Povidone Iodine Gel Swabstick Gel
NDC Package 67777-418-01

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

Package Information

Povidone Iodine Gel Swabstick gel is • Tear at notch • Remove applicator • Use only onceAs a first aid antiseptic:• Clean affected area• Apply 1 to 3 times daily• May be covered with a sterile bandage• If bandaged, let dry firstFor preoperative patient skin preparation:• Clean area• Apply to operative site prior to surgeryFor Venipuncture skin preparation:• Hold the swabstick at an angle and begin scrubbing in a circular motion over a 1-inch area, directly over the venipuncture site. This formulation utilizes a gel delivery system. Marketed by Dynarex Corporation, this product is identified by NDC 67777-418 and is authorized under FDA application M003.

Identification & Billing

NDC Package Code
67777-418-01
Package Description
10 BOX in 1 CASE / 50 PACKET in 1 BOX (67777-418-02) / .3 mL in 1 PACKET
Product Code
67777-418
11-Digit Billing Format
67777041801
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Povidone Iodine Gel Swabstick
Non-Proprietary Name
Povidone Iodine Gel Swabstick
Substance Name
Povidone-iodine
Dosage Form
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
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 10 mg/mL
Usage Information
• Tear at notch • Remove applicator • Use only onceAs a first aid antiseptic:• Clean affected area• Apply 1 to 3 times daily• May be covered with a sterile bandage• If bandaged, let dry firstFor preoperative patient skin preparation:• Clean area• Apply to operative site prior to surgeryFor Venipuncture skin preparation:• Hold the swabstick at an angle and begin scrubbing in a circular motion over a 1-inch area, directly over the venipuncture site. Continue this for a minimum of 30 seconds.• After scrubbing for 30 seconds, and using the same applicator, begin at the venipuncture site and move gradually outward in concentric circles to form a total prepped area measuring at least 3 inches in diameter. • Allow site to dry for approximately 30 seconds.• If the patient bend the arm, or if prepared site is touched with the fingers or with any other non-sterile object, the complete preparation must be repeated.

Regulatory & Marketing

Labeler Name
Dynarex Corporation
Product Type
Human Otc Drug
FDA Application #
M003
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
11-25-2022
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 67777-418-01 identifies a specific commercial package of 10 box in 1 case / 50 packet in 1 box (67777-418-02) / .3 ml in 1 packet of Povidone Iodine Gel Swabstick, a human over the counter drug labeled by Dynarex Corporation. This gel 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 Dynarex Corporation on November 25, 2022. The current certification is valid through December 31, 2026.

How is this Dynarex Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67777041801. 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)
67777-418-01
11-Digit CMS (5-4-2)
67777-0418-01

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