clotrimazole

Generic: clotrimazole

Labeler: marlex pharmaceuticals inc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name clotrimazole
Generic Name clotrimazole
Labeler marlex pharmaceuticals inc
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

clotrimazole 1 g/mL

Manufacturer
Marlex Pharmaceuticals Inc

Identifiers & Regulatory

Product NDC 10135-671
Product ID 10135-671_40a87948-bcf6-0552-e063-6394a90a2d0d
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M005
Listing Expiration 2026-12-31
Marketing Start 2018-12-01

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 10135671
Hyphenated Format 10135-671

Supplemental Identifiers

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
  • 1 BOTTLE in 1 CARTON (10135-671-81) / 10 mL in 1 BOTTLE
  • 1 BOTTLE in 1 CARTON (10135-671-91) / 30 mL in 1 BOTTLE
source: ndc

Packages (2)

10135-671-81 1 BOTTLE in 1 CARTON (10135-671-81) / 10 mL in 1 BOTTLE 10135-671-91 1 BOTTLE in 1 CARTON (10135-671-91) / 30 mL in 1 BOTTLE

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": "40a87948-bcf6-0552-e063-6394a90a2d0d", "openfda": {"nui": ["N0000175487", "M0002083"], "unii": ["G07GZ97H65"], "spl_set_id": ["d6e95c99-e055-436a-8ee6-40d6e199eaca"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "manufacturer_name": ["Marlex Pharmaceuticals Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (10135-671-81)  / 10 mL in 1 BOTTLE", "package_ndc": "10135-671-81", "marketing_start_date": "20181201"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (10135-671-91)  / 30 mL in 1 BOTTLE", "package_ndc": "10135-671-91", "marketing_start_date": "20200201"}], "brand_name": "Clotrimazole", "product_id": "10135-671_40a87948-bcf6-0552-e063-6394a90a2d0d", "dosage_form": "SOLUTION", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "10135-671", "generic_name": "Clotrimazole", "labeler_name": "Marlex Pharmaceuticals 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": "20181201", "listing_expiration_date": "20261231"}