Thera Wise Natural Hemorrhoidal Ointment
NDC Package 43347-158-01

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

Package Information

Thera Wise Natural Hemorrhoidal (witch hazel) ointment is when first opening, tear away safety seal.Adult: When practical cleanse the affected area with mild soap and warm water and rinse thoroughly and / orpat and blot with appropriate cleansing pad.Gently dry by patting or blotting with a toilet tissue or a soft cloth before application of this product.FOR INTRARECTAL USE: Remove cover from applicator, attach applicator to the tube.Lubricate applicator well, then gently insert applicator into the rectum.Thoroughly cleanse applicator after each use and replace cover.Apply to the affected area up to 6 times daily or after each bowel movement.Children under 12 years of age: consult a doctor. This formulation utilizes a ointment delivery system. Marketed by Derma Wise Skin Care Ltd., this product is identified by NDC 43347-158 and is authorized under FDA application M016.

Identification & Billing

NDC Package Code
43347-158-01
Package Description
1 TUBE, WITH APPLICATOR in 1 BOX / 28 g in 1 TUBE, WITH APPLICATOR
Product Code
43347-158
11-Digit Billing Format
43347015801
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Thera Wise Natural Hemorrhoidal
Non-Proprietary Name
Witch Hazel
Substance Name
Witch Hazel
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.
  • 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)
WITCH HAZEL 3.36 g/28g
Usage Information
When first opening, tear away safety seal.Adult: When practical cleanse the affected area with mild soap and warm water and rinse thoroughly and / orpat and blot with appropriate cleansing pad.Gently dry by patting or blotting with a toilet tissue or a soft cloth before application of this product.FOR INTRARECTAL USE: Remove cover from applicator, attach applicator to the tube.Lubricate applicator well, then gently insert applicator into the rectum.Thoroughly cleanse applicator after each use and replace cover.Apply to the affected area up to 6 times daily or after each bowel movement.Children under 12 years of age: consult a doctor.

Regulatory & Marketing

Labeler Name
Derma Wise Skin Care Ltd.
Product Type
Human Otc Drug
FDA Application #
M016
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
08-15-2016
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 43347-158-01 identifies a specific commercial package of 1 tube, with applicator in 1 box / 28 g in 1 tube, with applicator of Thera Wise Natural Hemorrhoidal, a human over the counter drug labeled by Derma Wise Skin Care Ltd.. This ointment is formulated for rectal; topical use and contains witch hazel 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 Derma Wise Skin Care Ltd. on August 15, 2016. The current certification is valid through December 31, 2027.

How is this Derma Wise Skin Care Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 43347015801. 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)
43347-158-01
11-Digit CMS (5-4-2)
43347-0158-01

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