Calamine Plus Pramoxine Hcl Aerosol, Spray
NDC Package 41250-235-41

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

Package Information

This product is approaching its end of marketing date. An upcoming end of marketing date means the product has been delisted but will remain in the NDC database until the end of marketing date is reached. In most cases, the FDA advises firms to use the expiration date of the last lot produced as the end marketing date, reflecting the possibility that the product may still be available even after manufacturing has stopped.

Calamine Plus Pramoxine Hcl (calamine plus spray) aerosols is shake well before usingadults and children 2 years of age and older: apply to affected area not more than 3 to 4 times dailycleanse 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 Meijer Distribution Inc., this product is identified by NDC 41250-235 and is authorized under FDA application M017.

Identification & Billing

NDC Package Code
41250-235-41
Package Description
116 g in 1 CANISTER
Product Code
41250-235
11-Digit Billing Format
41250023541
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 Pramoxine Hcl
Non-Proprietary Name
Calamine Plus Spray
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 to affected area not more than 3 to 4 times dailycleanse the skin with soap and waterlet dry before usechildren under 2 years of age: consult a doctor

Regulatory & Marketing

Labeler Name
Meijer Distribution Inc.
Product Type
Human Otc Drug
FDA Application #
M017
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
03-14-2020
End Marketing Date
06-30-2026
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 41250-235-41 identifies a specific commercial package of 116 g in 1 canister of Calamine Plus Pramoxine Hcl, a human over the counter drug labeled by Meijer Distribution 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 Meijer Distribution Inc. on March 14, 2020.

How is this Meijer Distribution Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 41250023541. 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)
41250-235-41
11-Digit CMS (5-4-2)
41250-0235-41

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