Benzydamine, cetylpyridinium
Sold as * andolex-c raspberry, Andolex-c, Andolex-c strawberry, Oroflam, Andolex-c honey/lemon, Andolex-c orange, Septolete co, Septolete plus, Andolex, Medi-keel 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
- 3
- Registrations
- 12
- Schedule source
- SAHPRA documentation
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Inova Pharmaceuticals (Pty) Ltd | * andolex-c raspberry, Andolex-c, Andolex-c strawberry, Oroflam, Andolex-c honey/lemon, Andolex-c orange, Andolex | lozenges, oral gel, 0,15/0,05, 3.00 mg | 310042, 330285, 330374, 340445, 350320, 360195, 550286 | Not determined | PIPIL |
| LHC Pharmaceuticals (Pty) Ltd | Septolete co, Septolete plus | lozenge, 1.5mg/5mg/ml | 540837, 540838.837, 560527, 560528.527 | S1 | PIPIL |
| Adcock ingram limitedCancelled | Medi-keel antiseptic and anti-inflammatory throat | spray | A400136 | Not determined | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| * andolex-c lozenges raspberry EACH LOZENGE CONTAINS: BENZYDAMINE HYDROCHLORIDE 3,00 mg, CETYLPYRIDINIUM CHLORIDE 1,33 mg | Lozenges | 31004231/16.4/0042 | Registered | Not determined | None |
| Andolex-c oral gel EACH 10,0 g GEL CONTAINS BENZYDAMINE HYDROCHLORIDE 0,1 g CETYLPYRIDINIUM CHLORIDE 0,01 g | Oral gel | 33028533/16.4/0285 | Registered | Not determined | None |
| Andolex-c lozenges strawberry EACH LOZENGE CONTAINS BENZYDAMINE HYDROCHLORIDE 3,0 mg CETYLPYRIDINIUM CHLORIDE 1,33 mg | Lozenges | 33037433/16.4/0374 | Registered | Not determined | None |
| Oroflam lozenges EACH LOZENGE CONTAINS BENZYDAMINE HYDROCHLORIDE 3,0 mg CETYLPYRIDINIUM CHLORIDE 1,33 mg | 3.00 mgLozenges | 34044534/16.4/0445Approved 5 January 2021 | Registered | Not determined | PIPIL |
| Andolex-c lozenges honey/lemon EACH LOZENGE CONTAINS BENZYDAMINE HYDROCHLORIDE 3,0 mg CETYLPYRIDINIUM CHLORIDE 1,33 mg | Lozenges | 35032035/16.4/0320 | Registered | Not determined | None |
| Andolex-c lozenges orange EACH LOZENGE CONTAINS BENZYDAMINE HYDROCHLORIDE 3,0 mg CETYLPYRIDINIUM CHLORIDE 1,33 mg | Lozenges | 36019536/16.4/0195 | Registered | Not determined | None |
| Septolete co lozenge EACH LOZENGE CONTAINS: BENZYDAMINE HYDROCHLORIDE 3,0 mg CETYLPYRIDINIUM CHLORIDE 1,0 mg | Lozenge | 54083754/16.4/0837 | Registered | Not determined | None |
| Septolete plus lozenge EACH LOZENGE CONTAINS: BENZYDAMINE HYDROCHLORIDE 3,0 mg CETYLPYRIDINIUM CHLORIDE 1,0 mg | Lozenge | 540838.83754/16.4/0838.837 | Registered | Not determined | None |
| Andolex 0,15/0,05 EACH 1,0 ml LIQUID CONTAINS BENZYDAMINE HYDROCHLORIDE 1,5 mg CETYLPYRIDINIUM CHLORIDE 1,34 mg | 0,15/0,05Liquid | 55028655/16.4/0286Approved 30 August 2022 | Registered | Not determined | PIPIL |
| Septolete co EACH 1,0 ml SOLUTION CONTAINS: BENZYDAMINE HYDROCHLORIDE 1,5 mg CETYLPYRIDINIUM CHLORIDE 5,0 mg | 1.5mg/5mg/mlOromucosal spray | 56052756/16.4/0527Approved 10 September 2024 | Registered | S1 | PIPIL |
| Septolete plus spray EACH 1,0 ml SOLUTION CONTAINS: BENZYDAMINE HYDROCHLORIDE 1,5 mg CETYLPYRIDINIUM CHLORIDE 5,0 mg | 1.5mg/5mg/mlOromucosal spray | 560528.52756/16.4/0528.527Approved 10 September 2024 | Old Medicine | Not determined | PIL |
| Medi-keel antiseptic and anti-inflammatory throat spray EACH 15,0 ml SOLUTION CONTAINS BENZYDAMINE HYDROCHLORIDE 22,50 mg CETYLPYRIDINIUM CHLORIDE 7,50 mg | Spray | A400136A40/16.5/0136 | Cancelled | 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.
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.
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.