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NICOTINE 2 mg Lozenge, 81-count — NDC 58602-0722-84 package photo

NICOTINE 2 mg Lozenge, 81-count

by Aurohealth LLC · 3 CONTAINER in 1 CARTON (58602-722-84) / 27 LOZENGE in 1 CONTAINER
NDC 58602-0722-84
🏷️ FDA NDC (as labeled) 58602-722-84 billing pads the product segment with a zero
This package
Contains81-count Pack sizes3 compare ↓
Also comes in: 108 lozenges 58602-0722-81 135 lozenges 58602-0722-85
OTC Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

🆔 Identity & classification

FDA NDC (as labeled) 58602-722-84
Product NDC 58602-722
11-digit billing NDC 58602072284
RxCUI 359817
UNII 6M3C89ZY6R
Application # ANDA215357
SPL Set ID cfe6fb63-2897-4e76-8288-1389f363b3c4
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 2022-11-03
Route ORAL
Dosage form LOZENGE
Substance NICOTINE
Why two NDCs? The FDA registers this code as 58602-722-84 — a 5-3-2 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 product segment → 58602-0722-84. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Cholinergic Nicotinic Agonist class.

Pharmacologic class Cholinergic Nicotinic Agonist
Drug family (ATC) Drugs used in nicotine dependence
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerAurohealth LLC
Application holderAUROBINDO PHARMA LTD
FDA applicationANDA215357 (ANDA)
Labeler code58602
First marketedNov 2022
Product typeHuman Otc Drug
Portfolio174 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📖 What it is MedlinePlus · NLM

Nicotine lozenges are used to help people stop smoking. Nicotine lozenges are in a class of medications called smoking cessation aids. They work by providing nicotine to your body to decrease the withdrawal symptoms experienced when smoking is stopped and to reduce the urge to smoke.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It's a fair question. Nicotine is what makes cigarettes addictive, and it does raise your heart rate and blood pressure. But it's the thousands of other chemicals in cigarette smok...
  • Is nicotine replacement actually safe — isn't nicotine the thing that's bad for you?
  • It comes down to one simple question: when do you smoke your first cigarette of the day? If it's within 30 minutes of waking up, you're a heavier, more dependent smoker and you'll...
  • It depends on the form you're using. With the gum or lozenge, hiccups, heartburn, and a tingling in the mouth are pretty common — these usually mean you're using it a bit too fast....
📖 Read our full Nicotine guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color White
ShapeOval
ImprintJ2
Size1 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 8F049NKY49
    A synthetic polymer made from cellulose that absorbs water. It's used as a binder and disintegrant to help tablets hold together and break apart properly in the digestive system.
  • UNII 9G5L16BK6N
    A thick, sweet liquid made from corn starch. It acts as a sweetener, thickener, and binder in medicines, helping create the right texture and taste while holding ingredients together.
  • UNII 2NX48Z0A9G
    Icodextrin is a glucose polymer derived from starch. It acts as a thickening agent and osmotic agent in medicines, helping to control texture and absorption in formulations like eye drops or injectable solutions.
  • 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 461P5CJN6T
    Modified corn starch derived from cornstarch and treated with octenyl succinic anhydride. It acts as a thickener, stabilizer, and emulsifier to improve texture and prevent separation in the medicine.
  • 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 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 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.

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

The official label also statesacesulfame potassium, artificial flavors, calcium polycarbophil, colloidal silicon dioxide, corn syrup solids, dextrin, magnesium stearate, mannitol, modified food starch (corn), natural flavors, potassium bicarbonate, sodium alginate, sodium carbonate, xanthan gum   Questions or comments? call 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST) Distributed by: AUROHEALTH LLC 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India Code: AP/DRUGS/04/2016  Revised: 09/2022

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

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

Inactive ingredient FAQ

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

💲 Pricing

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

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Try another pack size: 108 lozenges 135 lozenges
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Good Sense Nicotine 2 mg 00113-0344-05 L. 72 lozenges $0.336 — Availability likely —
Nicotine 2 mg 00536-1337-09 Rugby 24 lozenges $0.336 — Availability likely —
Nicotine Polacrilex 2 mg 45802-0344-05 Padagis 72 lozenges $0.336 — Availability likely —
Nicotine 2 mg 46122-0734-08 AmerisourceBergen 24 lozenges $0.336 — Availability likely —
Nicotine 2 mg 70000-0562-01 Cardinal 24 lozenges $0.336 — Availability likely —
foster and thrive nicotine 2 mg 70677-1174-01 Strategic 72 lozenges $0.336 — Availability likely —
foster and thrive nicotine 2 mg 70677-1176-01 Strategic 72 lozenges $0.336 — Availability likely —
Good Sense Nicotine 2 mg 00113-0734-02 L. 81 lozenges $0.355 — Availability likely —
Nicotine Mini 2 mg 00536-1239-81 Rugby 27 lozenges $0.355 — Availability likely —
Nicotine Polacrilex 2 mg 45802-0089-02 Padagis 81 lozenges $0.355 — Availability likely —
Nicotine Mini 2 mg 46122-0715-60 AmerisourceBergen 20 lozenges $0.355 — Availability likely —
Nicotine Mini 2 mg 46122-0731-15 AmerisourceBergen 27 lozenges $0.355 — Availability likely —
Nicotine Mini 2 mg 70000-0560-01 Cardinal 27 lozenges $0.355 — Availability likely —
Foster and Thrive Nicotine 2 mg 70677-1172-01 Strategic 81 lozenges $0.355 — Availability likely —
foster and thrive nicotine 2 mg 70677-1178-01 Strategic 81 lozenges $0.355 — 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 mg 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 mgthis 58602-0722-84 Aurohealth 81 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 —
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

🏛️
2022
On the market since
Nov 2022
📍
2026
Currently FDA-listed
4 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.

🔬 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 Nicotine (this brand).

Top reported reactions

Nausea1,591
Nicotine Dependence1,314
Headache856
Overdose828
Macular Degeneration795
Malaise754
Foetal Exposure During Pregnancy746

Age at onset

Neonate190
Infant21
Child11
Adolescent24
Adult2,317
Elderly504

Reporter sex

20,607 reports
Male · 42%
Female · 57%
Unknown · 0%

Serious outcomes

Hospitalization4,679
Death1,593
Life-threatening604
Disabling321
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,563 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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
58602-0722-81 4 CONTAINER in 1 CARTON (58602-722-81) / 27 LOZENGE in 1 CONTAINER 2022-11-03 Active
58602-0722-84 You're viewing this 3 CONTAINER in 1 CARTON (58602-722-84) / 27 LOZENGE in 1 CONTAINER 2022-11-03 Active
58602-0722-85 5 CONTAINER in 1 CARTON (58602-722-85) / 27 LOZENGE in 1 CONTAINER 2022-11-03 Active

Pack size FAQ

What quantity is in NDC 58602-0722-84?
NDC 58602-0722-84 is a 81-count package — 3 container in 1 carton / 27 lozenge in 1 container.
What is the difference between NDC 58602-0722-84 and NDC 58602-0722-81?
Both are NICOTINE 2 mg Lozenge — the drug itself is identical. NDC 58602-0722-84 is the 81-count package, while NDC 58602-0722-81 is the 108 lozenges package.
What NDC number is used to bill for this package of NICOTINE 2 mg Lozenge?
Bill NDC 58602-0722-84 — the 11-digit billing format is 58602072284. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

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

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 58602-722-84, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 58602-0722-84, written without dashes as 58602072284. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 58602-0722-84, the first segment (58602) is the labeler code FDA assigned to Aurohealth LLC; the middle segment (0722) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (84) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Aurohealth LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 108 lozenges (58602-0722-81), 135 lozenges (58602-0722-85). 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?
Aurohealth LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as an over-the-counter product, so it does not require a prescription. Follow the package directions, and ask your pharmacist if you are unsure whether it is right for you.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose
🎯 Indications and Usage 11 words ▾

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

⏱️ Dosage and Administration ~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 57 words ▾

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.

🧪 Active Ingredient 12 words ▾

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

🧪 Inactive Ingredients 64 words ▾

Inactive ingredients acesulfame potassium, artificial flavors, calcium polycarbophil, colloidal silicon dioxide, corn syrup solids, dextrin, magnesium stearate, mannitol, modified food starch (corn), natural flavors, potassium bicarbonate, sodium alginate, sodium carbonate, xanthan gum Questions or comments? call 1-855-274-4122 (Monday – Friday 8:30 AM to 5:00 PM EST) Distributed by: AUROHEALTH LLC 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India Code: AP/DRUGS/04/2016 Revised: 09/2022

🎯 Purpose 4 words ▾

Purpose Stop smoking aid

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 58602-0721-57 · Aurohealth 58602-0723-81 · Aurohealth →
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.