HomeNDC LookupIngredientsNicotine Polacrilex › 68391-0012-29
Berkley and Jensen NICOTINE Nicotine polacrilex 2 mg Gum, Chewing — NDC 68391-0012-29 package photo

Berkley and Jensen NICOTINE Nicotine polacrilex 2 mg Gum, Chewing

by BJWC · 2 CARTON in 1 CARTON (68391-012-29) / 110 BLISTER PACK in 1 CARTON / 1 GUM, CHEWING in 1 BLISTER PACK
NDC 68391-0012-29
🏷️ FDA NDC (as labeled) 68391-012-29 billing pads the product segment with a zero
This package
Contains1 gum, chewing in 1 blister pack Pack sizes4 compare ↓
OTC Generic Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ 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 →
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 68391-012-29
Product NDC 68391-012
11-digit billing NDC 68391001229
RxCUI 314119
UNII 6M3C89ZY6R
Application # ANDA206394
SPL Set ID cdaa2643-7630-41e8-bd48-4a760cf4a46a
Established class (EPC) Cholinergic Nicotinic Agonist
Chemical class Nicotine
DEA schedule Non-controlled
Marketing category ANDA
Marketing status Discontinued
FDA listing status Discontinued by firm
Marketing start 2017-02-28
Route ORAL
Dosage form GUM, CHEWING
Substance NICOTINE
Why two NDCs? The FDA registers this code as 68391-012-29 — 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 → 68391-0012-29. 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

LabelerBJWC
Application holderPERRIGO R AND D CO
FDA applicationANDA206394 (ANDA)
Labeler code68391
First marketedFeb 2017
Product typeHuman Otc Drug
Portfolio40 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

📖 What it is MedlinePlus · NLM

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.

Read the full MedlinePlus article ↗
📗 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 →
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
ShapeRectangle
Size19 mm
ScoringNot scored
FlavorPeppermint
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 H0G9379FGK
    Calcium carbonate is a white mineral powder used as a filler and buffering agent in medicines. It helps give tablets their bulk and size while neutralizing stomach acid in some formulations.
  • 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 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII 3OWL53L36A
    A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
  • UNII L7T10EIP3A
    A cooling compound from mint plants used as a flavoring agent and to create a fresh sensation in medicines. It helps mask bitter tastes and improve how the product feels in the mouth.
  • UNII RCZ785HI7S
    A synthetic polymer made from acrylic acid that absorbs moisture. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the active drug can be released and absorbed.
  • 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 96K6UQ3ZD4
    Sucralose is a synthetic sweetener made from sugar. It's added to medicines to improve taste without adding calories, helping make bitter or unpleasant-tasting drugs easier to take.
  • 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.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
  • UNII VCQ006KQ1E
    Xylitol is a naturally occurring sugar alcohol derived from plants. It's used in medicines as a sweetener, bulking agent, and to improve taste, especially in liquid formulations and chewable tablets.

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

The official label also statesacesulfame potassium, calcium carbonate, carnauba wax, gelatin, gum base, mannitol, menthol, natural and artificial mint and peppermint flavors, sodium bicarbonate, sodium carbonate anhydrous, sorbitol, sucralose, talc, titanium dioxide, xylitol

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 DailyMedingredient 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.
Try another pack size: 1 gum 1 gum 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 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 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 mgthis 68391-0012-29 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 56062-0646-60 Publix 1 gum FDA listed
nicotine 2 mg 51316-0151-10 CVS 1 gum FDA listed
Quitine Nicotine 2 mg 84720-0012-70 QUITINE 1 gum FDA listed
Nicotine 2 mg 72288-0518-06 Amazon.com 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

🏛️
2017
On the market since
Feb 2017
📍
2026
Currently FDA-listed
9 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
68391-0012-25 110 BLISTER PACK in 1 CARTON (68391-012-25) / 1 GUM, CHEWING in 1 BLISTER PACK 2017-02-28 Discontinued by firm
68391-0012-29 You're viewing this 2 CARTON in 1 CARTON (68391-012-29) / 110 BLISTER PACK in 1 CARTON / 1 GUM, CHEWING in 1 BLISTER PACK 2017-02-28 Discontinued by firm
68391-0012-76 240 BLISTER PACK in 1 CARTON (68391-012-76) / 1 GUM, CHEWING in 1 BLISTER PACK 2020-02-13 Active
68391-0012-70 2 CARTON in 1 PACKAGE (68391-012-70) / 120 BLISTER PACK in 1 CARTON (68391-012-76) / 1 GUM, CHEWING in 1 BLISTER PACK 2020-02-13 Active

Pack size FAQ

What quantity is in NDC 68391-0012-29?
NDC 68391-0012-29 is listed by the FDA — 2 carton in 1 carton / 110 blister pack in 1 carton / 1 gum, chewing in 1 blister pack.
What NDC number is used to bill for this package of Berkley and Jensen NICOTINE Nicotine polacrilex 2 mg Gum, Chewing?
Bill NDC 68391-0012-29 — the 11-digit billing format is 68391001229. 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 No longer marketed (per FDA listing data)
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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 68391-012-29, 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: 68391-0012-29, written without dashes as 68391001229. 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 68391-0012-29, the first segment (68391) is the labeler code FDA assigned to BJWC; the middle segment (0012) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (29) identifies this exact package size and type. Together they name one specific package of one specific product.
Does this product come in other package sizes?
Yes — the FDA directory lists 3 other package presentations of this same product, including 1 gum (68391-0012-25), 1 gum (68391-0012-76), 1 gum (68391-0012-70). 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?
BJWC 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 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 within 30 minutes of waking up, use Nicotine Polacrilex Gum, 4 mg • if you smoke your first cigarette more than 30 minutes after waking up, use Nicotine Polacrilex Gum, 2 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 20-25 o C (68-77 o F) • protect from light

🧪 Active Ingredient 13 words

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

🧪 Inactive Ingredients 31 words

Inactive ingredients acesulfame potassium, calcium carbonate, carnauba wax, 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 ↗
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.