Urea 39.5%

Product NDC: 59088-698
Requested package NDC: 59088-698-16
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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 (package): 59088-698-16 ndc (product): 59088-698 ndc11 (package): 59088069816

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

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