Denorex Extra Strength
NDC 0395-0059

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. What is NDC 0395-0059?
  4. Denorex Extra Strength Uses
  5. Active Ingredients UNII Codes
  6. Inactive Ingredients UNII Codes
  7. NDC to RxNorm Crosswalk
  8. Patient Education

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Denorex Extra Strength is a OTC MONOGRAPH FINAL-approved product labeled by Humco Holding Group, Inc.. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a product. This product entry covers the primary NDC 0395-0059 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
0395-0059
Proprietary Name:
Denorex Extra Strength
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:

Labeler & Regulatory Data

Labeler Name: [5]
Humco Holding Group, Inc.
Labeler Code:
0395
Product Label ID:
5d7f4d9c-2af3-4892-e053-2a91aa0a4327
FDA Application Number: [6]
part358H
Marketing Category: [8]
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.

Marketing Timeline

Start Marketing Date: [9]
06-17-2019
Listing Expiration Date: [11]
12-31-2022
Exclude Flag: [12]
I

Code Structure Chart

Product Details

What is NDC 0395-0059?

The NDC code 0395-0059 is assigned by the FDA to the product Denorex Extra Strength. This pharmaceutical product is labeled by Humco Holding Group, Inc. 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: 0395-0059-10. 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?

Shake well apply to wet hair gently massage into hair and scalp to work up a lather rinse thoroughly and repeat for best results, use at least twice weekly or as directed by a doctor

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: 1303358 - Denorex Extra Strength 3 % Medicated Shampoo, Reformulated Aug 2012
  • RxCUI: 1303358 - salicylic acid 30 MG/ML Medicated Shampoo [Denorex Extra Strength Reformulated Aug 2012]
  • RxCUI: 1303358 - Denorex Extra Strength Reformulated Aug 2012 30 MG/ML Medicated Shampoo
  • RxCUI: 205023 - salicylic acid 3 % Medicated Shampoo
  • RxCUI: 205023 - salicylic acid 30 MG/ML Medicated Shampoo

* Please review the full disclaimer at the bottom of this page.

Patient Education

Salicylic Acid Topical


Topical salicylic acid is used to help clear and prevent pimples and skin blemishes in people who have acne. Topical salicylic acid is also used to treat skin conditions that involve scaling or overgrowth of skin cells such as psoriasis (a skin disease in which red, scaly patches form on some areas of the body), ichthyoses (inborn conditions that cause skin dryness and scaling), dandruff, corns, calluses, and warts on the hands or feet. Topical salicylic acid should not be used to treat genital warts, warts on the face, warts with hair growing from them, warts in the nose or mouth, moles, or birthmarks. Salicylic acid is in a class of medications called keratolytic agents. Topical salicylic acid treats acne by reducing swelling and redness and unplugging blocked skin pores to allow pimples to shrink. It treats other skin conditions by softening and loosening dry, scaly, or thickened skin so that it falls off or can be removed easily.
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* 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".