North Woods Derma Gel Clear Gel
NDC Package 53125-801-57

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

North Woods Derma Gel Clear (alcohol) gel is directions• Read the entire label before using this product.• Place enough product on your palm to thoroughly cover your hands.• Rub hands together briskly until dry. This formulation utilizes a gel delivery system. Marketed by Superior Chemical Corporation, this product is identified by NDC 53125-801 and is authorized under FDA application 505G(a)(3).

Identification & Billing

NDC Package Code
53125-801-57
Package Description
550 mL in 1 BOTTLE, PUMP
Product Code
53125-801
11-Digit Billing Format
53125080157
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
North Woods Derma Gel Clear
Non-Proprietary Name
Alcohol
Substance Name
Alcohol
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)
ALCOHOL .7 mL/mL
Usage Information
Directions• Read the entire label before using this product.• Place enough product on your palm to thoroughly cover your hands.• Rub hands together briskly until dry.

Regulatory & Marketing

Labeler Name
Superior Chemical Corporation
Product Type
Human Otc Drug
FDA Application #
505G(a)(3)
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
08-01-2019
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 (53125-801). Click a package code to view its specific billing and regulatory data.

53125-801-04
3780 mL in 1 BOTTLE, PLASTIC
53125-801-09
500 mL in 1 BOTTLE, PUMP
53125-801-29
1000 mL in 1 BAG

* 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 53125-801-57 identifies a specific commercial package of 550 ml in 1 bottle, pump of North Woods Derma Gel Clear, a human over the counter drug labeled by Superior Chemical Corporation. This gel is formulated for topical use and contains alcohol 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 Superior Chemical Corporation on August 01, 2019. The current certification is valid through December 31, 2026.

How is this Superior Chemical Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 53125080157. 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)
53125-801-57
11-Digit CMS (5-4-2)
53125-0801-57

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