Is Blue Heron Pharmaceuticals, LLC FDA approved?

Blue Heron Pharmaceuticals, LLC holds no registered establishment of its own; 11 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Blue Heron Pharmaceuticals, LLC make?

11 products are listed under Blue Heron Pharmaceuticals, LLC in the openFDA NDC Directory, most often as cream; patch; liquid. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Blue Heron Pharmaceuticals, LLC

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

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Registered sites: 0
Active NDC listings: 11
Labeller names: 2
Live patents: 0
Countries: 0

Catalogue

Drug listings by form and route

11 active NDC listings: 8 human otc drug, 3 human prescription drug. By marketing category: UNAPPROVED DRUG OTHER 6, OTC MONOGRAPH DRUG 4, ANDA 1.

Dosage form	NDCs
cream	4
patch	4
liquid	2
tablet	1

Route	NDCs
topical	10
oral	1

Labeller name on the listing	NDCs
blue heron pharmaceuticals, llc	7
blue heron pharmaceuticals llc	4

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
Lidocaine 4% Patch	Lidocaine 4%	patch, topical	85622-521OTC MONOGRAPH DRUG
Lidocaine 4% Patch	Lidocaine 4%	patch, topical	85622-522OTC MONOGRAPH DRUG
Metaxalone	Metaxalone	tablet, oral	85622-950ANDA
NeuroCool Patches	NeuroCool Patches	patch, topical	85622-500OTC MONOGRAPH DRUG
NeuroFreeze	Menthol	liquid, topical	85622-511UNAPPROVED DRUG OTHER
NeuroSoothe	Camphor, Menthol	liquid, topical	85622-510UNAPPROVED DRUG OTHER
Neurocaine	Lidocaine	patch, topical	85622-501OTC MONOGRAPH DRUG
UREDEX	UREA	cream, topical	85622-601UNAPPROVED DRUG OTHER
UREVEX	UREA	cream, topical	85622-605UNAPPROVED DRUG OTHER
Urevia	Urea 39	cream, topical	85622-602UNAPPROVED DRUG OTHER
Urevia Plus	Urea 40%	cream, topical	85622-603UNAPPROVED DRUG OTHER

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Enquiry

Common questions

Is Blue Heron Pharmaceuticals, LLC FDA approved?: Blue Heron Pharmaceuticals, LLC holds no registered establishment of its own; 11 drug products are listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Blue Heron Pharmaceuticals, LLC make?: 11 products are listed under Blue Heron Pharmaceuticals, LLC in the openFDA NDC Directory, most often as cream; patch; liquid. 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.