Is Premier Brands of America Inc FDA approved?

Premier Brands of America Inc holds 3 FDA-registered establishments 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 Premier Brands of America Inc's drugs manufactured?

The FDA register lists Hudson, NY; Orangeburg, NY; Waverly, PA. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.

What drugs does Premier Brands of America Inc make?

33 products are listed under Premier Brands of America Inc in the openFDA NDC Directory, most often as aerosol, spray; patch; liquid. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Premier Brands of America Inc

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

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Registered sites: 3
Active NDC listings: 32
Labeller names: 3
Live patents: 0
Countries: 1
Base: United States

Authorisation

Registered operations

Analytical testing1Labelling3Finished drug manufacture3Packaging3

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Premier Brands of America Inc.Registrant: Premier Brands of America Inc	351 Fairview Ave, Suite 900, Hudson, New York (NY) 12534-1259, United States (USA)	Labelling, Finished drug manufacture, Packaging	3014258951117571503
Premier Brands of America Inc	7 Corporate Drive, Orangeburg, New York (NY) 10962, United States (USA)	Labelling, Finished drug manufacture, Packaging	2434554117557458
Premier Brands of America Inc.Registrant: Premier Brands of America Inc	45 Commerce Dr., Waverly, Pennsylvania (PA) 18471, United States (USA)	Analytical testing, Labelling, Finished drug manufacture, Packaging	3045030632144918509

Catalogue

Drug listings by form and route

32 active NDC listings: 32 human otc drug. By marketing category: OTC MONOGRAPH DRUG 32.

Dosage form	NDCs
aerosol, spray	10
patch	8
liquid	6
powder	4
aerosol, powder	2
gel	1
spray	1

Route	NDCs
topical	32

Labeller name on the listing	NDCs
premier brands of america inc.	23
premier brands of america, inc.	5
premier brands of america inc	4

Catalogue

Marketed products

Showing 32 of 33.

Brand	Generic name	Form / route	NDC
Anti- Fungal Miconazole Nitrate	Miconazole Nitrate	powder, topical	56104-253OTC MONOGRAPH DRUG
Anti-fungal Powder Miconazole Nitrate	Miconazole Nitrate	powder, topical	56104-500OTC MONOGRAPH DRUG
Antifungal Liquid	Tolnaftate	liquid, topical	56104-902OTC MONOGRAPH DRUG
Athletes Foot	Miconazole Nitrate	aerosol, powder, topical	56104-912OTC MONOGRAPH DRUG
Burn Relief	Lidocaine	aerosol, spray, topical	56104-914OTC MONOGRAPH DRUG
Calamine Plus Pramoxine HCl	Calamine Plus No Touch Spray	aerosol, spray, topical	56104-100OTC MONOGRAPH DRUG
Calamine Plus Pramoxine HCl	Calamine Plus Spray	aerosol, spray, topical	56104-251OTC MONOGRAPH DRUG
Foot Odor Control Powder	Tolnaftate	aerosol, spray, topical	56104-252OTC MONOGRAPH DRUG
Foot and Leg Pain Relief	Lidocaine	aerosol, spray, topical	56104-007OTC MONOGRAPH DRUG
Hydrocortisone	Hydrocortisone Continuous Spray	aerosol, spray, topical	56104-250OTC MONOGRAPH DRUG
Jock Itch Powder	Miconazole Nitrate	powder, topical	56104-122OTC MONOGRAPH DRUG
Liquid Bandage	Benzethonium chloride Plus Dyclonine hydrochloride	liquid, topical	56104-502OTC MONOGRAPH DRUG
Liquid Callus Remover	Salicylic Acid	liquid, topical	56104-501OTC MONOGRAPH DRUG
Liquid Wart Remover	Salicylic Acid	liquid, topical	56104-245OTC MONOGRAPH DRUG
Medicated Athletes Foot Powder	Miconazole Nitrate	powder, topical	56104-906OTC MONOGRAPH DRUG
Medicated Callus Removers	Salicylic Acid	patch, topical	56104-913OTC MONOGRAPH DRUG
Miconazole Nitrate	Antifungal Miconazole Powder Spray	aerosol, spray, topical	56104-121OTC MONOGRAPH DRUG
Miconazole Nitrate	Antifungal Powder Spray	aerosol, powder, topical	56104-907OTC MONOGRAPH DRUG
Miconazole nitrate	Antifungal Miconazole Liquid Continuous Spray	aerosol, spray, topical	56104-903OTC MONOGRAPH DRUG
Premier Solutions Antifungal Tolnaftate Liquid	Tolnaftate	aerosol, spray, topical	56104-247OTC MONOGRAPH DRUG
Premier Solutions Liquid Bandage	Benzethonium chloride Dyclonine hydrochloride	liquid, topical	56104-246OTC MONOGRAPH DRUG
Premier Solutions Liquid Corn and Callus Remover	Salicylic Acid	liquid, topical	56104-255OTC MONOGRAPH DRUG
Premier Solutions Wart Removers	Salicylic Acid	patch, topical	56104-911OTC MONOGRAPH DRUG
Salicylic Acid	Corn Removers	patch, topical	56104-011OTC MONOGRAPH DRUG
Salicylic Acid	Wart Removers	patch, topical	56104-017OTC MONOGRAPH DRUG
Salicylic Acid	Clear Medicated Corn removers	patch, topical	56104-258OTC MONOGRAPH DRUG
Salicylic Acid	Medicated Corn Remover	patch, topical	56104-905OTC MONOGRAPH DRUG
Salicylic Acid	Medicated Wart Removers	patch, topical	56104-910OTC MONOGRAPH DRUG
Salicylic acid	Callus Removers	patch, topical	56104-013OTC MONOGRAPH DRUG
Tolnaftate	Antifungal Liquid Spray	aerosol, spray, topical	56104-001OTC MONOGRAPH DRUG
Wart Remover Gel	Wart Remover Gel	gel, topical	56104-237OTC MONOGRAPH DRUG
Witch Hazel	Witch Hazel	spray, topical	56104-904OTC MONOGRAPH DRUG

Neighbours

Registered in the same town

Cerovene, Inc.Orangeburg, NY
Zennova LLCOrangeburg, NY
Professional Disposables International, Inc.Orangeburg, NY

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Enquiry

Common questions

Is Premier Brands of America Inc FDA approved?: Premier Brands of America Inc holds 3 FDA-registered establishments 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 Premier Brands of America Inc's drugs manufactured?: The FDA register lists Hudson, NY; Orangeburg, NY; Waverly, PA. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.
What drugs does Premier Brands of America Inc make?: 33 products are listed under Premier Brands of America Inc in the openFDA NDC Directory, most often as aerosol, spray; patch; liquid. 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.