Dragon Pain Relieving Balm Salve
NDC Package 83552-101-00

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Dragon Pain Relieving Balm (camphor, menthol) salves is adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. This formulation utilizes a salve delivery system. Marketed by Americanna Wellness, Inc., this product is identified by NDC 83552-101 and is authorized under FDA application 505G(a)(3).

Identification & Billing

NDC Package Code
83552-101-00
Package Description
1 JAR in 1 CARTON / 56.7 g in 1 JAR
Product Code
83552-101
11-Digit Billing Format
83552010100

Clinical Specifications

Proprietary Name
Dragon Pain Relieving Balm
Non-Proprietary Name
Camphor, Menthol
Substance Name
Camphor (synthetic); Menthol
Dosage Form
Salve - A thick ointment or cerate (a fat or wax based preparation with a consistency between an ointment and a plaster).
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
Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: do not use, consult a doctor.

Regulatory & Marketing

Labeler Name
Americanna Wellness, Inc.
Product Type
Human Otc Drug
FDA Application #
505G(a)(3)
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
07-10-2023
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 83552-101-00 identifies a specific commercial package of 1 jar in 1 carton / 56.7 g in 1 jar of Dragon Pain Relieving Balm, a human over the counter drug labeled by Americanna Wellness, Inc.. This salve is formulated for topical use and contains camphor (synthetic); menthol 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 Americanna Wellness, Inc. on July 10, 2023. The current certification is valid through December 31, 2026.

How is this Americanna Wellness, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83552010100. 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)
83552-101-00
11-Digit CMS (5-4-2)
83552-0101-00

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