thera plus antifungal clotrimazole

Generic: clotrimazole

Labeler: fourstar group usa, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name thera plus antifungal clotrimazole
Generic Name clotrimazole
Labeler fourstar group usa, inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

clotrimazole 10 mg/g

Manufacturer
FOURSTAR GROUP USA, INC.

Identifiers & Regulatory

Product NDC 80684-039
Product ID 80684-039_08a0ce90-0c11-15f4-e063-6294a90a6ca7
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M005
Listing Expiration 2026-12-31
Marketing Start 2022-01-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 80684039
Hyphenated Format 80684-039

Supplemental Identifiers

RxCUI
309367
UPC
0049696866620
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 thera plus antifungal clotrimazole (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 BOX (80684-039-01) / 14 g in 1 TUBE
source: ndc

Packages (1)

80684-039-01 1 TUBE in 1 BOX (80684-039-01) / 14 g in 1 TUBE

Ingredients (1)

clotrimazole (10 mg/g)

Linked Drug Pages (1)

Thera plus Antifungal Clotrimazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "08a0ce90-0c11-15f4-e063-6294a90a6ca7", "openfda": {"nui": ["N0000175487", "M0002083"], "upc": ["0049696866620"], "unii": ["G07GZ97H65"], "rxcui": ["309367"], "spl_set_id": ["1265be99-8922-4b76-bd63-19bfb42c3896"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "manufacturer_name": ["FOURSTAR GROUP USA, INC."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 BOX (80684-039-01)  / 14 g in 1 TUBE", "package_ndc": "80684-039-01", "marketing_start_date": "20220130"}], "brand_name": "Thera plus Antifungal Clotrimazole", "product_id": "80684-039_08a0ce90-0c11-15f4-e063-6294a90a6ca7", "dosage_form": "CREAM", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "80684-039", "generic_name": "CLOTRIMAZOLE", "labeler_name": "FOURSTAR GROUP USA, INC.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Thera plus Antifungal Clotrimazole", "active_ingredients": [{"name": "CLOTRIMAZOLE", "strength": "10 mg/g"}], "application_number": "M005", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20220130", "listing_expiration_date": "20261231"}