Calaclear Lotion
NDC Package 49035-402-96

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

Package Information

Calaclear (pramoxine hydrochloride and zinc acetate) lotions is adults and children 2 yrs. This formulation utilizes a lotion delivery system. Marketed by Wal-mart Stores, Inc., this product is identified by NDC 49035-402 and is authorized under FDA application M016.

Identification & Billing

NDC Package Code
49035-402-96
Package Description
177 mL in 1 BOTTLE, PLASTIC
Product Code
49035-402
11-Digit Billing Format
49035040296
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
  • RxCUI: 1248193 - CALACLEAR 1 % / 0.1 % Topical Lotion
  • RxCUI: 1248193 - pramoxine hydrochloride 10 MG/ML / zinc acetate 1 MG/ML Topical Lotion [Calaclear]
  • RxCUI: 1248193 - Calaclear (pramoxine hydrochloride 1 % / zinc acetate 0.1 % ) Topical Lotion

Clinical Specifications

Proprietary Name
Calaclear
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
Adults and children 2 yrs. of age and older. Shake well before using. Cleanse the skin with soap and water and let dry before each use. Apply lotion to the affected area using cotton or soft cloth, not more than 3 to 4 times daily as needed for comfort.Children under 2 years of age: Consult a doctor before use.

Regulatory & Marketing

Labeler Name
Wal-mart Stores, Inc.
Product Type
Human Otc Drug
FDA Application #
M016
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-03-2018
Listing Expiration
12-31-2027
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 49035-402-96 identifies a specific commercial package of 177 ml in 1 bottle, plastic of Calaclear, a human over the counter drug labeled by Wal-mart Stores, Inc.. 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 Wal-mart Stores, Inc. on January 03, 2018. The current certification is valid through December 31, 2027.

How is this Wal-mart Stores, Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 49035040296. 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)
49035-402-96
11-Digit CMS (5-4-2)
49035-0402-96

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