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
SALICYLIC ACID2 g/100g
UREA39.5 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiO414PZ4LPZ, 8W8T17847W
Rxcui2632843

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

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 g2023-03-24NoNoHistorical