FDA.reportPublic FDA data

FERNDALE LABORATORIES, INC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
18112121811212FERNDALE LABORATORIES, INC.1N2026-01-01780 W 8 Mile Rd Ferndale MI US 48220

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00304960513021DETACHOL - ADHESIVE REMOVER877-433-7626information@eloquesthealthcare.com
00304960513045DETACHOL - ADHESIVE REMOVER877-433-7626information@eloquesthealthcare.com
00304960513151DETACHOL - ADHESIVE REMOVER877-433-7626information@eloquesthealthcare.com
00304960513243DETACHOL - ADHESIVE REMOVER877-433-7626information@eloquesthealthcare.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
331221525708650K092297ELETONE CREAMFRO2009-10-09
331221606065960
331221911225675

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
FRO12009-10-09

NDC#

PRAX

Ferndale Laboratories, Inc.

pramoxine hydrochloride

LMX4

Ferndale Laboratories, Inc.

lidocaine

LMX5

Ferndale Laboratories, Inc.

lidocaine

RECTICARE

Ferndale Laboratories, Inc.

lidocaine

Recticare Advanced

Ferndale Laboratories, Inc.

lidocaine and mineral oil and phenylephrine HCl and white petrolatum

RECTICARE

Ferndale Laboratories, Inc.

lidocaine and glycerin

PMN#

GUDID#