Bite And Itch Lotion
NDC Package 11383-192-01

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

Package Information

Bite And Itch (diphenhydramine hydrochloride, pramoxine hydrochloride) lotions is usesTemporarily relieves pain and itching due to:scrapessunburnminor cutsminor burnsinsect bitesminor skin irritationspoison ivy, poison oak, or poison sumac. This formulation utilizes a lotion delivery system. Marketed by Weeks & Leo Co., Inc., this product is identified by NDC 11383-192 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
11383-192-01
Package Description
1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE
Product Code
11383-192
11-Digit Billing Format
11383019201
RxNorm Crosswalk
  • RxCUI: 1292321 - diphenhydrAMINE HCl 2 % / pramoxine HCl 1 % Topical Lotion
  • RxCUI: 1292321 - diphenhydramine hydrochloride 20 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Lotion
  • RxCUI: 1292321 - diphenhydramine hydrochloride 2 % / pramoxine hydrochloride 1 % Topical Lotion

Clinical Specifications

Proprietary Name
Bite And Itch
Non-Proprietary Name
Diphenhydramine Hydrochloride, Pramoxine Hydrochloride
Substance Name
Diphenhydramine Hydrochloride; Pramoxine Hydrochloride
Dosage Form
Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2
Administration Route
Cutaneous - Administration to the skin.
Active Ingredient(s)
Pharmacologic Class
Usage Information
UsesTemporarily relieves pain and itching due to:scrapessunburnminor cutsminor burnsinsect bitesminor skin irritationspoison ivy, poison oak, or poison sumac

Regulatory & Marketing

Labeler Name
Weeks & Leo Co., Inc.
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
06-15-2015
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (11383-192). Click a package code to view its specific billing and regulatory data.

11383-192-04
118 mL in 1 BOTTLE

* 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 11383-192-01 identifies a specific commercial package of 1 bottle in 1 carton / 118 ml in 1 bottle of Bite And Itch, a human over the counter drug labeled by Weeks & Leo Co., Inc.. This lotion is formulated for cutaneous use and contains diphenhydramine hydrochloride; pramoxine hydrochloride 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 Weeks & Leo Co., Inc. on June 15, 2015. The current certification is valid through December 31, 2026.

How is this Weeks & Leo Co., Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 11383019201. 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)
11383-192-01
11-Digit CMS (5-4-2)
11383-0192-01

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