Is Soteri Skin, Inc. FDA approved?

Soteri Skin, Inc. holds no registered establishment of its own; 3 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Soteri Skin, Inc. make?

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

Soteri Skin, Inc.

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

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Registered sites: 0
Active NDC listings: 3
Labeller names: 2
Live patents: 0
Countries: 0

Catalogue

Drug listings by form and route

3 active NDC listings: 3 human otc drug. By marketing category: OTC MONOGRAPH DRUG 3.

Dosage form	NDCs
emulsion	3

Route	NDCs
topical	3

Labeller name on the listing	NDCs
soteri skin, inc	2
soteri skin, inc.	1

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Soteri Skin Active Flare-Up Eczema Relief Cream	Colloidal Oatmeal	emulsion, topical	85265-102OTC MONOGRAPH DRUG
Soteri Skin Baby Eczema Relief Cream	Colloidal Oatmeal	emulsion, topical	85265-104OTC MONOGRAPH DRUG
Soteri Skin Long-Term Eczema Relief Cream	Colloidal Oatmeal	emulsion, topical	85265-103OTC MONOGRAPH DRUG

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Common questions

Is Soteri Skin, Inc. FDA approved?: Soteri Skin, Inc. holds no registered establishment of its own; 3 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Soteri Skin, Inc. make?: 3 products are listed under Soteri Skin, Inc. in the openFDA NDC Directory, most often as emulsion. 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.