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Nicotine Polacrilex, Original 2 mg Gum, Chewing — NDC 68016-0286-62 package photo

Nicotine Polacrilex, Original 2 mg Gum, Chewing

by Chain Drug Consortium, LLC · 11 BLISTER PACK in 1 CARTON (68016-286-62) / 10 GUM, CHEWING in 1 BLISTER PACK
NDC 68016-0286-62
🏷️ FDA NDC (as labeled) 68016-286-62 billing pads the product segment with a zero
OTC Generic On market Non-controlled
🗂️ Data synced 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

FDA NDC (as labeled) 68016-286-62
Product NDC 68016-286
11-digit billing NDC 68016028662
NCPDP billing unit EA — each (per item)
RxCUI 311975, 314119
UNII 6M3C89ZY6R
UPC 0840986029875, 0840986029882
Application # ANDA074507
SPL Set ID cb67cd5e-9264-4530-a678-da299476f356
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 2013-07-01
Marketing end 2026-12-31
Route BUCCAL
Dosage form GUM, CHEWING
Substance NICOTINE
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 PC NICOTINE 2 MG CHEWING GUM
FDB brand name Nicotine Gum
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 68016-286-62 — 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 → 68016-0286-62. 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

LabelerChain Drug Consortium, LLC
Application holderP AND L DEVELOPMENT LLC
FDA applicationANDA074507 (ANDA)
Labeler code68016
First marketedJul 2013
Product typeHuman Otc Drug
Portfolio49 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

Label name PC NICOTINE 2 MG CHEWING GUM Ingredient Nicotine Polacrilex
📗 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.

💊 What it looks like

Color white / yellow
ShapeSquare
Size14 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 23OV73Q5G9
    Acesulfame potassium is an artificial sweetener that tastes about 200 times sweeter than sugar. It's added to medicines to improve taste without adding calories or affecting blood sugar.
  • UNII 1P9D0Z171K
    BHT is a synthetic antioxidant that prevents fats and oils in medicines from breaking down and becoming rancid. It helps keep the product stable and effective during storage.
  • UNII R12CBM0EIZ
    A natural wax derived from a Brazilian palm tree, used as a coating and polish on tablets and capsules. It creates a smooth, shiny finish that protects the medicine and improves appearance.
  • UNII 8MDF5V39QO
    A white powder form of baking soda that acts as a buffer and pH regulator in medicines. It helps maintain the right acid-base balance and may aid tablet disintegration.
  • UNII 45P3261C7T
    Sodium carbonate is an alkaline mineral salt commonly used in medications as a buffer to help maintain pH balance and improve stability. It may also function as a disintegrant to help tablets break apart in the digestive system.
  • UNII 506T60A25R
    Sorbitol is a natural sugar alcohol derived from glucose. It serves as a sweetener, humectant, and bulking agent in medications to improve taste and help maintain moisture in the product.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.

7 inactive ingredients listed in the exact product block matched to this NDC.

The official label also statesacesulfame potassium, butylated hydroxytoluene, carnauba wax, flavors, gum base, sodium bicarbonate, sodium carbonate, sorbitol, talc. 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, talc.

Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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.
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 2 mg 00113-0029-25 L. 1 gum $0.231 — Availability likely —
good sense nicotine mint 2 mg 00113-0206-25 L. 1 gum $0.231 — Discontinued —
Good Sense Nicotine 2 mg 00113-0456-60 L. 1 gum $0.231 — Availability likely —
good sense nicotine 2 mg 00113-8100-25 L. 1 gum $0.231 — Availability likely —
Nicotine 2 mg 00536-1362-06 Rugby 10 gums $0.231 — Discontinued —
Nicotine 2 mg 00536-3029-06 Rugby 10 gums $0.231 — Availability likely —
Nicotine 2 mg 00536-3112-01 Rugby 10 gums $0.231 — Discontinued —
Rugby Nicotine Polacrilex Gum, Coated Fruit Flavor 2 mg 00536-3386-01 Rugby 10 gums $0.231 — Discontinued —
Nicotine 2 mg 00536-3404-01 Rugby 1 gum $0.231 — Discontinued —
nicotine 2 mg 45802-0827-25 Padagis 1 gum $0.231 — Availability likely —
Nicotine Polacrilex coated ice mint 2 mg 46122-0448-58 AmerisourceBergen 1 gum $0.231 — Availability likely —
Nicotine Polacrilex 2 mg 46122-0717-60 AmerisourceBergen 1 gum $0.231 — Availability likely —
Nicotine 2 mg 46122-0719-60 AmerisourceBergen 1 gum $0.231 — Availability likely —
Nicotine 2 mg 46122-0724-25 AmerisourceBergen 1 gum $0.231 — Availability likely —
Nicotine Polacrilex 2 mg 57237-0322-01 Rising 10 gums $0.231 — Availability likely —
Nicotine 2 mg 63739-0371-63 McKesson 1 gum $0.231 — Availability likely —
Nicotine Polacrilex Original 2 mg 70000-0345-01 CARDINAL 1 gum $0.231 — Availability likely —
Nicotine Polacrilex Coated Fruit 2 mg 70000-0346-01 CARDINAL 1 gum $0.231 — Availability likely —
Nicotine Polacrilex Coated Mint 2 mg 70000-0347-01 CARDINAL 1 gum $0.231 — Availability likely —
Nicotine Polacrilex Coated Ice Mint 2 mg 70000-0348-01 CARDINAL 1 gum $0.231 — Availability likely —
foster and thrive nicotine 2 mg 70677-1164-01 Strategic 1 gum $0.231 — Availability likely —
Foster and Thrive Nicotine 2 mg 70677-1166-01 Strategic 1 gum $0.231 — Availability likely —
foster and thrive nicotine 2 mg 70677-1170-01 Strategic 1 capsule $0.231 — Availability likely —
Foster and Thrive Nicotine 2 mg 70677-1192-01 Strategic 1 gum $0.231 — 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 — — FDA listed —
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 — — Discontinued —
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 mgthis 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

🏛️
2013
On the market since
Jul 2013
📍
2026
Currently FDA-listed
13 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.

🔬 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 — the ingredient across all brands.

Top reported reactions

Nicotine Dependence4,155
Intentional Drug Misuse3,482
Nausea2,944
Malaise1,522
Dizziness1,336
Headache1,303
Overdose1,144

Age at onset

Neonate197
Infant21
Child23
Adolescent24
Adult2,518
Elderly565

Reporter sex

38,040 reports
Male · 42%
Female · 58%
Unknown · 0%

Serious outcomes

Hospitalization5,302
Life-threatening684
Disabling410
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 2,319 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
68016-0286-62 You're viewing this 11 BLISTER PACK in 1 CARTON (68016-286-62) / 10 GUM, CHEWING in 1 BLISTER PACK 2013-07-01 Active

🧭 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) ✓ 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 68016-286-62, 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: 68016-0286-62, written without dashes as 68016028662. 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 68016-0286-62, the first segment (68016) is the labeler code FDA assigned to Chain Drug Consortium, LLC; the middle segment (0286) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (62) 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 it is currently marketed — but Chain Drug Consortium, LLC has reported a marketing end date of 2026-12-31, after which this package is expected to stop being marketed. The directory data on this page refreshes weekly.
Who lists this product with the FDA?
Chain Drug Consortium, LLC 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 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 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 28 words ▾

Active ingredient (in each chewing piece) - 2 mg Nicotine Polacrilex 2 mg (nicotine)

Active ingredient (in each chewing piece) - 4 mg Nicotine Polacrilex 4 mg (nicotine)

🧪 Inactive Ingredients 56 words ▾

Inactive ingredients - 2 mg acesulfame potassium, butylated hydroxytoluene, carnauba wax, flavors, gum base, sodium bicarbonate, sodium carbonate, sorbitol, talc.

Inactive ingredients - 4 mg 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, talc.

🎯 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 ↗
← 68016-0285-44 · Chain 68016-0287-62 · Chain →
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.