FDA.reportPublic FDA data

Medline

Product NDC
53329-147
11-digit product format
533290147
Labeler code
53329
Product ID
53329-147_5afac954-49e5-98fb-e063-6394a90ab6aa
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
2023-08-01
Marketing end
2027-09-01
Substance
MICONAZOLE NITRATE
Active strength
20 mg/mL
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MICONAZOLE NITRATE20 mg/mL

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
0d997d1d-8663-201f-e063-6394a90a285eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7b19f89e-0a13-4d4e-a994-a46d39d008b9Product name120251120
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
13c3e0af-2da2-8aec-9e17-1afd680d80c2Product name820221116
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
f46c867f-cde5-4f14-a7c1-18ae3a6efd1cProduct name120160303
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53329-147-44Medline118 mL in 1 TUBECREAM1182

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-147MEDLINE (MICONAZOLE NITRATE) CREAM [MEDLINE INDUSTRIES, LP]1Current NDC, 1 package rows20231230_0d997d1d-8663-201f-e063-6394a90a285e.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 18 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Triple AntifungalMICONAZOLE NITRATEAdvantice Health, LLC9a47fb1b-a41f-4c8a-8e43-7332853c308e2026-03-19WarningsExact identifier
application number: M005
AntifungalCLOTRIMAZOLEDynarex Corporation4d4cc4b4-c0b4-9e25-e063-6294a90a70b82026-03-18WarningsExact identifier
application number: M005
AntifungalMICONAZOLE NITRATEDynarex Corporation4d384385-f3c5-09ba-e063-6394a90aec7f2026-03-17WarningsExact identifier
application number: M005
Fungi Nail Toe and FootTOLNAFTATEKramer Laboratoriese21ccb83-54ff-4605-80bf-7b4b789c7cb72026-03-17WarningsExact identifier
application number: M005
Peunitory Fungal Nail TreatmentTOLNAFTATE 1%Guangzhou Huixue Biotechnology Co., Ltd.4d2e86bc-5122-ba4a-e063-6394a90acf132026-03-16WarningsExact identifier
application number: M005
DRMITSUI FOOT ANTIFUNGAL TREATMENTSALICYLIC ACIDZhenping Renren Industry Co., Ltd.4ce59d31-56fe-d74f-e063-6294a90a7cce2026-03-14WarningsExact identifier
application number: M005
NERANTE FUNGUS NAIL PENUNDECYLENIC ACIDGuangdong Quadrant Ecological Technology Co., Ltd.4ce3984b-53cd-a665-e063-6394a90afe5f2026-03-13WarningsExact identifier
application number: M005
FUNGAL NAIL TREATMENTUNDECYLENIC ACIDGuangdong Quadrant Ecological Technology Co., Ltd.4ce3f0e2-b532-b89f-e063-6294a90a7e252026-03-13WarningsExact identifier
application number: M005
BYT BANGYTONG HELPS WITH NAGELPILZTOLNAFTATE 1% HELPS WITH NAGELPILZ LIQUIDShenzhen Jindali Technology Co., Ltd49ed1cc8-e8e5-399c-e063-6394a90a044a2026-03-10WarningsExact identifier
application number: M005
Natouch Antifungal Wipes PlusANTIFUNGAL ANTISEPTIC WIPES PLUSNatouch LLCa85cb307-b3ad-1584-e053-2995a90a9a702026-03-10WarningsExact identifier
application number: M005
Tuymec Antifungal Medicated BarANTIFUNGAL MEDICATED BARGuangzhou Jingliang Cosmetics Co., Ltd.4cb6fdfd-116e-14e9-e063-6294a90a4de32026-03-10WarningsExact identifier
application number: M005
Tuymec Antifungal Medicated BarANTIFUNGAL MEDICATED BARGuangzhou Jingliang Cosmetics Co., Ltd.4cb73ebe-f9bb-5a8d-e063-6294a90a3c2b2026-03-10WarningsExact identifier
application number: M005
SootheSense Toenail Fungus TreatmentUNDECYLENIC ACIDGuangdong Quadrant Ecological Technology Co., Ltd.4ca2bbeb-3b8a-9482-e063-6294a90a57892026-03-09WarningsExact identifier
application number: M005
Natouch Antifungal Antiseptic WipesANTIFUNGAL ANTISEPTIC WIPESNatouch LLC4c84c556-8d0b-ec28-e063-6294a90af1d32026-03-08WarningsExact identifier
application number: M005
ANTIFUNGAL CreamANGELICA DAHURICA EXTRACTT, ASIATIC ACIDGuangzhou Mizi Biotechnology Co., LTD.4c586cd9-d356-34d8-e063-6294a90a4d112026-03-06WarningsExact identifier
application number: M005
FungiFoamTOLNAFTATEThe Tetra Corporation2449e8e5-9d7e-4119-9e7a-378efe55f8752026-03-06WarningsExact identifier
application number: M005
RoyceDerm ANTIFUNGAL .soap.CLOTRIMAZOLE 1%RoyceDerm LLC4c43e62b-9060-8962-e063-6394a90aff632026-03-05WarningsExact identifier
application number: M005
Derman AntifungalTOLNAFTATECompania Internacional de Comercio, S.A.P.I. de C.V.5784a783-1056-4d50-8d87-2df4f8e16b092026-03-05WarningsExact identifier
application number: M005
Antifungal PowderTOLNAFTATEARMY & AIR FORCE EXCHANGE SERVICE4c39e121-4919-a482-e063-6294a90a98cd2026-03-04WarningsExact identifier
application number: M005
ViLLsure Antifungal PenUNDECYLENIC ACID 25%ANTIFUNGAL PENJiangxi Yudexi Pharmaceutical Co., LTD4c28cf04-94ad-8db6-e063-6394a90a2eed2026-03-03WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998483miconazole nitrate 2 % Topical CreamPSN0d997d1d-8663-201f-e063-6394a90a285e2
998483miconazole nitrate 20 MG/ML Topical CreamSCD0d997d1d-8663-201f-e063-6394a90a285e2
998483miconazole nitrate 2 % Topical CreamSY0d997d1d-8663-201f-e063-6394a90a285e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53329-147-4453329014744118 mL in 1 TUBE (53329-147-44) 118 ml2023-08-012027-09-01NoNoHistorical