Is Calmoseptine Inc. FDA approved?

Calmoseptine Inc. holds no registered establishment of its own; 1 drug product is listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Calmoseptine Inc. make?

1 product is listed under Calmoseptine Inc. in the openFDA NDC Directory, most often as ointment. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Calmoseptine Inc.

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

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Registered sites: 0
Active NDC listings: 1
Live patents: 0
Countries: 0

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Marketed products

Brand	Generic name	Form / route	NDC
Calmoseptine	anorectal ointment	ointment, topical	0799-0001OTC MONOGRAPH DRUG

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Common questions

Is Calmoseptine Inc. FDA approved?: Calmoseptine Inc. holds no registered establishment of its own; 1 drug product is listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Calmoseptine Inc. make?: 1 product is listed under Calmoseptine Inc. in the openFDA NDC Directory, most often as ointment. 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.