Calmol 4 Suppository
NDC Package 67492-104-11

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

Package Information

Calmol 4 (zinc oxide and cocoa butter) suppositories is adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing padgently dry by patting or blotting with toilet tissue or a soft cloth before application of this productdetach one suppository from the strip; remove wrapper before inserting into rectum as follows: slowly peel down film wrapper by pulling evenly and slowly on tabs to expose suppositoryinsert 1 suppository bulb shape first into the rectum up to 6 times daily or after each bowl movementchildren under 12 years of age, consult a doctor. This formulation utilizes a suppository delivery system. Marketed by Resical Inc., this product is identified by NDC 67492-104 and is authorized under FDA application M015.

Identification & Billing

NDC Package Code
67492-104-11
Package Description
4 BLISTER PACK in 1 CARTON / 6 SUPPOSITORY in 1 BLISTER PACK
Product Code
67492-104
11-Digit Billing Format
67492010411
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
4 EA
RxNorm Crosswalk
  • RxCUI: 1049137 - cocoa butter 76 % / zinc oxide 10 % Rectal Suppository
  • RxCUI: 1049137 - cocoa butter 0.76 MG/MG / zinc oxide 0.1 MG/MG Rectal Suppository
  • RxCUI: 1049137 - cocoa butter 0.76 MG/MG / ZNO 0.1 MG/MG Rectal Suppository
  • RxCUI: 1113714 - Calmol 4, 76 % / 10 % Rectal Suppository
  • RxCUI: 1113714 - cocoa butter 0.76 MG/MG / zinc oxide 0.1 MG/MG Rectal Suppository [Calmol]

Clinical Specifications

Proprietary Name
Calmol 4
Non-Proprietary Name
Zinc Oxide And Cocoa Butter
Substance Name
Cocoa Butter; Zinc Oxide
Dosage Form
Suppository - A solid body of various weights and shapes, adapted for introduction into the rectal orifice of the human body; they usually melt, soften, or dissolve at body temperature.
Administration Route
Rectal - Administration to the rectum.
Active Ingredient(s)
Usage Information
Adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing padgently dry by patting or blotting with toilet tissue or a soft cloth before application of this productdetach one suppository from the strip; remove wrapper before inserting into rectum as follows: slowly peel down film wrapper by pulling evenly and slowly on tabs to expose suppositoryinsert 1 suppository bulb shape first into the rectum up to 6 times daily or after each bowl movementchildren under 12 years of age, consult a doctor

Regulatory & Marketing

Labeler Name
Resical Inc.
Product Type
Human Otc Drug
FDA Application #
M015
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
05-13-2006
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.

Other Available Packages

The following commercial packages are registered under the same Product NDC (67492-104). Click a package code to view its specific billing and regulatory data.

67492-104-12
2 BLISTER PACK in 1 CARTON / 6 SUPPOSITORY in 1 BLISTER PACK
67492-104-13
1 BLISTER PACK in 1 CARTON / 2 SUPPOSITORY in 1 BLISTER PACK

* 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 67492-104-11 identifies a specific commercial package of 4 blister pack in 1 carton / 6 suppository in 1 blister pack of Calmol 4, a human over the counter drug labeled by Resical Inc.. This product is billed for "EA" each discreet unit and contains an estimated amount of 4 billable units per package. This suppository is formulated for rectal use and contains cocoa butter; 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 Resical Inc. on May 13, 2006. The current certification is valid through December 31, 2026.

How is this Resical Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 67492010411. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 4 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)
67492-104-11
11-Digit CMS (5-4-2)
67492-0104-11

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