1. Home
  2. Labeler Index
  3. Simple Promise Pte Ltd
  4. 83311-335
  5. NDC Package Code: 83311-335-00 Simple Promise Simple H Hemorrhoid Relief Cream

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

Phenylephrine Hydrochloride,Pramoxine Hydrochloride Cream Topical - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
83311-335-00
Package Description:
1 TUBE in 1 BOX / 56.7 g in 1 TUBE
Product Code:
83311-335
Proprietary Name:
Simple Promise Simple H Hemorrhoid Relief Cream
Non-Proprietary Name:
Phenylephrine Hydrochloride, Pramoxine Hydrochloride
Substance Name:
Phenylephrine Hydrochloride; Pramoxine Hydrochloride
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.
11-Digit NDC Billing Format:
83311033500
NDC to 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
    • Product Type:
    Human Otc Drug
    Labeler Name:
    Simple Promise Pte Ltd
    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(s):
  • 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):
  • PHENYLEPHRINE HYDROCHLORIDE 2.5 mg/g
  • PRAMOXINE HYDROCHLORIDE 10 mg/g
    • Pharmacologic Class(es):
  • Adrenergic alpha1-Agonists - [MoA] (Mechanism of Action)
  • alpha-1 Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
    • Sample Package:
    No
    FDA Application Number:
    M015
    Marketing Category:
    OTC MONOGRAPH DRUG -
    Start Marketing Date:
    03-06-2023
    Listing Expiration Date:
    12-31-2024
    Exclude Flag:
    N
    Code Structure:

    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 disclaimer below.

    Frequently Asked Questions

    What is NDC 83311-335-00?

    The NDC Packaged Code 83311-335-00 is assigned to a 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. The product's dosage form is cream and is administered via topical form.

    Is NDC 83311-335 included in the NDC Directory?

    Yes, Simple Promise Simple H Hemorrhoid Relief Cream with product code 83311-335 is active and included in the NDC Directory. The product was first marketed by Simple Promise Pte Ltd on March 06, 2023 and its listing in the NDC Directory is set to expire on December 31, 2024 if the product is not updated or renewed by the manufacturer.

    What is the 11-digit format for NDC 83311-335-00?

    The 11-digit format is 83311033500. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

    This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

    10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
    5-3-283311-335-005-4-283311-0335-00