NDC 0135-0626 Nicorette
Nicotine Polacrilex Lozenge Oral

Product Information

What is NDC 0135-0626?

The NDC code 0135-0626 is assigned by the FDA to the product Nicorette which is a human over the counter drug product labeled by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The generic name of Nicorette is nicotine polacrilex. The product's dosage form is lozenge and is administered via oral form. The product is distributed in 3 packages with assigned NDC codes 0135-0626-01 1 container in 1 carton / 20 lozenge in 1 container, 0135-0626-02 4 container in 1 carton / 20 lozenge in 1 container, 0135-0626-03 6 container in 1 carton / 20 lozenge in 1 container. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code0135-0626
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.		Nicorette
Non-Proprietary Name What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.		Nicotine Polacrilex
Substance Name What is the Substance Name?
An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.		Nicotine
Product Type What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.		Human Otc Drug
Dosage FormLozenge - A solid preparation containing one or more medicaments, usually in a flavored, sweetened base which is intended to dissolve or disintegrate slowly in the mouth. A lollipop is a lozenge on a stick.
Administration Route(s) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Oral - Administration to or by way of the mouth.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.		Glaxosmithkline Consumer Healthcare Holdings (us) Llc
Labeler Code0135
FDA Application Number What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.		NDA021330
Marketing Category What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.		NDA - A product marketed under an approved New Drug Application.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.		04-11-2019
Listing Expiration Date What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.		12-31-2024
Exclude Flag What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I". 		N
NDC Code Structure

What are the uses for Nicorette?


Product Characteristics

Color(s)WHITE (C48325 - WHITE TO OFF-WHITE)
ShapeOVAL (C48345)
Size(s)15 MM
Imprint(s)N;2
N;4
Score1
Flavor(s)MINT (C73404 - ICE MINT)

Product Packages

NDC Code 0135-0626-01

Package Description: 1 CONTAINER in 1 CARTON / 20 LOZENGE in 1 CONTAINER

NDC Code 0135-0626-02

Package Description: 4 CONTAINER in 1 CARTON / 20 LOZENGE in 1 CONTAINER

NDC Code 0135-0626-03

Package Description: 6 CONTAINER in 1 CARTON / 20 LOZENGE in 1 CONTAINER

Product Details

What are Nicorette Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • NICOTINE 4 mg/1 - Nicotine is highly toxic alkaloid. It is the prototypical agonist at nicotinic cholinergic receptors where it dramatically stimulates neurons and ultimately blocks synaptic transmission. Nicotine is also important medically because of its presence in tobacco smoke.

Nicorette Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

Nicorette Inactive Ingredients UNII Codes

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

Pharmacologic Class(es)

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

* Please review the disclaimer below.

Patient Education

Nicotine Lozenges


Nicotine lozenges are used to help people stop smoking. Nicotine lozenges are in a class of medications called smoking cessation aids. They work by providing nicotine to your body to decrease the withdrawal symptoms experienced when smoking is stopped and to reduce the urge to smoke.
[Learn More]


* Please review the disclaimer below.

Nicorette Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents



Active Ingredient (In Each Lozenge) (2 Mg)



Nicotine polacrilex, 2 mg


Active Ingredient (In Each Lozenge) (4 Mg)



Nicotine polacrilex, 4 mg


Purpose



Stop smoking aid


Use



  • •reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking

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



  • •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



  • •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



  • •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.



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)



  • •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)



  • •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 (Ice Mint)



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

Inactive Ingredients (Ice Mint)



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


Questions Or Comments?



call toll-free 1-888-569-1743


Principal Display Panel



NDC 0135-0625-02

NEW

Nicorette

nicotine polacrilex lozenge, 2 mg •stop smoking aid

Lozenge

Coated

Ice Mint

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

If you smoke your first cigarette WITHIN 30 MINUTES of waking up, use Nicorette 4mg Lozenge.

2 mg

80 LOZENGES, 2mg EACH

(4 Packs of 20)

Includes User’s Guide

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.com or 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:

    GlaxoSmithKline Consumer Healthcare

    Warren, NJ 07059

    Made in the Switzerland

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

    ©2018 GSK group of companies or its licensor.

    106600XA

    NDC 0135-0626-02

    NEW

    Nicorette

    nicotine polacrilex lozenge, 4 mg •stop smoking aid

    Lozenge

    Coated Ice Mint

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

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

    4 mg

    80 LOZENGES, 2mg EACH

    (4 Packs of 20)

    Includes User’s Guide

    TO INCREASE YOUR SUCCESS IN QUITTING:

    • 5.You must be motivated to quit.
    • 6.Use Enough - Use at least 9 Nicorette Lozenges per day during the first six weeks.
    • 7.Use Long Enough - Use Nicorette for the full 12 weeks.
    • 8.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.com or 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:

      GlaxoSmithKline Consumer Healthcare

      Warren, NJ 07059

      Made in the Switzerland

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

      ©2018 GSK group of companies or its licensor.

      106608XA


* Please review the disclaimer below.