clotrimazole

Generic: clotrimazole

Labeler: top care (topco associates llc)
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name clotrimazole
Generic Name clotrimazole
Labeler top care (topco associates llc)
Dosage Form CREAM
Routes
VAGINAL
Active Ingredients

clotrimazole 10 mg/g

Manufacturer
TOP CARE (Topco Associates LLC)

Identifiers & Regulatory

Product NDC 36800-508
Product ID 36800-508_b5f02aa7-e582-40f1-a912-b43c32b64bd6
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M005
Marketing Start 2021-09-30
Marketing End 2026-05-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 36800508
Hyphenated Format 36800-508

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
VAGINAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (36800-508-01) / 28 g in 1 TUBE
source: ndc

Packages (1)

36800-508-01 1 TUBE in 1 CARTON (36800-508-01) / 28 g in 1 TUBE

Ingredients (1)

clotrimazole (10 mg/g)

Linked Drug Pages (1)

Clotrimazole ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["VAGINAL"], "spl_id": "b5f02aa7-e582-40f1-a912-b43c32b64bd6", "openfda": {"nui": ["N0000175487", "M0002083"], "unii": ["G07GZ97H65"], "spl_set_id": ["cdb619ea-29a3-4c17-a6ec-8ff0b2f31ab4"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "manufacturer_name": ["TOP CARE (Topco Associates LLC)"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (36800-508-01)  / 28 g in 1 TUBE", "package_ndc": "36800-508-01", "marketing_end_date": "20260530", "marketing_start_date": "20210930"}], "brand_name": "Clotrimazole", "product_id": "36800-508_b5f02aa7-e582-40f1-a912-b43c32b64bd6", "dosage_form": "CREAM", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "36800-508", "generic_name": "Clotrimazole", "labeler_name": "TOP CARE (Topco Associates LLC)", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Clotrimazole", "active_ingredients": [{"name": "CLOTRIMAZOLE", "strength": "10 mg/g"}], "application_number": "M005", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_end_date": "20260530", "marketing_start_date": "20210930"}