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  4. NDC Product Code: 0135-0225 Nicorette Fresh Mint

NDC 0135-0225 Nicorette Fresh Mint

View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 0135-0225?
  5. Nicorette Fresh Mint Uses
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.

Get all the details for National Drug Code (NDC) 0135-0225 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
0135-0225
Proprietary Name:
Nicorette Fresh Mint
Product Type: [3]
Labeler Name: [5]
Haleon Us Holdings Llc
Labeler Code:
0135
Product Label ID:
673fd19f-69b3-4f73-b9b4-18b5f4cbf69c
FDA Application Number: [6]
NDA018612
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.
Start Marketing Date: [9]
06-29-2009
End Marketing Date: [10]
08-13-2024
Listing Expiration Date: [11]
08-13-2024
Exclude Flag: [12]
D
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325)
WHITE (C48325 - CREAM)
WHITE (C48325 - BEIGE)
Shape:
SQUARE (C48350)
Size(s):
15 MM
14 MM
Imprint(s):
N2
N4
Score:
1
Flavor(s):
MINT (C73404 - WHITE ICE MINT)
CINNAMON (C73377)
MINT (C73404 - FRESH MINT)

Code Structure Chart

Product Details

What is NDC 0135-0225?

The NDC code 0135-0225 is assigned by the FDA to the product Nicorette Fresh Mint which is product labeled by Haleon Us Holdings Llc. The product's dosage form is . The product is distributed in 6 packages with assigned NDC codes 0135-0225-02 1 blister pack in 1 carton / 100 gum, chewing in 1 blister pack, 0135-0225-03 1 blister pack in 1 carton / 190 gum, chewing in 1 blister pack, 0135-0225-08 20 gum, chewing in 1 carton , 0135-0225-14 25 gum, chewing in 1 carton , 0135-0225-15 8 carton in 1 package / 25 gum, chewing in 1 carton, 0135-0225-17 2 carton in 1 package / 10 blister pack in 1 carton / 10 gum, chewing in 1 blister pack. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Nicorette Fresh Mint?

•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 6Weeks 7 to 9 Weeks 10 to 121 piece every 1 to 2 hours1 piece every 2 to 4 hours1 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.

Which are Nicorette Fresh Mint UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Nicorette Fresh Mint 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. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Nicorette Fresh Mint?

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:

* Please review the disclaimer below.

Patient Education

Nicotine Gum


Nicotine chewing gum is used to help people stop smoking cigarettes. Nicotine chewing gum should be used together with a smoking cessation program, which may include support groups, counseling, or specific behavioral change techniques. Nicotine gum is in a class of medications called smoking cessation aids. It works by providing nicotine to your body to decrease the withdrawal symptoms experienced when smoking is stopped and as a substitute oral activity to reduce the urge to smoke.
[Learn More]


* Please review the disclaimer below.

Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[6] 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.

[8] 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.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[10] What is the End Marketing Date? - This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

[11] 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] 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, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".