Orca Complete Menthol Pain Reliever Liquid
NDC Package 82939-000-01

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

Orca Complete Menthol Pain Reliever (menthol) liquids is adults and children 12 years of age and older: Place 8-10 drops onto ORCA Foam or similar reabsorbable gelatin sponge or gauze strip in a sterile fashion and apply to areas of discomfort in oral region. This formulation utilizes a liquid delivery system. Marketed by Orca Products, Llc, this product is identified by NDC 82939-000 and is authorized under FDA application M022.

Identification & Billing

NDC Package Code
82939-000-01
Package Description
1 BOTTLE, GLASS in 1 BOX / 10 mL in 1 BOTTLE, GLASS
Product Code
82939-000
11-Digit Billing Format
82939000001
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Orca Complete Menthol Pain Reliever
Non-Proprietary Name
Menthol
Substance Name
Menthol, Unspecified Form
Dosage Form
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
MENTHOL, UNSPECIFIED FORM 20 mg/mL
Usage Information
Adults and children 12 years of age and older: Place 8-10 drops onto ORCA Foam or similar reabsorbable gelatin sponge or gauze strip in a sterile fashion and apply to areas of discomfort in oral region. Allow to remain in place at least 1 minute and then spit out. Use up to 4 times daily or as directed by a dentist or doctor. Children under 12 years of age should be supervised in use of this product.Children under 12 years of age: Consult a dentist or doctor.

Regulatory & Marketing

Labeler Name
Orca Products, Llc
Product Type
Human Otc Drug
FDA Application #
M022
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
09-15-2022
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 (82939-000). Click a package code to view its specific billing and regulatory data.

82939-000-02
1 BOTTLE in 1 BOX / 13 mL in 1 BOTTLE

* 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 82939-000-01 identifies a specific commercial package of 1 bottle, glass in 1 box / 10 ml in 1 bottle, glass of Orca Complete Menthol Pain Reliever, a human over the counter drug labeled by Orca Products, Llc. This liquid is formulated for oral use and contains menthol, unspecified form 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 Orca Products, Llc on September 15, 2022. The current certification is valid through December 31, 2026.

How is this Orca Products, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 82939000001. 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)
82939-000-01
11-Digit CMS (5-4-2)
82939-0000-01

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