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WOFANLI Quit Smoking Nicotine Patches 3 mg/1001 Patch, 120 patches — NDC 85835-0016-02 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

WOFANLI Quit Smoking Nicotine Patches 3 mg/1001 Patch, 120 patches — NDC 85835-016-02 (Billing 85835-0016-02)

by Shenzhen Paxi Trading Co., Ltd. · 120 PATCH in 1 BOX

This is a package of 120 patches of WOFANLI Quit Smoking Nicotine Patches 3 mg/1001 Patch from Shenzhen Paxi Trading Co., Ltd., marketed since Dec 2025 and currently FDA-listed.

NDC 85835-0016-02
🏷️ FDA NDC (as labeled) 85835-016-02 billing pads the product segment with a zero
This package
Contains120 patches Pack sizes3 compare ↓
Product page 85835-0016-01 Also comes in: 60 patches 85835-016-01 180 patches 85835-016-03
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 85835-016-02 alone.

Record
FDA NDC Directory package listing · Human OTC drug
Code segments
85835 labeler · 016 product · 02 package
Package marketed since
Dec 9, 2025
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 8583501602 1
FDA record last changed
Jul 24, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 85835-016-02
Product NDC 85835-016
11-digit billing NDC 85835001602
RxCUI 2728721
UNII 6M3C89ZY6R
Application # M017
SPL Set ID 4582b4e9-0c24-069d-e063-6394a90a6f4b
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 2025-12-09
Route TOPICAL
Dosage form PATCH
Substance NICOTINE
Quick answers
  • RxCUI (RxNorm): 2728721
Why two NDCs? The FDA registers this code as 85835-016-02 — 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 → 85835-0016-02. 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 →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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.
Try another pack size: 60 patches 180 patches
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
85835-0016-01 85835-016-01 Main listing 60 PATCH in 1 BOX 2025-12-09 — Active
85835-0016-02 You're viewing this 120 PATCH in 1 BOX 2025-12-09 — Active
85835-0016-03 85835-016-03 180 PATCH in 1 BOX 2025-12-09 — Active

You're viewing one of 3 pack sizes for this product.

Pack size FAQ

What quantity is in this package?
This package contains 120 patches — 120 patch in 1 box.
How does this package differ from NDC 85835-0016-01?
Both are WOFANLI Quit Smoking Nicotine Patches 3 mg/1001 Patch — the drug itself is identical. This page's package is the 120 patches one, while NDC 85835-0016-01 is the 60 patches package.
What NDC number is used to bill for this package of WOFANLI Quit Smoking Nicotine Patches 3 mg/1001 Patch?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
WOFANLI Quit Smoking Nicotine Patches 3 mg/1001this 85835-0016-02 Shenzhen 120 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
Dec 2025
📍
2026
Currently FDA-listed
1 year listed
🔒
·
No generic listed yet
brand only
ℹ️No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route.

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 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 0841698D2F
    A synthetic polymer used as a film-coating agent to protect tablets and capsules. It helps control how quickly the medicine dissolves and improves the appearance of the finished product.
  • 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.

4 inactive ingredients 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.

Manufacturer & labeler

LabelerShenzhen Paxi Trading Co., Ltd.
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code85835
First marketedDec 2025
Product typeHuman Otc Drug
Portfolio15 products on file

More NDCs from Shenzhen Paxi Trading Co., Ltd. labeler code 85835

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 📦 Storage and Handling 🧪 Active Ingredient 🧪 Inactive Ingredients 🎯 Purpose 📄 Do Not Use 📄 Ask a Doctor Before Use If 📄 When Using This Product 📄 Stop Use and Ask a Doctor If 📄 Keep Out of Reach of Children 📄 Questions or Comments 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 96 words ▾

Use Apply to dry, clean, hair-free skin. 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.

If vivid dreams occur, remove the patch before bedtime. Do not cut patch in half or into smaller pieces 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.

⏱️ 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, follow the schedule below: Weeks 1 and 4 STEP 1 1 patch every 1 to 2 hours Weeks 5 and 7 STEP 2 1 patch every 2 to 4 hours Weeks 8 and 10 STEP 3 use I/2 patch/day Weeks 9 and 10 STEP 3 1 patch every 4 to 8 hours to increase your chances of quitting, use at least 9 nicotine patches daily during the first week.

If you experience strong or frequent cravings, you may apply a second patch within two hours. However, do not use one patch after another consecutively. if you smoke 10 or less cigarettes per day, start with Step 2 for 6 weeks, then Step 3 for 3 weeks. Apply to dry, clean, hair-free skin.

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. If vivid dreams occur, remove the patch before bedtime.

Do not cut patch in half or into smaller pieces 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 58 words ▾

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.

📦 Storage and Handling 6 words ▾

Other information Store at room temperature

🧪 Active Ingredient 4 words ▾

Active Ingredient Nicotine 3mg

🧪 Inactive Ingredients 10 words ▾

Inactive ingredients acrylate adhesive, aluminized polyester,cellulose paper, methacrylic acid copolymer.

🎯 Purpose 4 words ▾

Purpose Stop smoking aid

📄 Do Not Use 59 words ▾

Do not use Ask a doctor or pharmacist before use: - Contraindicated in heart disease, recent MI, or arrhythmia. Nicotine may increase heart rate. - History of seizures. - Uncontrolled hypertension. Nicotine may elevate blood pressure. - Stomach ulcer or diabetes . - If allergic to adhesive or with pre-existing skin conditions, higher risk of dermal reactions may occur.

📄 Ask a Doctor Before Use If 33 words ▾

Ask Doctor Ask a doctor or pharmacist before use if you: - are using non-nicotine smoking cessation drug . - are taking prescription medications for depression or asthma, your dosage may require adjustment.

📄 When Using This Product 21 words ▾

When Using When using this product - if you experience vivid dreams or other sleep disturbances, remove the patch at bedtime.

📄 Stop Use and Ask a Doctor If 51 words ▾

Stop Use - Patch-induced erythema persists beyond 4 days,localized edema develops, or a cutaneous rash appears. - irregular heartbeat or palpitations occur. - Symptoms of nicotine overdose may include persistent 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 61 words ▾

Keep Out Of Reach Of Children KEEP OUT OF REACH OF CHILDREN AND PETS. Used patches contain enough nicotine to poison children and pets. If swallowed, seek medical help immediately or contact a Poison Control Center 1-800-222-1222 right away. Save the pouch for patch disposal. Dispose of used patches by folding the sticky ends together and placing them in the pouch.

📄 Questions or Comments 12 words ▾

Questions After-sales service contact information: For any product inquiries, contact us: [email protected]

📄 Package Label / Principal Display Panel 5 words ▾

PRINCIPAL DISPLAY PANEL 1 2

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

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 Shenzhen Paxi Trading Co., Ltd.. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 60 patches (85835-0016-01), 180 patches (85835-0016-03). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Shenzhen Paxi Trading 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.
← 85835-0015-01 · Shenzhen 85837-0001-03 · SilkTears →
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.