FDA.reportPublic FDA data

NICOTINE

Manufacturer
Rite Aid Corporation
Effective date
2024-07-26
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:16:07

Label at a glance#

ProductNICOTINE TRANSDERMAL
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 • stop smoking completely when you begin using the patch • if you smoke more than 10 cigarettes per day, use the following schedule below: STEP 1 STEP 2 STEP 3 Use one 21mg patch/day Use one 14mg patch/day Use one 7mg patch/day Weeks 1-4 Weeks 5-6 ...

Label contents#

Full prescribing information#

SPL PRODUCT DATA ELEMENTS SECTION

SPL UNCLASSIFIED SECTION

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

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.

Do not use

OTC - DO NOT USE SECTION

  • if you continue to smoke, chew tobacco, use snuff, use nicotine gum, or use another nicotine patch 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. 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
  • stop smoking completely when you begin using the patch
  • if you smoke more than 10 cigarettes per day, use the following schedule below:

STEP 1

STEP 2

STEP 3

Use one 21mg patch/day

Use one 14mg patch/day

Use one 7mg patch/day

Weeks 1-4

Weeks 5-6

Weeks 7-8

  • if you smoke 10 or less cigarettes per day, start with Step 2 for 6 weeks, then Step 3 for 2 weeks and then stop
  • apply one new patch every 24 hours on skin that is dry, clean and hairless
  • remove backing from patch and immediately press onto skin. Hold for 10 seconds.
  • wash hands after applying or removing patch. Save pouch to use for patch disposal. Dispose of 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
  • 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

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

Questions or comments?

OTC - QUESTIONS SECTION

call 1-800-585-8682

Weekdays (9am-8pm ET) or visit us at www.habitrol.com

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 Kit

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Nicotine Transdermal System PATCH Kit

Kit CartonKit Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
892244{14 (24 HR nicotine 0.292 MG/HR Transdermal System) / 14 (24 HR nicotine 0.583 MG/HR Transdermal System) / 28 (24 HR nicotine 0.875 MG/HR Transdermal System) } PackGPCK4
198029nicotine 14 MG/Day 24HR Transdermal SystemPSN4
892244nicotine 21 MG-14 MG-7 MG 24 HR Transdermal System Kit (56)PSN4
198030nicotine 21 MG/Day 24HR Transdermal SystemPSN4
198031nicotine 7 MG/Day 24HR Transdermal SystemPSN4
19803124 HR nicotine 0.292 MG/HR Transdermal SystemSCD4
19802924 HR nicotine 0.583 MG/HR Transdermal SystemSCD4
19803024 HR nicotine 0.875 MG/HR Transdermal SystemSCD4
892244{28 (nicotine 21 MG per 24HR 1 Day Transdermal Patch) / 14 (nicotine 14 MG per 24HR 1 Day Transdermal Patch) / 14 (nicotine 7 MG per 24HR 1 Day Transdermal Patch) } PackSY4
198031nicotine 0.292 MG/HR 24HR Transdermal PatchSY4
198029nicotine 0.583 MG/HR 24HR Transdermal PatchSY4
198030nicotine 0.875 MG/HR 24HR Transdermal PatchSY4
198029nicotine 14 MG per 24HR 1 Day Transdermal PatchSY4
198029nicotine 14 MG/Day 24HR Transdermal SystemSY4
198030nicotine 21 MG per 24HR 1 Day Transdermal PatchSY4
198030nicotine 21 MG/Day 24HR Transdermal SystemSY4
198031nicotine 7 MG per 24HR 1 Day Transdermal PatchSY4
892244nicotine 7 MG-14 MG-21 MG in 24 HR Transdermal System KitSY4
198031nicotine 7 MG/Day 24HR Transdermal SystemSY4

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
11822-3627-32024-01-30C16284748780-11030e365-2b8f-111a-e063-dadaa90a10e2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11822-3627-3NICOTINE TRANSDERMAL1 in 1 PATCHKIT14
11822-3627-3NICOTINE TRANSDERMAL56 in 1 CARTONKIT564

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11822-3627NICOTINE TRANSDERMAL (NICOTINE) KIT [RITE AID CORPORATION]4Current NDC, Legacy NDC, 2 package rows20240727_ae6027da-5c96-ed47-e1ae-e900fc0f72ce.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-445-56EA - Each43598-44547641a53-e58f-40d8-b6eb-19cc20af359f12015-07-20

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11822-362711822-3627-3
43598-445

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
NameUNIIKind
Nicotine6M3C89ZY6RACTIB
Methacrylic Acid1CS02G8656IACT
Nicotine6M3C89ZY6RACTIB
Methacrylic Acid1CS02G8656IACT
Nicotine6M3C89ZY6RACTIB
Methacrylic Acid1CS02G8656IACT

Source Document#

Source XML

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-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 4 of 4 · 132 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10N020076-004HABITROL7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N020076-005HABITROL14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12f41ea6bd6efb…
2022-10-28 04:53 UTC2022-10N020076-006HABITROL21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1999-11-12f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020076-004HABITROL7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12e64feba35796…
2022-09-29 23:25 UTC2022-09N020076-005HABITROL14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12e64feba35796…
2022-09-29 23:25 UTC2022-09N020076-006HABITROL21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1999-11-12e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020076-004HABITROL7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020076-005HABITROL14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12cb3db0bc1861…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020076-006HABITROL21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1999-11-12cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N020076-004HABITROL7MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N020076-005HABITROL14MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD1999-11-12a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N020076-006HABITROL21MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALRLD, RS1999-11-12a50c72e98297…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NICOTINE TRANSDERMALNICOTINERite Aid Corporationae6027da-5c96-ed47-e1ae-e900fc0f72ce2024-07-26WarningsExact identifier
ndc (package): 11822-3627-3
ndc (product): 11822-3627
ndc11 (package): 11822362703
spl id: cc8505c5-38ba-5bb3-5c4d-0e7a1984eae4
spl set id: ae6027da-5c96-ed47-e1ae-e900fc0f72ce
Nicotine transdermal systemNICOTINEDr. Reddys Laboratories Inc.e2391b29-9bac-fc09-f2a5-a3370bc4e2c32024-07-25WarningsExact identifier
ndc (product): 43598-445

Reported adverse events (FAERS/openFDA)#

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