Nicotine (Nicorette, Nicorette Mint, Nicorette Microtab, Nicorette Transdermal, Nicorette Icy White, Nicorette Quickmist, Nicorette Freshmint, Nicorette Freshfruit)
Nicotine
Johnson & Johnson (Pty) Ltd û East London
Registration
- Applicant
- Johnson & Johnson (Pty) Ltd û East London
- Registrations
- 19
- Schedule source
- SAHPRA documentation
Variants
| Product | Strength and form | Registration | Status | Schedule | Leaflets |
|---|---|---|---|---|---|
| Nicorette patch 5 MG EACH 10 cm PATCH CONTAINS NICOTINE 8,3 mg | 5 mgPatch | 29015029/34/150 | Cancelled | Not determined | None |
| Nicorette patch 10 MG EACH 20 cm PATCH CONTAINS NICOTINE 16,6 mg | 10 mgPatch | 29015129/34/0151 | Cancelled | Not determined | None |
| Nicorette patch 15 MG EACH 30 cm PATCH CONTAINS NICOTINE 24.9 mg | 15 mgPatch | 29015229/34/0152 | Cancelled | Not determined | None |
| Nicorette mint 2 MG EACH PIECE OF GUM CONTAINS NICOTINE 2,0 mg | 2 mg | 30027230/34/0272 | Cancelled | Not determined | None |
| Nicorette mint 4 MG EACH GUM CONTAINS NICOTINE 4,0 mg | 4 mg | 30027330/34/0273 | Cancelled | Not determined | None |
| Nicorette inhaler EACH CARTRIDGE CONTAINS NICOTINE 10,0 mg | Inhaler | 34032934/34/0329 | Cancelled | Not determined | None |
| Nicorette microtab 2 MG EACH TABLET CONTAINS NICOTINE 2,0 mg | 2 mg | 37064337/34/0643 | Cancelled | Not determined | None |
| Nicorette transdermal patch 10 MG EACH PATCH CONTAINS NICOTINE 15,75 mg | 10 mgPatch | 45095245/32.16/0952 | Registered | Not determined | None |
| Nicorette transdermal patch 15 MG EACH PATCH CONTAINS NICOTINE 23,62 mg | 15 mgPatch | 45095345/32.16/0953 | Registered | Not determined | None |
| Nicorette transdermal patch 25 MG EACH PATCH CONTAINS NICOTINE 39,37 mg | 25 mgPatch | 45095445/32.16/0954 | Registered | Not determined | None |
| Nicorette icy white 2 MG EACH GUM CONTAINS:NICOTINE RESIN EQUIVALENT TO NICOTINE 2,0 mg | 2 mg | 46016446/34/0164 | Registered | Not determined | None |
| Nicorette icy white 4 MG EACH GUM CONTAINS:NICOTINE RESIN EQUIVALENT TO NICOTINE 4,0 mg | 4 mg | 46016546/34/0165 | Registered | Not determined | None |
| Nicorette quickmist EACH SPRAY CONTAINS: NICOTINE 1,0 mg | 1 mgOromucosal spray | 50054750/32.16/0547Approved 22 January 2024 | Registered | S1 | PIPIL |
| Nicorette freshmint 2 MG EACH GUM CONTAINS NICOTINE RESIN EQUIVALENT TO NICOTINE 2,0 mg | 2 mg | A400520A40/34/0520 | Registered | Not determined | None |
| Nicorette freshmint 4 MG EACH GUM CONTAINS NICOTINE RESIN EQUIVALENT TO NICOTINE 4,0 mg | 4 mg | A400523A40/34/0523 | Registered | Not determined | None |
| Nicorette freshfruit 2 MG EACH GUM CONTAINS NICOTINE RESIN EQUIVALENT TO NICOTINE 2,0 mg | 2 mg | A400565A40/34/0565 | Registered | Not determined | None |
| Nicorette freshfruit 4 MG EACH GUM CONTAINS NICOTINE RESIN EQUIVALENT TO NICOTINE 4,0 mg | 4 mg | A400566A40/34/0566 | Registered | Not determined | None |
| Nicorette 2 MG EACH PIECE OF GUM CONTAINS NICOTINE RESIN COMPLEX EQUIVALENT TO NICOTINE 2 mg | 2 mg | P0187P/34/187 | Cancelled | Not determined | None |
| Nicorette 4 MG EACH PIECE OF GUM CONTAINS NICOTINE RESIN COMPLEX EQUIVALENT TO NICOTINE 4 mg | 4 mg | P0188P/34/188 | Cancelled | Not determined | None |
Regulatory status
Where S1 sits on the scale
Sold by a pharmacist, no doctor's prescription needed.
Schedule 1 medicines are normally sold by a pharmacist, or by a supervised pharmacist intern or assistant, without a doctor's visit; a veterinarian, or a licensed dispensing doctor, dentist or nurse prescriber, may also supply them. A nurse or other non-doctor prescriber may only prescribe the specific substances the Schedule names for that purpose, and may only dispense them if licensed to do so. A child under 12 may only be sold one of these medicines on a prescription, or on a written order that names the purpose and carries a signature the seller recognises.
Schedule S1, read from the product's PI-PIL leaflet.
The Consolidated Schedules list this ingredient up to S3; the leaflet's S1 applies to this product.
Who may supply: A pharmacist, or a supervised pharmacist intern or assistant; manufacturers and wholesalers supplying people who may lawfully possess it; a veterinarian, who may prescribe, compound or dispense it; a medical practitioner or dentist, who may prescribe it, and may compound or dispense it only if licensed under section 22C(1)(a); a nurse or other registered non-doctor prescriber, who may prescribe only the Scheduled substances the Schedule identifies for that purpose, and dispense them if licensed to do so; and, for animal treatment, a person practising a para-veterinary profession, on a veterinarian's written or verbal instruction.
Consolidated Schedules listings for Nicotine
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
Pharmacological class: Others. (class 32.16)
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.
3-[(2S)-1-Methylpyrrolidin-2-yl]pyridine
Drag to rotate. Structure from PubChem CID 89594.
SAHPRA documents
Schedule Verification
This medication's schedule (S1) has been verified from official SAHPRA documents with 90% confidence.
These documents are provided by SAHPRA for informational purposes. Always consult with a healthcare professional for medical advice.