FDA.reportPublic FDA data

Anti-Fungal

Product NDC
52000-021
11-digit product format
520000021
Labeler code
52000
Product ID
52000-021_18f39e0a-6734-31b9-e063-6294a90a7204
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
CREAM
Route
TOPICAL
Labeler
Universal Distribution Center LLC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-04-15
Substance
MICONAZOLE NITRATE
Active strength
.02 g/g
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 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage52000-021-378dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage52000-021-37e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage52000-021-379bebd1f3094a…5416666fcb17…

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
Anti-Fungal
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MICONAZOLE NITRATE.02 g/g

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
8f316b0d-d308-4ae6-82c4-39bb0d1d474eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
52000-021-372022-02-21C16284748780-19d75b9d0-9dba-f424-e053-dadaa90a57ceAnti-Fungal Cream
52000-021-372020-01-31C16284748780-19d75b9d0-9dba-f424-e053-dadaa90a57ceAnti-Fungal Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52000-021-40Anti-Fungal14 g in 1 TUBECREAM146
52000-021-41Anti-Fungal1 in 1 BOXCREAM16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MICONAZOLE NITRATEACTIVE INGREDIENTVW4H1CYW1KANTI-FUNGAL (MICONAZOLE NITRATE) CREAM [UNIVERSAL DISTRIBUTION CENTER LLC]1
MICONAZOLEACTIVE MOIETY7NNO0D7S5MANTI-FUNGAL (MICONAZOLE NITRATE) CREAM [UNIVERSAL DISTRIBUTION CENTER LLC]1
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMANTI-FUNGAL (MICONAZOLE NITRATE) CREAM [UNIVERSAL DISTRIBUTION CENTER LLC]1
BUTYLATED HYDROXYANISOLEINACTIVE INGREDIENTREK4960K2UANTI-FUNGAL (MICONAZOLE NITRATE) CREAM [UNIVERSAL DISTRIBUTION CENTER LLC]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPANTI-FUNGAL (MICONAZOLE NITRATE) CREAM [UNIVERSAL DISTRIBUTION CENTER LLC]1
PEG-5 OLEATEINACTIVE INGREDIENT0240V77G50ANTI-FUNGAL (MICONAZOLE NITRATE) CREAM [UNIVERSAL DISTRIBUTION CENTER LLC]1
PEGOXOL 7 STEARATEINACTIVE INGREDIENT3EW5AXE5X5ANTI-FUNGAL (MICONAZOLE NITRATE) CREAM [UNIVERSAL DISTRIBUTION CENTER LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RANTI-FUNGAL (MICONAZOLE NITRATE) CREAM [UNIVERSAL DISTRIBUTION CENTER LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52000-021ANTI-FUNGAL (MICONAZOLE NITRATE) CREAM [UNIVERSAL DISTRIBUTION CENTER LLC]6Current NDC, Legacy NDC, 2 package rows20240522_8f316b0d-d308-4ae6-82c4-39bb0d1d474e.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 25 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TopCare Antifungal Maximum StrengthUNDECYLENIC ACIDTOPCO ASSOCIATES LLC7c44fb4e-0eef-4ced-b03f-a02ebe6c02642025-12-22WarningsExact identifier
application number: M005
Fungi Nail Toe and FootTOLNAFTATEKramer Laboratoriesa3ae043b-dc97-449b-b099-70bdf8e924822025-12-19WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLERUGBY LABORATORIES6de9155b-7070-38fd-e053-2a91aa0af6f62025-12-19WarningsExact identifier
application number: M005
HC Max Anti-FungalTOLNAFTATEKramer Laboratoriesee99cd87-549f-4a43-878e-b4d5935de0e02025-12-19WarningsExact identifier
application number: M005
Fungi Nail Anti-Fungal PenTOLNAFTATEKramer Laboratories1a0a3b14-d8f2-4363-b3c9-f5028e8eada32025-12-19WarningsExact identifier
application number: M005
TolnaftateFOOT ODOR CONTROL POWDER SPRAYWinco Foods, LLCcc257a18-247f-c787-e053-2a95a90a075a2025-12-16WarningsExact identifier
application number: M005
TolnaftateODOR CONTROL POWDER SPRAYWalgreen Companya113f568-bd20-4f02-8e09-1b8223a0a9fa2025-12-16WarningsExact identifier
application number: M005
Tobcharm Toenail Fungus Treatment LiquidTOENAIL FUNGUS TREATMENT LIQUIDGuangzhou Qiexiran Cosmetics Co., Ltd.45f92be2-0677-5989-e063-6394a90af2802025-12-15WarningsExact identifier
application number: M005
TEA TREE Oil ANTIFUNGAL CreamZINC UNDECYLENATE, UNDECYLENIC ACIDGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD45bd3ad0-a0d1-314f-e063-6394a90a9a3a2025-12-12WarningsExact identifier
application number: M005
Miconazole NitrateATHLETES FOOT POWDER SPRAY TALC FREETopco Associates LLC97334166-1dff-4ed2-ad31-f524b22097f92025-12-12WarningsExact identifier
application number: M005
Foot Odor Control PowderTOLNAFTATEMeijer Distribution Inc03fd2680-0040-aa8c-e063-6294a90a090f2025-12-12WarningsExact identifier
application number: M005
Foot Odor Control PowderTOLNAFTATEPremier Brands of America Inc.edb0a2da-aaa1-3b9b-e053-2995a90a50122025-12-12WarningsExact identifier
application number: M005
PedikleerTOLNAFTATERising Pharma Holdings, Inc.83396c51-7107-4d98-9d80-ebf6584f4dc82025-12-11WarningsExact identifier
application number: M005
ELAIMEI FUNGAL NAIL PATCHESTEA TREE OILShenzhen Shandian Jingling Technology Co., Ltd.457d08eb-e812-8f12-e063-6294a90ab85f2025-12-10WarningsExact identifier
application number: M005
Lofuanna FUNGAL NAIL PATCHESTEA TREE OILShenzhen Shandian Jingling Technology Co., Ltd.43da9ec2-5f2f-dfce-e063-6394a90aecca2025-12-10WarningsExact identifier
application number: M005
WRFAATGO ANTIFUNGAL Pen Undecylenic Acid 25%UNDECYLENIC ACID 25%Shenzhen Shandian Jingling Technology Co., Ltd.457f819b-0850-a97c-e063-6394a90ac3682025-12-09WarningsExact identifier
application number: M005
NAIL REPAIR PENUNDECYLENIC ACIDYunqi Cosmetics (Shenzhen) Co., Ltd45814b84-0e51-6c9d-e063-6394a90a29052025-12-09WarningsExact identifier
application number: M005
Miconazole NitrateMICONAZOLE NITRATE ANTIFUNGAL POWDER SPRAYBetter Living Brandsccfef81b-f271-4551-e053-2a95a90a8ac42025-12-09WarningsExact identifier
application number: M005
Miconazole NitrateANTI-FUNGAL MICONAZOLE ATHLETES FOOT SPRAY TALC FREEFoodhold USAa64c9371-0ac7-4c47-bc12-7bc77162b2442025-12-09WarningsExact identifier
application number: M005
Miconazole NitrateATHLETES FOOT POWDER SPRAY TALC FREEHarris Teeter, LLC02eb9c78-5a89-4958-b5a4-68f39e584cf22025-12-09WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998483miconazole nitrate 2 % Topical CreamPSN8f316b0d-d308-4ae6-82c4-39bb0d1d474e6
998483miconazole nitrate 20 MG/ML Topical CreamSCD8f316b0d-d308-4ae6-82c4-39bb0d1d474e6
998483miconazole nitrate 2 % Topical CreamSY8f316b0d-d308-4ae6-82c4-39bb0d1d474e6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52000-021-37520000021371 TUBE in 1 BOX (52000-021-37) > 14 g in 1 TUBE (52000-021-36) 1 tube2022-02-140000-00-00NoNoCurrent
52000-021-405200000214014 g in 1 TUBE14 gHistorical
52000-021-41520000021411 TUBE in 1 BOX (52000-021-41) / 14 g in 1 TUBE (52000-021-40) 1 tube2022-02-14NoNoCurrent