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 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
0920f780-b504-1fea-e063-6394a90ae5a9Available on FDA.report

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58657-489-01GM - Gram58657-48920d012e2-af13-46bf-81c1-76f9bacd263b12023-12-05
58657-489-03GM - Gram58657-489fd5edf21-bdc1-45a1-88a2-6d84004ec6c612023-12-05
58657-489-07GM - Gram58657-4894bb1dd3c-81cd-4327-8524-d6a51c335c4b12026-03-17

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

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 PercentUREAMethod Pharmaceuticals, LLC0920f780-b504-1fea-e063-6394a90ae5a92026-01-15Warnings, Adverse reactionsExact identifier
ndc (product): 58657-489

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