FDA.reportPublic FDA data

Urea Cream 40%

Product NDC
71399-8456
11-digit product format
713998456
Labeler code
71399
Product ID
71399-8456_6153c0bc-1246-4396-a26d-cd066b909ef5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Urea
Dosage form
CREAM
Route
TOPICAL
Labeler
Akron Pharma Inc.
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2024-09-13
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
0ce643e9-cf13-4b51-8ffd-8d5636d73e51Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
71399-8456-12023-04-03Urea Cream 40%
71399-8456-32023-04-03Urea Cream 40%
71399-8456-72023-04-03Urea Cream 40%
71399-8456-12023-01-30Urea Cream 40%
71399-8456-32023-01-30Urea Cream 40%
71399-8456-72023-01-30Urea Cream 40%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71399-8456-1Urea Cream 40%28.35 g in 1 BOTTLECREAM28.353
71399-8456-3Urea Cream 40%85 g in 1 BOTTLECREAM853
71399-8456-7Urea Cream 40%198.45 g in 1 BOTTLECREAM198.453

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71399-8456-1GM - Gram71399-8456c1d155ab-0fbe-42dd-bf35-011a5c741e9712022-01-06
71399-8456-3GM - Gram71399-8456e72028ad-b9a6-48c5-980f-e1597ea343b712022-01-06
71399-8456-7GM - Gram71399-845684ee9962-d0c4-48bb-80d8-9765df28594712022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71399-8456UREA CREAM 40% (UREA) CREAM [AKRON PHARMA INC.]3Current NDC, Legacy NDC, 3 package rows20240927_0ce643e9-cf13-4b51-8ffd-8d5636d73e51.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%UREAAkron Pharma Inc.0ce643e9-cf13-4b51-8ffd-8d5636d73e512024-09-25Warnings, Adverse reactionsExact identifier
ndc (product): 71399-8456

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198342urea 40 % Topical CreamPSN0ce643e9-cf13-4b51-8ffd-8d5636d73e513
198342urea 400 MG/ML Topical CreamSCD0ce643e9-cf13-4b51-8ffd-8d5636d73e513
198342urea 40 % Topical CreamSY0ce643e9-cf13-4b51-8ffd-8d5636d73e513

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71399-8456-17139984560128.35 g in 1 BOTTLE (71399-8456-1) 28.35 g2024-09-130000-00-00NoNoCurrent
71399-8456-37139984560385 g in 1 BOTTLE (71399-8456-3) 85 g2024-09-130000-00-00NoNoCurrent
71399-8456-771399845607198.45 g in 1 BOTTLE (71399-8456-7) 198.45 g2024-09-130000-00-00NoNoCurrent