Dermarad Relief Emulsion
NDC Package 76348-720-01

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

Package Information

Dermarad Relief (lidocaine emulsion) emulsions is usesFor the temporary relief of pain and itching associated with minor burns, sunburn, or minor skin irritations.Temporarily protects minor burns.Temporarily protects and helps relieve chapped or cracked skin. This formulation utilizes a emulsion delivery system. Marketed by Renu Laboratories, Llc, this product is identified by NDC 76348-720 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
76348-720-01
Package Description
1 TUBE in 1 BOX / 118 mL in 1 TUBE (76348-720-04)
Product Code
76348-720
11-Digit Billing Format
76348072001

Clinical Specifications

Proprietary Name
Dermarad Relief
Non-Proprietary Name
Lidocaine Emulsion
Substance Name
Allantoin; Lidocaine
Dosage Form
Emulsion - A dosage form consisting of a two-phase system comprised of at least two immiscible liquids1, one of which is dispersed as droplets (internal or dispersed phase) within the other liquid (external or continuous phase), generally stabilized with one or more emulsifying agents. (Note: Emulsion is used as a dosage form term unless a more specific term is applicable, e.g. cream, lotion, ointment.)
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)
Pharmacologic Class
Usage Information
UsesFor the temporary relief of pain and itching associated with minor burns, sunburn, or minor skin irritations.Temporarily protects minor burns.Temporarily protects and helps relieve chapped or cracked skin.

Regulatory & Marketing

Labeler Name
Renu Laboratories, Llc
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-03-2022
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 76348-720-01 identifies a specific commercial package of 1 tube in 1 box / 118 ml in 1 tube (76348-720-04) of Dermarad Relief, a human over the counter drug labeled by Renu Laboratories, Llc. This emulsion is formulated for topical use and contains allantoin; lidocaine 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 Renu Laboratories, Llc on January 03, 2022. The current certification is valid through December 31, 2026.

How is this Renu Laboratories, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76348072001. 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)
76348-720-01
11-Digit CMS (5-4-2)
76348-0720-01

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