FDA.reportPublic FDA data

Hermon Jock Itch spray.

Product NDC
85398-030
11-digit product format
853980030
Labeler code
85398
Product ID
85398-030_4b633528-667b-f34e-e063-6294a90a2b3d
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate 2%
Dosage form
LIQUID
Route
TOPICAL
Labeler
Beautivity LLC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-03-16
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 spray.
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
998533Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4b633528-667a-f34e-e063-6294a90a2b3dAvailable 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
85398-030-01Hermon Jock Itch spray.1 in 1 CARTONLIQUID11
85398-030-01Hermon Jock Itch spray.60 g in 1 BOTTLE, SPRAYLIQUID601

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 10 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Beilloso Hyaluronic AcidCLOTRIMAZOLE 1 PERCENT HYALURONIC ACIDJiangxi Yudexi Pharmaceutical Co., LTD4a712797-c992-dd8e-e063-6294a90a05922026-06-14WarningsExact identifier
application number: M005
Beilloso Balanitis ReliefMICONAZOLE NITRATE 2% BALANITIS RELIEFJiangxi Yudexi Pharmaceutical Co., LTD4a71c26f-dee5-7b7f-e063-6294a90afcc12026-06-14WarningsExact identifier
application number: M005
PUVIDA FUNGAL NAILTOLNAFTATE 1% FUNGAL NAILJiangxi Yudexi Pharmaceutical Co., LTD4c55fcad-c59f-9a6e-e063-6394a90a6c5f2026-06-14WarningsExact identifier
application number: M005
Klipp EXTRA STRENGTH TOENAIL FUNGUS TREATMENTKLIPP EXTRA STRENGTH TOENAIL FUNGUS TREATMENTGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd54430f20-72db-64f7-e063-6394a90a2cc32026-06-14WarningsExact identifier
application number: M005
Bldaxn FUNGAL NAIL RENEWZLUNDECYLENIC ACID 25% FUNGAL NAIL RENEWZLJiangxi Yudexi Pharmaceutical Co., LTD4993181e-68d5-6b91-e063-6294a90a65ce2026-06-12WarningsExact identifier
application number: M005
NATUHEAL MULTI -PURPOSE TREATMENTTOLNAFTATE 1% MULTI -PURPOSE TREATMENTJiangxi Yudexi Pharmaceutical Co., LTD4a469862-85ab-4c24-e063-6294a90ad2452026-06-12WarningsExact identifier
application number: M005
cmojsk TOENAIL FUNGUS PENUNDECYLENIC ACID 25% TOLNAFTATE 1% TOENAIL FUNGUS PENJiangxi Yudexi Pharmaceutical Co., LTD524bbb36-df7b-f21a-e063-6394a90ad0f12026-06-12WarningsExact identifier
application number: M005
BODYKOO NAIL FUNGUS TREATMENTUNDECYLENIC ACID 25% NAIL FUNGUS TREATMENTJiangxi Yudexi Pharmaceutical Co., LTD535191e9-dc55-0c60-e063-6394a90a330f2026-06-12WarningsExact identifier
application number: M005
Charmpoo Antifungal CreamMICONAZOLE NITRATE 2% ANTIFUNGAL CREAMJiangxi Yudexi Pharmaceutical Co., LTD5214a267-0bab-59b8-e063-6394a90adb842026-06-12WarningsExact identifier
application number: M005
EVERFERE ANTIFUNGALUNDECYLENIC ACID 10% ZINC UNDECYLENATE 12% ANTIFUNGALJiangxi Yudexi Pharmaceutical Co., LTD4bc99af7-ea08-8543-e063-6294a90a44cd2026-06-12WarningsExact identifier
application number: M005
nail fungus treatmentTOLNAFTATEGuangzhou Liyan Cosmetics Technology Co., Ltd.54ee5e53-8c99-01f8-e063-6394a90ae3822026-06-12WarningsExact identifier
application number: M005
Kopa Haiku Antifungal Soap.TOLNAFTATE 1%Trovina Co. Ltd514fc45c-aadb-6205-e063-6394a90ae4732026-06-11WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEYYBA CORP53fed66b-a371-38d2-e063-6294a90a510e2026-06-11WarningsExact identifier
application number: M005
SEEBEELLAR TOLNAFTATE 1% ANTIFUNGAL BODY WASHSEEBEELLAR TOLNAFTATE 1% ANTIFUNGAL BODY WASHGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd54050e6b-a7f1-5067-e063-6394a90aebe52026-06-11WarningsExact identifier
application number: M005
Velloryn 1% Clotrimazole ANTIFUNGALVELLORYN 1% CLOTRIMAZOLE ANTIFUNGALGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd540652da-f8f0-01ee-e063-6294a90a12e92026-06-11WarningsExact identifier
application number: M005
Fitcube NAIL REPAIR PENUNDECYLENIC ACID 25% TOLNAFTATE 1% NAIL REPAIR PENJiangxi Yudexi Pharmaceutical Co., LTD5365268e-7845-4a91-e063-6294a90ac6bf2026-06-10WarningsExact identifier
application number: M005
Maximum Strength Antifungal LiquidTOLNAFTATEWalgreens Company3858402f-783b-9292-e063-6294a90abe382026-06-10WarningsExact identifier
application number: M005
Hermon Antifungal cleansing barTOLNAFTATE 1%Beautivity LLC53cd1a2b-6ca6-c93b-e063-6394a90aaf3a2026-06-09WarningsExact identifier
application number: M005
Antifungal 1% Clotrimazole CreamANTIFUNGAL 1% CLOTRIMAZOLE CREAMTwincraft Inc.29698d9e-8449-ceee-e063-6394a90a366e2026-06-09WarningsExact identifier
application number: M005
Antifungal 1% Clotrimazole CreamANTIFUNGAL 1% CLOTRIMAZOLE CREAMDefense Soap LLC040264b2-8f2f-f059-e063-6294a90ad7202026-06-09WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998533miconazole nitrate 2 % Topical SprayPSN4b633528-667a-f34e-e063-6294a90a2b3d1
998533miconazole nitrate 20 MG/ML Topical SpraySCD4b633528-667a-f34e-e063-6294a90a2b3d1
998533miconazole nitrate 2 % Topical SpraySY4b633528-667a-f34e-e063-6294a90a2b3d1
998533miconazole nitrate 3 GM in 150 GM Topical SpraySY4b633528-667a-f34e-e063-6294a90a2b3d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
85398-030-01853980030011 BOTTLE, SPRAY in 1 CARTON (85398-030-01) / 60 g in 1 BOTTLE, SPRAY2026-03-16NoNoCurrent