NDC 85831-033 Aroamas Cot Nicotine Transdermal Patches Step 1

Nicotine Transdermal Patches Patch Topical - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This code was recently added to the official NDC directory and the product has entered commercial distribution.

Get all the details for National Drug Code (NDC) 85831-033 in one place. This page breaks down everything you need to know about the NDC, including proprietary name, active and inactive substances, package configurations, billing units, labeler information, and routes of administration. It also includes enhanced data such as HCPCS codes, FDA product labels with images, UNIIs, and RxNorm cross-references. Whether you're a healthcare professional verifying drug data or a consumer researching medication, this NDC page helps you make informed, accurate decisions.

NDC Product Code:
85831-033
Proprietary Name:
Aroamas Cot Nicotine Transdermal Patches Step 1
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
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 Name: [5]
Labeler Code:
85831
FDA Application Number: [6]
M017
Marketing Category: [8]
OTC MONOGRAPH DRUG -
Start Marketing Date: [9]
12-30-2025
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N
Code Navigator:

Code Structure Chart

Product Details

What is NDC 85831-033?

The NDC code 85831-033 is assigned by the FDA to the product Aroamas Cot Nicotine Transdermal Patches Step 1 which is a human over the counter drug product labeled by Pcheery Llc. The generic name of Aroamas Cot Nicotine Transdermal Patches Step 1 is nicotine transdermal patches. The product's dosage form is patch and is administered via topical form. The product is distributed in a single package with assigned NDC code 85831-033-01 21 patch in 1 carton / 1 patch in 1 patch. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Aroamas Cot Nicotine Transdermal Patches Step 1?

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 Aroamas Cot Nicotine Transdermal Patches Step 1 Active Ingredients?

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 18 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 Aroamas Cot Nicotine Transdermal Patches Step 1 UNII Codes?

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

Which are Aroamas Cot Nicotine Transdermal Patches Step 1 Inactive Ingredients 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 for Aroamas Cot Nicotine Transdermal Patches Step 1?

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.

* Please review the disclaimer below.

Product Footnotes

[1] 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.

[2] 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.

[3] 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.

[4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[6] 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.

[8] 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.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] 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.

[12] 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".