FDA.reportPublic FDA data

Medline

Product NDC
53329-218
11-digit product format
533290218
Labeler code
53329
Product ID
53329-218_42f3af59-a020-421e-e063-6294a90a6eab
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole nitrate
Dosage form
CREAM
Route
TOPICAL
Labeler
Medline Industries, LP
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-10-01
Substance
MICONAZOLE NITRATE
Active strength
20 mg/100g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
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
Medline
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MICONAZOLE NITRATE20 mg/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 SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1ea444eb-f2f5-8c63-e063-6294a90acac8Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53329-218-44Medline113 g in 1 TUBECREAM1133

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-218MEDLINE (MICONAZOLE NITRATE) CREAM [MEDLINE INDUSTRIES, LP]2Current NDC, 1 package rows20241010_1ea444eb-f2f5-8c63-e063-6294a90acac8.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 16 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EXTRA STRENGTH TOENAIIL RENEWAL PENUNDECYLENIC ACID, TOLNAFTATEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD4eea5ee7-0ef9-8d34-e063-6294a90af5952026-04-07WarningsExact identifier
application number: M005
EXTRA STRENGTH TOENAIIL RENEWAL SolutionUNDECYLENIC ACID, TOLNAFTATEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD4eeaa2f0-efc7-eab3-e063-6294a90a13b32026-04-07WarningsExact identifier
application number: M005
Extra Strength Toenail Renewal PenUNDECYLENIC ACID, TOLNAFTATEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD4eeb59d2-3891-2e45-e063-6294a90a4fcf2026-04-07WarningsExact identifier
application number: M005
RoyceDerm Tinea ANTIFUNGAL .soap.CLOTRIMAZOLE 1%RoyceDerm LLC4e889f2b-9ea1-b1a6-e063-6394a90a46542026-04-03WarningsExact identifier
application number: M005
Toenail Fungus Treatment Extra Strength PenTOLNAFTATE, UNDECYLENIC ACIDLianjiang Shanlilai E-commerce Co., Ltd.28fbcc50-a3ac-d6d1-e063-6294a90aa2b62026-04-02WarningsExact identifier
application number: M005
TOENAIL FUNGUS TREATMENT LiquidTOLNAFTATE, UNDECYLENIC ACIDLianjiang Shanlilai E-commerce Co., Ltd.28fc7049-e367-42bf-e063-6394a90a6f062026-04-02WarningsExact identifier
application number: M005
Fungal Nail PatchesTOLNAFTATE, UNDECYLENIC ACIDLianjiang Shanlilai E-commerce Co., Ltd.299a63ad-f321-117c-e063-6394a90a3a222026-04-02WarningsExact identifier
application number: M005
Secura Antifungal GreaselessMICONAZOLE NITRATESmith & Nephew Medical Ltd9be600e4-76ec-4071-a8ec-a0b23155271d2026-04-02WarningsExact identifier
application number: M005
FifthPulse Bacitracin ZincBACITRACIN ZINCWeCare Products LLC5c6b3ad8-c158-4cc0-b1ba-b829b5df12842026-04-02WarningsExact identifier
application number: M005
FifthPulse Miconazole Nitrate AntifungalMICONAZOLE NITRATEWeCare Products LLCb70238eb-afcb-4e09-976f-973df249241c2026-04-02WarningsExact identifier
application number: M005
ANTIFUNGAL PENUNDECYLENIC ACID, TERBINAFINE HYDROCHLORIDEHanyang Qisheng (Shenzhen) Technology Co., Ltd.4e85f338-ffd7-85b1-e063-6294a90a3c872026-04-02WarningsExact identifier
application number: M005
RoyceDerm Anti-Fungal CreamMICONAZOLE NITRATE 2%RoyceDerm LLC4e861073-88e8-b2f7-e063-6394a90ab94a2026-04-02WarningsExact identifier
application number: M005
Miconazole NitrateJOCK ITCH SPRAYCVS Pharmacy7b70d3ea-126a-42aa-8509-b982893c710b2026-04-01WarningsExact identifier
application number: M005
Fungicure Anti-Fungal LiquidTOLNAFTATEKobayashi Healthcare International, Inc.b18ee199-0659-733c-e053-2a95a90ab6b52026-04-01WarningsExact identifier
application number: M005
TolnaftateANTIFUNGAL LIQUID SPRAYCVS Pharmacy96cc594d-85c8-4f62-bc0a-3176c8739f212026-04-01WarningsExact identifier
application number: M005
TolnafateTOLNAFTATE POWDER SPRAYCVS Pharmacya7b6bd7c-23db-43e1-92f7-e27f5f4801de2026-04-01WarningsExact identifier
application number: M005
Baza AntifungalMICONAZOLE NITRATEColoplast Corp75182cb7-840a-423a-9c20-10840d6e1d652026-03-31WarningsExact identifier
application number: M005
MICONAZOLE Nitrate 2% Cream ANTIFUNGALMICONAZOLE NITRATETrifecta Pharmaceuticals Usa Llc80217dbb-a0f0-414a-8d22-a9a346b017aa2026-03-31WarningsExact identifier
application number: M005
RoyceDerm Antifungal BarCLOTRIMAZOLERoyceDerm LLC3abdc4a8-58dd-5bd0-e063-6294a90a1bca2026-03-31WarningsExact identifier
application number: M005
Critic Aid Clear AFMICONAZOLE NITRATEColoplast Corpcbc5d976-850a-476e-b179-b7a5a86755242026-03-31WarningsExact identifier
application number: M005

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53329-218-4453329021844113 g in 1 TUBE (53329-218-44) 113 g2024-10-01NoNoCurrent