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Nicotinell Mint Chewing Gum

Nicotine

Combination product

This product contains more than one active ingredient, so it has no single molecular structure.

Registration

Applicants
1
Registrations
2

Applicants and registrations

ApplicantBrandsDosagesRegistrationsScheduleLeaflets
Glaxosmithkline Consumer Healthcare SA (Pty) LtdNicotinell mint chewing gum2 mg, 4 mgA390607, A390608Not determinedNone

Variants

ProductStrength and formRegistrationStatusScheduleLeaflets
Nicotinell mint 2 MG coated chewing gum

EACH GUM CONTAINS NICOTINE 2,0 mg NICOTINE 2,0 mg

2 mgCoatedA390607A39/34/0607RegisteredNot determinedNone
Nicotinell mint 4 MG coated chewing gum

Referred to NICOTINE 4,0 mg NICOTINE 4,0 mg

4 mgCoatedA390608A39/34/0608RegisteredNot 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

  • S3: Nicotine

    • when intended for human medicinal use as an aid to smoking cessation or as a substitute for a tobacco product (as defined in the Tobacco Products Control Act, 1993, as amended);
    • except when registered for human medicinal use as an aid to smoking cessation and presented as nicotine gum or lozenges containing not more than 4 mg nicotine per piece; (S0)
    • except when intended for human medicinal use as an aid to smoking cessation, when registered and presented as nicotine transdermal patches for continuous application to the skin in strengths up to an including 21mg/ 24 hours or 25 mg/ 16 hours; (S1)
    • except when intended for human medicinal use as an aid to smoking cessation, when registered and presented as nicotine transdermal patches for continuous application to the skin in strengths containing more than 21mg/ 24 hours or 25 mg/ 16 hours; (S2)
    • except when registered for human medicinal use as an aid to smoking cessation and presented as nicotine gum or lozenges containing more than 4 mg nicotine per piece; (S2)
    • except when registered as metered sprays containing not more than 1 mg per dose; (S1)
    • except when registered as oral solid dosage forms containing not more than 2 mg; (S2)
    • except when registered as inhalers containing not more than 10 mg per cartridge. (S2)

    Consolidated Schedules 06 July 2026, lines 4004 to 4027

  • S2: Nicotine

    • when registered for human medicinal use as an aid to smoking cessation and presented as nicotine gum or lozenges containing more than 4mg nicotine per piece;
    • when registered as oral solid dosage forms containing 2mg or less;
    • when registered as inhalers containing 10mg or less per cartridge;
    • when intended for human medicinal use as an aid to smoking cessation, when registered and presented as nicotine transdermal patches for continuous application to the skin in strengths containing more than 21mg/ 24 hours or 25 mg/ 16 hours;
    • except when registered for human medicinal use as an aid to smoking cessation and presented as nicotine gum or lozenges containing not more than 4mg nicotine per piece; (S0)
    • except when intended for human medicinal use as an aid to smoking cessation, when registered and presented as nicotine transdermal patches for continuous application to the skin in strengths up to an including 21mg/ 24 hours or 25 mg/ 16 hours; (S1)
    • except when intended for human medicinal use as an aid to smoking cessation or as a substitute for a tobacco product (as defined in the Tobacco Products Control Act, 1993, as amended). (S3)

    Consolidated Schedules 06 July 2026, lines 2394 to 2415

  • S1: Nicotine

    • when intended for human medicinal use as an aid to smoking cessation, when registered and presented as nicotine transdermal patches for continuous application to the skin in strengths up to an including 21mg/ 24 hours or 25 mg/ 16 hours;
    • except when registered for human medicinal use as an aid to smoking cessation and presented as nicotine gum or lozenges containing not more than 4 mg nicotine per piece; (S0)
    • except when registered for human medicinal use as an aid to smoking cessation and presented as nicotine gum or lozenges containing more than 4 mg nicotine per piece; (S2)
    • except when intended for human medicinal use as an aid to smoking cessation, when registered and presented as nicotine transdermal patches for continuous application to the skin in strengths containing more than 21mg/ 24 hours or 25 mg/ 16 hours; (S2)
    • when registered as metered sprays containing not more than 1 mg per dose or less;
    • except when registered as oral solid dosage forms containing not more than 2 mg; (S2)
    • except when registered as inhalers containing not more than 10 mg per cartridge; (S2)
    • except when intended for human medicinal use as an aid to smoking cessation or as a substitute for a tobacco product (as defined in the Tobacco Products Control Act, 1993, as amended). (S3)

    Consolidated Schedules 06 July 2026, lines 890 to 917

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.

Background

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SAHPRA documents

SAHPRA has not published a professional information or patient information leaflet for this product.

Research articles

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