Pain Relief Patch
NDC 83559-005

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 83559-005?
  4. Pain Relief Patch Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. NDC to RxNorm Crosswalk
  9. Pharmacologic Classes

Product Information

Pain Relief Patch is a OTC MONOGRAPH DRUG-approved product labeled by Henan Enokon Medical Instrument Co., Ltd.. This medication is typically used as a allergens [cs]. It is supplied as a patch for topical administration. This product entry covers the primary NDC 83559-005 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
83559-005
Proprietary Name:
Pain Relief Patch
Non-Proprietary Name: [1]
Pain Relief Patch
Substance Name: [2]
Camphor (synthetic); Capsicum; Menthol
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]
Henan Enokon Medical Instrument Co., Ltd.
Labeler Code:
83559
Product Label ID:
1592d29d-e275-a44d-e063-6294a90ab17d
FDA Application Number: [6]
M017
Marketing Category: [8]
OTC MONOGRAPH DRUG

Marketing Timeline

Start Marketing Date: [9]
04-07-2024
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Code Structure Chart

Product Details

What is NDC 83559-005?

The NDC code 83559-005 is assigned by the FDA to the product Pain Relief Patch. This pharmaceutical product is labeled by Henan Enokon Medical Instrument Co., Ltd. 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: 83559-005-01. 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?

·Adults and children 12 years and over apply to affected area; change patch 1 to 2 times daily ·Children under 12 years, consult doctor before use How to apply: ·Clean and dry affected area ·Cut open pouch and remove patch ·Remove protective film and apply directly to area of pain ·Apply to affected area not more than 3 times daily ·Wash hands with soap after applying patch ·Reseal pouch containing unused patches

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.
  • CAMPHOR (SYNTHETIC) 80 mg/1001
  • CAPSICUM 16 mg/1001 - A plant genus of the family SOLANACEAE. The hot peppers yield CAPSAICIN, which activates VANILLOID RECEPTORS. Several varieties have sweet or pungent edible fruits that are used as vegetables when fresh and spices when the pods are dried.
  • MENTHOL 24 mg/1001 - A monoterpene cyclohexanol produced from mint oils.

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:

What is the NDC to RxNorm Crosswalk for this product?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 853132 - camphor 80 MG / capsicum 16 MG / menthol 24 MG Medicated Patch
  • RxCUI: 853132 - camphor 80 MG / Capsicum extract 16 MG / menthol 24 MG Medicated Patch

Which are the Pharmacologic Classes 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".