Medi-first Topical Analgesic Spray
NDC Package 78495-142-01

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

Package Information

Medi-first Topical Analgesic (lidocaine hci) sprays is spray an even layer of burn spray over cleaned affected area not more than 3-4 times dailynot to be used on Children under 12 years of age. This formulation utilizes a spray delivery system. Marketed by Ultra Distributors Inc, this product is identified by NDC 78495-142 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
78495-142-01
Package Description
59.1 mL in 1 BOTTLE, PUMP
Product Code
78495-142
11-Digit Billing Format
78495014201
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Medi-first Topical Analgesic
Non-Proprietary Name
Lidocaine Hci
Substance Name
Lidocaine Hydrochloride
Dosage Form
Spray - A liquid minutely divided as by a jet of air or steam.
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 20 mg/mL
Pharmacologic Class
Usage Information
Spray an even layer of burn spray over cleaned affected area not more than 3-4 times dailynot to be used on Children under 12 years of age

Regulatory & Marketing

Labeler Name
Ultra Distributors Inc
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
12-19-2020
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 78495-142-01 identifies a specific commercial package of 59.1 ml in 1 bottle, pump of Medi-first Topical Analgesic, a human over the counter drug labeled by Ultra Distributors Inc. This spray 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 Ultra Distributors Inc on December 19, 2020. The current certification is valid through December 31, 2026.

How is this Ultra Distributors Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 78495014201. 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)
78495-142-01
11-Digit CMS (5-4-2)
78495-0142-01

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