Barrier Balm Ointment
NDC Package 51514-0363-2

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

Barrier Balm ointment is directionsApply as needed. This formulation utilizes a ointment delivery system. Marketed by Autumn Harp, Inc., this product is identified by NDC 51514-0363 and is authorized under FDA application M016.

Identification & Billing

NDC Package Code
51514-0363-2
Package Description
1 TUBE in 1 CARTON / 15 g in 1 TUBE (51514-0363-1)
Product Code
51514-0363
11-Digit Billing Format
51514036302
RxNorm Crosswalk
  • RxCUI: 2665902 - dimethicone 13 % / petrolatum 41.9 % Topical Ointment
  • RxCUI: 2665902 - dimethicone 0.13 MG/MG / petrolatum 0.419 MG/MG Topical Ointment

Clinical Specifications

Proprietary Name
Barrier Balm
Non-Proprietary Name
Barrier Balm
Substance Name
Dimethicone 20; Petrolatum
Dosage Form
Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >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)
Usage Information
DirectionsApply as needed

Regulatory & Marketing

Labeler Name
Autumn Harp, Inc.
Product Type
Human Otc Drug
FDA Application #
M016
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
10-02-2023
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 (51514-0363). Click a package code to view its specific billing and regulatory data.

51514-0363-4
1 TUBE in 1 CARTON / 28 g in 1 TUBE (51514-0363-3)
51514-0363-6
1 TUBE in 1 CARTON / 48 g in 1 TUBE (51514-0363-5)

* 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 51514-0363-2 identifies a specific commercial package of 1 tube in 1 carton / 15 g in 1 tube (51514-0363-1) of Barrier Balm, a human over the counter drug labeled by Autumn Harp, Inc.. This ointment is formulated for topical use and contains dimethicone 20; petrolatum 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 Autumn Harp, Inc. on October 02, 2023. The current certification is valid through December 31, 2026.

How is this Autumn Harp, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 51514036302. 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 (5-4-1)
51514-0363-2
11-Digit CMS (5-4-2)
51514-0363-02

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