Fundamentals Handlotion
NDC Package 76665-021-08

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

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Fundamentals Handlotion is dispense lotion onto hands and rub into skin until absorbedSupervise children under 6 years of age when using this product to avoid swallowing. Marketed by Clean Beauty Concepts, this product is identified by NDC 76665-021 and is authorized under FDA application part333A.

Identification & Billing

NDC Package Code
76665-021-08
Package Description
236 mL in 1 BOTTLE, DISPENSING
Product Code
76665-021
11-Digit Billing Format
76665002108

Clinical Specifications

Proprietary Name
Fundamentals Handlotion
Dosage Form
-
Usage Information
Dispense lotion onto hands and rub into skin until absorbedSupervise children under 6 years of age when using this product to avoid swallowing

Regulatory & Marketing

Labeler Name
Clean Beauty Concepts
FDA Application #
part333A
Marketing Category
OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date
09-01-2020
Listing Expiration
12-31-2021
Exclude Flag
I
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 (76665-021). Click a package code to view its specific billing and regulatory data.

76665-021-01
3785 mL in 1 BOTTLE, DISPENSING
76665-021-02
60 mL in 1 BOTTLE, DISPENSING
76665-021-16
473 mL in 1 BOTTLE, DISPENSING

* 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 76665-021-08 identifies a specific commercial package of 236 ml in 1 bottle, dispensing of Fundamentals Handlotion, labeled by Clean Beauty Concepts. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Clean Beauty Concepts on September 01, 2020. The current certification is valid through December 31, 2021.

How is this Clean Beauty Concepts product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 76665002108. 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)
76665-021-08
11-Digit CMS (5-4-2)
76665-0021-08

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