KOBAYASHI America Manufacturing, LLC

Registered sites: 1
Drug products: 26
Live patents: 0
Countries: 1
Base: United States

Authorisation

Registered operations

What the FDA has registered these sites to do. This is the regulatory record, not a marketing claim.

LabellingPackagingRelabellingRepackaging

Sites

Facilities

Site	Location	Operations	FEI
KOBAYASHI America Manufacturing, LLC	Dalton, GAUnited States	Labelling, Packaging, Relabelling, Repackaging	3003079019

Catalogue

Marketed products

Showing 26 of 26.

Brand	Generic name	Form	Category
Arthriten Inflammatory Pain Formula	acetaminophen, aspirin, caffeine	TABLET, FILM COATED	OTC MONOGRAPH DRUG
BackAid	acetaminophen, caffeine	TABLET, FILM COATED	OTC MONOGRAPH DRUG
BackAid Max	acetaminophen, pamabrom	TABLET, FILM COATED	OTC MONOGRAPH DRUG
Diurex Max	Pamabrom	TABLET, FILM COATED	OTC MONOGRAPH DRUG
Diurex Ultimate	Caffeine	TABLET, FILM COATED	OTC MONOGRAPH DRUG
Diurex Ultra	Caffeine	TABLET, FILM COATED	OTC MONOGRAPH DRUG
Diurex Water Pills	Caffeine, magnesium salicylate	TABLET, COATED	OTC MONOGRAPH DRUG
Fungicure AF Wash	Sepia	SOAP	UNAPPROVED HOMEOPATHIC
Fungicure Anti-Fungal Liquid	Tolnaftate	LIQUID	OTC MONOGRAPH DRUG
Fungicure Anti-Fungal Wash	Sepia	SOAP	UNAPPROVED HOMEOPATHIC
Fungicure Intensive	Clotrimazole	LIQUID	OTC MONOGRAPH DRUG
Fungicure Liquid Gel	Clotrimazole	GEL	OTC MONOGRAPH DRUG
Fungicure Night Cream	Clotrimazole	CREAM	OTC MONOGRAPH DRUG
Nauzene	Sodium Citrate	TABLET, CHEWABLE	OTC MONOGRAPH DRUG
Nauzene Chewables Ginger Honey	Sodium citrate	TABLET, CHEWABLE	OTC MONOGRAPH DRUG
Prosacea	Sulphur	GEL	UNAPPROVED HOMEOPATHIC
Psoriasin Deep Moisturizing	Coal Tar	OINTMENT	OTC MONOGRAPH DRUG
Psoriasin In-Shower Treatment	Coal Tar	LOTION/SHAMPOO	OTC MONOGRAPH DRUG
Uricalm Maximum Strength	Phenazopyridine Hydochloride	TABLET, FILM COATED	UNAPPROVED DRUG OTHER
ZIMS MAX FREEZE	LIDOCAINE HYDROCHLORIDE and MENTHOL,	PATCH	OTC MONOGRAPH DRUG
ZIMS MAX FREEZE LEG CRAMP	Menthol	LIQUID	OTC MONOGRAPH DRUG
ZIMS MAX FREEZE LEG CRAMPS	CAMPHOR, MENTHOL	PATCH	OTC MONOGRAPH DRUG
ZIMS MAX FREEZE PRO FORMULA	MENTHOL, UNSPECIFIED FORM	GEL	OTC MONOGRAPH DRUG
ZIMS MAX FREEZE PRO FORMULA	MENTHOL, UNSPECIFIED FORM	GEL	OTC MONOGRAPH DRUG
ZIMS MAX FREEZE PRO FORMULA	MENTHOL	SPRAY	OTC MONOGRAPH DRUG
ZIMS MAX FREEZE PRO FORMULA	MENTHOL, UNSPECIFIED FORM	LIQUID	OTC MONOGRAPH DRUG

Provenance

Facility and operations data from the FDA Drug Establishments Current Registration Site. Product data from the openFDA National Drug Code Directory. Patent and exclusivity data from the FDA Orange Book. Shortage data from the FDA drug shortage database. Contact details the FDA publishes for registered establishments are deliberately not reproduced here. This entry is compiled from public records and has not been claimed by the company.