a nurse or other registered non-doctor prescriber, who may prescribe only the Scheduled substances the Schedule identifies for that purpose, and dispense them if licensed to do so; and, for animal treatment, a person practising a para-veterinary profession, on a veterinarian's written or verbal instruction.
Consolidated Schedules listings for Xylometazoline hydrochloride equivalent to xylometazoline
S2: Xylometazoline
- except when intended for nasal use.
Consolidated Schedules 06 July 2026, line 2767
S1: Xylometazoline
- when intended for nasal use.
Consolidated Schedules 06 July 2026, line 1211
Pharmacological class: Nasal decongestants. (class 16.1)
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
Schedule Verification
Zylovin, Lamar International (Pty) Ltd is scheduled S1 in its official SAHPRA documents, read with 90% confidence.
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.