Benzydamine (Andolex, Andolex Analgesic, Norflex Forte, Norflex, Andolex Alcohol Free, Zidoval Douche)
Benzydamine
Inova Pharmaceuticals (Pty) Ltd
Registration
- Applicant
- Inova Pharmaceuticals (Pty) Ltd
- Registrations
- 8
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Andolex cream EACH 1 g CREAM CONTAINS BENZYDAMINE HYDROCHLORIDE 30,0 mg | Cream | 29009329/3.1/0093 | Registered | Not determined | None |
| Andolex analgesic lozenges EACH LOZENGE CONTAINS BENZYDAMINE HYDROCHLORIDE 3,0 mg | 3 mgLozenges | 31023931/16/0239Approved 10 December 2020 | Registered | Not determined | PIPIL |
| Norflex gel forte EACH 100,0 g GEL CONTAINS BENZYDAMINE HYDROCHLORIDE 5,0 g | Gel | 32039132/3.1/0391 | Registered | Not determined | None |
| Norflex gel EACH 100,0 g GEL CONTAINS BENZYDAMINE HYDROCHLORIDE 3,00 g | Gel | 32054732/3.1/0547 | Registered | Not determined | None |
| Andolex alcohol free EACH 15,0 ml SOLUTION CONTAINS: BENZYDAMINE HYDROCHLORIDE 22,5 mg | Not listed | 51069751/16/0697 | Registered | Not determined | None |
| Andolex analgesic spray Each 15,0 ml solotion contains BENZYDAMINE HYDROCHLORIDE 0,045 g | Spray | 51092451/16.5/0924 | Registered | Not determined | None |
| Zidoval douche EACH BOTTLE CONTAINS BENZYDAMINE HYDROCHLORIDE 140,0 mg | 140,0 mgSolution | 55024355/18.6/0243Approved 13 September 2022 | Registered | Not determined | PIPIL |
| Andolex EACH 15 ml LIQUID CONTAINS BENZYDAMINE HYDROCHLORIDE 22,5 mg | Not listed | Z0040Z/16/40 | 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
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
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.
3-(1-Benzylindazol-3-yl)oxy-N,N-dimethylpropan-1-amine
Drag to rotate. Structure from PubChem CID 12555.
SAHPRA documents
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.