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Maxi Nicotine nicotine polacrilex 4 mg Lozenge — NDC 00536-1338-09 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Maxi Nicotine nicotine polacrilex 4 mg Lozenge — NDC 0536-1338-09 (Billing 00536-1338-09)

by Rugby Laboratories, Inc. · 3 BOTTLE, PLASTIC in 1 BOX / 24 LOZENGE in 1 BOTTLE, PLASTIC

This is a package of Maxi Nicotine nicotine polacrilex 4 mg Lozenge from Rugby Laboratories, Inc., marketed since Sep 2021 and currently FDA-listed; retail pharmacies pay about $0.3443 per unit (NADAC). It is the main listing for this product, which comes in 2 package sizes.

NDC 00536-1338-09
🏷️ FDA NDC (as labeled) 0536-1338-09 billing pads the labeler segment with a zero
This package
Contains24 lozenge in 1 bottle, plastic Cost per ea$0.3443 NADAC Per package$24.79 / 72 lozenges Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.3514/unit — full pricing hub ↓
Main listing for product 0536-1338 · Also comes in: 24 lozenges 0536-1338-35
OTC Generic 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) 0536-1338-09
Product NDC 0536-1338
11-digit billing NDC 00536133809
NCPDP billing unit EA — each (per item)
RxCUI 359818
UNII 6M3C89ZY6R
Application # ANDA209206
SPL Set ID 7c2e0872-75f6-4c4f-afff-3579375708de
Established class (EPC) Cholinergic Nicotinic Agonist
Chemical class Nicotine
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2021-09-17
Route ORAL
Dosage form LOZENGE
Substance NICOTINE

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 62100010004720
GPI class Nicotine Polacrilex
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 NICOTINE 4 MG LOZENGE
FDB brand name Nicotine Lozenge
Legend status O — Over-the-counter (OTC) drug or device
Quick answers
  • GSN (GCN sequence number): 048775
  • GCN: 14688
  • GPI-14 (Medi-Span): 62100010004720
  • HICL (First Databank): 002049
  • AHFS class code: 12:02.00.00
  • RxCUI (RxNorm): 359818
Why two NDCs? The FDA registers this code as 0536-1338-09 — a 4-4-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the labeler segment → 00536-1338-09. 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

Label name NICOTINE 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
  • 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 eaPer package
Retail pharmacies payNADAC · weekly $0.344 $24.79 / 72 lozenges
Medicaid paysCMS SDUD · 12 mo $0.3514 $25.30 / 72 lozenges
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $0.380 $0.330
▲ Up 2% over the last 24 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
00536-1338-09 You're viewing this Main listing 3 BOTTLE, PLASTIC in 1 BOX / 24 LOZENGE in 1 BOTTLE, PLASTIC $0.3443 / ea $24.79 2021-09-17 — Active
00536-1338-35 0536-1338-35 24 LOZENGE in 1 BOTTLE, PLASTIC $0.3443 / ea $8.26 2021-09-17 — Active

This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.3443 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in this package?
This package is listed by the FDA — 3 bottle, plastic in 1 box / 24 lozenge in 1 bottle, plastic.
What NDC number is used to bill for this package of Maxi Nicotine nicotine polacrilex 4 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.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
good sense nicotine 4 mg 00113-0873-05 L. 72 lozenges $0.344 — Availability likely —
Maxi Nicotine 4 mgthis 00536-1338-09 Rugby 24 lozenges $0.344 — Availability likely —
Nicotine Polacrilex 4 mg 45802-0873-05 Padagis 72 lozenges $0.344 — Availability likely —
Nicotine 4 mg 46122-0732-08 AmerisourceBergen 24 lozenges $0.344 — Availability likely —
Maxi Nicotine 4 mg 70000-0561-01 Cardinal 24 lozenges $0.344 — Availability likely —
foster and thrive nicotine 4 mg 70677-1175-01 Strategic 72 lozenges $0.344 — Availability likely —
foster and thrive nicotine 4 mg 70677-1177-01 Strategic 72 lozenges $0.344 — Availability likely —
Good Sense Nicotine 4 mg 00113-0957-02 L. 81 lozenges $0.389 — Availability likely +13%
Mini Nicotine 4 mg 00536-1241-81 Rugby 27 lozenges $0.389 — Availability likely +13%
Nicotine Polacrilex 4 mg 45802-0957-02 Padagis 81 lozenges $0.389 — Availability likely +13%
Mini Nicotine 4 mg 46122-0716-15 AmerisourceBergen 27 lozenges $0.389 — Availability likely +13%
Nicotine Mini 4 mg 70000-0559-01 Cardinal 27 lozenges $0.389 — Availability likely +13%
foster and thrive nicotine 4 mg 70677-1173-01 Strategic 81 lozenges $0.389 — Availability likely +13%
foster and thrive nicotine 4 mg 70677-1179-01 Strategic 81 lozenges $0.389 — Availability likely +13%
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 mg 00135-0626-01 Haleon 20 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 — — Discontinued —
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 —
Equate Nicotine 4 mg 79903-0354-20 WALMART 20 lozenges — — FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2021
On the market since
Sep 2021
📍
2026
Currently FDA-listed
5 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color white
ShapeRound
ImprintA754
Size16 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 9XZ8H6N6OH
    A plant-based cellulose derivative used as a binder to hold tablet ingredients together, a thickener in liquids, and a coating agent to control how fast the medicine dissolves.
  • 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 HM5Z15LEBN
    Potassium bicarbonate is a salt that acts as a buffer and pH regulator in medicines. It helps maintain a stable acid-alkaline balance so the drug stays effective and doesn't irritate the stomach or mouth.
  • UNII FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII C269C4G2ZQ
    Sodium alginate is a natural thickener and gelling agent derived from seaweed. In medicines, it acts as a binder to hold ingredients together, a thickener to adjust texture, and a disintegrant to help the tablet or capsule break apart for absorption.
  • 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 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.

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

The official label also statesacesulfame potassium, colloidal silicon dioxide, flavor, hydroxypropyl cellulose, magnesium stearate, mannitol, potassium bicarbonate, povidone, sodium alginate,  sodium carbonate, sucralose, 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.

Manufacturer & labeler

LabelerRugby Laboratories, Inc.
Application holderP AND L DEVELOPMENT LLC
FDA applicationANDA209206 (ANDA)
Labeler code00536
First marketedSep 2021
Product typeHuman Otc Drug
Portfolio14 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 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 (about 20 to 30 minutes).

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 (about 20 to 30 minutes) 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 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 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 (1-800-222-1222) right away

🧪 Active Ingredient 10 words ▾

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

🧪 Inactive Ingredients 23 words ▾

Inactive ingredients acesulfame potassium, colloidal silicon dioxide, flavor, hydroxypropyl cellulose, magnesium stearate, mannitol, potassium bicarbonate, povidone, sodium alginate, sodium carbonate, sucralose, xanthan gum

🎯 Purpose 4 words ▾

Purpose Stop smoking aid

📄 Ask a Doctor Before Use If 45 words ▾

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 your blood pressure. stomach ulcer or diabetes history of seizures

📄 Ask a Doctor or Pharmacist Before Use If 31 words ▾

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 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 53 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 (1-800-222-1222) right away

📄 Questions or Comments 8 words ▾

Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

📄 Package Label / Principal Display Panel 203 words ▾

Principal Display Panel compare to the active ingredient in Nicorette® Lozenge* nicotine polacrilex lozenges Stop Smoking Aid 4 mg Mint Flavor 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 Nicotine Polacrilex Lozenge. LOZENGES TO INCREASE YOUR SUCCESS IN QUITTING: 1.

You must be motivated to quit. 2. Use Enough - Use at least 9 Nicotine Polacrilex lozenges per day during the first six weeks.

3. Use Long Enough - Use Nicotine Polacrilex lozenges for the full 12 weeks. 4.

Use With a Support Program as directed in the enclosed User's Guide. not for sale to those under 18 years of age proof of age required not for sale in vending machines or from any source where proof of age cannot be verified *This product is not manufactured or distributed by Haleon group of companies, distributor of Nicorette® Lozenge. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. RETAIN OUTER CARTON FOR FULL PRODUCT USES, DIRECTIONS AND WARNINGS.

Distributed by: RUGBY® LABORATORIES Indianapolios, IN 46268

Package Label RUGBY Nicotine Lozenge Sugar Free Mint Flavor Nicotine Polacrilex USP, 4 mg

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
27.8K
Units reimbursed last 4 qtrs
3.5M
Gross reimbursed last 4 qtrs
$1.22M
Avg / prescription
$43.74
Avg / unit
$0.3514
Latest quarter Q1 2026
8.3KRx
Medicaid pays / ea
$0.3514
gross reimbursed
vs
NADAC / ea
$0.3443
acquisition cost
=
Spread
+$0.0071
+2% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
44% FFS 56% MCO
Fee-for-service · 12,126 Rx Managed care · 15,683 Rx
State Medicaid map
Alaska: 4,392 units · 599 per 100k residents AK Maine: 64,932 units · 4,655 per 100k residents ME Washington: 70,732 units · 905 per 100k residents WA Idaho: 8,784 units · 447 per 100k residents ID Montana: 1,152 units · 102 per 100k residents MT North Dakota: no data reported ND Minnesota: 91,155 units · 1,589 per 100k residents MN Wisconsin: 76,124 units · 1,288 per 100k residents WI Michigan: 164,333 units · 1,637 per 100k residents MI New York: 417,064 units · 2,131 per 100k residents NY Vermont: 26,640 units · 4,117 per 100k residents VT New Hampshire: 8,208 units · 585 per 100k residents NH Oregon: 107,088 units · 2,530 per 100k residents OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 71,852 units · 2,240 per 100k residents IA Illinois: 25,248 units · 201 per 100k residents IL Indiana: 173,950 units · 2,535 per 100k residents IN Ohio: 223,834 units · 1,899 per 100k residents OH Pennsylvania: 365,540 units · 2,820 per 100k residents PA New Jersey: 34,328 units · 370 per 100k residents NJ Massachusetts: 331,912 units · 4,741 per 100k residents MA California: 474,240 units · 1,217 per 100k residents CA Utah: 34,249 units · 1,002 per 100k residents UT Colorado: 20,746 units · 353 per 100k residents CO Nebraska: 10,112 units · 511 per 100k residents NE Missouri: 56,898 units · 918 per 100k residents MO Kentucky: 120,686 units · 2,667 per 100k residents KY West Virginia: 23,760 units · 1,342 per 100k residents WV Virginia: 45,845 units · 526 per 100k residents VA Maryland: 42,815 units · 693 per 100k residents MD Connecticut: 34,955 units · 966 per 100k residents CT Rhode Island: 47,074 units · 4,299 per 100k residents RI Arizona: 57,569 units · 775 per 100k residents AZ New Mexico: 2,544 units · 120 per 100k residents NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 2,592 units · 36.4 per 100k residents TN North Carolina: 119,456 units · 1,103 per 100k residents NC South Carolina: no data reported SC Delaware: 2,592 units · 251 per 100k residents DE Oklahoma: 58,008 units · 1,431 per 100k residents OK Louisiana: 14,787 units · 323 per 100k residents LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: 2,022 units · 298 per 100k residents DC Hawaii: 18,812 units · 1,311 per 100k residents HI Texas: 4,440 units · 14.6 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
14.64,741
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Massachusetts 4,741 /100k
2 Maine 4,655 /100k
3 Rhode Island 4,299 /100k
4 Vermont 4,117 /100k
5 Pennsylvania 2,820 /100k
6 Kentucky 2,667 /100k
7 Indiana 2,535 /100k
8 Oregon 2,530 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
24 lozenges this page00536-1338-09 27,809 Rx · $1,216,260
24 lozenges00536-1338-35 No Medicaid data
Drug total (last 4 qtrs): 27,809 Rx · 3,461,470 units · $1,216,260 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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 Maxi Nicotine (this brand).

Top reported reactions

Nausea699
Nicotine Dependence608
Macular Degeneration567
Oral Discomfort329
Dyspepsia314
Intentional Drug Misuse291
Malaise286

Reporter sex

6,149 reports

Serious outcomes

Death33
Life-threatening24
Disabling10
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 648 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.
← 00536-1337-09 · Rugby 00536-1348-97 · Rugby →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.