Is iSmile Dental Products, Inc. FDA approved?

iSmile Dental Products, Inc. holds no registered establishment of its own; 6 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does iSmile Dental Products, Inc. make?

6 products are listed under iSmile Dental Products, Inc. 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.

iSmile Dental Products, Inc.

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

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Registered sites: 0
Active NDC listings: 6
Live patents: 0
Countries: 0

Catalogue

Drug listings by form and route

6 active NDC listings: 6 human otc drug. By marketing category: OTC MONOGRAPH DRUG 6.

Dosage form	NDCs
gel	6

Route	NDCs
dental	6

Labeller name on the listing	NDCs
ismile dental products, inc.	6

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
iSmile Topical Anesthetic	Benzocaine	gel, dental	69498-001OTC MONOGRAPH DRUG
iSmile Topical Anesthetic	Benzocaine	gel, dental	69498-002OTC MONOGRAPH DRUG
iSmile Topical Anesthetic	Benzocaine	gel, dental	69498-003OTC MONOGRAPH DRUG
iSmile Topical Anesthetic	Benzocaine	gel, dental	69498-004OTC MONOGRAPH DRUG
iSmile Topical Anesthetic	Benzocaine	gel, dental	69498-005OTC MONOGRAPH DRUG
iSmile Topical Anesthetic	Benzocaine	gel, dental	69498-006OTC MONOGRAPH DRUG

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Enquiry

Common questions

Is iSmile Dental Products, Inc. FDA approved?: iSmile Dental Products, Inc. holds no registered establishment of its own; 6 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does iSmile Dental Products, Inc. make?: 6 products are listed under iSmile Dental Products, Inc. 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.