Nicotine Transdermal System

Manufacturer
EXELAN PHARMACEUTICALS, INC. | Aveva Drug Delivery Systems Inc.
Effective date
2025-06-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:38:49

Label at a glance#

ProductNicotine Transdermal System
Active ingredientNICOTINE
Label structure18 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 begin using the patch on your quit day If you smoke  more than 10 cigarettes per day , use the following schedule below: 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 p...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each patch)

OTC - ACTIVE INGREDIENT SECTION

Nicotine, 21 mg delivered over 24 hours 

Active ingredient (in each patch)

OTC - ACTIVE INGREDIENT SECTION

Nicotine, 14 mg delivered over 24 hours

Active ingredient (in each patch)

OTC - ACTIVE INGREDIENT SECTION

Nicotine, 7 mg delivered over 24 hours

Purpose

OTC - PURPOSE SECTION

Stop smoking aid

Use

INDICATIONS & USAGE SECTION

reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking.

Warnings

WARNINGS SECTION

OTC - PREGNANCY OR BREAST FEEDING SECTION

If you are pregnant or breast feeding, only use this medicine on the advice of your health care provider.

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.

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 have skin problems, because you are more likely to get rashes. 
  • stomach ulcer or diabetes 
  • history of seizures

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

  • if you have vivid dreams or other sleep disturbances, remove the 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 if 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
  • you have symptoms of an allergic reaction (such as difficulty breathing or rash)

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 pouch disposal. Dispose of the used patches by folding sticky end 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
  • begin using the patch on your quit day
  • If you smoke more than 10 cigarettes per day, use the following schedule below:
Weeks 1 thru 4Weeks 5 and 6 Weeks 7 and 8
 Step 1Step 2Step 3
 use one 21 mg patch/day use one 14 mg patch/day use one 7 mg patch/day
  • if you smoke 10 or less cigarettes per day, start with Step 2 for 6 weeks, then Step 3 for 2 weeks 
  • 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 the used patches 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 
  • it is important to complete treatment. If you feel you need to use the patch for a longer period to keep from smoking, talk to your health care provider.

Other information

SPL UNCLASSIFIED SECTION

  • store at 20°C - 25°C (68°F - 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

acrylate adhesive, polyester, silicone adhesive

Questions or comments?

OTC - QUESTIONS SECTION

1-888-889-8893

TO INCREASE YOUR SUCCESS IN QUITTING:

SPL UNCLASSIFIED SECTION

  1. You must be motivated to quit. 
  2. Use one patch daily according to directions. 
  3. It is important to complete treatment 
  4. If you feel you need to use patch for a longer period to keep from smoking, talk to your health care provider. 
  5. Use patch with a behavioral support program, such as the one described in the enclosed booklet.

SPL UNCLASSIFIED SECTION

  • Not for sale to persons under 18 years of age.
  • Proof of age required.
  • Not for sale in vending machines or from any source where proof of age cannot be verified.

SPL UNCLASSIFIED SECTION

For your family’s protection, patches are supplied in child-resistant pouches.

Do not use if individual pouch is open or torn

See bottom panel for lot number and expiration date.

See self-help guide inside.

SPL UNCLASSIFIED SECTION

Manufactured by
Aveva Drug Delivery Systems
A DifGen Company, Miramar, FL 33025


Distributed by:
Exelan Pharmaceuticals, Inc.
Boca Raton, FL 33432


1003769


Rev. 06/2025

PRINCIPAL DISPLAY PANEL - STEP ONE 21 mg CARTON

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Exelan

NDC 76282-783-40

Clear

Nicotine Transdermal

System Patch

21 mg

21 mg delivered over 24 hours

STOP SMOKING AID

Includes Behavior Support Program with Self-Help Guide

If you smoke MORE than 10 cigarettes per day: Start with Step 1.

If you smoke 10 or LESS cigarettes per day: Start with Step 2.

STEP ONE

14 PATCHES

Step 1Step 1

PRINCIPAL DISPLAY PANEL - STEP TWO 14 mg CARTON

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Exelan

NDC 76282-782-40

Clear

Nicotine Transdermal

System Patch

14 mg

14 mg delivered over 24 hours

STOP SMOKING AID

Includes Behavior Support Program with Self-Help Guide

If you smoke MORE than 10 cigarettes per day: Start with Step 1.

If you smoke 10 or LESS cigarettes per day: Start with Step 2.

STEP ONE

14 PATCHES

Step 2Step 2

PRINCIPAL DISPLAY PANEL - STEP THREE 7 mg CARTON

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Exelan

NDC 76282-781-40

Clear

Nicotine Transdermal

System Patch

7 mg

7 mg delivered over 24 hours

STOP SMOKING AID

Includes Behavior Support Program with Self-Help Guide

If you smoke MORE than 10 cigarettes per day: Start with Step 1.

If you smoke 10 or LESS cigarettes per day: Start with Step 2.

STEP ONE

14 PATCHES

Step 3Step 3

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198029nicotine 14 MG/Day 24HR Transdermal SystemPSN1
198030nicotine 21 MG/Day 24HR Transdermal SystemPSN1
198031nicotine 7 MG/Day 24HR Transdermal SystemPSN1
19803124 HR nicotine 0.292 MG/HR Transdermal SystemSCD1
19802924 HR nicotine 0.583 MG/HR Transdermal SystemSCD1
19803024 HR nicotine 0.875 MG/HR Transdermal SystemSCD1
198031nicotine 0.292 MG/HR 24HR Transdermal PatchSY1
198029nicotine 0.583 MG/HR 24HR Transdermal PatchSY1
198030nicotine 0.875 MG/HR 24HR Transdermal PatchSY1
198029nicotine 14 MG per 24HR 1 Day Transdermal PatchSY1
198029nicotine 14 MG/Day 24HR Transdermal SystemSY1
198030nicotine 21 MG per 24HR 1 Day Transdermal PatchSY1
198030nicotine 21 MG/Day 24HR Transdermal SystemSY1
198031nicotine 7 MG per 24HR 1 Day Transdermal PatchSY1
198031nicotine 7 MG/Day 24HR Transdermal SystemSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
NICOTINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76282-781-40Nicotine Transdermal System14 in 1 CARTONFILM, EXTENDED RELEASE141
76282-781-40Nicotine Transdermal System1 h in 1 POUCHFILM, EXTENDED RELEASE11
76282-782-40Nicotine Transdermal System14 in 1 CARTONFILM, EXTENDED RELEASE141
76282-782-40Nicotine Transdermal System1 h in 1 POUCHFILM, EXTENDED RELEASE11
76282-783-40Nicotine Transdermal System14 in 1 CARTONFILM, EXTENDED RELEASE141
76282-783-40Nicotine Transdermal System1 h in 1 POUCHFILM, EXTENDED RELEASE11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76282-783-40EA - Each76282-7831565d28a-dc40-4089-a56d-cf6f81a86a1112025-11-13
76282-782-40EA - Each76282-782220eccdf-f880-4342-a4a7-931157b06cda12025-11-13
76282-781-40EA - Each76282-7818e3ae685-29c1-4d3e-abf9-115d8e87b64412025-11-13

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76282-78376282-783-40
76282-78276282-782-40
76282-78176282-781-40

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074612-001NICOTINENICOTINE21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-20
A074612-002NICOTINENICOTINE7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL2003-07-28
A074612-003NICOTINENICOTINE14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-20

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A074612-001NICOTINE21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-2084e616aacf4f…
2026-09-14 22:38:342026-08A074612-002NICOTINE7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL2003-07-2884e616aacf4f…
2026-09-14 22:38:342026-08A074612-003NICOTINE14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-2084e616aacf4f…
2026-08-18 06:07:402026-07A074612-001NICOTINE21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-20caaa826d4ba7…
2026-08-18 06:07:402026-07A074612-002NICOTINE7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL2003-07-28caaa826d4ba7…
2026-08-18 06:07:402026-07A074612-003NICOTINE14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-20caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074612-001NICOTINE21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074612-002NICOTINE7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL2003-07-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074612-003NICOTINE14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-20011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074612-001NICOTINE21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074612-002NICOTINE7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL2003-07-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074612-003NICOTINE14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-2031067a03dcf5…
2025-08-23 18:47 UTC2025-08A074612-001NICOTINE21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074612-002NICOTINE7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL2003-07-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074612-003NICOTINE14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-206a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074612-001NICOTINE21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-20fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074612-002NICOTINE7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL2003-07-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074612-003NICOTINE14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074612-001NICOTINE21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-20b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074612-002NICOTINE7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL2003-07-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074612-003NICOTINE14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074612-001NICOTINE21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-2003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074612-002NICOTINE7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL2003-07-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074612-003NICOTINE14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074612-001NICOTINE21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-202680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074612-002NICOTINE7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL2003-07-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074612-003NICOTINE14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-202680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074612-001NICOTINE21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-205bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074612-002NICOTINE7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL2003-07-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074612-003NICOTINE14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-205bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074612-001NICOTINE21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-20d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074612-002NICOTINE7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL2003-07-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074612-003NICOTINE14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-20d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074612-001NICOTINE21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-20d06236e962d9…
2024-10-29 15:01 UTC2024-10A074612-002NICOTINE7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL2003-07-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A074612-003NICOTINE14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-20d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074612-001NICOTINE21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-2079d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074612-002NICOTINE7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL2003-07-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074612-003NICOTINE14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-2079d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074612-001NICOTINE21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMAL1997-10-20301d65b070ca…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nicotine Transdermal SystemNICOTINEEXELAN PHARMACEUTICALS, INC.5aeb4f5c-7cc4-4532-b76e-53bdee8e72202025-06-01WarningsExact identifier
ndc (package): 76282-781-40
ndc (package): 76282-782-40
ndc (package): 76282-783-40
ndc (product): 76282-782
ndc (product): 76282-783
ndc (product): 76282-781
ndc11 (package): 76282078140
ndc11 (package): 76282078340
ndc11 (package): 76282078240
spl id: 2aec5dc5-7c75-43f4-b724-de29ac1f84cb
spl set id: 5aeb4f5c-7cc4-4532-b76e-53bdee8e7220

Reported adverse events (FAERS/openFDA)#

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