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Nicotine 4 mg Gum, Chewing — NDC 00536-3405-01 package photo

Nicotine 4 mg Gum, Chewing

by Rugby Laboratories · 100 BLISTER PACK in 1 CARTON (0536-3405-01) / 1 GUM, CHEWING in 1 BLISTER PACK
NDC 00536-3405-01
🏷️ FDA NDC (as labeled) 0536-3405-01 billing pads the labeler segment with a zero
OTC Generic Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ Data synced Sep 3, 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

⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Feb 2013. 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) 0536-3405-01
Product NDC 0536-3405
11-digit billing NDC 00536340501
NCPDP billing unit EA — each (per item)
RxCUI 311975, 314119
UNII 6M3C89ZY6R
Application # ANDA079219
SPL Set ID d67149d5-4766-4b84-8205-f1a6b692f4c9
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 (certified through Feb 2013)
Marketing start 2009-07-08
Route BUCCAL
Dosage form GUM, CHEWING
Substance NICOTINE
GCN Seq No 013486
GCN 03201
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 4 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 0536-3405-01 — a 4-4-2 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 labeler segment → 00536-3405-01. 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.

🏭 Manufacturer & labeler

LabelerRugby Laboratories
Application holderP AND L DEVELOPMENT LLC
FDA applicationANDA079219 (ANDA)
Labeler code00536
First marketedJul 2009
Product typeHuman Otc Drug
Portfolio149 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 NICOTINE 4 MG CHEWING GUM Ingredient Nicotine Polacrilex
📖 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 →

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 pink
ShapeSquare
Size14 mm
ScoringNot scored
FlavorCinnamon
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 5C5403N26O
    Acacia is a natural gum derived from acacia tree sap. It serves as a binder, thickener, and emulsifier to help hold ingredients together, improve texture, and stabilize the medicine.
  • 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 6T47AS764T
    Red 40 Lake is a synthetic colorant made by combining Red 40 dye with aluminum hydroxide. It's used to give tablets, capsules, and other medicines a red or pink color for identification and appearance.
  • UNII UKE75GEA7F
    Hydroxypropyl cellulose is a plant-based polymer used as a binder and thickener. It helps hold tablet ingredients together, controls how fast the medicine dissolves, and improves the texture of liquid formulations.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • 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 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.

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

The official label also statesacacia, acesulfame potassium, butylated hydroxytoluene, carnauba wax, FD&C red #40 lake, gum base, hydroxypropyl cellullose, hypromellose, natural and artificial cinnamon flavors, sodium bicarbonate, sodium carbonate, sucralose, talc, titanium dioxide and 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 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 eaPer package
Retail pharmacies payNADAC · weekly $0.282 $28.17 / 100 gum
Medicaid paysCMS SDUD · 12 mo $0.3093 $30.93 / 100 gum
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
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.334 $0.246
▲ Up 15% 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.

🔁 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 —
Good Sense Nicotine 4 mg 00113-0532-60 L. 1 gum $0.282 — Availability likely —
good sense nicotine 4 mg 00113-8600-25 L. 1 gum $0.282 — Availability likely —
Nicotine 4 mg 00536-1372-06 Rugby 10 gums $0.282 — Discontinued —
Nicotine 4 mg 00536-3030-06 Rugby 10 gums $0.282 — Availability likely —
Nicotine 4 mg 00536-3113-01 Rugby 10 gums $0.282 — Discontinued —
Rugby Nicotine Polacrilex Gum, Coated Fruit Flavor 4 mg 00536-3387-01 Rugby 10 gums $0.282 — Discontinued —
Nicotine 4 mgthis 00536-3405-01 Rugby 1 gum $0.282 — Discontinued —
Nicotine 4 mg 45802-0651-25 Padagis 1 gum $0.282 — Availability likely —
Nicotine Polacrilex coated ice mint 4 mg 46122-0449-58 AmerisourceBergen 1 gum $0.282 — Availability likely —
Nicotine Polacrilex 4 mg 46122-0718-60 AmerisourceBergen 1 gum $0.282 — Availability likely —
Nicotine Polacrilex 4 mg 46122-0720-25 AmerisourceBergen 1 gum $0.282 — Availability likely —
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 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 Original 4 mg 70000-0341-01 CARDINAL 1 gum $0.282 — Availability likely —
Nicotine Polacrilex Coated Fruit 4 mg 70000-0342-01 CARDINAL 1 gum $0.282 — Availability likely —
Nicotine Polacrilex Coated Mint 4 mg 70000-0343-01 CARDINAL 1 gum $0.282 — Availability likely —
Nicotine Polacrilex Coated Ice Mint 4 mg 70000-0344-01 CARDINAL 1 gum $0.282 — Availability likely —
foster and thrive nicotine 4 mg 70677-1165-01 Strategic 1 gum $0.282 — Availability likely —
foster and thrive nicotine 4 mg 70677-1167-01 Strategic 1 gum $0.282 — Availability likely —
Foster and Thrive Nicotine 4 mg 70677-1171-01 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 00113-0170-25 L. 1 gum $0.313 — Discontinued +11%
Good Sense Nicotine 4 mg 00113-0854-60 L. 1 gum — — Discontinued —
Good Sense Nicotine 4 mg 00113-4111-06 L. 1 gum — — FDA listed —
Nicorette Original 4 mg 00135-0158-07 Haleon 110 gums — — FDA listed —
Nicorette Mint 4 mg 00135-0230-03 Haleon 50 gums — — FDA listed —
Nicorette Fruit Chill 4 mg 00135-0242-02 Haleon 100 gums — — FDA listed —
Nicorette Spearmint Burst 4 mg 00135-0355-03 Haleon 10 gums — — FDA listed —
Nicorette Cinnamon Surge 4 mg 00135-0467-01 Haleon 20 gums — — FDA listed —
Nicorette White Ice Mint 4 mg 00135-0475-01 Haleon 20 gums — — FDA listed —
Nicorette Spearmint Burst 4 mg 00135-0533-02 Haleon 10 gums — — FDA listed —
Nicotine 4 mg 00363-0919-06 Walgreen 1 gum — — FDA listed —
Nicotine Polacrilex MINT 4 mg 00363-1421-98 Walgreens 1 gum — — FDA listed —
Nicotine Polacrilex original 4 mg 00363-1609-62 Walgreens 1 gum — — FDA listed —
nicotine 4 mg 00363-2309-78 Walgreen 1 gum — — FDA listed —
Nicotine Polacrilex 4 mg 00363-3290-10 Walgreens 1 gum — — FDA listed —
Nicotine 4 mg 00363-3911-10 Walgreens 1 gum — — FDA listed —
nicotine 4 mg 00363-7103-06 Walgreen 1 gum — — FDA listed —
nicotine 4 mg 00363-7971-06 Walgreen 1 gum — — FDA listed —
Nicotine 4 mg 00363-9310-10 Walgreens 1 gum — — FDA listed —
Nicotine Polacrilex 4 mg 00363-9330-10 Walgreens 1 gum — — FDA listed —
Nicotine 4 mg 00363-9350-30 Walgreens 1 gum — — FDA listed —
nicotine 4 mg 11822-0170-01 Rite 1 gum — — FDA listed —
nicotine 4 mg 11822-0309-00 Rite 1 gum — — Discontinued —
Nicotine 4 mg 11822-0699-01 Rite 1 gum — — FDA listed —
nicotine 4 mg 11822-0971-01 Rite 1 gum — — FDA listed —
nicotine 4 mg 11822-1103-00 Rite 1 gum — — FDA listed —
Rugby Nicotine Polacrilex Gum, Original Flavor 4 mg 17856-3030-01 ATLANTIC 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 —
signature care nicotine 4 mg 21130-0820-78 Safeway 1 gum — — FDA listed —
Nicorette Fruit Chill nicotine polacrilex 4 mg 29485-5270-01 Lil' 10 gums — — FDA listed —
Nicorette White Mint nicotine polacrilex 4 mg 29485-5271-01 Lil' 10 gums — — FDA listed —
Nicotine 4 mg 30142-0309-06 Kroger 1 gum — — FDA listed —
Nicotine 4 mg 30142-0671-11 The 1 gum — — FDA listed —
nicotine 4 mg 30142-0848-06 Kroger 1 gum — — FDA listed —
Topcare Nicotine 4 mg 36800-0170-25 Topco 1 gum — — FDA listed —
Topcare Nicotine 4 mg 36800-0532-60 Topco 1 gum — — FDA listed —
Topcare Nicotine 4 mg 36800-0650-60 Topco 1 gum — — FDA listed —
topcare nicotine 4 mg 36800-0967-78 Topco 1 gum — — FDA listed —
nicotine 4 mg 37808-0611-96 H 1 gum — — FDA listed —
Nicotine 4 mg 37808-0658-06 H 1 gum — — FDA listed —
nicotine 4 mg 37808-0683-06 H 1 gum — — FDA listed —
nicotine 4 mg 37808-0739-06 H 1 gum — — FDA listed —
Nicotine 4 mg 37808-0821-16 H 1 gum — — FDA listed —
nicotine 4 mg 37808-0849-60 H 1 gum — — FDA listed —
Nicotine 4 mg 41250-0170-29 Meijer 1 gum — — FDA listed —
Nicotine 4 mg 41250-0510-06 Meijer 1 gum — — FDA listed —
Nicotine 4 mg 41250-0532-06 Meijer 1 gum — — FDA listed —
nicotine 4 mg 41250-0689-06 Meijer 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 —
Care One Nicotine 4 mg 41520-0854-78 American 1 gum — — FDA listed —
careone nicotine 4 mg 41520-0891-25 American 1 gum — — FDA listed —
nicotine 4 mg 42507-0309-78 HyVee 1 gum — — FDA listed —
Equate nicotine 4 mg 49035-0170-29 Wal-Mart 1 gum — — FDA listed —
equate nicotine 4 mg 49035-0309-78 Wal-Mart 1 gum — — FDA listed —
equate nicotine 4 mg 49035-0422-96 Wal-Mart 1 gum — — FDA listed —
equate Nicotine 4 mg 49035-0442-06 Wal-Mart 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 —
Good Sense 4 mg 50090-6240-00 A-S 1 gum — — FDA listed —
Nicotine 4 mg 50090-6674-00 A-S 110 gums — — FDA listed —
good sense nicotine 4 mg 50090-6695-00 A-S 1 gum — — FDA listed —
Nicotine 4 mg 51316-0309-10 CVS 1 gum — — FDA listed —
Nicotine Polacrilex 4 mg 55301-0429-44 AAFES/Your 1 gum — — FDA listed —
Nicotine Polacrilex 4 mg 55301-0504-44 AAFES/Your 1 gum — — FDA listed —
Nicotine Polacrilex 4 mg 55319-0966-20 Family 1 gum — — FDA listed —
Habitrol Nicotine Polacrilex 4 mg Coated Cinnamon 55741-0001-10 Dr. 10 gums — — FDA listed —
dg health nicotine 4 mg 55910-0122-58 Dolgencorp 1 gum — — FDA listed —
Rexall Nicotine 4 mg 55910-0532-60 Dolgencorp, 1 gum — — Discontinued —
Nicotine Polacrilex 4 mg 55910-0796-20 Dolgencorp, 1 gum — — FDA listed —
Nicotine 4 mg 55910-0918-20 Dolgencorp, 1 gum — — FDA listed —
Nicotine Polacrilex 4 mg 55910-0933-10 Dolgencorp, 1 gum — — FDA listed —
Nicotine Polacrilex 4 mg 55910-0976-20 Dolgencorp, 1 gum — — FDA listed —
Coated Nicotine 4 mg 56062-0369-60 Publix 1 gum — — FDA listed —
Nicotine Polacrilex Coated Mint 4 mg 56062-0429-44 Publix 10 gums — — FDA listed —
Nicotine Polacrilex Coated Fruit 4 mg 56062-0504-44 Publix 10 gums — — FDA listed —
Nicotine Polacrilex Origianl Flavor 4 mg 56062-0609-62 Publix 10 gums — — FDA listed —
Nicotine 4 mg 59726-0913-16 P 1 gum — — FDA listed —
Nicotine 4 mg 59726-0935-17 P 1 gum — — FDA listed —
Nicotine Polacrilex Gum 4 mg 63443-5057-01 Fertin 10 gums — — FDA listed —
kirkland signature quit 4 4 mg 63981-0170-01 Costco 1 gum — — FDA listed —
kirkland signature quit 4 4 mg 63981-0309-47 Costco 1 gum — — FDA listed —
Nicorette 4mg Cinnamon Surge 4 mg 66715-8123-00 Lil' 10 gums — — FDA listed —
Nicorette 4mg Fruit Chill Gum, Lil Drug Store 4 mg 66715-8124-00 Lil' 10 gums — — FDA listed —
Nicorette 4mg White Ice Mint Gum, Lil Drug Store 4 mg 66715-8125-00 Lil' 10 gums — — FDA listed —
Nicotine Polacrilex Coated Mint 4 mg 68016-0281-49 Chain 10 gums — — FDA listed —
Nicotine Polacrilex Coated Mint 4 mg 68016-0285-44 Chain 10 gums — — FDA listed —
Nicotine Polacrilex, Original 4 mg 68016-0287-62 Chain 10 gums — — FDA listed —
Nicotine Polacrilex 4 mg 68016-0293-44 Chain 1 gum — — FDA listed —
Nicotine Polacrilex Coated Mint 4 mg 68016-0560-00 Chain 10 gums — — FDA listed —
members mark nicotine 4 mg 68196-0170-01 Sam's 1 gum — — FDA listed —
members mark nicotine 4 mg 68196-0309-47 Sam's 1 gum — — FDA listed —
Members Mark Nicotine 4 mg 68196-0971-47 Sam's 1 gum — — FDA listed —
berkley and jensen nicotine 4 mg 68391-0170-06 BJWC 1 gum — — FDA listed —
Berkley and Jensen Nicotine 4 mg 68391-0309-25 BJWC 1 gum — — Discontinued —
Nicotine Polacrilex coated fruit 4 mg 69842-0025-15 CVS 1 gum — — FDA listed —
Nicotine Polacrilex coated cinnamon 4 mg 69842-0028-44 CVS 1 gum — — FDA listed —
Nicotine Polacrilex coated ice mint 4 mg 69842-0217-15 CVS 1 gum — — FDA listed —
Nicotine Polacrilex coated mint 4 mg 69842-0430-16 CVS 1 gum — — FDA listed —
Nicotine Polacrilex original 4 mg 69842-0609-15 CVS 1 gum — — FDA listed —
Nicotine 4 mg 72224-0930-10 Lucy 1 gum — — FDA listed —
Nicotine 4 mg 72224-0931-10 Lucy 1 gum — — FDA listed —
Nicotine Polacrilex 4 mg 72224-0933-10 Lucy 1 gum — — FDA listed —
Basic Care Nicotine 4 mg 72288-0003-06 Amazon.com 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 —
basic care nicotine 4 mg 72288-0532-06 Amazon.com 1 gum — — FDA listed —
basic care nicotine 4 mg 72288-0577-06 Amazon.com 1 gum — — FDA listed —
basic care nicotine 4 mg 72288-0693-01 Amazon.com 1 gum — — FDA listed —
Habitrol Nicotine Polacrilex Gum 4 mg Coated Fruit 75907-0300-10 Dr. 10 gums — — FDA listed —
Habitrol Nicotine Polacrilex Gum 4 mg Coated Mint 75907-0303-10 Dr. 10 gums — — FDA listed —
nicotine 4 mg 79481-0103-00 Meijer, 1 capsule — — FDA listed —
nicotine 4 mg 79481-0601-00 Meijer, 1 gum — — FDA listed —
up and up uncoated original nicotine 4 mg 82442-0170-02 Target 1 gum — — FDA listed —
Up And Up Coated Cinnamon Nicotine 4 mg 82442-0329-06 Target 1 gum — — FDA listed —
Up and Up Mint Nicotine 4 mg 82442-0500-96 Target 1 gum — — FDA listed —
Up and Up Nicotine 4 mg 82442-0532-78 Target 1 gum — — FDA listed —
up and up coated mint freeze nicotine 4 mg 82442-0723-06 Target 1 gum — — FDA listed —
Up And Up Coated Fruit Nicotine 4 mg 82442-0971-06 Target 1 gum — — FDA listed —
Blip 4 mg 82966-0309-60 Blip 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 —
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 (Mint) 4 mg 87494-0003-01 Guangzhou 60 gums — — FDA listed —
Oneoo Nicotine Gum (Grape) 4 mg 87494-0004-01 Guangzhou 60 gums — — FDA listed —
Oneoo Nicotine Gum (3 Flavors) 4 mg 87494-0006-01 Guangzhou 1 gum — — FDA listed —
Oneoo Nicotine Gum (Cinnamon) 4 mg 87494-0007-01 Guangzhou 60 gums — — Discontinued —
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

🏛️
2009
On the market since
Jul 2009
📍
2026
Currently FDA-listed
17 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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 00536-3405-01, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
46.6K
Units reimbursed last 4 qtrs
6.7M
Gross reimbursed last 4 qtrs
$2.07M
Avg / prescription
$44.42
Avg / unit
$0.3093
Latest quarter Q4 2025
12.2KRx
Medicaid pays / ea
$0.3093
gross reimbursed
vs
NADAC / ea
$0.2817
acquisition cost
=
Spread
+$0.0276
+10% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
56% FFS 44% MCO
Fee-for-service · 26,205 Rx Managed care · 20,372 Rx
State Medicaid map
Alaska: no data reported AK Maine: 86,808 units · 6,223 per 100k residents ME Washington: 37,410 units · 479 per 100k residents WA Idaho: no data reported ID Montana: 36,190 units · 3,197 per 100k residents MT North Dakota: no data reported ND Minnesota: 292,628 units · 5,101 per 100k residents MN Wisconsin: 116,010 units · 1,963 per 100k residents WI Michigan: 113,634 units · 1,132 per 100k residents MI New York: 939,541 units · 4,801 per 100k residents NY Vermont: 86,960 units · 13,440 per 100k residents VT New Hampshire: no data reported NH Oregon: 93,970 units · 2,220 per 100k residents OR Nevada: 22,660 units · 709 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 6,790 units · 212 per 100k residents IA Illinois: 44,910 units · 358 per 100k residents IL Indiana: 122,520 units · 1,785 per 100k residents IN Ohio: 197,200 units · 1,673 per 100k residents OH Pennsylvania: 271,948 units · 2,098 per 100k residents PA New Jersey: 23,482 units · 253 per 100k residents NJ Massachusetts: 1,219,290 units · 17,416 per 100k residents MA California: 1,225,643 units · 3,145 per 100k residents CA Utah: 135,730 units · 3,972 per 100k residents UT Colorado: 32,531 units · 553 per 100k residents CO Nebraska: 8,100 units · 410 per 100k residents NE Missouri: 49,258 units · 795 per 100k residents MO Kentucky: 212,301 units · 4,691 per 100k residents KY West Virginia: 6,700 units · 379 per 100k residents WV Virginia: 312,490 units · 3,585 per 100k residents VA Maryland: 87,942 units · 1,423 per 100k residents MD Connecticut: 353,490 units · 9,773 per 100k residents CT Rhode Island: 159,480 units · 14,564 per 100k residents RI Arizona: 68,931 units · 928 per 100k residents AZ New Mexico: 3,743 units · 177 per 100k residents NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 15,280 units · 214 per 100k residents TN North Carolina: 102,980 units · 950 per 100k residents NC South Carolina: 19,870 units · 370 per 100k residents SC Delaware: 3,060 units · 297 per 100k residents DE Oklahoma: 83,300 units · 2,055 per 100k residents OK Louisiana: 35,800 units · 783 per 100k residents LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: 5,330 units · 48.3 per 100k residents GA D.C.: 17,310 units · 2,549 per 100k residents DC Hawaii: 30,374 units · 2,117 per 100k residents HI Texas: no data reported TX Florida: 7,510 units · 33.2 per 100k residents FL
Units reimbursed · per 100k residents
33.217,416
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Massachusetts 17,416 /100k
2 Rhode Island 14,564 /100k
3 Vermont 13,440 /100k
4 Connecticut 9,773 /100k
5 Maine 6,223 /100k
6 Minnesota 5,101 /100k
7 New York 4,801 /100k
8 Kentucky 4,691 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

🔬 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
00536-3405-01 You're viewing this 100 BLISTER PACK in 1 CARTON (0536-3405-01) / 1 GUM, CHEWING in 1 BLISTER PACK 2009-07-08 Discontinued by firm

🧭 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) ✓ 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) ✓ Available
“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

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 0536-3405-01, 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: 00536-3405-01, written without dashes as 00536340501. 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 00536-3405-01, the first segment (00536) is the labeler code FDA assigned to Rugby Laboratories; the middle segment (3405) 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.
Who lists this product with the FDA?
Rugby Laboratories 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 32 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 36 words ▾

Inactive ingredients - 2 mg acacia, acesulfame potassium, butylated hydroxytoluene, carnauba wax, FD&C red #40 lake, gum base, hydroxypropyl cellullose, hypromellose, natural and artificial cinnamon flavors, sodium bicarbonate, sodium carbonate, sucralose, talc, titanium dioxide and 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 ↗
← 00536-3404-01 · Rugby 00536-3607-35 · Rugby →
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.