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Nicorette Spearmint Burst nicotine polacrilex 4 mg Gum, Chewing — NDC 00135-0355-03 package photo

Nicorette Spearmint Burst nicotine polacrilex 4 mg Gum, Chewing

by Haleon US Holdings LLC · 16 BLISTER PACK in 1 CARTON (0135-0355-03) / 10 GUM, CHEWING in 1 BLISTER PACK
NDC 00135-0355-03
🏷️ FDA NDC (as labeled) 0135-0355-03 billing pads the labeler segment with a zero
OTC Brand 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) 0135-0355-03
Product NDC 0135-0355
11-digit billing NDC 00135035503
NCPDP billing unit EA — each (per item)
RxCUI 105071, 209326, 311975, 314119
UNII 6M3C89ZY6R
Application # NDA020066
SPL Set ID 673fd19f-69b3-4f73-b9b4-18b5f4cbf69c
Established class (EPC) Cholinergic Nicotinic Agonist
Chemical class Nicotine
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2017-09-13
Route ORAL
Dosage form GUM, CHEWING
Substance NICOTINE
GPI-14 62100010002820
GPI class Nicorette
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 NICORETTE 4 MG CHEWING GUM
FDB brand name Nicorette
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 0135-0355-03 — 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 → 00135-0355-03. 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

LabelerHaleon US Holdings LLC
Application holderHALEON US HOLDINGS LLC
FDA applicationNDA020066 (NDA)
Labeler code00135
First marketedSep 2017
Product typeHuman Otc Drug
Portfolio404 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 NICORETTE 4 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 / brown / yellow
ShapeSquare
ImprintN4
Size15 mm
ScoringNot scored
FlavorSpearmint
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.

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

Inactive ingredient FAQ

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

💲 Pricing

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

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
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 mg 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 —
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 mgthis 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 —
Nicotine 4 mg 72288-0540-29 Amazon.com 1 gum — — FDA listed —
nicotine 4 mg 56062-0019-60 Publix 1 gum — — FDA listed —
nicotine 4 mg 56062-0812-71 Publix 1 gum — — FDA listed —
Quitine Nicotine 4 mg 84720-0309-70 QUITINE 1 gum — — FDA listed —
Oneoo Nicotine Gum (Cinnmon) 4 mg 87494-0005-01 Guangzhou 60 gums — — FDA listed —
About this product: this is the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
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

🏛️
1996
First FDA approval
Feb 1996
📍
2026
Currently FDA-listed
30 years listed
🛡️
2028
Latest patent/protection listed
not a guaranteed launch date
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Apr 2028. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Feb 9, 1996 RLD RS ⏳ ~1.6 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 8323683 — drug product
1996 1998 2000 2002 2004 2006 2008 2010 2012 2014 2016 2018 2020 2022 2024 2026 2028
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (1)
PatentTypeUse codeExpires
US 8323683 ↗ Drug product — Apr 30, 2028
Common questions
Is there a generic version of NICORETTE 4 MG CHEWING GUM?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for NICORETTE 4 MG CHEWING GUM. See the alternatives section for substitutable, lower-cost products.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
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
00135-0355-03 You're viewing this 16 BLISTER PACK in 1 CARTON (0135-0355-03) / 10 GUM, CHEWING in 1 BLISTER PACK 2017-09-13 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) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
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 0135-0355-03, 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: 00135-0355-03, written without dashes as 00135035503. 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 00135-0355-03, the first segment (00135) is the labeler code FDA assigned to Haleon US Holdings LLC; the middle segment (0355) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (03) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Haleon US Holdings LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Haleon US Holdings 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 ~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 a pharmacist before use if you are using a non-nicotine stop smoking drug taking a 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 (For Cinnamon Surge) oral blistering occurs 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.

🧪 Active Ingredient 20 words ▾

Active ingredient (in each chewing piece) Nicotine polacrilex (equal to 2 mg nicotine) Nicotine polacrilex (equal to 4 mg nicotine)

🧪 Inactive Ingredients ~1 min read ▾

Inactive ingredients (White Ice Mint) each 2 mg piece contains: acesulfame potassium, carnauba wax, edible ink, flavor, gum base, hypromellose, magnesium oxide, menthol, peppermint oil, polysorbate 80, sodium bicarbonate, sodium carbonate, starch, sucralose, titanium dioxide, xylitol each 4 mg piece contains: acesulfame potassium, carnauba wax, D&C yellow #10 Al. lake, edible ink, flavor, gum base, hypromellose, magnesium oxide, menthol, peppermint oil, polysorbate 80, sodium carbonate, starch, sucralose, titanium dioxide, xylitol

Inactive ingredients (Original) each 2 mg piece contains: flavors, glycerin, gum base, sodium bicarbonate, sodium carbonate, sorbitol each 4 mg piece contains: D&C yellow #10, flavors, glycerin, gum base, sodium carbonate, sorbitol

Inactive ingredients (Cinnamon Surge) each 2 mg piece contains: acacia, acesulfame potassium, carnauba wax, edible ink, gum base, hypromellose, magnesium oxide, menthol, natural and artificial cinnamon flavors, peppermint oil, polysorbate 80, sodium bicarbonate, sodium carbonate, sucralose, titanium dioxide, xylitol each 4 mg piece contains: acacia, acesulfame potassium, carnauba wax, D&C yellow #10 Al. lake, edible ink, gum base, hypromellose, magnesium oxide, menthol, natural and artificial cinnamon flavors, peppermint oil, polysorbate 80, sodium carbonate, sucralose, titanium dioxide, xylitol

Inactive ingredients (Mint) each 2 mg piece contains: acesulfame potassium, gum base, magnesium oxide, menthol, peppermint oil, sodium bicarbonate, sodium carbonate, xylitol each 4 mg piece contains: acesulfame potassium, D&C yellow #10 Al. lake, gum base, magnesium oxide, menthol, peppermint oil, sodium carbonate, xylitol

Inactive ingredients (Spearmint Burst) each 2 mg piece contains: acacia, acesulfame potassium, carnauba wax, edible ink, flavors, gum base, hypromellose, magnesium oxide, menthol, peppermint oil, polysorbate 80, sodium bicarbonate, sodium carbonate, sucralose, titanium dioxide, xylitol each 4 mg piece contains: acacia, acesulfame potassium, carnauba wax, D&C yellow #10 Al. lake, edible ink, flavors, gum base, hypromellose, magnesium oxide, menthol, peppermint oil, polysorbate 80, sodium carbonate, sucralose, 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 ↗
← 00135-0300-01 · Haleon 00135-0400-01 · Haleon →
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.