Ammonium chloride, diphenhydramine
Sold as Expectalin* liquid, Benylin original sugar and alcohol free, Diphal expectorant, Pulmocure, Lennamine expectorant, Benylin original, Beramin, Histodor expectorant, Elixirol, Ilvico expectorant, Norstan-diphenhydramine expectorant, Mediphen, Tusquit, Medipax
Combination product
This product contains more than one active ingredient, so it has no single molecular structure.
Background
Registration
- Applicants
- 10
- Registrations
- 14
- Schedule source
- SAHPRA documentation
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Johnson & Johnson (Pty) Ltd û East London | Expectalin* liquid, Benylin original sugar and alcohol free | Not stated | 280248, 340282 | Not determined | None |
| Medicine Developers International (Pty) LtdCertificate held by Mdi Healthcare CC | Diphal expectorant | 5 ml | 460087 | S2 | PIPIL |
| Alliance Pharma (Pty) Ltd | Pulmocure | Not stated | F0154 | Not determined | None |
| Pharmacare limited û woodmead2 of 3 cancelled | Lennamine expectorant, Histodor expectorant, Elixirol | Not stated | G0529, G1222, J0207 | Not determined | None |
| Warner-lambert SA (Pty) Ltd | Benylin original | Not stated | G0829 | Not determined | None |
| Hoechst Marion Roussel Ltd1 of 2 cancelled | Beramin, Norstan-diphenhydramine expectorant | syrup | G1005, L0241 | Not determined | None |
| Procter & Gamble South Africa Trading (Pty) LtdCancelled | Ilvico expectorant | Not stated | J0256 | Not determined | None |
| Brunel Laboratoria (Pty) Ltd | Mediphen | Not stated | P0196 | Not determined | None |
| Unimed Healthcare (Pty) Ltd | Tusquit | elixir | T0044 | Not determined | None |
| The Premier Pharmaceutical Co LtdCancelled | Medipax | Not stated | U0185 | Not determined | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Expectalin* liquid EACH 5 ml LIQUID CONTAINS AMMONIUM CHLORIDE 125 mg DIPHENHYDRAMINE HYDROCHLORIDE 12,5 mg | Not listed | 28024828/10.1/0248 | Registered | Not determined | None |
| Benylin original sugar and alcohol free EACH 5,0 ml LIQUID CONTAINS AMMONIUM CHLORIDE 125,0 mg DIPHENHYDRAMINE HYDROCHLORIDE 12,5 mg | Not listed | 34028234/10.1/0282 | Registered | Not determined | None |
| Diphal expectorant EACH 5,0 ml SOLUTION CONTAINS AMMONIUM CHLORIDE 136,0 mg DIPHENHYDRAMINE HYDROCHLORIDE 14,0 mg | 5 mlSolution | 46008746/10.1/0087Approved 26 March 2025 | Registered | S2 | PIPIL |
| Pulmocure EACH 5 ml SYRUP CONTAINS AMMONIUM CHLORIDE 125 mg DIPHENHYDRAMINE HYDROCHLORIDE 12,5 mg | Not listed | F0154F/10.1/154 | Registered | Not determined | None |
| Lennamine expectorant EACH 5,0 ml LIQUID CONTAINS AMMONIUM CHLORIDE 100,0 mg DIPHENHYDRAMINE HYDROCHLORIDE 10,0 mg | Not listed | G0529G/10.1/0529 | Cancelled | Not determined | None |
| Benylin original 5 ML AMMONIUM CHLORIDE A 125,0 MG DIPHENHYDRAMINE HYDROCHLORIDE A 12,50 MG | Not listed | G0829 | Old Medicine | Not determined | None |
| Beramin EACH 5 ml SYRUP CONTAINS AMMONIUM CHLORIDE A 125 mg DIPHENHYDRAMINE HYDROCHLORIDE A 12,5 mg | Not listed | G1005 | Old Medicine | Not determined | None |
| Histodor expectorant EACH 5 ML CONTAINS AMMONIUM CHLORIDE A 50 MG DIPHENHYDRAMINE HYDROCHLORIDE A 12 MG | Not listed | G1222 | Old Medicine | Not determined | None |
| Elixirol EACH 5 ml ELIXIR CONTAINS AMMONIUM CHLORIDE 125 mg DIPHENHYDRAMINE HYDROCHLORIDE 12,5 mg | Not listed | J0207J/10.1/207 | Cancelled | Not determined | None |
| Ilvico expectorant* EACH 5 ml SYRUP CONTAINS AMMONIUM CHLORIDE 170 mg DIPHENHYDRAMINE HYDROCHLORIDE 14 mg | Not listed | J0256J/10.1/256 | Cancelled | Not determined | None |
| Norstan-diphenhydramine expectorant syrup EACH 5 ml SYRUP CONTAINS AMMONIUM CHLORIDE 125 mg DIPHENHYDRAMINE HYDROCHLORIDE 12,5 mg | Syrup | L0241L/10.1/241 | Cancelled | Not determined | None |
| Mediphen* EACH 5 ml SYRUP CONTAINS AMMONIUM CHLORIDE 130 mg DIPHENHYDRAMINE HYDROCHLORIDE 12,5 mg | Not listed | P0196P/10.1/196 | Registered | Not determined | None |
| Tusquit elixir EACH 5 ml ELIXIR CONTAINS AMMONIUM CHLORIDE 125 mg DIPHENHYDRAMINE HYDROCHLORIDE 12,5 mg | Elixir | T0044T/10.1/44 | Registered | Not determined | None |
| Medipax* EACH 5 ml CONTAINS AMMONIUM CHLORIDE 125 mg DIPHENHYDRAMINE HYDROCHLORIDE 12,5 mg | Not listed | U0185U/10.1/185 | Cancelled | Not determined | None |
Regulatory status
Where S2 sits on the scale
A pharmacist can sell it directly, without a prescription.
Schedule 2 medicines sit behind the pharmacy counter. A pharmacist can decide to sell one of these directly, using their own professional judgement, without a doctor's prescription. It can also be dispensed against a prescription like the higher tiers, in which case the usual repeat limits apply. A child under 12 may only be sold a Schedule 2 substance on a prescription, or on a written order that names the purpose and carries a signature the seller recognises. Even though it cannot be advertised to the public in the ordinary sense, its price, name, pack size and strength can still be told to the public, as long as nothing links it to what it treats.
Schedule S2, read from the product's PI-PIL leaflet.
Who may supply: Only a pharmacist, pharmacist intern or supervised pharmacist's assistant may sell it without a prescription. It may otherwise be dispensed by a pharmacist 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); 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
Schedule Verification
Diphal expectorant, Medicine Developers International (Pty) Ltd is scheduled S2 in its official SAHPRA documents, read with 90% confidence.
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.