FDA.reportPublic FDA data

Miconazole Nitrate

Product NDC
42291-938
11-digit product format
422910938
Labeler code
42291
Product ID
42291-938_48c0e508-e6c0-3d43-e063-6294a90a3ade
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
POWDER
Route
TOPICAL
Labeler
AvKARE
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-06-05
Substance
MICONAZOLE NITRATE
Active strength
2 g/100g
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
Miconazole Nitrate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MICONAZOLE NITRATE2 g/100g

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
998461Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1a26534d-eeb8-8d17-e063-6294a90a70c7Available 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
42291-938-85Miconazole Nitrate85 g in 1 BOTTLEPOWDER852

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-938-85GM - Gram42291-938262c4b1b-dab1-42ea-a5bb-6c7a0067a55012024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-938MICONAZOLE NITRATE POWDER [AVKARE]1Current NDC, 1 package rows20240615_1a26534d-eeb8-8d17-e063-6294a90a70c7.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 13 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medi-First Clotrimazole 1% ANTIFUNGAL CreamCLOTRIMAZOLEUnifirst First Aid Corporation522eeb91-8378-32f4-e063-6394a90aff432026-05-20WarningsExact identifier
application number: M005
Kopa Haiku Antifungal CreamMICONAZOLE NITRATE 2%Trovina Co. Ltd47cf1251-5965-045a-e063-6394a90ab04f2026-05-19WarningsExact identifier
application number: M005
APUREE PRO Nailtific Maximum Strength Antifungal PatchesAPUREE PRO NAILTIFIC MAXIMUM STRENGTH ANTIFUNGAL PATCHESGuangzhou Meixi Biotechnology Co., Ltd.5218bd5d-53b4-107f-e063-6394a90ae7692026-05-18Exact identifier
application number: M005
APUREE Pro Nailtific Maximum Strength Dual-Action Antifungal PenAPUREE PRO NAILTIFIC MAXIMUM STRENGTH DUAL-ACTION ANTIFUNGAL PENGuangzhou Meixi Biotechnology Co., Ltd.521a0e40-a218-fabb-e063-6294a90ae9a22026-05-18WarningsExact identifier
application number: M005
Beukow Antifungal PenUNDECYLENIC ACID 25% ANTIFUNGAL PENJiangxi Yudexi Pharmaceutical Co., LTD511d1edf-dfda-477c-e063-6294a90aa4232026-05-17WarningsExact identifier
application number: M005
Nail Repair PenNAIL REPAIR PENShenzhen Earth Surface Trading Co., Ltd.520f6514-6660-d6a8-e063-6394a90adf822026-05-17WarningsExact identifier
application number: M005
Fungicure IntensiveCLOTRIMAZOLEKobayashi Healthcare International, Inc.1f1b413f-278e-434f-8590-4cf731663f5c2026-05-15WarningsExact identifier
application number: M005
Dr Scholls Fungal Nail Clear and Cure Tolnaftate AntifungalTOLNAFTATEScholl's Wellness Company LLC8abd6d8e-c69e-4374-ace8-d42b2d3e171e2026-05-14WarningsExact identifier
application number: M005
Dr.Scholl s Odor X Athlete s FootTOLNAFTATEScholl's Wellness Company LLC0e864882-5e00-491e-a008-0762c131637a2026-05-14WarningsExact identifier
application number: M005
Athletes FootTOLNAFTATERugby Laboratories50c46cf5-3e64-9e0f-e063-6294a90a23172026-05-14WarningsExact identifier
application number: M005
TOSSOYA Rainforest SecretGuard Antibacterial Quick-Cleanse WipesTOSSOYA RAINFOREST SECRETGUARD ANTIBACTERIAL QUICK-CLEANSE WIPESShenzhen Shierjie Biological Engineering Co., LTD3d53463d-8d8e-9030-e063-6294a90ab4542026-05-13WarningsExact identifier
application number: M005
Anti-Fungal PowderMICONAZOLE NITRATECVS Pharmacy1651bdd7-ab15-7a2d-e063-6294a90a8b912026-05-11WarningsExact identifier
application number: M005
Lightning X Hand CleanserETHYL ALCOHOLNantong Health & Beyond Hygienic Products Inc.51861f1e-8961-e876-e063-6394a90a2fd02026-05-11WarningsExact identifier
application number: M005
APUREE Nailtific Maximum Strength Antifungal Patches PROAPUREE NAILTIFIC MAXIMUM STRENGTH ANTIFUNGAL PATCHES PROGuangzhou Meixi Biotechnology Co., Ltd5189ebc5-8ee5-1b2c-e063-6294a90af5c82026-05-11WarningsExact identifier
application number: M005
APUREE Nailtific Maximum Strength Dual-Action Antifungal Pen ProAPUREE NAILTIFIC MAXIMUM STRENGTH DUAL-ACTION ANTIFUNGAL PEN PROGuangzhou Meixi Biotechnology Co., Ltd.518abf2b-6ac8-ab9b-e063-6294a90ae6932026-05-11WarningsExact identifier
application number: M005
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998461miconazole nitrate 2 % Topical PowderPSN1a26534d-eeb8-8d17-e063-6294a90a70c72
998461miconazole nitrate 0.02 MG/MG Topical PowderSCD1a26534d-eeb8-8d17-e063-6294a90a70c72
998461miconazole nitrate 2 % Topical PowderSY1a26534d-eeb8-8d17-e063-6294a90a70c72

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42291-938-854229109388585 g in 1 BOTTLE (42291-938-85) 85 g2024-06-05NoNoCurrent