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Nicotine transdermal system step 1 21 mg/24h Patch, Extended Release — NDC 00536-1108-88 package photo

Nicotine transdermal system step 1 21 mg/24h Patch, Extended Release

by Rugby Laboratories · 14 PATCH in 1 CARTON (0536-1108-88) / 24 h in 1 PATCH
NDC 00536-1108-88
🏷️ FDA NDC (as labeled) 0536-1108-88 billing pads the labeler segment with a zero
This package
Contains24 h in 1 patch Cost per ea$1.87 NADAC Per package$26.22 / 14 patch Pack sizes3 compare ↓
Also priced by: Medicaid pays $1.71/unit — full pricing hub ↓
Also comes in: 7 patches 00536-1108-52 28 patches 00536-1108-71
OTC Brand On market Non-controlled
🗂️ Data synced Sep 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

⚠️
Other active recalls for Nicotine (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
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
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 0536-1108-88
Product NDC 0536-1108
11-digit billing NDC 00536110888
NCPDP billing unit EA — each (per item)
Application # NDA020076
SPL Set ID ae406389-0f83-d5c8-bd2f-56075e57453a
Established class (EPC) Cholinergic Nicotinic Agonist
Chemical class Nicotine
DEA schedule Non-controlled
Marketing category NDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2016-04-01
Route TRANSDERMAL
Dosage form PATCH, EXTENDED RELEASE
Substance 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 0536-1108-88 — 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 → 00536-1108-88. 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.

🏭 Manufacturer & labeler

LabelerRugby Laboratories
Application holderDR REDDYS LABORATORIES SA
FDA applicationNDA020076 (NDA)
Labeler code00536
First marketedApr 2016
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
📖 What it is MedlinePlus · NLM

Nicotine skin patches are used to help people stop smoking cigarettes. They provide a source of nicotine that reduces the withdrawal symptoms experienced when smoking is stopped.

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

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 1CS02G8656
    Methacrylic acid is a synthetic polymer used as a coating material and binder in tablets and capsules. It helps control how and where the medication releases in the digestive system.

1 inactive ingredient listed in the exact product block matched to this NDC.

The official label also statesAcrylate adhesive, aluminized polyester, cellulose paper, methacrylic acid copolymer

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 eaPer package
Retail pharmacies payNADAC · weekly $1.873 $26.22 / 14 patch
Medicaid paysCMS SDUD · 12 mo $1.71 $23.96 / 14 patch
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per ea) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $1.873 $1.517
▲ Up 8% 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 18%
Nicotine transdermal system step 1 21 mg/24hthis 00536-1108-88 Rugby 14 patches $1.873 — Availability likely —
Nicotine 21 mg/24h 00536-5896-53 Rugby 7 pouches $1.873 — Availability likely —
Nicotine transdermal system step 1 21 mg/24h 43598-0448-28 Dr. 28 patches $1.873 — Discontinued —
Nicotine Transdermal System 21 mg/24h 46122-0353-74 AmerisourceBergen 14 pouches $1.873 — Availability likely —
Nicotine Transdermal System 21 mg/24h 46122-0568-03 AmerisourceBergen 28 pouches $1.873 — Availability likely —
Nicotine Transdermal System 21 mg/24h 50742-0670-07 Ingenus 7 pouches $1.873 — Availability likely —
Nicotine Transdermal System 21 mg/24h 68001-0434-88 BluePoint 7 pouches $1.873 — Availability likely —
Nicotine Transdermal System Patch Step 1 21 mg/24h 68001-0699-88 BluePoint 7 patches $1.873 — Availability likely —
Nicotine Transdermal System 21 mg/24h 70000-0512-01 Cardinal 7 pouches $1.873 — Availability likely —
Nicotine Transdermal System step 1 21 mg/24h 70000-0762-01 CARDINAL 7 patches $1.873 — Availability likely —
foster and thrive STEP 1 21 mg/24h 70677-1182-01 Strategic 14 pouches $1.873 — Availability likely —
Nicotine transdermal system step 1 21 mg/24h 70677-1266-01 Strategic 14 patches $1.873 — Availability likely —
Nicotine Transdermal System 21 mg/24h 76282-0783-40 EXELAN 14 pouches $1.873 — 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 the brand-name version. FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2016
On the market since
Apr 2016
📍
2026
Currently FDA-listed
10 years listed
🔓
·
Generic versions listed
see equivalents
✅Generic appears available

FDA-approved generic versions are listed, and recent pricing/market data suggests they may be available — see Therapeutic equivalents.

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 00536-1108-88, 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
14.2K
Units reimbursed last 4 qtrs
355.4K
Gross reimbursed last 4 qtrs
$608.2K
Avg / prescription
$42.75
Avg / unit
$1.7113
Latest quarter Q4 2025
3.5KRx
Medicaid pays / ea
$1.7113
gross reimbursed
vs
NADAC / ea
$1.8725
acquisition cost
=
Spread
−$0.1612
-9% 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 ⓘ
53% FFS 47% MCO
Fee-for-service · 7,496 Rx Managed care · 6,730 Rx
State Medicaid map
Alaska: no data reported AK Maine: 14,764 units · 1,058 per 100k residents ME Washington: 3,247 units · 41.6 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: 280 units · 35.8 per 100k residents ND Minnesota: 5,768 units · 101 per 100k residents MN Wisconsin: 11,186 units · 189 per 100k residents WI Michigan: 24,824 units · 247 per 100k residents MI New York: 59,928 units · 306 per 100k residents NY Vermont: 986 units · 152 per 100k residents VT New Hampshire: 1,950 units · 139 per 100k residents NH Oregon: 3,744 units · 88.4 per 100k residents OR Nevada: 3,083 units · 96.5 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 1,435 units · 44.7 per 100k residents IA Illinois: 5,259 units · 41.9 per 100k residents IL Indiana: 10,553 units · 154 per 100k residents IN Ohio: 15,830 units · 134 per 100k residents OH Pennsylvania: 24,098 units · 186 per 100k residents PA New Jersey: 13,801 units · 149 per 100k residents NJ Massachusetts: 5,949 units · 85.0 per 100k residents MA California: 47,574 units · 122 per 100k residents CA Utah: 2,984 units · 87.3 per 100k residents UT Colorado: 4,156 units · 70.7 per 100k residents CO Nebraska: 280 units · 14.2 per 100k residents NE Missouri: 6,434 units · 104 per 100k residents MO Kentucky: 17,722 units · 392 per 100k residents KY West Virginia: 5,049 units · 285 per 100k residents WV Virginia: 11,186 units · 128 per 100k residents VA Maryland: 14,733 units · 238 per 100k residents MD Connecticut: 2,257 units · 62.4 per 100k residents CT Rhode Island: 280 units · 25.6 per 100k residents RI Arizona: 8,637 units · 116 per 100k residents AZ New Mexico: 1,516 units · 71.7 per 100k residents NM Kansas: 1,040 units · 35.4 per 100k residents KS Arkansas: 602 units · 19.6 per 100k residents AR Tennessee: 4,635 units · 65.0 per 100k residents TN North Carolina: 5,194 units · 47.9 per 100k residents NC South Carolina: no data reported SC Delaware: 797 units · 77.3 per 100k residents DE Oklahoma: no data reported OK Louisiana: 5,100 units · 111 per 100k residents LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: 1,218 units · 11.0 per 100k residents GA D.C.: 7,308 units · 1,076 per 100k residents DC Hawaii: no data reported HI Texas: no data reported TX Florida: no data reported FL
Units reimbursed · per 100k residents
11.01,076
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 D.C. 1,076 /100k
2 Maine 1,058 /100k
3 Kentucky 392 /100k
4 New York 306 /100k
5 West Virginia 285 /100k
6 Michigan 247 /100k
7 Maryland 238 /100k
8 Wisconsin 189 /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 patches this page00536-1108-88 14,226 Rx · $608,157
7 patches00536-1108-52 No Medicaid data
28 patches00536-1108-71 No Medicaid data
Drug total (last 4 qtrs): 14,226 Rx · 355,387 units · $608,157 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%
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 3,613 905
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
00536-1108-88 You're viewing this 14 PATCH in 1 CARTON (0536-1108-88) / 24 h in 1 PATCH $1.87 / ea $26.22 2016-04-01 Active
00536-1108-52 7 PATCH in 1 CARTON (0536-1108-52) / 24 h in 1 PATCH — — 2026-03-20 Discontinued by firm
00536-1108-71 28 PATCH in 1 CARTON (0536-1108-71) / 24 h in 1 PATCH — — 2026-03-20 Discontinued by firm

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

Pack size FAQ

What quantity is in NDC 00536-1108-88?
NDC 00536-1108-88 is listed by the FDA — 14 patch in 1 carton / 24 h in 1 patch.
What NDC number is used to bill for this package of Nicotine transdermal system step 1 21 mg/24h Patch, Extended Release?
Bill NDC 00536-1108-88 — the 11-digit billing format is 00536110888. 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 ⏱️ 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 • 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: STEP 1 STEP 2 STEP 3 Use one 21 mg patch/day Use one 14 mg patch/day Use one 7 mg patch/day Weeks 1-4 Weeks 5-6 Weeks 7-8 • 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 • to avoid possible burns, remove patch before undergoing any MRI (magnetic resonance imaging) procedures • 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 this 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 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 42 words ▾

Active ingredient Step 1 (in each patch) Nicotine, 21 mg delivered over 24 hours

Active ingredient Step 2 (in each patch) Nicotine, 14 mg delivered over 24 hours

Active ingredient Step 3 (in each patch) Nicotine, 7 mg delivered over 24 hours

🧪 Inactive Ingredients 11 words ▾

Inactive ingredients Acrylate adhesive, aluminized polyester, cellulose paper, methacrylic acid copolymer

🎯 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 ↗
← 00536-1107-88 · Rugby 00536-1112-40 · Rugby →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.