Ellen Hand Sanitizer Spray
NDC Package 85537-101-11

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

Package Information

Ellen Hand Sanitizer (ethyl alcohol) sprays is a human otc drug administered via topical route. This formulation utilizes a spray delivery system. Marketed by Pt. Super Home Product Indonesia, this product is identified by NDC 85537-101 and is authorized under FDA application M005.

Identification & Billing

NDC Package Code
85537-101-11
Package Description
40 BOTTLE, SPRAY in 1 BOX / 100 mL in 1 BOTTLE, SPRAY (85537-101-01)
Product Code
85537-101
11-Digit Billing Format
85537010111
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Ellen Hand Sanitizer
Non-Proprietary Name
Ethyl Alcohol
Substance Name
Alcohol
Dosage Form
Spray - A liquid minutely divided as by a jet of air or steam.
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 60 mL/100mL

Regulatory & Marketing

Labeler Name
Pt. Super Home Product Indonesia
Product Type
Human Otc Drug
FDA Application #
M005
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
04-18-2025
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 85537-101-11 identifies a specific commercial package of 40 bottle, spray in 1 box / 100 ml in 1 bottle, spray (85537-101-01) of Ellen Hand Sanitizer, a human over the counter drug labeled by Pt. Super Home Product Indonesia. This spray 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 Pt. Super Home Product Indonesia on April 18, 2025. The current certification is valid through December 31, 2026.

How is this Pt. Super Home Product Indonesia product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 85537010111. 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)
85537-101-11
11-Digit CMS (5-4-2)
85537-0101-11

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