Truelipids Truelips Lip Balm Solution
NDC Package 61387-255-02

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

Package Information

Truelipids Truelips Lip Balm (white petrolatum) solution is keep out of reach of children. This formulation utilizes a solution delivery system. Marketed by Claridei Laboratories, Inc., this product is identified by NDC 61387-255 and is authorized under FDA application M016.

Identification & Billing

NDC Package Code
61387-255-02
Package Description
1 TUBE in 1 CARTON / 15 g in 1 TUBE (61387-255-01)
Product Code
61387-255
11-Digit Billing Format
61387025502

Clinical Specifications

Proprietary Name
Truelipids Truelips Lip Balm Cl Md
Non-Proprietary Name
White Petrolatum
Substance Name
Petrolatum
Dosage Form
Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.
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)
PETROLATUM 50 g/100g
Usage Information
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Regulatory & Marketing

Labeler Name
Claridei Laboratories, Inc.
Product Type
Human Otc Drug
FDA Application #
M016
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
11-29-2024
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 61387-255-02 identifies a specific commercial package of 1 tube in 1 carton / 15 g in 1 tube (61387-255-01) of Truelipids Truelips Lip Balm Cl Md, a human over the counter drug labeled by Claridei Laboratories, Inc.. This solution is formulated for topical use and contains petrolatum 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 Claridei Laboratories, Inc. on November 29, 2024. The current certification is valid through December 31, 2026.

How is this Claridei Laboratories, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61387025502. 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)
61387-255-02
11-Digit CMS (5-4-2)
61387-0255-02

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