FDA.reportPublic FDA data

Urea 40 Percent

Product NDC
58657-487
11-digit product format
586570487
Labeler code
58657
Product ID
58657-487_4aad643a-b8f7-e2cb-e063-6394a90affec
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Urea
Dosage form
CREAM
Route
TOPICAL
Labeler
Method Pharmaceuticals, LLC
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2021-11-15
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 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
d35b75e1-937d-ebc4-e053-2a95a90ac0d8Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58657-487-01Urea 40 Percent28.35 g in 1 BOTTLECREAM28.358
58657-487-03Urea 40 Percent85 g in 1 BOTTLECREAM858
58657-487-07Urea 40 Percent198.4 g in 1 BOTTLECREAM198.48

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58657-487-01GM - Gram58657-4876cc9ad67-4027-4a1a-977f-6cf12e22639412022-02-07
58657-487-03GM - Gram58657-487e3820119-276c-4c8a-8c62-164a4b76514a12022-02-07
58657-487-07GM - Gram58657-487b02e37c2-ec4f-48de-b296-a5fc2cf8097d12022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58657-487UREA 40 PERCENT (UREA) CREAM [METHOD PHARMACEUTICALS, LLC]6Current NDC, Legacy NDC, 3 package rows20241126_d35b75e1-937d-ebc4-e053-2a95a90ac0d8.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 40 PercentUREAMethod Pharmaceuticals, LLCd35b75e1-937d-ebc4-e053-2a95a90ac0d82026-02-12Warnings, Adverse reactionsExact identifier
ndc (product): 58657-487

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198342urea 40 % Topical CreamPSN6701225c-2c2e-41e8-8d43-ef77c00a9946103
198342urea 400 MG/ML Topical CreamSCD6701225c-2c2e-41e8-8d43-ef77c00a9946103
198342urea 40 % Topical CreamSY6701225c-2c2e-41e8-8d43-ef77c00a9946103
198342urea 40 % Topical CreamPSNee06a590-a104-4e97-b66c-cd37869038a5101
198342urea 400 MG/ML Topical CreamSCDee06a590-a104-4e97-b66c-cd37869038a5101
198342urea 40 % Topical CreamSYee06a590-a104-4e97-b66c-cd37869038a5101
198342urea 40 % Topical CreamPSN3d9bf300-cb72-463b-be9a-70c8d9a55b63100
198342urea 400 MG/ML Topical CreamSCD3d9bf300-cb72-463b-be9a-70c8d9a55b63100
198342urea 40 % Topical CreamSY3d9bf300-cb72-463b-be9a-70c8d9a55b63100
198342urea 40 % Topical CreamPSNd35b75e1-937d-ebc4-e053-2a95a90ac0d88
198342urea 400 MG/ML Topical CreamSCDd35b75e1-937d-ebc4-e053-2a95a90ac0d88
198342urea 40 % Topical CreamSYd35b75e1-937d-ebc4-e053-2a95a90ac0d88

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58657-487-015865704870128.35 g in 1 BOTTLE (58657-487-01) 28.35 g2021-11-150000-00-00NoNoCurrent
58657-487-035865704870385 g in 1 BOTTLE (58657-487-03) 85 g2021-11-150000-00-00NoNoCurrent
58657-487-0758657048707198.4 g in 1 BOTTLE (58657-487-07) 198.4 g2021-11-150000-00-00NoNoCurrent