Nicotine Transdermal System Patch

Manufacturer
BluePoint Laboratories | Dr. Reddy's Laboratories Inc.
Effective date
2026-07-10
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
daily-update
Hydrated at
2026-07-17 21:45:33

Label at a glance#

ProductNicotine Transdermal System Patch Step 1
Active ingredientNICOTINE
Label structure13 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: 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 hour...

Label contents#

Full prescribing information#

Active ingredient Step 1 (in each patch)

OTC - ACTIVE INGREDIENT SECTION

Nicotine, 21 mg delivered over 24 hours

Active ingredient Step 2 (in each patch)

OTC - ACTIVE INGREDIENT SECTION

Nicotine, 14 mg delivered over 24 hours

Active ingredient Step 3 (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 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 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 if your skin swells, or you get a rashirregular 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 patch disposal.

Dispose of the used patches 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
  • begin using the patch on your quit day
  • if you smoke more than 10 cigarettes per day, use the following schedule below: stepssteps
  • 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
  • to avoid possible burns, remove patch before undergoing any MRI (magnetic resonance imaging) procedures
  • 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 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

acrylate adhesive, aluminized polyester, cellulose paper, methacrylic acid copolymer

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-585-8682

Weekdays (9am-8pm EST)

TO INCREASE YOUR SUCCESS IN QUITTING:

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 the patch for a longer period to keep from smoking, talk to your health care provider.

5. Use patch with a behavioural support program, such as the one described in the enclosed booklet.

For your family's protection, patches are supplied in child-resistant pouches. Do not use if individual pouch is open or torn.

  • 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.

Principal Display Panel STEP 1

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68001-699-88

Nicotine Transdermal System Patch

21 mg delivered over 24 hours

STOP SMOKING AID

21 mg

Includes: Behavior Support Program with self-help guide

STEP 1

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

7 Patches (1 Week Kit)

The full treatment course for Step 1 is 28 patches (4 weeks); this package contains 7 patches (1 week course) only. Read the enclosed self-help guide for additional information.

21mg 7 patches21mg 7 patches

NDC 68001-699-90

Nicotine Transdermal System Patch

21 mg delivered over 24 hours

STOP SMOKING AID

21 mg

Includes: Behavior Support Program with self-help guide

STEP 1

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 (2 Week Kit)

The full treatment course for Step 1 is 28 patches (4 weeks); this package contains 14 patches (2 week course) only. Read the enclosed self-help guide for additional information.

21 mg 14 Patches21 mg 14 Patches

NDC 68001-699-91

Nicotine Transdermal System Patch

21 mg delivered over 24 hours

STOP SMOKING AID

21 mg

Includes: Behavior Support Program with self-help guide

STEP 1

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

28 Patches (4 Week Kit)

The full treatment course for Step 1 is 28 patches (4 weeks).

21mg 28 Patches21mg 28 Patches

Principal Display Panel STEP 2

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68001-698-88

Nicotine Transdermal System Patch

14 mg delivered over 24 hours

STOP SMOKING AID

14 mg

Includes: Behavior Support Program with self-help guide

STEP 2

IF YOU SMOKE MORE THAN 10 CIGARETTES PER DAY: USE AFTER COMPLETING STEP 1

IF YOU SMOKE 10 OR LESS CIGARETTES PER DAY: START WITH STEP 2

7 Patches (1 Week Kit)

14mg 7 Patches14mg 7 Patches

NDC 68001-698-90

Nicotine Transdermal System Patch

14 mg delivered over 24 hours

STOP SMOKING AID

14 mg

Includes: Behavior Support Program with self-help guide

STEP 2

IF YOU SMOKE MORE THAN 10 CIGARETTES PER DAY: USE AFTER COMPLETING STEP 1

IF YOU SMOKE 10 OR LESS CIGARETTES PER DAY: START WITH STEP 2

14 Patches (2 Week Kit)

14mg 14 Patches14mg 14 Patches

Principal Display Panel STEP 3

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68001-697-88

Nicotine Transdermal System Patch

7 mg delivered over 24 hours

STOP SMOKING AID

7 mg

Includes: Behavior Support Program with self-help guide

STEP 3

FOR USE AFTER COMPLETING STEP 2

7 Patches (1 Week Kit)

7mg7mg

NDC 68001-697-90

Nicotine Transdermal System Patch

7 mg delivered over 24 hours

STOP SMOKING AID

7 mg

Includes: Behavior Support Program with self-help guide

STEP 3

FOR USE AFTER COMPLETING STEP 2

14 Patches (2 Week Kit)

7mg 14 Patches7mg 14 Patches

DailyMed Product Concepts#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-699-88EA - Each68001-6990b559fec-ac8e-4f2b-a210-ae625573543212026-05-22
68001-699-90EA - Each68001-6992d8ab849-3a23-45e1-9620-27d12edc43bf12026-05-22
68001-699-91EA - Each68001-699c32e2dce-a418-4c99-bc17-ca48050210a512026-05-22
68001-698-88EA - Each68001-69858a5caa8-2403-4851-be49-9001d787cf2512026-05-22
68001-698-90EA - Each68001-6980187d797-eb60-4424-beed-445629038cc412026-05-22
68001-697-88EA - Each68001-697b0db622c-1522-4464-88a9-d9e5494273fc12026-05-22
68001-697-90EA - Each68001-6972ccba3cd-1ff8-4525-a478-6f144b2dfad712026-05-22

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

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

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22026-06-05daily-update2026-06-11 05:11:04
12026-05-07full-release2026-06-01 01:56:43

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
N020076-004HABITROLNICOTINE7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12
N020076-005HABITROLNICOTINE14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12
N020076-006HABITROLNICOTINE21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1999-11-12

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 22:38:342026-08N020076-004HABITROL7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-1284e616aacf4f…
2026-09-14 22:38:342026-08N020076-005HABITROL14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-1284e616aacf4f…
2026-09-14 22:38:342026-08N020076-006HABITROL21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1999-11-1284e616aacf4f…
2026-08-18 06:07:402026-07N020076-004HABITROL7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12caaa826d4ba7…
2026-08-18 06:07:402026-07N020076-005HABITROL14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12caaa826d4ba7…
2026-08-18 06:07:402026-07N020076-006HABITROL21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1999-11-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020076-004HABITROL7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020076-005HABITROL14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020076-006HABITROL21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1999-11-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020076-004HABITROL7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020076-005HABITROL14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020076-006HABITROL21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1999-11-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08N020076-004HABITROL7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020076-005HABITROL14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020076-006HABITROL21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1999-11-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020076-004HABITROL7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020076-005HABITROL14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020076-006HABITROL21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1999-11-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020076-004HABITROL7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020076-005HABITROL14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020076-006HABITROL21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1999-11-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020076-004HABITROL7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020076-005HABITROL14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020076-006HABITROL21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1999-11-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020076-004HABITROL7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020076-005HABITROL14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020076-006HABITROL21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1999-11-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020076-004HABITROL7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020076-005HABITROL14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020076-006HABITROL21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1999-11-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020076-004HABITROL7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020076-005HABITROL14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020076-006HABITROL21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1999-11-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020076-004HABITROL7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12d06236e962d9…
2024-10-29 15:01 UTC2024-10N020076-005HABITROL14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12d06236e962d9…
2024-10-29 15:01 UTC2024-10N020076-006HABITROL21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1999-11-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020076-004HABITROL7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020076-005HABITROL14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020076-006HABITROL21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1999-11-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020076-004HABITROL7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12301d65b070ca…

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 System Patch Step 3NICOTINE TRANSDERMAL SYSTEM PATCHBluePoint Laboratories4856e99a-badc-b957-e063-6294a90a86062026-07-10WarningsExact identifier
ndc (package): 68001-699-90
ndc (package): 68001-697-90
ndc (package): 68001-699-88
ndc (package): 68001-697-88
ndc (package): 68001-698-88
ndc (package): 68001-699-91
ndc (package): 68001-698-90
ndc (product): 68001-698
ndc (product): 68001-699
ndc (product): 68001-697
ndc11 (package): 68001069890
ndc11 (package): 68001069988
ndc11 (package): 68001069788
ndc11 (package): 68001069888
ndc11 (package): 68001069790
ndc11 (package): 68001069991
ndc11 (package): 68001069990
spl id: 563efbee-122d-62d6-e063-6394a90a2a2b
spl set id: 4856e99a-badc-b957-e063-6294a90a8606

Reported adverse events (FAERS/openFDA)#

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