Calm And Heal Melting Balm Cream
NDC Package 69366-505-28

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

Calm And Heal Melting Balm (allantoin) cream is usesTemporarily protects minor:•cuts•scrapes•burnsHelps prevent and helps relieve chapped or cracked skinHelps prevent and protect from the drying effects of wind and cold weather. This formulation utilizes a cream delivery system. Marketed by The Honest Company, Inc., this product is identified by NDC 69366-505 and is authorized under FDA application M016.

Identification & Billing

NDC Package Code
69366-505-28
Package Description
1 JAR in 1 CARTON / 15 g in 1 JAR
Product Code
69366-505
11-Digit Billing Format
69366050528

Clinical Specifications

Proprietary Name
Calm And Heal Melting Balm
Non-Proprietary Name
Allantoin
Substance Name
Allantoin
Dosage Form
Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
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)
ALLANTOIN .5 g/100g
Usage Information
UsesTemporarily protects minor:•cuts•scrapes•burnsHelps prevent and helps relieve chapped or cracked skinHelps prevent and protect from the drying effects of wind and cold weather

Regulatory & Marketing

Labeler Name
The Honest Company, Inc.
Product Type
Human Otc Drug
FDA Application #
M016
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
09-29-2020
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
Yes

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 (69366-505). Click a package code to view its specific billing and regulatory data.

69366-505-23
1 JAR in 1 CARTON / 50 g in 1 JAR

* 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 69366-505-28 identifies a specific commercial package of 1 jar in 1 carton / 15 g in 1 jar of Calm And Heal Melting Balm, a human over the counter drug labeled by The Honest Company, Inc.. This cream is formulated for topical use and contains allantoin 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 The Honest Company, Inc. on September 29, 2020. The current certification is valid through December 31, 2026.

How is this The Honest Company, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69366050528. 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)
69366-505-28
11-Digit CMS (5-4-2)
69366-0505-28

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