clotrimazole

Generic: clotrimazole

Labeler: akron pharma inc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name clotrimazole
Generic Name clotrimazole
Labeler akron pharma inc
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

clotrimazole 1 g/mL

Manufacturer
Akron Pharma Inc

Identifiers & Regulatory

Product NDC 71399-0500
Product ID 71399-0500_48c2d469-8ec5-1b48-e063-6294a90a1ef5
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M005
Listing Expiration 2027-12-31
Marketing Start 2024-09-13

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 713990500
Hyphenated Format 71399-0500

Supplemental Identifiers

UPC
0371399050038
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 clotrimazole (source: ndc)
Generic Name clotrimazole (source: ndc)
Application Number M005 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1 g/mL
source: ndc
Packaging
  • 10 mL in 1 BOTTLE (71399-0500-1)
  • 30 mL in 1 BOTTLE (71399-0500-3)
source: ndc

Packages (2)

71399-0500-1 10 mL in 1 BOTTLE (71399-0500-1) 71399-0500-3 30 mL in 1 BOTTLE (71399-0500-3)

Ingredients (1)

clotrimazole (1 g/mL)

Linked Drug Pages (1)

Clotrimazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "48c2d469-8ec5-1b48-e063-6294a90a1ef5", "openfda": {"nui": ["N0000175487", "M0002083"], "upc": ["0371399050038"], "unii": ["G07GZ97H65"], "spl_set_id": ["692d7e0f-50d4-4abb-8c74-36bc98064fe7"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "manufacturer_name": ["Akron Pharma Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 mL in 1 BOTTLE (71399-0500-1)", "package_ndc": "71399-0500-1", "marketing_start_date": "20240913"}, {"sample": false, "description": "30 mL in 1 BOTTLE (71399-0500-3)", "package_ndc": "71399-0500-3", "marketing_start_date": "20240913"}], "brand_name": "Clotrimazole", "product_id": "71399-0500_48c2d469-8ec5-1b48-e063-6294a90a1ef5", "dosage_form": "SOLUTION", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "71399-0500", "generic_name": "Clotrimazole", "labeler_name": "Akron Pharma Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Clotrimazole", "active_ingredients": [{"name": "CLOTRIMAZOLE", "strength": "1 g/mL"}], "application_number": "M005", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240913", "listing_expiration_date": "20271231"}