Lice Killing Shampoo
NDC Package 11383-310-02

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Lice Killing (piperonyl butoxide, pyrethrum extract) shampoos is a medication used to treat head lice, tiny insects that infest and irritate your scalp. This formulation utilizes a shampoo delivery system. Marketed by Weeks & Leo Co., Inc., this product is identified by NDC 11383-310 and is authorized under FDA application M031.

Identification & Billing

NDC Package Code
11383-310-02
Package Description
1 BOTTLE in 1 CARTON / 59 mL in 1 BOTTLE
Product Code
11383-310
11-Digit Billing Format
11383031002
RxNorm Crosswalk
  • RxCUI: 283219 - piperonyl butoxide 4 % / pyrethrins 0.33 % Medicated Shampoo
  • RxCUI: 283219 - piperonyl butoxide 40 MG/ML / pyrethrins 3.3 MG/ML Medicated Shampoo

Clinical Specifications

Proprietary Name
Lice Killing
Non-Proprietary Name
Piperonyl Butoxide, Pyrethrum Extract
Substance Name
Piperonyl Butoxide; Pyrethrum Extract
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
Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Active Ingredient(s)
Usage Information
This medication is used to treat head lice, tiny insects that infest and irritate your scalp. Permethrin is also used to help avoid infestation in people who have close contact with someone who has head lice. It belongs to a class of drugs known as pyrethrins. Permethrin works by paralyzing and killing lice and their eggs (nits).

Regulatory & Marketing

Labeler Name
Weeks & Leo Co., Inc.
Product Type
Human Otc Drug
FDA Application #
M031
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
05-17-2021
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

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

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 11383-310-02 identifies a specific commercial package of 1 bottle in 1 carton / 59 ml in 1 bottle of Lice Killing, a human over the counter drug labeled by Weeks & Leo Co., Inc.. This shampoo is formulated for topical use and contains piperonyl butoxide; pyrethrum extract as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Weeks & Leo Co., Inc. on May 17, 2021. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to treat head lice, tiny insects that infest and irritate your scalp. Permethrin is also used to help avoid infestation in people who have close contact with someone who has head lice. It belongs to a class of drugs known as pyrethrins. Permethrin works by paralyzing and killing lice and their eggs (nits).

How is this Weeks & Leo Co., Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 11383031002. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
11383-310-02
11-Digit CMS (5-4-2)
11383-0310-02

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.