Cream
NDC Package 61354-080-10

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

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Cream is for sunscreen use:apply liberally 15 minutes before sun exposureuse a water resistant sunscreen if swimming or sweatingreapply at least every 2 hourschildren under 6 months ask a doctor. Marketed by Oxygen Development Llc, this product is identified by NDC 61354-080 and is authorized under FDA application part352.

Identification & Billing

NDC Package Code
61354-080-10
Package Description
1 BOTTLE in 1 CARTON / 3 mg in 1 BOTTLE (61354-080-04)
Product Code
61354-080
11-Digit Billing Format
61354008010

Clinical Specifications

Proprietary Name
Cream
Dosage Form
-
Usage Information
For sunscreen use:apply liberally 15 minutes before sun exposureuse a water resistant sunscreen if swimming or sweatingreapply at least every 2 hourschildren under 6 months ask a doctor

Regulatory & Marketing

Labeler Name
Oxygen Development Llc
FDA Application #
part352
Marketing Category
OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph.
Start Marketing Date
02-22-2021
Listing Expiration
12-31-2024
Exclude Flag
I
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 (61354-080). Click a package code to view its specific billing and regulatory data.

61354-080-07
1 BOTTLE in 1 CARTON / 3 mg in 1 BOTTLE (61354-080-01)
61354-080-08
1 BOTTLE in 1 CARTON / 3 mg in 1 BOTTLE (61354-080-02)
61354-080-12
1 BOTTLE in 1 CARTON / 3 mg in 1 BOTTLE (61354-080-06)

* 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 61354-080-10 identifies a specific commercial package of 1 bottle in 1 carton / 3 mg in 1 bottle (61354-080-04) of Cream, labeled by Oxygen Development Llc. This is formulated for use and contains as the active substance.

Is this product currently listed with the FDA?

This product code is currently listed as inactive or excluded from the primary directory. It was introduced to the market by Oxygen Development Llc on February 22, 2021. The current certification is valid through December 31, 2024.

How is this Oxygen Development Llc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 61354008010. 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)
61354-080-10
11-Digit CMS (5-4-2)
61354-0080-10

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