NDC 70000-0531 Leader Medicated Dandruff Anti-seborrheic Dermatitis, Anti-dandruff

Selenium Sulfide Shampoo Topical - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
70000-0531
Proprietary Name:
Leader Medicated Dandruff Anti-seborrheic Dermatitis, Anti-dandruff
Non-Proprietary Name: [1]
Selenium Sulfide
Substance Name: [2]
Selenium Sulfide
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Shampoo - A liquid soap or detergent used to clean the hair and scalp and is often used as a vehicle for dermatologic agents.
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]
    Cardinal Health, 110 Dba Leader
    Labeler Code:
    70000
    FDA Application Number: [6]
    M032
    Marketing Category: [8]
    OTC MONOGRAPH DRUG -
    Start Marketing Date: [9]
    11-05-2019
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    GREEN (C48329)

    Product Packages

    NDC Code 70000-0531-1

    Package Description: 207 mL in 1 BOTTLE, PLASTIC

    Price per Unit: $0.01317 per ML

    Product Details

    What is NDC 70000-0531?

    The NDC code 70000-0531 is assigned by the FDA to the product Leader Medicated Dandruff Anti-seborrheic Dermatitis, Anti-dandruff which is a human over the counter drug product labeled by Cardinal Health, 110 Dba Leader. The generic name of Leader Medicated Dandruff Anti-seborrheic Dermatitis, Anti-dandruff is selenium sulfide. The product's dosage form is shampoo and is administered via topical form. The product is distributed in a single package with assigned NDC code 70000-0531-1 207 ml in 1 bottle, plastic . 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 Leader Medicated Dandruff Anti-seborrheic Dermatitis, Anti-dandruff?

    This medication is used to treat dandruff and a certain scalp infection (seborrheic dermatitis). It reduces itching, flaking, irritation, and redness of the scalp. Selenium sulfide is also used for a condition that causes discoloration of the skin (tinea versicolor). This medication belongs to a class of medications called anti-infectives. It works by slowing the growth of the yeast that causes the infection.

    What are Leader Medicated Dandruff Anti-seborrheic Dermatitis, Anti-dandruff 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.

    Which are Leader Medicated Dandruff Anti-seborrheic Dermatitis, Anti-dandruff UNII Codes?

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

    Which are Leader Medicated Dandruff Anti-seborrheic Dermatitis, Anti-dandruff 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:

    * Please review the disclaimer below.

    Patient Education

    Selenium Sulfide


    Selenium sulfide, an anti-infective agent, relieves itching and flaking of the scalp and removes the dry, scaly particles that are commonly referred to as dandruff or seborrhea. It is also used to treat tinea versicolor, a fungal infection of the skin. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.
    [Learn More]


    * 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".