Mini Nicotine

Manufacturer
Rugby Laboratories, Inc.
Effective date
2025-09-02
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:12:20

Label at a glance#

ProductMini Nicotine
Active ingredientNICOTINE
Label structure10 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 more than 30 minutes after waking up, use 2 mg nicotine lozenge if you smoke your first cigarette wi...

Label contents#

Full prescribing information#

Active ingredient (in each lozenge)

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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

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.
  • 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 (1-800-222-1222)

Directions (4 mg lozenge)

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

SPL UNCLASSIFIED SECTION

  • Phenylketonurics: Contains Phenylalanine 2.8 mg per lozenge
  • store at 20-25ºC (68-77ºF)
  • keep vial tightly closed and protect from light

Inactive ingredients

INACTIVE INGREDIENT SECTION

aspartame, calcium polycarbophil, flavor, maltodextrin, mannitol, sodium alginate, sodium bicarbonate, sodium stearyl fumarate, talc, xanthan gum

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel (4 mg lozenge)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

compare to the active ingredient in Nicorette® mini Lozenge*

nicotine

mini lozenge

Nicotine Polacrilex 4 mg

Stop Smoking Aid

Mint Flavor

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

If you smoke your first cigarette MORE THAN 30 MINUTES after waking up, use Nicotine Polacrilex 2 mg Lozenge.

LOZENGES, 4 mg Each (Vials)

TO INCREASE YOUR SUCCESS IN QUITTING:

1. You must be motivated to quit.

2.Use Enough - Use at least 9 Nicotine mini lozenges per day during the first six weeks.

3.Use Long Enough - Use Nicotine mini lozenges for the full 12 weeks.

4. Use With a Support Program as directed in the enclosed User's Guide.

  • 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

*This product is not manufactured or distributed by Haleon group of companies, distributor of Nicorette® mini Lozenge.

See inside for more details or visit www.nitthehabit.com

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

RETAIN OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed By:

RUGBY LABORATORIES

Indianapolis, IN 46268

Package Label (4 mg lozenge)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RUGBY Nicotine Mini Lozenge Mint Flavor
RUGBY Nicotine Mini Lozenge Mint Flavor

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
359818nicotine 4 MG Oral LozengePSN9
359818nicotine 4 MG Oral LozengeSCD9
359818nicotine 4 MG (as nicotine polacrilex 22.2 MG) Oral LozengeSY9
359818nicotine 4 MG TrocheSY9

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
NICOTINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0536-1241-812020-11-17C16284748780-1ab0e2407-275f-f274-e053-dbdaa90a6471Drug Facts
0536-1241-812020-09-27C16284748780-1ab0e2407-275f-f274-e053-dbdaa90a6471Drug Facts
0536-1241-812020-09-25C16284748780-1ab0e2407-275f-f274-e053-dbdaa90a6471Drug Facts
0536-1241-812020-07-22C16284748780-1ab0e2407-275f-f274-e053-dbdaa90a6471Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0536-1241-27Mini Nicotine27 in 1 BOTTLE, PLASTICLOZENGE279
0536-1241-27Mini Nicotine1 in 1 BOXLOZENGE19
0536-1241-81Mini Nicotine27 in 1 BOTTLE, PLASTICLOZENGE279
0536-1241-81Mini Nicotine3 in 1 BOXLOZENGE39

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1241-81EA - Each0536-124103f106da-42cb-47a6-9c06-4046274887f912019-10-07

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0536-12410536-1241-81, 0536-1241-27

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 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
A207868-001NICOTINE POLACRILEXNICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2019-02-07
A207868-002NICOTINE POLACRILEXNICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2019-02-07

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 22:38:342026-08A207868-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2019-02-0784e616aacf4f…
2026-09-14 22:38:342026-08A207868-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2019-02-0784e616aacf4f…
2026-08-18 06:07:402026-07A207868-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2019-02-07caaa826d4ba7…
2026-08-18 06:07:402026-07A207868-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2019-02-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A207868-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2019-02-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A207868-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2019-02-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207868-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2019-02-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A207868-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2019-02-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A207868-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2019-02-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A207868-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2019-02-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207868-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2019-02-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A207868-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2019-02-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207868-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2019-02-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A207868-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2019-02-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207868-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2019-02-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A207868-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2019-02-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207868-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2019-02-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A207868-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2019-02-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207868-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2019-02-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A207868-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2019-02-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207868-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2019-02-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A207868-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2019-02-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A207868-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2019-02-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A207868-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2019-02-07d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207868-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2019-02-0779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A207868-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2019-02-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207868-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2019-02-07301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A207868-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2019-02-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207868-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2019-02-071e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A207868-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2019-02-071e350fbaab3a…
2024-05-31 18:47 UTC2024-05A207868-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2019-02-078072bd15b7f6…
2024-05-31 18:47 UTC2024-05A207868-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2019-02-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207868-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2019-02-075c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A207868-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2019-02-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A207868-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2019-02-075d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A207868-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2019-02-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A207868-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2019-02-074b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A207868-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2019-02-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A207868-001NICOTINE POLACRILEXEQ 2MG BASETROCHE/LOZENGE / ORAL2019-02-0774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A207868-002NICOTINE POLACRILEXEQ 4MG BASETROCHE/LOZENGE / ORAL2019-02-0774a2ff9319b5…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2019-12-13 00:20 UTC2019-12A207868-001PC2019-10-0174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A207868-002PC2019-10-0174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A207868-001PC2019-10-013f01610625f2…
2019-12-14 00:12 UTC2019-12A207868-002PC2019-10-013f01610625f2…
2019-09-15 20:21 UTC2019-09A207868-001PC2019-10-01b00525d2431f…
2019-09-15 20:21 UTC2019-09A207868-002PC2019-10-01b00525d2431f…

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
Mini NicotineNICOTINE POLACRILEXRugby Laboratories, Inc.237471f8-ce0f-423b-993f-b4380fd890ff2025-09-02WarningsExact identifier
ndc (package): 0536-1241-81
ndc (package): 0536-1241-27
ndc (product): 0536-1241
ndc11 (package): 00536124127
ndc11 (package): 00536124181
spl id: a7edbfeb-3193-4578-891b-b2b77a6340ad
spl set id: 237471f8-ce0f-423b-993f-b4380fd890ff

Reported adverse events (FAERS/openFDA)#

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