SEFUDUN QUIT SMOKING NICOTINE PATCHES 21 mg Patch, 30 patches
by Shenzhen Shandian Jingling Technology Co., Ltd. · 30 PATCH in 1 BOX (83804-001-01)
NDC 83804-0001-01
🏷️ FDA NDC (as labeled)
83804-001-01
billing pads the product segment with a zero
OTC
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 →
⚠️
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)
83804-001-01
Product NDC
83804-001
11-digit billing NDC
83804000101
RxCUI
198030
UNII
6M3C89ZY6R
Application #
505G(a)(3)
SPL Set ID
314e6f25-8fd0-38ba-e063-6294a90aca8b
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
2025-03-27
Route
TRANSDERMAL
Dosage form
PATCH
Substance
NICOTINE
Why two NDCs?
The FDA registers this code as 83804-001-01 — 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 → 83804-0001-01. 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.
🏭 Manufacturer & labeler
LabelerShenzhen Shandian Jingling Technology Co., Ltd.
FDA application505G(a)(3) (OTC MONOGRAPH DRUG)
Labeler code83804
First marketedMar 2025
Product typeHuman Otc Drug
Portfolio18 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.
🩺 Clinical
📖 What it is MedlinePlus · NLM
Nicotine 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
- 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....
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Nicotine — tap one for details:
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.
💬 Questions about nicotine?
Ask a pharmacist →
Ask a licensed pharmacist directly — free, answered by our team.
🧪 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 J94PBK7X8S
A synthetic polymer derived from acrylic acid monomers. In medicines, it's used as a binder to hold tablet ingredients together and sometimes as a coating agent to control where and how the drug releases in the body.
-
UNII 74G4R6TH13
A synthetic polymer made by combining two plastic-like chemicals. It forms a coating on tablets or capsules that dissolves at a specific point in the digestive tract, controlling where and when the medicine releases.
-
UNII 2L9351NW8W
A synthetic polymer used as a film-forming agent and binder in medications. It helps create a protective coating around tablets or capsules and improves how the medicine holds together during manufacturing and storage.
3 inactive ingredients listed in the exact product block matched to this NDC.
The official label also statesmethacrylic acid copolymer POLYESTER-5 (TG-38) ACRYLIC 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.
💲 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 system | Per each | Per 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.
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price 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 | $1.756 | — | Availability likely | — |
| Nicotine 21 mg/24h 00536-5896-53 | Rugby | 7 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 | — |
| 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 Transdermal System step 1 21 mg/24h 70000-0762-01 | CARDINAL | 7 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 mgthis 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 | — |
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
🏛️
2025
On the market since
Mar 2025
📍
2026
Currently FDA-listed
1 year 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.
📊 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 SEFUDUN QUIT SMOKING NICOTINE PATCHES (this brand).
Top reported reactions
Age at onset
Reporter sex
Male · 43%
Female · 56%
Unknown · 1%
Serious outcomes
Reports over time (by year) — tap or hover for the count & year
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 NDC | Description | Marketing start | Status |
|---|---|---|---|
| 83804-0001-01 You're viewing this | 30 PATCH in 1 BOX (83804-001-01) | 2025-03-27 | Active |
🧭 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 FDA registers it as 83804-001-01, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 83804-0001-01, written without dashes as 83804000101. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 83804-0001-01, the first segment (83804) is the labeler code FDA assigned to Shenzhen Shandian Jingling Technology Co., Ltd.; the middle segment (0001) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (01) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Shenzhen Shandian Jingling Technology Co., Ltd.. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Shenzhen Shandian Jingling Technology 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.
📄 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 ▾
Use reduces withdrawal symptoms, ineluding nicotine cravingassocated with qultting sroking
⏱️ Dosage and Administration ▾
1. Clean your arms thoroughly 2. Take out the patch and stick it on your arm 3. Valid for up to 24 hours
⚠️ Warnings ▾
For external use only
🧪 Active Ingredient ▾
nicotine
🧪 Inactive Ingredients ▾
methacrylic acid copolymer POLYESTER-5 (TG-38) ACRYLIC ACID
🎯 Purpose ▾
nicotine patch
No label section mentions that — try another word, or open the full label on DailyMed below.
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.