Sterillium Foam Liquid
NDC Package 65616-006-16

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

Sterillium Foam (alcohol) liquids is apply to clean, dry hands, covering entire surface, including nailsRub until drySupervise children in the use of this product. This formulation utilizes a liquid delivery system. Marketed by Bode Chemie Gmbh, this product is identified by NDC 65616-006 and is authorized under FDA application 505G(a)(3).

Identification & Billing

NDC Package Code
65616-006-16
Package Description
8 BOTTLE, PUMP in 1 CARTON / 1000 mL in 1 BOTTLE, PUMP
Product Code
65616-006
11-Digit Billing Format
65616000616
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Sterillium Foam
Non-Proprietary Name
Alcohol
Substance Name
Alcohol
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
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 85 mL/100mL
Usage Information
Apply to clean, dry hands, covering entire surface, including nailsRub until drySupervise children in the use of this product

Regulatory & Marketing

Labeler Name
Bode Chemie Gmbh
Product Type
Human Otc Drug
FDA Application #
505G(a)(3)
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
09-25-2019
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (65616-006). Click a package code to view its specific billing and regulatory data.

65616-006-03
500 mL in 1 BOTTLE, PUMP
65616-006-06
1000 mL in 1 BOTTLE, PUMP
65616-006-07
1000 mL in 1 BOTTLE, PUMP
65616-006-11
2 BOTTLE, PUMP in 1 CARTON / 500 mL in 1 BOTTLE, PUMP
65616-006-12
4 BOTTLE, PUMP in 1 CARTON / 500 mL in 1 BOTTLE, PUMP
65616-006-13
8 BOTTLE, PUMP in 1 CARTON / 500 mL in 1 BOTTLE, PUMP
65616-006-14
2 BOTTLE, PUMP in 1 CARTON / 1000 mL in 1 BOTTLE, PUMP
65616-006-15
4 BOTTLE, PUMP in 1 CARTON / 1000 mL in 1 BOTTLE, PUMP
65616-006-17
4 BOTTLE, PUMP in 1 CARTON / 1000 mL in 1 BOTTLE, PUMP
65616-006-18
8 BOTTLE, PUMP in 1 CARTON / 1000 mL in 1 BOTTLE, PUMP

* 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 65616-006-16 identifies a specific commercial package of 8 bottle, pump in 1 carton / 1000 ml in 1 bottle, pump of Sterillium Foam, a human over the counter drug labeled by Bode Chemie Gmbh. This liquid 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 Bode Chemie Gmbh on September 25, 2019. The current certification is valid through December 31, 2027.

How is this Bode Chemie Gmbh product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65616000616. 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)
65616-006-16
11-Digit CMS (5-4-2)
65616-0006-16

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