Balmex Multi-purpose Ointment
NDC Package 52412-450-35

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

Package Information

Balmex Multi-purpose (petrolatum) ointment is apply as neededchange wet or soiled diapers promptly, cleanse the diaper area, and allow to dryapply ointment liberally as often as necessary, with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged. This formulation utilizes a ointment delivery system. Marketed by Randob Labs,ltd., this product is identified by NDC 52412-450 and is authorized under FDA application part347.

Identification & Billing

NDC Package Code
52412-450-35
Package Description
99 g in 1 TUBE
Product Code
52412-450
11-Digit Billing Format
52412045035
Billing Unit
GM - Billing unit of "gram" is used when a product is measured by its weight.
Units Per Package
99 GM
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Balmex Multi-purpose
Non-Proprietary Name
Petrolatum
Substance Name
Petrolatum
Dosage Form
Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
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)
PETROLATUM 511 mg/g
Usage Information
Apply as neededchange wet or soiled diapers promptly, cleanse the diaper area, and allow to dryapply ointment liberally as often as necessary, with each diaper change, especially at bedtime or any time when exposure to wet diapers may be prolonged

Regulatory & Marketing

Labeler Name
Randob Labs,ltd.
Product Type
Human Otc Drug
FDA Application #
part347
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
04-27-2015
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 52412-450-35 identifies a specific commercial package of 99 g in 1 tube of Balmex Multi-purpose, a human over the counter drug labeled by Randob Labs,ltd.. This product is billed per "GM" gram and contains an estimated amount of 99 billable units per package. This ointment is formulated for topical use and contains petrolatum 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 Randob Labs,ltd. on April 27, 2015. The current certification is valid through December 31, 2026.

How is this Randob Labs,ltd. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 52412045035. Quantities are measured in per "gm or gram", products billed per gram are products measured by weight.. There are 99 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)
52412-450-35
11-Digit CMS (5-4-2)
52412-0450-35

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