Tact Cool Gel
NDC Package 49873-704-01

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

Package Information

Tact Cool (diphenhydramine hydrochloride, levomenthol) gel is uses temporarily relieves pain and itching associated with■insect bites    ■minor skin irritations    ■minor cuts■scrapes    ■rashes due to poison ivy    ■sunburn    ■minor burns. This formulation utilizes a gel delivery system. Marketed by Sato Pharmaceutical Co., Ltd., this product is identified by NDC 49873-704 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
49873-704-01
Package Description
1 TUBE in 1 CARTON / 20 g in 1 TUBE
Product Code
49873-704
11-Digit Billing Format
49873070401
RxNorm Crosswalk
  • RxCUI: 1235317 - diphenhydrAMINE HCl 2 % / levomenthol 1 % Topical Gel
  • RxCUI: 1235317 - diphenhydramine hydrochloride 0.02 MG/MG / levomenthol 0.01 MG/MG Topical Gel
  • RxCUI: 1235322 - Tact Cool Jelly 2 % / 1 % Topical Gel
  • RxCUI: 1235322 - diphenhydramine hydrochloride 0.02 MG/MG / levomenthol 0.01 MG/MG Topical Gel [Tact]
  • RxCUI: 1235322 - Tact (diphenhydramine HCl 2 % / l-menthol 1 % ) Topical Gel

Clinical Specifications

Proprietary Name
Tact Cool Jelly
Non-Proprietary Name
Diphenhydramine Hydrochloride, Levomenthol
Substance Name
Diphenhydramine Hydrochloride; Levomenthol
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
Uses temporarily relieves pain and itching associated with■insect bites    ■minor skin irritations    ■minor cuts■scrapes    ■rashes due to poison ivy    ■sunburn    ■minor burns

Regulatory & Marketing

Labeler Name
Sato Pharmaceutical Co., Ltd.
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
10-02-1997
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 49873-704-01 identifies a specific commercial package of 1 tube in 1 carton / 20 g in 1 tube of Tact Cool Jelly, a human over the counter drug labeled by Sato Pharmaceutical Co., Ltd.. This gel is formulated for topical use and contains diphenhydramine hydrochloride; levomenthol 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 Sato Pharmaceutical Co., Ltd. on October 02, 1997. The current certification is valid through December 31, 2026.

How is this Sato Pharmaceutical Co., Ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49873070401. 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)
49873-704-01
11-Digit CMS (5-4-2)
49873-0704-01

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