dandrx 1% ketoconazole anti-dandruff

Generic: dandrx 1% ketoconazole anti-dandruff shampoo

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

Drug Facts

Product Profile

Brand Name dandrx 1% ketoconazole anti-dandruff
Generic Name dandrx 1% ketoconazole anti-dandruff shampoo
Labeler dandrx llc
Dosage Form LIQUID
Routes
TOPICAL
Active Ingredients

ketoconazole 1 g/100mL

Manufacturer
dandRX LLC

Identifiers & Regulatory

Product NDC 85521-001
Product ID 85521-001_324fb7bb-4b8f-e6e6-e063-6394a90adae1
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M016
Listing Expiration 2026-12-31
Marketing Start 2025-04-09

Pharmacologic Class

Established (EPC)
azole antifungal [epc]
Mechanism of Action
cytochrome p450 3a4 inhibitors [moa] cytochrome p450 3a5 inhibitors [moa] p-glycoprotein inhibitors [moa]
Chemical Structure
azoles [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 85521001
Hyphenated Format 85521-001

Supplemental Identifiers

RxCUI
240812
UNII
R9400W927I
NUI
N0000175487 M0002083 N0000182141 N0000190115 N0000185503

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 dandrx 1% ketoconazole anti-dandruff (source: ndc)
Generic Name dandrx 1% ketoconazole anti-dandruff shampoo (source: ndc)
Application Number M016 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1 g/100mL
source: ndc
Packaging
  • 236 mL in 1 BOTTLE (85521-001-01)
source: ndc

Packages (1)

85521-001-01 236 mL in 1 BOTTLE (85521-001-01)

Ingredients (1)

ketoconazole (1 g/100mL)

Linked Drug Pages (1)

dandRX 1% Ketoconazole Anti-Dandruff ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "324fb7bb-4b8f-e6e6-e063-6394a90adae1", "openfda": {"nui": ["N0000175487", "M0002083", "N0000182141", "N0000190115", "N0000185503"], "unii": ["R9400W927I"], "rxcui": ["240812"], "spl_set_id": ["324fb7bb-4b8e-e6e6-e063-6394a90adae1"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "pharm_class_moa": ["Cytochrome P450 3A4 Inhibitors [MoA]", "Cytochrome P450 3A5 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "manufacturer_name": ["dandRX LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "236 mL in 1 BOTTLE (85521-001-01)", "package_ndc": "85521-001-01", "marketing_start_date": "20250409"}], "brand_name": "dandRX 1% Ketoconazole Anti-Dandruff", "product_id": "85521-001_324fb7bb-4b8f-e6e6-e063-6394a90adae1", "dosage_form": "LIQUID", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]", "Cytochrome P450 3A4 Inhibitors [MoA]", "Cytochrome P450 3A5 Inhibitors [MoA]", "P-Glycoprotein Inhibitors [MoA]"], "product_ndc": "85521-001", "generic_name": "dandRX 1% Ketoconazole Anti-Dandruff Shampoo", "labeler_name": "dandRX LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "dandRX 1% Ketoconazole Anti-Dandruff", "active_ingredients": [{"name": "KETOCONAZOLE", "strength": "1 g/100mL"}], "application_number": "M016", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250409", "listing_expiration_date": "20261231"}