Topcare Lice Killing Creme Rinse Lotion
NDC Package 36800-629-26

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 Creme Rinse (permethrin) lotions is a medication used to treat head lice, tiny insects that infest and irritate your scalp. This formulation utilizes a lotion delivery system. Marketed by Topco Associates Llc, this product is identified by NDC 36800-629 and is authorized under FDA application ANDA076090.

Identification & Billing

NDC Package Code
36800-629-26
Package Description
2 BOTTLE in 1 CARTON / 59 mL in 1 BOTTLE
Product Code
36800-629
11-Digit Billing Format
36800062926

Clinical Specifications

Proprietary Name
Topcare Lice Killing Creme Rinse
Non-Proprietary Name
Permethrin
Substance Name
Permethrin
Dosage Form
Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2
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)
PERMETHRIN 1 mg/100mL
Pharmacologic Class
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
Topco Associates Llc
Product Type
Human Otc Drug
FDA Application #
ANDA076090
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
01-31-2020
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 36800-629-26 identifies a specific commercial package of 2 bottle in 1 carton / 59 ml in 1 bottle of Topcare Lice Killing Creme Rinse, a human over the counter drug labeled by Topco Associates Llc. This lotion is formulated for topical use and contains permethrin 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 January 31, 2020. 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 Topco Associates Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 36800062926. 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)
36800-629-26
11-Digit CMS (5-4-2)
36800-0629-26

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