Calmoseptine Ointment
NDC Package 0799-0001-04
Package Information
Calmoseptine (anorectal ointment) ointment is adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly.Gently dry by patting or blotting with toilet tissue or a soft cloth or air dry before application of this product.Apply externally to the affected area up to 6 times daily or after each bowel movement.Children under 12 years of age: consult a doctor. This formulation utilizes a ointment delivery system. Marketed by Calmoseptine Inc., this product is identified by NDC 0799-0001 and is authorized under FDA application M015.
Identification & Billing
- RxCUI: 1946476 - lanolin 15.7 % / menthol 0.44 % / petrolatum 24 % / zinc oxide 20.6 % Topical Ointment
- RxCUI: 1946476 - lanolin 0.157 MG/MG / menthol 0.0044 MG/MG / petrolatum 0.24 MG/MG / zinc oxide 0.206 MG/MG Topical Ointment
- RxCUI: 1946476 - Lanolin 0.157 MG/MG / Menthol 0.0044 MG/MG / Petrolatum 0.24 MG/MG / ZNO 0.206 MG/MG Topical Ointment
- RxCUI: 1946481 - Calmoseptine 15.7 % / 0.44 % / 24 % / 20.6 % Topical Ointment
- RxCUI: 1946481 - lanolin 0.157 MG/MG / menthol 0.0044 MG/MG / petrolatum 0.24 MG/MG / zinc oxide 0.206 MG/MG Topical Ointment [Calmoseptine]
Clinical Specifications
Regulatory & Marketing
Hierarchy Structure
- 0799 - Calmoseptine Inc.
- 0799-0001 - Calmoseptine
- 0799-0001-04 - 113 g in 1 TUBE
- 0799-0001 - Calmoseptine
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 (0799-0001). Click a package code to view its specific billing and regulatory data.
* 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 0799-0001-04 identifies a specific commercial package of 113 g in 1 tube of Calmoseptine, a human over the counter drug labeled by Calmoseptine Inc.. This product is billed per "GM" gram and contains an estimated amount of 113 billable units per package. This ointment is formulated for topical use and contains lanolin; menthol; petrolatum; 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 Calmoseptine Inc. on August 01, 1950. The current certification is valid through December 31, 2026.
How is this Calmoseptine Inc. product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 00799000104. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 113 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:
Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.
