Topcare Lice Killing Shampoo
NDC Package 76162-253-08

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

Package Information

Topcare Lice Killing (piperonyl butoxide, pyrethrum extract) shampoos is 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, 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 product Treatapply thoroughly to DRY HAIR or other affected area. This formulation utilizes a shampoo delivery system. Marketed by Topco Associates, Llc, this product is identified by NDC 76162-253 and is authorized under FDA application M031.

Identification & Billing

NDC Package Code
76162-253-08
Package Description
1 BOTTLE in 1 CARTON / 236 mL in 1 BOTTLE
Product Code
76162-253
11-Digit Billing Format
76162025308
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
Topcare 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
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, 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 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 longer use warm water to form a lather, shampoo, then thoroughly rinse for 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 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

Regulatory & Marketing

Labeler Name
Topco Associates, Llc
Product Type
Human Otc Drug
FDA Application #
M031
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
11-01-2023
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 76162-253-08 identifies a specific commercial package of 1 bottle in 1 carton / 236 ml in 1 bottle of Topcare Lice Killing, a human over the counter drug labeled by Topco Associates, Llc. 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 Topco Associates, Llc on November 01, 2023. The current certification is valid through December 31, 2026.

How is this Topco Associates, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76162025308. 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)
76162-253-08
11-Digit CMS (5-4-2)
76162-0253-08

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