Nicotine Polacrilex Original 2 mg and 4 mg - Leader

Manufacturer
CARDINAL HEALTH 110, LLC. DBA LEADER 70000
Effective date
2026-04-10
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
full-release
Hydrated at
2026-06-01 01:53:20

Label at a glance#

ProductNicotine Polacrilex Original
Active ingredientNICOTINE
Label structure20 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 important information begin using the gum on your quit day if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine gum if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine gum according to the following...

Label contents#

Full prescribing information#

Active ingredient (in each chewing piece) - 2 mg

OTC - ACTIVE INGREDIENT SECTION

Nicotine polacrilex (equal to 2 mg nicotine)

Active ingredient (in each chewing piece) - 4 mg

OTC - ACTIVE INGREDIENT SECTION

Nicotine polacrilex (equal to 4 mg nicotine)

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

  • a sodium-restricted diet
  • heart disease, recent heart attack, or irregular heartbeat. Nicotine can increase your heart rate.
  • high blood pressure not controlled with medication. Nicotine can increase 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, teeth, or jaw problems occur
  • 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

Pieces of nicotine gum may have enough nicotine to make children and pets sick. Wrap used pieces of gum in paper and throw away in the trash. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions - 2 mg

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 important information

  • begin using the gum on your quit day

  • if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine gum

  • if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine gum according to the following 12 week schedule:

Weeks 1 to 6

Weeks 7 to 9

Weeks 10 to 12

1 piece every
1 to 2 hours

1 piece every
2 to 4 hours

1 piece every
4 to 8 hours

  • nicotine gum is a medicine and must be used a certain way to get the best results

  • chew the gum slowly until it tingles. Then park it between your cheek and gum. When the tingle is gone, begin chewing again, until the tingle returns.

  • repeat this process until most of the tingle is gone (about 30 minutes)

  • do not eat or drink for 15 minutes before chewing the nicotine gum, or while chewing a piece

  • to improve your chances of quitting, use at least 9 pieces per day for the first 6 weeks

  • if you experience strong or frequent cravings, you may use a second piece within the hour. However, do not continuously use one piece after another since this may cause you hiccups, heartburn, nausea or other side effects.

  • do not use more than 24 pieces a day

  • it is important to complete treatment. If you feel you need to use the gum 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

  • before using this product, read the enclosed User's Guide for complete directions and other important information

  • begin using the gum on your quit day

  • if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine gum

  • if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine gum according to the following 12 week schedule:

Weeks 1 to 6

Weeks 7 to 9

Weeks 10 to 12

1 piece every
1 to 2 hours

1 piece every
2 to 4 hours

1 piece every
4 to 8 hours

  • nicotine gum is a medicine and must be used a certain way to get the best results

  • chew the gum slowly until it tingles. Then park it between your cheek and gum. When the tingle is gone, begin chewing again, until the tingle returns.

  • repeat this process until most of the tingle is gone (about 30 minutes)

  • do not eat or drink for 15 minutes before chewing the nicotine gum, or while chewing a piece

  • to improve your chances of quitting, use at least 9 pieces per day for the first 6 weeks

  • if you experience strong or frequent cravings, you may use a second piece within the hour. However, do not continuously use one piece after another since this may cause you hiccups, heartburn, nausea or other side effects.

  • do not use more than 24 pieces a day

  • it is important to complete treatment. If you feel you need to use the gum for a longer period to keep from smoking, talk to your health care provider.

Other information - 2 mg

SPL UNCLASSIFIED SECTION

  • each piece contains: calcium 115 mg, sodium 11 mg
  • store at 20 - 25ºC (68 - 77ºF)
  • protect from light

Other information - 4 mg

SPL UNCLASSIFIED SECTION

  • each piece contains: calcium 85 mg, sodium 11 mg
  • store at 20 - 25ºC (68 - 77ºF)
  • protect from light

Inactive ingredients - 2 mg

INACTIVE INGREDIENT SECTION

acesulfame potassium, butylated hydroxytoluene, carnauba wax, flavors, gum base, sodium bicarbonate, sodium carbonate, sorbitol, talc.

Inactive ingredients - 4 mg

INACTIVE INGREDIENT SECTION

acesulfame potassium, butylated hydroxytoluene, carnauba wax, D&C yellow #10 lake, FD&C blue #2 lake, FD&C red #40, FD&C yellow #6 lake, flavors, gum base, sodium bicarbonate, sodium carbonate, sorbitol and talc.

Questions or comments?

OTC - QUESTIONS SECTION

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

Principal display panel 2 mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO NICORETTE® GUM active ingredient*

Sugar-Free

Nicotine Gum

Nicotine Polacrilex Gum USP, 2 mg Nicotine

Stop Smoking Aid

2 mg

Original Flavor

For Those Who Smoke Their First Cigarette More Than 30 Minutes After Waking Up

If You Smoke Their First Cigarette WITHIN 30 Minutes of Waking Up, Use Nicotine Polacrilex Gum USP,4 mg

TO INCREASE YOUR SUCCESS IN QUITTING:

1. You Must be motivated to quit.

2. Use Enough - Chew at least 9 pieces of Nicotine polacrilex Gum per day during the first six weeks

3. Use Long Enough - Use Nicotine Polacrilex Gum 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 machine 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® Original Gum.

BLISTER PACKAGED FOR YOUR PROTECTION. DO NOT USE IF INDIVIDUAL SEALS ARE OPEN OR TORN.

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

Package label 2 mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADER Sugar Free Nicotine Original Flavor
LEADER Sugar Free Nicotine Original Flavor

Principal display panel 4 mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO NICORETTE® GUM active ingredient*

Sugar-Free

Nicotine Gum

Nicotine Polacrilex Gum USP, 4 mg (Nicotine)

Stop Smoking Aid

4 mg

Original 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 Gum USP, 2 mg

TO INCREASE YOUR SUCCESS IN QUITTING:

1. You must be motivated to quit.

2. Use Enough - Chew at least 9 pieces of Nicotine Polacrilex Gum per day during the first six weeks.

3. Use Long Enough -Use Nicotine Polacrilex Gum 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® Gum.

BLISTER PACKAGED FOR YOUR PROTECTION. DO NOT USE IF INDIVIDUAL SEALS ARE OPEN OR TORN.

DISTRIBUTED BY CARDINAL HEALTH

DUBLIN, OHIO 43017

Package label 4 mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADER Sugar Free Nicotine Gum Original Flavor
LEADER Sugar Free Nicotine Gum Original Flavor

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
314119nicotine polacrilex 2 MG Chewing GumPSN12
311975nicotine polacrilex 4 MG Chewing GumPSN12
314119nicotine 2 MG Chewing GumSCD12
311975nicotine 4 MG Chewing GumSCD12
314119nicotine 2 MG (as nicotine polacrilex 11.1 MG) Chewing GumSY12
311975nicotine 4 MG (as nicotine polacrilex 22.2 MG) Chewing GumSY12

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130096295133837GTIN-13: 0096295133837
EAN-13: 0096295133837
GTIN-12: 096295133837
UPC-A: 096295133837
GTIN storage (14 digits): 00096295133837
nicotine-gum-2-mg-and-4-mg-original-1.jpg
BarcodeEAN-130096295133844GTIN-13: 0096295133844
EAN-13: 0096295133844
GTIN-12: 096295133844
UPC-A: 096295133844
GTIN storage (14 digits): 00096295133844
nicotine-gum-2-mg-and-4-mg-original-2.jpg

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
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
dbebfdf8-6e0c-cfa8-fdbc-e5d7f1bf1562Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0341-1Nicotine PolacrilexOriginal50 in 1 CARTONGUM, CHEWING5012
70000-0341-1Nicotine PolacrilexOriginal1 in 1 BLISTER PACKGUM, CHEWING112
70000-0345-1Nicotine PolacrilexOriginal1 in 1 BLISTER PACKGUM, CHEWING112
70000-0345-1Nicotine PolacrilexOriginal50 in 1 CARTONGUM, CHEWING5012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0345-1EA - Each70000-034538fd4c86-c3b5-4870-8099-328f4a91284912018-11-06
70000-0341-1EA - Each70000-03411068710c-a1be-4615-9091-45260eac287712018-11-06

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-034570000-0345-1
70000-034170000-0341-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 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 · 2 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074507-001NICOTINE POLACRILEXNICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-15

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 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-1584e616aacf4f…
2026-08-18 06:07:402026-07A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-1587673890dc5c…
2021-03-12 10:30 UTC2021-03A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-15c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-153f01610625f2…
2019-09-15 20:21 UTC2019-09A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-15b00525d2431f…
2019-07-19 19:46 UTC2019-07A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-15ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-153f0d92c62455…
2023-05-13 08:27 UTC2023-05A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-15053a50430f4f…
2023-01-26 05:58 UTC2023-01A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-153bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-153a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074507-001NICOTINE POLACRILEXEQ 2MG BASEGUM, CHEWING / BUCCAL1999-03-15f41ea6bd6efb…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074707-001NICOTINE POLACRILEXNICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-19

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 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-1984e616aacf4f…
2026-08-18 06:07:402026-07A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-19caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-19bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-19782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-1987673890dc5c…
2021-03-12 10:30 UTC2021-03A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-195aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-198869cabd3fbd…
2020-11-12 02:37 UTC2020-11A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-19c0c555d07b60…
2019-12-14 00:12 UTC2019-12A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-193f01610625f2…
2019-09-15 20:21 UTC2019-09A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-19b00525d2431f…
2019-07-19 19:46 UTC2019-07A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-19ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-196a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-191c564ffb4f44…
2023-12-20 04:57 UTC2023-12A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-19ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-19a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-199b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-19a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-193f0d92c62455…
2023-05-13 08:27 UTC2023-05A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-19053a50430f4f…
2023-01-26 05:58 UTC2023-01A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-193bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-193a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A074707-001NICOTINE POLACRILEXEQ 4MG BASEGUM, CHEWING / BUCCAL1999-03-19f41ea6bd6efb…

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 Polacrilex OriginalNICOTINE POLACRILEXCARDINAL HEALTH 110, LLC. DBA LEADER 700004acbda22-9c87-49f2-ad5f-55b1e54bdf2e2026-04-10WarningsExact identifier
ndc (package): 70000-0345-1
ndc (package): 70000-0341-1
ndc (product): 70000-0345
ndc (product): 70000-0341
ndc11 (package): 70000034101
ndc11 (package): 70000034501
spl id: 905563ef-1910-4436-a4cd-351213b503af
spl set id: 4acbda22-9c87-49f2-ad5f-55b1e54bdf2e

Reported adverse events (FAERS/openFDA)#

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