NDC 52000-040 Capsaicin Heat


NDC Product Code 52000-040

NDC 52000-040-41

Package Description: 1 POUCH in 1 BOX > 2 PATCH in 1 POUCH (52000-040-40) > 3.28 g in 1 PATCH

NDC Product Information

Capsaicin Heat with NDC 52000-040 is a a human over the counter drug product labeled by Universal Distribution Center Llc. The generic name of Capsaicin Heat is capsaicin. The product's dosage form is patch and is administered via topical form.

Labeler Name: Universal Distribution Center Llc

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’.

Product Type: Human Otc Drug 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.

Capsaicin Heat Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • CAPSAICIN .025 g/100g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
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.

  • ROSIN (UNII: 88S87KL877)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

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

Labeler Name: Universal Distribution Center Llc
Labeler Code: 52000
FDA Application Number: part348 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.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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.

Start Marketing Date: 03-07-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 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.

Exclude Flag: N 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Capsaicin Heat Product Label Images

Capsaicin Heat Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Otc - Active Ingredient

Active IngredientCapsicum Extract Capsaicin 0.025%

Otc - Purpose

PurposeTopical Analgesic

Indications & Usage

  • UsesFor temporary relief of minor aches and pains of muscles & joints associated with:Simple BackacheArthritisStrainsBruisesSprains


WarningsExternal use only.

Otc - Do Not Use

  • Do not useon wounds or damaged skinwith a heating padwith, or at the same times as other external analgesicif you are allergic to any ingredients of this product

Otc - When Using

  • When using this productdo not use otherwise than as directed.avoid contact with the eyes, mucous membranes or rashesdo not bandage tightlydiscontinue use at least 1 hour before a bath or showerdo not use immediately after a bath or shower

Otc - Stop Use

  • Stop use and ask a doctor ifrash, itching or excessive skin irritation developsconditions worsensymptoms persist for more than 7 dayssymptoms clear up and occur again within a few days

Otc - Keep Out Of Reach Of Children

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of childrenIf swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Dosage & Administration

  • DirectionsAdults and Children 12 years of age and over:Clean and dry affected areaRemove patch from filmApply to affected area not more than 3 to 4 times dailyRemove patch from skin after at most 8 hours of applicationChildren under 12 years of age: Consult a doctor.


  • Other informationAvoid storing product in direct sunlightProtect product from excessive moisture

Inactive Ingredient

Inactive Ingredientslanolin, methyl salicylate, natural latex rubber, peppermint oil, petrolatum, rosin, zinc oxide

* Please review the disclaimer below.