Thera Plus Hemorrhoidal Cream
NDC Package 80684-210-01

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

Package Information

Thera Plus Hemorrhoidal (glycerin, phenylephrine hydrochloride, pramoxine hydrochloride, white petrolatum) cream is adults:when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. This formulation utilizes a cream delivery system. Marketed by Fourstar Group Usa, Inc., this product is identified by NDC 80684-210 and is authorized under FDA application M015.

Identification & Billing

NDC Package Code
80684-210-01
Package Description
26 g in 1 TUBE
Product Code
80684-210
11-Digit Billing Format
80684021001
RxNorm Crosswalk
  • RxCUI: 1293649 - glycerin 14.4 % / phenylephrine HCl 0.25 % / pramoxine HCl 1 % / white petrolatum 15 % Rectal Cream
  • RxCUI: 1293649 - glycerin 144 MG/ML / petrolatum 150 MG/ML / phenylephrine hydrochloride 2.5 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal Cream
  • RxCUI: 1293649 - glycerin 14.4 % / phenylephrine hydrochloride 0.25 % / pramoxine hydrochloride 1 % / white petrolatum 15 % Rectal Cream

Clinical Specifications

Proprietary Name
Thera Plus Hemorrhoidal
Non-Proprietary Name
Glycerin, Phenylephrine Hydrochloride, Pramoxine Hydrochloride, White Petrolatum
Substance Name
Glycerin; Phenylephrine Hydrochloride; Pramoxine Hydrochloride; White 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
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
Adults:when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. apply externally to the affected area up to 4 times daily, especially at night or in the morning or after each bowel movement.apply externally or in the lower portion of the anal canal only.for 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.Children under 12 years of age: consult a doctor.

Regulatory & Marketing

Labeler Name
Fourstar Group Usa, Inc.
Product Type
Human Otc Drug
FDA Application #
M015
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
03-12-2026
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 80684-210-01 identifies a specific commercial package of 26 g in 1 tube of Thera Plus Hemorrhoidal, a human over the counter drug labeled by Fourstar Group Usa, Inc.. This cream is formulated for topical use and contains glycerin; phenylephrine hydrochloride; pramoxine hydrochloride; white 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 Fourstar Group Usa, Inc. on March 12, 2026. The current certification is valid through December 31, 2027.

How is this Fourstar Group Usa, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 80684021001. 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)
80684-210-01
11-Digit CMS (5-4-2)
80684-0210-01

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