Evara

Product NDC: 85477-308
11-digit product format: 854770308
Labeler code: 85477
Product ID: 85477-308_3fc2bb16-70ef-41f8-9a6a-a6a42bf58e5f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Urea 40.5 Cream
Dosage form: CREAM
Route: TOPICAL
Labeler: Oncora Pharma, LLC
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2026-04-29
Substance: UREA
Active strength: 405 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: Evara
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
UREA	405 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
2741686	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
098d85ca-7f48-45a1-80ed-4d57936842b9	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
85477-308-08	Evara	227 g in 1 BOTTLE	CREAM	227		2

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
Evara	UREA 40.5 CREAM	Oncora Pharma, LLC	098d85ca-7f48-45a1-80ed-4d57936842b9	2026-05-01	Warnings, Adverse reactions	Exact identifier ndc (product): 85477-308

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
2741686	urea 40.5 % Topical Cream	PSN	098d85ca-7f48-45a1-80ed-4d57936842b9	2
2741686	urea 405 MG/ML Topical Cream	SCD	098d85ca-7f48-45a1-80ed-4d57936842b9	2
2741686	urea 40.5 % Topical Cream	SY	098d85ca-7f48-45a1-80ed-4d57936842b9	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
85477-308-08	85477030808	227 g in 1 BOTTLE (85477-308-08)	227 g	2026-04-29	No	No	Current