Maximum Strength Betadine Clear Spray
NDC Package 67618-183-06

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

Package Information

Maximum Strength Betadine Clear (benzalkonium cl and pramoxine hcl) sprays is •adults and children 2 years of age and older:•clean the affected area•spray a small amount of this product on the area 1 to 3 times daily•may be covered with sterile bandage•if bandaged, let dry first•children under 2 years of age:•consult a doctor. This formulation utilizes a spray delivery system. Marketed by Atlantis Consumer Healthcare, Inc., this product is identified by NDC 67618-183 and is authorized under FDA application M003.

Identification & Billing

NDC Package Code
67618-183-06
Package Description
177 mL in 1 BOTTLE
Product Code
67618-183
11-Digit Billing Format
67618018306

Clinical Specifications

Proprietary Name
Maximum Strength Betadine Clear
Non-Proprietary Name
Benzalkonium Cl And Pramoxine Hcl
Substance Name
Benzalkonium Chloride; Pramoxine Hydrochloride
Dosage Form
Spray - A liquid minutely divided as by a jet of air or steam.
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)
Usage Information
•adults and children 2 years of age and older:•clean the affected area•spray a small amount of this product on the area 1 to 3 times daily•may be covered with sterile bandage•if bandaged, let dry first•children under 2 years of age:•consult a doctor

Regulatory & Marketing

Labeler Name
Atlantis Consumer Healthcare, Inc.
Product Type
Human Otc Drug
FDA Application #
M003
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
12-22-2023
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 67618-183-06 identifies a specific commercial package of 177 ml in 1 bottle of Maximum Strength Betadine Clear, a human over the counter drug labeled by Atlantis Consumer Healthcare, Inc.. This spray is formulated for topical use and contains benzalkonium chloride; 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 Atlantis Consumer Healthcare, Inc. on December 22, 2023. The current certification is valid through December 31, 2026.

How is this Atlantis Consumer Healthcare, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67618018306. 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)
67618-183-06
11-Digit CMS (5-4-2)
67618-0183-06

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