Dermedial Anti-ouch Ointment
NDC Package 70983-030-01

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

Dermedial Anti-ouch (menthol) ointment is adults and children 12 years of age and older: Apply to affected area . This formulation utilizes a ointment delivery system. Marketed by Saje Natural Business Inc., this product is identified by NDC 70983-030 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
70983-030-01
Package Description
1 CANISTER in 1 BOX / 54.1 g in 1 CANISTER
Product Code
70983-030
11-Digit Billing Format
70983003001
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Dermedial Anti-ouch
Non-Proprietary Name
Menthol
Substance Name
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)
MENTHOL 12.7 mg/g
Usage Information
Adults and children 12 years of age and older: Apply to affected area 

Regulatory & Marketing

Labeler Name
Saje Natural Business Inc.
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
06-30-2025
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 (70983-030). Click a package code to view its specific billing and regulatory data.

70983-030-02
13.5 g in 1 CANISTER

* 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 70983-030-01 identifies a specific commercial package of 1 canister in 1 box / 54.1 g in 1 canister of Dermedial Anti-ouch, a human over the counter drug labeled by Saje Natural Business Inc.. This ointment is formulated for topical use and contains 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 June 30, 2025. The current certification is valid through December 31, 2026.

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: 70983003001. 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)
70983-030-01
11-Digit CMS (5-4-2)
70983-0030-01

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