First Shield Cream
NDC Package 49314-0003-2

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

Package Information

First Shield (benzalkonium chloride, lidocaine hci) cream is clean affected area apply a small amount not more than 3-4 times daily children under 2 years: do not use,consult a doctor. This formulation utilizes a cream delivery system. Marketed by Unishield, this product is identified by NDC 49314-0003 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
49314-0003-2
Package Description
25 POUCH in 1 BOX / .9 g in 1 POUCH (49314-0003-1)
Product Code
49314-0003
11-Digit Billing Format
49314000302

Clinical Specifications

Proprietary Name
First Shield
Non-Proprietary Name
Benzalkonium Chloride, Lidocaine Hci
Substance Name
Benzalkonium Chloride; Lidocaine Hydrochloride
Dosage Form
Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
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
clean affected area apply a small amount not more than 3-4 times daily children under 2 years: do not use,consult a doctor

Regulatory & Marketing

Labeler Name
Unishield
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
06-29-2026
Listing Expiration
12-31-2027
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 49314-0003-2 identifies a specific commercial package of 25 pouch in 1 box / .9 g in 1 pouch (49314-0003-1) of First Shield, a human over the counter drug labeled by Unishield. This cream is formulated for topical use and contains benzalkonium chloride; 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 Unishield on June 29, 2026. The current certification is valid through December 31, 2027.

How is this Unishield product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49314000302. 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 (5-4-1)
49314-0003-2
11-Digit CMS (5-4-2)
49314-0003-02

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