FDA.reportPublic FDA data

Urea Cream 40 Percent

Product NDC
58657-489
11-digit product format
586570489
Labeler code
58657
Product ID
58657-489_49ee2dc0-c081-673b-e063-6294a90aa6c6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Urea
Dosage form
CREAM
Route
TOPICAL
Labeler
Method Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2023-10-31
Substance
UREA
Active strength
400 mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Urea Cream 40 Percent
Listing expiration
2027-12-31

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
58657-489-01Urea Cream 40 Percent28.35 g in 1 BOTTLECREAM28.355
58657-489-03Urea Cream 40 Percent85 g in 1 BOTTLECREAM855
58657-489-07Urea Cream 40 Percent198.4 g in 1 BOTTLECREAM198.45

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58657-489UREA CREAM 40 PERCENT (UREA) CREAM [METHOD PHARMACEUTICALS, LLC]3Current NDC, 3 package rows20241126_0920f780-b504-1fea-e063-6394a90ae5a9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198342urea 40 % Topical CreamPSNe28969bc-c3a0-49e5-9947-aee0c6b8b0b5101
198342urea 400 MG/ML Topical CreamSCDe28969bc-c3a0-49e5-9947-aee0c6b8b0b5101
198342urea 40 % Topical CreamSYe28969bc-c3a0-49e5-9947-aee0c6b8b0b5101
198342urea 40 % Topical CreamPSN59afcfbe-fe04-49c9-b1c5-28f2c4311c01100
198342urea 400 MG/ML Topical CreamSCD59afcfbe-fe04-49c9-b1c5-28f2c4311c01100
198342urea 40 % Topical CreamSY59afcfbe-fe04-49c9-b1c5-28f2c4311c01100
198342urea 40 % Topical CreamPSN0920f780-b504-1fea-e063-6394a90ae5a95
198342urea 400 MG/ML Topical CreamSCD0920f780-b504-1fea-e063-6394a90ae5a95
198342urea 40 % Topical CreamSY0920f780-b504-1fea-e063-6394a90ae5a95

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58657-489-015865704890128.35 g in 1 BOTTLE (58657-489-01) 28.35 g2023-10-31NoNoCurrent
58657-489-035865704890385 g in 1 BOTTLE (58657-489-03) 85 g2023-10-31NoNoCurrent
58657-489-0758657048907198.4 g in 1 BOTTLE (58657-489-07) 198.4 g2026-01-15NoNoCurrent