Is RATIONALE GROUP PTY LTD FDA approved?

RATIONALE GROUP PTY LTD holds 1 FDA-registered establishment in Australia. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.

Where are RATIONALE GROUP PTY LTD's drugs manufactured?

The FDA register lists KYNETON. Registered operations: finished drug manufacture.

What drugs does RATIONALE GROUP PTY LTD make?

4 products are listed under RATIONALE GROUP PTY LTD in the openFDA NDC Directory, most often as emulsion; kit. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

RATIONALE GROUP PTY LTD

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

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Registered sites: 1
Active NDC listings: 2
Live patents: 0
Countries: 1
Base: Australia

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
RATIONALE GROUP PTY LTD	175 HIGH STREET, KYNETON, Victoria 3444, Australia (AUS)	Finished drug manufacture	3023425155756927393

Catalogue

Drug listings by form and route

2 active NDC listings: 2 human otc drug. By marketing category: OTC MONOGRAPH DRUG 2.

Dosage form	NDCs
emulsion	1
kit	1

Route	NDCs
topical	1

Labeller name on the listing	NDCs
rationale group pty ltd	2

Catalogue

Marketed products

Showing 2 of 4.

Brand	Generic name	Form / route	NDC
Rationale The Brilliance Tinted Serum SPF 50	ZINC OXIDE	emulsion, topical	83108-200OTC MONOGRAPH DRUG
Rationale The Discovery Travel Kit	ZINC OXIDE	kit	83108-210OTC MONOGRAPH DRUG

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Enquiry

Common questions

Is RATIONALE GROUP PTY LTD FDA approved?: RATIONALE GROUP PTY LTD holds 1 FDA-registered establishment in Australia. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
Where are RATIONALE GROUP PTY LTD's drugs manufactured?: The FDA register lists KYNETON. Registered operations: finished drug manufacture.
What drugs does RATIONALE GROUP PTY LTD make?: 4 products are listed under RATIONALE GROUP PTY LTD in the openFDA NDC Directory, most often as emulsion; kit. 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.