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nicotine 4 mg Gum, Chewing — NDC 56062-0019-78 package photo

nicotine 4 mg Gum, Chewing

by Publix Super Markets Inc · 100 BLISTER PACK in 1 CARTON (56062-019-78) / 1 GUM, CHEWING in 1 BLISTER PACK
NDC 56062-0019-78
🏷️ FDA NDC (as labeled) 56062-019-78 billing pads the product segment with a zero
This package
Contains1 gum, chewing in 1 blister pack Pack sizes2 compare ↓
Also comes in: 1 gum 56062-0019-60
OTC Generic On market Non-controlled
🗂️ Data synced Aug 13, 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

FDA NDC (as labeled) 56062-019-78
Product NDC 56062-019
11-digit billing NDC 56062001978
RxCUI 311975
UNII 6M3C89ZY6R
Application # ANDA206393
SPL Set ID 4ddba70a-3f45-4c76-a12a-6da256e9afc5
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 2026-06-11
Route ORAL
Dosage form GUM, CHEWING
Substance NICOTINE
Why two NDCs? The FDA registers this code as 56062-019-78 — a 5-3-2 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 product segment → 56062-0019-78. 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.

🏭 Manufacturer & labeler

LabelerPublix Super Markets Inc
Application holderPERRIGO R AND D CO
FDA applicationANDA206393 (ANDA)
Labeler code56062
First marketedJun 2026
Product typeHuman Otc Drug
Portfolio112 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.

🩺 Clinical

📗 Our plain-language guide HelloPharmacist
  • It's a fair question. Nicotine is what makes cigarettes addictive, and it does raise your heart rate and blood pressure. But it's the thousands of other chemicals in cigarette smok...
  • Is nicotine replacement actually safe — isn't nicotine the thing that's bad for you?
  • It comes down to one simple question: when do you smoke your first cigarette of the day? If it's within 30 minutes of waking up, you're a heavier, more dependent smoker and you'll...
  • It depends on the form you're using. With the gum or lozenge, hiccups, heartburn, and a tingling in the mouth are pretty common — these usually mean you're using it a bit too fast....
📖 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.

🧪 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.

💲 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 eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
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.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 1 gum
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Good Sense Nicotine 4 mg 00113-0053-06 L. 1 gum $0.282 — Availability likely —
Good Sense Nicotine 4 mg 00113-0422-25 L. 1 gum $0.282 — Discontinued —
foster and thrive nicotine 4 mg 70677-1167-01 Strategic 1 gum $0.282 — Availability likely —
foster and thrive nicotine 4 mg 70677-1193-01 Strategic 1 gum $0.282 — Availability likely —
Good Sense Nicotine 4 mg 00113-0532-60 L. 1 gum $0.282 — Availability likely —
Nicotine Polacrilex 4 mg 46122-0720-25 AmerisourceBergen 1 gum $0.282 — Availability likely —
Foster and Thrive Nicotine 4 mg 70677-1171-01 Strategic 1 gum $0.282 — Availability likely —
good sense nicotine 4 mg 00113-8600-25 L. 1 gum $0.282 — Availability likely —
Nicotine Polacrilex 4 mg 46122-0718-60 AmerisourceBergen 1 gum $0.282 — Availability likely —
Nicotine Polacrilex 4 mg 57237-0323-01 Rising 10 gums $0.282 — Availability likely —
Nicotine 4 mg 63739-0369-10 McKesson 1 gum $0.282 — Discontinued —
Nicotine Polacrilex 4 mg 46122-0725-71 AmerisourceBergen 1 gum $0.282 — Availability likely —
Nicotine 4 mg 46122-0733-60 AmerisourceBergen 1 gum $0.282 — Availability likely —
Nicotine 4 mg 45802-0651-25 Padagis 1 gum $0.282 — Availability likely —
foster and thrive nicotine 4 mg 70677-1165-01 Strategic 1 gum $0.282 — Availability likely —
Good Sense Nicotine 4 mg 00113-0170-25 L. 1 gum $0.313 — Discontinued —
Nicotine 4 mg 00363-3911-10 Walgreens 1 gum — — FDA listed —
Nicotine 4 mg 30142-0309-06 Kroger 1 gum — — FDA listed —
Rexall Nicotine 4 mg 55910-0532-60 Dolgencorp, 1 gum — — Discontinued —
berkley and jensen nicotine 4 mg 68391-0170-06 BJWC 1 gum — — FDA listed —
basic care nicotine 4 mg 72288-0170-02 Amazon.com 1 gum — — FDA listed —
basic care nicotine 4 mg 72288-0442-06 Amazon.com 1 gum — — FDA listed —
Good Sense 4 mg 50090-6240-00 A-S 1 gum — — FDA listed —
good sense nicotine 4 mg 50090-6695-00 A-S 1 gum — — FDA listed —
nicotine 4 mg 79481-0103-00 Meijer, 1 capsule — — FDA listed —
nicotine 4 mg 11822-0309-00 Rite 1 gum — — Discontinued —
topcare nicotine 4 mg 36800-0967-78 Topco 1 gum — — FDA listed —
Nicotine 4 mg 37808-0821-16 H 1 gum — — FDA listed —
Equate nicotine 4 mg 49035-0170-29 Wal-Mart 1 gum — — FDA listed —
Nicotine 4 mg 51316-0309-10 CVS 1 gum — — FDA listed —
Nicotine Polacrilex 4 mg 00363-9330-10 Walgreens 1 gum — — FDA listed —
blip 4 mg 82966-0971-60 Blip 1 gum — — FDA listed —
quitine nicotine 4 mg 84720-0532-70 QUITINE 1 gum — — FDA listed —
Oneoo Nicotine Gum (Mint) 4 mg 87494-0003-01 Guangzhou 60 gums — — FDA listed —
nicotine 4 mg 11822-0170-01 Rite 1 gum — — FDA listed —
Nicotine 4 mg 11822-0699-01 Rite 1 gum — — FDA listed —
signature care nicotine 4 mg 21130-0173-78 Safeway 1 gum — — FDA listed —
signature care nicotine 4 mg 21130-0522-25 Safeway 1 gum — — FDA listed —
Good Sense Nicotine 4 mg 00113-0854-60 L. 1 gum — — Discontinued —
Nicotine 4 mg 30142-0671-11 The 1 gum — — FDA listed —
Nicorette Cinnamon Surge 4 mg 00135-0467-01 Haleon 20 gums — — FDA listed —
nicotine 4 mg 37808-0849-60 H 1 gum — — FDA listed —
kirkland signature quit 4 4 mg 63981-0309-47 Costco 1 gum — — FDA listed —
Up And Up Coated Fruit Nicotine 4 mg 82442-0971-06 Target 1 gum — — FDA listed —
nicotine 4 mg 11822-0971-01 Rite 1 gum — — FDA listed —
nicotine 4 mg 30142-0848-06 Kroger 1 gum — — FDA listed —
Topcare Nicotine 4 mg 36800-0650-60 Topco 1 gum — — FDA listed —
Habitrol Nicotine Polacrilex 4 mg Coated Cinnamon 55741-0001-10 Dr. 10 gums — — FDA listed —
Nicotine 4 mg 59726-0913-16 P 1 gum — — FDA listed —
members mark nicotine 4 mg 68196-0170-01 Sam's 1 gum — — FDA listed —
Nicotine 4 mg 72224-0930-10 Lucy 1 gum — — FDA listed —
Up and Up Mint Nicotine 4 mg 82442-0500-96 Target 1 gum — — FDA listed —
Topcare Nicotine 4 mg 36800-0532-60 Topco 1 gum — — FDA listed —
Nicorette Fruit Chill 4 mg 00135-0242-02 Haleon 100 gums — — FDA listed —
nicotine 4 mg 37808-0611-96 H 1 gum — — FDA listed —
Nicotine 4 mg 41250-0510-06 Meijer 1 gum — — FDA listed —
nicotine 4 mg 42507-0309-78 HyVee 1 gum — — FDA listed —
Nicotine 4 mg 50090-6674-00 A-S 110 gums — — FDA listed —
Nicotine Polacrilex 4 mg 55910-0976-20 Dolgencorp, 1 gum — — FDA listed —
Nicotine 4 mg 59726-0935-17 P 1 gum — — FDA listed —
members mark nicotine 4 mg 68196-0309-47 Sam's 1 gum — — FDA listed —
Nicorette Spearmint Burst 4 mg 00135-0355-03 Haleon 10 gums — — FDA listed —
nicotine 4 mg 37808-0683-06 H 1 gum — — FDA listed —
Care One Nicotine 4 mg 41520-0854-78 American 1 gum — — FDA listed —
equate nicotine 4 mg 49035-0422-96 Wal-Mart 1 gum — — FDA listed —
Nicotine 4 mg 55910-0918-20 Dolgencorp, 1 gum — — FDA listed —
Nicotine 4 mg 00363-9350-30 Walgreens 1 gum — — FDA listed —
Basic Care Nicotine 4 mg 72288-0003-06 Amazon.com 1 gum — — FDA listed —
basic care nicotine 4 mg 72288-0577-06 Amazon.com 1 gum — — FDA listed —
Habitrol Nicotine Polacrilex Gum 4 mg Coated Fruit 75907-0300-10 Dr. 10 gums — — FDA listed —
nicotine 4 mg 79481-0601-00 Meijer, 1 gum — — FDA listed —
Oneoo Nicotine Gum (3 Flavors) 4 mg 87494-0006-01 Guangzhou 1 gum — — FDA listed —
Topcare Nicotine 4 mg 36800-0170-25 Topco 1 gum — — FDA listed —
equate nicotine 4 mg 49035-0309-78 Wal-Mart 1 gum — — FDA listed —
Nicotine Polacrilex 4 mg 55319-0966-20 Family 1 gum — — FDA listed —
Habitrol Nicotine Polacrilex Gum 4 mg Coated Mint 75907-0303-10 Dr. 10 gums — — FDA listed —
Blip 4 mg 82966-0309-60 Blip 1 gum — — FDA listed —
Oneoo Nicotine Gum (Cinnamon) 4 mg 87494-0007-01 Guangzhou 60 gums — — Discontinued —
Good Sense Nicotine 4 mg 00113-4111-06 L. 1 gum — — FDA listed —
Nicorette Spearmint Burst 4 mg 00135-0533-02 Haleon 10 gums — — FDA listed —
Nicotine 4 mg 41250-0170-29 Meijer 1 gum — — FDA listed —
nicotine 4 mg 41250-0689-06 Meijer 1 gum — — FDA listed —
Nicotine Polacrilex 4 mg 55910-0796-20 Dolgencorp, 1 gum — — FDA listed —
kirkland signature quit 4 4 mg 63981-0170-01 Costco 1 gum — — FDA listed —
Members Mark Nicotine 4 mg 68196-0971-47 Sam's 1 gum — — FDA listed —
Berkley and Jensen Nicotine 4 mg 68391-0309-25 BJWC 1 gum — — Discontinued —
nicotine 4 mg 00363-2309-78 Walgreen 1 gum — — FDA listed —
Nicotine 4 mg 72224-0931-10 Lucy 1 gum — — FDA listed —
up and up uncoated original nicotine 4 mg 82442-0170-02 Target 1 gum — — FDA listed —
Up and Up Nicotine 4 mg 82442-0532-78 Target 1 gum — — FDA listed —
signature care nicotine 4 mg 21130-0820-78 Safeway 1 gum — — FDA listed —
Nicorette White Ice Mint 4 mg 00135-0475-01 Haleon 20 gums — — FDA listed —
careone nicotine 4 mg 41520-0891-25 American 1 gum — — FDA listed —
dg health nicotine 4 mg 55910-0122-58 Dolgencorp 1 gum — — FDA listed —
Nicotine Polacrilex 4 mg 55910-0933-10 Dolgencorp, 1 gum — — FDA listed —
Nicotine Polacrilex 4 mg 00363-3290-10 Walgreens 1 gum — — FDA listed —
Nicotine 4 mg 00363-9310-10 Walgreens 1 gum — — FDA listed —
basic care nicotine 4 mg 72288-0532-06 Amazon.com 1 gum — — FDA listed —
basic care nicotine 4 mg 72288-0693-01 Amazon.com 1 gum — — FDA listed —
Up And Up Coated Cinnamon Nicotine 4 mg 82442-0329-06 Target 1 gum — — FDA listed —
up and up coated mint freeze nicotine 4 mg 82442-0723-06 Target 1 gum — — FDA listed —
quitine nicotine 4 mg 84720-0854-70 QUITINE 1 gum — — FDA listed —
Nicotine Polacrilex 4 mg 84720-0933-03 Quitine 1 gum — — FDA listed —
Oneoo Nicotine Gum (Grape) 4 mg 87494-0004-01 Guangzhou 60 gums — — FDA listed —
Nicorette Mint 4 mg 00135-0230-03 Haleon 50 gums — — FDA listed —
Nicotine 4 mg 37808-0658-06 H 1 gum — — FDA listed —
Nicotine 4 mg 41250-0854-06 Meijer 1 gum — — Discontinued —
careone nicotine 4 mg 41520-0843-60 American 1 gum — — FDA listed —
Equate nicotine 4 mg 49035-0532-06 Wal-Mart 1 gum — — Discontinued —
Equate Nicotine 4 mg 49035-0854-06 Wal-Mart 1 gum — — FDA listed —
Coated Nicotine 4 mg 56062-0369-60 Publix 1 gum — — FDA listed —
Nicotine 4 mg 00363-0919-06 Walgreen 1 gum — — FDA listed —
nicotine 4 mg 00363-7103-06 Walgreen 1 gum — — FDA listed —
Nicotine Polacrilex 4 mg 72224-0933-10 Lucy 1 gum — — FDA listed —
nicotine 4 mg 11822-1103-00 Rite 1 gum — — FDA listed —
Nicorette Original 4 mg 00135-0158-07 Haleon 110 gums — — FDA listed —
Nicotine 4 mg 41250-0532-06 Meijer 1 gum — — FDA listed —
equate Nicotine 4 mg 49035-0442-06 Wal-Mart 1 gum — — FDA listed —
nicotine 4 mg 00363-7971-06 Walgreen 1 gum — — FDA listed —
Nicotine 4 mg 72288-0540-29 Amazon.com 1 gum — — FDA listed —
nicotine 4 mgthis 56062-0019-78 Publix 1 gum — — FDA listed —
nicotine 4 mg 56062-0812-71 Publix 1 gum — — FDA listed —
Quitine Nicotine 4 mg 84720-0309-70 QUITINE 1 gum — — FDA listed —
Oneoo Nicotine Gum (Cinnmon) 4 mg 87494-0005-01 Guangzhou 60 gums — — 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

🏛️
2026
On the market since
Jun 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
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.

🔬 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 (this brand).

Top reported reactions

Nausea1,591
Nicotine Dependence1,314
Headache856
Overdose828
Macular Degeneration795
Malaise754
Foetal Exposure During Pregnancy746

Age at onset

Neonate190
Infant21
Child11
Adolescent24
Adult2,317
Elderly504

Reporter sex

20,607 reports
Male · 42%
Female · 57%
Unknown · 0%

Serious outcomes

Hospitalization4,679
Death1,593
Life-threatening604
Disabling321
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,563 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
56062-0019-60 20 BLISTER PACK in 1 CARTON (56062-019-60) / 1 GUM, CHEWING in 1 BLISTER PACK 2026-06-11 Active
56062-0019-78 You're viewing this 100 BLISTER PACK in 1 CARTON (56062-019-78) / 1 GUM, CHEWING in 1 BLISTER PACK 2026-06-11 Active

Pack size FAQ

What quantity is in NDC 56062-0019-78?
NDC 56062-0019-78 is listed by the FDA — 100 blister pack in 1 carton / 1 gum, chewing in 1 blister pack.
What NDC number is used to bill for this package of nicotine 4 mg Gum, Chewing?
Bill NDC 56062-0019-78 — the 11-digit billing format is 56062001978. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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 ✓ Available
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) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
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

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
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 56062-019-78, 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: 56062-0019-78, written without dashes as 56062001978. 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 56062-0019-78, the first segment (56062) is the labeler code FDA assigned to Publix Super Markets Inc; the middle segment (0019) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (78) 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 Publix Super Markets Inc. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 1 other package presentation of this same product, including 1 gum (56062-0019-60). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Publix Super Markets Inc 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.

📄 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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 12 words ▾

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

⏱️ Dosage and Administration ~1 min read ▾

Directions • 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 Nicotine Polacrilex Gum, 2 mg • if you smoke your first cigarette within 30 minutes of waking up, use Nicotine Polacrilex Gum, 4 mg 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 ~1 min read ▾

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. 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 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, 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. 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 right away (1-800-222-1222).

📦 Storage and Handling 26 words ▾

Other information • each piece contains: calcium 80 mg and sodium 11 mg • store at 68-77 ° F (20-25 ° C) • protect from light

🧪 Active Ingredient 13 words ▾

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

🧪 Inactive Ingredients 35 words ▾

Inactive ingredients acesulfame potassium, calcium carbonate, carnauba wax, D&C yellow no. 10, gelatin, gum base, mannitol, menthol, natural and artificial mint and peppermint flavors, sodium bicarbonate, sodium carbonate anhydrous, sorbitol, sucralose, talc, titanium dioxide, xylitol

🎯 Purpose 4 words ▾

Purpose Stop smoking aid

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 56062-0003-30 · Publix 56062-0020-06 · Publix →
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.