FDA.reportPublic FDA data

UREA

Product NDC
24470-939
Requested package NDC
24470-939-01
11-digit product format
244700939
Labeler code
24470
Product ID
24470-939_0fa43016-708e-c2e2-e063-6394a90ab5de
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
UREA
Dosage form
CREAM
Route
TOPICAL
Labeler
Cintex Services, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2024-01-23
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
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
0fa4445e-554c-c791-e063-6294a90a9713Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24470-939-01UREA28.35 g in 1 BOTTLE, PLASTICCREAM28.351
24470-939-01UREA1 in 1 CARTONCREAM11
24470-939-03UREA85 g in 1 BOTTLE, PLASTICCREAM851
24470-939-07UREA198.4 g in 1 BOTTLE, PLASTICCREAM198.41

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24470-939-01GM - Gram24470-9392a136667-6a8d-4141-a357-7cc6287d13b312024-03-12
24470-939-03GM - Gram24470-9390d3d3e19-d217-4035-9498-a082f6af722e12024-03-12
24470-939-07GM - Gram24470-939431b6ac4-2f6c-4928-93f1-e80aa9338e6112024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24470-939UREA CREAM [CINTEX SERVICES, LLC]1Current NDC, 4 package rows20240124_0fa4445e-554c-c791-e063-6294a90a9713.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
UREAUREACintex Services, LLC0fa4445e-554c-c791-e063-6294a90a97132024-01-23Warnings, Adverse reactionsExact identifier
ndc (package): 24470-939-01
ndc (product): 24470-939
ndc11 (package): 24470093901

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198342urea 40 % Topical CreamPSN0fa4445e-554c-c791-e063-6294a90a97131
198342urea 400 MG/ML Topical CreamSCD0fa4445e-554c-c791-e063-6294a90a97131
198342urea 40 % Topical CreamSY0fa4445e-554c-c791-e063-6294a90a97131

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
24470-939-01244700939011 BOTTLE, PLASTIC in 1 CARTON (24470-939-01) / 28.35 g in 1 BOTTLE, PLASTIC2024-01-23NoNoCurrent