Miconazole Nitrate

Product NDC
69256-039
11-digit product format
692560039
Labeler code
69256
Product ID
69256-039_458bf011-d6c6-f0c4-e063-6394a90a638b
Type
HUMAN OTC DRUG
Nonproprietary name
Athletes Foot Powder Spray Talc Free
Dosage form
AEROSOL, POWDER
Route
TOPICAL
Labeler
Harris Teeter, LLC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-05-22
Substance
MICONAZOLE NITRATE
Active strength
2.6 g/130g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 8 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage69256-039-46fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage69256-039-4686f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage69256-039-46bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage69256-039-468dfbde2a14a4…c9ff85d89658…

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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MICONAZOLE NITRATE2.6 g/130g

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
998428Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
02eb9c78-5a89-4958-b5a4-68f39e584cf2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69256-039-46Miconazole Nitrate130 g in 1 CANAEROSOL, POWDER1308

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69256-039MICONAZOLE NITRATE (ATHLETES FOOT POWDER SPRAY TALC FREE) AEROSOL, POWDER [HARRIS TEETER, LLC]6Current NDC, Legacy NDC, 1 package rows20241212_02eb9c78-5a89-4958-b5a4-68f39e584cf2.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
998428miconazole nitrate 2 % Powder SprayPSN02eb9c78-5a89-4958-b5a4-68f39e584cf28
998428miconazole nitrate 0.02 MG/MG Powder SpraySCD02eb9c78-5a89-4958-b5a4-68f39e584cf28
998428miconazole nitrate 2 % Powder SpraySY02eb9c78-5a89-4958-b5a4-68f39e584cf28

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69256-039-4669256003946130 g in 1 CAN (69256-039-46) 130 g2017-05-220000-00-00NoNoCurrent