Surgical Scrub Brush/sponge With Nail Cleaner Sponge
NDC Package 84128-002-01

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

Package Information

Surgical Scrub Brush/sponge With Nail Cleaner (povidone iodine) sponges is ●Wet hands, wrists and forearms to the elbows with water. This formulation utilizes a sponge delivery system. Marketed by Xinxiang Xinda Technology Co.,ltd, this product is identified by NDC 84128-002 and is authorized under FDA application M003.

Identification & Billing

NDC Package Code
84128-002-01
Package Description
30 BAG in 1 BOX / 1 PATCH in 1 BAG / 20 mL in 1 PATCH
Product Code
84128-002
11-Digit Billing Format
84128000201
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Surgical Scrub Brush/sponge With Nail Cleaner
Non-Proprietary Name
Povidone Iodine
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
Cutaneous - Administration to the skin.
Active Ingredient(s)
POVIDONE-IODINE 10 g/100mL
Usage Information
●Wet hands, wrists and forearms to the elbows with water. Hands should be held higher than the elbows at all times ●Clean under nails with nail pick provided · Use the brush side toclean the nails, cuticles and interdigital spaces between the fingersand the sponge side to scrub the hands and forearms. Wet sponge and squeeze to work up lather · ●Scrub the nails, cuticles and interdigital spaces between the fingers, hands and forearms for 3 minutes in total . Scrub for an additional 2 minutes with using the sponge side only ●Rinse the hands, wrists and forearms with plenty of water ●Dry with a sterile towel from hands to elbows.Hold hands upwards.

Regulatory & Marketing

Labeler Name
Xinxiang Xinda Technology Co.,ltd
Product Type
Human Otc Drug
FDA Application #
M003
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
02-27-2024
Listing Expiration
12-31-2027
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 84128-002-01 identifies a specific commercial package of 30 bag in 1 box / 1 patch in 1 bag / 20 ml in 1 patch of Surgical Scrub Brush/sponge With Nail Cleaner, a human over the counter drug labeled by Xinxiang Xinda Technology Co.,ltd. This sponge is formulated for cutaneous 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 Xinxiang Xinda Technology Co.,ltd on February 27, 2024. The current certification is valid through December 31, 2027.

How is this Xinxiang Xinda Technology Co.,ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 84128000201. 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)
84128-002-01
11-Digit CMS (5-4-2)
84128-0002-01

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