Hemorrhoidal Cream
NDC Package 52410-8440-6

11-digit billing NDC: 52410844006
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Hemorrhoidal (glycerin, phenylephrine hcl, pramoxine hcl, white petrolatum) cream is adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. This formulation utilizes a cream delivery system. Marketed by Shield Line Llc, this product is identified by NDC 52410-8440 and is authorized under FDA application M015.

Identification & Billing

NDC Package Code
52410-8440-6
Package Description
1 TUBE in 1 CARTON / 51 g in 1 TUBE
Product Code
52410-8440
11-Digit Billing Format
52410844006

Clinical Specifications

Proprietary Name
Hemorrhoidal
Non-Proprietary Name
Glycerin, Phenylephrine Hcl, Pramoxine Hcl, White Petrolatum
Substance Name
Glycerin; Phenylephrine Hydrochloride; Pramoxine Hydrochloride; Petrolatum
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
Rectal - Administration to the rectum.
Active Ingredient(s)
Pharmacologic Class
Usage Information
Adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or a soft cloth before applying cream.when first opening the tube, puncture foil seal with top end of capapply externally or in the lower portion of the anal canal onlyapply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movementfor application in the lower anal canal: remove cover from dispensing cap. Attach dispensing cap to tube. Lubricate dispensing cap well, then gently insert dispensing cap partway into the anus.thoroughly cleanse dispensing cap after each use and replace coverchildren under 12 years of age: ask a doctor

Regulatory & Marketing

Labeler Name
Shield Line Llc
Product Type
Human Otc Drug
FDA Application #
M015
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
09-25-2007
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 52410-8440-6 identifies a specific commercial package of 1 tube in 1 carton / 51 g in 1 tube of Hemorrhoidal, a human over the counter drug labeled by Shield Line Llc. This cream is formulated for rectal use and contains glycerin; phenylephrine hydrochloride; pramoxine hydrochloride; 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 Shield Line Llc on September 25, 2007. The current certification is valid through December 31, 2027.

How is this Shield Line Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52410844006. 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)
52410-8440-6
11-Digit CMS (5-4-2)
52410-8440-06

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