FDA.reportPublic FDA data

Urea Cream 40%

Product NDC
16477-340
11-digit product format
164770340
Labeler code
16477
Product ID
16477-340_42f70c2c-33ab-99df-e063-6394a90a5f86
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
400 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 40%
Listing expiration
2026-12-31

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
16477-340-01Urea Cream 40%1 in 1 CARTONCREAM113
16477-340-01Urea Cream 40%28.35 g in 1 BOTTLE, PLASTICCREAM28.3513
16477-340-03Urea Cream 40%85 g in 1 BOTTLE, PLASTICCREAM8513
16477-340-03Urea Cream 40%1 in 1 CARTONCREAM113
16477-340-07Urea Cream 40%1 in 1 CARTONCREAM113
16477-340-07Urea Cream 40%198.4 g in 1 BOTTLE, PLASTICCREAM198.413

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16477-340UREA CREAM 40% (UREA) CREAM [LASER PHARMACEUTICALS, LLC]11Current NDC, Legacy NDC, 6 package rows20241013_ef2db58d-e760-417d-8574-45a411c49b47.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198342urea 40 % Topical CreamPSNef2db58d-e760-417d-8574-45a411c49b4713
198342urea 400 MG/ML Topical CreamSCDef2db58d-e760-417d-8574-45a411c49b4713
198342urea 40 % Topical CreamSYef2db58d-e760-417d-8574-45a411c49b4713

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16477-340-01164770340011 BOTTLE, PLASTIC in 1 CARTON (16477-340-01) / 28.35 g in 1 BOTTLE, PLASTIC2018-05-040000-00-00NoNoCurrent
16477-340-03164770340031 BOTTLE, PLASTIC in 1 CARTON (16477-340-03) / 85 g in 1 BOTTLE, PLASTIC2018-05-040000-00-00NoNoCurrent
16477-340-07164770340071 BOTTLE, PLASTIC in 1 CARTON (16477-340-07) / 198.4 g in 1 BOTTLE, PLASTIC2018-05-040000-00-00NoNoCurrent