Nicotine

Manufacturer: TYA Pharmaceuticals
Effective date: 2011-08-23
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 22:40:18

Label at a glance#

ProductNicotine

Active ingredientNicotine

Label structure6 sections

Dosage and administration

If you are under 18 years of age, ask a doctor before use Before using this product, read the enclosed self-help guide for complete directions and other information Stop smoking completely when you begin using the patch If you smoke more than 10 cigarettes per day, use the following schedule: Weeks 1 thru 4 Weeks 5 and 6 Weeks 7 and 8 STEP 1 STEP 2 STEP 3 use one 21 mg patch/day use one 14 mg patch/day use one 7 m...

Contacts and useful links#

PhoneLabel contact1-877-440-7867

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each patch)

OTC - ACTIVE INGREDIENT SECTION

Nicotine, 14 mg delivered over 24 hours

Purpose

OTC - PURPOSE SECTION

Stop smoking aid

Uses

INDICATIONS & USAGE SECTION

Reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking

Warnings

WARNINGS SECTION

OTC - PREGNANCY OR BREAST FEEDING SECTION

Smoking can seriously harm your child. Try to stop smoking without using any nicotine replacement medicine. This medicine is believed to be safer than smoking. However, the risks to your child from this medicine are not fully known. If you are pregnant or breast-feeding, only use this medicine on the advice of your health care provider.

Do not use

OTC - DO NOT USE SECTION

If you continue to smoke, chew tobacco, use snuff, use nicotine gum, or use nicotine patch or other nicotine-containing products

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

Heart disease, recent heart attack, or irregular heartbeat. Nicotine can increase your heart rate.
High blood pressure not controlled with medication. Nicotine can increase your blood pressure.
An allergy to adhesive tape or skin problems because you are more likely to get rashes

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

Using a non-nicotine stop smoking drug
Taking a prescription medicine for depression or asthma. Your prescription dose may need to be adjusted.

When using this product

OTC - WHEN USING SECTION

Do not smoke even when not wearing the patch. The nicotine in your skin will still be entering your bloodstream for several hours after you take off the patch.
If you have vivid dreams or other sleep disturbances, remove this patch at bedtime

Stop use and ask a doctor if

OTC - STOP USE SECTION

Skin redness caused by the patch does not go away after four days, or your skin swells, or you get a rash
Irregular heartbeat or palpitations occur
You get symptoms of nicotine overdose, such as nausea, vomiting, dizziness, weakness, and rapid heartbeat

Keep out of reach of children and pets

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Used patches have enough nicotine to poison children and pets. If swallowed, get medical help or contact a Poison Control Center right away. Save pouch to use for patch disposal. Dispose of used patch by folding sticky ends together and putting in pouch.

Directions

DOSAGE & ADMINISTRATION SECTION

If you are under 18 years of age, ask a doctor before use
Before using this product, read the enclosed self-help guide for complete directions and other information
Stop smoking completely when you begin using the patch
If you smoke more than 10 cigarettes per day, use the following schedule:

Weeks 1 thru 4	Weeks 5 and 6	Weeks 7 and 8
STEP 1	STEP 2	STEP 3
use one 21 mg patch/day	use one 14 mg patch/day	use one 7 mg patch/day

If you smoke 10 or start with for 6 weeks, then for 2 weeks and then stop less cigarettes per day, Step 2 Step 3
Apply one new patch every 24 hours on skin that is dry, clean, and hairless
Remove backing from patch and immediately press onto skin. Hold for 10 seconds.
Wash hands after applying or removing patch. Save pouch to use for patch disposal. Dispose of used patch by folding sticky ends together and putting in pouch.
The used patch should be removed and a new one applied to a different skin site at the same time each day
If you have vivid dreams, you may remove the patch at bedtime and apply a new one in the morning
Do not wear more than one patch at a time
Do not cut patch in half or into smaller pieces
Do not leave patch on for more than 24 hours because it may irritate your skin and loses strength after 24 hours
Stop using the patch at the end of 8 weeks. If you still feel the need to use the patch talk to your doctor.

Other information

SPL UNCLASSIFIED SECTION

Store at 20°-25°C (68°-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

acrylate adhesive, polyester, silicone adhesive

Comments or questions?

Call-1-877-440-7867 8 AM - 8PM ET, Monday-Friday

This product is not affiliated with Novartis Consumer Health, Inc.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
198029	nicotine 14 MG/Day 24HR Transdermal System	PSN	2
198029	24 HR nicotine 0.583 MG/HR Transdermal System	SCD	2
198029	nicotine 0.583 MG/HR 24HR Transdermal Patch	SY	2
198029	nicotine 14 MG per 24HR 1 Day Transdermal Patch	SY	2
198029	nicotine 14 MG/Day 24HR Transdermal System	SY	2

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
NICOTINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
64725-5895-1	2019-11-27	C162847	48780-1	9855e2a2-4482-60a7-e053-dbdaa90a05bd	f00d85f4-2b4f-4281-b72e-9de730140e41

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
64725-5895-1	Nicotine	14 h in 1 BOX	PATCH	14		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
64725-5895	NICOTINE PATCH [TYA PHARMACEUTICALS]	2	Legacy NDC, 1 package rows	20140925_f00d85f4-2b4f-4281-b72e-9de730140e41.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0536-5895-33	EA - Each	0536-5895	63ad1db9-145b-46b4-825c-6dd446714b3b	1	2015-06-09
0536-5895-53	EA - Each	0536-5895	0da8c4fd-bcf0-48c2-a3cc-66177e0b574a	1	2017-06-15
0536-5895-71	EA - Each	0536-5895	3e810ef8-444b-4469-86ef-631f7f01572f	1	2019-10-07
0536-5895-88	EA - Each	0536-5895	d359ffb1-33ff-40b0-8b63-b75a9583e172	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Nicotine	ACTIVE INGREDIENT	6M3C89ZY6R	2
Nicotine	ACTIVE MOIETY	6M3C89ZY6R	2
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

Nicotine
DIMETHICONE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
64725-5895	64725-5895-1
0536-5895

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Nicotine	6M3C89ZY6R	ACTIB
DIMETHICONE	92RU3N3Y1O	IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A074612-001	NICOTINE	NICOTINE	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20
A074612-002	NICOTINE	NICOTINE	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	2003-07-28
A074612-003	NICOTINE	NICOTINE	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A074612-001	NICOTINE	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074612-002	NICOTINE	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	2003-07-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A074612-003	NICOTINE	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074612-001	NICOTINE	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074612-002	NICOTINE	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	2003-07-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A074612-003	NICOTINE	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074612-001	NICOTINE	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074612-002	NICOTINE	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	2003-07-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A074612-003	NICOTINE	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074612-001	NICOTINE	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074612-002	NICOTINE	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	2003-07-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074612-003	NICOTINE	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074612-001	NICOTINE	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074612-002	NICOTINE	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	2003-07-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A074612-003	NICOTINE	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074612-001	NICOTINE	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074612-002	NICOTINE	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	2003-07-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074612-003	NICOTINE	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074612-001	NICOTINE	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074612-002	NICOTINE	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	2003-07-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074612-003	NICOTINE	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074612-001	NICOTINE	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074612-002	NICOTINE	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	2003-07-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074612-003	NICOTINE	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074612-001	NICOTINE	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074612-002	NICOTINE	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	2003-07-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074612-003	NICOTINE	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074612-001	NICOTINE	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074612-002	NICOTINE	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	2003-07-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074612-003	NICOTINE	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074612-001	NICOTINE	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074612-002	NICOTINE	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	2003-07-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074612-003	NICOTINE	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074612-001	NICOTINE	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074612-002	NICOTINE	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	2003-07-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A074612-003	NICOTINE	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074612-001	NICOTINE	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074612-002	NICOTINE	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	2003-07-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074612-003	NICOTINE	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074612-001	NICOTINE	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`301d65b070ca…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nicotine	NICOTINE	Rugby Laboratories	2dd4cbda-5c46-4655-b69d-21b7d2e912cf	2024-06-05	Warnings	Exact identifier ndc (product): 0536-5895
0f3e08a2-667b-48cf-b9ce-2ca878a74081			f00d85f4-2b4f-4281-b72e-9de730140e41	2011-08-23	Warnings	Exact identifier spl id: 0f3e08a2-667b-48cf-b9ce-2ca878a74081 spl set id: f00d85f4-2b4f-4281-b72e-9de730140e41

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.