Nicotine

Manufacturer
Sam's West Inc | Haleon US Holdings LLC
Effective date
2025-06-10
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 01:02:48

Label at a glance#

ProductNicotine transdermal system
Active ingredientNICOTINE
Label structure9 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 • stop smoking completely when you begin using the patch • 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 pat...

Label contents#

Full prescribing information#

Active ingredient (in each patch)

OTC - ACTIVE INGREDIENT SECTION

Nicotine, 21 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.

Do Not Use

OTC - DO NOT USE SECTION

  • if you continue to smoke, chew tobacco, use snuff, or use a nicotine gum 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 have 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 blood stream 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 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

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
  • stop smoking completely when you begin using the patch
  • if you smoke more than 10 cigarettes per day, use according to the following 10 week schedule:
  1. STEP 1
  1. STEP 2
  1. STEP 3
  1. Use one 21 mg patch/day
  1. Use one 14 mg patch/day
  1. Use one 7 mg patch/day
  1. Weeks 1-6
  1. Weeks 7-8
  1. Weeks 9-10
  • if you smoke 10 or less cigarettes per day, do not use STEP 1 (21mg). Start with STEP 2 (14mg), for 6 weeks, then STEP 3 (7mg) 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
  • stop using the patch at the end of 10 weeks. If you started with STEP 2, 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

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

Questions or comments?

OTC - QUESTIONS SECTION

call toll-free 1-866-255-5205 (English/Spanish) weekdays

TO INCREASE YOUR SUCCESS IN QUITTING:

  • You must be motivated to quit.
  • Complete the full treatment program, applying a new patch every day.
  • Use with a support program as described in the enclosed User’s Guide.
  • For your family’s protection, Nicotine Patches are supplied in child-resistant pouches. Do not use if individual pouch/packet is damaged or open.
  • Nicotine transdermal system 21 mg delivered over 24 hours
  • Stop smoking aid
  • Not for sale to those under 18 years of age.
  • Prrof of age required.
  • Not for sale in vending machines or from any source where proof of age cannot be verified.
  • Free Audio CD upon request. See inside.
  • What is the Nicotine Patch and How is it Used?
  • Nicotine Patch is a small, nicotine-containing patch. When you put on a Nicotine Patch, nicotine passes through the skin and into your body. Nicotine Patch is 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 24 or 16-hour period you wear the Nicotine Patch. This helps to reduce cravings you may have for nicotine.
  • Read carton and enclosed User’s Guide before using this product. Keep the carton and User’s Guide. They contain important information.
  • THE SIMPLY RIGHT™ PROMISE
  • Simply Right is dedicated to providing healthful, gentle, and safe personal care products for the entire family. We continuously strive to be your trusted partner in wellness and exceed your expectations.
  • We would like to hear from you with any comments or suggestions. In the continental US or Canada, you can call us toll-free at 1-800-255-5205, Monday through Friday, from 8 am to 5 pm CST. Or you can send us an email at samsclub.com.
  • Distributed by:
  • SAM’S West, Inc.
  • Bentonville, AR 72716
  • *NICODERM is a licensed trademark of the GlaxoSmithKline group of companies.
  • SATISFACTION GUARANTEED BY REFUND OR EXCHANGE
  • Made in Switzerland
  • Send comments/questions to:
  • GCSP 5.4376.4C
  • Consumer Relations
  • P.O. Box 13398
  • Research Triangle Park, NC 27709-9627

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68196-194-03

nicotine patch

Nicotine Transdermal System 21mg delivered over 24 hours Stop smoking aid

21 mg

SIMPLY RIGHT™

Health Care

Compare to NicoDerm®CQ® *

Includes behavior support program enrollment form & user’s 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 1

21 clear patches

©2011

101775XA

101775XA Nicotine Patch Sams 21 mg 21 ct carton
101775XA Nicotine Patch Sams 21 mg 21 ct carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198030nicotine 21 MG/Day 24HR Transdermal SystemPSN10
19803024 HR nicotine 0.875 MG/HR Transdermal SystemSCD10
198030nicotine 0.875 MG/HR 24HR Transdermal PatchSY10
198030nicotine 21 MG per 24HR 1 Day Transdermal PatchSY10
198030nicotine 21 MG/Day 24HR Transdermal SystemSY10

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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68196-194-032024-03-21C16284748780-1ba0f9c33-2416-a910-e053-dadaa90a0b85Drug Facts
68196-194-032024-01-30C16284748780-1ba0f9c33-2416-a910-e053-dadaa90a0b85Drug Facts
68196-194-032022-07-15C16284748780-1ba0f9c33-2416-a910-e053-dadaa90a0b85Drug Facts
68196-194-032021-01-29C16284748780-1ba0f9c33-2416-a910-e053-dadaa90a0b85Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68196-194-03Nicotinetransdermal system21 in 1 CARTONPATCH, EXTENDED RELEASE2110
68196-194-03Nicotinetransdermal system24 h in 1 PATCHPATCH, EXTENDED RELEASE2410

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
NICOTINEACTIVE INGREDIENT6M3C89ZY6R4
NICOTINEACTIVE MOIETY6M3C89ZY6R4
ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE)INACTIVE INGREDIENTL5F16ZG4ZU4
HIGH DENSITY POLYETHYLENEINACTIVE INGREDIENTUG00KM4WR74

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68196-19468196-194-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 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 · 4 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7SYSTEM / TRANSDERMALNAExact identifier — unii+route
4 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7FILM, EXTENDED RELEASE / TRANSDERMAL85 mgExact identifier — unii+route
4 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7SYSTEM / TRANSDERMALNAExact identifier — unii+route
4 equally ranked IID candidates
HIGH DENSITY POLYETHYLENEHIGH DENSITY POLYETHYLENEUG00KM4WR7FILM, EXTENDED RELEASE / TRANSDERMAL85 mgExact identifier — unii+route
4 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
Nicotine transdermal systemNICOTINESam's West Inccd9aa56c-ac88-4f9b-9ff9-a9720af6c1a72025-06-10WarningsExact identifier
ndc (package): 68196-194-03
ndc (product): 68196-194
ndc11 (package): 68196019403
spl id: 0688260f-58f8-41f6-8b77-4e16833f58cc
spl set id: cd9aa56c-ac88-4f9b-9ff9-a9720af6c1a7

Reported adverse events (FAERS/openFDA)#

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