Topcare Hemorrhoidal Ointment
NDC Package 36800-499-16

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

Package Information

Topcare Hemorrhoidal (mineral oil, petrolatum, phenylephrine hcl) ointment is •adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. This formulation utilizes a ointment delivery system. Marketed by Topco Associates Llc, this product is identified by NDC 36800-499 and is authorized under FDA application M015.

Identification & Billing

NDC Package Code
36800-499-16
Package Description
1 TUBE in 1 CARTON / 57 g in 1 TUBE
Product Code
36800-499
11-Digit Billing Format
36800049916
RxNorm Crosswalk
  • RxCUI: 1372298 - mineral oil 14 % / petrolatum 74.9 % / phenylephrine HCl 0.25 % Rectal Ointment
  • RxCUI: 1372298 - mineral oil 0.14 MG/MG / petrolatum 0.749 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal Ointment
  • RxCUI: 1372298 - mineral oil 14 % / petrolatum 74.9 % / phenylephrine hydrochloride 0.25 % Rectal Ointment

Clinical Specifications

Proprietary Name
Topcare Hemorrhoidal
Non-Proprietary Name
Mineral Oil, Petrolatum, Phenylephrine Hcl
Substance Name
Mineral Oil; Petrolatum; Phenylephrine Hydrochloride
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.
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 ointment.•when first opening the tube, puncture foil seal with top end of cap apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement•intrarectal use: remove cover from applicator, attach applicator to tube, lubricate applicator well and gently insert applicator into the rectum, thoroughly cleanse applicator after each use and replace cover•also apply ointment to external area•regular use provides continual therapy for relief of symptoms•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
03-28-2014
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.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 36800-499-16 identifies a specific commercial package of 1 tube in 1 carton / 57 g in 1 tube of Topcare Hemorrhoidal, a human over the counter drug labeled by Topco Associates Llc. This ointment is formulated for rectal use and contains mineral oil; 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 Topco Associates Llc on March 28, 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: 36800049916. 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)
36800-499-16
11-Digit CMS (5-4-2)
36800-0499-16

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