FDA.reportPublic FDA data

Urea 40 Percent

Product NDC
72162-1668
11-digit product format
721621668
Labeler code
72162
Product ID
72162-1668_ce18811d-88e5-4660-aef6-be4b5b0a24eb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Urea
Dosage form
CREAM
Route
TOPICAL
Labeler
Bryant Ranch Prepack
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2021-11-15
Substance
UREA
Active strength
400 mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Urea 40 PercentUREABryant Ranch Prepackee06a590-a104-4e97-b66c-cd37869038a52026-03-27Warnings, Adverse reactionsExact identifier
ndc (product): 72162-1668

Additional Listing Data#

Finished product
Yes
Brand name base
Urea 40 Percent
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
UREA400 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
198342Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ee06a590-a104-4e97-b66c-cd37869038a5Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-1668-2Urea 40 Percent198.4 g in 1 BOTTLECREAM198.4101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-1668-2GM - Gram72162-16680e212dcb-7fef-4482-a9eb-178289e1562412025-02-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-1668UREA 40 PERCENT (UREA) CREAM [BRYANT RANCH PREPACK]100Current NDC, 1 package rows20241228_ee06a590-a104-4e97-b66c-cd37869038a5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198342urea 40 % Topical CreamPSNee06a590-a104-4e97-b66c-cd37869038a5101
198342urea 400 MG/ML Topical CreamSCDee06a590-a104-4e97-b66c-cd37869038a5101
198342urea 40 % Topical CreamSYee06a590-a104-4e97-b66c-cd37869038a5101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-1668-272162166802198.4 g in 1 BOTTLE (72162-1668-2) 198.4 g2026-03-27NoNoCurrent