Is Stratus Pharmaceuticals, Inc. FDA approved?

Stratus Pharmaceuticals, Inc. holds no registered establishment of its own; 14 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Stratus Pharmaceuticals, Inc. make?

14 products are listed under Stratus Pharmaceuticals, Inc. in the openFDA NDC Directory, most often as cream; suppository; lotion. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Stratus Pharmaceuticals, Inc.

Data as of 28 Sept 2026 · How to read this entry

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Registered sites: 0
Active NDC listings: 14
Labeller names: 4
Live patents: 0
Countries: 0

Catalogue

Drug listings by form and route

14 active NDC listings: 14 human otc drug. By marketing category: OTC MONOGRAPH DRUG 14.

Dosage form	NDCs
cream	3
suppository	3
lotion	2
ointment	2
gel	1
liquid	1
suspension	1
tincture	1

Route	NDCs
topical	11
rectal	3

Labeller name on the listing	NDCs
stratus pharmaceuticals	5
stratus pharmaceuticals inc	5
stratus pharmaceuticals inc	3
stratus pharmaceuticals, inc.	1

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
ARCTIC RELIEF	MENTHOL, UNSPECIFIED FORM	gel, topical	58980-615OTC MONOGRAPH DRUG
AZOLEN	MICONAZOLE NITRATE	liquid, topical	58980-819OTC MONOGRAPH DRUG
Azolen	Miconazole Nitrate	tincture, topical	58980-818OTC MONOGRAPH DRUG
BACITRACIN ZINC	BACITRACIN ZINC	ointment, topical	58980-011OTC MONOGRAPH DRUG
Benzoyl Peroxide Acne Wash 5%	Benzoyl Peroxide	suspension, topical	58980-332OTC MONOGRAPH DRUG
Double Antibiotic	BACITRACIN ZINC and POLYMYXIN B SULFATE	ointment, topical	58980-012OTC MONOGRAPH DRUG
LIDOCAINE	LIDOCAINE	cream, topical	58980-823OTC MONOGRAPH DRUG
Lidocaine	Lidocaine	cream, topical	58980-824OTC MONOGRAPH DRUG
Lidocaine	Lidocaine	cream, topical	58980-826OTC MONOGRAPH DRUG
Peviderm Pramoxine Hydrocholride 1%	Pramoxine Hydrochloride	lotion, topical	58980-913OTC MONOGRAPH DRUG
Pramoxine Hydrochloride Anorectal	Pramoxine Hydrochloride	lotion, topical	58980-522OTC MONOGRAPH DRUG
Stratuscare Adult Glycerin	Glycerin	suppository, rectal	58980-410OTC MONOGRAPH DRUG
Stratuscare Bisacodyl	Bisacodyl	suppository, rectal	58980-415OTC MONOGRAPH DRUG
Stratuscare Glycerin Laxative Pediatric	Glycerin	suppository, rectal	58980-409OTC MONOGRAPH DRUG

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Enquiry

Common questions

Is Stratus Pharmaceuticals, Inc. FDA approved?: Stratus Pharmaceuticals, Inc. holds no registered establishment of its own; 14 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Stratus Pharmaceuticals, Inc. make?: 14 products are listed under Stratus Pharmaceuticals, Inc. in the openFDA NDC Directory, most often as cream; suppository; lotion. 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.