FDA.reportPublic FDA data

Hongocura

Manufacturer
MENPER DISTRIBUTORS, INC. | RNV, LLC
Effective date
2025-07-22
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:08:21

Label at a glance#

ProductHongocura M
Active ingredientUNDECYLENIC ACID
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient  Purpose

Undecylenic Acid 20% v/v.................Antifungal

OTC - PURPOSE SECTION

Purpose

  • Antifungal

WARNINGS SECTION

Warnings

For external use only. Flammable: Keep away from fire and flame.

Do not use on children 

  • Under 2 years of age, unless directed by a doctor
  • for diaper rash

Stop use and ask a doctor if 

  • Irritation occurs 
  • there is no improvement within 4 weeks

When using this product 

  • Avoid contact with eyes and mucus membrane

INDICATIONS & USAGE SECTION

Do not use on children

  • Under 2 years of age, unless directed by a doctor
  • for diaper rash

Stop use and ask a doctor if

  • Irritation occurs
  • there is no improvement within 4 weeks

When using this product

  • Avoid contact with eyes and mucus membrane

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding,consult a doctor before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children.If swallowed, get medical help or contact a Posion Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions 

  • clean the affected area and dry throughly
  • apply a thin layer of Hongocura M Antifungal Sprayover the affected area twice daily (morning and night) or as directed by a doctor 
  • supervise children in use of this product
  • for athlete's foot: Pay special attention to spaces between the toes; wear well-fitting, ventilated shoes, and change shoes and socks at least once daily
  • for athlete's foot and ringworm, use daily for 4 weeks. if condition persists longer, consult a doctor
  • this product is not effective on the scalp or nails
  • store between 15°-30°C(59°-86°F)

INACTIVE INGREDIENT SECTION

Inactive Ingredients

isopropyl alcohol and water.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HongoMSprayHongoMSpray

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53145-219-032023-07-28C16284748780-19d75b9d0-afdb-f424-e053-dadaa90a57ceHongocura M
53145-219-032021-04-17C16284748780-19d75b9d0-afdb-f424-e053-dadaa90a57ceHongocura M
53145-219-032020-01-31C16284748780-19d75b9d0-afdb-f424-e053-dadaa90a57ceHongocura M

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53145-219-03HongocuraM60 mL in 1 BOTTLE, SPRAYSPRAY608
53145-219-03HongocuraM1 in 1 CARTONSPRAY18

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
UNDECYLENIC ACIDACTIVE INGREDIENTK3D86KJ24N2
UNDECYLENIC ACIDACTIVE MOIETYK3D86KJ24N2
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M4163022
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53145-21953145-219-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
ISOPROPYL ALCOHOLND2M416302IACT
WATER059QF0KO0RIACT
UNDECYLENIC ACIDK3D86KJ24NACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 14 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302LOTION, AUGMENTED / TOPICAL2070 mgExact identifier — unii+route
14 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL / TOPICAL75 mgExact identifier — unii+route
14 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SWAB / TOPICAL43.9 %w/wExact identifier — unii+route
14 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact identifier — unii+route
14 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SOLUTION / TOPICAL40 %w/vExact identifier — unii+route
14 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302OIL / TOPICAL72 mgExact identifier — unii+route
14 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SPONGE / TOPICAL4 %w/wExact identifier — unii+route
14 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302OIL / TOPICAL72 mgExact identifier — unii+route
14 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SWAB / TOPICAL43.9 %w/wExact identifier — unii+route
14 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL, METERED / TOPICAL525 mgExact identifier — unii+route
14 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302LOTION, AUGMENTED / TOPICAL2070 mgExact identifier — unii+route
14 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302SPONGE / TOPICAL4 %w/wExact identifier — unii+route
14 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL / TOPICAL75 mgExact identifier — unii+route
14 equally ranked IID candidates
ISOPROPYL ALCOHOLISOPROPYL ALCOHOLND2M416302GEL, METERED / TOPICAL525 mgExact identifier — unii+route
14 equally ranked IID candidates

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
Hongocura MUNDECYLENIC ACIDMENPER DISTRIBUTORS, INC.b4adb7b0-59b4-4b3c-9b0e-1869bb5431742025-07-22WarningsExact identifier
ndc (package): 53145-219-03
ndc (product): 53145-219
ndc11 (package): 53145021903
spl id: 3a8a5464-a254-ca2c-e063-6294a90aa0fe
spl set id: b4adb7b0-59b4-4b3c-9b0e-1869bb543174

Reported adverse events (FAERS/openFDA)#

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