antifungal

Generic: clotrimazole

Labeler: encube ethicals, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name antifungal
Generic Name clotrimazole
Labeler encube ethicals, inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

clotrimazole 10 mg/g

Manufacturer
Encube Ethicals, Inc.

Identifiers & Regulatory

Product NDC 21922-094
Product ID 21922-094_c9cf3a99-2b28-49c8-85f9-f693ca847074
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M005
Listing Expiration 2026-12-31
Marketing Start 2025-03-06

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 21922094
Hyphenated Format 21922-094

Supplemental Identifiers

RxCUI
309367
UPC
0321922094053
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 antifungal (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
  • 1 TUBE in 1 CARTON (21922-094-04) / 14 g in 1 TUBE
  • 1 TUBE in 1 CARTON (21922-094-05) / 28 g in 1 TUBE
source: ndc

Packages (2)

21922-094-04 1 TUBE in 1 CARTON (21922-094-04) / 14 g in 1 TUBE 21922-094-05 1 TUBE in 1 CARTON (21922-094-05) / 28 g in 1 TUBE

Ingredients (1)

clotrimazole (10 mg/g)

Linked Drug Pages (1)

ANTIFUNGAL ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "c9cf3a99-2b28-49c8-85f9-f693ca847074", "openfda": {"nui": ["N0000175487", "M0002083"], "upc": ["0321922094053"], "unii": ["G07GZ97H65"], "rxcui": ["309367"], "spl_set_id": ["afbc28f8-bb76-424d-9d73-136e6c283ead"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "manufacturer_name": ["Encube Ethicals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (21922-094-04)  / 14 g in 1 TUBE", "package_ndc": "21922-094-04", "marketing_start_date": "20250306"}, {"sample": false, "description": "1 TUBE in 1 CARTON (21922-094-05)  / 28 g in 1 TUBE", "package_ndc": "21922-094-05", "marketing_start_date": "20250306"}], "brand_name": "ANTIFUNGAL", "product_id": "21922-094_c9cf3a99-2b28-49c8-85f9-f693ca847074", "dosage_form": "CREAM", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "21922-094", "generic_name": "Clotrimazole", "labeler_name": "Encube Ethicals, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "ANTIFUNGAL", "active_ingredients": [{"name": "CLOTRIMAZOLE", "strength": "10 mg/g"}], "application_number": "M005", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250306", "listing_expiration_date": "20261231"}