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 47 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FIRST SHIELDBENZALKONIUM CHLORIDE, LIDOCAINE HCIEver Ready First Aidee198aa1-ad0d-9185-e053-2a95a90a65952024-01-15WarningsExact identifier
application number: M005
Ever Ready HAND SANITIZERETHYL ALCOHOLEver Ready First Aidec1af7ef-3c95-9c60-e053-2a95a90acf472024-01-15WarningsExact identifier
application number: M005
MY MEDIC SUPER SANITIZERETHYL ALCOHOLSled Distribution, LLCe7451738-75d5-5dc4-e053-2a95a90a7aee2024-01-15WarningsExact identifier
application number: M005
Medical SuperALCOHOLBeijing HKKY Medical Tech. Co., Ltd.ed2649c6-d971-4338-8745-cd0a40f7b0c22024-01-13WarningsExact identifier
application number: M005
ER Hand Sanitizer PacketsALCOHOLEVER READY FIRST AIDd0b6d09c-26e0-45c7-8d37-7d42143b2e312024-01-11WarningsExact identifier
application number: M005
clotrimazoleCLOTRIMAZOLEProficient Rx LPeeb241a3-93ee-4b74-8cbb-65713d15e7e02024-01-01WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEProficient Rx LPba1dc4a4-073f-4f30-bb9c-9ed0437004312024-01-01WarningsExact identifier
application number: M005
RUGBY ANTIFUNGAL CLOTRIMAZOLECLOTRIMAZOLEProficient Rx LP7c64553b-589c-4e65-a6f0-b2847bbbe8a62024-01-01WarningsExact identifier
application number: M005
Dr. Scholls Instant Cool Athletes foot treatment with MentholTOLNAFTATEScholl's Wellness Companydad00745-e411-35b8-e053-2a95a90a10002023-12-21WarningsExact identifier
application number: M005
TINEACIDETOLNAFTATEBlaine Labs Inc.273eb424-5dc3-40c8-9ea7-2f732cbd11c92023-12-21WarningsExact identifier
application number: M005
TERPENICOL ANTIFUNGALUNDECYLENIC ACIDBlaine Labs Inc.a020334e-aac9-4ea5-a0ea-8e5b021fe2eb2023-12-21WarningsExact identifier
application number: M005
TERPENICOLUNDECYLENIC ACIDBlaine Labs Inc.efd99ed1-07d3-4862-ae47-883f7d1c91c62023-12-21WarningsExact identifier
application number: M005
sunmark antifungalTOLNAFTATEA-S Medication Solutions6f85fbb0-297c-4949-83f2-ed9a521721542023-12-16WarningsExact identifier
application number: M005
Miconazole NitrateMICONAZOLE NITRATEA-S Medication Solutions7a0ef38a-9584-4e67-ba86-c31f86da1ed02023-12-11WarningsExact identifier
application number: M005
Miconazole NitrateMICONAZOLE NITRATEA-S Medication Solutions7d284f6f-a970-49fe-b45a-d5c6c2688bc22023-12-11WarningsExact identifier
application number: M005
Hi VeticTOLNAFTATESato Pharmaceutical Co., Ltd.2096e241-3ed3-49cd-88c4-71db1fd2934a2023-12-06WarningsExact identifier
application number: M005
Undecylenic AcidUNDECYLENIC ACIDChemco Corporation7391b53f-5567-1f45-e053-2991aa0a4fce2023-12-05WarningsExact identifier
application number: M005
Hi VeticTOLNAFTATESato Pharmaceutical Co., Ltd.be92b480-56e8-4371-adbc-40fe74f6747c2023-12-01WarningsExact identifier
application number: M005
Antifungal CreamANTIFUNGALBluePoint Laboratoriesb4c4240f-f84c-ec5e-e053-2a95a90aa0822023-11-17WarningsExact identifier
application number: M005
Antifungal CreamANTIFUNGALBluePoint Laboratoriesb564f971-2a9b-a605-e053-2995a90aee692023-11-17WarningsExact 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