Urea 39.5%

Product NDC: 59088-698
11-digit product format: 590880698
Labeler code: 59088
Product ID: 59088-698_ea2adf3e-cea5-43b2-e053-2995a90a89a6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Urea
Dosage form: CREAM
Route: TOPICAL
Labeler: PureTek Corporation
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2023-01-20
Substance: UREA
Active strength: 395 mg/g
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: Urea 39.5%
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
UREA	395 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
2627282	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
ea2adf3e-cea6-43b2-e053-2995a90a89a6	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59088-698-16	Urea 39.5%	227 g in 1 JAR	CREAM	227		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59088-698-16	GM - Gram	59088-698	060b3f7b-b235-4bca-9cb2-9f0fd3a53647	1	2023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59088-698	UREA 39.5% (UREA) CREAM [PURETEK CORPORATION]	1	Current NDC, 1 package rows	20230124_ea2adf3e-cea6-43b2-e053-2995a90a89a6.zip

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
Urea 39.5%	UREA	PureTek Corporation	ea2adf3e-cea6-43b2-e053-2995a90a89a6	2023-01-20	Warnings, Adverse reactions	Exact identifier ndc (product): 59088-698

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
2627282	urea 39.5 % Topical Cream	PSN	ea2adf3e-cea6-43b2-e053-2995a90a89a6	1
2627282	urea 395 MG/ML Topical Cream	SCD	ea2adf3e-cea6-43b2-e053-2995a90a89a6	1
2627282	urea 39.5 % Topical Cream	SY	ea2adf3e-cea6-43b2-e053-2995a90a89a6	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
59088-698-16	59088069816	227 g in 1 JAR (59088-698-16)	227 g	2023-01-20	No	No	Current