Calamine Plus Aerosol, Spray
NDC Package 49035-030-01

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

Package Information

Calamine Plus (ferric oxide red, pramoxine hydrochloride, zinc oxide) aerosols is directionsshake well before usingadults and children 2 years of age and oldercleanse the skin with soap and waterlet dry before useapply as needed to the affected area, not more than 3 to 4 times a day. This formulation utilizes a aerosol, spray delivery system. Marketed by Wal-mart Stores, Inc., this product is identified by NDC 49035-030 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
49035-030-01
Package Description
177 mL in 1 CANISTER
Product Code
49035-030
11-Digit Billing Format
49035003001
RxNorm Crosswalk
  • RxCUI: 1544717 - calamine 8 % / pramoxine HCl 1 % Topical Spray
  • RxCUI: 1544717 - calamine 80 MG/ML / pramoxine hydrochloride 10 MG/ML Topical Spray
  • RxCUI: 1544717 - calamine 8 % / pramoxine hydrochloride 1 % Topical Spray

Clinical Specifications

Proprietary Name
Calamine Plus
Non-Proprietary Name
Ferric Oxide Red, Pramoxine Hydrochloride, Zinc Oxide
Substance Name
Ferric Oxide Red; Pramoxine Hydrochloride; Zinc Oxide
Dosage Form
Aerosol, Spray - An aerosol product which utilizes a compressed gas as the propellant to provide the force necessary to expel the product as a wet spray; it is applicable to solutions of medicinal agents in aqueous solvents.
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)
Usage Information
Directionsshake well before usingadults and children 2 years of age and oldercleanse the skin with soap and waterlet dry before useapply as needed to the affected area, not more than 3 to 4 times a day

Regulatory & Marketing

Labeler Name
Wal-mart Stores, Inc.
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
03-03-2013
End Marketing Date
09-30-2026
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 49035-030-01 identifies a specific commercial package of 177 ml in 1 canister of Calamine Plus, a human over the counter drug labeled by Wal-mart Stores, Inc.. This aerosol, spray is formulated for topical use and contains ferric oxide red; pramoxine hydrochloride; zinc oxide 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 March 03, 2013.

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: 49035003001. 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)
49035-030-01
11-Digit CMS (5-4-2)
49035-0030-01

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