FDA.reportPublic FDA data

Antifungal Ringworm Treatment

Product NDC
83004-030
11-digit product format
830040030
Labeler code
83004
Product ID
83004-030_48714aae-1dbd-dd89-e063-6294a90a73e6
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
SPRAY
Route
TOPICAL
Labeler
Rida LLC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-01-14
Substance
MICONAZOLE NITRATE
Active strength
2 g/100mL
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
Antifungal Ringworm Treatment
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MICONAZOLE NITRATE2 g/100mL

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
eb953281-cf86-44cf-a3d1-37b8d344a6bcAvailable 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
83004-030-01Antifungal Ringworm Treatment1 in 1 CARTONSPRAY11
83004-030-01Antifungal Ringworm Treatment120 mL in 1 TUBESPRAY1201

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 5 of 51 · 1,004 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
REINREUDE MULTI-PURPOSE TREATMENTTOLNAFTATE 1% MULTI-PURPOSE TREATMENTJiangxi Yudexi Pharmaceutical Co., LTD4a380945-9235-783a-e063-6294a90a094d2026-07-21WarningsExact identifier
application number: M005
SERYNTH Multi-Purpose Nail SolutionTOLNAFTATE 1% MULTI-PURPOSE NAIL SOLUTIONJiangxi Yudexi Pharmaceutical Co., LTD4a4af770-2bba-52a8-e063-6294a90ac2872026-07-21WarningsExact identifier
application number: M005
SERYNTH ClotrimazoleCLOTRIMAZOLE1% CLOTRIMAZOLEJiangxi Yudexi Pharmaceutical Co., LTD4a4b304a-1acc-9185-e063-6394a90a11762026-07-21WarningsExact identifier
application number: M005
SERYNTH FUNGI NAILTOLNAFTATE 1% FUNGI NAILJiangxi Yudexi Pharmaceutical Co., LTD4a4c6b7a-3c3e-1510-e063-6294a90a409a2026-07-21WarningsExact identifier
application number: M005
SERYNTH HELPS WITH FUNGAL NAILTOLNAFTATE 1% HELPS WITH FUNGAL NAILJiangxi Yudexi Pharmaceutical Co., LTD4a4c9ad1-e652-2b3b-e063-6394a90a29352026-07-21WarningsExact identifier
application number: M005
DERMFREE HELPS WITH NAGELPILZTOLNAFTATE 1% HELPS WITH NAGELPILZJiangxi Yudexi Pharmaceutical Co., LTD4a4d9361-3633-59b2-e063-6294a90aa3ea2026-07-21WarningsExact identifier
application number: M005
OURUI ONE FUNGAL NAIL TREATMENTTOLNAFTATE 1% FUNGAL NAIL TREATMENTJiangxi Yudexi Pharmaceutical Co., LTD4a473f03-f4cc-74ef-e063-6394a90ac7072026-07-20WarningsExact identifier
application number: M005
AVENASTER FUNGAL NAIL CARE DUO SET (NIGHT)UNDECYLENIC ACID 25% FUNGAL NAIL CARE DUO SET (NIGHT)Jiangxi Yudexi Pharmaceutical Co., LTD51eb8766-cc94-360d-e063-6294a90a69532026-07-20WarningsExact identifier
application number: M005
TINGOLE FUNGAL NAIL PatchesTOLNAFTATE 1% FUNGAL NAIL PATCHESJiangxi Yudexi Pharmaceutical Co., LTD5272c6fa-75f7-c698-e063-6394a90ac81e2026-07-20WarningsExact identifier
application number: M005
Vamy ANTIFUNGALTOLNAFTATE 1% ANTIFUNGALJiangxi Yudexi Pharmaceutical Co., LTD4dfdf3a2-95a8-9176-e063-6294a90a64de2026-07-20WarningsExact identifier
application number: M005
Antifungal creamANTIFUNGAL CREAMShenzhen Earth Surface Trading Co., Ltd.5708cc16-9a26-fd3c-e063-6394a90ac0ee2026-07-20WarningsExact identifier
application number: M005
TrpWinner TOENAIL FUNGUS PENUNDECYLENIC ACID 25% TOENAIL FUNGUS PENJiangxi Yudexi Pharmaceutical Co., LTD523c2a9c-3b35-bf73-e063-6394a90ae17d2026-07-20WarningsExact identifier
application number: M005
Charmpoo Antifungal CreamMICONAZOLE NITRATE 2% ANTIFUNGAL CREAMJiangxi Yudexi Pharmaceutical Co., LTD4ac347b5-d21b-cc9a-e063-6394a90a54962026-07-20WarningsExact identifier
application number: M005
Charmpoo TINEA VERSICOLOR TREATMENT ANTIFUNGALCLOTRIMAZOLE 1% TINEA VERSICOLOR TREATMENT ANTIFUNGALJiangxi Yudexi Pharmaceutical Co., LTD4ac31b1d-59d7-f45c-e063-6294a90a0d3d2026-07-20WarningsExact identifier
application number: M005
IraEvanes ANTIFUNGAL FOOTTOLNAFTATE 1% ANTIFUNGAL FOOTJiangxi Yudexi Pharmaceutical Co., LTD4d851a99-a453-e829-e063-6294a90a91182026-07-20WarningsExact identifier
application number: M005
LYSSERA Fungal Nail RenewalUNDECYLENIC ACID 25% ANTIFUNGAJiangxi Yudexi Pharmaceutical Co., LTD4dea6df4-e66b-c24a-e063-6294a90afca72026-07-20WarningsExact identifier
application number: M005
Kakalsa TOENAIL FUNGUS TREATMENTUNDECYLENIC ACID 25% TOENAIL FUNGUS TREATMENTJiangxi Yudexi Pharmaceutical Co., LTD5123c0c3-bba8-d61c-e063-6394a90aab702026-07-20WarningsExact identifier
application number: M005
SOVS FUNGAL NAIL REPAIR RENEWALUNDECYLENIC ACID 25% FUNGAL NAIL REPAIR RENEWALJiangxi Yudexi Pharmaceutical Co., LTD536b0c48-691e-755b-e063-6294a90a778e2026-07-20WarningsExact identifier
application number: M005
Tea Tree AntifungalCLOTRIMAZOLEHONG KONG UNORDERED TRADING CO., LIMITED56de35b7-b57d-1c62-e063-6294a90a757d2026-07-18WarningsExact identifier
application number: M005
ACTIV-CHARCOAL ANTIFUNGALTOLNAFTATEHONG KONG UNORDERED TRADING CO., LIMITED56def103-40ef-cd88-e063-6394a90a07172026-07-18WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998533miconazole nitrate 2 % Topical SprayPSNeb953281-cf86-44cf-a3d1-37b8d344a6bc1
998533miconazole nitrate 20 MG/ML Topical SpraySCDeb953281-cf86-44cf-a3d1-37b8d344a6bc1
998533miconazole nitrate 2 % Topical SpraySYeb953281-cf86-44cf-a3d1-37b8d344a6bc1
998533miconazole nitrate 3 GM in 150 GM Topical SpraySYeb953281-cf86-44cf-a3d1-37b8d344a6bc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83004-030-01830040030011 TUBE in 1 CARTON (83004-030-01) / 120 mL in 1 TUBE1 tube2026-01-14NoNoCurrent