Genuine First Aid First Aid Antibiotic Bacitracin Zinc Cream
NDC Package 50814-058-01

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

Package Information

Genuine First Aid First Aid Antibiotic Bacitracin Zinc (bacitracin zinc, neomycin sulfate, polymyxin b sulfate) cream is clean the affected area.Apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily.May be covered with a sterile bandage. This formulation utilizes a cream delivery system. Marketed by Gfa Production (xiamen) Co., Ltd., this product is identified by NDC 50814-058 and is authorized under FDA application M004.

Identification & Billing

NDC Package Code
50814-058-01
Package Description
.9 g in 1 PACKAGE
Product Code
50814-058
11-Digit Billing Format
50814005801
RxNorm Crosswalk
  • RxCUI: 283616 - bacitracin zinc 400 UNT / neomycin sulfate 3.5 MG / polymixin B sulfate 5000 UNT in 1 GM Topical Cream
  • RxCUI: 283616 - bacitracin 400 UNT/ML / neomycin 3.5 MG/ML / polymyxin B 5000 UNT/ML Topical Cream

Clinical Specifications

Proprietary Name
Genuine First Aid First Aid Antibiotic Bacitracin Zinc
Non-Proprietary Name
Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate
Substance Name
Bacitracin Zinc; Neomycin Sulfate; Polymyxin B Sulfate
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 the affected area.Apply a small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily.May be covered with a sterile bandage.

Regulatory & Marketing

Labeler Name
Gfa Production (xiamen) Co., Ltd.
Product Type
Human Otc Drug
FDA Application #
M004
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-01-2020
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 50814-058-01 identifies a specific commercial package of .9 g in 1 package of Genuine First Aid First Aid Antibiotic Bacitracin Zinc, a human over the counter drug labeled by Gfa Production (xiamen) Co., Ltd.. This cream is formulated for topical use and contains bacitracin zinc; neomycin sulfate; polymyxin b sulfate 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 Gfa Production (xiamen) Co., Ltd. on January 01, 2020. The current certification is valid through December 31, 2026.

How is this Gfa Production (xiamen) Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 50814005801. 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)
50814-058-01
11-Digit CMS (5-4-2)
50814-0058-01

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