Dukal Povidone-iodine Scrub Winged Sponges Sponge
NDC Package 65517-0037-2

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

Package Information

Dukal Povidone-iodine Scrub Winged Sponges (povidone-iodine scrub winged sponges) sponges is apply product to skin as needed. This formulation utilizes a sponge delivery system. Marketed by Dukal Llc, this product is identified by NDC 65517-0037 and is authorized under FDA application 505G(a)(3).

Identification & Billing

NDC Package Code
65517-0037-2
Package Description
4 APPLICATOR in 1 POUCH / 109 mL in 1 APPLICATOR
Product Code
65517-0037
11-Digit Billing Format
65517003702

Clinical Specifications

Proprietary Name
Dukal Povidone-iodine Scrub Winged Sponges
Non-Proprietary Name
Povidone-iodine Scrub Winged Sponges
Substance Name
Povidone-iodine
Dosage Form
Sponge - A porous, interlacing, absorbent material that contains a drug. It is typically used for applying or introducing medication, or for cleansing. A sponge usually retains its shape.
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)
POVIDONE-IODINE 1.1 g/100mL
Usage Information
Apply product to skin as needed.

Regulatory & Marketing

Labeler Name
Dukal Llc
Product Type
Human Otc Drug
FDA Application #
505G(a)(3)
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
09-15-2022
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (65517-0037). Click a package code to view its specific billing and regulatory data.

65517-0037-1
2 APPLICATOR in 1 POUCH / 109 mL in 1 APPLICATOR

* 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 65517-0037-2 identifies a specific commercial package of 4 applicator in 1 pouch / 109 ml in 1 applicator of Dukal Povidone-iodine Scrub Winged Sponges, a human over the counter drug labeled by Dukal Llc. This sponge is formulated for topical use and contains povidone-iodine 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 Dukal Llc on September 15, 2022. The current certification is valid through December 31, 2026.

How is this Dukal Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65517003702. 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)
65517-0037-2
11-Digit CMS (5-4-2)
65517-0037-02

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