Hemorroidal Cooling Gel
NDC Package 68016-054-09

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

Package Information

Hemorroidal Cooling Gel (phenylephrine, witch hazel) gel is children under 12 years of age; ask a doctor before useAdults: when practical, clean the affected area by patting or blotting with an appropriate cleansing wipegently dry by patting or blotting with a tissue or soft cloth before applyingwhen first opening tube, remove foil sealapply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement. This formulation utilizes a gel delivery system. Marketed by Pharmacy Value Alliance, Llc, this product is identified by NDC 68016-054 and is authorized under FDA application M015.

Identification & Billing

NDC Package Code
68016-054-09
Package Description
1 TUBE in 1 BOX / 26 g in 1 TUBE
Product Code
68016-054
11-Digit Billing Format
68016005409

Clinical Specifications

Proprietary Name
Hemorroidal Cooling Gel
Non-Proprietary Name
Phenylephrine, Witch Hazel
Substance Name
Phenylephrine Hydrochloride; Witch Hazel
Dosage Form
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
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
Children under 12 years of age; ask a doctor before useAdults: when practical, clean the affected area by patting or blotting with an appropriate cleansing wipegently dry by patting or blotting with a tissue or soft cloth before applyingwhen first opening tube, remove foil sealapply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement

Regulatory & Marketing

Labeler Name
Pharmacy Value Alliance, Llc
Product Type
Human Otc Drug
FDA Application #
M015
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
08-02-2018
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 68016-054-09 identifies a specific commercial package of 1 tube in 1 box / 26 g in 1 tube of Hemorroidal Cooling Gel, a human over the counter drug labeled by Pharmacy Value Alliance, Llc. This gel is formulated for topical use and contains phenylephrine hydrochloride; 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 Pharmacy Value Alliance, Llc on August 02, 2018. The current certification is valid through December 31, 2026.

How is this Pharmacy Value Alliance, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 68016005409. 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)
68016-054-09
11-Digit CMS (5-4-2)
68016-0054-09

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