Nystatin

Sold as Adco-nystatin, Adco-nystatin vaginal, Candacide, Canstat, Canstat vaginal, Canstat topical, Nystacid

S2Read from the PI-PIL document and verified

No structure available

This product's active ingredient could not be matched to a single known compound.

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Registration

Applicants: 3
Registrations: 10
Schedule source: SAHPRA documentation

Applicants and registrations

Applicant	Brands	Dosages	Registrations	Schedule	Leaflets
Adcock ingram limitedCancelled	Adco-nystatin, Adco-nystatin vaginal	suspension, tablets, cream	270389, 280323, 280337	Not determined	None
Ranbaxy Pharmaceutical (Pty) Ltd	Candacide	100 000 iu per ml	310288	S2	PI PIL
Pharmacare limited û woodmead1 of 6 cancelled	Canstat, Canstat vaginal, Canstat topical, Nystacid	000 u 500, 000 U 100, suspension, ointment, oral suspension	D0169, D0170, D0171, F0158, L0394, R0316	Not determined	None

Variants

Product	Strength and form	Registration	Status	Schedule	Leaflets
Adco-nystatin suspension EACH 1 ml SUSPENSION CONTAINS NYSTATIN 20 mg	Suspension	27038927/20.1.7/0389	Cancelled	Not determined	None
Adco-nystatin vaginal tablets EACH TABLET CONTAINS NYSTATIN 20 mg	Tablets	28032328/18.6/0323	Cancelled	Not determined	None
Adco-nystatin vaginal cream EACH 4 g CREAM CONTAINS NYSTATIN 23 mg	Cream	28033728/18.6/0337	Cancelled	Not determined	None
Candacide oral suspension EACH 1,0 ml SUSPENSION CONTAINS NYSTATIN 100 000 u	100 000 iu per mlSuspension	31028831/20.1.7/0288Approved 24 January 2022	Registered	S2	PI PIL
Canstat oral tablet 500 000 u/tablet EACH TABLET CONTAINS NYSTATIN 500 000 UNITS	000 u 500Oral tablet /tablet	D0169D/20.1.7/169	Cancelled	Not determined	None
Canstat vaginal tablets 100 000 u/tablet EACH TABLET CONTAINS NYSTATIN 100 000 UNITS	000 U 100Tablets /tablet	D0170D/20.1.7/170	Registered	Not determined	None
Canstat suspension EACH 1 ml SUSPENSION CONTAINS NYSTATIN 100 000 UNITS	Suspension	D0171D/20.1.7/171	Registered	Not determined	None
Canstat topical EACH 1 g CREAM CONTAINS NYSTATIN 100 000 UNITS	Not listed	F0158F/13.9.2/158	Registered	Not determined	None
Nystacid ointment EACH 1 G OINTMENT CONTAINS NYSTATIN 100000 IU	Ointment	L0394L/20.1.6/394	Registered	Not determined	None
Nystacid oral suspension EACH 1 ML SUSPENSION CONTAINS NYSTATIN 100000 IU	Oral suspension	R0316R/20.1.7/316	Registered	Not determined	None

Regulatory status

Where S2 sits on the scale

S0S1S2S3S4S5S6S7S8

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 S4; 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 Nystatin

S4: Nystatin
- when intended for systemic use or the initial treatment of vaginal candidiasis;
- except when presented as oral drops containing not more than 100 000 I.U. per millilitre, (S2)
- 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)
- except when intended and registered as a stock remedy for pigeons in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).
Consolidated Schedules 06 July 2026, lines 7340 to 7356
S2: Nystatin
- when presented as oral drops containing not more than100 000 I.U. per millilitre, and
- 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 systemic use or the initial treatment of vaginal candidiasis, (S4)
- except when intended and registered as a stock remedy for pigeons in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).
Consolidated Schedules 06 July 2026, lines 2438 to 2449
S1: Nystatin
- when intended for application to the skin, and
- when intended for human vaginal use, specifically for the treatment of recurrent vaginal candidiasis, and
- except when presented as oral drops containing not more than 100 000 I.U. per millilitre, (S2)
- except when intended for systemic use or the initial treatment of vaginal candidiasis, (S4)
- except when intended and registered as a stock remedy for pigeons in terms of the provisions of the Fertilizers, Farm Feeds, Agricultural Remedies and Stock Remedies Act, 1947 (Act 36 of 1947).
Consolidated Schedules 06 July 2026, lines 926 to 937

Pharmacological class: Antifungal antibiotics. (class 20.1.7)

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 verified from official documents

Schedule Verification

Candacide oral suspension, Ranbaxy Pharmaceutical (Pty) Ltd is scheduled S2 in its official SAHPRA documents, read with 90% confidence.

Professional information (PI)For healthcare professionalsCandacide oral suspension, Ranbaxy Pharmaceutical (Pty) Ltd Patient information leaflet (PIL)For patients and carersCandacide oral suspension, Ranbaxy Pharmaceutical (Pty) Ltd

These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.

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