Indications and uses
Reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking
Nicotine
- Manufacturer
- Clinical Solutions Wholesale
- Effective date
- 2013-12-01
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 22:37:53
Label at a glance#
ProductNicotine
Active ingredientNicotine
Label structure10 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...
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient (in each patch)
Nicotine, 21 mg delivered over 24 hours
Purpose
Stop smoking aid
Uses
Reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking
Warnings
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.
Do not use
- 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
- 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
- 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
- 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
- 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
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
- 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 less cigarettes per day, start with Step 2 for 6 weeks, then Step 3 for 2 weeks and then stop
- 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
Store at 20°-25°C (68°-77°F)
Inactive ingredients
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
Principal Display Panel - Step 1 – 21 mg Carton Label
Rugby®
NDC 0536-5896-88
COMPARE TO THE ACTIVE INGREDIENT IN HABITROL®*
Clear
Nicotine
Transdermal System
21 mg delivered over 24 hours
STOP SMOKING AID
21 mg
Includes Behavior Support Program with Self-Help Guide
Free Audio CD upon request.
STEP ONE
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
14 Patches
*Habitrol® is a registered trademark of Novartis Consumer Health, Inc.
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 198030 | nicotine 21 MG/Day 24HR Transdermal System | PSN | 1 |
| 198030 | 24 HR nicotine 0.875 MG/HR Transdermal System | SCD | 1 |
| 198030 | nicotine 0.875 MG/HR 24HR Transdermal Patch | SY | 1 |
| 198030 | nicotine 21 MG per 24HR 1 Day Transdermal Patch | SY | 1 |
| 198030 | nicotine 21 MG/Day 24HR Transdermal System | SY | 1 |
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| NICOTINE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 58118-9842-4 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-00a9-f424-e053-dadaa90a57ce | 0d026350-1c4e-4377-b24e-b586cbc794e5 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58118-9842-1 | Nicotine | 24 h in 1 PATCH | PATCH | 24 | 1 | |
| 58118-9842-1 | Nicotine | 1 in 1 POUCH | PATCH | 1 | 1 | |
| 58118-9842-4 | Nicotine | 14 in 1 CARTON | PATCH | 14 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 58118-9842 | NICOTINE PATCH [CLINICAL SOLUTIONS WHOLESALE] | 1 | Legacy NDC, 3 package rows | 20131223_0d026350-1c4e-4377-b24e-b586cbc794e5.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0536-5896-33 | EA - Each | 0536-5896 | 8d3ec621-fa77-4562-a992-252daf2602ac | 1 | 2014-10-03 |
| 0536-5896-53 | EA - Each | 0536-5896 | 74566b39-ea1a-4b80-8046-bc617ca69d3c | 1 | 2017-06-15 |
| 0536-5896-71 | EA - Each | 0536-5896 | e795a3ca-90dc-427f-8c0e-ebc57c16081b | 1 | 2017-06-15 |
| 0536-5896-88 | EA - Each | 0536-5896 | ed416e8f-6e0e-42b3-b1ed-b5da2efce244 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Nicotine | ACTIVE INGREDIENT | 6M3C89ZY6R | 1 | |
| Nicotine | ACTIVE MOIETY | 6M3C89ZY6R | 1 | |
| dimethicone | INACTIVE INGREDIENT | 92RU3N3Y1O | 1 |
Products#
Every source-derived product name is available through these pages.
- Nicotine
- dimethicone
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 58118-9842 | 58118-9842-1, 58118-9842-4 |
| 0536-5896 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| Nicotine | 6M3C89ZY6R | ACTIB |
| dimethicone | 92RU3N3Y1O | IACT |
Source Document#
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | 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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | 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.
| 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 | 0536-5896 |
| 0d026350-1c4e-4377-b24e-b586cbc794e5 | 0d026350-1c4e-4377-b24e-b586cbc794e5 | 2013-12-01 | Warnings | 0d026350-1c4e-4377-b24e-b586cbc794e5 0d026350-1c4e-4377-b24e-b586cbc794e5 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.