FDA.reportPublic FDA data

Urea 40 Percent

Product NDC
58657-487
Requested package NDC
58657-487-03
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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 (package): 58657-487-03
ndc (product): 58657-487
ndc11 (package): 58657048703

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

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
58657-487-035865704870385 g in 1 BOTTLE (58657-487-03) 85 g2021-11-150000-00-00NoNoCurrent