Pranicura 5 Cream
NDC Package 71831-004-01

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

Package Information

Pranicura 5 (glycerin, kaolin, calamine, menthol) cream is uses • Helps relieve the itching and discomfort associated with anorectal disorders •Provides temporary relief from the symptoms of perianal skin irritation • For the temporaryrelief of itching associated with moist anorectal conditions • For the temporary relief ofirritation and burning. This formulation utilizes a cream delivery system. Marketed by Pranicura Products Llc, this product is identified by NDC 71831-004 and is authorized under FDA application M015.

Identification & Billing

NDC Package Code
71831-004-01
Package Description
60 g in 1 JAR
Product Code
71831-004
11-Digit Billing Format
71831000401

Clinical Specifications

Proprietary Name
Pranicura 5
Non-Proprietary Name
Glycerin, Kaolin, Calamine, Menthol
Substance Name
Glycerin; Kaolin; Menthol; Zinc Oxide
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)
Pharmacologic Class
Usage Information
Uses • Helps relieve the itching and discomfort associated with anorectal disorders •Provides temporary relief from the symptoms of perianal skin irritation • For the temporaryrelief of itching associated with moist anorectal conditions • For the temporary relief ofirritation and burning

Regulatory & Marketing

Labeler Name
Pranicura Products Llc
Product Type
Human Otc Drug
FDA Application #
M015
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
10-18-2021
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 71831-004-01 identifies a specific commercial package of 60 g in 1 jar of Pranicura 5, a human over the counter drug labeled by Pranicura Products Llc. This cream is formulated for topical use and contains glycerin; kaolin; menthol; zinc oxide 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 Pranicura Products Llc on October 18, 2021. The current certification is valid through December 31, 2026.

How is this Pranicura Products Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 71831000401. 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)
71831-004-01
11-Digit CMS (5-4-2)
71831-0004-01

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