Cooling Gel
NDC Package 13709-346-01

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

Package Information

Cooling Gel (pain relief cooling gel) gel is 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 soft cloth before applying gelWhen first opening the tube, puncture foil seal with the top end of the capApply externally to the affected area up to 4 times dailyChildren under 12 years of age: Ask a doctor. This formulation utilizes a gel delivery system. Marketed by Neilmed Pharmaceuticals Inc., this product is identified by NDC 13709-346 and is authorized under FDA application M015.

Identification & Billing

NDC Package Code
13709-346-01
Package Description
1 TUBE in 1 CARTON / 25.5 g in 1 TUBE
Product Code
13709-346
11-Digit Billing Format
13709034601
RxNorm Crosswalk
  • RxCUI: 2727426 - phenylephrine HCl 0.25 % / witch hazel 50.5 % Rectal Gel
  • RxCUI: 2727426 - phenylephrine hydrochloride 0.0025 MG/MG / witch hazel 0.505 MG/MG Rectal Gel
  • RxCUI: 2727426 - phenylephrine hydrochloride 0.25 % / witch hazel 50.5 % Rectal Gel

Clinical Specifications

Proprietary Name
Cooling Gel
Non-Proprietary Name
Pain Relief Cooling Gel
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
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 soft cloth before applying gelWhen first opening the tube, puncture foil seal with the top end of the capApply externally to the affected area up to 4 times dailyChildren under 12 years of age: Ask a doctor

Regulatory & Marketing

Labeler Name
Neilmed Pharmaceuticals Inc.
Product Type
Human Otc Drug
FDA Application #
M015
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
11-13-2025
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 13709-346-01 identifies a specific commercial package of 1 tube in 1 carton / 25.5 g in 1 tube of Cooling Gel, a human over the counter drug labeled by Neilmed Pharmaceuticals Inc.. 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 Neilmed Pharmaceuticals Inc. on November 13, 2025. The current certification is valid through December 31, 2026.

How is this Neilmed Pharmaceuticals Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 13709034601. 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)
13709-346-01
11-Digit CMS (5-4-2)
13709-0346-01

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