Pramoxine Hydrochloride Anorectal Lotion
NDC Package 58980-522-80

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

Pramoxine Hydrochloride Anorectal (pramoxine hydrochloride) lotions is shake well before using.When practical, cleansethe affected area with mild soap and warm water and rinse thoroughly.Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.Adults and children 12 years of age and older: apply to affected area up to five times daily.Children under 12 years of age, consult a Physician. This formulation utilizes a lotion delivery system. Marketed by Stratus Pharmaceuticals, this product is identified by NDC 58980-522 and is authorized under FDA application M015.

Identification & Billing

NDC Package Code
58980-522-80
Package Description
1 BOTTLE in 1 BOX / 237 mL in 1 BOTTLE
Product Code
58980-522
11-Digit Billing Format
58980052280
Billing Unit
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Pramoxine Hydrochloride Anorectal
Non-Proprietary Name
Pramoxine Hydrochloride
Substance Name
Pramoxine Hydrochloride
Dosage Form
Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2
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)
PRAMOXINE HYDROCHLORIDE 1 mg/mL
Usage Information
Shake well before using.When practical, cleansethe affected area with mild soap and warm water and rinse thoroughly.Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.Adults and children 12 years of age and older: apply to affected area up to five times daily.Children under 12 years of age, consult a Physician.

Regulatory & Marketing

Labeler Name
Stratus Pharmaceuticals
Product Type
Human Otc Drug
FDA Application #
M015
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
11-01-2025
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 (58980-522). Click a package code to view its specific billing and regulatory data.

58980-522-40
1 BOTTLE in 1 BOX / 118 mL in 1 BOTTLE

* 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 58980-522-80 identifies a specific commercial package of 1 bottle in 1 box / 237 ml in 1 bottle of Pramoxine Hydrochloride Anorectal, a human over the counter drug labeled by Stratus Pharmaceuticals. This lotion is formulated for topical use and contains pramoxine hydrochloride 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 Stratus Pharmaceuticals on November 01, 2025. The current certification is valid through December 31, 2026.

How is this Stratus Pharmaceuticals product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 58980052280. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. 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)
58980-522-80
11-Digit CMS (5-4-2)
58980-0522-80

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