UREVEX

Product NDC: 85622-605
11-digit product format: 856220605
Labeler code: 85622
Product ID: 85622-605_89018c92-8004-4cd5-b111-71b86b393730
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: UREA
Dosage form: CREAM
Route: TOPICAL
Labeler: Blue Heron Pharmaceuticals, LLC
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2026-04-28
Substance: UREA
Active strength: 200 mg/g
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: UREVEX
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
UREA	200 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8W8T17847W	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
198886	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1ed71529-7607-47ff-bd16-3c9a63e1c733	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
85622-605-03	UREVEX	85 g in 1 BOTTLE, PLASTIC	CREAM	85		1

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
UREVEX	UREA	Blue Heron Pharmaceuticals, LLC	1ed71529-7607-47ff-bd16-3c9a63e1c733	2026-04-28	Warnings, Adverse reactions	Exact identifier ndc (product): 85622-605

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8W8T17847W	UREA	57-13-6	UREA

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
198886	urea 20 % Topical Cream	PSN	1ed71529-7607-47ff-bd16-3c9a63e1c733	1
198886	urea 200 MG/ML Topical Cream	SCD	1ed71529-7607-47ff-bd16-3c9a63e1c733	1
198886	urea 17 GM in 85 GM Topical Cream	SY	1ed71529-7607-47ff-bd16-3c9a63e1c733	1
198886	urea 20 % Topical Cream	SY	1ed71529-7607-47ff-bd16-3c9a63e1c733	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
85622-605-03	85622060503	85 g in 1 BOTTLE, PLASTIC	85 g	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Urevex 20%	Blue Heron Pharmaceuticals, LLC \| Mission Pharmacal	2026-04-28	HUMAN PRESCRIPTION DRUG LABEL	1