Is CONE MEDICAL Co., Ltd. FDA approved?

CONE MEDICAL Co., Ltd. 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 CONE MEDICAL Co., Ltd.'s drugs manufactured?

The FDA register lists Gyeonggi 12918. Registered operations: labelling, finished drug manufacture, relabelling.

What drugs does CONE MEDICAL Co., Ltd. make?

4 products are listed under CONE MEDICAL Co., Ltd. in the openFDA NDC Directory, most often as paste; paste, dentifrice. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

CONE MEDICAL Co., Ltd.

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

Request a quote Claim this profile

Registered sites: 1
Active NDC listings: 4
Live patents: 0
Countries: 1
Base: South Korea

Authorisation

Registered operations

Labelling1Finished drug manufacture1Relabelling1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
CONE MEDICAL Co., Ltd.	45 Jojeong-daero, Hanam, Gyeonggi 12918, Korea, South (KOR)	Labelling, Finished drug manufacture, Relabelling	3021615151695811691

Catalogue

Drug listings by form and route

4 active NDC listings: 4 human otc drug. By marketing category: UNAPPROVED DRUG OTHER 4.

Dosage form	NDCs
paste	2
paste, dentifrice	2

Route	NDCs
dental	4

Labeller name on the listing	NDCs
cone medical co., ltd.	4

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
MIMIBO PREMIUM TOOTH	Silicon Dioxide, Tocopherol Acetate, Tetrasodium Pyrophosphate	paste, dentifrice, dental	73527-0003UNAPPROVED DRUG OTHER
MIMIBO PREMIUM TOOTH	Silicon Dioxide, Tocopherol Acetate, Tetrasodium Pyrophosphate	paste, dentifrice, dental	73527-0004UNAPPROVED DRUG OTHER
ONETOOTH CLINIC TOOTH	Silicon Dioxide, Tocopherol Acetate, Tetrasodium Pyrophosphate	paste, dental	73527-0002UNAPPROVED DRUG OTHER
ONETOOTHCLINIC TOOTH	Silicon Dioxide, Tocopherol Acetate, Sodium Pyrophosphate	paste, dental	73527-0001UNAPPROVED DRUG OTHER

Compare

Comparable companies in South Korea

Aekyung Industrial Co., Ltd.1 site · 64 NDC
Amorepacific Group1 site · 53 NDC
I World Pharmaceutical Co., Ltd.1 site · 48 NDC
CELLTRION Inc1 site · 36 NDC
LAON COMMERCE CO LTD1 site · 28 NDC
TAI GUK PHARM. CO., LTD1 site · 28 NDC
Lydia Co Ltd.1 site · 27 NDC
SUNJIN BEAUTY SCIENCE CO., LTD.1 site · 27 NDC
fmg Co.Ltd1 site · 23 NDC
DONG IL PHARMS CO., LTD.1 site · 17 NDC

Enquiry

Common questions

Is CONE MEDICAL Co., Ltd. FDA approved?: CONE MEDICAL Co., Ltd. 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 CONE MEDICAL Co., Ltd.'s drugs manufactured?: The FDA register lists Gyeonggi 12918. Registered operations: labelling, finished drug manufacture, relabelling.
What drugs does CONE MEDICAL Co., Ltd. make?: 4 products are listed under CONE MEDICAL Co., Ltd. in the openFDA NDC Directory, most often as paste; paste, dentifrice. 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.