FDA.reportPublic FDA data

Hermon Jock Itch Antifungal Treatment Cream

Product NDC
85398-032
11-digit product format
853980032
Labeler code
85398
Product ID
85398-032_4dbc521c-2f60-9736-e063-6294a90ad85d
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate 2%
Dosage form
CREAM
Route
TOPICAL
Labeler
Beautivity LLC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-01-01
Substance
MICONAZOLE NITRATE
Active strength
1.2 g/60g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
Hermon Jock Itch Antifungal Treatment Cream
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MICONAZOLE NITRATE1.2 g/60g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
VW4H1CYW1KInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
998483Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4dbc521c-2f5f-9736-e063-6294a90ad85dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85398-032-01Hermon Jock Itch Antifungal Treatment Kit Antifungal Cream and .Soap. for Jock Itch60 g in 1 CARTONCREAM1 g in 601.2 g in 60g1
85398-032-01Hermon Jock Itch Antifungal Treatment Cream60 g in 1 CARTONCREAM601

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 14 of 51 · 1,004 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CLOTRIMAZOLECLOTRIMAZOLERugby Laboratories, Inc.2c60e631-5930-4420-886d-eb1990c720b62026-05-11WarningsExact identifier
application number: M005
TolfyraTOLNAFTATEOncora Pharma, LLCb28ee9f2-fc45-4336-b374-be7aa51d44e92026-05-11WarningsExact identifier
application number: M005
clotrimazoleCLOTRIMAZOLEA-S Medication Solutionsc0f58a0d-a304-41f9-bbdf-c2e488230cf02026-05-11WarningsExact identifier
application number: M005
Inlifay ANTIFUNGALTOLNAFTATEGuangdong Aimu Biological Technology Co., Ltd5148b838-d26e-cf66-e063-6394a90ae4692026-05-09WarningsExact identifier
application number: M005
HuiPoLii NAIL PFLASTERTOLNAFTATE 1% NAIL PFLASTERJiangxi Yudexi Pharmaceutical Co., LTD514b1c2d-cecb-30a2-e063-6394a90af2662026-05-08WarningsExact identifier
application number: M005
Recuren Plus Jock Itch CreamMICONAZOLE NITRATE 2%REGENEREN PLUS LTD450dab4d-168a-60b8-e063-6394a90ab3032026-05-08WarningsExact identifier
application number: M005
OSIMOON FUNGAL NAIL TREATMENT KitFUNGAL NAIL TREATMENT KITGuangzhou Jingliang Cosmetics Co., Ltd.51465ebf-3b5f-e2bf-e063-6394a90adaf22026-05-07WarningsExact identifier
application number: M005
RoyceDerm Tinea Antifungal CreamMICONAZOLE NITRATE 2%RoyceDerm LLC40089a7d-c893-4e90-e063-6294a90aa6f92026-05-06WarningsExact identifier
application number: M005
QQE Fungal Nail TreatmentTOLNAFTATE 1%Guangzhou Huixue Biotechnology Co., Ltd.510ff705-e2cb-b77b-e063-6394a90a9e722026-05-05WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEAkron Pharma Inc692d7e0f-50d4-4abb-8c74-36bc98064fe72026-05-05WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEKJD Pharma Private Limited5115f8e3-5668-5207-e063-6394a90a76502026-05-05WarningsExact identifier
application number: M005
NATURAL CURES FUNGAL NAIL PatchesTOLNAFTATE 1% FUNGAL NAIL PATCHESJiangxi Yudexi Pharmaceutical Co., LTD510a8df7-ea6d-d634-e063-6294a90aea532026-05-04WarningsExact identifier
application number: M005
Hand Sanitizer Lemon ScentedALCOHOLTaizhou Juheng Biotechnology Co., Ltd.21387234-0ac9-499d-97bf-90bccc4782ad2026-05-04WarningsExact identifier
application number: M005
Uauko Fungal Nail TreatmentFUNGAL NAIL TREATMENTGuangzhou Jingliang Cosmetics Co., Ltd.50d16854-ab90-d6cf-e063-6294a90a21b12026-05-02WarningsExact identifier
application number: M005
NAIL RENEWTOLNAFTATENailrenew Corpa0df4ee5-1276-41b7-a1c4-8fcbfc7f97b52026-05-02WarningsExact identifier
application number: M005
MHB SKIN HYDRATING HAND SANITIZER, CITRUS PEELALCOHOL HAND SANITIZER SPRAYCROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.4934c20d-6295-aeb8-e063-6394a90adfeb2026-04-30WarningsExact identifier
application number: M005
MHB SKIN HYDRATING HAND SANITIZER, MELON MUSE 35mlALCOHOL HAND SANITIZERCROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.4931f2e4-0fef-a8c7-e063-6394a90ac16e2026-04-30WarningsExact identifier
application number: M005
MINADCIN TOENAIL FUNGUS PENUNDECYLENIC ACID 25% TOENAIL FUNGUS PENJiangxi Yudexi Pharmaceutical Co., LTD50a9264e-aba0-0ae2-e063-6294a90acfff2026-04-30WarningsExact identifier
application number: M005
ANTIFUNGALUNDECYLENIC ACIDChemco Corporation50893584-c1c6-9ffa-e063-6394a90ae1772026-04-29WarningsExact identifier
application number: M005
MHB SKIN HYDRATING HAND SANITIZER, LILY MISTALCOHOL HAND SANITIZERCROWN (YANGZHOU) HEALTH & BEAUTY CO., LTD.50949ae2-3ebe-08d2-e063-6394a90a20462026-04-29WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998483miconazole nitrate 2 % Topical CreamPSN4800a93b-7042-827b-e063-6294a90acd951
998483miconazole nitrate 2 % Topical CreamPSN4dbc521c-2f5f-9736-e063-6294a90ad85d1
1807715tolnaftate 1 % Medicated Bar SoapPSN4800a93b-7042-827b-e063-6294a90acd951
998483miconazole nitrate 20 MG/ML Topical CreamSCD4800a93b-7042-827b-e063-6294a90acd951
998483miconazole nitrate 20 MG/ML Topical CreamSCD4dbc521c-2f5f-9736-e063-6294a90ad85d1
1807715tolnaftate 0.01 MG/MG Medicated Bar SoapSCD4800a93b-7042-827b-e063-6294a90acd951
998483miconazole nitrate 2 % Topical CreamSY4800a93b-7042-827b-e063-6294a90acd951
998483miconazole nitrate 2 % Topical CreamSY4dbc521c-2f5f-9736-e063-6294a90ad85d1
1807715tolnaftate 1 % Medicated Bar SoapSY4800a93b-7042-827b-e063-6294a90acd951

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85398-032-018539800320160 g in 1 CARTON (85398-032-01) 60 g2026-01-01NoNoCurrent