Is Balassa Laboratories Inc. FDA approved?

Balassa Laboratories 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 Balassa Laboratories Inc.'s drugs manufactured?

The FDA register lists Port Orange, FL. Registered operations: labelling, finished drug manufacture, packaging.

What drugs does Balassa Laboratories Inc. make?

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

Balassa Laboratories Inc.

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

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Registered sites: 1
Active NDC listings: 7
Live patents: 0
Countries: 1
Base: United States

Authorisation

Registered operations

Labelling1Finished drug manufacture1Packaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Balassa Laboratories Inc.	509 Herbert St, Unit A, Port Orange, Florida (FL) 32129, United States (USA)	Labelling, Finished drug manufacture, Packaging	1050280069162485

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
stick	7

Route	NDCs
topical	7

Labeller name on the listing	NDCs
balassa laboratories inc.	7

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
CornStick	Salicylic Acid	stick, topical	10107-240OTC MONOGRAPH DRUG
Herb Street Anti-Itch Stick	Hydrocortisone	stick, topical	10107-429OTC MONOGRAPH DRUG
Herb Street Arthritis Relief	Menthol/Camphor	stick, topical	10107-431OTC MONOGRAPH DRUG
Herb Street Backache and Sore Muscle Relief	Menthol	stick, topical	10107-432OTC MONOGRAPH DRUG
Herb Street Sore Muscle Relief	Methyl Salicylate	stick, topical	10107-420OTC MONOGRAPH DRUG
WartStick	Salicylic Acid	stick, topical	10107-250OTC MONOGRAPH DRUG
WartStick Plantar	Salicylic Acid	stick, topical	10107-251OTC MONOGRAPH DRUG

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Enquiry

Common questions

Is Balassa Laboratories Inc. FDA approved?: Balassa Laboratories 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 Balassa Laboratories Inc.'s drugs manufactured?: The FDA register lists Port Orange, FL. Registered operations: labelling, finished drug manufacture, packaging.
What drugs does Balassa Laboratories Inc. make?: 7 products are listed under Balassa Laboratories Inc. in the openFDA NDC Directory, most often as stick. 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.