Is Mydent International FDA approved?

Mydent International holds no registered establishment of its own; 7 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Mydent International make?

7 products are listed under Mydent International in the openFDA NDC Directory, most often as gel. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Mydent International

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

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Registered sites: 0
Active NDC listings: 7
Live patents: 0
Countries: 0

Catalogue

Drug listings by form and route

7 active NDC listings: 7 human otc drug. By marketing category: OTC MONOGRAPH DRUG 7.

Dosage form	NDCs
gel	7

Route	NDCs
dental	7

Labeller name on the listing	NDCs
mydent international	7

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Defend	Benzocaine	gel, dental	70721-001OTC MONOGRAPH DRUG
Defend	Benzocaine	gel, dental	70721-002OTC MONOGRAPH DRUG
Defend	Benzocaine	gel, dental	70721-003OTC MONOGRAPH DRUG
Defend	Benzocaine	gel, dental	70721-004OTC MONOGRAPH DRUG
Defend	Benzocaine	gel, dental	70721-005OTC MONOGRAPH DRUG
Defend	Benzocaine	gel, dental	70721-006OTC MONOGRAPH DRUG
Defend	Benzocaine	gel, dental	70721-007OTC MONOGRAPH DRUG

Compare

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Enquiry

Common questions

Is Mydent International FDA approved?: Mydent International holds no registered establishment of its own; 7 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Mydent International make?: 7 products are listed under Mydent International in the openFDA NDC Directory, most often as gel. 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.