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Nicotine Patches 14 mg/14mg Patch — NDC 85333-0004-02 package photo

Nicotine Patches 14 mg/14mg Patch

by Zhejiang FTA Shengzuozhi Biotechnology Co., LTD · 14 PATCH in 1 BOX (85333-004-02) / 14 mg in 1 PATCH
NDC 85333-0004-02
🏷️ FDA NDC (as labeled) 85333-004-02 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 →

🆔 Identity & classification

FDA NDC (as labeled) 85333-004-02
Product NDC 85333-004
11-digit billing NDC 85333000402
RxCUI 198029
UNII 6M3C89ZY6R
Application # M016
SPL Set ID 4d4427b0-25c3-ddf6-e063-6394a90a6153
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 2026-03-18
Route TRANSDERMAL
Dosage form PATCH
Substance NICOTINE
Why two NDCs? The FDA registers this code as 85333-004-02 — 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 → 85333-0004-02. 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.

🏭 Manufacturer & labeler

LabelerZhejiang FTA Shengzuozhi Biotechnology Co., LTD
FDA applicationM016 (OTC MONOGRAPH DRUG)
Labeler code85333
First marketedMar 2026
Product typeHuman Otc Drug
Portfolio5 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
  • 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.

💊 What it looks like

Color green
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 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.

From the label’s inactive-ingredient sectionacrylate adhesive, polyester backing film

This is label-wide narrative text, not a normalized exact-product ingredient list. A label can cover multiple strengths or packages.

Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

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

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer 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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Nicotine 14 mg/24h 70677-0031-01 Strategic 14 pouches $1.765 — Discontinued —
Nicotine transdermal system step 2 14 mg/24h 00536-1107-88 Rugby 14 patches $1.855 — Availability likely —
Nicotine 14 mg/24h 00536-5895-53 Rugby 7 pouches $1.855 — Availability likely —
Nicotine transdermal system step 2 14 mg/24h 43598-0447-70 Dr. 7 patches $1.855 — Discontinued —
Nicotine Transdermal System 14 mg/24h 46122-0352-74 AmerisourceBergen 14 pouches $1.855 — Availability likely —
Nicotine Transdermal System 14 mg/24h 50742-0669-07 Ingenus 7 pouches $1.855 — Availability likely —
Nicotine Transdermal System 14 mg/24h 68001-0433-88 BluePoint 7 pouches $1.855 — Availability likely —
Nicotine Transdermal System Patch Step 2 14 mg/24h 68001-0698-88 BluePoint 7 patches $1.855 — Availability likely —
Nicotine Transdermal System 14 mg/24h 70000-0511-01 Cardinal 7 pouches $1.855 — Availability likely —
Nicotine Transdermal System step 2 14 mg/24h 70000-0761-01 CARDINAL 7 patches $1.855 — Availability likely —
foster and thrive STEP 2 14 mg/24h 70677-1181-01 Strategic 14 pouches $1.855 — Availability likely —
Nicotine transdermal system step 2 14 mg/24h 70677-1265-01 Strategic 14 patches $1.855 — Availability likely —
Nicotine Transdermal System 14 mg/24h 76282-0782-40 EXELAN 14 pouches $1.855 — Availability likely —
Nicoderm Cq 14 mg/24h 00135-0195-02 Haleon 14 patches — — FDA listed —
Nicotine transdermal system step 2 14 mg/24h 00363-0457-74 Walgreens 14 patches — — FDA listed —
Nicotine Transdermal System 14 mg/24h 00363-1244-01 Walgreens 14 pouches — — FDA listed —
Nicotine Transdermal System 14 mg/24h 03215-0121-14 Aveva 14 patches — — FDA listed —
Nicotine Transdermal System 14 mg/24h 03215-1202-07 Aveva 7 pouches — — FDA listed —
Nicotine transdermal system 14 mg/24h 11673-0195-02 Target 14 patches — — FDA listed —
Nicotine transdermal system step 2 14 mg/24h 11822-4974-00 Rite 14 patches — — FDA listed —
Nicotine Transdermal System 14 mg/24h 36800-0034-14 Topco 14 pouches — — FDA listed —
Nicotine Transdermal System 14 mg/24h 37808-0460-01 H-E-B 14 pouches — — FDA listed —
Nicotine transdermal system 14 mg/24h 49035-0195-02 Wal-Mart 14 patches — — FDA listed —
Nicotine 14 mg/24h 50090-1148-00 A-S 14 pouches — — FDA listed —
Medline 14 mg 53329-0191-89 Medline 14 patches — — FDA listed —
Habitrol Step 2 14 mg/24h 55741-0447-70 Dr. 7 patches — — FDA listed —
Nicotine transdermal system step 2 14 mg/24h 59450-0002-74 The 14 patches — — FDA listed —
Nicotine transdermal system step 2 14 mg/24h 59779-0445-70 CVS 7 patches — — Discontinued —
Nicotine transdermal system step 2 14 mg/24h 60429-0444-14 Golden 14 patches — — FDA listed —
Nicotine transdermal system step 2 14 mg/24h 63868-0734-14 Chain 14 patches — — FDA listed —
Nicotine 14 mg/24h 79481-0053-01 Meijer, 14 pouches — — FDA listed —
Sielkin QUIT SMOKING NICOTINE PATCHES 14mg 14 mg/g 83364-0016-01 YITONGBADA 30 patches — — FDA listed —
Nicotine Transdermal System 14 mg/24h 84720-0121-14 Quitine 14 patches — — FDA listed —
Nicotine Stop Smoking Aid 14 mg 84735-0013-01 Hengyang 30 patches — — Discontinued —
Rstrvbr QUIT SMOKING 14 mg/1001 85248-0131-01 Jiangxi 30 patches — — FDA listed —
Nicotine Patches 14 mg/14mgthis 85333-0004-02 Zhejiang 14 patches — — FDA listed —
WOFANLI Quit Smoking Nicotine Patches 14 mg/1001 85835-0005-01 Shenzhen 30 patches — — FDA listed —
WOFANLI Quit Smoking Nicotine Patches 14 mg/1001 85835-0008-01 Shenzhen 15 patches — — FDA listed —
NicDuic Quit Smoking Nicotine Patches 2 Step 14 mg/1001 85835-0011-01 Shenzhen 30 patches — — FDA listed —
NicDuic Quit Smoking Nicotine Patches 1-3 Step 14 mg/1001 85835-0014-01 Shenzhen 15 patches — — FDA listed —
Nicotine Stop Smoking AID 14 mg 87278-0007-01 Guangxi 60 patches — — FDA listed —
Nicotine Patch 14 mg 87704-0003-01 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
🔒
·
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.

🔬 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 Patches — the ingredient across all brands.

Top reported reactions

Chest Pain3
Headache3
Insomnia3
Nausea3
Anaemia2
Asthenia2
Chromaturia2

Age at onset

Adult1

Reporter sex

37 reports
Male · 50%
Female · 50%

Serious outcomes

Hospitalization12
Life-threatening2
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 3 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
85333-0004-02 You're viewing this 14 PATCH in 1 BOX (85333-004-02) / 14 mg in 1 PATCH 2026-03-18 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 85333-004-02, 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: 85333-0004-02, written without dashes as 85333000402. 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 85333-0004-02, the first segment (85333) is the labeler code FDA assigned to Zhejiang FTA Shengzuozhi Biotechnology Co., LTD; the middle segment (0004) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) 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 Zhejiang FTA Shengzuozhi Biotechnology Co., LTD. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Zhejiang FTA Shengzuozhi Biotechnology 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 12 words ▾

Uses helps reduce withdrawal symptoms including nicotine craving associated with quitting smoking

⏱️ Dosage and Administration 10 words ▾

Directions Apply one patch to clean, dry skin once daily.

⚠️ Warnings 13 words ▾

Warnings Do not smoke or use other nicotine products while using this product.

🧪 Inactive Ingredients 5 words ▾

acrylate adhesive, polyester backing film

🎯 Purpose 4 words ▾

Purpose Stop smoking aid

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