Leader Triple Antibiotic And Pain Relief Ointment
NDC Package 70000-0625-1

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

Package Information

Leader Triple Antibiotic And Pain Relief (bacitracin, neomycin, polymxin, pramoxine) ointment is clean the affected area and dry thoroughly 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 dailyMay be covered with a sterile bandageChildren under 2 years of age: ask doctor. This formulation utilizes a ointment delivery system. Marketed by Cardinal Health 110 Dba Leader, this product is identified by NDC 70000-0625 and is authorized under FDA application M004.

Identification & Billing

NDC Package Code
70000-0625-1
Package Description
1 TUBE in 1 BOX / 28.4 g in 1 TUBE
Product Code
70000-0625
11-Digit Billing Format
70000062501
RxNorm Crosswalk
  • RxCUI: 1359350 - bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG in GM Topical Ointment
  • RxCUI: 1359350 - bacitracin 0.5 UNT/MG / neomycin 0.0035 MG/MG / polymyxin B 10 UNT/MG / pramoxine hydrochloride 0.01 MG/MG Topical Ointment
  • RxCUI: 1359350 - bacitracin 500 UNT / neomycin 3.5 MG / polymyxin B 10,000 UNT / pramoxine HCl 10 MG per GM Topical Ointment

Clinical Specifications

Proprietary Name
Leader Triple Antibiotic And Pain Relief
Non-Proprietary Name
Bacitracin, Neomycin, Polymxin, Pramoxine
Substance Name
Bacitracin Zinc; Neomycin Sulfate; Polymyxin B Sulfate; Pramoxine Hydrochloride
Dosage Form
Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >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 and dry thoroughly 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 dailyMay be covered with a sterile bandageChildren under 2 years of age: ask doctor

Regulatory & Marketing

Labeler Name
Cardinal Health 110 Dba Leader
Product Type
Human Otc Drug
FDA Application #
M004
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
02-15-2023
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 70000-0625-1 identifies a specific commercial package of 1 tube in 1 box / 28.4 g in 1 tube of Leader Triple Antibiotic And Pain Relief, a human over the counter drug labeled by Cardinal Health 110 Dba Leader. This ointment is formulated for topical use and contains bacitracin zinc; 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 Cardinal Health 110 Dba Leader on February 15, 2023. The current certification is valid through December 31, 2026.

How is this Cardinal Health 110 Dba Leader product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70000062501. 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)
70000-0625-1
11-Digit CMS (5-4-2)
70000-0625-01

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