Anti-itch Cream
NDC Package 80489-005-01

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

Package Information

Anti-itch (zinc acetate , diphenhydramine) cream is a medication used to temporarily relieve itching and pain caused by minor burns/cuts/scrapes, sunburn, insect bites, minor skin irritations, or rashes from poison ivy, poison oak, or poison sumac. This formulation utilizes a cream delivery system. Marketed by Ol Pharma Tech, Llc, this product is identified by NDC 80489-005 and is authorized under FDA application M016.

Identification & Billing

NDC Package Code
80489-005-01
Package Description
1 TUBE in 1 CARTON / 28.3 g in 1 TUBE
Product Code
80489-005
11-Digit Billing Format
80489000501
RxNorm Crosswalk
  • RxCUI: 1292313 - diphenhydrAMINE HCl 1 % / zinc acetate 0.1 % Topical Cream
  • RxCUI: 1292313 - diphenhydramine hydrochloride 10 MG/ML / zinc acetate 1 MG/ML Topical Cream
  • RxCUI: 1292313 - diphenhydramine hydrochloride 1 % / zinc acetate 0.1 % Topical Cream

Clinical Specifications

Proprietary Name
Anti-itch
Non-Proprietary Name
Zinc Acetate , Diphenhydramine
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
This medication is used to temporarily relieve itching and pain caused by minor burns/cuts/scrapes, sunburn, insect bites, minor skin irritations, or rashes from poison ivy, poison oak, or poison sumac. Diphenhydramine belongs to a class of drugs known as antihistamines. It works by blocking the effects of a certain natural substance (histamine) that causes itching. This product may also contain other ingredients (skin protectants such as allantoin, zinc acetate) that may help relieve symptoms such as dry skin, weeping, or oozing. Read the product package for more information. Depending on the brand and the form of diphenhydramine skin product you are using, the package information may state that its use is not recommended in children younger than 2, 6, or 12 years unless directed by the doctor. If you are self-treating with this medication, it is important to read the package instructions carefully before you start using this product to be sure it is right for you. (See also Precautions section.)

Regulatory & Marketing

Labeler Name
Ol Pharma Tech, Llc
Product Type
Human Otc Drug
FDA Application #
M016
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-01-2021
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 80489-005-01 identifies a specific commercial package of 1 tube in 1 carton / 28.3 g in 1 tube of Anti-itch, a human over the counter drug labeled by Ol Pharma Tech, 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 Ol Pharma Tech, Llc on January 01, 2021. The current certification is valid through December 31, 2026.

What are the primary indications for this medication?

This medication is used to temporarily relieve itching and pain caused by minor burns/cuts/scrapes, sunburn, insect bites, minor skin irritations, or rashes from poison ivy, poison oak, or poison sumac. Diphenhydramine belongs to a class of drugs known as antihistamines. It works by blocking the effects of a certain natural substance (histamine) that causes itching. This product may also contain other ingredients (skin protectants such as allantoin, zinc acetate) that may help relieve symptoms such as dry skin, weeping, or oozing. Read the product package for more information. Depending on the brand and the form of diphenhydramine skin product you are using, the package information may state that its use is not recommended in children younger than 2, 6, or 12 years unless directed by the doctor. If you are self-treating with this medication, it is important to read the package instructions carefully before you start using this product to be sure it is right for you. (See also Precautions section.)

How is this Ol Pharma Tech, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 80489000501. 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)
80489-005-01
11-Digit CMS (5-4-2)
80489-0005-01

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