NDC 53247-124 Liceout

Piperonyl Butoxide And Pyrethrum Extract Shampoo Topical - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
53247-124
Proprietary Name:
Liceout
Non-Proprietary Name: [1]
Piperonyl Butoxide And Pyrethrum Extract
Substance Name: [2]
Piperonyl Butoxide; Pyrethrum Extract
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 Code:
    53247
    FDA Application Number: [6]
    M031
    Marketing Category: [8]
    OTC MONOGRAPH DRUG -
    Start Marketing Date: [9]
    01-02-2022
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
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    Product Details

    What is NDC 53247-124?

    The NDC code 53247-124 is assigned by the FDA to the product Liceout which is a human over the counter drug product labeled by Bob Barker Company Inc.. The generic name of Liceout is piperonyl butoxide and pyrethrum extract. The product's dosage form is shampoo and is administered via topical form. The product is distributed in 2 packages with assigned NDC codes 53247-124-01 150 packet in 1 case / 29.6 ml in 1 packet, 53247-124-02 3785 ml in 1 jug . 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 Liceout?

    Shake Well Before UsingAdults and children 2 years and over.TreatApply thoroughly to hair or other affected area. For head lice, first apply behind ears and to back of neck.Allow product to remain for 10 minutes, but no longeruse warm water to form a lather, shampoo, then thoroughly rinseFor head lice, towel dry hair and comb out tangles.Check daily for any lice/nits.A second treatment must be done in 7 to 10 days to kill any newly hatched lice.If infestation continues, see a doctor for other treatments.

    What are Liceout 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 Liceout UNII Codes?

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

    Which are Liceout 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:

    What is the NDC to RxNorm Crosswalk for Liceout?

    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: 2599624 - Liceout 3 % / 0.3 % Medicated Shampoo
    • RxCUI: 2599624 - piperonyl butoxide 30 MG/ML / pyrethrins 3 MG/ML Medicated Shampoo [Liceout]
    • RxCUI: 2599624 - Liceout (piperonyl butoxide 3 % / pyrethrins 0.3 % ) Medicated Shampoo
    • RxCUI: 283217 - piperonyl butoxide 3 % / pyrethrins 0.3 % Medicated Shampoo
    • RxCUI: 283217 - piperonyl butoxide 30 MG/ML / pyrethrins 3 MG/ML Medicated Shampoo

    * Please review the disclaimer below.

    Patient Education

    Pyrethrin and Piperonyl Butoxide Topical


    Pyrethrin and piperonyl butoxide shampoo is used to treat lice (small insects that attach themselves to the skin on the head, body, or pubic area ['crabs']) in adults and children 2 years of age and older. Pyrethrin and piperonyl butoxide is in a class of medications called pediculicides. It works by killing lice.
    [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".