Uracin 20%

Product NDC: 59088-257
11-digit product format: 590880257
Labeler code: 59088
Product ID: 59088-257_4b4791a6-ccb2-9f5f-e063-6394a90af273
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Urea 20%
Dosage form: CREAM
Route: TOPICAL
Labeler: PureTek Corporation
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2026-02-20
Substance: UREA
Active strength: .2 g/g
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: Uracin 20%
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
UREA	.2 g/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
4305c057-bd6f-bb58-e063-6294a90abe75	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59088-257-16	Uracin 20%	227 g in 1 JAR	CREAM	227		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59088-257-16	GM - Gram	59088-257	2d3c687c-27d5-4a15-a929-101ec0aa3737	1	2026-03-17

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
Uracin 20%	UREA 20%	PureTek Corporation	4305c057-bd6f-bb58-e063-6294a90abe75	2026-02-20	Warnings, Adverse reactions	Exact identifier ndc (product): 59088-257

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	4305c057-bd6f-bb58-e063-6294a90abe75	5
198886	urea 200 MG/ML Topical Cream	SCD	4305c057-bd6f-bb58-e063-6294a90abe75	5
198886	urea 17 GM in 85 GM Topical Cream	SY	4305c057-bd6f-bb58-e063-6294a90abe75	5
198886	urea 20 % Topical Cream	SY	4305c057-bd6f-bb58-e063-6294a90abe75	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
59088-257-16	59088025716	227 g in 1 JAR (59088-257-16)	227 g	2026-02-20	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Uracin 20% Cream Rx only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.	PureTek Corporation	2026-02-20	HUMAN PRESCRIPTION DRUG LABEL	5