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

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.

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

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings For topical use only. Avoid contact with eyes, lips or mucous membranes.

Adverse reactions cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

adverse reactions

Adverse Reactions Transient stinging, burning, itching or irritation may occur and normally disappear upon discontinuing the use of this product. To report SUSPECTED ADVERSE REACTIONS, contact Method Pharmaceuticals, LLC at 1-877-250-3427; or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

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 Identifiers#

Field, Values table
FieldValues
Unii8W8T17847W
Rxcui198342

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

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