clotrimazole

Generic: clotrimazole

Labeler: trifecta pharmaceuticals usa llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name clotrimazole
Generic Name clotrimazole
Labeler trifecta pharmaceuticals usa llc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

clotrimazole 1 g/100g

Manufacturer
TRIFECTA PHARMACEUTICALS USA LLC

Identifiers & Regulatory

Product NDC 69396-001
Product ID 69396-001_3d0eea58-f83c-2b5d-e063-6294a90a1c05
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M005
Listing Expiration 2026-12-31
Marketing Start 2015-03-10

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69396001
Hyphenated Format 69396-001

Supplemental Identifiers

RxCUI
309367
UPC
0094922042002 0850026393545 0040232454998
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/100g
source: ndc
Packaging
  • 1 TUBE in 1 BOX (69396-001-04) / 113.4 g in 1 TUBE
  • 1 TUBE in 1 BOX (69396-001-05) / 15 g in 1 TUBE
  • 144 PACKAGE in 1 BOX (69396-001-09) / .9 g in 1 PACKAGE
  • 10 TUBE in 1 BOX (69396-001-10) / 30 g in 1 TUBE
  • 1 TUBE in 1 BOX (69396-001-20) / 28.4 g in 1 TUBE
  • 3 TUBE in 1 BOX (69396-001-33) / 30 g in 1 TUBE
  • 4 TUBE in 1 BOX (69396-001-44) / 30 g in 1 TUBE
  • 5 TUBE in 1 BOX (69396-001-55) / 28.4 g in 1 TUBE
  • 4 TUBE in 1 BOX (69396-001-66) / 30 g in 1 TUBE
source: ndc

Packages (9)

69396-001-04 1 TUBE in 1 BOX (69396-001-04) / 113.4 g in 1 TUBE 69396-001-05 1 TUBE in 1 BOX (69396-001-05) / 15 g in 1 TUBE 69396-001-09 144 PACKAGE in 1 BOX (69396-001-09) / .9 g in 1 PACKAGE 69396-001-10 10 TUBE in 1 BOX (69396-001-10) / 30 g in 1 TUBE 69396-001-20 1 TUBE in 1 BOX (69396-001-20) / 28.4 g in 1 TUBE 69396-001-33 3 TUBE in 1 BOX (69396-001-33) / 30 g in 1 TUBE 69396-001-44 4 TUBE in 1 BOX (69396-001-44) / 30 g in 1 TUBE 69396-001-55 5 TUBE in 1 BOX (69396-001-55) / 28.4 g in 1 TUBE 69396-001-66 4 TUBE in 1 BOX (69396-001-66) / 30 g in 1 TUBE

Ingredients (1)

clotrimazole (1 g/100g)

Linked Drug Pages (1)

Clotrimazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "3d0eea58-f83c-2b5d-e063-6294a90a1c05", "openfda": {"nui": ["N0000175487", "M0002083"], "upc": ["0094922042002", "0850026393545", "0040232454998"], "unii": ["G07GZ97H65"], "rxcui": ["309367"], "spl_set_id": ["6b74d405-42d6-4c46-ba78-3007d1e8ffb8"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "manufacturer_name": ["TRIFECTA PHARMACEUTICALS USA LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 BOX (69396-001-04)  / 113.4 g in 1 TUBE", "package_ndc": "69396-001-04", "marketing_start_date": "20220503"}, {"sample": false, "description": "1 TUBE in 1 BOX (69396-001-05)  / 15 g in 1 TUBE", "package_ndc": "69396-001-05", "marketing_start_date": "20160823"}, {"sample": false, "description": "144 PACKAGE in 1 BOX (69396-001-09)  / .9 g in 1 PACKAGE", "package_ndc": "69396-001-09", "marketing_start_date": "20220309"}, {"sample": false, "description": "10 TUBE in 1 BOX (69396-001-10)  / 30 g in 1 TUBE", "package_ndc": "69396-001-10", "marketing_start_date": "20240703"}, {"sample": false, "description": "1 TUBE in 1 BOX (69396-001-20)  / 28.4 g in 1 TUBE", "package_ndc": "69396-001-20", "marketing_start_date": "20150310"}, {"sample": false, "description": "3 TUBE in 1 BOX (69396-001-33)  / 30 g in 1 TUBE", "package_ndc": "69396-001-33", "marketing_start_date": "20240610"}, {"sample": false, "description": "4 TUBE in 1 BOX (69396-001-44)  / 30 g in 1 TUBE", "package_ndc": "69396-001-44", "marketing_start_date": "20241106"}, {"sample": false, "description": "5 TUBE in 1 BOX (69396-001-55)  / 28.4 g in 1 TUBE", "package_ndc": "69396-001-55", "marketing_start_date": "20231106"}, {"sample": false, "description": "4 TUBE in 1 BOX (69396-001-66)  / 30 g in 1 TUBE", "package_ndc": "69396-001-66", "marketing_start_date": "20240318"}], "brand_name": "Clotrimazole", "product_id": "69396-001_3d0eea58-f83c-2b5d-e063-6294a90a1c05", "dosage_form": "CREAM", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "69396-001", "generic_name": "Clotrimazole", "labeler_name": "TRIFECTA PHARMACEUTICALS USA LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Clotrimazole", "active_ingredients": [{"name": "CLOTRIMAZOLE", "strength": "1 g/100g"}], "application_number": "M005", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20150310", "listing_expiration_date": "20261231"}