Is Burkhart Dental Supply Co., Inc FDA approved?

Burkhart Dental Supply Co., Inc holds no registered establishment of its own; 28 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Burkhart Dental Supply Co., Inc make?

28 products are listed under Burkhart Dental Supply Co., Inc in the openFDA NDC Directory, most often as gel; concentrate; injection, solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Burkhart Dental Supply Co., Inc

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

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Registered sites: 0
Active NDC listings: 28
Labeller names: 2
Live patents: 0
Countries: 0

Catalogue

Drug listings by form and route

28 active NDC listings: 16 human prescription drug, 12 human otc drug. By marketing category: UNAPPROVED DRUG OTHER 14, OTC MONOGRAPH DRUG 12, NDA AUTHORIZED GENERIC 2.

Dosage form	NDCs
gel	24
concentrate	2
injection, solution	2

Route	NDCs
dental	26
submucosal	2

Labeller name on the listing	NDCs
burkhart dental supply inc	26
burkhart dental supply co., inc	2

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Articaine Hydrochloride and Epinephrine	ARTICAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATE	injection, solution, submucosal	43498-816NDA AUTHORIZED GENERIC
Articaine Hydrochloride and Epinephrine	ARTICAINE HYDROCHLORIDE, EPINEPHRINE BITARTRATE	injection, solution, submucosal	43498-993NDA AUTHORIZED GENERIC
Burkhart	Sodium Fluoride	gel, dental	43498-100UNAPPROVED DRUG OTHER
Burkhart	Sodium Fluoride	gel, dental	43498-101UNAPPROVED DRUG OTHER
Burkhart	Sodium Fluoride	gel, dental	43498-102UNAPPROVED DRUG OTHER
Burkhart	Sodium Fluoride	gel, dental	43498-103UNAPPROVED DRUG OTHER
Burkhart	Sodium Fluoride	gel, dental	43498-104UNAPPROVED DRUG OTHER
Burkhart	Sodium Fluoride	gel, dental	43498-105UNAPPROVED DRUG OTHER
Burkhart	Sodium Fluoride	gel, dental	43498-106UNAPPROVED DRUG OTHER
Burkhart	Sodium Fluoride	gel, dental	43498-107UNAPPROVED DRUG OTHER
Burkhart	Sodium Fluoride	gel, dental	43498-108UNAPPROVED DRUG OTHER
Burkhart	Sodium Fluoride	gel, dental	43498-109UNAPPROVED DRUG OTHER
Burkhart	Stannous Fluoride	concentrate, dental	43498-200UNAPPROVED DRUG OTHER
Burkhart	Stannous Fluoride	concentrate, dental	43498-201UNAPPROVED DRUG OTHER
Burkhart	Stannous Fluoride	gel, dental	43498-250OTC MONOGRAPH DRUG
Burkhart	Stannous Fluoride	gel, dental	43498-251OTC MONOGRAPH DRUG
Burkhart Neutral pH	Sodium Fluoride	gel, dental	43498-150UNAPPROVED DRUG OTHER
Burkhart Neutral pH	Sodium Fluoride	gel, dental	43498-151UNAPPROVED DRUG OTHER
Burkhart Topical Anesthetic	Benzocaine	gel, dental	43498-310OTC MONOGRAPH DRUG
Burkhart Topical Anesthetic	Benzocaine	gel, dental	43498-311OTC MONOGRAPH DRUG
Burkhart Topical Anesthetic	Benzocaine	gel, dental	43498-312OTC MONOGRAPH DRUG
Burkhart Topical Anesthetic	Benzocaine	gel, dental	43498-313OTC MONOGRAPH DRUG
Burkhart Topical Anesthetic	Benzocaine	gel, dental	43498-314OTC MONOGRAPH DRUG
Burkhart Topical Anesthetic	Benzocaine	gel, dental	43498-315OTC MONOGRAPH DRUG
Burkhart Topical Anesthetic	Benzocaine	gel, dental	43498-316OTC MONOGRAPH DRUG
Burkhart Topical Anesthetic	Benzocaine	gel, dental	43498-317OTC MONOGRAPH DRUG
Burkhart Topical Anesthetic	Benzocaine	gel, dental	43498-318OTC MONOGRAPH DRUG
Burkhart Topical Anesthetic	Benzocaine	gel, dental	43498-319OTC MONOGRAPH DRUG

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Enquiry

Common questions

Is Burkhart Dental Supply Co., Inc FDA approved?: Burkhart Dental Supply Co., Inc holds no registered establishment of its own; 28 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Burkhart Dental Supply Co., Inc make?: 28 products are listed under Burkhart Dental Supply Co., Inc in the openFDA NDC Directory, most often as gel; concentrate; injection, 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.