Theraplus Ointment
NDC Package 55621-005-01

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

Package Information

Theraplus (phenylephrine hci) ointment is uses-helps relieve the local itching and discomfort associated with hemorrhoids-temporarily shrinks hemorrhoid tissue and relieves burning-temporarily provides a coating for relief of anorectal discomforts-temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful. This formulation utilizes a ointment delivery system. Marketed by Zhejiang Jingwei Pharmaceutical Co., Ltd., this product is identified by NDC 55621-005 and is authorized under FDA application M015.

Identification & Billing

NDC Package Code
55621-005-01
Package Description
42 g in 1 TUBE
Product Code
55621-005
11-Digit Billing Format
55621000501
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
Theraplus Plus
Non-Proprietary Name
Phenylephrine Hci
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
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
Uses-helps relieve the local itching and discomfort associated with hemorrhoids-temporarily shrinks hemorrhoid tissue and relieves burning-temporarily provides a coating for relief of anorectal discomforts-temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

Regulatory & Marketing

Labeler Name
Zhejiang Jingwei Pharmaceutical Co., Ltd.
Product Type
Human Otc Drug
FDA Application #
M015
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
03-01-2013
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 55621-005-01 identifies a specific commercial package of 42 g in 1 tube of Theraplus Plus, a human over the counter drug labeled by Zhejiang Jingwei Pharmaceutical Co., Ltd.. This ointment is formulated for topical 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 Zhejiang Jingwei Pharmaceutical Co., Ltd. on March 01, 2013. The current certification is valid through December 31, 2026.

How is this Zhejiang Jingwei Pharmaceutical Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 55621000501. 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)
55621-005-01
11-Digit CMS (5-4-2)
55621-0005-01

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