Topcare Hemorrhoidal Suppository
NDC Package 36800-279-53

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

Package Information

Topcare Hemorrhoidal (cocoa butter, phenylephrine hcl) suppositories is •adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. This formulation utilizes a suppository delivery system. Marketed by Topco Associates Llc, this product is identified by NDC 36800-279 and is authorized under FDA application M015.

Identification & Billing

NDC Package Code
36800-279-53
Package Description
12 BLISTER PACK in 1 CARTON / 1 SUPPOSITORY in 1 BLISTER PACK
Product Code
36800-279
11-Digit Billing Format
36800027953
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
12 EA
RxNorm Crosswalk
  • RxCUI: 1438497 - cocoa butter 88.4 % / phenylephrine HCl 0.25 % Rectal Suppository
  • RxCUI: 1438497 - cocoa butter 0.884 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal Suppository

Clinical Specifications

Proprietary Name
Topcare Hemorrhoidal
Non-Proprietary Name
Cocoa Butter, Phenylephrine Hcl
Substance Name
Cocoa Butter; Phenylephrine Hydrochloride
Dosage Form
Suppository - A solid body of various weights and shapes, adapted for introduction into the rectal orifice of the human body; they usually melt, soften, or dissolve at body temperature.
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 insertion of this product.•detach one suppository from the strip; remove the foil wrapper before inserting into the rectum as follows:•hold suppository with rounded end up•see illustrations: carefully separate foil tabs by inserting tip of fingernail at end marked “peel down”•slowly and evenly peel apart (do not tear) foil by pulling tabs down both sides, to expose the suppository•remove exposed suppository from wrapper•insert one suppository into the rectum up to 4 times daily, especially at night, in the morning or after each bowel movement•children under 12 years of age: ask a doctor

Regulatory & Marketing

Labeler Name
Topco Associates Llc
Product Type
Human Otc Drug
FDA Application #
M015
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
11-03-2014
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (36800-279). Click a package code to view its specific billing and regulatory data.

36800-279-62
24 BLISTER PACK in 1 CARTON / 1 SUPPOSITORY in 1 BLISTER PACK

* 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 36800-279-53 identifies a specific commercial package of 12 blister pack in 1 carton / 1 suppository in 1 blister pack of Topcare Hemorrhoidal, a human over the counter drug labeled by Topco Associates Llc. This suppository is formulated for rectal use and contains cocoa butter; 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 Topco Associates Llc on November 03, 2014. The current certification is valid through December 31, 2026.

How is this Topco Associates Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 36800027953. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 12 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)
36800-279-53
11-Digit CMS (5-4-2)
36800-0279-53

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