Phenylephrine
Sold as Minims phenylephrine hydrochloride, Sudafed pe sinus decongestant, Phenylephrine cipla, Hypopress, Phenpressor, Rusaine, Phenylephrine ps equity, Phenylephrine RBC, Phenylcord, Paripres, Phenylephrine hetero, Phenylephrine fresenius, Phenylephrine covan, Phenylephrine hydrochloride, Ei-deel, Phenylephrine eye, Optimed, Naphensyl, Sine off sinus, Preferin liquifilm sterile eye, Phenylephrine hydrochloride nose, Eye-gene nf eye, Fenox nasal
3-[(1R)-1-Hydroxy-2-(methylamino)ethyl]phenol
Drag to rotate. Structure from PubChem CID 6041.
Background
Registration
- Applicants
- 19
- Registrations
- 28
- Schedule source
- SAHPRA documentation
Applicants and registrations
| Applicant | Brands | Dosages | Registrations | Schedule | Leaflets |
|---|---|---|---|---|---|
| Soflens (Pty) Ltd1 of 2 cancelled | Minims phenylephrine hydrochloride | 2,5 %, 10 % | 310458, D0022 | Not determined | None |
| Johnson & Johnson (Pty) Ltd û East LondonCancelled | Sudafed pe sinus decongestant | Not stated | 420099 | Not determined | None |
| Cipla Medpro (Pty) LtdCancelled | Phenylephrine cipla | Not stated | 520466 | Not determined | None |
| Umsebe healthcare | Hypopress | 0,1 mg/ml, 0.1/ 10mg/ml | 550352, 550353 | S4 | PIPIL |
| Juno Pharma SA (Pty) LtdCertificate held by Kahma Biotech (Pty) Ltd | Phenpressor | 10 mg | 550361 | Not determined | PIPIL |
| Unimed Healthcare (Pty) LtdCertificate held by Lebasi Pharmaceuticals (Pty) Ltd | Rusaine | 10 mg | 560060 | S1 | PIPIL |
| Equity Pharmaceutical (Pty) Ltd | Phenylephrine ps equity | 50 ug/ml | 570540 | Not determined | None |
| RBC Pharmaceuticals (Pty) Ltd | Phenylephrine RBC | 10 mg/ml | 580131 | Not determined | None |
| Accord Healthcare (Pty) Ltd | Phenylcord | 10 mg/ml | 590062 | Not determined | None |
| Ruby Pharmaceuticals (Pty) Ltd | Paripres | Not stated | 590417 | Not determined | None |
| Hetero Drugs South Africa (Pty) Ltd | Phenylephrine hetero | 100 mg/10 ml | 590460 | Not determined | None |
| Fresenius Kabi Manufacturing SA (Pty) Ltd | Phenylephrine fresenius | 10 mg/1 ml | 590892 | Not determined | None |
| Adcock ingram limitedCertificate held by Abbott Laboratories South Africa (Pty) Ltd1 of 2 cancelled | Phenylephrine covan, Phenylephrine hydrochloride | 10 mg/mL | F0011, LX0113 | S4 | PIPIL |
| Abbott Laboratories S.A. (Pty) LtdCertificate held by Abbott Laboratories South Africa (Pty) Ltd | Phenylephrine hydrochloride | 10 mg/mL | H0630 | S4 | PIPIL |
| Specpharm Holdings (Pty) Ltd | Ei-deel | Not stated | H1230 | Not determined | None |
| The Premier Pharmaceutical Co LtdCancelled | Phenylephrine eye, Optimed, Naphensyl | drops, 0,25 %, 1 % | H1307, H1310, H1403, H1596 | Not determined | None |
| Pharmacare limited û woodmead3 of 4 cancelled | Sine off sinus, Phenylephrine hydrochloride nose, Eye-gene nf eye | spray, drops, 1% | J0066, L0137, L0138, X0132 | Not determined | None |
| Abbvie (Pty) LtdCancelled | Preferin liquifilm sterile eye | drops | J0084 | Not determined | None |
| Boots Pharmaceuticals (Pty) LtdCancelled | Fenox nasal | spray | Z0254 | Not determined | None |
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Minims phenylephrine hydrochloride 2,5 % EACH 0,5 ml EYE DROPS CONTAINS PHENYLEPHRINE HYDROCHLORIDE 12,50 mg | 2,5 % | 31045831/15.4/0458 | Cancelled | Not determined | None |
| Sudafed pe sinus decongestant EACH TABLET CONTAINS PHENYLEPHRINE HYDROCHLORIDE 10,0 mg | Not listed | 42009942/5.8/0099 | Cancelled | Not determined | None |
| Phenylephrine cipla Each injection contains: Phenylphrine | Not listed | 52046652/7.2/0466 | Cancelled | Not determined | None |
| Hypopress 0,1 mg/ml EACH 1,0 ml SOLUTION CONTAINS PHENYLEPHRINE HYDROCHLORIDE 0,1 mg | 0,1 mg/mlSolution for injection or infusion | 55035255/6.1/0352Approved 10 May 2024 | Registered | S4 | PIPIL |
| Hypopress 10 mg/ml EACH 1,0 ml SOLUTION CONTAINS PHENYLEPHRINE HYDROCHLORIDE 10,0 mg | 0.1/ 10mg/mlSolution for injection or infusion | 55035355/6.1/0353Approved 9 November 2021 | Registered | Not determined | PIPIL |
| Phenpressor 10 mg/ml EACH 1,0 ml SOLUTION CONTAINS PHENYLEPHRINE HYDROCHLORIDE 10,0 mg | 10 mgInjection | 55036155/7.2/0361Approved 18 April 2023 | Registered | Not determined | PIPIL |
| Rusaine 10 mg/ml EACH 1,0 ml SOLUTION CONTAINS PHENYLEPHRINE HYDROCHLORIDE 10, 0 mg | 10 mgSolution for injection/infusion | 56006056/7.2/0060Approved 6 June 2023 | Registered | S1 | PIPIL |
| Phenylephrine 50 ug/ml ps equity Each 1,0 ml solution contains: Phenylephrine Hydrochloride equivalent to phenylephrine 50,0 ug | 50 ug/ml | 57054057/6.1/0540 | Registered | Not determined | None |
| Phenylephrine 10 mg/ml RBC EACH 1,0 ml SOLUTION CONTAINS: PHENYLEPHRINE HYDROCHLORIDE 10,0 mg | 10 mg/ml | 58013158/7.2/0131 | Registered | Not determined | None |
| Phenylcord 10 mg/ml EACH VIAL CONTAINS: PHENYLEPHRINE HYDROCHLORIDE 10,0 mg | 10 mg/ml | 59006259/7.2/0062 | Registered | Not determined | None |
| Paripres EACH 1,0 ml SOLUTION CONTAINS: PHENYLEPHRINE HYDROCHLORIDE 10,0 mg | Not listed | 59041759/7.2/0417 | Registered | Not determined | None |
| Phenylephrine 100 mg/10 ML hetero EACH 10,0 ml SOLUTION CONTAINS: PHENYLEPHRINE HYDROCHLORIDE 100,0 mg | 100 mg/10 ml | 59046059/7.2/0460 | Registered | Not determined | None |
| Phenylephrine 10 mg/1 ML fresenius EACH 1,0 ml SOLUTION CONTAINS: PHENYLEPHRINE HYDROCHLORIDE 10,0 mg | 10 mg/1 ml | 59089259/7.2/0892 | Registered | Not determined | None |
| Minims phenylephrine hydrochloride 10 % EACH 100 ml CONTAINS PHENYLEPHRINE HYDROCHLORIDE 10 g | 10 % | D0022D/15.4/22 | Registered | Not determined | None |
| Phenylephrine covan EACH 1 ml CONTAINS PHENYLEPHRINE 100 mg | Not listed | F0011F/15.4/11 | Cancelled | Not determined | None |
| Phenylephrine hydrochloride injection EACH I ml CONTAINS: PHENYLEPHRINE HYDROCHLORIDE A 10 mg | 10 mg/mLSolution for injection. | H0630Approved 5 October 2022 | Old Medicine | S4 | PIPIL |
| Ei-deel EACH 10 ml CONTAINS PHENYLEPHRINE HYDROCHLORIDE A 0,01 g | Not listed | H1230 | Old Medicine | Not determined | None |
| Phenylephrine eye drops EACH 1 ml CONTAINS PHENYLEPHRINE HYDROCHLORIDE A 1,0 mg | Drops | H1307 | Cancelled | Not determined | None |
| Optimed EACH 1 ml CONTAINS PHENYLEPHRINE HYDROCHLORIDE A 12,5 mg | Not listed | H1310 | Cancelled | Not determined | None |
| Naphensyl 1 % EACH 10 ml CONTAINS :PHENYLEPHRINE HYDROCHLORIDE A 100 mg | 1 % | H1403 | Cancelled | Not determined | None |
| Naphensyl 0,25 % EACH 1 ml SOLUTION CONTAINS: PHENYLEPHRINE HYDROCHLORIDE A 2,5 mg | 0,25 % | H1596 | Cancelled | Not determined | None |
| Sine - off sinus spray EACH 100 ml CONTAINS PHENYLEPHRINE HYDROCHLORIDE 0,5 g | -Spray | J0066J/16.1/66 | Cancelled | Not determined | None |
| Preferin liquifilm sterile eye drops EACH 1 ml SOLUTION CONTAINS PHENYLEPHRINE HYDROCHLORIDE 1,32 mg | Drops | J0084J/15.4/84 | Cancelled | Not determined | None |
| Phenylephrine hydrochloride nose drops EACH 15 ml CONTAINS PHENYLEPHRINE HYDROCHLORIDE 37,5 mg | Drops | L0137L/16.1/137 | Cancelled | Not determined | None |
| Phenylephrine hydrochloride 1% nose drops EACH 15 ml CONTAINS PHENYLEPHRINE HYDROCHLORIDE 150,0 mg | 1%Drops | L0138L/16.1/138 | Cancelled | Not determined | None |
| Phenylephrine hydrochloride injection EACH 1,0 ml SOLUTION CONTAINS PHENYLEPHRINE HYDROCHLORIDE 10,0 mg | 10 mg/mLSolution for injection. | LX0113L/5.1/113Approved 5 October 2022 | Registered | S4 | PIPIL |
| Eye-gene nf eye drops EACH 1 ml SOLUTION CONTAINS PHENYLEPHRINE HYDROCHLORIDE 1 mg | Drops | X0132X/15.4/132 | Registered | Not determined | None |
| Fenox nasal spray EACH 15 ml BOTTLE CONTAINS PHENYLEPHRINE 75,0 mg | Spray | Z0254Z/16.1/254 | Cancelled | Not determined | None |
Regulatory status
Where S4 sits on the scale
Prescription-only medicine.
Schedule 4 covers most ordinary prescription medicines. You need a prescription from an authorised prescriber, such as a doctor or dentist, and a pharmacist dispenses it. 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 S4, read from the product's PI-PIL leaflet.
Who may supply: A pharmacist dispensing 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); manufacturers and wholesalers may supply people who may lawfully possess it; and, for animal treatment, a person practising a para-veterinary profession, on a veterinarian's written or verbal instruction.
Consolidated Schedules listings for Phenylephrine hydrochloride
S4: Phenylephrine
- when intended for injection
- except ophthalmic preparations containing 0,2 percent or less. (S0)
- except for oral dosage forms, nasal dosage forms, or ophthalmic dosage forms containing more than 0,2 percent (S1)
Consolidated Schedules 06 July 2026, lines 7545 to 7552
S1: Phenylephrine
- when intended for oral dosage forms, nasal dosage forms, or ophthalmic dosage forms containing more than 0,2 percent; (S1)
- except ophthalmic preparations containing 0,2 percent or less; (S0)
- except when intended for injection. (S4)
Consolidated Schedules 06 July 2026, lines 1007 to 1014
Pharmacological class: Cardiac stimulants. (class 6.1)
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
Hypopress 0,1 mg/ml, Umsebe healthcare is scheduled S4 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.