Is OTCM FDA approved?

OTCM holds 1 FDA-registered establishment in South Korea. 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 OTCM's drugs manufactured?

The FDA register lists 33658. Registered operations: finished drug manufacture.

What drugs does OTCM make?

1 product is listed under OTCM in the openFDA NDC Directory, most often as cream. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

OTCM

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

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Registered sites: 1
Active NDC listings: 1
Live patents: 0
Countries: 1
Base: South Korea

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
OTCM JANGHANG FACTORYRegistrant: OTCM	1000-1, Oknam-ri, Janghang-eup, Seocheon, 33658, Korea, South (KOR)	Finished drug manufacture	3038514538696834174

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
HERA UV PROTECTOR INVISIBLE SUNSCREEN	Avobenzone, Homosalate, Octisalate, Octocrylene	cream, topical	87746-150OTC MONOGRAPH DRUG

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Enquiry

Common questions

Is OTCM FDA approved?: OTCM holds 1 FDA-registered establishment in South Korea. 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 OTCM's drugs manufactured?: The FDA register lists 33658. Registered operations: finished drug manufacture.
What drugs does OTCM make?: 1 product is listed under OTCM in the openFDA NDC Directory, most often as cream. 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.