FDA.reportPublic FDA data

Urea 41%

Product NDC
59088-489
Requested package NDC
59088-489-16
11-digit product format
590880489
Labeler code
59088
Product ID
59088-489_da5d8eae-8d63-d354-e053-2995a90a7999
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Urea
Dosage form
CREAM
Route
TOPICAL
Labeler
PureTek Corporation
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2022-06-07
Substance
UREA
Active strength
410 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 41%
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
UREA410 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8W8T17847WInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1436933Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
da5d8eae-8d64-d354-e053-2995a90a7999Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59088-489-16Urea 41%227 g in 1 BOTTLECREAM2271

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-489-16GM - Gram59088-48922a1e7d7-5852-424e-8a1b-30fd54f4a45212022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-489UREA 41% (UREA) CREAM [PURETEK CORPORATION]1Current NDC, Legacy NDC, 1 package rows20220608_da5d8eae-8d64-d354-e053-2995a90a7999.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Urea 41%UREAPureTek Corporationda5d8eae-8d64-d354-e053-2995a90a79992022-06-07Warnings, Adverse reactionsExact identifier
ndc (package): 59088-489-16
ndc (product): 59088-489
ndc11 (package): 59088048916

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1436933urea 41 % Topical CreamPSNda5d8eae-8d64-d354-e053-2995a90a79991
1436933urea 410 MG/ML Topical CreamSCDda5d8eae-8d64-d354-e053-2995a90a79991
1436933urea 41 % Topical CreamSYda5d8eae-8d64-d354-e053-2995a90a79991

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59088-489-1659088048916227 g in 1 BOTTLE (59088-489-16) 227 g2022-06-070000-00-00NoNoCurrent