Top Medicated Oil
NDC Package 82198-0009-1

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

Package Information

Top Medicated Oil (camphor, menthol, methyl salicylate) oils is • adults and children 12 years of age and older: apply 3 to 4 drops of medicated oil to the affected area 1 to 2 times daily. This formulation utilizes a oil delivery system. Marketed by Big 5 Nutrition Llc, this product is identified by NDC 82198-0009 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
82198-0009-1
Package Description
50 mL in 1 BOTTLE
Product Code
82198-0009
11-Digit Billing Format
82198000901

Clinical Specifications

Proprietary Name
Top Medicated Oil
Non-Proprietary Name
Camphor, Menthol, Methyl Salicylate
Substance Name
Camphor (natural); Menthol, Unspecified Form; Methyl Salicylate
Dosage Form
Oil - An unctuous, combustible substance which is liquid, or easily liquefiable, on warming, and is soluble in ether but insoluble in water. Such substances, depending on their origin, are classified as animal, mineral, or vegetable oils.
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 12 years of age and older: apply 3 to 4 drops of medicated oil to the affected area 1 to 2 times daily. After applying the product, a warm pad may be placed on the affected area for 10 minutes and then massage as shown in the illustrations. • children under 12 years of age: consult your physician.• refer to the above warnings; use otherwise than as directed may be dangerous.

Regulatory & Marketing

Labeler Name
Big 5 Nutrition Llc
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-01-2023
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 82198-0009-1 identifies a specific commercial package of 50 ml in 1 bottle of Top Medicated Oil, a human over the counter drug labeled by Big 5 Nutrition Llc. This oil is formulated for topical use and contains camphor (natural); menthol, unspecified form; methyl salicylate 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 Big 5 Nutrition Llc on January 01, 2023. The current certification is valid through December 31, 2026.

How is this Big 5 Nutrition Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 82198000901. 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)
82198-0009-1
11-Digit CMS (5-4-2)
82198-0009-01

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