Calahist Clear Lotion
NDC Package 0363-9412-97

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

Package Information

Calahist Clear (pramoxine hydrochloride and zinc acetate) lotions is ■ shake well before using ■ cleanse the skin with soap and water ■ let dry before each use ■ apply lotion to the affected area using cotton or soft clothadults and children 2 years and olderNot more than 3 to 4 times daily as needed for comfortchildren under 2 yearsConsult a doctor before use. This formulation utilizes a lotion delivery system. Marketed by Walgreen Company, this product is identified by NDC 0363-9412 and is authorized under FDA application M016.

Identification & Billing

NDC Package Code
0363-9412-97
Package Description
177 mL in 1 BOTTLE
Product Code
0363-9412
11-Digit Billing Format
00363941297
RxNorm Crosswalk
  • RxCUI: 1234546 - pramoxine HCl 1 % / zinc acetate 0.1 % Topical Lotion
  • RxCUI: 1234546 - pramoxine hydrochloride 10 MG/ML / zinc acetate 1 MG/ML Topical Lotion

Clinical Specifications

Proprietary Name
Calahist Clear
Non-Proprietary Name
Pramoxine Hydrochloride And Zinc Acetate
Substance Name
Pramoxine Hydrochloride; Zinc Acetate
Dosage Form
Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2
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
■ shake well before using ■ cleanse the skin with soap and water ■ let dry before each use ■ apply lotion to the affected area using cotton or soft clothadults and children 2 years and olderNot more than 3 to 4 times daily as needed for comfortchildren under 2 yearsConsult a doctor before use

Regulatory & Marketing

Labeler Name
Walgreen Company
Product Type
Human Otc Drug
FDA Application #
M016
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
10-16-2023
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 0363-9412-97 identifies a specific commercial package of 177 ml in 1 bottle of Calahist Clear, a human over the counter drug labeled by Walgreen Company. This lotion is formulated for topical use and contains pramoxine 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 Walgreen Company on October 16, 2023. The current certification is valid through December 31, 2026.

How is this Walgreen Company product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00363941297. 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 (4-4-2)
0363-9412-97
11-Digit CMS (5-4-2)
00363-9412-97

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