Benzydamine
3-(1-Benzylindazol-3-yl)oxy-N,N-dimethylpropan-1-amine
Drag to rotate. Structure from PubChem CID 12555.
Background
Listing
- Schedules
- Schedule 1 to 3, conditions apply
- Exceptions reach
- Schedule 0
- Source
- Consolidated Schedules 06 July 2026
Registered medicines
2 registered products listed
Counted through the register's ingredient index, which does not reach every record.
| Name | Brands | Dosages | Applicants | Registrations | Schedule |
|---|---|---|---|---|---|
| Benzydamine | Andolex, Andolex analgesic, Norflex forte, +8 more | cream, 3 mg, gel, spray, +1 more | 3 applicants | 13 registrations | S1 to S3conditions apply |
| Benzydamine, chlorhexidine gluconate | Andolex-c rinse, Oranix, Throflam-co, +7 more | oral, 15 ml, 22.5 mg/18 mg, spray | 5 applicants | 10 registrations | S1 |
1 more registered product name Benzydamine in their active ingredient
| Name | Brands | Dosages | Applicants | Registrations | Schedule |
|---|---|---|---|---|---|
| Benzydamine, cetylpyridinium | * andolex-c raspberry, Andolex-c, Andolex-c strawberry, +7 more | lozenges, oral gel, 3.00 mg, lozenge, +3 more | 3 applicants | 12 registrations | S1 |
Regulatory status
Where S1 to S3 sits on the scale
Depends on which listing applies
At the least restrictive, Schedule 1: sold by a pharmacist, no doctor's prescription needed. At the most restrictive, Schedule 3: needs a doctor's prescription, dispensed by a pharmacist. The listings below say which applies to which form, strength or pack size.
Schedule S1 to S3, as the Consolidated Schedules list it.
Who may supply: A pharmacist dispensing 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); manufacturers and wholesalers may supply people who may lawfully possess it; and, for animal treatment, a person practising a para-veterinary profession, on a veterinarian's written or verbal instruction.
Consolidated Schedules listings for Benzydamine
S3: Benzydamine
- except preparations and mixtures-
- except containing 3 percent or less of benzydamine, when intended for application to the skin; (S0)
- except containing more than 3 percent of benzydamine, but not exceeding 5 percent, when intended for application to the skin; (S1)
- except 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 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 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
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.