Extra Strength Balm Ointment
NDC Package 70983-027-01

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

Package Information

Extra Strength Balm (capsicum and menthol) ointment is for the temporary relief of minor aches and pains of muscles and joints associated with • simple backache • arthritis • strains • bruises • sprains. This formulation utilizes a ointment delivery system. Marketed by Saje Natural Business Inc, this product is identified by NDC 70983-027 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
70983-027-01
Package Description
1 JAR in 1 BOX / 25 g in 1 JAR
Product Code
70983-027
11-Digit Billing Format
70983002701

Clinical Specifications

Proprietary Name
Extra Strength Balm
Non-Proprietary Name
Capsicum And Menthol
Substance Name
Capsicum; Menthol
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)
Pharmacologic Class
Usage Information
For the temporary relief of minor aches and pains of muscles and joints associated with • simple backache • arthritis • strains • bruises • sprains. Provides warming pain relief.

Regulatory & Marketing

Labeler Name
Saje Natural Business Inc
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
02-18-2023
Listing Expiration
12-31-2027
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 70983-027-01 identifies a specific commercial package of 1 jar in 1 box / 25 g in 1 jar of Extra Strength Balm, a human over the counter drug labeled by Saje Natural Business Inc. This ointment is formulated for topical use and contains capsicum; 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 Saje Natural Business Inc on February 18, 2023. The current certification is valid through December 31, 2027.

How is this Saje Natural Business Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 70983002701. 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)
70983-027-01
11-Digit CMS (5-4-2)
70983-0027-01

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