NDC 11822-0866 Lice

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

Product Information

NDC Product Code:
Proprietary Name:
Non-Proprietary Name: [1]
Piperonyl Butoxide, Pyrethrum Extract
Substance Name: [2]
Piperonyl Butoxide; Pyrethrum Extract
NDC Directory Status:
Human Otc Drug
Product Type: [3]
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]
    Rite Aid Corporation
    Labeler Code:
    FDA Application Number: [6]
    Marketing Category: [8]
    OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
    Start Marketing Date: [9]
    Listing Expiration Date: [11]
    Exclude Flag: [12]
    Code Structure:
    Code Navigator:

    Product Characteristics


    Product Packages

    NDC Code 11822-0866-1

    Package Description: 1 BOTTLE in 1 CARTON / 236 mL in 1 BOTTLE

    Product Details

    What is NDC 11822-0866?

    The NDC code 11822-0866 is assigned by the FDA to the product Lice which is a human over the counter drug product labeled by Rite Aid Corporation. The generic name of Lice is piperonyl butoxide, pyrethrum extract. 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 11822-0866-1 1 bottle in 1 carton / 236 ml in 1 bottle. 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 Lice?

    Shake well before using•Important: Read warnings before useAdults and children 2 years and over:Inspect•check each household member with a magnifying glass in bright light for lice/nits (eggs)•look for tiny nits near scalp, beginning at back of neck and behind ears•examine small sections of hair at a time•unlike dandruff which moves when touched, nits stick to the hair•if either lice or nits are found, treat with this productTreat•apply thoroughly to DRY 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 longer•use warm water to form a lather, shampoo, then thoroughly rinse•for head lice, towel dry hair and comb out tanglesRemove lice and their eggs (nits)•use a fine-tooth or special lice/nit comb. Remove any remaining nits by hand (using a throw-away glove).•hair should remain slightly damp while removing nits•if hair dries during combing, dampen slightly with water•for head lice, part hair into sections. Do one section at a time starting on top of the head. Longer hair may take 1 to 2 hours.•lift a 1 -to 2-inch wide strand of hair. Place comb as close to scalp as possible and comb with a firm, even motion away from scalp.•pin back each strand of hair after combing•clean comb often. Wipe nits away with tissue and discard in a plastic bag. Seal bag and discard to prevent lice from coming back.•after combing, thoroughly recheck for lice/nits. Repeat combing if necessary.•check daily for any lice/nits that you missed•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•Children under 2 years: ask a doctor

    What are Lice 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 Lice UNII Codes?

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

    Which are Lice 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 Lice?

    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: 283219 - piperonyl butoxide 4 % / pyrethrins 0.33 % Medicated Shampoo
    • RxCUI: 283219 - piperonyl butoxide 40 MG/ML / pyrethrins 3.3 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".