2-count Heat Patches
NDC 68016-067
View dosage, usage, ingredients, routes, and UNII mappings.
Product Information
This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
2-count Heat Patches is a OTC MONOGRAPH NOT FINAL-approved product labeled by Chain Drug Consortium, Llc. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a product. This product entry covers the primary NDC 68016-067 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.
Primary Identification
NDC Product Code:
68016-067
Proprietary Name:
2-count Heat Patches
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:
Labeler & Regulatory Data
Labeler Name: [5]
Labeler Code:
68016
Product Label ID:
FDA Application Number: [6]
part348
Marketing Category: [8]
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Marketing Timeline
Start Marketing Date: [9]
06-01-2017
Listing Expiration Date: [11]
12-31-2024
Exclude Flag: [12]
I
Product Characteristics
Shape:
RECTANGLE (C48347)
Code Structure Chart
Product Details
What is NDC 68016-067?
The NDC code 68016-067 is assigned by the FDA to the product 2-count Heat Patches. This pharmaceutical product is labeled by Chain Drug Consortium, Llc and is currently categorized as listed product. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 68016-067-02. 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?
For Use on Adults and Childrens 12 Years of Age or OlderClean and dru affected area; ensure area is fully dry before applicationRemove patch from filmApply to treatement sitePatch may be trimmerd to best fit treatment site; trim patch before removing filmWash hands after applicationDiscard after signle useCaution:Take care when using on elderly ot incapacited personsDo not use more than 8 hoursDo not use the Capsaicin Heat Patch more than 3-4 times dailyDo not exceed 7 days of continue use
Which are the associated UNII Codes?
The UNII codes for the active ingredients in this product are:
- CAPSAICIN (UNII: S07O44R1ZM)
- CAPSAICIN (UNII: S07O44R1ZM) (Active Moiety)
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:
- HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
- PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
- LIQUID PETROLEUM (UNII: 6ZAE7X688J)
- STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)
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: 1043399 - capsaicin 0.025 % Medicated Patch
- RxCUI: 1043399 - capsaicin 0.00025 MG/MG Medicated Patch
* Please review the full disclaimer at the bottom of this page.
Patient Education
Capsaicin Transdermal Patch
Nonprescription (over-the-counter) capsaicin patches (Aspercreme Warming, Salonpas Pain Relieving Hot, others) are used to relieve minor pain in muscles and joints caused by arthritis, backaches, muscle strains, bruises, cramps, and sprains. Prescription capsaicin patches (Qutenza) are used to relieve the pain of postherpetic neuralgia (PHN; the burning, stabbing pain or aches that may last for months or years after an attack of shingles). Prescription capsaicin patches (Qutenza) are also used to relieve the pain of diabetic neuropathy (numbness or tingling due to nerve damage in people who have diabetes). Capsaicin is a substance that is found in chili peppers. It works by affecting nerve cells in the skin that are associated with pain, which results in decreased activity of these nerve cells and a reduced sense of pain.
[Learn More]
* Please review the full disclaimer at the bottom of this page.
Product & Regulatory Definitions
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".
