Is Ferndale Laboratories, Inc. FDA approved?

Ferndale Laboratories, 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 Ferndale Laboratories, Inc.'s drugs manufactured?

The FDA register lists Ferndale, MI. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.

What drugs does Ferndale Laboratories, Inc. make?

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

Ferndale Laboratories, Inc.

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

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Registered sites: 1
Active NDC listings: 8
Live patents: 0
Countries: 1
Base: United States

Authorisation

Registered operations

Analytical testing1Labelling1Finished drug manufacture1Packaging1

Sites

Registered establishments

Establishment	Address	Registered for	FEI / DUNS
Ferndale Laboratories, Inc.	780 W 8 Mile Rd, Ferndale, Michigan (MI) 48220, United States (USA)	Analytical testing, Labelling, Finished drug manufacture, Packaging	1811212005320536

Catalogue

Drug listings by form and route

8 active NDC listings: 8 human otc drug. By marketing category: OTC MONOGRAPH DRUG 8.

Dosage form	NDCs
cream	4
lotion	2
cloth	1
ointment	1

Route	NDCs
topical	8

Labeller name on the listing	NDCs
ferndale laboratories, inc.	8

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
DerMend Moisturizing Anti-Itch	pramoxine hydrochloride	lotion, topical	0496-0586OTC MONOGRAPH DRUG
Dr. Mom Butt Balm	dimethicone petrolatum	ointment, topical	0496-0590OTC MONOGRAPH DRUG
LMX4	lidocaine	cream, topical	0496-0882OTC MONOGRAPH DRUG
LMX5	lidocaine	cream, topical	0496-0883OTC MONOGRAPH DRUG
PRAX	pramoxine hydrochloride	lotion, topical	0496-0748OTC MONOGRAPH DRUG
RECTICARE	lidocaine	cream, topical	0496-0892OTC MONOGRAPH DRUG
RECTICARE	lidocaine and glycerin	cloth, topical	0496-0980OTC MONOGRAPH DRUG
Recticare Advanced	lidocaine and mineral oil and phenylephrine HCl and white petrolatum	cream, topical	0496-0978OTC MONOGRAPH DRUG

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Enquiry

Common questions

Is Ferndale Laboratories, Inc. FDA approved?: Ferndale Laboratories, 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 Ferndale Laboratories, Inc.'s drugs manufactured?: The FDA register lists Ferndale, MI. Registered operations: analytical testing, labelling, finished drug manufacture, packaging.
What drugs does Ferndale Laboratories, Inc. make?: 8 products are listed under Ferndale Laboratories, Inc. in the openFDA NDC Directory, most often as cream; lotion; cloth. 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.