Topcare Antibiotic Cream
NDC Package 36800-976-58

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

Package Information

Topcare Antibiotic (neomycin, polymyxin b, pramoxine hydrochloride) cream is •adults and children 2 years of age or older:•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•children under 2 years of age: ask a doctor. This formulation utilizes a cream delivery system. Marketed by Topco Associates Llc, this product is identified by NDC 36800-976 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
36800-976-58
Package Description
1 TUBE in 1 CARTON / 14 g in 1 TUBE
Product Code
36800-976
11-Digit Billing Format
36800097658
RxNorm Crosswalk
  • RxCUI: 1359360 - neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical Cream
  • RxCUI: 1359360 - neomycin 3.5 MG/ML / polymyxin B 10000 UNT/ML / pramoxine hydrochloride 10 MG/ML Topical Cream
  • RxCUI: 1359360 - neomycin (as neomycin sulfate) 0.35 % / polymyxin B (as polymyxin B sulfate) 10,000 UNT/ML / pramoxine (as pramoxine HCl) 1 % Topical Cream
  • RxCUI: 1359360 - neomycin 0.35 % / polymyxin B 10,000 UNT/ML / pramoxine HCl 1 % Topical Cream

Clinical Specifications

Proprietary Name
Topcare Antibiotic
Non-Proprietary Name
Neomycin, Polymyxin B, Pramoxine Hydrochloride
Substance Name
Neomycin Sulfate; Polymyxin B Sulfate; Pramoxine 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
•adults and children 2 years of age or older:•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•children under 2 years of age: ask a doctor

Regulatory & Marketing

Labeler Name
Topco Associates Llc
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
04-03-2020
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 36800-976-58 identifies a specific commercial package of 1 tube in 1 carton / 14 g in 1 tube of Topcare Antibiotic, a human over the counter drug labeled by Topco Associates Llc. This cream is formulated for topical use and contains neomycin sulfate; polymyxin b sulfate; pramoxine 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 Topco Associates Llc on April 03, 2020. The current certification is valid through December 31, 2026.

How is this Topco Associates Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 36800097658. 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)
36800-976-58
11-Digit CMS (5-4-2)
36800-0976-58

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