FDA.reportPublic FDA data

UREA

Product NDC
63629-2040
11-digit product format
636292040
Labeler code
63629
Product ID
63629-2040_8346b38d-4599-4fb7-b304-33375e32148d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
UREA
Dosage form
LOTION
Route
TOPICAL
Labeler
Bryant Ranch Prepack
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2014-09-19
Substance
UREA
Active strength
40 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
UREA40 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
351155Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1a6722de-c80a-40b5-b86b-953ef6e5e569Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-2040-1UREA227 g in 1 BOTTLELOTION227101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2040-1GM - Gram63629-20409fb5a362-2580-4d34-ba26-2d0f5801808412021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2040UREA (UREA) LOTION [BRYANT RANCH PREPACK]101Current NDC, Legacy NDC, 1 package rows20240524_1a6722de-c80a-40b5-b86b-953ef6e5e569.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 Prepack1a6722de-c80a-40b5-b86b-953ef6e5e5692024-05-21Warnings, Adverse reactionsExact identifier
ndc (product): 63629-2040

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
351155urea 40 % Topical LotionPSN1a6722de-c80a-40b5-b86b-953ef6e5e569101
351155urea 400 MG/ML Topical LotionSCD1a6722de-c80a-40b5-b86b-953ef6e5e569101
351155urea 40 % Bioadhesive Topical SuspensionSY1a6722de-c80a-40b5-b86b-953ef6e5e569101
351155urea 40 % Topical LotionSY1a6722de-c80a-40b5-b86b-953ef6e5e569101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-2040-163629204001227 g in 1 BOTTLE (63629-2040-1) 227 g2014-09-190000-00-00NoNoCurrent