HomeNDC LookupIngredientsNicotine › 00536-5896-88
Nicotine 21 mg/24h Patch, 14 pouches — NDC 00536-5896-88 package photo

Nicotine 21 mg/24h Patch, 14 pouches

by Rugby Laboratories · 14 POUCH in 1 CARTON (0536-5896-88) / 1 h in 1 POUCH
NDC 00536-5896-88
🏷️ FDA NDC (as labeled) 0536-5896-88 billing pads the labeler segment with a zero
This package
Contains14 pouches Cost per ea$1.76 NADAC Per package$24.58 / 14 h Pack sizes3 compare ↓
Also priced by: Medicaid pays $1.65/unit — full pricing hub ↓
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 →
🚨
Active recall for this product.
Class III · May 14, 2026 — Failed Impurities/Degradation Specifications: Elevated levels of oxidative-related impurities, exceeding shelf-life specifications during stability testing of individual units. (AVEVA Drug Delivery Systems, Inc.) · FDA recall D-0550-2026
Check your lot/expiration against the official notice — look up the recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 0536-5896-88
Product NDC 0536-5896
11-digit billing NDC 00536589688
NCPDP billing unit EA — each (per item)
RxCUI 198029, 198030, 198031
UNII 6M3C89ZY6R
Application # ANDA074612
SPL Set ID 2dd4cbda-5c46-4655-b69d-21b7d2e912cf
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 2024-06-25
Route TRANSDERMAL
Dosage form PATCH
Substance NICOTINE
GPI-14 62100005008540
GPI class Nicotine
GCN Seq No 016427
GCN 03423
HICL code 006249
Ingredient (HICL) Nicotine
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 21 MG/24HR PATCH
FDB brand name Nicotine Patch
Legend status O — Over-the-counter (OTC) drug or device
Why two NDCs? The FDA registers this code as 0536-5896-88 — 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 → 00536-5896-88. 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

LabelerRugby Laboratories
Application holderDIFGEN PHARMACEUTICALS LLC
FDA applicationANDA074612 (ANDA)
Labeler code00536
First marketedJun 2024
Product typeHuman Otc Drug
Portfolio149 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

Label name NICOTINE 21 MG/24HR PATCH Ingredient Nicotine
📗 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 →
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.

🧪 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.

💲 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 $1.756 $24.58 / 14 h
Medicaid paysCMS SDUD · 12 mo $1.65 $23.17 / 14 h
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
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $1.772 $1.517
▲ Up 1% 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Nicotine 21 mg/24h 70677-0032-01 Strategic 14 pouches $1.533 FDA listed save 13%
Nicotine transdermal system step 1 21 mg/24h 00536-1108-88 Rugby 14 patches $1.756 Availability likely
Nicotine 21 mg/24hthis 00536-5896-88 Rugby 14 pouches $1.756 Availability likely
Nicotine transdermal system step 1 21 mg/24h 43598-0448-28 Dr. 28 patches $1.756 Discontinued
Nicotine Transdermal System 21 mg/24h 46122-0353-74 AmerisourceBergen 14 pouches $1.756 Availability likely
Nicotine Transdermal System 21 mg/24h 46122-0568-03 AmerisourceBergen 28 pouches $1.756 Availability likely
Nicotine Transdermal System 21 mg/24h 50742-0670-07 Ingenus 7 pouches $1.756 Availability likely
Nicotine Transdermal System 21 mg/24h 68001-0434-88 BluePoint 7 pouches $1.756 Availability likely
Nicotine Transdermal System Patch Step 1 21 mg/24h 68001-0699-88 BluePoint 7 patches $1.756 Availability likely
Nicotine Transdermal System 21 mg/24h 70000-0512-01 Cardinal 7 pouches $1.756 Availability likely
Nicotine Transdermal System step 1 21 mg/24h 70000-0762-01 CARDINAL 7 patches $1.756 Availability likely
foster and thrive STEP 1 21 mg/24h 70677-1182-01 Strategic 14 pouches $1.756 Availability likely
Nicotine transdermal system step 1 21 mg/24h 70677-1266-01 Strategic 14 patches $1.756 Availability likely
Nicotine Transdermal System 21 mg/24h 76282-0783-40 EXELAN 14 pouches $1.756 Availability likely
Nicoderm Cq 21 mg/24h 00135-0194-01 Haleon 7 patches FDA listed
Nicotine transdermal system step 1 21 mg/24h 00363-0455-70 Walgreens 7 patches FDA listed
Nicotine Transdermal System 21 mg/24h 00363-1245-01 Walgreens 14 pouches FDA listed
Nicotine Transdermal System 21 mg/24h 03215-0122-14 Aveva 14 patches FDA listed
Nicotine Transdermal System 21 mg/24h 03215-1203-07 Aveva 7 pouches FDA listed
Nicotine transdermal system 21 mg/24h 11673-0194-01 Target 7 patches Discontinued
Nicotine transdermal system step 1 21 mg/24h 11822-4975-00 Rite 7 patches FDA listed
Nicotine Transdermal System 21 mg/24h 36800-0038-14 Topco 14 pouches FDA listed
Nicotine Transdermal System 21 mg/24h 37808-0461-01 H-E-B 14 pouches FDA listed
Nicotine transdermal system 21 mg/24h 49035-0194-01 Wal-Mart 7 patches FDA listed
Nicotine 21 mg/24h 50090-1697-00 A-S 14 pouches FDA listed
Nicotine Transdermal System 21 mg/24h 50090-7936-00 A-S 14 patches FDA listed
Medline 21 mg 53329-0192-89 Medline 14 patches FDA listed
Habitrol Step 1 21 mg/24h 55741-0448-28 Dr. 28 patches FDA listed
Nicotine transdermal system step 1 21 mg/24h 55910-0313-02 DOLGENCORP, 2 patches FDA listed
Nicotine transdermal system step 1 21 mg/24h 59450-0003-74 The 14 patches FDA listed
Nicotine transdermal system step 1 21 mg/24h 59779-0448-02 CVS 2 pouches FDA listed
Nicotine transdermal system step 1 21 mg/24h 60429-0445-14 Golden 14 patches FDA listed
Nicotine transdermal system step 1 21 mg/24h 63868-0735-14 Chain 14 patches FDA listed
Nicotine 21 mg/24h 79481-0052-01 Meijer, 14 pouches FDA listed
Sielkin QUIT SMOKING NICOTINE PATCHES 21mg 21 mg/g 83364-0017-01 YITONGBADA 30 patches FDA listed
Sefudun Quit Smoking Nicotine Patches 21 mg 83804-0001-01 Shenzhen 30 patches FDA listed
NWRB Nicotine Transdermal Patch 21 mg 84288-0007-01 Dongkou 30 patches FDA listed
Nicotine Transdermal System 21 mg/24h 84720-0122-14 Quitine 14 patches FDA listed
QUIT SMOKING Proven Patches 21 mg/g 84867-0013-01 Jiashen 30 patches FDA listed
Rstrvbr QUIT SMOKING 21 mg/1001 85248-0130-01 Jiangxi 30 patches FDA listed
Serynth Nicotine Transdermal Stop Smoking Aid 21 mg/1001 85248-0164-01 Jiangxi 21 patches FDA listed
Nicotine Patches 21 mg/21mg 85333-0003-02 Zhejiang 14 patches FDA listed
Nicotine Patches 21 mg/1001 85795-0002-01 Shenzhen 30 patches FDA listed
WOFANLI Quit Smoking Nicotine Patches 21 mg/1001 85835-0004-01 Shenzhen 30 patches FDA listed
WOFANLI Quit Smoking Nicotine Patches 21 mg/1001 85835-0009-01 Shenzhen 30 patches FDA listed
NicDuic Quit Smoking Nicotine Patches 1 Step 21 mg/1001 85835-0012-01 Shenzhen 30 patches FDA listed
NicDuic Quit Smoking Nicotine Patches 1-3 Step 21 mg/1001 85835-0013-01 Shenzhen 30 patches FDA listed
quit smoking patches 21 mg 87135-0001-01 Henan 30 patches FDA listed
GUHIO Nicotine Patch 21 mg 87278-0001-01 Guangxi 42 patches FDA listed
Nicotine Stop Smoking AID 21 mg 87278-0002-01 Guangxi 60 patches FDA listed
Nicotine Stop Smoking AID 21 mg 87278-0009-01 Guangxi 60 patches FDA listed
Hqlsey Quit Smoking Patches 21 mg/1001 87405-0001-01 Hansen 14 patches FDA listed
Nicotine Patch 21 mg 87704-0004-01 Guangzhou 30 patches FDA listed
Nicotine transdermal system 21 mg/24h 68196-0194-03 Sam's 21 patches Discontinued
Nicotine Transdermal System step 1 21 mg/24h 46122-0833-45 AmerisourceBergen 14 patches FDA listed
Nicotine Transdermal System step 1 21 mg/24h 76162-0742-14 Topco 14 patches 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

🏛️
2024
On the market since
Jun 2024
📍
2026
Currently FDA-listed
2 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.

🗺️ 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 00536-5896-88, 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 – Q4 2025 · 4 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
164.3K
Units reimbursed last 4 qtrs
4.2M
Gross reimbursed last 4 qtrs
$6.98M
Avg / prescription
$42.48
Avg / unit
$1.6548
Latest quarter Q4 2025
37.7KRx
Medicaid pays / ea
$1.6548
gross reimbursed
vs
NADAC / ea
$1.7559
acquisition cost
=
Spread
−$0.1011
-6% 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
40% FFS 60% MCO
Fee-for-service · 65,232 Rx Managed care · 99,034 Rx
State Medicaid map
Alaska: 10,255 units · 1,399 per 100k residents AK Maine: 53,269 units · 3,819 per 100k residents ME Washington: 33,333 units · 427 per 100k residents WA Idaho: 7,259 units · 370 per 100k residents ID Montana: 11,087 units · 979 per 100k residents MT North Dakota: 4,881 units · 623 per 100k residents ND Minnesota: 85,717 units · 1,494 per 100k residents MN Wisconsin: 63,108 units · 1,068 per 100k residents WI Michigan: 173,373 units · 1,727 per 100k residents MI New York: 585,558 units · 2,992 per 100k residents NY Vermont: 12,043 units · 1,861 per 100k residents VT New Hampshire: no data reported NH Oregon: 42,729 units · 1,009 per 100k residents OR Nevada: 7,758 units · 243 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 56,515 units · 1,762 per 100k residents IA Illinois: 116,031 units · 925 per 100k residents IL Indiana: 279,626 units · 4,075 per 100k residents IN Ohio: 368,978 units · 3,131 per 100k residents OH Pennsylvania: 415,836 units · 3,208 per 100k residents PA New Jersey: 144,121 units · 1,551 per 100k residents NJ Massachusetts: 423,342 units · 6,047 per 100k residents MA California: 163,925 units · 421 per 100k residents CA Utah: 17,983 units · 526 per 100k residents UT Colorado: 21,113 units · 359 per 100k residents CO Nebraska: 14,872 units · 752 per 100k residents NE Missouri: 107,841 units · 1,740 per 100k residents MO Kentucky: 120,951 units · 2,672 per 100k residents KY West Virginia: 38,725 units · 2,188 per 100k residents WV Virginia: 191,125 units · 2,193 per 100k residents VA Maryland: 121,077 units · 1,959 per 100k residents MD Connecticut: 110,995 units · 3,069 per 100k residents CT Rhode Island: 80,531 units · 7,354 per 100k residents RI Arizona: 17,822 units · 240 per 100k residents AZ New Mexico: 6,376 units · 302 per 100k residents NM Kansas: 7,141 units · 243 per 100k residents KS Arkansas: 7,013 units · 229 per 100k residents AR Tennessee: 23,235 units · 326 per 100k residents TN North Carolina: 122,229 units · 1,128 per 100k residents NC South Carolina: 25,248 units · 470 per 100k residents SC Delaware: 8,978 units · 871 per 100k residents DE Oklahoma: 11,296 units · 279 per 100k residents OK Louisiana: 55,230 units · 1,207 per 100k residents LA Mississippi: 2,139 units · 72.8 per 100k residents MS Alabama: no data reported AL Georgia: 15,128 units · 137 per 100k residents GA D.C.: 8,740 units · 1,287 per 100k residents DC Hawaii: no data reported HI Texas: 19,934 units · 65.4 per 100k residents TX Florida: 2,692 units · 11.9 per 100k residents FL
Units reimbursed · per 100k residents
11.97,354
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 Rhode Island 7,354 /100k
2 Massachusetts 6,047 /100k
3 Indiana 4,075 /100k
4 Maine 3,819 /100k
5 Pennsylvania 3,208 /100k
6 Ohio 3,131 /100k
7 Connecticut 3,069 /100k
8 New York 2,992 /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.
14 pouches this page00536-5896-88 164,266 Rx · $6,978,557
28 pouches00536-5896-71 41,264 Rx · $1,868,762
7 pouches00536-5896-53 6,260 Rx · $231,812
Drug total (last 4 qtrs): 211,790 Rx · 5,456,294 units · $9,079,130 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Nicotrol Ns (matched by generic name) — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Nicotrol Ns. CMS lists 2 products for this generic; we show the highest-spend one. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$1.96M
Claims incl. refills
3K
Beneficiaries
1.6K
Spend / beneficiary
$1,189.65
Spend / claim
$656.98
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 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 — the ingredient across all brands.

Top reported reactions

Nicotine Dependence6,170
Nausea4,675
Intentional Drug Misuse3,782
Application Site Erythema3,559
Application Site Pruritus3,506
Dizziness2,612
Product Quality Issue2,500

Age at onset

Neonate203
Infant21
Child27
Adolescent25
Adult3,254
Elderly869

Reporter sex

60,670 reports
Male · 39%
Female · 61%
Unknown · 0%

Serious outcomes

Hospitalization6,717
Death1,992
Life-threatening798
Disabling504
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 3,613 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 Per unit Per pack Marketing startStatus
00536-5896-53 7 POUCH in 1 CARTON (0536-5896-53) / 1 h in 1 POUCH $1.76 / ea $12.29 2024-06-25 Active
00536-5896-71 28 POUCH in 1 CARTON (0536-5896-71) / 1 h in 1 POUCH $1.76 / ea $49.16 2024-06-25 Active
00536-5896-88 You're viewing this 14 POUCH in 1 CARTON (0536-5896-88) / 1 h in 1 POUCH $1.76 / ea $24.58 2024-06-25 Active

This pack effectively ties for the lowest per-ea cost of the 3 priced pack sizes ($1.76 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 78% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 00536-5896-88?
NDC 00536-5896-88 contains 14 pouches — 14 pouch in 1 carton / 1 h in 1 pouch.
What is the difference between NDC 00536-5896-88 and NDC 00536-5896-53?
Both are Nicotine 21 mg/24h Patch — the drug itself is identical. NDC 00536-5896-88 is the 14 pouches package, while NDC 00536-5896-53 is the 7 pouches package.
What NDC number is used to bill for this package of Nicotine 21 mg/24h Patch?
Bill NDC 00536-5896-88 — the 11-digit billing format is 00536589688. 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.

📄 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 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 before using this product, read the enclosed self-help guide for complete directions and other information begin using the patch on your quit day If you smoke more than 10 cigarettes per day , use the following schedule below: Weeks 1 thru 4 Weeks 5 and 6 Weeks 7 and 8 Step 1 Step 2 Step 3 use one 21 mg patch/day use one 14 mg patch/day use one 7 mg patch/day if you smoke 10 or less cigarettes per day, start with Step 2 for 6 weeks, then Step 3 for 2 weeks apply one new patch every 24 hours on skin that is dry, clean, and hairless remove backing from patch and immediately press onto skin.

Hold for 10 seconds. wash hands after applying or removing patch. Save pouch to use for patch disposal. Dispose of the used patches by folding sticky ends together and putting in pouch. the used patch should be removed and a new one applied to a different skin site at the same time each day if you have vivid dreams, you may remove the patch at bedtime and apply a new one in the morning do not wear more than one patch at a time do not cut patch in half or into smaller pieces do not leave patch on for more than 24 hours because it may irritate your skin and loses strength after 24 hours it is important to complete treatment.

If you feel you need to use the patch for a longer period to keep from smoking, talk to your health care provider.

⚠️ Warnings ~1 min read

Warnings If you are pregnant or breast feeding, only use this medicine on the advice of your health care provider. Smoking can seriously harm your child. Try to stop smoking without using any nicotine replacement medicine.

This medicine is believed to be safer than smoking. However, the risks to your child from this medicine are not fully known. Ask a doctor before use if you have heart disease, recent heart attack, or irregular heartbeat.

Nicotine can increase your heart rate. high blood pressure not controlled with medication. Nicotine can increase your blood pressure. an allergy to adhesive tape or have skin problems, because you are more likely to get rashes. stomach ulcer or diabetes history of seizures Ask a doctor or pharmacist before use if you are using a non-nicotine stop smoking drug taking a prescription medicine for depression or asthma. Your prescription dose may need to be adjusted.

When using this product if you have vivid dreams or other sleep disturbances, remove the patch at bedtime Stop use and ask a doctor if skin redness caused by the patch does not go away after four days, or if your skin swells, or you get a rash irregular heartbeat or palpitations occur you get symptoms of nicotine overdose, such as nausea, vomiting, dizziness, 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 Used patches have enough nicotine to poison children and pets.

If swallowed, get medical help or contact a Poison Control Center 1-800-222-1222 right away. Save pouch to use for patch disposal. Dispose of the used patches by folding sticky ends together and putting in pouch.

🧪 Active Ingredient 36 words

Active ingredient (in each patch) Nicotine, 21 mg delivered over 24 hours

Active ingredient (in each patch) Nicotine, 14 mg delivered over 24 hours

Active ingredient (in each patch) Nicotine, 7 mg delivered over 24 hours

🧪 Inactive Ingredients 7 words

Inactive ingredients acrylate adhesive, polyester, silicone adhesive

🎯 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 ↗
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.