FDA.reportPublic FDA data

Desenex

Manufacturer
Crown Laboratories
Effective date
2026-01-12
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:32:23

Label at a glance#

ProductDesenex
Active ingredientMICONAZOLE NITRATE
Label structure9 sections

Indications and uses

Cures most athlete’s foot (tinea pedis) Relieves itching, burning, cracking, and discomfort

Dosage and administration

Wash the affected area and dry thoroughly. Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor. Supervise children in the use of this product. Pay special attention to spaces between the toes; wear well fitting, ventilated shoes, and change shoes and socks at least once daily. Use daily for 4 weeks. If condition persists longer, consult a doctor. This pro...

Storage and handling

store at 20 o - 25 o C (68 o - 77 o F) [see USP Controlled Room Temperature].

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Miconazole nitrate 2%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

  • Cures most athlete’s foot (tinea pedis)
  • Relieves itching, burning, cracking, and discomfort

Warnings

WARNINGS SECTION

For external use only.

Avoid contact with eyes.

Do not use

OTC - DO NOT USE SECTION

on children under 2 years of age unless directed by a doctor.

If irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a doctor.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a poison control center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Wash the affected area and dry thoroughly. Apply a thin layer of the product over affected area twice daily (morning and night) or as directed by a doctor. Supervise children in the use of this product. Pay special attention to spaces between the toes; wear well fitting, ventilated shoes, and change shoes and socks at least once daily. Use daily for 4 weeks. If condition persists longer,
consult a doctor. This product is not effective on the scalp or nails.

Other information

STORAGE AND HANDLING SECTION

  • store at 20 o - 25 oC (68 o - 77 oF) [see USP Controlled Room Temperature].

Inactive ingredients

INACTIVE INGREDIENT SECTION

1,2-Hexanediol, Aloe Barbadensis Leaf Juice Powder, Beta-Glucan, Caprylyl Glycol, Fragrance, Glycerin, Potassium Sorbate, Sodium Benzoate, Tapioca Starch, Tricalcium Phosphate, Water, Zea Mays (Corn) Starch

Questions?

OTC - QUESTIONS SECTION

call 1-833-279-6522

Principal Display

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Desenex®

Antifungal Foot Powder

with 2% Miconazole Nitrate

PRESCRIPTION STRENGTH

Cures Most Athlete's Foot

Triple Action Powder

Relieves Itching, Burning, and Scaling

Attacks and Absorbs Moisture

All Day Odor Control

NET WT. 1.5 oz [43g]

PRODUCT PACKAGED BY WEIGHT NOT VOLUME

©2023 Crown Laboratories, Inc.

Distributed by: Crown Laboratories, Inc . Johnson City, TN 37604

DESENEX is a registered trademark of Crown Laboratories, Inc.

P12319.01

Desenex 1.5oz labelDesenex 1.5oz label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998465Desenex 2 % Topical PowderPSN4
998461miconazole nitrate 2 % Topical PowderPSN4
998465miconazole nitrate 0.02 MG/MG Topical Powder [Desenex]SBD4
998461miconazole nitrate 0.02 MG/MG Topical PowderSCD4
998465Desenex 0.02 MG/MG Topical PowderSY4
998465Desenex 2 % Topical PowderSY4
998461miconazole nitrate 2 % Topical PowderSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
MICONAZOLE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130303160225154GTIN-13: 0303160225154
EAN-13: 0303160225154
GTIN-12: 303160225154
UPC-A: 303160225154
GTIN storage (14 digits): 00303160225154		P12319.01 Desenex label.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0316-0225-01Desenex43 g in 1 BOTTLE, PLASTICPOWDER434
0316-0225-02Desenex85 g in 1 BOTTLE, PLASTICPOWDER854

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0316-0225-15GM - Gram0316-022501400da0-bdbd-4a2e-9de5-d2848d3a99ef12019-01-24
0316-0225-30GM - Gram0316-022541ddbc5d-8568-478a-a3a1-fdee93d77f5412019-01-24

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0316-02250316-0225-01, 0316-0225-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
STARCH, TAPIOCA24SC3U704IIACT
TRICALCIUM PHOSPHATEK4C08XP666IACT
CAPRYLYL GLYCOL00YIU5438UIACT
WATER059QF0KO0RIACT
STARCH, CORNO8232NY3SJIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
ALOE VERA LEAFZY81Z83H0XIACT
YEAST .BETA.-D-GLUCAN44FQ49X6UNIACT
GLYCERINPDC6A3C0OXIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
MICONAZOLE NITRATEVW4H1CYW1KACTIB
SODIUM BENZOATEOJ245FE5EUIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32025-11-12monthly-update2026-06-03 17:39:20
22023-11-10full-release2026-05-31 23:59:47

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DesenexMICONAZOLE NITRATECrown Laboratories09964187-12f1-bbe6-e063-6394a90acba02026-01-12WarningsExact identifier
ndc (package): 0316-0225-02
ndc (package): 0316-0225-01
ndc (product): 0316-0225
ndc11 (package): 00316022501
ndc11 (package): 00316022502
spl id: 4833f384-eb1d-0049-e063-6394a90a9f53
spl set id: 09964187-12f1-bbe6-e063-6394a90acba0

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.