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Oxymetazoline (Sinustop Paediatric Nasal Metered, Sinustop Paediatric Nasal, Nazene Paediatric Nasal Metered, Nazene Paediatric Nasal, Nazene Adult Nasal Metered, Nazene Adult Nasal, Allergex Eye, Sinustop Nasal)

Oxymetazoline

Adcock ingram limited

Registration

Applicant
Adcock ingram limited
Certificate holder
Adcock ingram limited
Registrations
8

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Sinustop paediatric nasal metered spray1 mlPaediatric nasal metered spray390199A39/16.1/0199Approved 28 September 2021RegisteredNot determinedPIPIL
Sinustop paediatric nasal drops

EACH 1,0 ml SOLUTION CONTAINS OXYMETAZOLINE HYDROCHLORIDE 0,250 mg

DropsA390198A39/16.1/0198RegisteredNot determinedNone
Nazene paediatric nasal metered spray

EACH 1,0 ml SOLUTION CONTAINS OXYMETAZOLINE HYDROCHLORIDE 0,250 mg

SprayA390200A39/16.1/0200RegisteredNot determinedNone
Nazene paediatric nasal drops

EACH 1,0 ml SOLUTION CONTAINS OXYMETAZOLINE HYDROCHLORIDE 0,250 mg

DropsA390201A39/16.1/0201CancelledNot determinedNone
Nazene adult nasal metered spray

EACH 1,0 ml SOLUTION CONTAINS OXYMETAZOLINE HYDROCHLORIDE 0,50 mg

1 mlNasal metered sprayA390211A39/16.1/0211Approved 27 September 2021RegisteredNot determinedPIPIL
Nazene adult nasal drops

EACH 1,0 ml SOLUTION CONTAINS OXYMETAZOLINE HYDROCHLORIDE 0,500 mg

DropsA390225A39/16.1/0225CancelledNot determinedNone
Allergex eye drops

EACH 1 ml CONTAINS :OXYMETAZOLINE HYDROCHLORIDE A 0,25 mg

DropsH1274Old MedicineNot determinedNone
Sinustop nasal spray

EACH 1 ml SOLUTION CONTAINS OXYMETAZOLINE HYDROCHLORIDE 0,5 mg

SprayY0251Y/16.1/251RegisteredNot determinedNone

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

  • S2: Oxymetazoline

    • except when intended for nasal use

    Consolidated Schedules 06 July 2026, line 2476

  • S1: Oxymetazoline

    • when intended for nasal use.

    Consolidated Schedules 06 July 2026, line 952

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.

C16H24N2O260.37 g/mol

6-tert-Butyl-3-(4,5-dihydro-1H-imidazol-2-ylmethyl)-2,4-dimethylphenol

Drag to rotate. Structure from PubChem CID 4636.

SAHPRA documents

These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.

Background

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Research articles

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