FDA.reportPublic FDA data

Urea 40 Percent

Product NDC
63629-9267
11-digit product format
636299267
Labeler code
63629
Product ID
63629-9267_e91f44df-bbf1-484a-b84f-73ca9e47545e
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

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
6701225c-2c2e-41e8-8d43-ef77c00a9946Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-9267-1Urea 40 Percent198.4 g in 1 BOTTLECREAM198.4103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-9267-1GM - Gram63629-9267d0479f43-1538-4d17-9058-c15560f7f1d112022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-9267UREA 40 PERCENT (UREA) CREAM [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 1 package rows20240511_6701225c-2c2e-41e8-8d43-ef77c00a9946.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 40 PercentUREABryant Ranch Prepack6701225c-2c2e-41e8-8d43-ef77c00a99462026-04-24Warnings, Adverse reactionsExact identifier
ndc (product): 63629-9267

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198342urea 40 % Topical CreamPSN6701225c-2c2e-41e8-8d43-ef77c00a9946103
198342urea 400 MG/ML Topical CreamSCD6701225c-2c2e-41e8-8d43-ef77c00a9946103
198342urea 40 % Topical CreamSY6701225c-2c2e-41e8-8d43-ef77c00a9946103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-9267-163629926701198.4 g in 1 BOTTLE (63629-9267-1) 198.4 g2024-04-040000-00-00NoNoCurrent