Benzydamine, chlorhexidine gluconate (Gesoral)
Benzydamine, chlorhexidine gluconate
Pharma Dynamics (Pty) Ltd
Registration
- Applicant
- Pharma Dynamics (Pty) Ltd
- Certificate holder
- Pharma Dynamics (Pty) Ltd
- Registrations
- 1
- Schedule source
- SAHPRA documentation
Variants
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 S3; 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 Benzydamine hydrochloride, and chlorhexidine gluconate
S3: Benzydamine
- except preparations and mixtures-
- containing 3 percent or less of benzydamine, when intended for application to the skin; (S0)
- containing more than 3 percent of benzydamine, but not exceeding 5 percent, when intended for application to the skin; (S1)
- intended for use as a mouth rinse or for topical application in the mouth and throat; provided that the total dose swallowed does not exceed 36 milligrams of benzydamine per day; (S1)
- containing 3 milligrams or less of benzydamine per throat lozenge: Provided that the total dose swallowed does not exceed 36 milligrams of benzydamine per day and the pack size does not exceed 16 lozenges. (S0)
- intended for human vaginal use. (S2)
Consolidated Schedules 06 July 2026, lines 3189 to 3203
S2: Benzydamine
- when intended for human vaginal use; (S3)
- except preparations and mixtures containing 3 percent or less of benzydamine, when intended for application to the skin; (S0)
- except preparations containing more than 3 percent of benzydamine, but not exceeding 5 percent, when intended for application to the skin; (S1)
- except preparations and mixtures intended for use as a mouth rinse or for topical application in the mouth and throat; provided that the total dose swallowed does not exceed 36 milligrams of benzydamine per day; (S1)
- except preparations and mixtures containing 3 milligrams or less of benzydamine per throat lozenge: Provided that the total dose swallowed does not exceed 36 milligrams of benzydamine per day and the pack size does not exceed 16 lozenges. (S0)
Consolidated Schedules 06 July 2026, lines 1660 to 1676
S1: Benzydamine
- preparations and mixtures intended for use as a mouth rinse or for topical application in the mouth and throat; provided that the total dose swallowed does not exceed 36 milligrams of benzydamine per day. (S3)
- preparations containing more than 3 percent of benzydamine, but not exceeding 5 percent, when intended for application to the skin; (S3)
- except preparations and mixtures containing 3 percent or less of benzydamine, when intended for application to the skin; (S0) or
- except preparations and mixtures containing 3 milligrams or less of benzydamine per throat lozenge: Provided that the total dose swallowed does not exceed 36 milligrams of benzydamine per day and the pack size does not exceed 16 lozenges; (S0)
- except when indicated for human vaginal use. (S2)
Consolidated Schedules 06 July 2026, lines 172 to 188
S1: Chlorhexidine
- when intended for human vaginal use.
Consolidated Schedules 06 July 2026, line 320
Pharmacological class: Naso-pharyngeal and bucco-pharyngeal antiseptics. (class 16.4)
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.
Combination product
This product contains more than one active ingredient, so it has no single molecular structure.
SAHPRA documents
Schedule Verification
This medication's schedule (S1) has been verified from official SAHPRA documents with 90% confidence.
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.