NICORETTE

Manufacturer
Haleon US Holdings LLC
Effective date
2025-06-04
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:02:20

Label at a glance#

ProductNICORETTE
Active ingredientNICOTINE
Label structure13 sections

Dosage and administration

if you are under 18 years of age, ask a doctor before use. No studies have been done to show if this product will work for you. before using this product, read the enclosed User’s Guide for complete directions and other important information begin using the lozenge on your quit day if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine lozenge if you smoke your first cigarette more tha...

Storage and handling

store at 20 - 25°C (68 - 77°F) store in the original container

Label contents#

Full prescribing information#

Active ingredient (in each lozenge) (2 mg)

OTC - ACTIVE INGREDIENT SECTION

Nicotine polacrilex, 2 mg

Active ingredient (in each lozenge) (4 mg)

OTC - ACTIVE INGREDIENT SECTION

Nicotine polacrilex, 4 mg

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.
  • stomach ulcer or diabetes
  • history of seizures

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • using a non-nicotine stop smoking drug
  • taking prescription medicine for depression or asthma. Your prescription dose may need to be adjusted.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • mouth problems occur
  • persistent indigestion or severe sore throat occurs
  • irregular heartbeat or palpitations occur
  • you get symptoms of nicotine overdose such as nausea, vomiting, dizziness, diarrhea, 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

Nicotine lozenges may have enough nicotine to make children and pets sick. If you need to remove the lozenge, wrap it in paper and throw away in the trash. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions (2 mg)

DOSAGE & ADMINISTRATION SECTION

  • if you are under 18 years of age, ask a doctor before use. No studies have been done to show if this product will work for you.
  • before using this product, read the enclosed User’s Guide for complete directions and other important information
  • begin using the lozenge on your quit day
  • if you smoke your first cigarette within 30 minutes of waking up,use 4 mg nicotine lozenge
  • if you smoke your first cigarette more than 30 minutes after waking up,use 2 mg nicotine lozenge according to the following 12 week schedule:

Weeks 1 to 6

Weeks 7 to 9

Weeks 10 to 12

1 lozenge every

1 to 2 hours

1 lozenge every

2 to 4 hours

1 lozenge every

4 to 8 hours

  • nicotine lozenge is a medicine and must be used a certain way to get the best results
  • place the lozenge in your mouth and allow the lozenge to slowly dissolve. Minimize swallowing. Do not chew or swallow lozenge.
  • you may feel a warm or tingling sensation
  • occasionally move the lozenge from one side of your mouth to the other until completely dissolved
  • do not eat or drink 15 minutes before using or while the lozenge is in your mouth
  • to improve your chances of quitting, use at least 9 lozenges per day for the first 6 weeks
  • do not use more than one lozenge at a time or continuously use one lozenge after another since this may cause you hiccups, heartburn, nausea or other side effects
  • do not use more than 5 lozenges in 6 hours. Do not use more than 20 lozenges per day.
  • it is important to complete treatment. If you feel you need to use the lozenge for a longer period to keep from smoking, talk to your health care provider.

Directions (4 mg)

DOSAGE & ADMINISTRATION SECTION

  • if you are under 18 years of age, ask a doctor before use. No studies have been done to show if this product will work for you.
  • before using this product, read the enclosed User’s Guide for complete directions and other important information
  • begin using the lozenge on your quit day
  • if you smoke your first cigarette more than 30 minutes after waking up,use 2 mg nicotine lozenge
  • if you smoke your first cigarette within 30 minutes of waking up,use 4 mg nicotine lozenge according to the following 12 week schedule:

Weeks 1 to 6

Weeks 7 to 9

Weeks 10 to 12

1 lozenge every

1 to 2 hours

1 lozenge every

2 to 4 hours

1 lozenge every

4 to 8 hours

  • nicotine lozenge is a medicine and must be used a certain way to get the best results
  • place the lozenge in your mouth and allow the lozenge to slowly dissolve. Minimize swallowing. Do not chew or swallow lozenge.
  • you may feel a warm or tingling sensation
  • occasionally move the lozenge from one side of your mouth to the other until completely dissolved
  • do not eat or drink 15 minutes before using or while the lozenge is in your mouth
  • to improve your chances of quitting, use at least 9 lozenges per day for the first 6 weeks
  • do not use more than one lozenge at a time or continuously use one lozenge after another since this may cause you hiccups, heartburn, nausea or other side effects
  • do not use more than 5 lozenges in 6 hours. Do not use more than 20 lozenges per day.
  • it is important to complete treatment. If you feel you need to use the lozenge 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)
  • store in the original container

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, flavors, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, polysorbate 80, potassium aluminum silicate, sodium carbonate anhydrous, sucralose, titanium dioxide, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

call toll-free 1-888-569-1743

Additional Information

SPL UNCLASSIFIED SECTION

  • 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

TAMPER EVIDENT FEATURE:The lozenge container is protected in a clear plastic shell, sealed to a printed card.

Do not use if the printed card or plastic shell is torn or broken, or if there is any evidence that the printed card was separated from the plastic shell.

Retain this package for complete product information.

Includes Quit Support Program

TO INCREASE YOUR SUCCESS IN QUITTING:

  1. You must be motivated to quit.
  2. Use Enough - Use at least 9 Nicorette Lozenges per day during the first six weeks.
  3. Use Long Enough - Use Nicorette for the full 12 weeks.
  4. Use With a Support Program as directed in the enclosed User’s Guide.

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

TO OPEN

PUSH

LIFT

TO CLOSE

Push Cap Closed until you hear a CLICK to ensure child resistance

CLICK

Distributed By:

Haleon

Warren, NJ 07059

Made in the Switzerland

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

©2023 Haleon group of companies or its licensor.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0135-0625-01

HALEON

NICORETTE

nicotine polacrilex lozenge, 2 mg ׀ stop smoking aid

Lozenge

2 mg

FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE MORE THAN 30 MINUTES AFTER WAKING UP.

If you smoke your first cigarette WITHIN30 MINUTES of waking up, use Nicorette 4 mg Lozenge.

SUGAR FREE

20 LOZENGES, 2 mg EACH(1 Pack of 20)

Includes User’s Guide

Coated Ice Mint

216965

216965 Nicorette Mini Lozenge 2 mg 20 ct.jpg
216965 Nicorette Mini Lozenge 2 mg 20 ct.jpg

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0135-0626-01

HALEON

NICORETTE

nicotine polacrilex lozenge, 4 mg ׀ stop smoking aid

Lozenge

4 mg

FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE WITHIN 30 MINUTES OF WAKING UP.

If you smoke your first cigarette MORE THAN30 MINUTES after waking up, use Nicorette 2 mg Lozenge.

SUGAR FREE

20 LOZENGES, 4 mg EACH(1 Pack of 20)

Includes User’s Guide

Coated Ice Mint

216969

216969 Nicorette Mini Lozenge 4 mg 20 ct.jpg
216969 Nicorette Mini Lozenge 4 mg 20 ct.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
968849Nicorette 2 MG Oral LozengePSN8
968851Nicorette 4 MG Oral LozengePSN8
359817nicotine 2 MG Oral LozengePSN8
359818nicotine 4 MG Oral LozengePSN8
968849nicotine 2 MG Oral Lozenge [Nicorette]SBD8
968851nicotine 4 MG Oral Lozenge [Nicorette]SBD8
359817nicotine 2 MG Oral LozengeSCD8
359818nicotine 4 MG Oral LozengeSCD8
968849Nicorette 2 MG (nicotine polacrilex 11.1 MG) Oral LozengeSY8
968849Nicorette 2 MG Oral LozengeSY8
968849Nicorette 2 MG TrocheSY8
968851Nicorette 4 MG (nicotine polacrilex 22.2 MG) Oral LozengeSY8
968851Nicorette 4 MG Oral LozengeSY8
359817nicotine 2 MG (as nicotine polacrilex 11.1 MG) Oral LozengeSY8
359817nicotine 2 MG TrocheSY8
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSY8
359818nicotine 4 MG TrocheSY8

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
0135-0625-01NICORETTE20 in 1 CONTAINERLOZENGE208
0135-0625-01NICORETTE1 in 1 CARTONLOZENGE18
0135-0625-02NICORETTE20 in 1 CONTAINERLOZENGE208
0135-0625-02NICORETTE4 in 1 CARTONLOZENGE48
0135-0625-03NICORETTE6 in 1 CARTONLOZENGE68
0135-0625-03NICORETTE20 in 1 CONTAINERLOZENGE208
0135-0626-01NICORETTE20 in 1 CONTAINERLOZENGE208
0135-0626-01NICORETTE1 in 1 CARTONLOZENGE18
0135-0626-02NICORETTE4 in 1 CARTONLOZENGE48
0135-0626-02NICORETTE20 in 1 CONTAINERLOZENGE208
0135-0626-03NICORETTE6 in 1 CARTONLOZENGE68
0135-0626-03NICORETTE20 in 1 CONTAINERLOZENGE208

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0135-0625-01EA - Each0135-0625e821e14d-ba1b-4e14-a3ef-8830d1f1155f12024-02-14
0135-0625-02EA - Each0135-06255b3aa39d-39a3-4c7c-b5ea-c0a5d9bcf8bf12025-07-08
0135-0626-01EA - Each0135-062683023675-afe7-47a0-8c00-5922930a69e912021-09-07
0135-0626-02EA - Each0135-0626b9590240-bdab-4c80-a78d-10202b4f7e5e12024-04-05
0135-0626-03EA - Each0135-062622edf42e-ba3c-4a02-bdd1-73db9f2cc4b212024-12-10

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0135-06250135-0625-01, 0135-0625-02, 0135-0625-03
0135-06260135-0626-01, 0135-0626-02, 0135-0626-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

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 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021330-001NICORETTENICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORALRLD2002-10-31
N021330-002NICORETTENICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2002-10-31

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 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N021330-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2002-10-3184e616aacf4f…
2026-09-14 22:38:342026-08N021330-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2002-10-3184e616aacf4f…
2026-08-18 06:07:402026-07N021330-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2002-10-31caaa826d4ba7…
2026-08-18 06:07:402026-07N021330-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2002-10-31caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021330-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2002-10-31011fe1cb6892…
2026-02-19 14:30 UTC2026-02N021330-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2002-10-31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021330-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2002-10-3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021330-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2002-10-3131067a03dcf5…
2025-08-23 18:47 UTC2025-08N021330-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2002-10-316a471c1ec25d…
2025-08-23 18:47 UTC2025-08N021330-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2002-10-316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021330-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2002-10-31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021330-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2002-10-31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021330-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2002-10-31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021330-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2002-10-31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021330-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2002-10-3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021330-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2002-10-3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021330-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2002-10-312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021330-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2002-10-312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021330-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2002-10-315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021330-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2002-10-315bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021330-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2002-10-31d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021330-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2002-10-31d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021330-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2002-10-31d06236e962d9…
2024-10-29 15:01 UTC2024-10N021330-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2002-10-31d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021330-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2002-10-3179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021330-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2002-10-3179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021330-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2002-10-31301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021330-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2002-10-31301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021330-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2002-10-311e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021330-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2002-10-311e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021330-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2002-10-318072bd15b7f6…
2024-05-31 18:47 UTC2024-05N021330-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2002-10-318072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021330-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2002-10-315c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021330-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2002-10-315c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021330-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2002-10-315d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N021330-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2002-10-315d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021330-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2002-10-314b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N021330-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2002-10-314b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021330-001NICORETTEEQ 2MG BASETROCHE/LOZENGE / ORALRLD2002-10-3174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N021330-002NICORETTEEQ 4MG BASETROCHE/LOZENGE / ORALRLD, RS2002-10-3174a2ff9319b5…

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
NICORETTENICOTINE POLACRILEXHaleon US Holdings LLCf350e050-2173-43e0-8738-848382ce07002025-06-04WarningsExact identifier
ndc (package): 0135-0626-01
ndc (package): 0135-0626-03
ndc (package): 0135-0626-02
ndc (package): 0135-0625-02
ndc (package): 0135-0625-01
ndc (package): 0135-0625-03
ndc (product): 0135-0626
ndc (product): 0135-0625
ndc11 (package): 00135062502
ndc11 (package): 00135062501
ndc11 (package): 00135062503
ndc11 (package): 00135062601
ndc11 (package): 00135062603
ndc11 (package): 00135062602
spl id: 36c1b8d5-e876-dc22-e063-6294a90aff3b
spl set id: f350e050-2173-43e0-8738-848382ce0700

Reported adverse events (FAERS/openFDA)#

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