Cetilar Cream
NDC Package 84797-000-49

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

Package Information

Cetilar (menthol 1.4%) cream is adults and children over 12 years:Apply to the affect area not more than 3 to 4 times dailyAfter applying, wash hands with soap and waterChildren 12 years or younger, consult a doctor. This formulation utilizes a cream delivery system. Marketed by Pharmanutra Usa Corp., this product is identified by NDC 84797-000 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
84797-000-49
Package Description
1 TUBE in 1 CARTON / 49 g in 1 TUBE
Product Code
84797-000
11-Digit Billing Format
84797000049
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Cetilar
Non-Proprietary Name
Menthol 1.4%
Substance Name
Menthol
Dosage Form
Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 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 1.4 g/100g
Usage Information
Adults and children over 12 years:Apply to the affect area not more than 3 to 4 times dailyAfter applying, wash hands with soap and waterChildren 12 years or younger, consult a doctor

Regulatory & Marketing

Labeler Name
Pharmanutra Usa Corp.
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
02-01-2025
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 84797-000-49 identifies a specific commercial package of 1 tube in 1 carton / 49 g in 1 tube of Cetilar, a human over the counter drug labeled by Pharmanutra Usa Corp.. This cream 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 Pharmanutra Usa Corp. on February 01, 2025. The current certification is valid through December 31, 2026.

How is this Pharmanutra Usa Corp. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 84797000049. 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)
84797-000-49
11-Digit CMS (5-4-2)
84797-0000-49

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