Calamine Plus Aerosol, Spray
NDC Package 46122-745-31

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

Package Information

Calamine Plus (calamine plus pramoxine hcl) aerosols is shake well before usingadults and children 2 years of age and older: apply as needed to the affected area, not more than 3 or 4 times daily cleanse the skin with soap and waterlet dry before usechildren under 2 years of age: consult a doctor. This formulation utilizes a aerosol, spray delivery system. Marketed by Amerisourcebergen Drug Corporation, this product is identified by NDC 46122-745 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
46122-745-31
Package Description
116 g in 1 CANISTER
Product Code
46122-745
11-Digit Billing Format
46122074531
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
116 GM
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
Calamine Plus Pramoxine Hcl
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
Shake well before usingadults and children 2 years of age and older: apply as needed to the affected area, not more than 3 or 4 times daily cleanse the skin with soap and waterlet dry before usechildren under 2 years of age: consult a doctor

Regulatory & Marketing

Labeler Name
Amerisourcebergen Drug Corporation
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-03-2023
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 46122-745-31 identifies a specific commercial package of 116 g in 1 canister of Calamine Plus, a human over the counter drug labeled by Amerisourcebergen Drug Corporation. 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 Amerisourcebergen Drug Corporation on January 03, 2023. The current certification is valid through December 31, 2026.

How is this Amerisourcebergen Drug Corporation product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 46122074531. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 116 total billable units per package. 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)
46122-745-31
11-Digit CMS (5-4-2)
46122-0745-31

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