FDA.reportPublic FDA data

UREA

Product NDC
63629-2036
Requested package NDC
63629-2036-1
11-digit product format
636292036
Labeler code
63629
Product ID
63629-2036_d9802356-9353-48bf-94c3-27dbc8eda1c3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
UREA
Dosage form
CREAM
Route
TOPICAL
Labeler
Bryant Ranch Prepack
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2013-12-02
Substance
UREA
Active strength
39 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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
UREA39 g/100g

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
1093289Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
11cb2ff3-464a-4554-a39c-bae9f0ee456bAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-2036-1UREA227 g in 1 BOTTLECREAM227102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2036-1GM - Gram63629-2036611d9db7-84fd-4fbb-98aa-1d07979f19e912021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2036UREA (UREA) CREAM [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 1 package rows20240110_11cb2ff3-464a-4554-a39c-bae9f0ee456b.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
UREAUREABryant Ranch Prepack11cb2ff3-464a-4554-a39c-bae9f0ee456b2024-01-09Warnings, Adverse reactionsExact identifier
ndc (package): 63629-2036-1
ndc (product): 63629-2036
ndc11 (package): 63629203601

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1093289urea 39 % Topical CreamPSN11cb2ff3-464a-4554-a39c-bae9f0ee456b102
1093289urea 390 MG/ML Topical CreamSCD11cb2ff3-464a-4554-a39c-bae9f0ee456b102
1093289urea 39 % Topical CreamSY11cb2ff3-464a-4554-a39c-bae9f0ee456b102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-2036-163629203601227 g in 1 BOTTLE (63629-2036-1) 227 g2021-02-050000-00-00NoNoCurrent