FDA.reportPublic FDA data

MICONAZOLE Nitrate 2% Cream ANTIFUNGAL

Product NDC
69396-014
11-digit product format
693960014
Labeler code
69396
Product ID
69396-014_4e55e0bf-9e9d-d877-e063-6294a90a9d59
Type
HUMAN OTC DRUG
Nonproprietary name
MICONAZOLE NITRATE
Dosage form
CREAM
Route
TOPICAL
Labeler
Trifecta Pharmaceuticals Usa Llc
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-03-22
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 2% Cream ANTIFUNGAL
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
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
80217dbb-a0f0-414a-8d22-a9a346b017aaAvailable 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
69396-014-04MICONAZOLE Nitrate 2% Cream ANTIFUNGAL118.3 g in 1 TUBECREAM118.314
69396-014-05MICONAZOLE Nitrate 2% Cream ANTIFUNGAL15 g in 1 TUBECREAM1514
69396-014-20MICONAZOLE Nitrate 2% Cream ANTIFUNGAL1 in 1 BOXCREAM114
69396-014-20MICONAZOLE Nitrate 2% Cream ANTIFUNGAL30 g in 1 TUBECREAM3014
69396-014-33MICONAZOLE Nitrate 2% Cream ANTIFUNGAL3 in 1 BOXCREAM314
69396-014-33MICONAZOLE Nitrate 2% Cream ANTIFUNGAL30 g in 1 TUBECREAM3014
69396-014-44MICONAZOLE Nitrate 2% Cream ANTIFUNGAL30 g in 1 TUBECREAM3014
69396-014-44MICONAZOLE Nitrate 2% Cream ANTIFUNGAL4 in 1 BOXCREAM414
69396-014-66MICONAZOLE Nitrate 2% Cream ANTIFUNGAL6 in 1 BOXCREAM614
69396-014-66MICONAZOLE Nitrate 2% Cream ANTIFUNGAL30 g in 1 TUBECREAM3014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69396-014-05GM - Gram69396-01467a4d687-f389-41b0-90b6-be0807a7d1e612024-01-04
69396-014-20GM - Gram69396-0146d9d1334-578d-493a-b171-4ffa9ada0f5f12018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69396-014MICONAZOLE NITRATE 2% CREAM ANTIFUNGAL (MICONAZOLE NITRATE) CREAM [TRIFECTA PHARMACEUTICALS USA LLC]13Current NDC, Legacy NDC, 10 package rows20250207_80217dbb-a0f0-414a-8d22-a9a346b017aa.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 35 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ONIADBA Fungal Nail Treatment SwabsTOLNAFTATE,UNDECYLENIC ACIDShenzhen Boyimei Technology Co., Ltd.3baa99ab-6d22-8d7d-e063-6294a90af3e82025-08-05WarningsExact identifier
application number: M005
MICONAZOLE Nitrate 2% Cream ANTIFUNGALMICONAZOLE NITRATEPreferred Pharmaceuticals Inc.cca84334-2e2d-4991-9d1e-d5b7c9ffd3922025-08-01WarningsExact identifier
application number: M005
RoyceDerm CoolDefense Refreshing Shower GelTOLNAFTATE 1.0%RoyceDerm LLC3b3216d6-8cc8-ea89-e063-6294a90ab6912025-07-31WarningsExact identifier
application number: M005
SUNMARK MICONAZOLE NITRATE antifungalMICONAZOLE NITRATEStrategic Sourcing Services LLC7c15d95a-5b89-4789-8c91-3f61d7ec77072025-07-30WarningsExact identifier
application number: M005
AntifungalMICONAZOLE NITRATEAdvanced Rx LLCe13eb653-3916-444a-ae86-1738c0308b792025-07-28WarningsExact identifier
application number: M005
Meridian Unwrapped Antibacterial DeodorantBENZETHONIUM CHLORIDEYangzhou Hongshengding Chemical Co.,Ltd.a2b9570f-312c-4f46-994d-efe057b247aa2025-07-28WarningsExact identifier
application number: M005
Meridian Antibacterial DeodorantBENZETHONIUM CHLORIDEYangzhou Hongshengding Chemical Co.,Ltd.b41b130f-48fd-47d4-a94e-74433ae44de22025-07-28WarningsExact identifier
application number: M005
Rugby Clotrimazole Antifungal CreamCLOTRIMAZOLEPreferred Pharmaceuticals Inc.bd567e91-7152-4612-83e0-8e8a00c2d2c52025-07-25WarningsExact identifier
application number: M005
HongocuraUNDECYLENIC ACID, ZINC UNDECYLENATEMENPER DISTRIBUTORS, INC.c69b735e-0ffe-4328-bd9f-3c1ac6798c082025-07-22WarningsExact identifier
application number: M005
Hongocura PinceladasUNDECYLENIC ACIDMenper Distributors, Inc.4b9a3a70-d646-47c6-b969-5c4d759d23a42025-07-22WarningsExact identifier
application number: M005
Hongocura MUNDECYLENIC ACIDMENPER DISTRIBUTORS, INC.b4adb7b0-59b4-4b3c-9b0e-1869bb5431742025-07-22WarningsExact identifier
application number: M005
Hongocura SUNDECYLENIC ACIDMENPER DISTRIBUTORS, INC.4a21f371-bfc1-4e66-af16-55b3283872b72025-07-22WarningsExact identifier
application number: M005
FifthPulse Miconazole Nitrate Cream 1ozMICONAZOLE NITRATEFront Pharmaceutical PLC3a37a3a8-9d05-926c-e063-6294a90a9ed82025-07-18WarningsExact identifier
application number: M005
FifthPulse Miconazole Nitrate Cream 4ozMICONAZOLE NITRATEFront Pharmaceutical PLC3a382b79-dde9-dde0-e063-6294a90a53bb2025-07-18WarningsExact identifier
application number: M005
FifthPulse clotrimazole cream 4ozCLOTRIMAZOLE 1%Front Pharmaceutical PLC3a389093-48f2-29cb-e063-6294a90ada372025-07-18WarningsExact identifier
application number: M005
PHARMBANNER Tea Tree Oil Antifungal Soap.TEA TREE OIL ANTIFUNGAL SOAP.Shenzhen Xinxin Yunhai Technology Co., Ltd.3a0860b0-346e-7024-e063-6394a90ace812025-07-16WarningsExact identifier
application number: M005
TopCare AntifungalCLOTRIMAZOLETopco Associates LLC6757eb2a-73e0-4bd0-a332-5713fdf3445d2025-07-16WarningsExact identifier
application number: M005
UpandUp ClotrimazoleCLOTRIMAZOLETarget Corporationcb2b7d38-9988-493b-9843-56c2f59eed2f2025-07-16WarningsExact identifier
application number: M005
Jock ItchCLOTRIMAZOLETARGET Corporation1ae551e7-69de-4eef-b4f7-5e1a880e631d2025-07-16WarningsExact identifier
application number: M005
Athletes FootCLOTRIMAZOLEFRED'S, INC.d2d8f44e-2dfa-446b-855e-86e0d6d2d0df2025-07-15WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998483miconazole nitrate 2 % Topical CreamPSN80217dbb-a0f0-414a-8d22-a9a346b017aa14
998483miconazole nitrate 20 MG/ML Topical CreamSCD80217dbb-a0f0-414a-8d22-a9a346b017aa14
998483miconazole nitrate 2 % Topical CreamSY80217dbb-a0f0-414a-8d22-a9a346b017aa14
998483miconazole nitrate 2 % Topical CreamPSNfd7dd2eb-03a7-ef1f-e053-6294a90a85572
998483miconazole nitrate 20 MG/ML Topical CreamSCDfd7dd2eb-03a7-ef1f-e053-6294a90a85572
998483miconazole nitrate 2 % Topical CreamSYfd7dd2eb-03a7-ef1f-e053-6294a90a85572
998483miconazole nitrate 2 % Topical CreamPSN14d2a661-a490-41ca-b84f-f2be3bc271b41
998483miconazole nitrate 20 MG/ML Topical CreamSCD14d2a661-a490-41ca-b84f-f2be3bc271b41
998483miconazole nitrate 2 % Topical CreamSY14d2a661-a490-41ca-b84f-f2be3bc271b41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69396-014-0469396001404118.3 g in 1 TUBE (69396-014-04) 118.3 g2022-09-23NoNoCurrent
69396-014-056939600140515 g in 1 TUBE (69396-014-05) 15 g2016-03-220000-00-00NoNoCurrent
69396-014-20693960014201 TUBE in 1 BOX (69396-014-20) / 30 g in 1 TUBE1 tube2016-03-220000-00-00NoNoCurrent
69396-014-33693960014333 TUBE in 1 BOX (69396-014-33) / 30 g in 1 TUBE3 tube2024-03-22NoNoCurrent
69396-014-44693960014444 TUBE in 1 BOX (69396-014-44) / 30 g in 1 TUBE4 tube2024-02-29NoNoCurrent
69396-014-66693960014666 TUBE in 1 BOX (69396-014-66) / 30 g in 1 TUBE6 tube2024-02-22NoNoCurrent