Granulotion
NDC Package 65121-885-23

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

Package Information

Granulotion (menthol, zinc oxide) lotions is when practical, cleanse the affected area with mild soap and warm water. This formulation utilizes a lotion delivery system. Marketed by Pure Source, Llc, this product is identified by NDC 65121-885 and is authorized under FDA application M015.

Identification & Billing

NDC Package Code
65121-885-23
Package Description
1 BOTTLE in 1 BOX / 28.349 g in 1 BOTTLE
Product Code
65121-885
11-Digit Billing Format
65121088523
RxNorm Crosswalk
  • RxCUI: 1492398 - menthol 0.11 % / zinc oxide 5.1 % Topical Lotion
  • RxCUI: 1492398 - menthol 1.1 MG/ML / zinc oxide 51 MG/ML Topical Lotion
  • RxCUI: 1492398 - Menthol 1.1 MG/ML / ZNO 51 MG/ML Topical Lotion
  • RxCUI: 1492403 - Granulotion 0.11 % / 5.1 % Topical Lotion
  • RxCUI: 1492403 - menthol 1.1 MG/ML / zinc oxide 51 MG/ML Topical Lotion [Granulotion Medicated Lotion]

Clinical Specifications

Proprietary Name
Granulotion
Non-Proprietary Name
Menthol, Zinc Oxide
Substance Name
Menthol; Zinc Oxide
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)
Pharmacologic Class
Usage Information
When practical, cleanse the affected area with mild soap and warm water. Pat or allow to air dry. Apply a layer of GranuLotion® up to 6 times daily for inflammation, 1 time per day for continued site maintenance. Use a soft tipped applicator for hard to reach areas. Repeat as needed to protect the skin or until the condition resolves.

Regulatory & Marketing

Labeler Name
Pure Source, Llc
Product Type
Human Otc Drug
FDA Application #
M015
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
03-26-2014
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 65121-885-23 identifies a specific commercial package of 1 bottle in 1 box / 28.349 g in 1 bottle of Granulotion, a human over the counter drug labeled by Pure Source, Llc. This lotion is formulated for topical use and contains menthol; 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 Pure Source, Llc on March 26, 2014. The current certification is valid through December 31, 2026.

How is this Pure Source, Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 65121088523. 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)
65121-885-23
11-Digit CMS (5-4-2)
65121-0885-23

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