Is American Distilling Inc. FDA approved?

American Distilling 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.

What drugs does American Distilling Inc. make?

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

American Distilling Inc.

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

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

Authorisation

Registered operations

Active ingredient (API) manufacture1Finished drug manufacture1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
American Distilling Inc.	31 East High Street, East Hampton, Connecticut (CT) 06424, United States (USA)	Active ingredient (API) manufacture, Finished drug manufacture	1218029065524738

Catalogue

Drug listings by form and route

3 active NDC listings: 3 bulk ingredient. By marketing category: BULK INGREDIENT 3.

Dosage form	NDCs
liquid	3

Route	NDCs

Labeller name on the listing	NDCs
american distilling inc.	3

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
-	witch hazel	liquid	18474-001BULK INGREDIENT
-	witch hazel	liquid	18474-002BULK INGREDIENT
-	witch hazel	liquid	18474-003BULK INGREDIENT

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Enquiry

Common questions

Is American Distilling Inc. FDA approved?: American Distilling 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 American Distilling Inc.'s drugs manufactured?: The FDA register lists East Hampton, CT. Registered operations: active ingredient (API) manufacture, finished drug manufacture.
What drugs does American Distilling Inc. make?: 3 products are listed under American Distilling Inc. in the openFDA NDC Directory, most often as 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.