Lonazem Ointment
NDC Package 69435-1200-1

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

Package Information

Lonazem (menthol, petrolatum) ointment is adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. This formulation utilizes a ointment delivery system. Marketed by Peer Pharm Ltd., this product is identified by NDC 69435-1200 and is authorized under FDA application M015.

Identification & Billing

NDC Package Code
69435-1200-1
Package Description
10 TUBE in 1 CARTON / 3 g in 1 TUBE
Product Code
69435-1200
11-Digit Billing Format
69435120001
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Lonazem
Non-Proprietary Name
Menthol, Petrolatum
Substance Name
Menthol; Petrolatum
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)
Usage Information
Adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by blotting or patting with a tissue or a soft cloth before applying ointment.Apply to the affected area up to 6 times daily, especially at night, in the morning or after ' each bowel movement.EXTERNAL USE: Apply to external anal area.INTRARECTAL USE: Lubricate applicator well with Lonazem ointment, then gently insert applicator into the rectum.Children under 12 years of age: consult a doctor

Regulatory & Marketing

Labeler Name
Peer Pharm Ltd.
Product Type
Human Otc Drug
FDA Application #
M015
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
03-01-2024
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 69435-1200-1 identifies a specific commercial package of 10 tube in 1 carton / 3 g in 1 tube of Lonazem, a human over the counter drug labeled by Peer Pharm Ltd.. This ointment is formulated for topical use and contains menthol; petrolatum 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 Peer Pharm Ltd. on March 01, 2024. The current certification is valid through December 31, 2027.

How is this Peer Pharm Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69435120001. 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)
69435-1200-1
11-Digit CMS (5-4-2)
69435-1200-01

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