FDA.reportPublic FDA data

Urea Cream 40 Percent

Product NDC
72162-2203
11-digit product format
721622203
Labeler code
72162
Product ID
72162-2203_47c029cd-a0dc-45a7-a91f-729889bcf007
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Urea
Dosage form
CREAM
Route
TOPICAL
Labeler
Bryant Ranch Prepack
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2023-10-31
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 Cream 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
e28969bc-c3a0-49e5-9947-aee0c6b8b0b5Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-2203-4Urea Cream 40 Percent85 g in 1 BOTTLECREAM85101
72162-2203-7Urea Cream 40 Percent28.35 g in 1 BOTTLECREAM28.35101
72162-2203-8Urea Cream 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
72162-2203-4GM - Gram72162-2203830457ad-5d7a-446c-899a-5f6dfdbb31bd12024-02-14
72162-2203-7GM - Gram72162-2203b834f68a-00ef-427d-bdbb-36797da3f8c512024-02-14
72162-2203-8GM - Gram72162-22030bc51f41-41a9-4c0b-ad58-dcd614a97d0d12026-03-17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2203UREA CREAM 40 PERCENT (UREA) CREAM [BRYANT RANCH PREPACK]100Current NDC, 3 package rows20231227_e28969bc-c3a0-49e5-9947-aee0c6b8b0b5.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 Cream 40 PercentUREABryant Ranch Prepacke28969bc-c3a0-49e5-9947-aee0c6b8b0b52026-02-13Warnings, Adverse reactionsExact identifier
ndc (product): 72162-2203

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198342urea 40 % Topical CreamPSNe28969bc-c3a0-49e5-9947-aee0c6b8b0b5101
198342urea 400 MG/ML Topical CreamSCDe28969bc-c3a0-49e5-9947-aee0c6b8b0b5101
198342urea 40 % Topical CreamSYe28969bc-c3a0-49e5-9947-aee0c6b8b0b5101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2203-47216222030485 g in 1 BOTTLE (72162-2203-4) 85 g2023-12-19NoNoCurrent
72162-2203-77216222030728.35 g in 1 BOTTLE (72162-2203-7) 28.35 g2023-12-19NoNoCurrent
72162-2203-872162220308198.4 g in 1 BOTTLE (72162-2203-8) 198.4 g2023-12-19NoNoCurrent