Diphenhydramine
Sold as Bennet's diphenhydramine, Benadryl, Benadryl elixer, Phentamine elixer, Betasleep, Allergin parenteral, Allergin elixer/elikser, Children cough 5b, Allergin, Teens cherry cough, Benylin paediatric, Sleepeze-pm
2-Benzhydryloxy-N,N-dimethylethanamine
Drag to rotate. Structure from PubChem CID 3100.
Background
Registration
- Applicants
- 8
- Registrations
- 13
- Schedule source
- Consolidated Schedules 06 July 2026
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Hersol Manufacturing Laboratories CCCancelled | Bennet's diphenhydramine | elixir | 280483 | S2 | None |
| Warner-lambert SA (Pty) Ltd | Benadryl, Benadryl elixer | capsule | C0540, C0541 | S2 | None |
| The Premier Pharmaceutical Co LtdCancelled | Phentamine elixer | Not stated | C0648 | S2 | None |
| Adcock ingram limited2 of 3 cancelled | Betasleep, Allergin elixer/elikser, Allergin | cream | C0653, C0937, G2014 | S2 | None |
| Genpharm Pharmaceuticals (1993) (Pty) Ltd | Allergin parenteral | Not stated | C0933 | S2 | None |
| Resmed healthcare | Children cough 5b, Teens cherry cough | mixture, syrup | G0926, G921 | S2 | None |
| Johnson & Johnson (Pty) Ltd û East London | Benadryl, Benylin paediatric | cream | G2080, H0012 | S2 | None |
| Haleon South Africa (Pty) Ltd | Sleepeze-pm | tablets | N0037 | S2 | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Bennet's diphenhydramine elixir* EACH 5 ml ELIXIR CONTAINS DIPHENHYDRAMINE HYDROCHLORIDE 12,5 mg | Elixir | 28048328/5.7/0483 | Cancelled | S2 | None |
| Benadryl capsule CAPSULE DIPHENHYDRAMINE HYDROCHLORIDE A 25 MG | Capsule | C0540 | Old Medicine | S2 | None |
| Benadryl elixer 5 ML DIPHENHYDRAMINE HYDROCHLORIDE A 12,5 MG | Not listed | C0541 | Old Medicine | S2 | None |
| Phentamine elixer 5 ML DIPHENHYDRAMINE HYDROCHLORIDE A 12,5 MG | Not listed | C0648 | Cancelled | S2 | None |
| Betasleep CAPSULE DIPHENHYDRAMINE HYDROCHLORIDE 50 MG | Not listed | C0653C/2.2/653 | Registered | S2 | None |
| Allergin parenteral 1 ML DIPHENHYDRAMINE HYDROCHLORIDE A 10 MG | Not listed | C0933 | Old Medicine | S2 | None |
| Allergin elixer/elikser EACH 5 ml ELIXER CONTAINS DIPHENHYDRAMINE HYDROCHLORIDE A 12,5 mg | Not listed | C0937 | Cancelled | S2 | None |
| Children cough mixture 5b Each liquid contains: 5 ml Diphenhydramine Hydrochloride 6 mg ( half-strength) ; Ammonium chloride; methyl hydroxybenzoate; propyl hydroxybenzoate, Cherry essence, red colour | Mixture | G0926 | Old Medicine | S2 | None |
| Allergin cream EACH 100 g CREAM CONTAINS DIPHENHYDRAMINE HYDROCHLORIDE A 2,0 g | Cream | G2014 | Cancelled | S2 | None |
| Benadryl cream EACH 10,0 g CONTAINS DIPHENHYDRAMINE HYDROCHLORIDE A 200,0 mg | Cream | G2080 | Old Medicine | S2 | None |
| Teens cherry cough syrup Each 5 ml oral liquid contains :Diphenhydramine Hydrochloride 6 mg ( half-strength) ; Ammonium chloride; methyl hydroxybenzoate; propyl hydroxybenzoate, Cherry essence, red colour | Syrup | G921G0921 | Old Medicine | S2 | None |
| Benylin paediatric EACH 5,0 ml SYRUP CONTAINS DIPHENHYDRAMINE HYDROCHLORIDE 7,0 mg | Not listed | H0012H/1001/12 | Registered | S2 | None |
| Sleepeze-pm tablets EACH TABLET CONTAINS DIPHENHYDRAMINE HYDROCHLORIDE 25 mg | Tablets | N0037N/2.2/37 | Registered | S2 | 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, matched to the Consolidated Schedules by ingredient, confidence high.
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.
Consolidated Schedules listings for Diphenhydramine hydrochloride
S2: Diphenhydramine
Consolidated Schedules 06 July 2026, line 1865
Pharmacological class: Antihistaminics, anti-emetics and antivertigo preparations. (class 5.7)
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.