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AROAMAS COT NICOTINE TRANSDERMAL PATCHES STEP 1 .3 g/1001; 18 g/1001 Patch, 21 patches — NDC 85831-0033-01 package photo

AROAMAS COT NICOTINE TRANSDERMAL PATCHES STEP 1 .3 g/1001; 18 g/1001 Patch, 21 patches

by PCHEERY LLC · 21 PATCH in 1 CARTON (85831-033-01) / 1 PATCH in 1 PATCH
NDC 85831-0033-01
🏷️ FDA NDC (as labeled) 85831-033-01 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 →

This page is curated, coded, and maintained by

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

🆔 Identity & classification

FDA NDC (as labeled) 85831-033-01
Product NDC 85831-033
11-digit billing NDC 85831003301
UNII L7T10EIP3A, 6M3C89ZY6R
UPC 0810027282712
Application # M017
SPL Set ID 457c860b-091d-8350-e063-6294a90a2f98
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 2025-12-30
Route TOPICAL
Dosage form PATCH
Substance MENTHOL; NICOTINE
Why two NDCs? The FDA registers this code as 85831-033-01 — 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 → 85831-0033-01. 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.

🏭 Manufacturer & labeler

LabelerPCHEERY LLC
FDA applicationM017 (OTC MONOGRAPH DRUG)
Labeler code85831
First marketedDec 2025
Product typeHuman Otc Drug
Portfolio4 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 is this product?

This is an over-the-counter nicotine transdermal patch (Step 1 strength) that adheres to the skin to deliver nicotine through the skin. The patch also contains menthol, which is typically included for its cooling and soothing properties. Nicotine in these patches is commonly used as part of smoking cessation programs to help reduce withdrawal symptoms and cravings when someone is trying to quit smoking.

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.

🧪 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 75IZZ8Y727
    Camphor oil is a colorless to pale yellow essential oil derived from the camphor laurel tree. It's used in medicines as a flavoring agent and mild skin-soothing ingredient in topical formulations.
  • UNII I6OER6U04L
    A plant extract from chrysanthemum flowers used as a natural colorant and flavoring agent in medicines. It may contribute mild taste or visual appeal to the final product.
  • UNII VCA5491KVF
    A fragrant oil extracted from clove leaves, used as a flavoring and aromatic agent to mask unpleasant tastes or add pleasant scent to medicines.
  • UNII 02VJ3CEY9G
    Codonopsis pilosula root is a plant-derived ingredient used in traditional herbal preparations. It typically serves as an active botanical component or filler that adds substance and traditional therapeutic properties to the formulation.
  • UNII 6YR2608RSU
    A plant-derived material from tobacco leaves used as a natural flavoring or aromatic agent in some medicines. It provides taste and smell characteristics to make certain formulations more palatable or distinctive.

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

The official label also statesCODONOPSIS PILOSULA ROOT, CHRYSANTHEMUM INDICUM FLOWER,CLOVE LEAF OIL,TOBACCO LEAF, CAMPHOR OIL

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 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
Aroamas Cot Nicotine Transdermal Patches Step 1 .3 g/1001; 18 g/1001this 85831-0033-01 PCHEERY 21 patches — — FDA listed —
Aroamas Cot Nicotine Transdermal Patches Kit .3 g/1001; 18 g/1001 85831-0032-04 PCHEERY 56 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.

🔬 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 AROAMAS COT NICOTINE TRANSDERMAL PATCHES STEP 1 (this brand).

Top reported reactions

Deep Vein Thrombosis1
Headache1
Inappropriate Schedule Of Drug Administration1
Nicotine Dependence1
Pulmonary Embolism1
Treatment Noncompliance1

Reporter sex

3 reports
Female · 100%

Serious outcomes

Hospitalization1
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
85831-0033-01 You're viewing this 21 PATCH in 1 CARTON (85831-033-01) / 1 PATCH in 1 PATCH 2025-12-30 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 85831-033-01, 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: 85831-0033-01, written without dashes as 85831003301. 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 85831-0033-01, the first segment (85831) is the labeler code FDA assigned to PCHEERY LLC; the middle segment (0033) 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 PCHEERY LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
PCHEERY LLC 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 ~1 min read ▾

if you are under 18 years of age, ask a doctor before use. before using this product, read the enclosed self help guidefor complete directions and other information begin using the patch on your quit day if you smoke more than 10cigarettes per day, use the following schedule below: lf you smoke 10 or less cigarettes per day, do not use Step 1(21 mg). Start with Step 2(14 mg) for 6 weeks, then Step3(7 mg) for 2 weeks and then stop. apply one new patch every 24 hours on skin that is dry, clean and hairless. removebacking from patch and immediately press onto skin.

Hold for 10 seconds. wash hands after applying or removing patchSave pouch to use for patch disposal Dispose of the used patches by folding sticky ends together and putting in pouch. the used patch should be removed and a new one applied to a different skin site at the same time each day. if you havevivid dreams, you may remove the patch at bedtime and apply a new one in the morning. you may wear the patch for 18to 24 hours do not wear more than one patch at a time do not cut patch in half or into smaller pieces do not leavepatch on for more than 24 hours because if may irritate your skin and loses strength after 24 hours to avoid possibleburns, remove patch before underaoing and MRllmaanetic resonance imaging) procedures it is important to complete treatment. lf you feel you need to use the patch for a longer period to keep from smoking, talk to your health care provider. steps

⏱️ Dosage and Administration 10 words ▾

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

⚠️ Warnings ~1 min read ▾

lf you are pregnant or breast-feeding, only use this medicine on the advice ofyour health care provider. Smoking can seriously harm your child. Try to stop smoking without using any nicotine replacement medicine.

This medicine is believed to safer than smoking. However, the risks to your child from this medicine are not fully known. If you have Heart disease, recent heart attack, or ireqular heartbeat, Nicotine can increase your heart rate.

High blood pressurenot controlled with medication. Nicotine can increase your blood pressure. An allergy to adhesive tape or have skinproblems, because you are more likely to get rashes.

Stomach ulcer or diabetes. History of seizures. 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. If you have vivid dreams or other sleep disturbances, remove this patch at bedtime. 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. You have symptoms of an allergic reaction (such as diffculty breathing or rash) Used patches have enough nicotine to poison children and pets. lf swallowed, get medical help or contact a Poison Control Center right away. Save pouch to use for patch disposal.

Dispose of the usedpatches by folding sticky ends together and putting in pouch.

🧪 Active Ingredient 4 words ▾

Nicotine 18% Menthol 0.3%

🧪 Inactive Ingredients 11 words ▾

CODONOPSIS PILOSULA ROOT, CHRYSANTHEMUM INDICUM FLOWER,CLOVE LEAF OIL,TOBACCO LEAF, CAMPHOR OIL

🎯 Purpose 3 words ▾

Stop smoking aid

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 85831-0032-04 · PCHEERY 85831-0034-01 · PCHEERY →
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.