Polvo De Sulfa First Aid Antibiotic Powder
NDC Package 48201-105-75

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

Package Information

Polvo De Sulfa First Aid Antibiotic (bacitracin zinc, polymyxin b sulfate) powders is adults and children 2 years of age and older:clean the affected areaapply a light dusting of the powder on the area 1 to 3 times dailymay be covered with a sterile bandageChildren under 2 years of age: consult a doctor. This formulation utilizes a powder delivery system. Marketed by Grandall Distributing, Llc, this product is identified by NDC 48201-105 and is authorized under FDA application M004.

Identification & Billing

NDC Package Code
48201-105-75
Package Description
1 BOTTLE in 1 BOX / 7.5 g in 1 BOTTLE
Product Code
48201-105
11-Digit Billing Format
48201010575
RxNorm Crosswalk
  • RxCUI: 308513 - bacitracin 500 UNT / polymyxin B 10,000 UNT per GM Topical Powder
  • RxCUI: 308513 - bacitracin 0.5 UNT/MG / polymyxin B 10 UNT/MG Topical Powder
  • RxCUI: 308513 - bacitracin 500 UNT/GM / polymyxin B 10,000 UNT/GM Topical Powder

Clinical Specifications

Proprietary Name
Polvo De Sulfa First Aid Antibiotic
Non-Proprietary Name
Bacitracin Zinc, Polymyxin B Sulfate
Substance Name
Bacitracin Zinc; Polymyxin B Sulfate
Dosage Form
Powder - An intimate mixture of dry, finely divided drugs and/or chemicals that may be intended for internal or external use.
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
Adults and children 2 years of age and older:clean the affected areaapply a light dusting of the powder on the area 1 to 3 times dailymay be covered with a sterile bandageChildren under 2 years of age: consult a doctor

Regulatory & Marketing

Labeler Name
Grandall Distributing, Llc
Product Type
Human Otc Drug
FDA Application #
M004
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
07-18-2024
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 48201-105-75 identifies a specific commercial package of 1 bottle in 1 box / 7.5 g in 1 bottle of Polvo De Sulfa First Aid Antibiotic, a human over the counter drug labeled by Grandall Distributing, Llc. This powder is formulated for topical use and contains bacitracin zinc; 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 Grandall Distributing, Llc on July 18, 2024. The current certification is valid through December 31, 2026.

How is this Grandall Distributing, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 48201010575. 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)
48201-105-75
11-Digit CMS (5-4-2)
48201-0105-75

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