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Nicotine Polacrilex Coated Mint 2 mg Gum, Chewing — NDC 70000-0347-1 (Billing 70000-0347-01) · Product 70000-0347

by CARDINAL HEALTH 110, LLC. DBA LEADER 70000 · 10 BLISTER PACK in 1 CARTON (70000-0347-1) / 1 GUM, CHEWING in 1 BLISTER PACK

NDC 70000-0347-1 (billing 70000-0347-01) is a package of Nicotine Polacrilex Coated Mint 2 mg Gum, Chewing from CARDINAL HEALTH 110, LLC. DBA LEADER 70000, marketed since Jul 2018 and currently FDA-listed; retail pharmacies pay about $0.2328 per unit (NADAC). It is the main listing for product NDC 70000-0347, its only package size.

NDC 70000-0347-01
🏷️ FDA NDC (as labeled) 70000-0347-1 billing pads the package segment with a zero
OTC Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70000-0347-1
Product NDC 70000-0347
11-digit billing NDC 70000034701
NCPDP billing unit EA — each (per item)
RxCUI 311975, 314119
UNII 6M3C89ZY6R
UPC 0096295133752, 0096295133790
Application # ANDA078699
SPL Set ID 2c420ee4-0ed0-4a3f-bc92-202d825d0ca3
Established class (EPC) Cholinergic Nicotinic Agonist
Chemical class Nicotine
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2018-07-03
Route BUCCAL
Dosage form GUM, CHEWING
Substance NICOTINE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 62100010002810
GPI class Nicotine Polacrilex
GCN Seq No 004930
GCN 03200
HICL code 002049
Ingredient (HICL) Nicotine Polacrilex
HIC1 code J
Therapeutic class — broad (HIC1) Autonomic Nervous System
HIC2 code J3
Therapeutic class — intermediate (HIC2) Ganglionic Stimulants
HIC3 code J3A
Therapeutic class — specific (HIC3) Smoking Deterrent Agents (Ganglionic Stim,Others)
AHFS code 12:02.00.00
AHFS class Smoking Cessation Agents
FDB label name NICOTINE 2 MG CHEWING GUM
FDB brand name Nicotine Gum
Legend status O — Over-the-counter (OTC) drug or device
Quick answers for NDC 70000-0347-1
  • GSN (GCN sequence number): 004930
  • GCN: 03200
  • GPI-14 (Medi-Span): 62100010002810
  • HICL (First Databank): 002049
  • AHFS class code: 12:02.00.00
  • RxCUI (RxNorm): 311975
  • 11-digit billing NDC: 70000034701
Why two NDCs? The FDA registers this code as 70000-0347-1 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 70000-0347-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Cholinergic Nicotinic Agonist class.

Pharmacologic class Cholinergic Nicotinic Agonist
Drug family (ATC) Drugs used in nicotine dependence
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name NICOTINE 2 MG CHEWING GUM Ingredient Nicotine Polacrilex
📗 Our plain-language guide HelloPharmacist
  • That's a really common concern, and it's worth addressing. Nicotine replacement products do deliver nicotine, but in a much more controlled way — without the tar, carbon monoxide,...
  • What exactly does nicotine replacement do — isn't it just replacing one nicotine habit with another?
  • Yes, it actually does matter. If you typically smoke your first cigarette within 30 minutes of waking up, your nicotine dependence is likely stronger, so you'd use the higher-stren...
  • How do I know which strength to use — and does it matter when I have my first cigarette in the morning?
📖 Read our full Nicotine guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eaPer package
Retail pharmacies payNADAC · weekly $0.233 $2.33 / 10 gum
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $0.262 $0.203
▲ Up 6% over the last 24 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
70000-0347-01 70000-0347-1 You're viewing this Main listing 10 BLISTER PACK in 1 CARTON (70000-0347-1) / 1 GUM, CHEWING in 1 BLISTER PACK 2018-07-03 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Good Sense Nicotine 2 mg 00113-0029-25 L. 1 gum $0.233 — Availability likely —
good sense nicotine mint 2 mg 00113-0206-25 L. 1 gum $0.233 — Discontinued —
Good Sense Nicotine 2 mg 00113-0456-60 L. 1 gum $0.233 — Availability likely —
good sense nicotine 2 mg 00113-8100-25 L. 1 gum $0.233 — Availability likely —
Nicotine 2 mg 00536-1362-06 Rugby 10 gums $0.233 — Discontinued —
Nicotine 2 mg 00536-3029-06 Rugby 10 gums $0.233 — Availability likely —
Nicotine 2 mg 00536-3112-01 Rugby 10 gums $0.233 — Discontinued —
Rugby Nicotine Polacrilex Gum, Coated Fruit Flavor 2 mg 00536-3386-01 Rugby 10 gums $0.233 — Discontinued —
Nicotine 2 mg 00536-3404-01 Rugby 1 gum $0.233 — Discontinued —
nicotine 2 mg 45802-0827-25 Padagis 1 gum $0.233 — Availability likely —
Nicotine Polacrilex coated ice mint 2 mg 46122-0448-58 AmerisourceBergen 1 gum $0.233 — Availability likely —
Nicotine Polacrilex 2 mg 46122-0717-60 AmerisourceBergen 1 gum $0.233 — Availability likely —
Nicotine 2 mg 46122-0719-60 AmerisourceBergen 1 gum $0.233 — Availability likely —
Nicotine 2 mg 46122-0724-25 AmerisourceBergen 1 gum $0.233 — Availability likely —
Nicotine Polacrilex 2 mg 57237-0322-01 Rising 10 gums $0.233 — Availability likely —
Nicotine 2 mg 63739-0371-63 McKesson 1 gum $0.233 — Availability likely —
Nicotine Polacrilex Original 2 mg 70000-0345-01 CARDINAL 1 gum $0.233 — Availability likely —
Nicotine Polacrilex Coated Fruit 2 mg 70000-0346-01 CARDINAL 1 gum $0.233 — Availability likely —
Nicotine Polacrilex Coated Mint 2 mgthis 70000-0347-01 CARDINAL 1 gum $0.233 — Availability likely —
Nicotine Polacrilex Coated Ice Mint 2 mg 70000-0348-01 CARDINAL 1 gum $0.233 — Availability likely —
foster and thrive nicotine 2 mg 70677-1164-01 Strategic 1 gum $0.233 — Availability likely —
Foster and Thrive Nicotine 2 mg 70677-1166-01 Strategic 1 gum $0.233 — Availability likely —
foster and thrive nicotine 2 mg 70677-1170-01 Strategic 1 capsule $0.233 — Availability likely —
Foster and Thrive Nicotine 2 mg 70677-1192-01 Strategic 1 gum $0.233 — Availability likely —
good sense nicotine 2 mg 00113-1352-78 L. 1 gum — — FDA listed —
Good Sense Nicotine 2 mg 00113-6020-06 L. 1 gum — — FDA listed —
Nicorette Original 2 mg 00135-0157-07 Haleon 110 gums — — FDA listed —
Nicorette Mint 2 mg 00135-0229-05 Haleon 170 gums — — FDA listed —
Nicorette Fruit Chill 2 mg 00135-0241-02 Haleon 100 gums — — FDA listed —
Nicorette Cinnamon Surge 2 mg 00135-0466-01 Haleon 20 gums — — FDA listed —
Nicorette White Ice Mint 2 mg 00135-0474-01 Haleon 20 gums — — FDA listed —
Nicorette Spearmint Burst 2 mg 00135-0532-02 Haleon 10 gums — — FDA listed —
Nicotine 2 mg 00363-0456-06 Walgreen 1 gum — — FDA listed —
nicotine 2 mg 00363-1012-78 Walgreen 1 gum — — FDA listed —
Nicotine Polacrilex MINT 2 mg 00363-1420-98 Walgreens 1 gum — — FDA listed —
Nicotine Polacrilex original 2 mg 00363-1608-62 Walgreens 1 gum — — FDA listed —
Nicotine 2 mg 00363-7050-06 Walgreen 1 gum — — FDA listed —
Nicotine 2 mg 00363-7269-06 Walgreen 1 gum — — FDA listed —
Nicotine Polacrilex 2 mg 00363-9240-10 Walgreens 1 gum — — FDA listed —
Nicotine 2 mg 00363-9250-10 Walgreens 1 gum — — FDA listed —
Nicotine Polacrilex 2 mg 00363-9260-10 Walgreens 1 gum — — FDA listed —
Nicotine Polacrilex 2 mg 00363-9270-10 Walgreens 1 gum — — FDA listed —
Nicotine 2 mg 00363-9290-30 Walgreens 1 gum — — FDA listed —
Nicotine 2 mg 11822-0029-01 Rite 1 gum — — FDA listed —
nicotine 2 mg 11822-0269-01 Rite 1 gum — — Discontinued —
nicotine 2 mg 11822-0352-01 Rite 1 gum — — Discontinued —
Nicotine 2 mg 11822-0456-01 Rite 1 gum — — FDA listed —
nicotine 2 mg 11822-0755-00 Rite 1 gum — — Discontinued —
nictoine gum 2 mg 11822-0904-01 Rite 1 gum — — Discontinued —
Nicotine Polacrilex 2 mg 11822-2331-02 Rite 1 gum — — FDA listed —
Rugby Nicotine Polacrilex Gum, Mint Flavor 2 mg 17856-1362-01 ATLANTIC 1 gum — — FDA listed —
signature care nicotine 2 mg 21130-0186-78 Safeway 1 gum — — FDA listed —
signature care nicotine 2 mg 21130-0269-78 Safeway 1 gum — — FDA listed —
nicotine 2 mg 21130-0389-25 Safeway 1 gum — — FDA listed —
Nicotine 2 mg 30142-0208-06 Kroger 1 gum — — FDA listed —
nicotine 2 mg 30142-0749-06 Kroger 1 gum — — FDA listed —
Nicotine 2 mg 30142-0859-11 The 1 gum — — FDA listed —
TopCare Nicotine 2 mg 36800-0029-25 Topco 1 gum — — FDA listed —
topcare nicotine 2 mg 36800-0269-78 Topco 1 gum — — FDA listed —
Topcare Nicotine 2 mg 36800-0456-60 Topco 1 gum — — FDA listed —
Topcare Nicotine 2 mg 36800-0460-25 Topco 1 gum — — FDA listed —
Topcare Nicotine 2 mg 36800-0863-78 Topco 1 gum — — FDA listed —
Nicotine 2 mg 37808-0682-06 H 1 gum — — FDA listed —
Nicotine 2 mg 37808-0711-06 H 1 gum — — FDA listed —
nicotine 2 mg 37808-0781-60 H 1 gum — — FDA listed —
Nicotine 2 mg 37808-0820-16 H 1 gum — — FDA listed —
HEB Nicotine 2 mg 37808-0863-96 H 1 gum — — FDA listed —
nicotine 2 mg 37808-0909-06 H 1 gum — — FDA listed —
nicotine 2 mg 41250-0029-29 Meijer 1 gum — — FDA listed —
Nicotine 2 mg 41250-0209-06 Meijer 1 gum — — FDA listed —
Nicotine 2 mg 41250-0456-06 Meijer 1 gum — — FDA listed —
nicotine 2 mg 41250-0529-06 Meijer 1 gum — — FDA listed —
care one nicotine 2 mg 41520-0352-78 American 1 gum — — FDA listed —
careone nicotine 2 mg 41520-0711-60 American 1 gum — — FDA listed —
CareOne nicotine 2 mg 41520-0792-25 American 1 gum — — FDA listed —
Nicotine 2 mg 42507-0343-78 HyVee 1 gum — — FDA listed —
Equate nicotine 2 mg 49035-0029-29 Wal-Mart 1 gum — — FDA listed —
equate nicotine 2 mg 49035-0206-96 Wal-Mart 1 gum — — FDA listed —
Equate nicotine 2 mg 49035-0352-06 Wal-Mart 1 gum — — FDA listed —
equate nicotine 2 mg 49035-0365-06 Wal-Mart 1 gum — — FDA listed —
equate nicotine 2 mg 49035-0415-78 Wal-Mart 1 gum — — FDA listed —
Equate Nicotine 2 mg 49035-0456-06 Wal-Mart 1 gum — — FDA listed —
Rugby Nicotine Polacrilex Gum, Mint Flavor 2 mg 50090-3560-00 A-S 10 gums — — FDA listed —
good sense nicotine 2 mg 50090-7063-00 A-S 1 gum — — FDA listed —
Nicotine Polacrilex 2 mg 55301-0428-44 AAFES/Your 1 gum — — FDA listed —
Nicotine Polacrilex 2 mg 55301-0503-44 AAFES/Your 1 gum — — FDA listed —
Habitrol Nicotine Polacrilex 2 mg Coated Cinnamon 55741-0004-10 Dr. 10 gums — — FDA listed —
coated nicotine 2 mg 56062-0110-60 Publix 1 gum — — FDA listed —
Nicotine 2 mg 56062-0298-71 Publix 1 gum — — FDA listed —
Nicotine Polacrilex Coated Mint 2 mg 56062-0428-44 Publix 10 gums — — FDA listed —
Nicotine Polacrilex Coated Fruit 2 mg 56062-0503-44 Publix 10 gums — — FDA listed —
Nicotine Polacrilex Original Flavor 2 mg 56062-0608-62 Publix 10 gums — — FDA listed —
Nicotine 2 mg 59726-0592-16 P 1 gum — — FDA listed —
Nicotine 2 mg 59726-0929-17 P 1 gum — — FDA listed —
Kirkland Signature Quit 2 2 mg 63981-0012-47 Costco 1 gum — — FDA listed —
kirkland signature quit 2 2 mg 63981-0029-56 Costco 1 gum — — FDA listed —
Nicotine Polacrilex Coated Mint 2 mg 68016-0280-49 Chain 10 gums — — FDA listed —
Nicotine Polacrilex Coated Mint 2 mg 68016-0284-44 Chain 10 gums — — FDA listed —
Nicotine Polacrilex, Original 2 mg 68016-0286-62 Chain 10 gums — — FDA listed —
Nicotine Polacrilex 2 mg 68016-0292-44 Chain 1 gum — — FDA listed —
Nicotine Polacrilex Coated Mint 2 mg 68016-0559-00 Chain 10 gums — — FDA listed —
Members Mark Nicotine 2 mg 68196-0012-47 Sam's 1 gum — — FDA listed —
members mark nicotine 2 mg 68196-0029-01 Sam's 1 gum — — FDA listed —
members mark nicotine 2 mg 68196-0269-47 Sam's 1 gum — — FDA listed —
Berkley and Jensen NICOTINE 2 mg 68391-0012-25 BJWC 1 gum — — Discontinued —
berkley and jensen nicotine 2 mg 68391-0029-06 BJWC 1 gum — — FDA listed —
Nicotine Polacrilex coated fruit 2 mg 69842-0024-15 CVS 1 gum — — FDA listed —
Nicotine Polacrilex coated cinnamon 2 mg 69842-0026-44 CVS 1 gum — — FDA listed —
Nicotine Polacrilex coated ice mint 2 mg 69842-0216-15 CVS 1 gum — — FDA listed —
Nicotine Polacrilex coated mint 2 mg 69842-0428-16 CVS 1 gum — — FDA listed —
Nicotine Polacrilex original 2 mg 69842-0608-15 CVS 1 gum — — FDA listed —
Nicotine Polacrilex 2 mg 72224-0924-10 Lucy 1 gum — — FDA listed —
Nicotine Polacrilex 2 mg 72224-0925-10 Lucy 1 gum — — FDA listed —
Nicotine Polacrilex 2 mg 72224-0927-10 Lucy 1 gum — — FDA listed —
basic care nicotine 2 mg 72288-0029-02 Amazon.com 1 gum — — FDA listed —
Basic Care Nicotine 2 mg 72288-0292-06 Amazon.com 1 gum — — FDA listed —
Basic Care Nicotine 2 mg 72288-0352-06 Amazon.com 1 gum — — FDA listed —
Basic Care Nicotine 2 mg 72288-0456-06 Amazon.com 1 gum — — FDA listed —
basic care nicotine 2 mg 72288-0811-01 Amazon.com 1 gum — — FDA listed —
Habitrol Nicotine Polacrilex Gum 2 mg Coated Fruit 75907-0301-10 Dr. 10 gums — — FDA listed —
Habitrol Nicotine Polacrilex Gum 2 mg Coated Mint 75907-0302-10 Dr. 10 gums — — FDA listed —
nicotine 2 mg 79481-0100-00 Meijer, 1 gum — — FDA listed —
nicotine 2 mg 79481-0755-00 Meijer, 1 gum — — FDA listed —
up and up uncoated nicotine 2 mg 82442-0029-02 Target 1 gum — — FDA listed —
Up And Up Coated Mint Freeze Nicotine 2 mg 82442-0100-06 Target 1 gum — — FDA listed —
up and up nicotine 2 mg 82442-0269-06 Target 1 gum — — FDA listed —
up and up coated cool mint nicotine 2 mg 82442-0456-78 Target 1 gum — — FDA listed —
up and up coated cinnamon nicotine 2 mg 82442-0700-06 Target 1 gum — — FDA listed —
up and up uncoated mint nicotine 2 mg 82442-0899-96 Target 1 gum — — FDA listed —
Blip 2 mg 82966-0012-60 Blip 1 gum — — FDA listed —
Blip 2 mg 82966-0269-60 Blip 1 gum — — FDA listed —
quitine nicotine 2 mg 84720-0352-70 QUITINE 1 gum — — FDA listed —
quitine nicotine 2 mg 84720-0456-70 QUITINE 1 gum — — FDA listed —
Nicotine Polacrilex 2 mg 84720-0927-03 Quitine 1 gum — — FDA listed —
Nicotine 2 mg 55154-6818-00 Cardinal 1 gum — — FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2018
On the market since
Jul 2018
📍
2026
Currently FDA-listed
8 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerCARDINAL HEALTH 110, LLC. DBA LEADER 70000
Application holderP AND L DEVELOPMENT LLC
FDA applicationANDA078699 (ANDA)
Labeler code70000
First marketedJul 2018
Product typeHuman Otc Drug
Portfolio17 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Ask a Doctor Before Use If 📄 Ask a Doctor or Pharmacist Before Use If 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 11 words ▾

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

⏱️ Dosage and Administration ~3 min read ▾

Directions - 2 mg 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 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.

⚠️ Warnings 57 words ▾

Warnings 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.

🧪 Active Ingredient 31 words ▾

Active ingredient (in each chewing piece) -2 mg Nicotine polacrilex (equal to 2 mg nicotine)

Active ingredient (in each chewing piece) - 4 mg Nicotine polacrilex (equal to 4 mg nicotine)

🧪 Inactive Ingredients 55 words ▾

Inactive ingredients - 2 mg acacia, acesulfame potassium, carnauba wax, flavors, gum base, hydroxypropyl cellulose, magnesium oxide, sodium bicarbonate, sodium carbonate, talc, titanium dioxide, xylitol.

Inactive ingredients - 4 mg acacia, acesulfame potassium, carnauba wax, D&C yellow #10 aluminum lake, flavors, gum base, hydroxypropyl cellulose, magnesium oxide, sodium bicarbonate, sodium carbonate, talc, titanium dioxide, xylitol.

🎯 Purpose 4 words ▾

Purpose Stop smoking aid

📄 Ask a Doctor Before Use If 44 words ▾

Ask a doctor before use if you have 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 31 words ▾

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 47 words ▾

Stop use and ask a doctor if 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 51 words ▾

Keep out of reach of children and pets. 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.

📄 Questions or Comments 9 words ▾

Questions or comments? Call 1- 877-753-3935 Monday-Friday 9AM-5PM EST

📄 Package Label / Principal Display Panel ~2 min read ▾

Principal display panel 2 mg COMPARE TO NICORETTE® GUM active ingredient* Sugar-Free Nicotine Gum Nicotine Polacrilex Gum USP, 2 mg (Nicotine) Stop Smoking Aid 2 mg Coated Mint Flavor 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 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 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® Mint Gum BLISTER PACKAGED FOR YOUR PROTECTION. DO NOT USE IF INDIVIDUAL SEALS ARE OPEN OR TORN . DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 46017 www.myleader.com

Package label 2 mg LEADER Sugar Free Nicotine Gum Coated Mint Flavor Nicotine polacrilex (equal to 2 mg nicotine)

Principal display panel 4 mg COMPARE TO NICORETTE® GUM active ingredient* Sugar-Free Nicotine Gum Nicotine Polacrilex Gum USP, 4 mg (Nicotine) Stop Smoking Aid 4 mg Coated 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 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 www.myleader.com

Package label 4 mg LEADER Sugar Free Nicotine Gum Coated Mint Flavor Nicotine polacrilex (equal to 4 mg nicotine)

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Nicotine Polacrilex Coated Mint (this brand).

Top reported reactions

Nausea700
Nicotine Dependence608
Macular Degeneration567
Oral Discomfort329
Dyspepsia314
Intentional Drug Misuse291
Malaise286

Reporter sex

6,149 reports

Serious outcomes

Death33
Disabling10
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 648 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) ✓ Available
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 70000-0347-1, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 70000-0347-01, written without dashes as 70000034701. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 70000-0347-01, the first segment (70000) is the labeler code FDA assigned to CARDINAL HEALTH 110, LLC. DBA LEADER 70000; the middle segment (0347) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by CARDINAL HEALTH 110, LLC. DBA LEADER 70000. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
CARDINAL HEALTH 110, LLC. DBA LEADER 70000 is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 70000-0346-01 · CARDINAL 70000-0348-01 · CARDINAL →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.