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NICORETTE nicotine polacrilex 4 mg Lozenge, 80-count — NDC 00135-0626-02 package photo

NICORETTE nicotine polacrilex 4 mg Lozenge, 80-count

by Haleon US Holdings LLC · 4 CONTAINER in 1 CARTON (0135-0626-02) / 20 LOZENGE in 1 CONTAINER
NDC 00135-0626-02
🏷️ FDA NDC (as labeled) 0135-0626-02 billing pads the labeler segment with a zero
This package
Contains80-count Pack sizes3 compare ↓
Also comes in: 20 lozenges 00135-0626-01 120 lozenges 00135-0626-03
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) 0135-0626-02
Product NDC 0135-0626
11-digit billing NDC 00135062602
NCPDP billing unit EA — each (per item)
RxCUI 359817, 359818, 968849, 968851
UNII 6M3C89ZY6R
Application # NDA021330
SPL Set ID f350e050-2173-43e0-8738-848382ce0700
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 2019-04-11
Route ORAL
Dosage form LOZENGE
Substance NICOTINE
GPI-14 62100010004720
GPI class Nicorette
GCN Seq No 048775
GCN 14688
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 LOZENGE
FDB brand name Nicorette
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 0135-0626-02 — 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 → 00135-0626-02. 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 applicationNDA021330 (NDA)
Labeler code00135
First marketedApr 2019
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 LOZENGE Ingredient Nicotine Polacrilex
📖 What it is MedlinePlus · NLM

Nicotine lozenges are used to help people stop smoking. Nicotine lozenges are in a class of medications called smoking cessation aids. They work by providing nicotine to your body to decrease the withdrawal symptoms experienced when smoking is stopped and 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 white
ShapeOval
Imprintn;4
Size15 mm
ScoringNot scored
FlavorMint
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 T1FAD4SS2M
    Aluminum silicate is a mineral compound used as a thickener, absorbent, and anti-caking agent in medicines. It helps give liquid or powder formulations the right texture and prevents clumping.
  • 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 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • 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 OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • 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 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII RWP5GA015D
    Potassium is a mineral element used in medicines as a buffering agent to help maintain the product's pH balance and stability. It may also serve as an electrolyte component in certain formulations.
  • 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 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 TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

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

The official label also statesacesulfame potassium, flavors, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, polysorbate 80, potassium aluminum silicate, sodium carbonate anhydrous, sucralose, titanium dioxide, xanthan gum

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

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

Inactive ingredient FAQ

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

💲 Pricing

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

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 20 lozenges 120 lozenges
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 00113-0873-05 L. 72 lozenges $0.336 — Availability likely —
Maxi Nicotine 4 mg 00536-1338-09 Rugby 24 lozenges $0.336 — Availability likely —
Nicotine Polacrilex 4 mg 45802-0873-05 Padagis 72 lozenges $0.336 — Availability likely —
Nicotine 4 mg 46122-0732-08 AmerisourceBergen 24 lozenges $0.336 — Availability likely —
Maxi Nicotine 4 mg 70000-0561-01 Cardinal 24 lozenges $0.336 — Availability likely —
foster and thrive nicotine 4 mg 70677-1175-01 Strategic 72 lozenges $0.336 — Availability likely —
foster and thrive nicotine 4 mg 70677-1177-01 Strategic 72 lozenges $0.336 — Availability likely —
Good Sense Nicotine 4 mg 00113-0957-02 L. 81 lozenges $0.391 — Availability likely —
Mini Nicotine 4 mg 00536-1241-81 Rugby 27 lozenges $0.391 — Availability likely —
Nicotine Polacrilex 4 mg 45802-0957-02 Padagis 81 lozenges $0.391 — Availability likely —
Mini Nicotine 4 mg 46122-0716-15 AmerisourceBergen 27 lozenges $0.391 — Availability likely —
Nicotine Mini 4 mg 70000-0559-01 Cardinal 27 lozenges $0.391 — Availability likely —
foster and thrive nicotine 4 mg 70677-1173-01 Strategic 81 lozenges $0.391 — Availability likely —
foster and thrive nicotine 4 mg 70677-1179-01 Strategic 81 lozenges $0.391 — Availability likely —
good sense nicotine 4 mg 00113-1190-10 L. 108 lozenges — — FDA listed —
Good Sense Nicotine 4 mg 00113-5023-27 L. 80 lozenges — — FDA listed —
Good Sense Nicotine 4 mg 00113-7031-14 L. 135 lozenges — — FDA listed —
good sense nicotine 4 mg 00113-7999-60 L. 20 lozenges — — FDA listed —
Nicorette 4 mg 00135-0511-01 Haleon 72 lozenges — — FDA listed —
Nicorette 4 mgthis 00135-0626-02 Haleon 80 lozenges — — FDA listed —
Nicorette 4 mg 00135-0636-01 Haleon 216 lozenges — — FDA listed —
Nicorette 4 mg 00135-1500-01 Haleon 20 lozenges — — FDA listed —
Nicorette Peppermint 4 mg 00135-8060-20 Haleon 20 lozenges — — FDA listed —
Nicorette Cherry Peppermint 4 mg 00135-8071-20 Haleon 20 lozenges — — FDA listed —
Nicotine 4 mg 00363-0424-05 Walgreen 72 lozenges — — FDA listed —
Nicotine 4 mg 00363-0873-05 Walgreen 72 lozenges — — FDA listed —
Maxi Nicotine 4 mg 00363-0960-08 Walgreens 27 lozenges — — FDA listed —
Nicotine Mini 4 mg 00363-0979-81 Walgreens 27 lozenges — — FDA listed —
nicotine mini 4 mg 00363-1130-07 Walgreen 81 lozenges — — FDA listed —
Mini Nicotine 4 mg 00363-2640-35 Walgreens 27 lozenges — — FDA listed —
Nicotine 4 mg 00363-4190-05 Walgreen 72 lozenges — — FDA listed —
Nicotine Mini 4 mg 00363-5770-20 Walgreens 20 lozenges — — FDA listed —
nicotine mini 4 mg 00363-6011-07 Walgreen 81 lozenges — — FDA listed —
nicotine 4 mg 00363-7044-02 Walgreen 80 lozenges — — FDA listed —
Nicotine 4 mg 00363-9580-08 Walgreens 27 lozenges — — FDA listed —
Nicotine 4 mg 00363-9620-24 Walgreens 24 lozenges — — FDA listed —
nicotine 4 mg 11822-0009-01 Rite 72 lozenges — — FDA listed —
nicotine 4 mg 11822-0424-00 Rite 72 lozenges — — FDA listed —
Nicotine 4 mg 11822-0873-00 Rite 108 lozenges — — FDA listed —
Nicotine 4 mg 11822-0905-04 Rite 24 lozenges — — FDA listed —
Mini Nicotine 4 mg 11822-0957-01 Rite 10 lozenges — — Discontinued —
Nicotine 4 mg 11822-1649-00 Rite 80 lozenges — — FDA listed —
Maxi Nicotine 4 mg 11822-3317-00 Rite 27 lozenges — — FDA listed —
Mini Nicotine 4 mg 17856-1241-01 ATLANTIC 50 lozenges — — FDA listed —
signature care nicotine 4 mg 21130-0185-02 Safeway 81 lozenges — — FDA listed —
signature care nicotine 4 mg 21130-0211-05 Safeway 72 lozenges — — Discontinued —
Nicotine 4 mg 21130-0636-05 Safeway 72 lozenges — — FDA listed —
Nicotine 4 mg 30142-0190-05 Kroger 72 lozenges — — FDA listed —
Nicotine Mini 4 mg 30142-0209-02 Kroger 81 lozenges — — FDA listed —
nicotine 4 mg 30142-0797-07 Kroger 81 lozenges — — FDA listed —
Nicotine 4 mg 30142-0873-05 Kroger 72 lozenges — — FDA listed —
Topcare Nicotine 4 mg 36800-0539-05 Topco 72 lozenges — — FDA listed —
Topcare Nicotine 4 mg 36800-0873-05 Topco 72 lozenges — — FDA listed —
Topcare Nicotine 4 mg 36800-0957-02 Topco 81 lozenges — — FDA listed —
nicotine 4 mg 37808-0383-10 H 108 lozenges — — FDA listed —
nicotine 4 mg 37808-0563-10 H 108 lozenges — — FDA listed —
Nicotine 4 mg 37808-0707-01 H 27 lozenges — — FDA listed —
nicotine polacrilex 4 mg 37808-0948-03 H 24 lozenges — — FDA listed —
nicotine 4 mg 41250-0190-05 Meijer 72 lozenges — — FDA listed —
Nicotine 4 mg 41250-0424-05 Meijer 72 lozenges — — FDA listed —
mini nicotine 4 mg 41250-0637-07 Meijer 81 lozenges — — FDA listed —
nicotine 4 mg 41250-0873-03 Meijer 24 lozenges — — FDA listed —
Nicotine 4 mg 41250-0957-02 Meijer 81 lozenges — — FDA listed —
care one nicotine 4 mg 41520-0873-05 American 72 lozenges — — FDA listed —
CareOne Mini Nicotine Polacrilex 4 mg 41520-0957-02 American 81 lozenges — — FDA listed —
Nicotine 4 mg 42507-0690-10 HyVee 108 lozenges — — FDA listed —
Nicotine Polacrilex 4 mg 43598-0485-10 Dr. 108 lozenges — — FDA listed —
Nicotine Polacrilex 4 mg 43598-0487-10 Dr. 108 lozenges — — Discontinued —
Nicotine Polacrilex 4 mg 43598-0489-10 Dr. 108 lozenges — — FDA listed —
Equate Nicotine 4 mg 49035-0190-10 Wal-Mart 108 lozenges — — FDA listed —
Mini Nicotine 4 mg 49035-0436-08 EQUATE 27 lozenges — — FDA listed —
Equate Nicotine 4 mg 49035-0702-10 Wal-Mart 108 lozenges — — FDA listed —
equate nicotine 4 mg 49035-0791-10 Wal-Mart 108 lozenges — — FDA listed —
equate nicotine 4 mg 49035-0873-03 Wal-Mart 24 lozenges — — FDA listed —
Nicotine Polacrilex 4 mg 50090-1154-00 A-S 72 lozenges — — FDA listed —
good sense nicotine 4 mg 50090-7060-00 A-S 72 lozenges — — FDA listed —
Nicotine 4 mg 51316-0190-10 CVS 108 lozenges — — FDA listed —
exchange select nicotine 4 mg 55301-0873-16 Army 144 lozenges — — FDA listed —
exchange select nicotine 4 mg 55301-0957-60 Army 20 lozenges — — FDA listed —
Mini Nicotine 4 mg 55910-0662-20 Dolgencorp, 20 lozenges — — FDA listed —
Rexall Nicotine 4 mg 55910-0957-60 Dolgencorp, 20 lozenges — — FDA listed —
stop smoking aid 4 mg 56062-0873-04 Publix 48 lozenges — — FDA listed —
Nicotine Mini 4 mg 57237-0321-42 Rising 24 lozenges — — FDA listed —
Nicotine 4 mg 58602-0723-81 Aurohealth 108 lozenges — — FDA listed —
Nicotine 4 mg 58602-0836-07 Aurohealth 24 lozenges — — FDA listed —
Nicotine 4 mg 58602-0855-81 Aurohealth 108 lozenges — — FDA listed —
Nicotine 4 mg 58602-0904-07 Aurohealth 24 lozenges — — FDA listed —
Nicotine 4 mg 58602-0906-07 Aurohealth 24 lozenges — — FDA listed —
Nicotine 4 mg 59640-0151-27 H 80 lozenges — — FDA listed —
Mini Nicotine 4 mg 59726-0264-27 P 27 lozenges — — FDA listed —
Nicotine Mini 4 mg 59726-0652-04 P 27 lozenges — — FDA listed —
nicotine 4 mg 59779-0873-04 CVS 48 lozenges — — FDA listed —
Nicotine 4 mg 59779-0957-02 CVS 81 lozenges — — FDA listed —
Nicotine Mini 4 mg 63548-0264-00 PLD 27 lozenges — — FDA listed —
Nicotine Polacrilex Lozenge Mint 4 mg 63868-0732-24 Chain 24 lozenges — — Discontinued —
Kirkland Signature Nicotine 4 mg 63981-0190-37 Costco 270 lozenges — — FDA listed —
kirkland signature quit 4 4 mg 63981-0873-37 Costco 270 lozenges — — FDA listed —
Mini Nicotine 4 mg 68016-0087-81 Chain 27 lozenges — — FDA listed —
Nicotine Polacrilex 4 mg 68071-3957-07 NuCare 216 lozenges — — FDA listed —
members mark nicotine 4 mg 68196-0084-08 Sam's 216 lozenges — — FDA listed —
Members Mark Nicotine 4 mg 68196-0873-13 Sam's 189 lozenges — — Discontinued —
members mark mini nicotine 4 mg 68196-0957-07 Sam's 216 lozenges — — FDA listed —
berkley and jensen nicotine polacrilex 4 mg 68391-0873-13 BJWC 189 lozenges — — FDA listed —
berkley and jensen nicotine 4 mg 68391-0957-01 BJWC 27 lozenges — — FDA listed —
Nicotine 4 mg 69842-0564-10 CVS 10 lozenges — — FDA listed —
Nicotine 4 mg 69842-0595-27 CVS 80 lozenges — — FDA listed —
nicotine 4 mg 69842-0828-07 CVS 81 lozenges — — Discontinued —
Nicotine Sugar Free 4 mg 69842-0858-24 CVS 24 lozenges — — FDA listed —
Mini Nicotine 4 mg 69842-0934-08 CVS 27 lozenges — — FDA listed —
Nicotine Mini 4 mg 69842-0964-08 CVS 27 lozenges — — FDA listed —
Nicotine Polacrilex 4 mg 71335-2730-01 Bryant 81 lozenges — — FDA listed —
Nicotine Polacrilex 4 mg 72162-2267-02 Bryant 72 lozenges — — FDA listed —
Nicotine Polacrilex 4 mg 72162-2288-02 Bryant 81 lozenges — — FDA listed —
Basic Care Nicotine 4 mg 72288-0077-09 Amazon.com 27 lozenges — — FDA listed —
Basic Care Nicotine 4 mg 72288-0190-03 Amazon.com 24 lozenges — — FDA listed —
Amazon Basic Care Nicotine Polacrilex 4 mg 72288-0266-14 Amazon.com 144 lozenges — — FDA listed —
basic care nicotine 4 mg 72288-0509-58 Amazon.com 40 lozenges — — FDA listed —
basic care nicotine 4 mg 72288-0642-07 Amazon.com 81 lozenges — — FDA listed —
Amazon Basic Care Nicotine Polacrilex 4 mg 72288-0690-21 Amazon.com 110592 lozenges — — FDA listed —
basic care nicotine 4 mg 72288-0873-03 Amazon.com 24 lozenges — — FDA listed —
basic care nicotine 4 mg 72288-0957-01 Amazon.com 27 lozenges — — FDA listed —
Nicotine Mini 4 mg 72888-0187-53 Advagen 27 lozenges — — FDA listed —
topcare nicotine 4 mg 76162-0700-27 Topco 80 lozenges — — FDA listed —
Mini Nicotine 4 mg 79481-0301-00 Meijer, 27 lozenges — — FDA listed —
Mini Nicotine 4 mg 79481-0957-02 Meijer, 81 lozenges — — FDA listed —
nicotine 4 mg 79481-1100-00 Meijer, 20 lozenges — — FDA listed —
equate nicotine 4 mg 79903-0104-08 WALMART 108 lozenges — — FDA listed —
Mini Nicotine 4 mg 79903-0128-08 WALMART 27 lozenges — — FDA listed —
equate nicotine 4 mg 79903-0182-20 WALMART 20 lozenges — — FDA listed —
up and up cherry ice nicotine 4 mg 82442-0000-07 Target 81 lozenges — — FDA listed —
up and up cherry nicotine 4 mg 82442-0190-03 Target 24 lozenges — — FDA listed —
up and up citrus mini nicotine 4 mg 82442-0399-07 Target 81 lozenges — — FDA listed —
up and up nicotine 4 mg 82442-0741-27 Target 80 lozenges — — FDA listed —
up and up mint nicotine 4 mg 82442-0873-03 Target 24 lozenges — — FDA listed —
up and up nicotine mini mint 4 mg 82442-0957-02 Target 108 lozenges — — FDA listed —
Nicotine 4 mg 82966-0002-81 BLIP 108 lozenges — — FDA listed —
Blip 4 mg 82966-0303-00 Blip 27 lozenges — — FDA listed —
Blip 4 mg 82966-0957-01 Blip 27 lozenges — — FDA listed —
Mini Nicotine 4 mg 83253-0264-27 HC 27 lozenges — — FDA listed —
Nicotine Mini 4 mg 83253-0979-27 HC 27 lozenges — — FDA listed —
quitine nicotine 4 mg 84720-0007-76 QUITINE 120 lozenges — — FDA listed —
quitine mini nicotine 4 mg 84720-0009-07 QUITINE 216 lozenges — — FDA listed —
Quitine Nicotine 4 mg 84720-0190-11 QUITINE 168 lozenges — — FDA listed —
Habitrol Lozenge Original Flavor 4 mg 43598-0983-13 Dr. 135 lozenges — — FDA listed —
Habitrol Lozenge Cherry 4 mg 43598-0985-13 Dr. 135 lozenges — — FDA listed —
Dg Health Nicotine 4 mg 55910-0669-60 Dolgencorp 20 lozenges — — FDA listed —
nicotine coated 4 mg 56062-0681-60 Publix 20 lozenges — — FDA listed —
nicotine 4 mg 56062-0509-03 Publix 24 lozenges — — FDA listed —
nicotine 4 mg 56062-0671-24 Publix 24 lozenges — — FDA listed —
nicotine 4 mg 56062-0957-02 Publix 81 lozenges — — FDA listed —
Nicotine Mini 4 mg 72288-0375-01 Amazon.com 27 lozenges — — FDA listed —
Nicotine 4 mg 51316-0787-60 CVS 20 lozenges — — FDA listed —
Quitine Nicotine 4 mg 84720-0400-76 QUITINE 120 lozenges — — FDA listed —
nicotine 4 mg 59779-0424-00 CVS 108 lozenges — — FDA listed —
nicotine 4 mg 72288-0651-14 Amazon.com 216 lozenges — — FDA listed —
Nicotine Mini 4 mg 72288-0739-14 Amazon.com 135 lozenges — — FDA listed —
Nicotine 4 mg 72288-0869-76 Amazon.com 120 lozenges — — 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

🏛️
2019
On the market since
Apr 2019
📍
2026
Currently FDA-listed
7 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

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

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
00135-0626-01 1 CONTAINER in 1 CARTON (0135-0626-01) / 20 LOZENGE in 1 CONTAINER 2019-04-11 Active
00135-0626-02 You're viewing this 4 CONTAINER in 1 CARTON (0135-0626-02) / 20 LOZENGE in 1 CONTAINER 2019-04-11 Active
00135-0626-03 6 CONTAINER in 1 CARTON (0135-0626-03) / 20 LOZENGE in 1 CONTAINER 2019-10-23 Active

Pack size FAQ

What quantity is in NDC 00135-0626-02?
NDC 00135-0626-02 is a 80-count package — 4 container in 1 carton / 20 lozenge in 1 container.
What is the difference between NDC 00135-0626-02 and NDC 00135-0626-01?
Both are NICORETTE nicotine polacrilex 4 mg Lozenge — the drug itself is identical. NDC 00135-0626-02 is the 80-count package, while NDC 00135-0626-01 is the 20 lozenges package.
What NDC number is used to bill for this package of NICORETTE nicotine polacrilex 4 mg Lozenge?
Bill NDC 00135-0626-02 — the 11-digit billing format is 00135062602. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Over-the-counter (OTC) product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 0135-0626-02, 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: 00135-0626-02, written without dashes as 00135062602. 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 00135-0626-02, the first segment (00135) is the labeler code FDA assigned to Haleon US Holdings LLC; the middle segment (0626) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) 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.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 20 lozenges (00135-0626-01), 120 lozenges (00135-0626-03). 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?
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 📦 Storage and Handling 🧪 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. No studies have been done to show if this product will work for you. before using this product, read the enclosed User’s Guide for complete directions and other important information begin using the lozenge on your quit day if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine lozenge if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine lozenge according to the following 12 week schedule: Weeks 1 to 6 Weeks 7 to 9 Weeks 10 to 12 1 lozenge every 1 to 2 hours 1 lozenge every 2 to 4 hours 1 lozenge every 4 to 8 hours nicotine lozenge is a medicine and must be used a certain way to get the best results place the lozenge in your mouth and allow the lozenge to slowly dissolve.

Minimize swallowing. Do not chew or swallow lozenge. you may feel a warm or tingling sensation occasionally move the lozenge from one side of your mouth to the other until completely dissolved do not eat or drink 15 minutes before using or while the lozenge is in your mouth to improve your chances of quitting, use at least 9 lozenges per day for the first 6 weeks do not use more than one lozenge at a time or continuously use one lozenge after another since this may cause you hiccups, heartburn, nausea or other side effects do not use more than 5 lozenges in 6 hours.

Do not use more than 20 lozenges per day. it is important to complete treatment. If you feel you need to use the lozenge 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. No studies have been done to show if this product will work for you. before using this product, read the enclosed User’s Guide for complete directions and other important information begin using the lozenge on your quit day if you smoke your first cigarette more than 30 minutes after waking up, use 2 mg nicotine lozenge if you smoke your first cigarette within 30 minutes of waking up, use 4 mg nicotine lozenge according to the following 12 week schedule: Weeks 1 to 6 Weeks 7 to 9 Weeks 10 to 12 1 lozenge every 1 to 2 hours 1 lozenge every 2 to 4 hours 1 lozenge every 4 to 8 hours nicotine lozenge is a medicine and must be used a certain way to get the best results place the lozenge in your mouth and allow the lozenge to slowly dissolve.

Minimize swallowing. Do not chew or swallow lozenge. you may feel a warm or tingling sensation occasionally move the lozenge from one side of your mouth to the other until completely dissolved do not eat or drink 15 minutes before using or while the lozenge is in your mouth to improve your chances of quitting, use at least 9 lozenges per day for the first 6 weeks do not use more than one lozenge at a time or continuously use one lozenge after another since this may cause you hiccups, heartburn, nausea or other side effects do not use more than 5 lozenges in 6 hours.

Do not use more than 20 lozenges per day. it is important to complete treatment. If you feel you need to use the lozenge 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 heart disease, recent heart attack, or irregular heartbeat.

Nicotine can increase your heart rate. high blood pressure not controlled with medication. Nicotine can increase your 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 problems occur persistent indigestion or severe sore throat occurs 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. Nicotine lozenges may have enough nicotine to make children and pets sick. If you need to remove the lozenge, wrap it in paper and throw away in the trash.

In case of overdose, get medical help or contact a Poison Control Center right away.

📦 Storage and Handling 15 words ▾

Other information store at 20 - 25°C (68 - 77°F) store in the original container

🧪 Active Ingredient 22 words ▾

Active ingredient (in each lozenge) (2 mg) Nicotine polacrilex, 2 mg

Active ingredient (in each lozenge) (4 mg) Nicotine polacrilex, 4 mg

🧪 Inactive Ingredients 24 words ▾

Inactive ingredients acesulfame potassium, flavors, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, polysorbate 80, potassium aluminum silicate, sodium carbonate anhydrous, sucralose, titanium dioxide, xanthan gum

🎯 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 ↗
← 00135-0625-01 · Haleon 00135-0627-01 · 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.