Is Birchwood Laboratories LLC FDA approved?

Birchwood Laboratories LLC 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 Birchwood Laboratories LLC's drugs manufactured?

The FDA register lists Eden Prairie, MN. Registered operations: finished drug manufacture.

What drugs does Birchwood Laboratories LLC make?

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

Birchwood Laboratories LLC

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

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Birchwood Laboratories LLC	7900 Fuller Road, Eden Prairie, Minnesota (MN) 55344, United States (USA)	Finished drug manufacture	2182825096488432

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
solution	3

Route	NDCs
rectal	3
topical	3

Labeller name on the listing	NDCs
birchwood laboratories llc	3

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
AER Pre-moistened Witch Hazel Pad	Witch Hazel	solution, rectal, topical	50289-3250OTC MONOGRAPH DRUG
AER Traveler Towelette	AER Traveler	solution, rectal, topical	50289-4200OTC MONOGRAPH DRUG
B-SURE Traveler Towelette	B-SURE Traveler	solution, rectal, topical	50289-9250OTC MONOGRAPH DRUG

Neighbours

Registered in the same town

Apex International Mfg., LLCEden Prairie, MN
RedPharm DrugEden Prairie, MN

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Enquiry

Common questions

Is Birchwood Laboratories LLC FDA approved?: Birchwood Laboratories LLC 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 Birchwood Laboratories LLC's drugs manufactured?: The FDA register lists Eden Prairie, MN. Registered operations: finished drug manufacture.
What drugs does Birchwood Laboratories LLC make?: 3 products are listed under Birchwood Laboratories LLC in the openFDA NDC Directory, most often as solution. 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.