Itch Stopping Cream
NDC Package 69396-150-01

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

Package Information

Itch Stopping Cream (diphenhydramine hydrochloride 2%, zinc acetate 0.1%) cream is temporarily relieves pain and itching associated withinsect bitesminor burnsminor skin irritationsunburnscrapesrashes due to poison ivy, poison oak, and poison sumacdries the weeping and oozing of poison ivy, poison oak and poison sumac. This formulation utilizes a cream delivery system. Marketed by Trifecta Pharmaceuticals Usa, Llc., this product is identified by NDC 69396-150 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
69396-150-01
Package Description
1 TUBE in 1 BOX / 28.3 g in 1 TUBE
Product Code
69396-150
11-Digit Billing Format
69396015001
RxNorm Crosswalk
  • RxCUI: 1087026 - diphenhydrAMINE HCl 2 % / zinc acetate 0.1 % Topical Cream
  • RxCUI: 1087026 - diphenhydramine hydrochloride 20 MG/ML / zinc acetate 1 MG/ML Topical Cream
  • RxCUI: 1087026 - diphenhydramine hydrochloride 2 % / zinc acetate 0.1 % Topical Cream

Clinical Specifications

Proprietary Name
Itch Stopping Cream
Non-Proprietary Name
Diphenhydramine Hydrochloride 2%, Zinc Acetate 0.1%
Substance Name
Diphenhydramine Hydrochloride; Zinc Acetate
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
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
Temporarily relieves pain and itching associated withinsect bitesminor burnsminor skin irritationsunburnscrapesrashes due to poison ivy, poison oak, and poison sumacdries the weeping and oozing of poison ivy, poison oak and poison sumac

Regulatory & Marketing

Labeler Name
Trifecta Pharmaceuticals Usa, Llc.
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
11-29-2023
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 69396-150-01 identifies a specific commercial package of 1 tube in 1 box / 28.3 g in 1 tube of Itch Stopping Cream, a human over the counter drug labeled by Trifecta Pharmaceuticals Usa, Llc.. This cream is formulated for topical use and contains diphenhydramine hydrochloride; zinc acetate 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 Trifecta Pharmaceuticals Usa, Llc. on November 29, 2023. The current certification is valid through December 31, 2026.

How is this Trifecta Pharmaceuticals Usa, Llc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69396015001. 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)
69396-150-01
11-Digit CMS (5-4-2)
69396-0150-01

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