Minoxidil
Sold as Loniten, Regaine
3-Hydroxy-2-imino-6-piperidin-1-ylpyrimidin-4-amine
Drag to rotate. Structure from PubChem CID 4201.
Background
Registration
- Applicants
- 2
- Registrations
- 4
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Pfizer Laboratories (Pty) Ltd | Loniten | 5 mg, 10 mg | N0165, N0166 | Not determined | None |
| Johnson & Johnson (Pty) Ltd û East LondonCancelled | Regaine | gel | U0140, Y0031 | Not determined | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Loniten 5 MG EACH TABLET CONTAINS MINOXIDIL 5 mg | 5 mg | N0165N/7.1/165 | Registered | Not determined | None |
| Loniten 10 MG EACH TABLET CONTAINS MINOXIDIL 10 mg | 10 mg | N0166N/7.1/166 | Registered | Not determined | None |
| Regaine EACH 1 ml SOLUTION CONTAINS MINOXIDIL 20 mg | Not listed | U0140U/13.4.2/140 | Cancelled | Not determined | None |
| Regaine gel EACH 1,0 g GEL CONTAINS MINOXIDIL 20,0 mg | Gel | Y0031Y/13.4.2/31 | Cancelled | Not determined | None |
Regulatory status
This product is still scheduled by law even when this site could not determine which tier it falls under. The label carries the S number in a square border; ask a pharmacist if you need to know its schedule.
Listings for this ingredient that could not be applied to this product
S4: Minoxidil
- exept when intended for application to the scalp in preparations containing not more than 2 percent (m/v) and which are registered in terms of the Act. (S2)
Consolidated Schedules 06 July 2026, lines 7148 to 7149
S2: Minoxidil
- when intended for application to the scalp in preparations containing not more than 2 percent (m/v) and which are registered in terms of the Act. (S4)
Consolidated Schedules 06 July 2026, lines 2350 to 2351
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.