Benzocaine, dequalinium
Combination product
This product contains more than one active ingredient, so it has no single molecular structure.
Registration
- Applicants
- 1
- Registrations
- 1
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Pharmacare limited û woodmead | Orosoothe | Not stated | V0073 | Not determined | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Orosoothe EACH LOZENGE CONTAINS BENZOCAINE 10 mg DEQUALINIUM CHLORIDE O,25 mg | Not listed | V0073V/16.4/73 | Registered | Not determined | None |
Regulatory status
This product is still scheduled by law even when this site could not determine which tier it falls under. The label carries the S number in a square border; ask a pharmacist if you need to know its schedule.
Listings for this ingredient that could not be applied to this product
S4: Benzocaine
- when intended for ophthalmic or parenteral use;
- except in lozenges containing 30 milligrams or less of benzocaine, per dosage unit; (S1)
- except when intended for topical use; (S1)
- except in preparations containing 2 percent or less of benzocaine. (S1)
Consolidated Schedules 06 July 2026, lines 5467 to 5475
S2: Dequalinium
- when intended for human vaginal use;
- except when intended for oral topical use, as oral solutions or lozenges (S1)
Consolidated Schedules 06 July 2026, lines 1791 to 1795
S1: Benzocaine
- when intended for topical use;
- in oral preparations containing 2 percent or less of benzocaine;
- in lozenges containing 30 milligrams or less of benzocaine, per dosage unit;
- except when intended for ophthalmic or parenteral use. (S4)
Consolidated Schedules 06 July 2026, lines 156 to 164
S1: Dequalinium
- when intended for oral topical use, as oral solutions or lozenges;
- except when intended for human vaginal use. (S2)
Consolidated Schedules 06 July 2026, lines 359 to 363
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.
Background
SAHPRA documents
SAHPRA has not published a professional information or patient information leaflet for this product.