tinea versicolor treatment cream

Generic: clotrimazole

Labeler: beautivity llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name tinea versicolor treatment cream
Generic Name clotrimazole
Labeler beautivity llc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

clotrimazole 10 mg/g

Manufacturer
Beautivity LLC

Identifiers & Regulatory

Product NDC 85398-002
Product ID 85398-002_4c059bb0-15ad-ca94-e063-6294a90a4643
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M005
Listing Expiration 2027-12-31
Marketing Start 2025-05-12

Pharmacologic Class

Established (EPC)
azole antifungal [epc]
Chemical Structure
azoles [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 85398002
Hyphenated Format 85398-002

Supplemental Identifiers

RxCUI
309367
UNII
G07GZ97H65
NUI
N0000175487 M0002083

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 tinea versicolor treatment cream (source: ndc)
Generic Name clotrimazole (source: ndc)
Application Number M005 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/g
source: ndc
Packaging
  • 60 g in 1 TUBE (85398-002-01)
source: ndc

Packages (1)

85398-002-01 60 g in 1 TUBE (85398-002-01)

Ingredients (1)

clotrimazole (10 mg/g)

Linked Drug Pages (1)

Tinea Versicolor Treatment Cream ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "4c059bb0-15ad-ca94-e063-6294a90a4643", "openfda": {"nui": ["N0000175487", "M0002083"], "unii": ["G07GZ97H65"], "rxcui": ["309367"], "spl_set_id": ["32d71d7e-3c78-6b63-e063-6294a90adaed"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "manufacturer_name": ["Beautivity LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 g in 1 TUBE (85398-002-01)", "package_ndc": "85398-002-01", "marketing_start_date": "20250512"}], "brand_name": "Tinea Versicolor Treatment Cream", "product_id": "85398-002_4c059bb0-15ad-ca94-e063-6294a90a4643", "dosage_form": "CREAM", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "85398-002", "generic_name": "Clotrimazole", "labeler_name": "Beautivity LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Tinea Versicolor Treatment Cream", "active_ingredients": [{"name": "CLOTRIMAZOLE", "strength": "10 mg/g"}], "application_number": "M005", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250512", "listing_expiration_date": "20271231"}