urea cream 40%

Generic: urea

Labeler: akron pharma inc.
NDC Directory HUMAN PRESCRIPTION DRUG UNAPPROVED DRUG OTHER Inactive Finished

Drug Facts

Product Profile

Brand Name urea cream 40%
Generic Name urea
Labeler akron pharma inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

urea 400 mg/g

Manufacturer
Akron Pharma Inc.

Identifiers & Regulatory

Product NDC 71399-8456
Product ID 71399-8456_6153c0bc-1246-4396-a26d-cd066b909ef5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category UNAPPROVED DRUG OTHER
Listing Expiration 2026-12-31
Marketing Start 2024-09-13

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 713998456
Hyphenated Format 71399-8456

Supplemental Identifiers

RxCUI
198342
UPC
0371399845672 0371399845634 0371399845610
UNII
8W8T17847W

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name urea cream 40% (source: ndc)
Generic Name urea (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 400 mg/g
source: ndc
Packaging
  • 28.35 g in 1 BOTTLE (71399-8456-1)
  • 85 g in 1 BOTTLE (71399-8456-3)
  • 198.45 g in 1 BOTTLE (71399-8456-7)
source: ndc

Packages (3)

71399-8456-1 28.35 g in 1 BOTTLE (71399-8456-1) 71399-8456-3 85 g in 1 BOTTLE (71399-8456-3) 71399-8456-7 198.45 g in 1 BOTTLE (71399-8456-7)

Ingredients (1)

urea (400 mg/g)

Linked Drug Pages (1)

Urea Cream 40% ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "6153c0bc-1246-4396-a26d-cd066b909ef5", "openfda": {"upc": ["0371399845672", "0371399845634", "0371399845610"], "unii": ["8W8T17847W"], "rxcui": ["198342"], "spl_set_id": ["0ce643e9-cf13-4b51-8ffd-8d5636d73e51"], "manufacturer_name": ["Akron Pharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "28.35 g in 1 BOTTLE (71399-8456-1)", "package_ndc": "71399-8456-1", "marketing_start_date": "20240913"}, {"sample": false, "description": "85 g in 1 BOTTLE (71399-8456-3)", "package_ndc": "71399-8456-3", "marketing_start_date": "20240913"}, {"sample": false, "description": "198.45 g in 1 BOTTLE (71399-8456-7)", "package_ndc": "71399-8456-7", "marketing_start_date": "20240913"}], "brand_name": "Urea Cream 40%", "product_id": "71399-8456_6153c0bc-1246-4396-a26d-cd066b909ef5", "dosage_form": "CREAM", "product_ndc": "71399-8456", "generic_name": "Urea", "labeler_name": "Akron Pharma Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Urea Cream 40%", "active_ingredients": [{"name": "UREA", "strength": "400 mg/g"}], "marketing_category": "UNAPPROVED DRUG OTHER", "marketing_start_date": "20240913", "listing_expiration_date": "20261231"}