Applause Gel
NDC Package 67858-693-06

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

Applause (instant hand sanitizer) gel is place a palmful ( 5 grams) of product in one hand,.Spread on both hands and rub into the skin until dry (approximately 1 to 2 minutes).Place a smaller amolunt (2.5 grams) into one hand, spread over both hands to wrist and rub into the skin until dry (approximately 30 seconds).Will air dry in 15 seconds. This formulation utilizes a gel delivery system. Marketed by Questspecialty Corporation, this product is identified by NDC 67858-693 and is authorized under FDA application 505G(a)(3).

Identification & Billing

NDC Package Code
67858-693-06
Package Description
4 BOTTLE, PLASTIC in 1 CARTON / 3407 g in 1 BOTTLE, PLASTIC (67858-693-05)
Product Code
67858-693
11-Digit Billing Format
67858069306
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Applause
Non-Proprietary Name
Instant Hand Sanitizer
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 3 g/5g
Usage Information
Place a palmful ( 5 grams) of product in one hand,.Spread on both hands and rub into the skin until dry (approximately 1 to 2 minutes).Place a smaller amolunt (2.5 grams) into one hand, spread over both hands to wrist and rub into the skin until dry (approximately 30 seconds).Will air dry in 15 seconds.

Regulatory & Marketing

Labeler Name
Questspecialty Corporation
Product Type
Human Otc Drug
FDA Application #
505G(a)(3)
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
10-02-2018
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 (67858-693). Click a package code to view its specific billing and regulatory data.

67858-693-02
24 BOTTLE in 1 CARTON / 107 g in 1 BOTTLE (67858-693-01)
67858-693-04
12 BOTTLE, PLASTIC in 1 CARTON / 212 g in 1 BOTTLE, PLASTIC (67858-693-03)
67858-693-07
187358 g in 1 DRUM
67858-693-09
12 BOTTLE, PLASTIC in 1 CARTON / 424 g in 1 BOTTLE, PLASTIC (67858-693-08)

* 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 67858-693-06 identifies a specific commercial package of 4 bottle, plastic in 1 carton / 3407 g in 1 bottle, plastic (67858-693-05) of Applause, a human over the counter drug labeled by Questspecialty 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 Questspecialty Corporation on October 02, 2018. The current certification is valid through December 31, 2026.

How is this Questspecialty Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67858069306. 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)
67858-693-06
11-Digit CMS (5-4-2)
67858-0693-06

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