Unishield Hand Sanitizer Gel
NDC Package 49314-0004-1

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

Package Information

Unishield Hand Sanitizer (ethyl alcohol) gel is usesHand sanitizer to help reduce bacteria that potentially can cause diseaseFor use when soap and water are not available. This formulation utilizes a gel delivery system. Marketed by Unishield, this product is identified by NDC 49314-0004 and is authorized under FDA application M005.

Identification & Billing

NDC Package Code
49314-0004-1
Package Description
25 PACKET in 1 BOX / .9 mL in 1 PACKET
Product Code
49314-0004
11-Digit Billing Format
49314000401
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Unishield Hand Sanitizer
Non-Proprietary Name
Ethyl Alcohol
Substance Name
Alcohol
Dosage Form
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
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)
ALCOHOL 75 mL/100mL
Usage Information
UsesHand sanitizer to help reduce bacteria that potentially can cause diseaseFor use when soap and water are not available

Regulatory & Marketing

Labeler Name
Unishield
Product Type
Human Otc Drug
FDA Application #
M005
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
11-15-2023
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 49314-0004-1 identifies a specific commercial package of 25 packet in 1 box / .9 ml in 1 packet of Unishield Hand Sanitizer, a human over the counter drug labeled by Unishield. This gel is formulated for topical use and contains alcohol 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 November 15, 2023. The current certification is valid through December 31, 2026.

How is this Unishield product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49314000401. 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)
49314-0004-1
11-Digit CMS (5-4-2)
49314-0004-01

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