Australian Gold Spf 15 Lip Balm Stick
NDC Package 84061-128-01

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

Package Information

Australian Gold Spf 15 Lip Balm (octinoxate, octocrylene, oxybenzone, octisalate, petroleum jelly) sticks is apply liberally before sun exposure and as needed. This formulation utilizes a stick delivery system. Marketed by Australian Gold, this product is identified by NDC 84061-128 and is authorized under FDA application M020.

Identification & Billing

NDC Package Code
84061-128-01
Package Description
1 g in 1 CONTAINER
Product Code
84061-128
11-Digit Billing Format
84061012801

Clinical Specifications

Proprietary Name
Australian Gold Spf 15 Lip Balm
Non-Proprietary Name
Octinoxate, Octocrylene, Oxybenzone, Octisalate, Petroleum Jelly
Substance Name
Octinoxate; Octisalate; Octocrylene; Oxybenzone; Petrolatum
Dosage Form
Stick - A dosage form prepared in a relatively long and slender often cylindrical form.
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)
Usage Information
Apply liberally before sun exposure and as needed. Children under 6 months of age: Ask a doctor before use.

Regulatory & Marketing

Labeler Name
Australian Gold
Product Type
Human Otc Drug
FDA Application #
M020
Marketing Category
OTC MONOGRAPH DRUG -
Start Marketing Date
01-01-2025
Listing Expiration
12-31-2027
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 84061-128-01 identifies a specific commercial package of 1 g in 1 container of Australian Gold Spf 15 Lip Balm, a human over the counter drug labeled by Australian Gold. This stick is formulated for topical use and contains octinoxate; octisalate; octocrylene; oxybenzone; 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 Australian Gold on January 01, 2025. The current certification is valid through December 31, 2027.

How is this Australian Gold product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 84061012801. 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)
84061-128-01
11-Digit CMS (5-4-2)
84061-0128-01

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