Is Kool-Down Inc. FDA approved?

Kool-Down Inc. holds no registered establishment of its own; 2 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Kool-Down Inc. make?

2 products are listed under Kool-Down Inc. in the openFDA NDC Directory, most often as cream. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Kool-Down Inc.

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

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Registered sites: 0
Active NDC listings: 2
Labeller names: 2
Live patents: 0
Countries: 0

Catalogue

Drug listings by form and route

2 active NDC listings: 2 human otc drug. By marketing category: OTC MONOGRAPH DRUG 2.

Dosage form	NDCs
cream	2

Route	NDCs
topical	2

Labeller name on the listing	NDCs
kool-down inc	1
kool-down inc.	1

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Burn Relief Extra Strength Kool-Down	Lidocaine - 3.9%	cream, topical	61566-279OTC MONOGRAPH DRUG
Burn Relief Professional Bio-Kool	Lidocaine - 4%	cream, topical	61566-201OTC MONOGRAPH DRUG

Enquiry

Common questions

Is Kool-Down Inc. FDA approved?: Kool-Down Inc. holds no registered establishment of its own; 2 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Kool-Down Inc. make?: 2 products are listed under Kool-Down Inc. in the openFDA NDC Directory, most often as cream. 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.