Codeine
Sold as Codeine phosphate, Codeine phosphate sad, A-lennon codeine, Codeine phosphate B.P.C., Norstan- codeine phosphate
(4R,4AR,7S,7aR,12bS)-9-methoxy-3-methyl-2,4,4a,7,7a,13-hexahydro-1H-4,12-methanobenzofuro[3,2-e]isoquinolin-7-ol
Drag to rotate. Structure from PubChem CID 5284371.
Background
Registration
- Applicants
- 4
- Registrations
- 7
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Pharmacare limited û woodmead2 of 3 cancelled | Codeine phosphate, Codeine phosphate sad, A-lennon codeine | 15 mg, syrup | B1189, B1190, B1192 | Not determined | None |
| The Premier Pharmaceutical Co LtdCancelled | Codeine phosphate, Codeine phosphate B.P.C. | syrup | B1252, G0897 | Not determined | None |
| Allied Drug Company (Pty) Ltd | Codeine phosphate | syrup | BV0324 | Not determined | None |
| Hoechst Marion Roussel LtdCancelled | Norstan- codeine phosphate | norstan-syrup | G1017 | Not determined | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Codeine phosphate 15 MG tablets EACH TABLET CONTAINS CODEINE PHOSPHATE A 15 mg | 15 mgTablets | B1189 | Cancelled | Not determined | None |
| Codeine phosphate syrup sad 5 ML CODEINE PHOSPHATE A 25 MG | Syrup | B1190 | Cancelled | Not determined | None |
| A-lennon codeine CODEINE PHOSPHATE A 30,0 mg | Not listed | B1192 | Old Medicine | Not determined | None |
| Codeine phosphate syrup 10 ML CODEINE PHOSPHATE A 50 MG | Syrup | B1252 | Cancelled | Not determined | None |
| Codeine phosphate syrup EACH 25 ml CONTAINS CODEINE PHOSPHATE A 25 mg | Syrup | BV0324 | Old Medicine | Not determined | None |
| Codeine phosphate syrup B.P.C. 2,5 ML CODEINE PHOSPHATE A 12,5 MG | Syrup | G0897 | Cancelled | Not determined | None |
| Norstan-syrup codeine phosphate EACH 5 ML SYRUP CONTAINS CODEINE PHOSPHATE A 25 MG | Norstan-syrup | G1017 | Cancelled | 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
S6: Codeine
- single component codeine preparations;
- oral solid preparations, in combination with one or more therapeutically active substances, in preparations not registered in terms of the Act, or when intended for export; (S2, S3)
- liquid oral preparations and mixtures, in combination with one or more therapeutically active substances, in preparations not registered in terms of the Act, or when intended for export. (S2, S3)
Consolidated Schedules 06 July 2026, lines 10128 to 10136
S3: Codeine
- oral solid preparations, in combination with one or more therapeutically active substances, containing more than 10 milligrams of codeine (calculated as base) per dosage unit, when contained in products registered in terms of the Act, and not intended for export;
- liquid oral preparations and mixtures, in combination with one or more therapeutically active substances, containing more than 10 milligrams of codeine (calculated as base) per 5 millilitre dosage unit, when contained in products registered in terms of the Act, and not intended for export;
- except oral solid preparations, in combination with one or more therapeutically active substances, containing not more than 10 milligrams of codeine (calculated as base) per dosage unit, with a maximum daily dose not exceeding 80 milligrams, and in packs containing sufficient dosage units for a maximum treatment period of 5 days and limited to one pack per customer, when contained in products registered in terms of the Act, and not intended for export; (S2)
- except liquid oral preparations and mixtures, in combination with one or more therapeutically active substances, containing not more than 10 milligrams of codeine (calculated as base) per 5 millilitre dosage unit, with a maximum daily dose not exceeding 80 milligrams, and with a pack size not exceeding 100 millilitres and limited to one pack per customer, when contained in products registered in terms of the Act, and not intended for export; (S2)
- except single component codeine preparations. (S6)
Consolidated Schedules 06 July 2026, lines 3350 to 3372
S2: Codeine
- oral solid preparations, in combination with one or more therapeutically active substances, containing not more than 10 milligrams of codeine (calculated as base) per dosage unit, with a maximum daily dose not exceeding 80 milligrams, and in packs containing sufficient dosage units for a maximum treatment period of 5 days, and limited to one pack per customer, when contained in products registered in terms of the Act, and not intended for export;
- liquid oral preparations and mixtures, in combination with one or more therapeutically active substances, containing not more than 10 milligrams of codeine (calculated as base) per 5 millilitre dosage unit, with a maximum daily dose not exceeding 80 milligrams, and with a pack size not exceeding 100 millilitres, when contained in products registered in terms of the Act, and not intended for export;
- except oral solid preparations, in combination with one or more therapeutically active substances, containing more than 10 milligrams of codeine (calculated as base) per dosage unit; (S3)
- except liquid oral preparations and mixtures, in combination with one or more therapeutically active substances, containing more than 10 milligrams of codeine (calculated as base) per 5 millilitre dosage unit; (S3)
- except single component codeine preparations. (S6)
Consolidated Schedules 06 July 2026, lines 1758 to 1778
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.