Is Dharma Research, Inc. FDA approved?

Dharma Research, Inc. 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 Dharma Research, Inc.'s drugs manufactured?

The FDA register lists Miami, FL. Registered operations: finished drug manufacture.

What drugs does Dharma Research, Inc. make?

42 products are listed under Dharma Research, Inc. in the openFDA NDC Directory, most often as gel; aerosol, foam; gel, dentifrice. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Dharma Research, Inc.

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

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Registered sites: 1
Active NDC listings: 42
Labeller names: 2
Live patents: 0
Countries: 1
Base: United States

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Dharma Research, Inc.	5220 NW 72nd Avenue Bay 15, Miami, Florida (FL) 33166, United States (USA)	Finished drug manufacture	3010131268078444642

Catalogue

Drug listings by form and route

42 active NDC listings: 21 human otc drug, 21 human prescription drug. By marketing category: OTC MONOGRAPH DRUG 21, UNAPPROVED DRUG OTHER 21.

Dosage form	NDCs
gel	26
aerosol, foam	4
gel, dentifrice	4
liquid	4
mouthwash	2
solution	1
spray	1

Route	NDCs
dental	42
oral	26
topical	7

Labeller name on the listing	NDCs
dharma research, inc.	29
dharma research, inc.	13

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Avant	Benzocaine	gel, dental	53045-140OTC MONOGRAPH DRUG
Avant	Benzocaine	gel, dental	53045-141OTC MONOGRAPH DRUG
Avant	Benzocaine	gel, dental	53045-142OTC MONOGRAPH DRUG
Avant	Benzocaine	gel, dental	53045-144OTC MONOGRAPH DRUG
Avant	Benzocaine	gel, dental	53045-145OTC MONOGRAPH DRUG
Avant	Benzocaine	gel, dental	53045-146OTC MONOGRAPH DRUG
Avant	Benzocaine	gel, dental	53045-147OTC MONOGRAPH DRUG
Avant	Sodium Fluoride	liquid, dental	53045-267UNAPPROVED DRUG OTHER
Avant	Sodium Fluoride	liquid, dental	53045-268UNAPPROVED DRUG OTHER
Frenna AC	Aluminum Chloride	solution, dental, oral, topical	53045-300UNAPPROVED DRUG OTHER
Ioline	Benzocaine	gel, dental, oral	53045-137OTC MONOGRAPH DRUG
Iolite	Benzocaine	gel, dental, oral	53045-130OTC MONOGRAPH DRUG
Iolite	Benzocaine	gel, dental, oral	53045-131OTC MONOGRAPH DRUG
Iolite	Benzocaine	gel, dental, oral	53045-132OTC MONOGRAPH DRUG
Iolite	Benzocaine	gel, dental, oral	53045-133OTC MONOGRAPH DRUG
Iolite	Benzocaine	gel, dental, oral	53045-134OTC MONOGRAPH DRUG
Iolite	Benzocaine	gel, dental, oral	53045-135OTC MONOGRAPH DRUG
Iolite	Benzocaine	gel, dental, oral	53045-136OTC MONOGRAPH DRUG
Iolite	Benzocaine	gel, dental, oral	53045-138OTC MONOGRAPH DRUG
Iolite-S	Benzocaine	spray, dental	53045-127OTC MONOGRAPH DRUG
Ionite APF	Sodium Fluoride	gel, dental, oral	53045-200UNAPPROVED DRUG OTHER
Ionite APF	Sodium Fluoride	gel, dental, oral	53045-201UNAPPROVED DRUG OTHER
Ionite APF	Sodium Fluoride	gel, dental, oral	53045-202UNAPPROVED DRUG OTHER
Ionite APF	Sodium Fluoride	gel, dental, oral	53045-203UNAPPROVED DRUG OTHER
Ionite APF	Sodium Fluoride	gel, dental, oral	53045-204UNAPPROVED DRUG OTHER
Ionite APF	Sodium Fluoride	gel, dental, oral, topical	53045-205UNAPPROVED DRUG OTHER
Ionite APF	Sodium Fluoride	gel, dental, oral	53045-206UNAPPROVED DRUG OTHER
Ionite APF	Sodium Fluoride	gel, dental, oral	53045-207UNAPPROVED DRUG OTHER
Ionite APF Foam	Sodium Fluoride	aerosol, foam, dental, oral, topical	53045-250UNAPPROVED DRUG OTHER
Ionite APF Foam	Sodium Fluoride	aerosol, foam, dental, oral, topical	53045-251UNAPPROVED DRUG OTHER
Ionite APF Foam	Sodium Fluoride	aerosol, foam, dental, oral, topical	53045-252UNAPPROVED DRUG OTHER
Ionite APF Foam	Sodium Fluoride	aerosol, foam, dental, oral, topical	53045-253UNAPPROVED DRUG OTHER
Ionite APF Neutral	Sodium Fluoride	gel, dental, oral	53045-235UNAPPROVED DRUG OTHER
Ionite APF Neutral	Sodium Fluoride	gel, dental, oral, topical	53045-237UNAPPROVED DRUG OTHER
Ionite H	Stannous Fluoride	gel, dentifrice, dental	53045-270OTC MONOGRAPH DRUG
Ionite H	Stannous Fluoride	gel, dentifrice, dental	53045-271OTC MONOGRAPH DRUG
Ionite H	Stannous Fluoride	mouthwash, dental	53045-275OTC MONOGRAPH DRUG
Ionite H	Stannous Fluoride	mouthwash, dental	53045-276OTC MONOGRAPH DRUG
Ionite H	Sodium Fluoride, Potassium Nitrate	gel, dentifrice, dental	53045-280UNAPPROVED DRUG OTHER
Ionite H	Sodium Fluoride, Potassium Nitrate	gel, dentifrice, dental	53045-281UNAPPROVED DRUG OTHER
Ionite R	Sodium Fluoride	liquid, dental, oral	53045-265UNAPPROVED DRUG OTHER
Ionite R	Sodium Fluoride	liquid, dental, oral	53045-266UNAPPROVED DRUG OTHER

Neighbours

Registered in the same town

Ionetix CorporationMiami, FL · 2 sites
P & L Development, LLCMiami, FL
Prime Enterprises, LLC dba Prime Matter LabsMiami, FL
Medipharm Laboratories, IncMiami, FL
Advanced Generic CorporationMiami, FL
Aldama Pharmaceuticals IncMiami, FL
Alternative Pharmacal CorporationMiami, FL
Dextrum Laboratories Inc.Miami, FL
Fridababy, LLCMiami, FL
GADAL Laboratories, IncMiami, FL
Germa Products LLCMIAMI, FL
Image Amazon LLCMiami, FL

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Enquiry

Common questions

Is Dharma Research, Inc. FDA approved?: Dharma Research, Inc. 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 Dharma Research, Inc.'s drugs manufactured?: The FDA register lists Miami, FL. Registered operations: finished drug manufacture.
What drugs does Dharma Research, Inc. make?: 42 products are listed under Dharma Research, Inc. in the openFDA NDC Directory, most often as gel; aerosol, foam; gel, dentifrice. 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.