FDA.reportPublic FDA data

Urea 39.5% with 2% Salicylic Acid

Product NDC
59088-210
11-digit product format
590880210
Labeler code
59088
Product ID
59088-210_f7aa7b4f-3cb5-6113-e053-6394a90a4188
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Urea, Salicylic Acid
Dosage form
CREAM
Route
TOPICAL
Labeler
PureTek Corporation
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2023-03-24
Substance
SALICYLIC ACID; UREA
Active strength
2; 39.5 g/100g; g/100g
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% with 2% Salicylic Acid
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
UREA39.5 g/100g
SALICYLIC ACID2 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8W8T17847WInternal UNII lookup
O414PZ4LPZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2632843Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f7aa7b4f-3cb4-6113-e053-6394a90a4188Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59088-210-16Urea 39.5% with 2% Salicylic Acid227 g in 1 JARCREAM2271

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59088-210-16GM - Gram59088-21095dc5d16-2794-4f71-b450-02d13733615812023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59088-210UREA 39.5% WITH 2% SALICYLIC ACID (UREA, SALICYLIC ACID) CREAM [PURETEK CORPORATION]1Current NDC, 1 package rows20230331_f7aa7b4f-3cb4-6113-e053-6394a90a4188.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 39.5% with 2% Salicylic AcidUREA, SALICYLIC ACIDPureTek Corporationf7aa7b4f-3cb4-6113-e053-6394a90a41882023-03-24Warnings, Adverse reactionsExact identifier
ndc (product): 59088-210

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2632843salicylic acid 2 % / urea 39.5 % Topical CreamPSNf7aa7b4f-3cb4-6113-e053-6394a90a41881
2632843salicylic acid 20 MG/ML / urea 395 MG/ML Topical CreamSCDf7aa7b4f-3cb4-6113-e053-6394a90a41881
2632843salicylic acid 2 % / urea 39.5 % Topical CreamSYf7aa7b4f-3cb4-6113-e053-6394a90a41881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59088-210-1659088021016227 g in 1 JAR (59088-210-16) 227 g2023-03-24NoNoCurrent