FDA.reportPublic FDA data

Urea Cream 41%

Product NDC
16477-341
11-digit product format
164770341
Labeler code
16477
Product ID
16477-341_42f7100f-e9e2-69fd-e063-6294a90a0f68
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Urea
Dosage form
CREAM
Route
TOPICAL
Labeler
Laser Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2018-05-04
Substance
UREA
Active strength
410 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Urea Cream 41%
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
UREA410 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
1436933Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ada4d313-1050-4501-9c93-68dfb3a2c9e4Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
16477-341-08Urea Cream 41%227 g in 1 BOTTLE, PLASTICCREAM22711
16477-341-08Urea Cream 41%1 in 1 CARTONCREAM111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16477-341-08GM - Gram16477-34111f5f3aa-e795-4b8f-a6db-1509c6ea966c12018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16477-341UREA CREAM 41% (UREA) CREAM [LASER PHARMACEUTICALS, LLC]9Current NDC, Legacy NDC, 2 package rows20241109_ada4d313-1050-4501-9c93-68dfb3a2c9e4.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 41%UREALaser Pharmaceuticals, LLCada4d313-1050-4501-9c93-68dfb3a2c9e42025-11-06Warnings, Adverse reactionsExact identifier
ndc (product): 16477-341

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1436933urea 41 % Topical CreamPSNada4d313-1050-4501-9c93-68dfb3a2c9e411
1436933urea 410 MG/ML Topical CreamSCDada4d313-1050-4501-9c93-68dfb3a2c9e411
1436933urea 41 % Topical CreamSYada4d313-1050-4501-9c93-68dfb3a2c9e411

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16477-341-08164770341081 BOTTLE, PLASTIC in 1 CARTON (16477-341-08) / 227 g in 1 BOTTLE, PLASTIC2018-05-040000-00-00NoNoCurrent