Simple Promise Simple H Hemorrhoid Relief Cream
NDC Package 83311-335-00

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

Package Information

Simple Promise Simple H Hemorrhoid Relief Cream (phenylephrine hydrochloride, pramoxine hydrochloride) 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 Simple Promise Pte Ltd, this product is identified by NDC 83311-335 and is authorized under FDA application M015.

Identification & Billing

NDC Package Code
83311-335-00
Package Description
1 TUBE in 1 BOX / 56.7 g in 1 TUBE
Product Code
83311-335
11-Digit Billing Format
83311033500
RxNorm Crosswalk
  • RxCUI: 1293856 - phenylephrine HCl 0.25 % / pramoxine HCl 1 % Rectal Cream
  • RxCUI: 1293856 - phenylephrine hydrochloride 2.5 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal Cream
  • RxCUI: 1293856 - phenylephrine hydrochloride 0.25 % / pramoxine hydrochloride 1 % Rectal Cream

Clinical Specifications

Proprietary Name
Simple Promise Simple H Hemorrhoid Relief Cream
Non-Proprietary Name
Phenylephrine Hydrochloride, Pramoxine Hydrochloride
Substance Name
Phenylephrine Hydrochloride; Pramoxine Hydrochloride
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 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 cap • apply externally or in the lower portion of the anal canal only • apply externally to the affected area 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
Simple Promise Pte Ltd
Product Type
Human Otc Drug
FDA Application #
M015
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
03-06-2023
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 83311-335-00 identifies a specific commercial package of 1 tube in 1 box / 56.7 g in 1 tube of Simple Promise Simple H Hemorrhoid Relief Cream, a human over the counter drug labeled by Simple Promise Pte Ltd. This cream is formulated for topical use and contains phenylephrine hydrochloride; pramoxine 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 Simple Promise Pte Ltd on March 06, 2023. The current certification is valid through December 31, 2026.

How is this Simple Promise Pte Ltd product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 83311033500. 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)
83311-335-00
11-Digit CMS (5-4-2)
83311-0335-00

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