Itch Relief Cream
NDC Package 69452-449-37

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

Package Information

Itch Relief (diphenhydramine hydrochloride and zinc acetate) cream is ■ children under 2 years of age: ask a doctor ■ adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily ■ do not use more than directed. This formulation utilizes a cream delivery system. Marketed by Bionpharma Inc., this product is identified by NDC 69452-449 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
69452-449-37
Package Description
1 TUBE in 1 CARTON / 35.4 g in 1 TUBE
Product Code
69452-449
11-Digit Billing Format
69452044937
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 Relief
Non-Proprietary Name
Diphenhydramine Hydrochloride And Zinc Acetate
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
■ children under 2 years of age: ask a doctor ■ adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily ■ do not use more than directed

Regulatory & Marketing

Labeler Name
Bionpharma Inc.
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
07-16-2024
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 69452-449-37 identifies a specific commercial package of 1 tube in 1 carton / 35.4 g in 1 tube of Itch Relief, a human over the counter drug labeled by Bionpharma Inc.. 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 Bionpharma Inc. on July 16, 2024. The current certification is valid through December 31, 2026.

How is this Bionpharma Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69452044937. 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)
69452-449-37
11-Digit CMS (5-4-2)
69452-0449-37

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