NDC 75940-192 Herklin Lice Treatment
Piperonyl Butoxide, Pyrethrum Extract Shampoo Topical

Table of Contents

    1. Product Information
    2. Product Packages
    3. What is NDC 75940-192?
    4. Herklin Lice Treatment Uses
    5. Active Ingredients
    6. Active Ingredients UNII Codes
    7. Inactive Ingredients UNII Codes
    8. NDC to RxNorm Crosswalk
    9. Patient Education

Product Information

NDC Product Code75940-192
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.		Herklin Lice Treatment
Non-Proprietary Name 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.		Piperonyl Butoxide, Pyrethrum Extract
Substance Name 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.		Piperonyl Butoxide; Pyrethrum Extract
Product Type 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.		Human Otc Drug
NDC Directory StatusACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage FormShampoo - 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) 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.		Marcasusa Llc
Labeler Code75940
SPL SET ID:018e8b94-b52b-466c-8265-51fb68a67bcf
FDA Application Number 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.		part358G
Marketing Category 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.		OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.		07-16-2018
Listing Expiration Date 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.		12-31-2023
Exclude Flag 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". 		N
NDC Code Structure

Product Packages

NDC Code 75940-192-09

Package Description: 59 mL in 1 BOTTLE

Product Details

What is NDC 75940-192?

The NDC code 75940-192 is assigned by the FDA to the product Herklin Lice Treatment which is a human over the counter drug product labeled by Marcasusa Llc. The generic name of Herklin Lice Treatment 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 75940-192-09 59 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 Herklin Lice Treatment?

​Important: Read warnings before use.adults and children 2 years and over: Inspectcheck each household member with a magnifying glass in bright light for lice/nits (eggs)look for tiny nits near scalp, beginin at back of neck and behind earsexamine small sections of hair at a timeunlike dandruff which moves when touched, nits stick to the hairif either lice or nits are found, treat with this product​Treatapply 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 longeruse warm water to form a lather, shampoo, then thoroughly rinsefor head lice, towel dry hair and comb out tangles.​Remove 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 nitsif hair dries during combing dampen slightly with waterfor head lice, part hair into sections. Do one section at a time starting on top of head.  Longer hair may take 1 to 2 hours.life 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 combingclean comb often. Wipe nits away with tissue and discard in a plastic bag.  Seal bag and discard to prevent lice froom coming back.after combing, thoroughly recheck for lice/nits. Repeat combing if necessary.a second treatment must be done in 7 to 10 days to kill any newly hatched liceIf infestation continues, see a doctor for other treatments.​children under 2 years:​ aska doctor

What are Herklin Lice Treatment 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 Herklin Lice Treatment UNII Codes?

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

Which are Herklin Lice Treatment 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 Herklin Lice Treatment?

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: 1988409 - Herklin 4 % / 0.33 % Medicated Shampoo
  • RxCUI: 1988409 - piperonyl butoxide 40 MG/ML / pyrethrins 3.3 MG/ML Medicated Shampoo [Herklin]
  • RxCUI: 1988409 - Herklin (piperonyl butoxide 4 % / pyrethrins 0.33 % ) Medicated Shampoo
  • 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.
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* Please review the disclaimer below.

Product Label

We have moved the product label and warning information to a dedicated page, please follow the link below:

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