Fargelin Hemorrhoidal Ointment
NDC Package 55614-610-01

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

Package Information

Fargelin Hemorrhoidal (calamine, petrolatum and phenylephrine hydrochloride) ointment is classified as a

administered via rectal; topical route. This formulation utilizes a ointment delivery system. Marketed by Madison One Acme Inc, this product is identified by NDC 55614-610 and is authorized under FDA application M015.

Identification & Billing

NDC Package Code
55614-610-01
Package Description
20 g in 1 TUBE, WITH APPLICATOR
Product Code
55614-610
11-Digit Billing Format
55614061001

Clinical Specifications

Proprietary Name
Fargelin Hemorrhoidal
Non-Proprietary Name
Calamine, Petrolatum And Phenylephrine Hydrochloride
Substance Name
Ferric Oxide Red; Petrolatum; Phenylephrine Hydrochloride; Zinc Oxide
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
  • Rectal - Administration to the rectum.
  • 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

Regulatory & Marketing

Labeler Name
Madison One Acme Inc
Product Type
Human Otc Drug
FDA Application #
M015
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
11-27-2019
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 55614-610-01 identifies a specific commercial package of 20 g in 1 tube, with applicator of Fargelin Hemorrhoidal, a human over the counter drug labeled by Madison One Acme Inc. This ointment is formulated for rectal; topical use and contains ferric oxide red; petrolatum; phenylephrine hydrochloride; 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 Madison One Acme Inc on November 27, 2019. The current certification is valid through December 31, 2026.

How is this Madison One Acme Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55614061001. 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)
55614-610-01
11-Digit CMS (5-4-2)
55614-0610-01

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