Jelcaine Sterile Jelly
NDC Package 71351-025-30

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

Package Information

Jelcaine Sterile (lidocaine hcl jelly usp, 2%) jellies is adults and children 2 years of age and older: Apply externally to the affected area not more than 3-4 time daily.Children under 2 years of age: Do not use. This formulation utilizes a jelly delivery system. Marketed by Brookfield Pharmaceuticals, Llc, this product is identified by NDC 71351-025 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
71351-025-30
Package Description
30 mL in 1 TUBE
Product Code
71351-025
11-Digit Billing Format
71351002530
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Units Per Package
30 ML
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Jelcaine Sterile
Non-Proprietary Name
Lidocaine Hcl Jelly Usp, 2%
Substance Name
Lidocaine Hydrochloride
Dosage Form
Jelly - A class of gels, which are semisolid systems that consist of suspensions made up of either small inorganic particles or large organic molecules interpenetrated by a liquid--in which the structural coherent matrix contains a high portion of liquid, usually water.
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)
LIDOCAINE HYDROCHLORIDE 20 mg/mL
Pharmacologic Class
Usage Information
Adults and children 2 years of age and older: Apply externally to the affected area not more than 3-4 time daily.Children under 2 years of age: Do not use. Consult a doctor.

Regulatory & Marketing

Labeler Name
Brookfield Pharmaceuticals, Llc
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
09-10-2024
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 71351-025-30 identifies a specific commercial package of 30 ml in 1 tube of Jelcaine Sterile, a human over the counter drug labeled by Brookfield Pharmaceuticals, Llc. This jelly is formulated for topical use and contains lidocaine hydrochloride 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 Brookfield Pharmaceuticals, Llc on September 10, 2024. The current certification is valid through December 31, 2026.

How is this Brookfield Pharmaceuticals, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71351002530. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. There are 30 total billable units per package. 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)
71351-025-30
11-Digit CMS (5-4-2)
71351-0025-30

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