Is Pharmaceutical Specialties, Inc. FDA approved?

Pharmaceutical Specialties, 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 Pharmaceutical Specialties, Inc.'s drugs manufactured?

The FDA register lists Rochester, MN. Registered operations: labelling, finished drug manufacture, packaging.

What drugs does Pharmaceutical Specialties, Inc. make?

5 products are listed under Pharmaceutical Specialties, Inc. in the openFDA NDC Directory, most often as cream; shampoo; soap. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Pharmaceutical Specialties, Inc.

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

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Registered sites: 1
Active NDC listings: 5
Labeller names: 2
Live patents: 0
Countries: 1
Base: United States

Authorisation

Registered operations

Labelling1Finished drug manufacture1Packaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Pharmaceutical Specialties, Inc.	1620 Industrial Drive NW, Rochester, Minnesota (MN) 55901, United States (USA)	Labelling, Finished drug manufacture, Packaging	2150117076499557

Catalogue

Drug listings by form and route

5 active NDC listings: 5 human otc drug. By marketing category: OTC MONOGRAPH DRUG 5.

Dosage form	NDCs
cream	2
shampoo	1
soap	1
stick	1

Route	NDCs
topical	5

Labeller name on the listing	NDCs
pharmaceutical specialties, inc.	4
pharmaceutical specialties inc	1

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Vanicream	Pyrithione Zinc	shampoo, topical	45334-206OTC MONOGRAPH DRUG
Vanicream Anti-perspirant/Deodorant	Aluminum zirconium trichlorohydrex gly	stick, topical	45334-305OTC MONOGRAPH DRUG
Vanicream Facial Moisturizer Broad Spectrum SPF30	zinc oxide	cream, topical	45334-325OTC MONOGRAPH DRUG
Vanicream HC Anti-Itch	Hydrocortisone	cream, topical	45334-327OTC MONOGRAPH DRUG
Vanicream Z-Bar	pyrithione zinc	soap, topical	45334-392OTC MONOGRAPH DRUG

Neighbours

Registered in the same town

Mississippi Welders Supply Company, Inc.ROCHESTER, MN
Mayo Clinic PET Radiochemistry FacilityRochester, MN

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Enquiry

Common questions

Is Pharmaceutical Specialties, Inc. FDA approved?: Pharmaceutical Specialties, 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 Pharmaceutical Specialties, Inc.'s drugs manufactured?: The FDA register lists Rochester, MN. Registered operations: labelling, finished drug manufacture, packaging.
What drugs does Pharmaceutical Specialties, Inc. make?: 5 products are listed under Pharmaceutical Specialties, Inc. in the openFDA NDC Directory, most often as cream; shampoo; soap. 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.