FDA.reportPublic FDA data

Cura Hongo

Product NDC
55758-102
11-digit product format
557580102
Labeler code
55758
Product ID
55758-102_43d08a3e-0caf-49ed-e063-6294a90af5f2
Type
HUMAN OTC DRUG
Nonproprietary name
Clotrimazole
Dosage form
CREAM
Route
TOPICAL
Labeler
Pharmadel LLC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-05-31
Substance
CLOTRIMAZOLE
Active strength
1 g/100g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage55758-10255758-102-02DDiscontinued by firm2026-10-15

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 1 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage55758-10255758-102-02DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Cura Hongo
Brand name suffix
Antifungal
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOTRIMAZOLE1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G07GZ97H65Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
309367Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
df031309-2778-00cf-e053-2a95a90a5eeaAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b64d2752-34ef-378a-1f4f-8bff32b0d1aeProduct name420250626
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9Product name220250121
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55758-102-02Cura HongoAntifungal56.7 g in 1 TUBECREAM56.77
55758-102-02Cura HongoAntifungal1 in 1 CARTONCREAM17
55758-102-03Cura HongoAntifungal1 in 1 CARTONCREAM17
55758-102-03Cura HongoAntifungal57 g in 1 TUBECREAM577

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55758-102CURA HONGO ANTIFUNGAL (CLOTRIMAZOLE) CREAM [PHARMADEL LLC]5Current NDC, Legacy NDC, 4 package rows20241210_df031309-2778-00cf-e053-2a95a90a5eea.zip

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 7 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EZBIORT 1% Tolnaftate Nail Essence with BiotinTOLNAFTATEGuangzhou Borderless Technology Co., Ltd.5629df38-1079-be4f-e063-6394a90a1c6a2026-07-09WarningsExact identifier
application number: M005
ZENJBUST Undecylenic Acid 25% Antifungal PenUNDECYLENIC ACID 25% ANTIFUNGAL PENShenzhen Xituo Electronics Co., Ltd563a6704-f662-3f08-e063-6394a90a43692026-07-09WarningsExact identifier
application number: M005
Antifungal CreamANTIFUNGALPreferred Pharmaceuticals Inc.c6098653-351a-449f-9b1a-0c617074f2b92026-07-08WarningsExact identifier
application number: M005
YEARCHOICE Fungal Nail RenewalFUNGAL NAIL RENEWALGuangzhou Jingliang Cosmetics Co., Ltd.561b650d-028c-687c-e063-6394a90a166a2026-07-08WarningsExact identifier
application number: M005
CAREALL ClotrimazoleCLOTRIMAZOLENew World Imports, Inc561d3e64-ab9c-1074-e063-6394a90a12982026-07-08WarningsExact identifier
application number: M005
Beautifier Life ALCOHOL WIPESBEAUTIFIER LIFE ALCOHOL WIPESShenzhen Shierjie Biological Engineering Co., LTD323ef469-e37c-00ad-e063-6394a90ab6f72026-07-08WarningsExact identifier
application number: M005
Folliculitis Treatment CreamMICONAZOLE NITRATE 2%Guangxi Keyun E-commerce Co., Ltd.5625652a-193d-0318-e063-6294a90a56f32026-07-08WarningsExact identifier
application number: M005
PureWellness FUNGAL FUSION Antifungal and Antimicrobial KitFUNGAL FUSION ANTIFUNGAL AND ANTIMICROBIAL KITPureWellness LLC25db8c55-0fa9-4795-8e05-4d3a7aaf01482026-07-06WarningsExact identifier
application number: M005
FUNGAL NAIL NIGHTTIME RENEWAL PATCHESTOLNAFTATE 1%100 KARMA INC3b9ab6e0-8773-f909-e063-6394a90ac1c92026-07-03WarningsExact identifier
application number: M005
TOENAIL FUNGUS TREATMENT25% UNDECYLENIC ACID100 KARMA INC3bb000dc-5e6c-b43b-e063-6394a90a63a92026-07-03WarningsExact identifier
application number: M005
Treatonic Toenail Fungus Treatment KitTOENAIL FUNGUS TREATMENT100 KARMA INC3d4bbc65-955f-8fd8-e063-6294a90adc442026-07-03WarningsExact identifier
application number: M005
Treatonic Nailtonic Repair Pens25% UNDECYLENIC ACID100 KARMA INC4a9c32b3-e78d-3c85-e063-6394a90a7bf22026-07-03WarningsExact identifier
application number: M005
Initial Treatonic FUNGAL NAIL RENEWAL PATCHESTOLNAFTATE 1%100 KARMA INC48e377b4-abb1-34cf-e063-6294a90a2ea32026-07-03WarningsExact identifier
application number: M005
Treatonic TONENAIL FUNGUS TREATONIC kit.25% UNDECYLENIC ACID AND TOLNAFTATE 1%100 KARMA INC4c197131-9ca8-6024-e063-6294a90aa9cb2026-07-03WarningsExact identifier
application number: M005
Treatonic Antifungal Pen25% UNDECYLENIC ACID100 KARMA INC52d89172-e8a7-70c0-e063-6294a90a35632026-07-03WarningsExact identifier
application number: M005
FUNGINIX ANTI-FUNGAL TREATMENTUNDECYLENIC ACIDThe Sisquoc Healthcare Corporation92db5433-5a1b-4cb9-b8eb-217c2a807a992026-07-02WarningsExact identifier
application number: M005
Anti DandruffKETOCONAZOLEGuangzhou ChuanMa International Trading Co.,Ltd.4cfe234c-49c0-18e8-e063-6294a90a0b1d2026-07-02WarningsExact identifier
application number: M005
Terpenicol Antifungal CreamMICONAZOLE NITRATEBlaine Labs Inc.9a4ec493-0b36-4bb8-aa9a-55cf5f79aeaa2026-07-01WarningsExact identifier
application number: M005
BeamBalm ANTIFUNGAL FOOT SOAKING PACKZINC UNDECYLENATE 5% ANTIFUNGAL FOOT SOAKING PACKJiangxi Yudexi Pharmaceutical Co., LTD50044b55-8553-ca52-e063-6394a90a0e542026-07-01WarningsExact identifier
application number: M005
VENROCKUNDECYLENIC ACIDGuangzhou Oupeng Cosmetics Co., Ltd.558af06e-6fe1-c926-e063-6394a90a738c2026-07-01WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309367clotrimazole 1 % Topical CreamPSNdf031309-2778-00cf-e053-2a95a90a5eea7
309367clotrimazole 10 MG/ML Topical CreamSCDdf031309-2778-00cf-e053-2a95a90a5eea7
309367clotrimazole 1 % Topical CreamSYdf031309-2778-00cf-e053-2a95a90a5eea7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55758-102-02557580102021 TUBE in 1 CARTON (55758-102-02) > 56.7 g in 1 TUBE1 tube2022-05-310000-00-00NoNoCurrent
55758-102-03557580102031 TUBE in 1 CARTON (55758-102-03) / 57 g in 1 TUBE1 tube2026-01-01NoNoCurrent