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Nicotine Stop Smoking AID 21 mg Patch, 60 patches — NDC 87278-0009-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Nicotine Stop Smoking AID 21 mg Patch, 60 patches — NDC 87278-009-01 (Billing 87278-0009-01)

by Guangxi Keyun E-commerce Co., Ltd. · 60 PATCH in 1 BOX / 1 PATCH in 1 PATCH

This is a package of 60 patches of Nicotine Stop Smoking AID 21 mg Patch from Guangxi Keyun E-commerce Co., Ltd., marketed since Mar 2026 and currently FDA-listed. It is this product's only package size.

NDC 87278-0009-01
🏷️ FDA NDC (as labeled) 87278-009-01 billing pads the product segment with a zero
OTC On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 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 →

This page is curated, coded, and maintained by

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

NDC database record

One package, one record: these facts belong to NDC 87278-009-01 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
87278 labeler · 009 product · 01 package
Package marketed since
Mar 20, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 8727800901 1
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 ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 87278-009-01
Product NDC 87278-009
11-digit billing NDC 87278000901
RxCUI 198030
UNII 6M3C89ZY6R
Application # 505G(a)(3)
SPL Set ID 4d724a5a-425e-e441-e063-6294a90a761e
Established class (EPC) Cholinergic Nicotinic Agonist
Chemical class Nicotine
DEA schedule Non-controlled
Marketing category OTC MONOGRAPH DRUG
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-03-20
Route TRANSDERMAL
Dosage form PATCH
Substance NICOTINE
Quick answers
  • RxCUI (RxNorm): 198030
Why two NDCs? The FDA registers this code as 87278-009-01 — 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 → 87278-0009-01. 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

📖 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.

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
87278-0009-01 You're viewing this Main listing 60 PATCH in 1 BOX / 1 PATCH in 1 PATCH 2026-03-20 — Active

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 mgthis 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 —
About this product: other versions of the same ingredient, strength and form are listed above, least expensive first, with FDA equivalence ratings where 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

🏛️
2026
On the market since
Mar 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
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.

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

  • UNII 25GT92NY0C
    A synthetic polymer made from acrylic compounds. It's used in tablet coatings and film formulations to help protect the medicine and control how quickly it dissolves in the body.
  • 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.
  • UNII SMD1X3XO9M
    Powdered cellulose is a fine, plant-based powder made from purified wood fibers. In medicines, it acts as a filler to add bulk and volume, and helps tablets or capsules hold together during manufacturing and storage.

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

The official label also states2-Hydroxyethyl Acrylate Powdered Cellulose Methacrylic Acid

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

LabelerGuangxi Keyun E-commerce Co., Ltd.
FDA application505G(a)(3) (OTC MONOGRAPH DRUG)
Labeler code87278
First marketedMar 2026
Product typeHuman Otc Drug
Portfolio20 products on file

More NDCs from Guangxi Keyun E-commerce Co., Ltd. labeler code 87278

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 ⏱️ Dosage and Administration ⚠️ Warnings 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 6 words ▾

Helps reducewithdrawal symptoms,such as nicotine cravings,duringsmokingcessation.

⏱️ Dosage and Administration 30 words ▾

Apply one patch to a clean,dry,and hairless area of skin (e.g.,upper arm or torso) Replace thepatchevery24hourswithanewone. Rotate application sites to avoid skin irritation. Step1+(28mg)-For smokers of 10+ cigarettes/day. Applyonupperarm/hip;avoidbrokenskin. Replaceafter24hours.

⚠️ Warnings 7 words ▾

For external use only,flammable,keep awayfromheat or flame

🧪 Active Ingredient 1 words ▾

NICOTINE(21mg)

🧪 Inactive Ingredients 6 words ▾

2-Hydroxyethyl Acrylate Powdered Cellulose Methacrylic Acid

🎯 Purpose 3 words ▾

Stop Smoking Aid

📄 Do Not Use 10 words ▾

Not for non-smokers.

Keep away from children/pets.·Consult doctor if pregnant/nursing.

📄 When Using This Product 14 words ▾

When using section. Avoid smoking or using other nicotine-containing products to prevent nicotine overdose

📄 Stop Use and Ask a Doctor If 18 words ▾

OTC- Stop Use Section.lf you experience severe skin irritation, rregular heartbeat, or: symptoms of nicotine overdose(e.g.,dizziness, nausea, vomiting)

📄 Keep Out of Reach of Children 7 words ▾

Keep away from children/pets..Consult doctor if pregnant/nursing

📄 Package Label / Principal Display Panel 1 words ▾

label

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.

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

Is this NDC FDA-approved?
An NDC listing does not by itself establish FDA approval — the NDC Directory records that a product is listed with FDA, not that it was reviewed and approved. This listing's marketing category is "Otc Monograph Drug". Products approved under an application carry an NDA, ANDA, or BLA number.
Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Guangxi Keyun E-commerce Co., Ltd.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Guangxi Keyun E-commerce Co., Ltd. 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.
← 87278-0008-01 · Guangxi 87278-0010-01 · Guangxi →
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.