Is KUTOL PRODUCTS COMPANY FDA approved?

KUTOL PRODUCTS COMPANY holds 1 FDA-registered establishment in the United States. 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 KUTOL PRODUCTS COMPANY's drugs manufactured?

The FDA register lists SHARONVILLE, OH. Registered operations: finished drug manufacture.

What drugs does KUTOL PRODUCTS COMPANY make?

9 products are listed under KUTOL PRODUCTS COMPANY in the openFDA NDC Directory, most often as soap; solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

KUTOL PRODUCTS COMPANY

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

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Registered sites: 1
Active NDC listings: 9
Labeller names: 3
Live patents: 0
Countries: 1
Base: United States

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
KUTOL PRODUCTS COMPANY	100 PARTNERSHIP WAY, SHARONVILLE, Ohio (OH) 45241, United States (USA)	Finished drug manufacture	1513988004236139

Catalogue

Drug listings by form and route

9 active NDC listings: 9 human otc drug. By marketing category: OTC MONOGRAPH DRUG 9.

Dosage form	NDCs
soap	5
solution	4

Route	NDCs
topical	9

Labeller name on the listing	NDCs
kutol products company	6
kutol products company, inc.	2
kutol products company	1

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Antibacterial Hand Cleanser	Benzalkonium chloride	soap, topical	50865-215OTC MONOGRAPH DRUG
E2 SANITIZING HAND	E2 SANITIZING HAND	soap, topical	50865-017OTC MONOGRAPH DRUG
Foaming Advanced Antibacterial Hand	benzalkonium chloride	soap, topical	50865-213OTC MONOGRAPH DRUG
Foaming Sanitizing Hand	benzalkonium chloride	soap, topical	50865-683OTC MONOGRAPH DRUG
Foaming Sanitizing Hand	alcohol	soap, topical	50865-710OTC MONOGRAPH DRUG
Golden Medicated	Medicated Lotion Soap	solution, topical	50865-060OTC MONOGRAPH DRUG
Santi-Gel Instant Hand Sanitizer	Santi-Gel Instant Hand Sanitizer	solution, topical	50865-056OTC MONOGRAPH DRUG
Soft and Silky Antiseptic	Antiseptic Lotion Soap	solution, topical	50865-025OTC MONOGRAPH DRUG
eZFoam Foaming Alcohol Hand Sanitizer	Foaming Hand Sanitizer	solution, topical	50865-688OTC MONOGRAPH DRUG

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Enquiry

Common questions

Is KUTOL PRODUCTS COMPANY FDA approved?: KUTOL PRODUCTS COMPANY holds 1 FDA-registered establishment in the United States. 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 KUTOL PRODUCTS COMPANY's drugs manufactured?: The FDA register lists SHARONVILLE, OH. Registered operations: finished drug manufacture.
What drugs does KUTOL PRODUCTS COMPANY make?: 9 products are listed under KUTOL PRODUCTS COMPANY in the openFDA NDC Directory, most often as soap; solution. 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.