Septihol Hand Sanitizer Aerosol, Foam
NDC Package 0519-6257-35

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

Package Information

Septihol Hand Sanitizer (alcohol) aerosols is spray product on hands, enough to cover all surfaces. This formulation utilizes a aerosol, foam delivery system. Marketed by Steris Corporation, this product is identified by NDC 0519-6257 and is authorized under FDA application M003.

Identification & Billing

NDC Package Code
0519-6257-35
Package Description
24 BOTTLE in 1 CASE / 255 mL in 1 BOTTLE (0519-6257-36)
Product Code
0519-6257
11-Digit Billing Format
00519625735
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Septihol Hand Sanitizer
Non-Proprietary Name
Alcohol
Substance Name
Alcohol
Dosage Form
Aerosol, Foam - A dosage form containing one or more active ingredients, surfactants, aqueous or nonaqueous liquids, and the propellants; if the propellant is in the internal (discontinuous) phase (i.e., of the oil-in-water type), a stable foam is discharged, and if the propellant is in the external (continuous) phase (i.e., of the water-in-oil type), a spray or a quick-breaking foam is discharged.
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 62 mL/100mL
Usage Information
Spray product on hands, enough to cover all surfaces. Rub hands together until all surfaces are wet and fully covered. Continue rubbing until hands feel dry. Do not rinse or wipe off sanitizer.

Regulatory & Marketing

Labeler Name
Steris Corporation
Product Type
Human Otc Drug
FDA Application #
M003
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
05-01-2021
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 0519-6257-35 identifies a specific commercial package of 24 bottle in 1 case / 255 ml in 1 bottle (0519-6257-36) of Septihol Hand Sanitizer, a human over the counter drug labeled by Steris Corporation. This aerosol, foam 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 Steris Corporation on May 01, 2021. The current certification is valid through December 31, 2026.

How is this Steris Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00519625735. 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 (4-4-2)
0519-6257-35
11-Digit CMS (5-4-2)
00519-6257-35

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