FDA.reportPublic FDA data

DERMACURE

Product NDC
85477-909
Requested package NDC
85477-909-30
11-digit product format
854770909
Labeler code
85477
Product ID
85477-909_3f5bc584-a52c-3b5e-e063-6294a90a5674
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Urea 41%
Dosage form
CREAM
Route
TOPICAL
Labeler
Oncora Pharma, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2025-06-03
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
DERMACURE
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
3f5bc584-a52f-3b5e-e063-6294a90a5674Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85477-909-30DERMACURE227 g in 1 JARCREAM2271

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
85477-909-30GM - Gram85477-909f91e6315-88f4-47da-b5ee-057c4b50d25612025-11-13

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
DERMACUREUREA 41%Oncora Pharma, LLC3f5bc584-a52f-3b5e-e063-6294a90a56742025-09-21Warnings, Adverse reactionsExact identifier
ndc (package): 85477-909-30
ndc (product): 85477-909
ndc11 (package): 85477090930

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1436933urea 41 % Topical CreamPSN3f5bc584-a52f-3b5e-e063-6294a90a56741
1436933urea 410 MG/ML Topical CreamSCD3f5bc584-a52f-3b5e-e063-6294a90a56741
1436933urea 41 % Topical CreamSY3f5bc584-a52f-3b5e-e063-6294a90a56741

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85477-909-3085477090930227 g in 1 JAR (85477-909-30) 227 g2025-09-11NoNoCurrent