FDA.reportPublic FDA data

UREA

Product NDC
24470-939
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 Identifiers#

Field, Values table
FieldValues
Unii8W8T17847W
Rxcui198342

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

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 formatDescriptionUnitsMarketing startSampleExclude flagStatus
24470-939-01244700939011 BOTTLE, PLASTIC in 1 CARTON (24470-939-01) / 28.35 g in 1 BOTTLE, PLASTIC2024-01-23NoNoHistorical
24470-939-032447009390385 g in 1 BOTTLE, PLASTIC (24470-939-03) 85 g2024-01-23NoNoHistorical
24470-939-0724470093907198.4 g in 1 BOTTLE, PLASTIC (24470-939-07) 198.4 g2024-01-23NoNoHistorical