Is GC Medical Equipment, Inc. FDA approved?

GC Medical Equipment, Inc. holds 3 FDA-registered establishments across 2 countries. 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 GC Medical Equipment, Inc.'s drugs manufactured?

At registered sites in South Korea, the United States. The FDA register lists Chungcheongbuk-do 28119; Alsip, IL; Peninsula, OH. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.

What drugs does GC Medical Equipment, Inc. make?

14 products are listed under GC Medical Equipment, Inc. in the openFDA NDC Directory, most often as paste, dentifrice; gas; liquid. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

GC Medical Equipment, Inc.

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

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Registered sites: 3
Active NDC listings: 14
Labeller names: 3
Live patents: 0
Countries: 2
Base: United States

Authorisation

Registered operations

Analytical testing1Active ingredient (API) manufacture1Labelling1Finished drug manufacture3Packaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
GC Biopharma Corp_Ochang PlantRegistrant: GC Biopharma Corp.	586, Gwahaksaneop 2-ro, Ochang-eup, Cheongwon-gu, Cheongju, Chungcheongbuk-do 28119, Korea, South (KOR)	Analytical testing, Active ingredient (API) manufacture, Labelling, Finished drug manufacture, Packaging	3009561235689517000
GC America Inc.	3737 W. 127th Street, Alsip, Illinois (IL) 60803, United States (USA)	Finished drug manufacture	1410097005473608
GC Medical Equipment, Inc.	4655 State Road, Peninsula, Ohio (OH) 44264, United States (USA)	Finished drug manufacture	3003500482129946943

Catalogue

Drug listings by form and route

14 active NDC listings: 12 human otc drug, 1 human prescription drug, 1 plasma derivative. By marketing category: OTC MONOGRAPH DRUG 12, BLA 1, UNAPPROVED MEDICAL GAS 1.

Dosage form	NDCs
paste, dentifrice	12
gas	1
liquid	1

Route	NDCs
dental	12
intravenous	1
respiratory (inhalation)	1

Labeller name on the listing	NDCs
gc america inc.	12
gc biopharma corp.	1
gc medical equipment, inc.	1

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Alyglo	Human immunoglobulin G	liquid, intravenous	61476-104BLA
MIPaste One	MIPaste One	paste, dentifrice, dental	61596-400OTC MONOGRAPH DRUG
MIPaste One Kids Blue Raspberry	MIPaste One Kids Blue Raspberry	paste, dentifrice, dental	61596-103OTC MONOGRAPH DRUG
MIPaste One Kids Bubble Gum	MIPaste One Kids Bubble Gum	paste, dentifrice, dental	61596-101OTC MONOGRAPH DRUG
MIPaste One Kids Cotton Candy	MIPaste One Kids Cotton Candy	paste, dentifrice, dental	61596-102OTC MONOGRAPH DRUG
MIPaste One Perio	MIPaste One Perio	paste, dentifrice, dental	61596-300OTC MONOGRAPH DRUG
MIPaste Plus Melon	MIPaste Plus Melon	paste, dentifrice, dental	61596-804OTC MONOGRAPH DRUG
MIPaste Plus Mint	MIPaste Plus Mint	paste, dentifrice, dental	61596-801OTC MONOGRAPH DRUG
MIPaste Plus Strawberry	MIPaste Plus Strawberry	paste, dentifrice, dental	61596-800OTC MONOGRAPH DRUG
MIPaste Plus Strawberry	sodium fluoride	paste, dentifrice, dental	61596-986OTC MONOGRAPH DRUG
MIPaste Plus Tutti Frutti	MIPaste Plus Tutti Frutti	paste, dentifrice, dental	61596-803OTC MONOGRAPH DRUG
MIPaste Plus Vanilla	MIPaste Plus Vanilla	paste, dentifrice, dental	61596-802OTC MONOGRAPH DRUG
MIPasteOne Kids Blue Raspberry	MI Paste One Kids Blue Raspberry	paste, dentifrice, dental	61596-100OTC MONOGRAPH DRUG
Oxygen	Oxygen	gas, respiratory (inhalation)	66878-001UNAPPROVED MEDICAL GAS

Neighbours

Registered in the same town

Menasha Packaging Company LLCAlsip, IL

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Enquiry

Common questions

Is GC Medical Equipment, Inc. FDA approved?: GC Medical Equipment, Inc. holds 3 FDA-registered establishments across 2 countries. 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 GC Medical Equipment, Inc.'s drugs manufactured?: At registered sites in South Korea, the United States. The FDA register lists Chungcheongbuk-do 28119; Alsip, IL; Peninsula, OH. Registered operations: analytical testing, active ingredient (API) manufacture, labelling, finished drug manufacture, packaging.
What drugs does GC Medical Equipment, Inc. make?: 14 products are listed under GC Medical Equipment, Inc. in the openFDA NDC Directory, most often as paste, dentifrice; gas; liquid. 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.