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

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
UREAUREABryant Ranch Prepack1a6722de-c80a-40b5-b86b-953ef6e5e5692024-05-21Warnings, Adverse reactionsExact identifier
ndc (product): 63629-2040

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

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