FDA.reportPublic FDA data

Urea Cream 41%

Product NDC
16477-341
Requested package NDC
16477-341-08
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

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. Every label matching the complete exact-identifier union is deduplicated and paginated 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 (package): 16477-341-08
ndc (product): 16477-341
ndc11 (package): 16477034108

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

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