Radiaguard Advanced Radiation Relief Lotion
NDC Package 81034-103-00

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

Package Information

Radiaguard Advanced Radiation Relief (lidocaine hydrochloride) lotions is adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.Children under 2 years of age: consult a doctor. This formulation utilizes a lotion delivery system. Marketed by Smooth Side, Inc, this product is identified by NDC 81034-103 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
81034-103-00
Package Description
113 g in 1 TUBE
Product Code
81034-103
11-Digit Billing Format
81034010300
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
113 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Radiaguard Advanced Radiation Relief
Non-Proprietary Name
Lidocaine Hydrochloride
Substance Name
Lidocaine Hydrochloride
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)
LIDOCAINE HYDROCHLORIDE 10 mg/g
Pharmacologic Class
Usage Information
Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.Children under 2 years of age: consult a doctor.

Regulatory & Marketing

Labeler Name
Smooth Side, Inc
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
10-01-2020
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 81034-103-00 identifies a specific commercial package of 113 g in 1 tube of Radiaguard Advanced Radiation Relief, a human over the counter drug labeled by Smooth Side, Inc. This product is billed per "GM" gram and contains an estimated amount of 113 billable units per package. This lotion is formulated for topical use and contains lidocaine hydrochloride 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 Smooth Side, Inc on October 01, 2020. The current certification is valid through December 31, 2026.

How is this Smooth Side, Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 81034010300. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 113 total billable units per package. 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)
81034-103-00
11-Digit CMS (5-4-2)
81034-0103-00

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