Is Australian Gold FDA approved?

Australian Gold holds no registered establishment of its own; 5 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Australian Gold make?

5 products are listed under Australian Gold in the openFDA NDC Directory, most often as stick. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Australian Gold

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 0
Active NDC listings: 5
Live patents: 0
Countries: 0

Catalogue

Drug listings by form and route

5 active NDC listings: 5 human otc drug. By marketing category: OTC MONOGRAPH DRUG 5.

Dosage form	NDCs
stick	5

Route	NDCs
topical	5

Labeller name on the listing	NDCs
australian gold	5

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Australian Gold SPF 15 Lip Balm	Octinoxate, Octocrylene, Oxybenzone, Octisalate, Petroleum Jelly	stick, topical	84061-128OTC MONOGRAPH DRUG
Australian Gold SPF 30 Lip Balm	Avobenzone, Homosalate, Octisalate, Petrolatum	stick, topical	84061-125OTC MONOGRAPH DRUG
Australian Gold SPF 30 Lip Balm	Avobenzone, Homosalate, Octisalate, Petrolatum	stick, topical	84061-126OTC MONOGRAPH DRUG
Designer Lip Smoothie SPF 15 Lip Balm	Avobenzone, Octisalate, Homosalate, Petrolatum	stick, topical	84061-127OTC MONOGRAPH DRUG
SPF 50 Sunscreen Stick	Zinc Oxide	stick, topical	84061-129OTC MONOGRAPH DRUG

Enquiry

Common questions

Is Australian Gold FDA approved?: Australian Gold holds no registered establishment of its own; 5 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Australian Gold make?: 5 products are listed under Australian Gold in the openFDA NDC Directory, most often as stick. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.