NICODERM

Manufacturer
Haleon US Holdings LLC
Effective date
2025-07-14
Label type
HUMAN OTC DRUG LABEL
Version
14
Source
full-release
Hydrated at
2026-06-01 01:07:18

Label at a glance#

ProductNICODERM CQ
Active ingredientNICOTINE
Label structure16 sections

Dosage and administration

if you are under 18 years of age, ask a doctor before use before using this product, read the enclosed User's 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 according to the following 10-week schedule: STEP 1 STEP 2 STEP 3 Use one 21 mg patch/day Use one 14 mg patch/day Use one 7 mg patch/day Weeks 1-6 Weeks 7-8 Weeks 9-1...

Storage and handling

store at 20-25°C (68-77°F)

Label contents#

Full prescribing information#

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

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

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.

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 ulcers 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 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. Dispose of the used patches by folding sticky ends together. Replace in pouch and discard.

Directions

DOSAGE & ADMINISTRATION SECTION

  • if you are under 18 years of age, ask a doctor before use
  • before using this product, read the enclosed User's 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 according to the following 10-week schedule:

STEP 1

STEP 2

STEP 3

Use one 21 mg patch/day

Use one 14 mg patch/day

Use one 7 mg patch/day

Weeks 1-6

Weeks 7-8

Weeks 9-10

  • if you smoke 10 or less cigarettes per day,do not use STEP 1 (21 mg).Start with STEP 2 (14 mg)for 6 weeks, then STEP 3 (7 mg)for 2 weeks and then stop.
  • steps 2 and 3 allow you to gradually reduce your level of nicotine. Completing the full program will increase your chances of quitting successfully.
  • apply one new patch every 24 hours on skin that is dry, clean and hairless. Save pouch for disposing of the patch after use.
  • remove backing from patch and immediately press onto skin. Hold for 10 seconds.
  • wash hands after applying or removing patch. Throw away the patch by folding sticky ends together. Replace in its pouch and discard. See enclosed User's Guide for safety and handling.
  • you may wear the patch for 16 or 24 hours
  • if you crave cigarettes when you wake up, wear the patch for 24 hours
  • if you have vivid dreams or other sleep disturbances, you may remove the patch at bedtime and apply a new one in the morning
  • the used patch should be removed and a new one applied to a different skin site at the same time each day
  • 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

STORAGE AND HANDLING SECTION

  • store at 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

ethylene vinyl acetate-copolymer, polyisobutylene and high density polyethylene between clear polyester backings

Questions or comments?

OTC - QUESTIONS SECTION

call toll-free 1-800-834-5895

Additional Information ( Step 1)

SPL UNCLASSIFIED SECTION

Read carton and enclosed User’s Guide before using this product. Keep this carton and User’s Guide. They contain important information.

Includes User’s Guide with MyQuit Program Enrollment Offer.

What is the NicoDerm CQPatch and How is it Used?
NicoDerm CQis a small, nicotine-containing patch. When you put on a NicoDerm CQpatch, nicotine passes through the skin and into your body. NicoDerm CQis very thin and uses special material to control how fast nicotine passes through the skin. Unlike the sudden jolts of nicotine delivered by cigarettes, the amount of nicotine you receive remains relatively smooth throughout the 16 or 24 hour period you wear the NicoDerm CQpatch. This helps to reduce cravings you may have for nicotine.

READ THE LABEL
Nicotine Transdermal System
STOP SMOKING AID
STEP 1
14 clear patches (2-week kit)

  • Not for sale to those 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.

Trademarks are owned by or licensed to the GSK group of companies.

For more information and for a FREE individualized stop smoking program, please visit www.nicodermcq.comor see inside for more details.

U.S. Patent No. 7,622,136

8,075,911

TO INCREASE YOUR SUCCESS IN QUITTING:

1. You must be motivated to quit.

2. Complete the full treatment program, applying a new patch every day.

3. Use with a support program as described in the enclosed User's Guide.

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

NicoDerm CQ is a three step program. You start with the highest level of medicine and

gradually step down your dose. If you smoke 10 or less cigarettes per day, start with Step 2.

Made in Ireland

©2022 GSK group of companies or its licensor.

200697

Additional Information ( Step 2)

SPL UNCLASSIFIED SECTION

Read carton and enclosed User’s Guide before using this product. Keep this carton and User’s Guide. They contain important information.

Includes User’s Guide with MyQuit Program Enrollment Offer.

What is the NicoDerm CQPatch and How is it Used?
NicoDerm CQis a small, nicotine-containing patch. When you put on a NicoDerm CQpatch, nicotine passes through the skin and into your body. NicoDerm CQis very thin and uses special material to control how fast nicotine passes through the skin. Unlike the sudden jolts of nicotine delivered by cigarettes, the amount of nicotine you receive remains relatively smooth throughout the 16 or 24 hour period you wear the NicoDerm CQpatch. This helps to reduce cravings you may have for nicotine.

READ THE LABEL
Nicotine Transdermal System
STOP SMOKING AID
STEP 2
14 clear patches (2-week kit)

  • Not for sale to those 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.

Trademarks are owned by or licensed to the GSK group of companies.

For more information and for a FREE individualized stop smoking program, please visit www.nicodermcq.comor see inside for more details.

U.S. Patent No. 7,622,136

8,075,911

TO INCREASE YOUR SUCCESS IN QUITTING:

1. You must be motivated to quit.

2. Complete the full treatment program, applying a new patch every day.

3. Use with a support program as described in the enclosed User's Guide.

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

NicoDerm CQ is a three step program. You start with the highest level of medicine and

gradually step down your dose. If you smoke 10 or less cigarettes per day, start with Step 2.

Made in Ireland

©2022 GSK group of companies or its licensor.

201227

Additional Information ( Step 3)

SPL UNCLASSIFIED SECTION

Read carton and enclosed User’s Guide before using this product. Keep this carton and User’s Guide. They contain important information.

Includes User’s Guide with MyQuit Program Enrollment Offer.

What is the NicoDerm CQ Patch and How is it Used?

NicoDerm CQis a small, nicotine-containing patch. When you put on a NicoDerm CQpatch, nicotine passes through the skin and into your body. NicoDerm CQis very thin and uses special material to control how fast nicotine passes through the skin. Unlike the sudden jolts of nicotine delivered by cigarettes, the amount of nicotine you receive remains relatively smooth throughout the 16 or 24 hour period you wear the NicoDerm CQpatch. This helps to reduce cravings you may have for nicotine.

READ THE LABEL
Nicotine Transdermal System
STOP SMOKING AID
STEP 3
14 clear patches (2-week kit)

  • Not for sale to those 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.

Trademarks are owned by or licensed to the GSK group of companies.

For more information and for a FREE individualized stop smoking program, please visit www.nicodermcq.comor see inside for more details.

U.S. Patent No. 7,622,136

8,075,911

TO INCREASE YOUR SUCCESS IN QUITTING:

1. You must be motivated to quit.

2. Complete the full treatment program, applying a new patch every day.

3. Use with a support program as described in the enclosed User's Guide.

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

NicoDerm CQ is a three step program. You start with the highest level of medicine and

gradually step down your dose. If you smoke 10 or less cigarettes per day, start with Step 2.

Made in Ireland

©2022 GSK group of companies or its licensor.

201228

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0135-0194-02

NicoDerm CQ

Nicotine Transdermal System 21 mg Delivered over 24 Hours

STOP SMOKING AID

CLEAR PATCH

EXTENDED RELEASE24 HOURS

SMARTCONTROL TECHNOLOGY

STEP 1

21 mg

IF YOU SMOKE MORE THAN 10 CIGARETTESA DAY, START WITH STEP 1

10 OR LESS CIGARETTESA DAY, START WITH STEP 2

ACTUAL SIZE

14 clear patches( 2-week kit)

The full course of treatment for STEP 1 is 42 patches (6 weeks); this package contains 14 patches (2-week course) only.

Read the enclosed User’s Guide for additional information.

200697 Nicoderm CQ 21mg clear patch 14 count.jpg
200697 Nicoderm CQ 21mg clear patch 14 count.jpg

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0135-0195-02

NicoDerm CQ

Nicotine Transdermal System 14 mg Delivered over 24 Hours

STOP SMOKING AID

CLEAR PATCH

EXTENDED RELEASE24 HOURS

SMARTCONTROL TECHNOLOGY

STEP 2

14 mg

IF YOU SMOKE 10 OR LESS CIGARETTESA DAY, START WITH STEP 2

MORE THAN 10 CIGARETTESA DAY, START WITH STEP 1

ACTUAL SIZE

14 clear patches( 2-week kit)

The full course of treatment for STEP 2 is 2 or 6 weeks (depending on how many cigarettes you smoke per day).
Read the enclosed User’s Guide for additional information.

PA201227 Nicoderm CQ 14 mg clear patch 14 count
PA201227 Nicoderm CQ 14 mg clear patch 14 count

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0135-0196-02

NicoDerm CQ

Nicotine Transdermal System 7 mg Delivered over 24 Hours

STOP SMOKING AID

CLEAR PATCH

EXTENDED RELEASE24 HOURS

SMARTCONTROL TECHNOLOGY

STEP 3

7 mg

FOR USE AFTER COMPLETING STEP 2

ACTUAL SIZE

14 clear patches( 2-week kit)

201228_ Nicoderm CQ 21mg clear patch 14 count.jpg
201228_ Nicoderm CQ 21mg clear patch 14 count.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
351429NICODERM CQ (Step 1) 21 MG/Day 24HR Transdermal SystemPSN14
351427NICODERM CQ (Step 2) 14 MG/Day 24HR Transdermal SystemPSN14
351433NICODERM CQ (Step 3) 7 MG/Day 24HR Transdermal SystemPSN14
198029nicotine 14 MG/Day 24HR Transdermal SystemPSN14
198030nicotine 21 MG/Day 24HR Transdermal SystemPSN14
198031nicotine 7 MG/Day 24HR Transdermal SystemPSN14
35143324 HR nicotine 0.292 MG/HR Transdermal System [Nicoderm C-Q]SBD14
35142724 HR nicotine 0.583 MG/HR Transdermal System [Nicoderm C-Q]SBD14
35142924 HR nicotine 0.875 MG/HR Transdermal System [Nicoderm C-Q]SBD14
19803124 HR nicotine 0.292 MG/HR Transdermal SystemSCD14
19802924 HR nicotine 0.583 MG/HR Transdermal SystemSCD14
19803024 HR nicotine 0.875 MG/HR Transdermal SystemSCD14
35143324 HR Nicoderm C-Q 0.292 MG/HR Transdermal SystemSY14
35142724 HR Nicoderm C-Q 0.583 MG/HR Transdermal SystemSY14
35142924 HR Nicoderm C-Q 0.875 MG/HR Transdermal SystemSY14
351433Nicoderm C-Q 0.292 MG/HR 24HR Transdermal PatchSY14
351427Nicoderm C-Q 0.583 MG/HR 24HR Transdermal PatchSY14
351429Nicoderm C-Q 0.875 MG/HR 24HR Transdermal PatchSY14
351429Nicoderm CQ (Step 1) 21 MG/Day 24HR Transdermal PatchSY14
351429NICODERM CQ (Step 1) 21 MG/Day 24HR Transdermal SystemSY14
351427Nicoderm CQ (Step 2) 14 MG/Day 24HR Transdermal PatchSY14
351427NICODERM CQ (Step 2) 14 MG/Day 24HR Transdermal SystemSY14
351433Nicoderm CQ (Step 3) 7 MG/Day 24HR Transdermal PatchSY14
351433NICODERM CQ (Step 3) 7 MG/Day 24HR Transdermal SystemSY14
198031nicotine 0.292 MG/HR 24HR Transdermal PatchSY14
198029nicotine 0.583 MG/HR 24HR Transdermal PatchSY14
198030nicotine 0.875 MG/HR 24HR Transdermal PatchSY14
198029nicotine 14 MG per 24HR 1 Day Transdermal PatchSY14
198029nicotine 14 MG/Day 24HR Transdermal SystemSY14
198030nicotine 21 MG per 24HR 1 Day Transdermal PatchSY14
198030nicotine 21 MG/Day 24HR Transdermal SystemSY14
198031nicotine 7 MG per 24HR 1 Day Transdermal PatchSY14
198031nicotine 7 MG/Day 24HR Transdermal SystemSY14

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0135-0194-01NICODERMCQ24 h in 1 PATCHPATCH, EXTENDED RELEASE2414
0135-0194-01NICODERMCQ7 in 1 CARTONPATCH, EXTENDED RELEASE714
0135-0194-02NICODERMCQ14 in 1 CARTONPATCH, EXTENDED RELEASE1414
0135-0194-02NICODERMCQ24 h in 1 PATCHPATCH, EXTENDED RELEASE2414
0135-0194-03NICODERMCQ1 in 1 PACKAGEPATCH, EXTENDED RELEASE114
0135-0194-03NICODERMCQ21 in 1 CARTONPATCH, EXTENDED RELEASE2114
0135-0194-05NICODERMCQ14 in 1 CARTONPATCH, EXTENDED RELEASE1414
0135-0194-08NICODERMCQ24 h in 1 PATCHPATCH, EXTENDED RELEASE2414
0135-0195-02NICODERMCQ24 h in 1 PATCHPATCH, EXTENDED RELEASE2414
0135-0195-02NICODERMCQ14 in 1 CARTONPATCH, EXTENDED RELEASE1414
0135-0195-03NICODERMCQ1 in 1 PACKAGEPATCH, EXTENDED RELEASE114
0135-0195-03NICODERMCQ21 in 1 CARTONPATCH, EXTENDED RELEASE2114
0135-0195-05NICODERMCQ14 in 1 CARTONPATCH, EXTENDED RELEASE1414
0135-0195-08NICODERMCQ24 h in 1 PATCHPATCH, EXTENDED RELEASE2414
0135-0196-02NICODERMCQ24 h in 1 PATCHPATCH, EXTENDED RELEASE2414
0135-0196-02NICODERMCQ14 in 1 CARTONPATCH, EXTENDED RELEASE1414
0135-0196-05NICODERMCQ14 in 1 CARTONPATCH, EXTENDED RELEASE1414
0135-0196-08NICODERMCQ24 h in 1 PATCHPATCH, EXTENDED RELEASE2414

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0135-0194-01EA - Each0135-0194764c561d-0286-41c7-8803-a84b913ac63c12012-07-24
0135-0194-02EA - Each0135-0194ed1b78a8-f9d2-4184-9f11-ca2887f2940912012-07-24
0135-0194-03EA - Each0135-01945fa417a3-c62e-4436-bd7b-d75721ec0f5c12014-06-03
0135-0194-05EA - Each0135-0194afb31bf6-e1ae-4c33-83c1-44178201df7512014-06-03
0135-0194-08EA - Each0135-0194e311bc3a-9018-4bab-bf70-37b3e89496e212024-01-04
0135-0195-02EA - Each0135-01951051b6d9-5b9d-422f-b685-5af1e5bb2eae12012-07-24
0135-0195-03EA - Each0135-0195178d1ec3-2586-400d-a8a4-3246f132f4c612014-06-03
0135-0195-05EA - Each0135-01959c878f3a-cf66-48ca-9809-3447f30fa33312014-06-03
0135-0196-02EA - Each0135-0196d4f28401-2889-4953-8b2c-f686ad25943912012-07-24
0135-0196-05EA - Each0135-01961562ebf8-f662-4ce6-9d0f-3649e6fa6de212014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
NICOTINEACTIVE INGREDIENT6M3C89ZY6R5
NICOTINEACTIVE MOIETY6M3C89ZY6R5
ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE)INACTIVE INGREDIENTL5F16ZG4ZU5
HIGH DENSITY POLYETHYLENEINACTIVE INGREDIENTUG00KM4WR75

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 30 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7FILM, EXTENDED RELEASE / TRANSDERMAL85 mgExact identifier — unii+route
30 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7SYSTEM / TRANSDERMALNAExact identifier — unii+route
30 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7FILM, EXTENDED RELEASE / TRANSDERMAL85 mgExact identifier — unii+route
30 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7SYSTEM / TRANSDERMALNAExact identifier — unii+route
30 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7SYSTEM / TRANSDERMALNAExact identifier — unii+route
30 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7FILM, EXTENDED RELEASE / TRANSDERMAL85 mgExact identifier — unii+route
30 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7SYSTEM / TRANSDERMALNAExact identifier — unii+route
30 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7FILM, EXTENDED RELEASE / TRANSDERMAL85 mgExact identifier — unii+route
30 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7SYSTEM / TRANSDERMALNAExact identifier — unii+route
30 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7SYSTEM / TRANSDERMALNAExact identifier — unii+route
30 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7FILM, EXTENDED RELEASE / TRANSDERMAL85 mgExact identifier — unii+route
30 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7FILM, EXTENDED RELEASE / TRANSDERMAL85 mgExact identifier — unii+route
30 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7FILM, EXTENDED RELEASE / TRANSDERMAL85 mgExact identifier — unii+route
30 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7SYSTEM / TRANSDERMALNAExact identifier — unii+route
30 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7SYSTEM / TRANSDERMALNAExact identifier — unii+route
30 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7FILM, EXTENDED RELEASE / TRANSDERMAL85 mgExact identifier — unii+route
30 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7FILM, EXTENDED RELEASE / TRANSDERMAL85 mgExact identifier — unii+route
30 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7SYSTEM / TRANSDERMALNAExact identifier — unii+route
30 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7FILM, EXTENDED RELEASE / TRANSDERMAL85 mgExact identifier — unii+route
30 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7FILM, EXTENDED RELEASE / TRANSDERMAL85 mgExact identifier — unii+route
30 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7SYSTEM / TRANSDERMALNAExact identifier — unii+route
30 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7SYSTEM / TRANSDERMALNAExact identifier — unii+route
30 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7SYSTEM / TRANSDERMALNAExact identifier — unii+route
30 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7FILM, EXTENDED RELEASE / TRANSDERMAL85 mgExact identifier — unii+route
30 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7SYSTEM / TRANSDERMALNAExact identifier — unii+route
30 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7SYSTEM / TRANSDERMALNAExact identifier — unii+route
30 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7SYSTEM / TRANSDERMALNAExact identifier — unii+route
30 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7FILM, EXTENDED RELEASE / TRANSDERMAL85 mgExact identifier — unii+route
30 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7FILM, EXTENDED RELEASE / TRANSDERMAL85 mgExact identifier — unii+route
30 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7FILM, EXTENDED RELEASE / TRANSDERMAL85 mgExact identifier — unii+route
30 equally ranked IID candidates

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
N020165-004NICODERM CQNICOTINE21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1996-08-02
N020165-005NICODERM CQNICOTINE14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1996-08-02
N020165-006NICODERM CQNICOTINE7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1996-08-02

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 22:38:342026-08N020165-004NICODERM CQ21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1996-08-0284e616aacf4f…
2026-09-14 22:38:342026-08N020165-005NICODERM CQ14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1996-08-0284e616aacf4f…
2026-09-14 22:38:342026-08N020165-006NICODERM CQ7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1996-08-0284e616aacf4f…
2026-08-18 06:07:402026-07N020165-004NICODERM CQ21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1996-08-02caaa826d4ba7…
2026-08-18 06:07:402026-07N020165-005NICODERM CQ14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1996-08-02caaa826d4ba7…
2026-08-18 06:07:402026-07N020165-006NICODERM CQ7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1996-08-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020165-004NICODERM CQ21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1996-08-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020165-005NICODERM CQ14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1996-08-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02N020165-006NICODERM CQ7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1996-08-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020165-004NICODERM CQ21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1996-08-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020165-005NICODERM CQ14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1996-08-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020165-006NICODERM CQ7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1996-08-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08N020165-004NICODERM CQ21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1996-08-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020165-005NICODERM CQ14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1996-08-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08N020165-006NICODERM CQ7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1996-08-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020165-004NICODERM CQ21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1996-08-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020165-005NICODERM CQ14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1996-08-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020165-006NICODERM CQ7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1996-08-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020165-004NICODERM CQ21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1996-08-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020165-005NICODERM CQ14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1996-08-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020165-006NICODERM CQ7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1996-08-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020165-004NICODERM CQ21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1996-08-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020165-005NICODERM CQ14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1996-08-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020165-006NICODERM CQ7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1996-08-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020165-004NICODERM CQ21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1996-08-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020165-005NICODERM CQ14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1996-08-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020165-006NICODERM CQ7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1996-08-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020165-004NICODERM CQ21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1996-08-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020165-005NICODERM CQ14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1996-08-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020165-006NICODERM CQ7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1996-08-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020165-004NICODERM CQ21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1996-08-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020165-005NICODERM CQ14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1996-08-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020165-006NICODERM CQ7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1996-08-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020165-004NICODERM CQ21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1996-08-02d06236e962d9…
2024-10-29 15:01 UTC2024-10N020165-005NICODERM CQ14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1996-08-02d06236e962d9…
2024-10-29 15:01 UTC2024-10N020165-006NICODERM CQ7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1996-08-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020165-004NICODERM CQ21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1996-08-0279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020165-005NICODERM CQ14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1996-08-0279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020165-006NICODERM CQ7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1996-08-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020165-004NICODERM CQ21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1996-08-02301d65b070ca…

Observed Orange Book patent history#

Patent history page 1 of 2 · 75 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N020165-00492050592019-12-15Drug product2016-01-0674a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020165-00486636802020-02-13Drug product2014-03-3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020165-00489993792020-02-13U-16862015-05-0474a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020165-00480759112021-05-22Drug product2012-03-0974a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020165-00592050592019-12-15Drug product2016-01-0674a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020165-00586636802020-02-13Drug product2014-03-3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020165-00589993792020-02-13U-16862015-05-0474a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020165-00580759112021-05-22Drug product74a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020165-00692050592019-12-15Drug product2016-01-0674a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020165-00686636802020-02-13Drug product2014-03-3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020165-00689993792020-02-13U-16862015-05-0474a2ff9319b5…
2019-12-13 00:20 UTC2019-12N020165-00680759112021-05-22Drug product74a2ff9319b5…
2021-12-28 21:50 UTC2021-12N020165-00480759112021-05-22Drug product2012-03-09782e0a99824c…
2021-12-28 21:50 UTC2021-12N020165-00580759112021-05-22Drug product782e0a99824c…
2021-12-28 21:50 UTC2021-12N020165-00680759112021-05-22Drug product782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020165-00480759112021-05-22Drug product2012-03-0987673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020165-00580759112021-05-22Drug product87673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020165-00680759112021-05-22Drug product87673890dc5c…
2021-03-12 10:30 UTC2021-03N020165-00480759112021-05-22Drug product2012-03-095aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N020165-00580759112021-05-22Drug product5aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N020165-00680759112021-05-22Drug product5aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020165-00486636802020-02-13Drug product2014-03-318869cabd3fbd…
2020-12-22 03:56 UTC2020-12N020165-00489993792020-02-13U-16862015-05-048869cabd3fbd…
2020-12-22 03:56 UTC2020-12N020165-00480759112021-05-22Drug product2012-03-098869cabd3fbd…
2020-12-22 03:56 UTC2020-12N020165-00586636802020-02-13Drug product2014-03-318869cabd3fbd…
2020-12-22 03:56 UTC2020-12N020165-00589993792020-02-13U-16862015-05-048869cabd3fbd…
2020-12-22 03:56 UTC2020-12N020165-00580759112021-05-22Drug product8869cabd3fbd…
2020-12-22 03:56 UTC2020-12N020165-00686636802020-02-13Drug product2014-03-318869cabd3fbd…
2020-12-22 03:56 UTC2020-12N020165-00689993792020-02-13U-16862015-05-048869cabd3fbd…
2020-12-22 03:56 UTC2020-12N020165-00680759112021-05-22Drug product8869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020165-00486636802020-02-13Drug product2014-03-31c0c555d07b60…
2020-11-12 02:37 UTC2020-11N020165-00489993792020-02-13U-16862015-05-04c0c555d07b60…
2020-11-12 02:37 UTC2020-11N020165-00480759112021-05-22Drug product2012-03-09c0c555d07b60…
2020-11-12 02:37 UTC2020-11N020165-00586636802020-02-13Drug product2014-03-31c0c555d07b60…
2020-11-12 02:37 UTC2020-11N020165-00589993792020-02-13U-16862015-05-04c0c555d07b60…
2020-11-12 02:37 UTC2020-11N020165-00580759112021-05-22Drug productc0c555d07b60…
2020-11-12 02:37 UTC2020-11N020165-00686636802020-02-13Drug product2014-03-31c0c555d07b60…
2020-11-12 02:37 UTC2020-11N020165-00689993792020-02-13U-16862015-05-04c0c555d07b60…
2020-11-12 02:37 UTC2020-11N020165-00680759112021-05-22Drug productc0c555d07b60…
2019-12-14 00:12 UTC2019-12N020165-00492050592019-12-15Drug product2016-01-063f01610625f2…

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
NICODERM CQNICOTINEHaleon US Holdings LLC93b2d1b9-83c1-40b5-b6af-90c38c8d6cef2025-07-14WarningsExact identifier
ndc (package): 0135-0194-02
ndc (package): 0135-0195-02
ndc (package): 0135-0195-03
ndc (package): 0135-0195-05
ndc (package): 0135-0194-03
ndc (package): 0135-0194-01
ndc (package): 0135-0194-08
ndc (package): 0135-0196-05
ndc (package): 0135-0195-08
ndc (package): 0135-0196-08
ndc (package): 0135-0196-02
ndc (package): 0135-0194-05
ndc (product): 0135-0195
ndc (product): 0135-0196
ndc (product): 0135-0194
ndc11 (package): 00135019505
ndc11 (package): 00135019402
ndc11 (package): 00135019502
ndc11 (package): 00135019605
ndc11 (package): 00135019602
ndc11 (package): 00135019405
ndc11 (package): 00135019408
ndc11 (package): 00135019503
ndc11 (package): 00135019608
ndc11 (package): 00135019401
ndc11 (package): 00135019508
ndc11 (package): 00135019403
spl id: 39e81d62-9ad8-8f7f-e063-6394a90a17b2
spl set id: 93b2d1b9-83c1-40b5-b6af-90c38c8d6cef

Reported adverse events (FAERS/openFDA)#

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