Aroamas Cot Nicotine Transdermal Patches Step 2 Patch
NDC 85831-034

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 85831-034?
  4. Aroamas Cot Nicotine Transdermal Patches Step 2 Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. Pharmacologic Classes

Product Information

Aroamas Cot Nicotine Transdermal Patches Step 2 (nicotine transdermal patches) is a OTC MONOGRAPH DRUG-approved product labeled by Pcheery Llc. This medication is typically used as a cholinergic nicotinic agonist [epc]. It is supplied as a patch for topical administration. This product entry covers the primary NDC 85831-034 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
85831-034
Proprietary Name:
Aroamas Cot Nicotine Transdermal Patches Step 2
Non-Proprietary Name: [1]
Nicotine Transdermal Patches
Substance Name: [2]
Menthol; Nicotine
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Patch - A drug delivery system that often contains an adhesive backing that is usually applied to an external site on the body. Its ingredients either passively diffuse from, or are actively transported from, some portion of the patch. Depending upon the patch, the ingredients are either delivered to the outer surface of the body or into the body. A patch is sometimes synonymous with the terms ‘extended release film’ and ‘system’.
Administration Route(s): [4]
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Labeler & Regulatory Data

Labeler Name: [5]
Pcheery Llc
Labeler Code:
85831
Product Label ID:
4580d7f0-92a9-d0d0-e063-6394a90ac393
FDA Application Number: [6]
M017
Marketing Category: [8]
OTC MONOGRAPH DRUG

Marketing Timeline

Start Marketing Date: [9]
12-30-2025
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 85831-034?

The NDC code 85831-034 is assigned by the FDA to the product Aroamas Cot Nicotine Transdermal Patches Step 2. It is commonly known by its generic name, nicotine transdermal patches. This pharmaceutical product is labeled by Pcheery Llc and is currently categorized as listed product. The medication is a patch administered via topical route. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 85831-034-01. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

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 informationbegin using the patch on your quit dayif 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 hoursdo not wear more than one patch at a timedo not cut patch in half or into smaller piecesdo not leavepatch on for more than 24 hours because if may irritate your skin and loses strength after 24 hoursto avoid possibleburns, remove patch before underaoing and MRllmaanetic resonance imaging) proceduresit 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.

What are Active Ingredients of this product?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • MENTHOL .3 g/1001 - A monoterpene cyclohexanol produced from mint oils.
  • NICOTINE 12 g/1001 - Nicotine is highly toxic alkaloid. It is the prototypical agonist at nicotinic cholinergic receptors where it dramatically stimulates neurons and ultimately blocks synaptic transmission. Nicotine is also important medically because of its presence in tobacco smoke.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

Which are the Pharmacologic Classes of this product?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".