Benzocaine
Sold as Orajel mouth, Nitro toothache, Orosoothe
Background
Registration
- Applicants
- 3
- Registrations
- 3
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Alliance Pharma (Pty) Ltd | Orajel mouth | gel | 280163 | Not determined | None |
| Beige Pharmaceuticals (Pty) Ltd | Nitro toothache | drops | H1462 | Not determined | None |
| Pharmacare limited û woodmead | Orosoothe | Not stated | V0073 | Not determined | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Orajel mouth gel EACH 1 g GEL CONTAINS BENZOCAINE 100 mg | Gel | 28016328/4/0163 | Registered | Not determined | None |
| Nitro toothache drops EACH 5 ml CONTAINS BENZOCAINE A 0,05 g | Drops | H1462 | Old Medicine | Not determined | None |
| 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
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
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
SAHPRA has not published a professional information or patient information leaflet for this product.