Uracin 20%

Product NDC
59088-257
11-digit product format
590880257
Labeler code
59088
Product ID
59088-257_5c0579be-fa05-3c79-e063-6294a90ad03b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Urea 20%
Dosage form
CREAM
Route
TOPICAL
Labeler
PureTek Corporation
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2026-02-02
Substance
UREA
Active strength
.2 g/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
UREA.2 g/g

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59088-257-16Uracin 20%227 g in 1 JARCREAM2275

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-257-16GM - Gram59088-2572d3c687c-27d5-4a15-a929-101ec0aa373712026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198886urea 20 % Topical CreamPSN4305c057-bd6f-bb58-e063-6294a90abe755
198886urea 200 MG/ML Topical CreamSCD4305c057-bd6f-bb58-e063-6294a90abe755
198886urea 17 GM in 85 GM Topical CreamSY4305c057-bd6f-bb58-e063-6294a90abe755
198886urea 20 % Topical CreamSY4305c057-bd6f-bb58-e063-6294a90abe755

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59088-257-0859088025708113 g in 1 JAR (59088-257-08) 113 g2026-10-06NoNoCurrent
59088-257-1659088025716227 g in 1 JAR (59088-257-16) 227 g2026-02-20NoNoCurrent