Bactine Liquid
NDC Package 65197-820-80

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

Package Information

Bactine (bactine max wound wash) liquids is clean the affected area, apply a small amount of this product on the area 1 to 3 times daily; may be covered with a sterile bandage (let dry first). This formulation utilizes a liquid delivery system. Marketed by Wellspring Pharmaceutical Corporation, this product is identified by NDC 65197-820 and is authorized under FDA application M003.

Identification & Billing

NDC Package Code
65197-820-80
Package Description
1 BOTTLE in 1 CARTON / 236 mL in 1 BOTTLE
Product Code
65197-820
11-Digit Billing Format
65197082080
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Bactine Max
Non-Proprietary Name
Bactine Max Wound Wash
Substance Name
Benzalkonium Chloride
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route
Cutaneous - Administration to the skin.
Active Ingredient(s)
BENZALKONIUM CHLORIDE .13 g/100mL
Usage Information
Clean the affected area, apply a small amount of this product on the area 1 to 3 times daily; may be covered with a sterile bandage (let dry first).

Regulatory & Marketing

Labeler Name
Wellspring Pharmaceutical Corporation
Product Type
Human Otc Drug
FDA Application #
M003
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
04-15-2023
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 65197-820-80 identifies a specific commercial package of 1 bottle in 1 carton / 236 ml in 1 bottle of Bactine Max, a human over the counter drug labeled by Wellspring Pharmaceutical Corporation. This liquid is formulated for cutaneous use and contains benzalkonium chloride 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 April 15, 2023. The current certification is valid through December 31, 2026.

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

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65197082080. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
65197-820-80
11-Digit CMS (5-4-2)
65197-0820-80

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