Home › NDC Lookup › Ingredients › Nicotine › 68196-0194-03
Nicotine transdermal system 21 mg/24h Patch, Extended Release — NDC 68196-0194-03 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Nicotine transdermal system 21 mg/24h Patch, Extended Release — NDC 68196-194-03 (Billing 68196-0194-03)

by Sam's West Inc · 21 PATCH in 1 CARTON / 24 h in 1 PATCH

This is a package of Nicotine transdermal system 21 mg/24h Patch, Extended Release from Sam's West Inc, no longer marketed (first marketed Mar 2012), no longer in the FDA NDC Directory. It is this product's only package size.

NDC 68196-0194-03
🏷️ FDA NDC (as labeled) 68196-194-03 billing pads the product segment with a zero
OTC Brand Discontinued Non-controlled ⚠ Discontinued by firm ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

NDC database record

One package, one record: these facts belong to NDC 68196-194-03 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
68196 labeler · 194 product · 03 package
Listing certified through
Dec 31, 2026
Barcode (UPC-A, from the NDC)
3 6819619403 4
FDA record last changed
Jul 24, 2026
⚠️
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 ↗
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 68196-194-03
Product NDC 68196-194
11-digit billing NDC 68196019403
RxCUI 198030
UNII 6M3C89ZY6R
Application # NDA020165
SPL Set ID cd9aa56c-ac88-4f9b-9ff9-a9720af6c1a7
Established class (EPC) Cholinergic Nicotinic Agonist
Chemical class Nicotine
DEA schedule Non-controlled
Marketing category NDA
Marketing status Discontinued
FDA listing status Discontinued by firm
Marketing start 2012-03-02
Route TRANSDERMAL
Dosage form PATCH, EXTENDED RELEASE
Substance NICOTINE
Quick answers
  • RxCUI (RxNorm): 198030
Why two NDCs? The FDA registers this code as 68196-194-03 — 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 → 68196-0194-03. 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 →
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.
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
68196-0194-03 You're viewing this Main listing 21 PATCH in 1 CARTON / 24 h in 1 PATCH 2012-03-02 — Discontinued by firm

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Nicotine 21 mg/24h 70677-0032-01 Strategic 14 pouches $1.533 — FDA listed —
Nicotine transdermal system step 1 21 mg/24h 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/24hthis 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

🏛️
2012
On the market since
Mar 2012
📍
2026
Currently FDA-listed
14 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.

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.

🧪 Avoiding an ingredient? See Nicotine inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

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

  • UNII L5F16ZG4ZU
    A plastic-like polymer made by combining ethylene and vinyl acetate. It's used as a binder to hold tablet ingredients together and may also serve as a coating or sustained-release agent to control how quickly the medicine dissolves.
  • UNII UG00KM4WR7
    A plastic polymer used as a container material and film coating. It helps protect the medicine from moisture and air exposure during storage and shipping.

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

The official label also statesethylene vinyl acetate-copolymer, polyisobutylene and high density polyethylene between clear polyester backings

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

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

Inactive ingredient FAQ

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

Manufacturer & labeler

LabelerSam's West Inc
Application holderCHATTEM INC DBA SANOFI CONSUMER HEALTHCARE
FDA applicationNDA020165 (NDA)
Labeler code68196
First marketedMar 2012
Product typeHuman Otc Drug
Portfolio58 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

FDA label — Drug Facts FDA SPL

The complete FDA label for this product — the official Drug Facts labeling, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage 11 words ▾

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

⏱️ Dosage and Administration ~2 min read ▾

Directions • if you are under 18 years of age, ask a doctor before use • before using this product, read the enclosed User’s Guide for complete directions and other information • stop smoking completely when you begin using the patch • if you smoke more than 10 cigarettes per day, use according to the following 10 week schedule: 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 1-6 Weeks 7-8 Weeks 9-10 • if you smoke 10 or less cigarettes per day, do not use STEP 1 (21mg).

Start with STEP 2 (14mg) , for 6 weeks, then STEP 3 (7mg) for 2 weeks and then stop. • steps 2 and 3 allow you to gradually reduce your level of nicotine. Completing the full program will increase your chances of quitting successfully. • apply one new patch every 24 hours on skin that is dry, clean and hairless. Save pouch for disposing of the patch after use. • remove backing from patch and immediately press onto skin.

Hold for 10 seconds. • wash hands after applying or removing patch. Throw away the patch by folding sticky ends together. Replace in its pouch and discard.

See enclosed User’s Guide for safety and handling. • you may wear the patch for 16 or 24 hours • if you crave cigarettes when you wake up, wear the patch for 24 hours • if you have vivid dreams or other sleep disturbances, you may remove the patch at bedtime and apply a new one in the morning • the used patch should be removed and a new one applied to a different skin site at the same time each day • 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 • stop using the patch at the end of 10 weeks.

If you started with STEP 2 , stop using the patch at the end of 8 weeks. If you still feel the need to use the patch, talk to your doctor.

⚠️ 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. Do Not Use • if you continue to smoke, chew tobacco, use snuff, or use a nicotine gum or other nicotine containing products 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. 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 • do not smoke even when not wearing the patch. The nicotine in your skin will still be entering your blood stream for several hours after you take off the patch. • 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 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. Dispose of the used patches by folding sticky ends together.

Replace in pouch and discard.

🧪 Active Ingredient 12 words ▾

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

🧪 Inactive Ingredients 14 words ▾

Inactive ingredients ethylene vinyl acetate-copolymer, polyisobutylene and high density polyethylene between clear polyester backings

🎯 Purpose 4 words ▾

Purpose Stop smoking aid

📄 Do Not Use 23 words ▾

Do Not Use • if you continue to smoke, chew tobacco, use snuff, or use a nicotine gum or other nicotine containing products

📄 Ask a Doctor Before Use If 55 words ▾

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.

📄 Ask a Doctor or Pharmacist Before Use If 84 words ▾

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 • do not smoke even when not wearing the patch.

The nicotine in your skin will still be entering your blood stream for several hours after you take off the patch. • if you have vivid dreams or other sleep disturbances remove this patch at bedtime

📄 When Using This Product 50 words ▾

When using this product • do not smoke even when not wearing the patch. The nicotine in your skin will still be entering your blood stream for several hours after you take off the patch. • if you have vivid dreams or other sleep disturbances remove this patch at bedtime

📄 Stop Use and Ask a Doctor If 53 words ▾

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

🤰 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 46 words ▾

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. Dispose of the used patches by folding sticky ends together. Replace in pouch and discard.

📄 Questions or Comments ~2 min read ▾

Questions or comments? call toll-free 1-866-255-5205 (English/Spanish) weekdays TO INCREASE YOUR SUCCESS IN QUITTING: • You must be motivated to quit. • Complete the full treatment program, applying a new patch every day. • Use with a support program as described in the enclosed User’s Guide. For your family’s protection, Nicotine Patches are supplied in child-resistant pouches. Do not use if individual pouch/packet is damaged or open.

Nicotine transdermal system 21 mg delivered over 24 hours Stop smoking aid • Not for sale to those under 18 years of age. • Prrof of age required. • Not for sale in vending machines or from any source where proof of age cannot be verified. Free Audio CD upon request. See inside.

What is the Nicotine Patch and How is it Used? Nicotine Patch is a small, nicotine-containing patch. When you put on a Nicotine Patch, nicotine passes through the skin and into your body.

Nicotine Patch is very thin and uses special material to control how fast nicotine passes through the skin. Unlike the sudden jolts of nicotine delivered by cigarettes, the amount of nicotine you receive remains relatively smooth throughout the 24 or 16-hour period you wear the Nicotine Patch. This helps to reduce cravings you may have for nicotine.

Read carton and enclosed User’s Guide before using this product. Keep the carton and User’s Guide. They contain important information.

THE SIMPLY RIGHT™ PROMISE Simply Right is dedicated to providing healthful, gentle, and safe personal care products for the entire family. We continuously strive to be your trusted partner in wellness and exceed your expectations. We would like to hear from you with any comments or suggestions.

In the continental US or Canada, you can call us toll-free at 1-800-255-5205, Monday through Friday, from 8 am to 5 pm CST. Or you can send us an email at samsclub.com. Distributed by: SAM’S West, Inc.

Bentonville, AR 72716 *NICODERM is a licensed trademark of the GlaxoSmithKline group of companies. SATISFACTION GUARANTEED BY REFUND OR EXCHANGE Made in Switzerland Send comments/questions to: GCSP 5.4376.4C Consumer Relations P.O. Box 13398 Research Triangle Park, NC 27709-9627

📄 Package Label / Principal Display Panel 83 words ▾

Principal Display Panel NDC 68196-194-03 nicotine patch Nicotine Transdermal System 21mg delivered over 24 hours Stop smoking aid 21 mg SIMPLY RIGHT ™ Health Care Compare to NicoDerm ® CQ ® * Includes behavior support program enrollment form & user’s guide If you smoke more than 10 cigarettes per day: start with step 1 If you smoke 10 or less cigarettes per day: start with step 2 step 1 21 clear patches ©2011 101775XA 101775XA Nicotine Patch Sams 21 mg 21 ct carton

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

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 transdermal system (this brand).

Top reported reactions

Nausea1,095
Product Adhesion Issue924
Overdose778
Headache773
Foetal Exposure During Pregnancy750
Nicotine Dependence748
Treatment Noncompliance682

Age at onset

Neonate190
Infant20
Child12
Adolescent24
Adult1,404
Elderly559

Reporter sex

16,316 reports
Male · 43%
Female · 57%
Unknown · 0%

Serious outcomes

Hospitalization4,730
Death1,606
Life-threatening623
Disabling323
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,213 458
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.

About this NDC listing & data coverage

Over-the-counter (OTC) product No longer marketed (per FDA listing data)
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.
What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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.
Who lists this product with the FDA?
Sam's West Inc 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.
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.