Miconazole
Sold as Gyno-daktarin, Gyno-brentan vc, Covarex, Dermazole, Vari-miconazole m/m, Tibozole, Dak-o-, Oramico, Gyno-daktarin vc, Daktarin, Gynospor vaginal
1-[2-(2,4-Dichlorophenyl)-2-[(2,4-dichlorophenyl)methoxy]ethyl]imidazole
Drag to rotate. Structure from PubChem CID 4189.
Background
Registration
- Applicants
- 7
- Registrations
- 13
- Schedule source
- SAHPRA documentation
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Johnson & Johnson (Pty) Ltd û East LondonCertificate held by Janssen1 of 2 cancelled | Gyno-daktarin, Daktarin | 20mg / 1g, 200 mg 1 | 290349, L0183 | S1 | PIPIL |
| Janssen Pharmaceutica (Pty) LtdCancelled | Gyno-brentan vc, Tibozole, Dak-o-, Gyno-daktarin vc, Daktarin, Gyno-daktarin | dak-o-gel, cream, 200 mg | 290601, 370100, 440932, G0061, G0106, L0368 | Not determined | None |
| Glenmark Pharmaceuticals South Africa (Pty) Ltd | Covarex | Not stated | 330124 | Not determined | None |
| Unimed Healthcare (Pty) Ltd | Dermazole | Not stated | 340182 | Not determined | None |
| Barrs Pharmaceutical Industries (Pty) Ltd | Vari-miconazole m/m | 2 % | 360233 | Not determined | None |
| Lebasi Pharmaceuticals (Pty) Ltd | Oramico | gel | 570035 | Not determined | None |
| Pharmacare limited û woodmeadCancelled | Gynospor vaginal | cream | S0085 | Not determined | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Gyno-daktarin 1 200 MG EACH OVULE CONTAINS MICONAZOLE NITRATE 1 200,0 mg | 200 mg 1 | 29034929/18.6/0349 | Cancelled | Not determined | None |
| Gyno-brentan vc 1 G MICONAZOLE NITRATE 20 MG | Not listed | 29060129/18.6/0601 | Cancelled | Not determined | None |
| Covarex EACH 100,0 g CREAM CONTAINS MICONAZOLE NITRATE 2,0 g | Not listed | 33012433/13.9.2/0124 | Registered | Not determined | None |
| Dermazole EACH 1,0 g CREAM CONTAINS MICONAZOLE NITRATE 20,0 mg | Not listed | 34018234/13.9.2/0182 | Registered | Not determined | None |
| Vari-miconazole 2 % m/m oral gel EACH 1,0 g GEL CONTAINS MICONAZOLE 20,0 mg | 2 %Oral gel | 36023336/20.2.2/0233 | Registered | Not determined | None |
| Tibozole EACH TABLET CONTAINS MICONAZOLE NITRATE 10,0 mg | Not listed | 37010037/20.2.2/0100 | Cancelled | Not determined | None |
| Dak-o-gel EACH 1,0 g GEL CONTAINS MICONAZOLE 20,0 mg | Dak-o-gel | 44093244/20.2.2/0932 | Cancelled | Not determined | None |
| Oramico gel EACH 1,0 g GEL CONTAINS MICONAZOLE 20,0 mg | Gel | 57003557/20.2.2/0035 | Registered | Not determined | None |
| Gyno-daktarin vc* EACH 100 g CREAM CONTAINS MICONAZOLE 2 g | Not listed | G0061G/18.6/61 | Cancelled | Not determined | None |
| Daktarin cream* EACH 1 g CREAM CONTAINS MICONAZOLE NITRATE 20 mg | Cream | G0106G/13.9.2/106 | Cancelled | Not determined | None |
| Daktarin 2% EACH g CONTAINS MICONAZOLE 20 mg | 20mg / 1gCream | L0183L/20.2.2/183Approved 25 November 2011 | Registered | S1 | PIPIL |
| Gyno-daktarin 200 MG EACH VAGINAL CAPSULE CONTAINS MICONAZOLE NITRATE 200 mg | 200 mg | L0368L/18.6/368 | Cancelled | Not determined | None |
| Gynospor vaginal cream EACH 1 g CREAM CONTAINS MICONAZOLE NITRATE 20 mg | Cream | S0085S/18.6/85 | Cancelled | 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 S4; 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 Miconazole
S4: Miconazole
- except when intended for application to the skin; (S1) and
- except when intended for human vaginal use, specifically for the treatment of recurrent vaginal candidiasis; (S1) and
- except when intended for human use in preparations containing 2 per cent or less of miconazole, when intended for the topical treatment of fungal infections of the mouth (oral candidiasis). (S2)
Consolidated Schedules 06 July 2026, lines 7125 to 7130
S2: Miconazole
- when intended for human use in preparations containing 2 percent or less of miconazole, for the topical treatment of fungal infections of the mouth (oral candidiasis). (S1, S4)
Consolidated Schedules 06 July 2026, lines 2347 to 2348
S1: Miconazole
- when intended for human vaginal use specifically for the treatment of recurrent vaginal candidiasis; (S4) and
- when intended for application to the skin. (S4)
- except for topical treatment of fungal infections of the mouth. (S2)
Consolidated Schedules 06 July 2026, lines 838 to 851
Pharmacological class: Fungicides. (class 20.2.2)
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
Daktarin 2%, Johnson & Johnson (Pty) Ltd û East London 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.