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 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
ef2db58d-e760-417d-8574-45a411c49b47Available on FDA.report

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16477-340-01GM - Gram16477-3402fabc5b4-16cc-4910-96e8-1c0363cc788e12018-10-11
16477-340-03GM - Gram16477-340bb9cabc5-d2d8-4241-aa5a-6813ba73352a12018-06-11
16477-340-07GM - Gram16477-3400cfc34e5-a86e-4b9a-a5d9-18558c714c0512018-06-11

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

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%UREALaser Pharmaceuticals, LLCef2db58d-e760-417d-8574-45a411c49b472025-11-06Warnings, Adverse reactionsExact identifier
ndc (product): 16477-340

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