Dermatool Hemorrhoidal Cream
NDC Package 84728-413-01

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

Package Information

Dermatool Hemorrhoidal (glycerin, lidocaine, petrolatum, phenylephrine hcl) cream is for the temporary relief of pain, soreness, and burning. This formulation utilizes a cream delivery system. Marketed by Papalo Group Llc, this product is identified by NDC 84728-413 and is authorized under FDA application M015.

Identification & Billing

NDC Package Code
84728-413-01
Package Description
1 TUBE in 1 CARTON / 42.5 g in 1 TUBE
Product Code
84728-413
11-Digit Billing Format
84728041301
RxNorm Crosswalk
  • RxCUI: 2642220 - glycerin 14.4 % / lidocaine 5 % / phenylephrine HCl 0.25 % / white petrolatum 15 % Rectal Cream
  • RxCUI: 2642220 - glycerin 144 MG/ML / lidocaine 50 MG/ML / petrolatum 150 MG/ML / phenylephrine hydrochloride 2.5 MG/ML Rectal Cream

Clinical Specifications

Proprietary Name
Dermatool Hemorrhoidal
Non-Proprietary Name
Glycerin, Lidocaine, Petrolatum, Phenylephrine Hcl
Substance Name
Glycerin; Lidocaine; Petrolatum; Phenylephrine Hydrochloride
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
For the temporary relief of pain, soreness, and burning. Helps relieve the local itching and discomfort associated with hemorrhoids. Temporarily shrinks hemorrhoidal tissue. Temporarily provides a coating for the relief of anorectal discomforts. Temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful.

Regulatory & Marketing

Labeler Name
Papalo Group Llc
Product Type
Human Otc Drug
FDA Application #
M015
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
05-10-2023
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 84728-413-01 identifies a specific commercial package of 1 tube in 1 carton / 42.5 g in 1 tube of Dermatool Hemorrhoidal, a human over the counter drug labeled by Papalo Group Llc. This cream is formulated for topical use and contains glycerin; lidocaine; petrolatum; phenylephrine 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 Papalo Group Llc on May 10, 2023. The current certification is valid through December 31, 2027.

How is this Papalo Group Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 84728041301. 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)
84728-413-01
11-Digit CMS (5-4-2)
84728-0413-01

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