Benzydamine, chlorhexidine gluconate
Sold as Andolex-c rinse, Oranix, Throflam-co, Gesoral, Chlorzyd antiseptic throat gargle, Chlorzyd anttiseptic throat, Cepacol plus mouthwash, Cepacol plus throat, Medi-keel c antiseptic and anti-inflammatory mouthwash, Medi-keel c antiseptic and anti-inflammatory throat
Combination product
This product contains more than one active ingredient, so it has no single molecular structure.
Background
Registration
- Applicants
- 5
- Registrations
- 10
- Schedule source
- SAHPRA documentation
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Inova Pharmaceuticals (Pty) LtdCertificate held by Inova Pharmaceutical (Pty) Ltd | Andolex-c rinse, Oranix | oral, 22.5 mg/18 mg | 310143, 340391 | Not determined | PIPIL |
| Pharmacare limited û woodmeadCertificate held by Pharmacare limited | Throflam-co | 15 ml | 410190 | Not determined | PIPIL |
| Pharma Dynamics (Pty) Ltd | Gesoral | 15 ml | 480942 | S1 | PIPIL |
| Unicorn Pharmaceuticals (Pty) Ltd | Chlorzyd antiseptic throat gargle, Chlorzyd anttiseptic throat | spray | 530606, 530607 | Not determined | None |
| Adcock ingram limited1 of 4 cancelled | Cepacol plus mouthwash, Cepacol plus throat, Medi-keel c antiseptic and anti-inflammatory mouthwash, Medi-keel c antiseptic and anti-inflammatory throat | spray | A390623, A390624, A390626, A390628 | Not determined | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Andolex-c oral rinse EACH 15,0 ml SOLUTION CONTAINS BENZYDAMINE HYDROCHLORIDE 22,5 mg CHLORHEXIDINE GLUCONATE 18,00 mg | Oral | 31014331/16.4/0143 | Registered | Not determined | None |
| Oranix EACH 15,0 ml SOLUTION CONTAINS BENZYDAMINE HYDROCHLORIDE 22,5 mg CHLORHEXIDINE GLUCONATE 18,0 mg | 22.5 mg/18 mgSolutions. | 34039134/16.4/0391Approved 18 October 2021 | Registered | Not determined | PIPIL |
| Throflam-co EACH 15,0 ml SOLUTION CONTAINS BENZYDAMINE HYDROCHLORIDE 22,50 mg CHLORHEXIDINE GLUCONATE 18,0 mg | 15 mlSolution | 41019041/16/0190Approved 18 April 2008 | Registered | Not determined | PIPIL |
| Gesoral oral spray Each 15 ml oral spray solution contains BENZYDAMINE HYDROCHLORIDE 22,5 mg and CHLORHEXIDINE GLUCONATE 18,0 mg | 15 mlOral spray. | 48094248/16.4/0942Approved 3 March 2025 | Registered | S1 | PIPIL |
| Chlorzyd antiseptic throat gargle EACH 15,0 ml SOLUTION CONTAINS BENZYDAMINE HYDROCHLORIDE 22,0 mg CHLORHEXIDINE GLUCONATE 18,0 mg | Not listed | 53060653/16.4/0606 | Registered | Not determined | None |
| Chlorzyd anttiseptic throat spray EACH 30,0 ml SOLUTION CONTAINS BENZYDAMINE HYDROCHLORIDE 45,0 mg CHLORHEXIDINE GLUCONATE 36,0 mg | Spray | 53060753/16.4/0607 | Registered | Not determined | None |
| Cepacol plus mouthwash EACH 15,0 ml SOLUTION BENZYDAMINE HYDROCHLORIDE 22,50 mg CHLORHEXIDINE GLUCONATE 18,0 mg | Not listed | A390623A39/16.4/0623 | Cancelled | Not determined | None |
| Cepacol plus throat spray EACH 15,0 ml SOLUTION CONTAINS BENZYDAMINE HYDROCHLORIDE 22,50 mg CHLORHEXIDINE GLUCONATE 18,0 mg | Spray | A390624A39/16.4/0624 | Registered | Not determined | None |
| Medi-keel c antiseptic and anti-inflammatory mouthwash EACH 15,0 ml SOLUTION CONTAINS BENZYDAMINE HYDROCHLORIDE 22,50 mg CHLORHEXIDINE GLUCONATE 18,0 mg | Not listed | A390626A39/16.4/0626 | Registered | Not determined | None |
| Medi-keel c antiseptic and anti-inflammatory throat spray EACH 15,0 ml SOLUTION CONTAINS BENZYDAMINE HYDROCHLORIDE 22,50 mg CHLORHEXIDINE GLUCONATE 18,0 mg | Spray | A390628A39/16.4/0628 | 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 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.
SAHPRA documents
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.