Ethyl Alcohol Gel
NDC Package 59448-011-01

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

Package Information

Ethyl Alcohol (alcohol) gel is not recommended for infants. This formulation utilizes a gel delivery system. Marketed by Asp Global Llc, this product is identified by NDC 59448-011 and is authorized under FDA application M003.

Identification & Billing

NDC Package Code
59448-011-01
Package Description
53 mL in 1 BOTTLE, PLASTIC
Product Code
59448-011
11-Digit Billing Format
59448001101
RxNorm Crosswalk
  • RxCUI: 545626 - sodium monofluorophosphate 0.76 % Toothpaste
  • RxCUI: 545626 - sodium monofluorophosphate 0.0076 MG/MG Toothpaste
  • RxCUI: 545626 - sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )Toothpaste
  • RxCUI: 545626 - sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )Toothpaste
  • RxCUI: 545626 - sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )Toothpaste

Clinical Specifications

Proprietary Name
Ethyl Alcohol
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 70 mL/100mL
Usage Information
Not recommended for infants. Wet hands thoroughly with product & allow to self dry. Children under 6 years of age should be supervised when using this product . Adults & 6+ ChildrenBrush teeth thoroughly after meals or at least twice a day or use as directed by a dentist or physicianChildren under 6 yrs.To minimize swallowing use a pea - sized amount and supervise brushing.Children under 2 yrs.Ask a dentist or physician.NDC NO. 84132-100-10

Regulatory & Marketing

Labeler Name
Asp Global Llc
Product Type
Human Otc Drug
FDA Application #
M003
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
03-02-2025
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 59448-011-01 identifies a specific commercial package of 53 ml in 1 bottle, plastic of Ethyl Alcohol, a human over the counter drug labeled by Asp Global Llc. 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 Asp Global Llc on March 02, 2025. The current certification is valid through December 31, 2026.

How is this Asp Global Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 59448001101. 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)
59448-011-01
11-Digit CMS (5-4-2)
59448-0011-01

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