clotrimazole (topical solution), 1%

Generic: clotrimazole

Labeler: puro pharma inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name clotrimazole (topical solution), 1%
Generic Name clotrimazole
Labeler puro pharma inc.
Dosage Form SOLUTION
Routes
TOPICAL
Active Ingredients

clotrimazole 10 mg/mL

Manufacturer
Puro Pharma Inc.

Identifiers & Regulatory

Product NDC 83474-003
Product ID 83474-003_46f2ddcb-401f-9ed7-e063-6394a90a7a63
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M005
Listing Expiration 2026-12-31
Marketing Start 2024-04-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 83474003
Hyphenated Format 83474-003

Supplemental Identifiers

RxCUI
309370
UPC
0383474003341
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 (topical solution), 1% (source: ndc)
Generic Name clotrimazole (source: ndc)
Application Number M005 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (83474-003-34) / 10 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

83474-003-34 1 BOTTLE, DROPPER in 1 CARTON (83474-003-34) / 10 mL in 1 BOTTLE, DROPPER

Ingredients (1)

clotrimazole (10 mg/mL)

Linked Drug Pages (1)

Clotrimazole (Topical Solution), 1% ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "46f2ddcb-401f-9ed7-e063-6394a90a7a63", "openfda": {"nui": ["N0000175487", "M0002083"], "upc": ["0383474003341"], "unii": ["G07GZ97H65"], "rxcui": ["309370"], "spl_set_id": ["cb424fa8-3ed5-45cd-b03f-64675584b34e"], "pharm_class_cs": ["Azoles [CS]"], "pharm_class_epc": ["Azole Antifungal [EPC]"], "manufacturer_name": ["Puro Pharma Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (83474-003-34)  / 10 mL in 1 BOTTLE, DROPPER", "package_ndc": "83474-003-34", "marketing_start_date": "20240415"}], "brand_name": "Clotrimazole (Topical Solution), 1%", "product_id": "83474-003_46f2ddcb-401f-9ed7-e063-6394a90a7a63", "dosage_form": "SOLUTION", "pharm_class": ["Azole Antifungal [EPC]", "Azoles [CS]"], "product_ndc": "83474-003", "generic_name": "Clotrimazole", "labeler_name": "Puro Pharma Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Clotrimazole (Topical Solution), 1%", "active_ingredients": [{"name": "CLOTRIMAZOLE", "strength": "10 mg/mL"}], "application_number": "M005", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240415", "listing_expiration_date": "20261231"}