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Nicotine 4 mg Lozenge, 108-count — NDC 11822-0873-00 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Nicotine 4 mg Lozenge, 108-count — NDC 11822-0873-0 (Billing 11822-0873-00)

by Rite Aid Corporation · 4 CONTAINER in 1 CARTON / 27 LOZENGE in 1 CONTAINER

This is a package of 108 lozenges of Nicotine 4 mg Lozenge from Rite Aid Corporation, marketed since Feb 2006 and currently FDA-listed, this package's marketing is listed to end Oct 2026. It is the main listing for this product, which comes in 3 package sizes.

NDC 11822-0873-00
🏷️ FDA NDC (as labeled) 11822-0873-0 billing pads the package segment with a zero
This package
Contains108-count Pack sizes3 compare ↓
Main listing for product 11822-0873 · Also comes in: 72 lozenges 11822-0873-1 168 lozenges 11822-0873-5
OTC Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Sep 3, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 11822-0873-0
Product NDC 11822-0873
11-digit billing NDC 11822087300
RxCUI 359818
UNII 6M3C89ZY6R
UPC 0012345678905
Application # ANDA077007
SPL Set ID 8b24aefd-1881-4126-9188-29896a17a06d
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 2006-02-24
Marketing end 2026-10-31
Route ORAL
Dosage form LOZENGE
Substance NICOTINE
Quick answers
  • RxCUI (RxNorm): 359818
Why two NDCs? The FDA registers this code as 11822-0873-0 — a 5-4-1 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 package segment → 11822-0873-00. 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: 72 lozenges 168 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
11822-0873-00 You're viewing this Main listing 4 CONTAINER in 1 CARTON / 27 LOZENGE in 1 CONTAINER 2011-09-08 Oct 31, 2026 Active
11822-0873-01 11822-0873-1 3 CONTAINER in 1 CARTON / 24 LOZENGE in 1 CONTAINER 2009-09-01 Sep 30, 2026 Discontinued by firm
11822-0873-05 11822-0873-5 7 CONTAINER in 1 CARTON / 24 LOZENGE in 1 CONTAINER 2023-07-19 — Discontinued by firm

Pack size FAQ

What quantity is in this package?
This is a 108-count package — 4 container in 1 carton / 27 lozenge in 1 container.
How does this package differ from NDC 11822-0873-01?
Both are Nicotine 4 mg Lozenge — the drug itself is identical. This page's package is the 108-count one, while NDC 11822-0873-01 is the 72 lozenges package.
What NDC number is used to bill for this package of Nicotine 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.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
good sense nicotine 4 mg 00113-0873-05 L. 72 lozenges $0.344 — Availability likely —
Maxi Nicotine 4 mg 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 —
Mini Nicotine 4 mg 00536-1241-81 Rugby 27 lozenges $0.389 — Availability likely —
Nicotine Polacrilex 4 mg 45802-0957-02 Padagis 81 lozenges $0.389 — Availability likely —
Mini Nicotine 4 mg 46122-0716-15 AmerisourceBergen 27 lozenges $0.389 — Availability likely —
Nicotine Mini 4 mg 70000-0559-01 Cardinal 27 lozenges $0.389 — Availability likely —
foster and thrive nicotine 4 mg 70677-1173-01 Strategic 81 lozenges $0.389 — Availability likely —
foster and thrive nicotine 4 mg 70677-1179-01 Strategic 81 lozenges $0.389 — 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 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 mgthis 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

🏛️
2006
On the market since
Feb 2006
📍
2026
Currently FDA-listed
20 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.

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

LabelerRite Aid Corporation
Application holderPERRIGO R AND D CO
FDA applicationANDA077007 (ANDA)
Labeler code11822
First marketedFeb 2006
Product typeHuman Otc Drug
Portfolio326 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. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). 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 📄 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 12 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 20-30 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 20-30 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 right away. (1-800-222-1222)

📦 Storage and Handling 40 words ▾

Other information • each lozenge contains: sodium 17 mg • Phenylketonurics: Contains Phenylalanine 5.1 mg per lozenge • sugar alcohol content: 1 g mannitol per lozenge • store at 20-25°C (68-77°F) • keep vial tightly closed and protect from light

🧪 Active Ingredient 10 words ▾

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

🧪 Inactive Ingredients 17 words ▾

Inactive ingredients aspartame, magnesium stearate, mannitol, natural peppermint flavor, potassium bicarbonate, sodium alginate, sodium carbonate, xanthan gum

🎯 Purpose 4 words ▾

Purpose Stop smoking aid

📄 Ask a Doctor Before Use If 50 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 33 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 56 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 right away. (1-800-222-1222)

📄 Questions or Comments ~3 min read ▾

Questions or comments? call toll-free 1-866-751-9303 Consumer Information Nicotine Polacrilex Lozenge 2 mg and 4 mg User's Guide How to Use Nicotine Polacrilex Lozenges and Tips to Help You Quit Smoking. • 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 PLANNING YOUR SUCCESS 1) The key to accomplishing anything important is commitment. When it comes to quitting smoking, that is especially true. Nicotine Polacrilex Lozenges can help if you really want to quit.

Nicotine Polacrilex Lozenges help reduce withdrawal symptoms including nicotine craving associated with quitting smoking. 2) Your chances of staying off cigarettes are much better if you start with at least 9 Nicotine Polacrilex Lozenges daily. For best results, use the lozenges on a regular schedule (as outlined in this User's Guide).

3) Start using Nicotine Polacrilex Lozenges on your quit date. 4) This User's Guide outlines a 12-week plan for Nicotine Polacrilex Lozenges. Even though you may feel confident about your non-smoking status after a few weeks, it's important to stick with the plan to help you remain smoke free.

Even a single cigarette can put you right back to square one. 5) Nicotine Polacrilex Lozenges work best when used together with a support plan. See information to the right for instructions on enrollment in the SmokeFreeHabits.com Free & Personalized Support Plan.

6) After the first six weeks, start using fewer Nicotine Polacrilex Lozenges, as directed in the instructions, gradually reducing your use over the next six weeks. If you feel the need to use the lozenges for a longer period to keep from smoking, talk to your health care provider. 7) If you have questions about using Nicotine Polacrilex Lozenges, please talk to your pharmacist, family doctor, or call toll-free 1-866-751-9303.

YES! YOU WANT TO QUIT. Wonderful.

You've made the most important decision of all, to stop smoking. And by choosing Nicotine Polacrilex Lozenges to help you, you're starting on the right path. Now remember, using Nicotine Polacrilex Lozenges doesn't just mean taking a Nicotine Polacrilex Lozenge.

It means setting and following a program like the one we suggest in this User's Guide. Your own success depends on your effort, your level of addiction to tobacco, and your commitment to following your program. LET'S FACE IT.

Quitting smoking isn't easy! You or someone you know may have tried unsuccessfully. That's okay.

It's hard to stop smoking the first time you try. The important part is to learn from your previous attempts, consider what went wrong and keep trying to quit until you succeed. Look to this User's Guide for support as you undergo this terrific task.

The guide includes important information on how to use Nicotine Polacrilex Lozenges and also gives you tips to help you stop smoking. Refer back to it often for advice, answers, and encouragement to help you stay on track. GET MOTIVATED.

STAY MOTIVATED. Everyone has a reason for quitting–whether you're concerned about your health, your appearance, family or peer pressure, or the effect of secondhand smoke on your loved ones–all of the above, or something else entirely. Whatever your reasons, write them down.

There's a wallet card on the bottom of this User's Guide. Write your reasons on the card and carry it with you. When you have an urge to smoke or experience a difficult moment it can help you focus on your reasons for quitting.

Lots of people quit with a co-worker, spouse or friend and use them as a quitting buddy. You can help each other out by providing extra encouragement in tough moments. There may be support groups in your area for people trying to quit.

Call your local chapter of the American Lung Association, American Cancer Society or American Heart Association for further information. Toll free phone numbers are printed on the wallet card on the bottom of this User's Guide. UNDERSTANDING THE D… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 79 words ▾

Principal Display Panel FREE FROM SUGAR FREE DYE FREE Compare to the active ingredient of Nicorette ® Lozenge Nicotine Lozenge 4 mg Nicotine Polacrilex Lozenge 4 mg (nicotine) Stop Smoking Aid 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, 2 mg Includes User’s Guide ACTUAL SIZE MINT FLAVOR 108 LOZENGES, 4 mg EACH (CONTAINERS OF 27) 873-83-nicotine-lozenge

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

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 — 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 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 it is currently marketed — but Rite Aid Corporation has reported a marketing end date of 2026-10-31, after which this package is expected to stop being marketed. 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 72 lozenges (11822-0873-01), 168 lozenges (11822-0873-05). 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?
Rite Aid Corporation 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.
← 11822-0870-01 · Rite 11822-0891-02 · Rite →
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.