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Nicorette Cherry Peppermint nicotine polacrilex 2 mg Lozenge, 20-count — NDC 00135-8070-20 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Nicorette Cherry Peppermint nicotine polacrilex 2 mg Lozenge, 20-count — NDC 0135-8070-20 (Billing 00135-8070-20)

by Haleon US Holdings LLC · 1 VIAL in 1 PACKAGE / 20 LOZENGE in 1 VIAL

This is a package of 20 lozenges of Nicorette Cherry Peppermint nicotine polacrilex 2 mg Lozenge from Haleon US Holdings LLC, marketed since Apr 2026 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 00135-8070-20
🏷️ FDA NDC (as labeled) 0135-8070-20 billing pads the labeler segment with a zero
This package
Contains20-count Pack sizes2 compare ↓
Main listing for product 0135-8070 · Also comes in: 81 lozenges 0135-8070-81
OTC Brand On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 0135-8070-20
Product NDC 0135-8070
11-digit billing NDC 00135807020
RxCUI 359817, 359818, 968849, 968851
UNII 6M3C89ZY6R
Application # NDA022360
SPL Set ID 35438b53-2760-bcfe-e063-6394a90a65c0
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 2026-04-01
Route ORAL
Dosage form LOZENGE
Substance NICOTINE
Quick answers
  • RxCUI (RxNorm): 359817
Why two NDCs? The FDA registers this code as 0135-8070-20 — 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 → 00135-8070-20. 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.

Clinical

📗 Our plain-language guide HelloPharmacist
  • That's a really common concern, and it's worth addressing. Nicotine replacement products do deliver nicotine, but in a much more controlled way — without the tar, carbon monoxide,...
  • What exactly does nicotine replacement do — isn't it just replacing one nicotine habit with another?
  • Yes, it actually does matter. If you typically smoke your first cigarette within 30 minutes of waking up, your nicotine dependence is likely stronger, so you'd use the higher-stren...
  • How do I know which strength to use — and does it matter when I have my first cigarette in the morning?
📖 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.

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: 81 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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
00135-8070-20 You're viewing this Main listing 1 VIAL in 1 PACKAGE / 20 LOZENGE in 1 VIAL 2026-04-01 — Active
00135-8070-81 0135-8070-81 3 VIAL in 1 PACKAGE / 27 LOZENGE in 1 VIAL 2026-04-01 — Active

Pack size FAQ

What quantity is in this package?
This is a 20-count package — 1 vial in 1 package / 20 lozenge in 1 vial.
How does this package differ from NDC 00135-8070-81?
Both are Nicorette Cherry Peppermint nicotine polacrilex 2 mg Lozenge — the drug itself is identical. This page's package is the 20-count one, while NDC 00135-8070-81 is the 81 lozenges package.
What NDC number is used to bill for this package of Nicorette Cherry Peppermint nicotine polacrilex 2 mg Lozenge?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Good Sense Nicotine 2 mg 00113-0344-05 L. 72 lozenges $0.347 — Availability likely —
Nicotine 2 mg 00536-1337-09 Rugby 24 lozenges $0.347 — Availability likely —
Nicotine Polacrilex 2 mg 45802-0344-05 Padagis 72 lozenges $0.347 — Availability likely —
Nicotine 2 mg 46122-0734-08 AmerisourceBergen 24 lozenges $0.347 — Availability likely —
Nicotine 2 mg 70000-0562-01 Cardinal 24 lozenges $0.347 — Availability likely —
foster and thrive nicotine 2 mg 70677-1174-01 Strategic 72 lozenges $0.347 — Availability likely —
foster and thrive nicotine 2 mg 70677-1176-01 Strategic 72 lozenges $0.347 — Availability likely —
Good Sense Nicotine 2 mg 00113-0734-02 L. 81 lozenges $0.374 — Availability likely —
Nicotine Mini 2 mg 00536-1239-81 Rugby 27 lozenges $0.374 — Availability likely —
Nicotine Polacrilex 2 mg 45802-0089-02 Padagis 81 lozenges $0.374 — Availability likely —
Nicotine Mini 2 mg 46122-0715-60 AmerisourceBergen 20 lozenges $0.374 — Availability likely —
Nicotine Mini 2 mg 46122-0731-15 AmerisourceBergen 27 lozenges $0.374 — Availability likely —
Nicotine Mini 2 mg 70000-0560-01 Cardinal 27 lozenges $0.374 — Availability likely —
Foster and Thrive Nicotine 2 mg 70677-1172-01 Strategic 81 lozenges $0.374 — Availability likely —
foster and thrive nicotine 2 mg 70677-1178-01 Strategic 81 lozenges $0.374 — Availability likely —
Good Sense Nicotine 2 mg 00113-1125-10 L. 108 lozenges — — FDA listed —
Good Sense Nicotine 2 mg 00113-2502-27 L. 80 lozenges — — FDA listed —
Good Sense Nicotine 2 mg 00113-7020-14 L. 135 lozenges — — FDA listed —
Good Sense Nicotine 2 mg 00113-7969-01 L. 81 lozenges — — FDA listed —
Nicorette 2 mg 00135-0508-02 Haleon 81 lozenges — — FDA listed —
Nicorette 2 mg 00135-0510-01 Haleon 72 lozenges — — FDA listed —
Nicorette 2 mg 00135-0625-01 Haleon 20 lozenges — — FDA listed —
Nicorette 2 mg 00135-0635-01 Haleon 216 lozenges — — FDA listed —
Nicorette 2 mg 00135-2800-01 Haleon 20 lozenges — — FDA listed —
Nicorette Peppermint 2 mg 00135-8050-20 Haleon 20 lozenges — — FDA listed —
Nicorette Cherry Peppermint 2 mgthis 00135-8070-20 Haleon 20 lozenges — — FDA listed —
nicotine 2 mg 00363-0124-05 Walgreen 72 lozenges — — FDA listed —
nicotine 2 mg 00363-0201-05 Walgreen 72 lozenges — — FDA listed —
Nicotine Mini 2 mg 00363-0262-35 Walgreens 27 lozenges — — FDA listed —
Nicotine 2 mg 00363-0411-05 Walgreen 72 lozenges — — FDA listed —
nicotine mini 2 mg 00363-0734-02 Walgreen 81 lozenges — — Discontinued —
nicotine 2 mg 00363-1825-07 Walgreen 81 lozenges — — FDA listed —
Nicotine 2 mg 00363-4049-02 Walgreen 80 lozenges — — FDA listed —
Nicotine 2 mg 00363-5760-20 Walgreens 20 lozenges — — FDA listed —
Nicotine Mini 2 mg 00363-7051-07 Walgreen 81 lozenges — — FDA listed —
Nicotine 2 mg 00363-9570-08 Walgreens 27 lozenges — — FDA listed —
Nicotine 2 mg 00363-9590-08 Walgreens 27 lozenges — — FDA listed —
Nicotine 2 mg 00363-9610-24 Walgreens 24 lozenges — — FDA listed —
Nicotine 2 mg 00363-9780-81 Walgreens 27 lozenges — — FDA listed —
nicotine 2 mg 11822-0124-01 Rite 72 lozenges — — FDA listed —
nicotine 2 mg 11822-0201-00 Rite 72 lozenges — — FDA listed —
Nicotine 2 mg 11822-0344-00 Rite 108 lozenges — — FDA listed —
nicotine 2 mg 11822-1720-00 Rite 80 lozenges — — FDA listed —
Nicotine Mini 2 mg 11822-3315-01 Rite 27 lozenges — — FDA listed —
Nicotine Mini 2 mg 17856-1239-01 ATLANTIC 50 lozenges — — FDA listed —
signature care nicotine 2 mg 21130-0172-02 Safeway 81 lozenges — — FDA listed —
signature care nicotine 2 mg 21130-0700-05 Safeway 72 lozenges — — FDA listed —
Nicotine Mini 2 mg 30142-0060-02 Kroger 81 lozenges — — FDA listed —
Nicotine 2 mg 30142-0124-05 Kroger 72 lozenges — — FDA listed —
Nicotine 2 mg 30142-0344-05 Kroger 72 lozenges — — FDA listed —
nicotine 2 mg 30142-0696-07 Kroger 81 lozenges — — FDA listed —
topcare nicotine polacrilex 2 mg 36800-0375-05 Topco 72 lozenges — — FDA listed —
Topcare Nicotine 2 mg 36800-0734-02 Topco 81 lozenges — — FDA listed —
nicotine 2 mg 37808-0533-10 H 108 lozenges — — FDA listed —
nicotine 2 mg 37808-0617-10 H 108 lozenges — — FDA listed —
nicotine lozenge 2 mg 37808-0674-03 H 24 lozenges — — FDA listed —
Nicotine 2 mg 37808-0900-01 H 27 lozenges — — Discontinued —
nicotine 2 mg 41250-0201-03 Meijer 24 lozenges — — FDA listed —
nicotine 2 mg 41250-0344-03 Meijer 24 lozenges — — FDA listed —
mini nicotine 2 mg 41250-0587-07 Meijer 81 lozenges — — FDA listed —
nicotine 2 mg 41250-0700-05 Meijer 72 lozenges — — FDA listed —
Nicotine 2 mg 41250-0734-02 Meijer 81 lozenges — — FDA listed —
careone nicotine 2 mg 41520-0701-05 American 72 lozenges — — FDA listed —
CareOne Nicotine 2 mg 41520-0734-02 American 81 lozenges — — FDA listed —
Nicotine 2 mg 42507-0344-10 HyVee 108 lozenges — — FDA listed —
Nicotine Polacrilex 2 mg 43598-0484-10 Dr. 108 lozenges — — FDA listed —
Nicotine Polacrilex 2 mg 43598-0486-10 Dr. 108 lozenges — — FDA listed —
Nicotine Polacrilex 2 mg 43598-0488-10 Dr. 108 lozenges — — FDA listed —
equate nicotine 2 mg 49035-0124-10 Wal-Mart 108 lozenges — — FDA listed —
Equate Nicotine 2 mg 49035-0201-10 Wal-Mart 108 lozenges — — FDA listed —
Nicotine Mini 2 mg 49035-0493-08 EQUATE 27 lozenges — — FDA listed —
Equate Nicotine 2 mg 49035-0734-01 Wal-Mart 27 lozenges — — FDA listed —
Equate nicotine 2 mg 49035-0900-10 Wal-Mart 108 lozenges — — FDA listed —
Equate Nicotine 2 mg 49035-0998-03 Wal-Mart 24 lozenges — — FDA listed —
Nicotine Polacrilex 2 mg 50090-1152-00 A-S 72 lozenges — — FDA listed —
Good Sense Nicotine 2 mg 50090-7061-00 A-S 72 lozenges — — FDA listed —
exchange select nicotine 2 mg 55301-0617-16 Army 144 lozenges — — FDA listed —
exchange select nicotine 2 mg 55301-0734-60 Army 20 lozenges — — FDA listed —
stop smoking aid 2 mg 56062-0344-04 Publix 48 lozenges — — FDA listed —
Nicotine 2 mg 56062-0636-00 Publix 24 lozenges — — FDA listed —
Nicotine Mini 2 mg 57237-0320-42 Rising 24 lozenges — — FDA listed —
Nicotine 2 mg 58602-0722-81 Aurohealth 108 lozenges — — FDA listed —
Nicotine 2 mg 58602-0835-07 Aurohealth 24 lozenges — — FDA listed —
Nicotine 2 mg 58602-0854-81 Aurohealth 108 lozenges — — FDA listed —
Nicotine 2 mg 58602-0903-07 Aurohealth 24 lozenges — — FDA listed —
Nicotine 2 mg 58602-0905-07 Aurohealth 24 lozenges — — FDA listed —
Nicotine 2 mg 59640-0099-27 H 80 lozenges — — FDA listed —
Nicotine Mini 2 mg 59726-0262-35 P 27 lozenges — — FDA listed —
Nicotine 2 mg 59726-0650-02 P 27 lozenges — — FDA listed —
Nicotine 2 mg 59779-0344-04 CVS 48 lozenges — — FDA listed —
Nicotine 2 mg 59779-0397-10 CVS 108 lozenges — — FDA listed —
Nicotine 2 mg 59779-0734-02 CVS 81 lozenges — — FDA listed —
Nicotine Mini 2 mg 63548-0262-00 PLD 27 lozenges — — FDA listed —
Nicotine Polacrilex Lozenge Mint 2 mg 63868-0733-24 Chain 24 lozenges — — Discontinued —
Kirkland Signature Nicotine 2 mg 63981-0124-37 Costco 270 lozenges — — FDA listed —
kirkland signature quit 2 2 mg 63981-0344-37 Costco 270 lozenges — — FDA listed —
members mark nicotine 2 mg 68196-0082-09 Sam's 27 lozenges — — FDA listed —
members mark Nicotine 2 mg 68196-0734-07 Sam's 216 lozenges — — FDA listed —
members mark nicotine 2 mg 68196-0811-08 Sam's 216 lozenges — — FDA listed —
berkley and jensen nicotine 2 mg 68391-0344-13 BJWC 189 lozenges — — FDA listed —
berkley and jensen nicotine 2 mg 68391-0734-01 BJWC 27 lozenges — — FDA listed —
nicotine 2 mg 69842-0587-27 CVS 80 lozenges — — FDA listed —
nicotine 2 mg 69842-0605-07 CVS 81 lozenges — — Discontinued —
Nicotine Sugar Free 2 mg 69842-0662-10 CVS 10 lozenges — — FDA listed —
Nicotine Sugar Free 2 mg 69842-0932-08 CVS 27 lozenges — — FDA listed —
Nicotine Sugar Free 2 mg 69842-0957-24 CVS 24 lozenges — — FDA listed —
Nicotine Mini 2 mg 69842-0976-08 CVS 27 lozenges — — FDA listed —
Nicotine Polacrilex 2 mg 71335-2729-01 Bryant 81 lozenges — — FDA listed —
Nicotine Polacrilex 2 mg 72162-2266-02 Bryant 72 lozenges — — FDA listed —
Nicotine Polacrilex 2 mg 72162-2287-02 Bryant 81 lozenges — — FDA listed —
basic care nicotine 2 mg 72288-0124-05 Amazon.com 72 lozenges — — FDA listed —
basic care nicotine 2 mg 72288-0223-07 Amazon.com 81 lozenges — — FDA listed —
basic care nicotine 2 mg 72288-0344-03 Amazon.com 24 lozenges — — FDA listed —
basic care nicotine 2 mg 72288-0492-76 Amazon.com 120 lozenges — — FDA listed —
Nicotine Mini 2 mg 72288-0569-04 Amazon.com 135 lozenges — — FDA listed —
Amazon Basic Care Nicotine Polacrilex 2 mg 72288-0623-14 Amazon.com 144 lozenges — — FDA listed —
Amazon Basic Care Nicotine Polacrilex 2 mg 72288-0694-21 Amazon.com 216 lozenges — — FDA listed —
basic care nicotine 2 mg 72288-0734-01 Amazon.com 27 lozenges — — FDA listed —
basic care nicotine 2 mg 72288-0808-09 Amazon.com 27 lozenges — — FDA listed —
Nicotine Mini 2 mg 72888-0186-53 Advagen 27 lozenges — — FDA listed —
Topcare Nicotine 2 mg 76162-0403-27 Topco 80 lozenges — — FDA listed —
Mini Nicotine 2 mg 79481-0223-01 Meijer, 27 lozenges — — FDA listed —
mini nicotine 2 mg 79481-0734-02 Meijer, 81 lozenges — — FDA listed —
nicotine 2 mg 79481-1123-00 Meijer, 20 lozenges — — FDA listed —
euqate nicotine 2 mg 79903-0101-20 WALMART 20 lozenges — — FDA listed —
Nicotine Mini 2 mg 79903-0127-08 WALMART 27 lozenges — — FDA listed —
equate nicotine 2 mg 79903-0160-08 WALMART 108 lozenges — — FDA listed —
up and up citrus mini nicotine 2 mg 82442-0023-07 Target 81 lozenges — — FDA listed —
up and up cherry nicotine 2 mg 82442-0124-03 Target 24 lozenges — — FDA listed —
up and up mint nicotine 2 mg 82442-0344-03 Target 24 lozenges — — FDA listed —
up and up nicotine 2 mg 82442-0490-27 Target 80 lozenges — — FDA listed —
up and up mint mini nicotine 2 mg 82442-0734-02 Target 81 lozenges — — FDA listed —
Up and Up Mini Nicotine 2 mg 82442-0802-07 Target 81 lozenges — — FDA listed —
Nicotine 2 mg 82966-0001-81 BLIP 108 lozenges — — FDA listed —
Blip 2 mg 82966-0222-00 Blip 27 lozenges — — FDA listed —
Blip 2 mg 82966-0734-01 Blip 27 lozenges — — FDA listed —
Nicotine Mini 2 mg 83253-0262-27 HC 27 lozenges — — FDA listed —
Nicotine 2 mg 83253-0978-27 HC 27 lozenges — — FDA listed —
quitine nicotine 2 mg 84720-0000-76 QUITINE 120 lozenges — — FDA listed —
Quitine Mini Nicotine 2 mg 84720-0034-07 QUITINE 216 lozenges — — FDA listed —
Quitine nicotine 2 mg 84720-0124-11 QUITINE 168 lozenges — — FDA listed —
Habitrol Lozenge Original Flavor 2 mg 43598-0982-13 Dr. 135 lozenges — — FDA listed —
Habitrol Lozenge Cherry 2 mg 43598-0984-13 Dr. 135 lozenges — — FDA listed —
nicotine coated 2 mg 56062-0543-60 Publix 20 lozenges — — FDA listed —
Nicotine 2 mg 51316-0319-60 CVS 20 lozenges — — FDA listed —
nicotine 2 mg 56062-0499-03 Publix 24 lozenges — — FDA listed —
nicotine 2 mg 56062-0734-02 Publix 81 lozenges — — FDA listed —
Equate Nicotine 2 mg 79903-0353-20 WALMART 20 lozenges — — FDA listed —
Nicotine 2 mg 72288-0771-05 Amazon.com 72 lozenges — — FDA listed —
nicotine 2 mg 59779-0201-03 CVS 24 lozenges — — FDA listed —
nicotine mini 2 mg 72288-0797-14 Amazon.com 135 lozenges — — FDA listed —
Nicotine 2 mg 00363-2511-27 Walgreen 80 lozenges — — FDA listed —
nicotine 2 mg 72288-0888-14 Amazon.com 216 lozenges — — FDA listed —
Quitine Nicotine 2 mg 84720-0222-76 QUITINE 120 lozenges — — FDA listed —
nicotine 2 mg 59368-0463-02 Sixarp, 216 lozenges — — FDA listed —
good sense nicotine 2 mg 00113-6305-60 L. 20 lozenges — — FDA listed —
Nicotine 2 mg 72288-0969-76 Amazon.com 120 lozenges — — FDA listed —
Nicotine 2 mg 21130-0772-02 Safeway 81 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

🏛️
2009
First FDA approval
May 2009
📍
2026
Currently FDA-listed
17 years listed
🛡️
2029
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 Jun 2029. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved May 18, 2009 RLD RS ⏳ ~2.7 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 8940772 — drug product
US 8501164 — drug product
US 8501164 — drug product
US 8940772 — drug product
2009 2011 2013 2015 2017 2019 2021 2023 2025 2027 2029
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 (4)
PatentTypeUse codeExpires
US 8940772 ↗ Drug product — Apr 30, 2029
US 8501164 ↗ Drug product — Jun 14, 2029
US 8501164 ↗ Drug product — Jun 14, 2029
US 8940772 ↗ Drug product — Apr 30, 2029
Common questions
Is there a generic version of this drug?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for this drug. 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.

What it looks like

Color white
ShapeOval
Imprint4
Size11 mm
ScoringNot scored
FlavorPeppermint
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

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.

Manufacturer & labeler

LabelerHaleon US Holdings LLC
Application holderHALEON US HOLDINGS LLC
FDA applicationNDA022360 (NDA)
Labeler code00135
First marketedApr 2026
Product typeHuman Otc Drug
Portfolio405 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.

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 📄 Ask a Doctor Before Use If 📄 Ask a Doctor or Pharmacist Before Use If 📄 Stop Use and Ask a Doctor If 🤰 If Pregnant or Breast-Feeding 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 11 words ▾

Use reduces withdrawal symptoms, including nicotine craving, associated with quitting smoking

⏱️ Dosage and Administration ~1 min read ▾

Directions if you are under 18 years of age, ask a doctor before use. 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.

⚠️ 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 a 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.

🧪 Active Ingredient 24 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 58 words ▾

Inactive ingredients (2 mg) acesulfame potassium, anhydrous dibasic calcium phosphate, carmine (color), crospovidone, flavors, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, sodium bicarbonate, sodium carbonate anhydrous, sucralose, xanthan gum, xylitol

Inactive ingredients (4 mg) acesulfame potassium, anhydrous dibasic calcium phosphate, carmine (color), crospovidone, flavors, hypromellose, magnesium stearate, mannitol, microcrystalline cellulose, sodium bicarbonate, sodium carbonate anhydrous, sucralose, xanthan gum, xylitol

🎯 Purpose 4 words ▾

Purpose Stop smoking aid

📄 Ask a Doctor Before Use If 42 words ▾

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 32 words ▾

Ask a doctor or 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 51 words ▾

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)

🤰 If Pregnant or Breast-Feeding 56 words ▾

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.

📄 Keep Out of Reach of Children 52 words ▾

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.

📄 Questions or Comments 6 words ▾

Questions or comments? call toll-free 1-888-569-1743

📄 Package Label / Principal Display Panel 152 words ▾

Principal Display Panel – 2 mg NEW CHERRY PEPPERMINT FLAVOR NDC 0135-8070-20 HALEON $5.00 Coupon Inside NICORETTE nicotine polacrilex lozenge, 2 mg stop smoking aid mini Lozenge 2 mg FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE MORE THAN 30 MINUTES AFTER WAKING UP. If you smoke your first cigarette WITHIN 30 MINUTES of waking up, use Nicorette 4 mg Lozenge. 20 LOZENGES, 2 mg Each CHERRY PEPPERMINT Nicorette Mini Lozenge Cherry Peppermint 2 mg 20 ct.jpg

Principal Display Panel – 4 mg NEW CHERRY PEPPERMINT FLAVOR NDC 0135-8071-20 HALEON $5.00 Coupon Inside NICORETTE nicotine polacrilex lozenge, 4 mg stop smoking aid mini Lozenge 4 mg FOR THOSE WHO SMOKE THEIR FIRST CIGARETTE WITHIN 30 MINUTES OF WAKING UP. If you smoke your first cigarette MORE THAN 30 MINUTES after waking up, use Nicorette 2 mg Lozenge. 20 LOZENGES, 4 mg Each CHERRY PEPPERMINT Nicorette Mini Lozenge Cherry Peppermint 4 mg 20 ct.jpg

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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 Nicorette Cherry Peppermint (this brand).

Top reported reactions

Nicotine Dependence2,997
Intentional Drug Misuse2,815
Nausea1,643
Malaise850
Oral Discomfort627
Dizziness587
Dyspepsia573

Reporter sex

0 reports
Male · 41%
Female · 58%
Unknown · 0%

Serious outcomes

Death148
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,028 256
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.

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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 1 other package presentation of this same product, including 81 lozenges (00135-8070-81). 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.
← 00135-8060-20 · Haleon 00135-8071-20 · 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.