Nicotine Transdermal System

Manufacturer: Chain Drug Consortium, LLC | Aveva Drug Delivery Systems
Effective date: 2024-02-19
Label type: HUMAN OTC DRUG LABEL
Version: 8
Source: full-release
Hydrated at: 2026-06-01 00:08:47

Label at a glance#

ProductNicotine Transdermal System Step 3

Active ingredientNICOTINE

Label structure12 sections

Dosage and administration

if you are under 18 years of age, ask a doctor before use before using this product, read the enclosed self-help guide for complete directions and other information begin using the patch on your quit day if you smoke more than 10 cigarettes per day, use the following schedule below: Weeks 1 thru 2 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...

Contacts and useful links#

PhoneLabel contact1-844-562-7963

Label contents#

Full prescribing information#

Active ingredient(in each patch)

OTC - ACTIVE INGREDIENT SECTION

Step 1 - Nicotine, 21 mg delivered over 24 hours

Step 2 - Nicotine, 14 mg delivered over 24 hours

Step 3 - 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.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.

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. 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 yousmoke more than 10 cigarettes per day,use the following schedule below:
Weeks 1 thru 2 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 2for 6 weeks, then Step 3for 2 weeks
apply one new patch every 24 hours on skin that is dry, clean and hairless
remove backing from patch and immediately press onto skin. Hold for 10 seconds.
wash hands after applying or removing patch. Save pouch to use for patch disposal. Dispose of the used patches by folding sticky ends together and putting in pouch.
the used patch should be removed and a new one applied to a different skin site at the same time each day
if you have vivid dreams, you may remove the patch at bedtime and apply a new one in the morning
do not wear more than one patch at a time
do not cut patch in half or into smaller pieces
do not leave patch on for more than 24 hours because it may irritate your skin and loses strength after 24 hours
it is important to complete treatment. If you feel you need to use the patch for a longer period to keep from smoking, talk to your health care provider.

Other information

SPL UNCLASSIFIED SECTION

store at 20 ^°C – 25 ^°C (68 ^°F – 77 ^°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

acrylate adhesive, polyester, silicone adhesive

Comments or Questions?

OTC - QUESTIONS SECTION

1-844-562-7963

TO INCREASE YOUR SUCCESS IN QUITTING:

SPL UNCLASSIFIED SECTION

1. You must be motivated to quit.

2. Use one patch daily according to directions.

3. It is important to complete treatment.

4. If you feel you need to use the patch for a longer period to keep from smoking, talk to your health care provider.

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

PRINCIPAL DISPLAY PANEL - 7 mg CARTON

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Nicotine Transdermal System

NDC No. 68016-290-88

14 Patches

7mgcarton.jpg

PRINCIPAL DISPLAY PANEL - 14 mg CARTON

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Nicotine Transdermal System

NDC No. 68016-289-88

14 Patches

14mgcarton.jpg

PRINCIPAL DISPLAY PANEL- 21 mg CARTON

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Nicotine Transdermal System

NDC No. 68016-288-88

14 Patches

21mgcarton.jpg

RxCUI, Display, Full name table
RxCUI	Display	Full name	Type
198031	Nicotine (Transdermal)	24 HR nicotine 0.292 MG/HR Transdermal System	SCD Active
198029	Nicotine (Transdermal)	24 HR nicotine 0.583 MG/HR Transdermal System	SCD Active
198030	Nicotine (Transdermal)	24 HR nicotine 0.875 MG/HR Transdermal System	SCD Active

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
198029	nicotine 14 MG/Day 24HR Transdermal System	PSN	8
198030	nicotine 21 MG/Day 24HR Transdermal System	PSN	8
198031	nicotine 7 MG/Day 24HR Transdermal System	PSN	8
198031	24 HR nicotine 0.292 MG/HR Transdermal System	SCD	8
198029	24 HR nicotine 0.583 MG/HR Transdermal System	SCD	8
198030	24 HR nicotine 0.875 MG/HR Transdermal System	SCD	8
198031	nicotine 0.292 MG/HR 24HR Transdermal Patch	SY	8
198029	nicotine 0.583 MG/HR 24HR Transdermal Patch	SY	8
198030	nicotine 0.875 MG/HR 24HR Transdermal Patch	SY	8
198029	nicotine 14 MG per 24HR 1 Day Transdermal Patch	SY	8
198029	nicotine 14 MG/Day 24HR Transdermal System	SY	8
198030	nicotine 21 MG per 24HR 1 Day Transdermal Patch	SY	8
198030	nicotine 21 MG/Day 24HR Transdermal System	SY	8
198031	nicotine 7 MG per 24HR 1 Day Transdermal Patch	SY	8
198031	nicotine 7 MG/Day 24HR Transdermal System	SY	8

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
NICOTINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68016-288-88	2026-01-29	C162847	48780-1	49896155-bffd-586f-e063-e6dba90add90	NICOTINE TRANSDERMAL SYSTEM, STEP 1, STEP 2, STEP 3
68016-289-88	2026-01-29	C162847	48780-1	49896155-bffd-586f-e063-e6dba90add90	NICOTINE TRANSDERMAL SYSTEM, STEP 1, STEP 2, STEP 3
68016-290-88	2026-01-29	C162847	48780-1	49896155-bffd-586f-e063-e6dba90add90	NICOTINE TRANSDERMAL SYSTEM, STEP 1, STEP 2, STEP 3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68016-288-88	Nicotine Transdermal System Step 1	14 in 1 CARTON	PATCH, EXTENDED RELEASE	14	8
68016-288-88	Nicotine Transdermal System Step 1	1 in 1 POUCH	PATCH, EXTENDED RELEASE	1	8
68016-289-88	Nicotine Transdermal System Step 2	14 in 1 CARTON	PATCH, EXTENDED RELEASE	14	8
68016-289-88	Nicotine Transdermal System Step 2	1 in 1 POUCH	PATCH, EXTENDED RELEASE	1	8
68016-290-88	Nicotine Transdermal System Step 3	1 in 1 POUCH	PATCH, EXTENDED RELEASE	1	8
68016-290-88	Nicotine Transdermal System Step 3	14 in 1 CARTON	PATCH, EXTENDED RELEASE	14	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68016-288	NICOTINE TRANSDERMAL SYSTEM STEP 3 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 2 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 1 (NICOTINE) PATCH, EXTENDED RELEASE [CHAIN DRUG CONSORTIUM, LLC]	8	Legacy NDC, 2 package rows	20240220_9b5ca2c9-de95-4800-a533-eaf6d5541cb8.zip
68016-289	NICOTINE TRANSDERMAL SYSTEM STEP 3 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 2 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 1 (NICOTINE) PATCH, EXTENDED RELEASE [CHAIN DRUG CONSORTIUM, LLC]	8	Legacy NDC, 2 package rows	20240220_9b5ca2c9-de95-4800-a533-eaf6d5541cb8.zip
68016-290	NICOTINE TRANSDERMAL SYSTEM STEP 3 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 2 (NICOTINE) PATCH, EXTENDED RELEASE NICOTINE TRANSDERMAL SYSTEM STEP 1 (NICOTINE) PATCH, EXTENDED RELEASE [CHAIN DRUG CONSORTIUM, LLC]	8	Legacy NDC, 2 package rows	20240220_9b5ca2c9-de95-4800-a533-eaf6d5541cb8.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68016-288-88	EA - Each	68016-288	178ac9c3-b1f9-48d2-99ab-d58befc678c9	1	2014-07-02
68016-289-88	EA - Each	68016-289	16b82173-cbf7-4738-85b5-84add66fcda4	1	2014-07-02
68016-290-88	EA - Each	68016-290	5911a840-c309-487b-ab90-be7c1085e725	1	2014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
NICOTINE	ACTIVE INGREDIENT	6M3C89ZY6R	2
NICOTINE	ACTIVE MOIETY	6M3C89ZY6R	2
ETHYL ACETATE	INACTIVE INGREDIENT	76845O8NMZ	2
ETHYLBENZENE	INACTIVE INGREDIENT	L5I45M5G0O	2
HEPTANE	INACTIVE INGREDIENT	456148SDMJ	2
HIGH DENSITY POLYETHYLENE	INACTIVE INGREDIENT	UG00KM4WR7	2
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	2
TOLUENE	INACTIVE INGREDIENT	3FPU23BG52	2
VINYL ACETATE	INACTIVE INGREDIENT	L9MK238N77	2
XYLENE	INACTIVE INGREDIENT	D856J1047R	2

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

Nicotine Transdermal System Step 3
Nicotine
DIMETHICONE
Nicotine Transdermal System Step 2
Nicotine Transdermal System Step 1

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
68016-288	68016-288-88
68016-289	68016-289-88
68016-290	68016-290-88

Ingredients#

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

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

Name, UNII, Kind table
Name	UNII	Kind
DIMETHICONE	92RU3N3Y1O	IACT
NICOTINE	6M3C89ZY6R	ACTIB
DIMETHICONE	92RU3N3Y1O	IACT
NICOTINE	6M3C89ZY6R	ACTIB
DIMETHICONE	92RU3N3Y1O	IACT
NICOTINE	6M3C89ZY6R	ACTIB

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 · 36 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	TABLET, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 11 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	TAPE / TOPICAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	SOLUTION / TOPICAL	40 %w/v		Exact identifier — unii candidate 11 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	LOTION, AUGMENTED / TOPICAL		2070 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	OINTMENT / TOPICAL	94 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
ETHYL ACETATE	ETHYL ACETATE	76845O8NMZ	TABLET, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 7 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	OINTMENT / OPHTHALMIC	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	SYSTEM / TRANSDERMAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	TABLET, COATED / ORAL	25 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	JELLY / VAGINAL	42.6 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	CREAM / TOPICAL	54.5 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	SUPPOSITORY / RECTAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	CAPSULE / ORAL	10 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	TABLET / ORAL	50 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
ETHYL ACETATE	ETHYL ACETATE	76845O8NMZ	FILM, EXTENDED RELEASE / TRANSDERMAL	0.05 mg		Exact identifier — unii candidate 7 equally ranked IID candidates
ETHYL ACETATE	ETHYL ACETATE	76845O8NMZ	CAPSULE, EXTENDED RELEASE / ORAL	382.26 mg		Exact identifier — unii candidate 7 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	PASTE / TOPICAL	2.5 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	LOTION / TOPICAL		2070 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	SWAB / TOPICAL	43.9 %w/w		Exact identifier — unii candidate 11 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	FILM, EXTENDED RELEASE / TRANSDERMAL		85 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	GEL / TOPICAL		6400 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
ETHYL ACETATE	ETHYL ACETATE	76845O8NMZ	SYSTEM / TRANSDERMAL		41 mg	Exact identifier — unii candidate 7 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	TABLET, EXTENDED RELEASE / ORAL	0.64 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	CAPSULE, EXTENDED RELEASE / ORAL	4.53 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
ETHYL ACETATE	ETHYL ACETATE	76845O8NMZ	SUSPENSION / ORAL	NA		Exact identifier — unii candidate 7 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	OIL / TOPICAL		72 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
ETHYL ACETATE	ETHYL ACETATE	76845O8NMZ	SOLUTION / TOPICAL	31 %w/w		Exact identifier — unii candidate 7 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	SPRAY / TOPICAL		1504 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
ETHYL ACETATE	ETHYL ACETATE	76845O8NMZ	SOLUTION / ORAL		13 mg	Exact identifier — unii candidate 7 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	GEL, METERED / TOPICAL		525 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	TABLET, DELAYED RELEASE / ORAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	OIL / AURICULAR (OTIC)		6 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
ISOPROPYL ALCOHOL	ISOPROPYL ALCOHOL	ND2M416302	SPONGE / TOPICAL	4 %w/w		Exact identifier — unii candidate 11 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	GEL / TOPICAL	26 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	PASTE / DENTAL		60 mg	Exact identifier — unii candidate 18 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 44.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	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.

Product history page 1 of 4 · 132 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A074612-001	NICOTINE	21MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A074612-002	NICOTINE	7MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	2003-07-28	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A074612-003	NICOTINE	14MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	1997-10-20	`c2088c7a36db…`
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…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
11b7496f-6483-00a4-e063-6394a90a0b41			9b5ca2c9-de95-4800-a533-eaf6d5541cb8	2024-02-19	Warnings	Exact identifier spl id: 11b7496f-6483-00a4-e063-6394a90a0b41 spl set id: 9b5ca2c9-de95-4800-a533-eaf6d5541cb8

Reported adverse events (FAERS/openFDA)#

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

Weeks 1 thru 2	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

Nicotine Transdermal System

Label at a glance#

Dosage and administration

Contacts and useful links#

Label contents#

Full prescribing information#

Active ingredient(in each patch)

Purpose

Use

Warnings

Ask a doctor before use if you have

Ask a doctor or pharmacist before use if you are

When using this product

Stop use and ask a doctor if

Keep out of reach of children and pets.

Directions

Other information

Inactive ingredients

Comments or Questions?

TO INCREASE YOUR SUCCESS IN QUITTING:

PRINCIPAL DISPLAY PANEL - 7 mg CARTON

PRINCIPAL DISPLAY PANEL - 14 mg CARTON

PRINCIPAL DISPLAY PANEL- 21 mg CARTON

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DailyMed RxNorm Mappings#

DailyMed Pharmacologic Classes#

DailyMed Product Concepts#

FDA-Initiated Inactive NDC Indexing#

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DailyMed Dashboard NDC Coverage#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Products#

NDC Codes#

Ingredients#

Source Document#

Inactive ingredient matches#

Orange Book application contexts#

Orange Book products#

Observed Orange Book product history#

openFDA label cross-check#

Reported adverse events (FAERS/openFDA)#