Bactine Max Antibiotic And Lidocaine Max Pain Relief Ointment
NDC Package 65197-827-05

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

Package Information

Bactine Max Antibiotic And Lidocaine Max Pain Relief (lidocaine) ointment is a medication used to help reduce itching and pain from certain skin conditions (such as scrapes, minor skin irritations, insect bites). This formulation utilizes a ointment delivery system. Marketed by Wellspring Pharmaceutical Corporation, this product is identified by NDC 65197-827 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
65197-827-05
Package Description
1 TUBE in 1 BOX / 14.2 g in 1 TUBE
Product Code
65197-827
11-Digit Billing Format
65197082705

Clinical Specifications

Proprietary Name
Bactine Max Antibiotic And Lidocaine Max Pain Relief
Non-Proprietary Name
Lidocaine
Substance Name
Bacitracin Zinc; Lidocaine Hydrochloride; Polymyxin B Sulfate
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
This product is used to help reduce itching and pain from certain skin conditions (such as scrapes, minor skin irritations, insect bites). It may also be used to help relieve nerve pain after shingles (infection with herpes zoster virus). Lidocaine belongs to a class of drugs known as local anesthetics. It works by causing a temporary loss of feeling in the area where you apply the patch.

Regulatory & Marketing

Labeler Name
Wellspring Pharmaceutical Corporation
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-15-2024
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 65197-827-05 identifies a specific commercial package of 1 tube in 1 box / 14.2 g in 1 tube of Bactine Max Antibiotic And Lidocaine Max Pain Relief, a human over the counter drug labeled by Wellspring Pharmaceutical Corporation. This ointment is formulated for topical use and contains bacitracin zinc; lidocaine hydrochloride; 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 Wellspring Pharmaceutical Corporation on January 15, 2024. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This product is used to help reduce itching and pain from certain skin conditions (such as scrapes, minor skin irritations, insect bites). It may also be used to help relieve nerve pain after shingles (infection with herpes zoster virus). Lidocaine belongs to a class of drugs known as local anesthetics. It works by causing a temporary loss of feeling in the area where you apply the patch.

How is this Wellspring Pharmaceutical Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65197082705. 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)
65197-827-05
11-Digit CMS (5-4-2)
65197-0827-05

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