Sodium cromoglycate
Sold as Hay-crom, Cromogen, Cromobex, Cromal, Lecrolyn sdu, Lecrolyn, Vividrin eye, Bausch and lomb vividrin nasal, Stop-allerg eye
No structure available
This product's active ingredient could not be matched to a single known compound.
Background
Registration
- Applicants
- 6
- Registrations
- 12
- Schedule source
- SAHPRA documentation
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Ascendis Pharma (Pty) LtdCancelled | Hay-crom | Not stated | 280373 | Not determined | None |
| Norton Healthcare (Pty) LtdCancelled | Cromogen | 5 mg | 280457 | Not determined | None |
| Ipharma (Pty) Ltd | Cromobex, Lecrolyn sdu, Lecrolyn | 20 mg/ml, 40 mg/ml | 290382, 310320, 310321, 310322, 310323 | S1 | PIPIL |
| Cipla Medpro (Pty) LtdCancelled | Cromal | 5 | 300120, 431134 | Not determined | None |
| Soflens (Pty) Ltd1 of 2 cancelled | Vividrin eye, Bausch and lomb vividrin nasal | drops, spray | W0086, W0087 | Not determined | None |
| Adcock ingram limited | Stop-allerg eye | 1 ml | W0430 | S2 | PIPIL |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Hay-crom EACH 1,0 ml SOLUTION CONTAINS SODIUM CROMOGLYCATE 20,0 mg | Not listed | 28037328/15.4/0373 | Cancelled | Not determined | None |
| Cromogen 5 MG EACH METERED DOSE CONTAINS SODIUM CROMOGLYCATE 5,0 mg | 5 mg | 28045728/10.2.1/0457 | Cancelled | Not determined | None |
| Cromobex EACH 1 ml CONTAINS SODIUM CROMOGLYCATE DIHYDRATE EQUIVALENT TO SODIUM CROMOGLYCATE 20 mg | 20 mg/mlEye drops, solution. | 29038229/15.4/0382Approved 14 April 2023 | Registered | S1 | PIPIL |
| Cromal-5 EACH INHALATION CONTAINS SODIUM CROMOGLYCATE 5 mg | 5 | 30012030/10.2.1/0120 | Cancelled | Not determined | None |
| Lecrolyn 20 mg/ml sdu EACH 1,0 ml SOLUTION CONTAINS SODIUM CROMOGLYCATE 20,0 mg | 20 mg/ml | 31032031/15.4/0320 | Registered | Not determined | None |
| Lecrolyn 40 mg/ml sdu EACH 1,0 ml SOLUTION CONTAINS SODIUM CROMOGLYCATE 40,0 mg | 40 mg/ml | 31032131/15.4/0321 | Registered | Not determined | None |
| Lecrolyn 20 mg/ml EACH 1,0 ml SOLUTION CONTAINS SODIUM CROMOGLYCATE 20,0 mg | 20 mg/ml | 31032231/15.4/0322 | Registered | Not determined | None |
| Lecrolyn 40 mg/ml EACH 1,0 ml SOLUTION CONTAINS SODIUM CROMOGLYCATE 40,0 mg | 40 mg/ML | 31032331/15.4/0323 | Registered | Not determined | None |
| Cromal EACH 1,0 ml DROPS CONTAIN SODIUM CROMOGLYCATE 20,0 mg | Not listed | 43113443/15.4/1134 | Cancelled | Not determined | None |
| Vividrin eye drops EACH 1 ml CONTAINS SODIUM CROMOGLYCATE 20 mg | Drops | W0086W/15.4/0086 | Registered | Not determined | None |
| Bausch and lomb vividrin nasal spray EACH 1 ml NASAL SPRAY CONTAINS SODIUM CROMOGLYCATE 20 mg | Spray | W0087W/16.1/87 | Cancelled | Not determined | None |
| Stop-allerg eye drops EACH 1 mL SOLUTION CONTAINS SODIUM CROMOGLYCATE 20 mg | 1 mlEye drop, solution | W0430W/15.4/430Approved 27 March 2025 | Registered | S2 | PIPIL |
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.
The Consolidated Schedules list this ingredient up to S4; the leaflet's S2 applies to this product.
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 Sodium cromoglycate
S4: Sodium cromoglycate
- when intended for veterinary use.
Consolidated Schedules 06 July 2026, line 7946
S2: Sodium cromoglycate
- except when intended for veterinary use.
Consolidated Schedules 06 July 2026, line 2668
Pharmacological class: Others. (class 15.4)
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
Cromobex, Ipharma (Pty) Ltd is scheduled S1 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.