Nicotine

Sold as Nicorette, Nicorette mint, Nicorette microtab, Nicorette transdermal, Nicorette icy white, Nicorette quickmist, Nicotinell fruit chewing gum, Nicotinell mint chewing gum, Nicorette freshmint, Nicorette freshfruit, Nicotinell tts

S1Read from the PI-PIL document and verified

C₁₀H₁₄N₂162.23 g/mol

3-[(2S)-1-Methylpyrrolidin-2-yl]pyridine

Drag to rotate. Structure from PubChem CID 89594.

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Registration

Applicants: 2
Registrations: 26
Schedule source: SAHPRA documentation

Applicants and registrations

Applicant	Brands	Dosages	Registrations	Schedule	Leaflets
Johnson & Johnson (Pty) Ltd û East LondonCertificate held by Johnson &Amp; Johnson (Pty) Ltd9 of 19 cancelled	Nicorette, Nicorette mint, Nicorette microtab, Nicorette transdermal, Nicorette icy white, Nicorette quickmist, Nicorette freshmint, Nicorette freshfruit	1 mg, 2 mg, 4 mg, 5 mg, 10 mg, 15 mg, inhaler, 25 mg	290150, 290151, 290152, 300272, 300273, 340329, 370643, 450952, 450953, 450954, 460164, 460165, 500547, A400520, A400523, A400565, A400566, P0187, P0188	S1	PI PIL
Glaxosmithkline Consumer Healthcare SA (Pty) Ltd1 of 7 cancelled	Nicotinell fruit chewing gum, Nicotinell mint chewing gum, Nicotinell tts	2 mg, 4 mg, 10, 20, 30	A390605, A390606, A390607, A390608, Y0348, Y0349, Y0350	Not determined	None

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	PI PIL
Nicotinell fruit 2 MG coated chewing gum EACH GUM CONTAINS NICOTINE 2,0 mg	2 mgCoated	A390605A39/34/0605	Registered	Not determined	None
Nicotinell fruit 4 MG coated chewing gum Referred to NICOTINE 4,0 mg	4 mgCoated	A390606A39/34/0606	Registered	Not determined	None
Nicotinell mint 2 MG coated chewing gum EACH GUM CONTAINS NICOTINE 2,0 mg NICOTINE 2,0 mg	2 mgCoated	A390607A39/34/0607	Registered	Not determined	None
Nicotinell mint 4 MG coated chewing gum Referred to NICOTINE 4,0 mg NICOTINE 4,0 mg	4 mgCoated	A390608A39/34/0608	Registered	Not determined	None
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
Nicotinell tts 10 EACH 10 cm ADHESIVE PAD CONTAINS NICOTINE 17,5 mg	10	Y0348Y/34/348	Registered	Not determined	None
Nicotinell tts 20 EACH 20 cm ADHESIVE PAD CONTAINS NICOTINE 35 mg	20	Y0349Y/34/349	Registered	Not determined	None
Nicotinell tts 30 EACH 30 cm ADHESIVE PAD CONTAINS NICOTINE 52.5 mg	30	Y0350Y/34/350	Cancelled	Not determined	None

Regulatory status

Where S1 sits on the scale

S0S1S2S3S4S5S6S7S8

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.

SAHPRA documents

Schedule verified from official documents

Schedule Verification

Nicorette quickmist, Johnson & Johnson (Pty) Ltd û East London is scheduled S1 in its official SAHPRA documents, read with 90% confidence.

Professional information (PI)For healthcare professionalsNicorette quickmist, Johnson & Johnson (Pty) Ltd û East London Patient information leaflet (PIL)For patients and carersNicorette quickmist, Johnson & Johnson (Pty) Ltd û East London

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

Research articles

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