FDA.reportPublic FDA data

Remedy Antifungal

Product NDC
53329-169
11-digit product format
533290169
Labeler code
53329
Product ID
53329-169_425303b5-9f9c-efc3-e063-6294a90ae594
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
POWDER
Route
TOPICAL
Labeler
Medline Industries, LP
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-11-19
Substance
MICONAZOLE NITRATE
Active strength
2 g/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
Remedy Antifungal
Listing expiration
2026-12-31

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
998461Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
021b4a31-d7f6-4921-b4b1-cbe832eecd93Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53329-169-79Remedy Antifungal85 g in 1 BOTTLEPOWDER857

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53329-169-79GM - Gram53329-169d7f0b2ab-0b3f-4d75-9e74-5193056608bb12015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MICONAZOLE NITRATEACTIVE INGREDIENTVW4H1CYW1KREMEDY ANTIFUNGAL (MICONAZOLE NITRATE) POWDER [MEDLINE INDUSTRIES, INC.]1
MICONAZOLEACTIVE MOIETY7NNO0D7S5MREMEDY ANTIFUNGAL (MICONAZOLE NITRATE) POWDER [MEDLINE INDUSTRIES, INC.]1
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0REMEDY ANTIFUNGAL (MICONAZOLE NITRATE) POWDER [MEDLINE INDUSTRIES, INC.]1
7-DEHYDROCHOLESTEROLINACTIVE INGREDIENTBK1IU07GKFREMEDY ANTIFUNGAL (MICONAZOLE NITRATE) POWDER [MEDLINE INDUSTRIES, INC.]1
APHANIZOMENON FLOS-AQUAEINACTIVE INGREDIENT49VG1X560XREMEDY ANTIFUNGAL (MICONAZOLE NITRATE) POWDER [MEDLINE INDUSTRIES, INC.]1
CAPRYLIC/CAPRIC/LINOLEIC TRIGLYCERIDEINACTIVE INGREDIENTU73D397055REMEDY ANTIFUNGAL (MICONAZOLE NITRATE) POWDER [MEDLINE INDUSTRIES, INC.]1
CLOVEINACTIVE INGREDIENTK48IKT5321REMEDY ANTIFUNGAL (MICONAZOLE NITRATE) POWDER [MEDLINE INDUSTRIES, INC.]1
CORN OILINACTIVE INGREDIENT8470G57WFMREMEDY ANTIFUNGAL (MICONAZOLE NITRATE) POWDER [MEDLINE INDUSTRIES, INC.]1
EGG PHOSPHOLIPIDSINACTIVE INGREDIENT1Z74184RGVREMEDY ANTIFUNGAL (MICONAZOLE NITRATE) POWDER [MEDLINE INDUSTRIES, INC.]1
ETHYLENE BRASSYLATEINACTIVE INGREDIENT9A87HC7RODREMEDY ANTIFUNGAL (MICONAZOLE NITRATE) POWDER [MEDLINE INDUSTRIES, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXREMEDY ANTIFUNGAL (MICONAZOLE NITRATE) POWDER [MEDLINE INDUSTRIES, INC.]1
GLYCYRRHIZINATE DIPOTASSIUMINACTIVE INGREDIENTCA2Y0FE3FXREMEDY ANTIFUNGAL (MICONAZOLE NITRATE) POWDER [MEDLINE INDUSTRIES, INC.]1
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B0REMEDY ANTIFUNGAL (MICONAZOLE NITRATE) POWDER [MEDLINE INDUSTRIES, INC.]1
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9REMEDY ANTIFUNGAL (MICONAZOLE NITRATE) POWDER [MEDLINE INDUSTRIES, INC.]1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSREMEDY ANTIFUNGAL (MICONAZOLE NITRATE) POWDER [MEDLINE INDUSTRIES, INC.]1
METHYL DIHYDROJASMONATE (SYNTHETIC)INACTIVE INGREDIENT3GW44CIE3YREMEDY ANTIFUNGAL (MICONAZOLE NITRATE) POWDER [MEDLINE INDUSTRIES, INC.]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUREMEDY ANTIFUNGAL (MICONAZOLE NITRATE) POWDER [MEDLINE INDUSTRIES, INC.]1
SOY PROTEININACTIVE INGREDIENTR44IWB3RN5REMEDY ANTIFUNGAL (MICONAZOLE NITRATE) POWDER [MEDLINE INDUSTRIES, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJREMEDY ANTIFUNGAL (MICONAZOLE NITRATE) POWDER [MEDLINE INDUSTRIES, INC.]1
STARCH, TAPIOCAINACTIVE INGREDIENT24SC3U704IREMEDY ANTIFUNGAL (MICONAZOLE NITRATE) POWDER [MEDLINE INDUSTRIES, INC.]1
VANILLAINACTIVE INGREDIENTQ74T35078HREMEDY ANTIFUNGAL (MICONAZOLE NITRATE) POWDER [MEDLINE INDUSTRIES, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RREMEDY ANTIFUNGAL (MICONAZOLE NITRATE) POWDER [MEDLINE INDUSTRIES, INC.]1
YEASTINACTIVE INGREDIENT3NY3SM6B8UREMEDY ANTIFUNGAL (MICONAZOLE NITRATE) POWDER [MEDLINE INDUSTRIES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-169REMEDY ANTIFUNGAL (MICONAZOLE NITRATE) POWDER [MEDLINE INDUSTRIES, LP]6Current NDC, Legacy NDC, 1 package rows20241011_021b4a31-d7f6-4921-b4b1-cbe832eecd93.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 1 of 51 · 1,004 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Defense Antifungal Medicated BarTOLNAFTATEDefense Soap LLC812d78ea-a14a-e3a2-e053-2a91aa0a6ff52026-09-09WarningsExact identifier
application number: M005
MedlineMICONAZOLE NITRATEMedline Industries, LP0d997d1d-8663-201f-e063-6394a90a285e2026-09-08WarningsExact identifier
application number: M005
Remedy Antifungal With OlivamineMICONAZOLE NITRATEMedline Industries, LP28c5183e-05b4-1754-e054-00144ff8d46c2026-09-08WarningsExact identifier
application number: M005
ClaravieMICONAZOLE NITRATE 2%Gentell LLC5afdc429-cb44-703c-e063-6294a90a971a2026-09-08WarningsExact identifier
application number: M005
Inlifay ANTIFUNGALMICONAZOLE NITRATE 2% ANTIFUNGALJiangxi Yudexi Pharmaceutical Co., LTD4a832f39-ac11-d8b3-e063-6394a90acb392026-09-06WarningsExact identifier
application number: M005
Noicaky FUNGAL NAIL PatchesTOLNAFTATE 1% FUNGAL NAIL PATCHESWenzhou Yuyuan Pharmaceutical Co., Ltd.5adcc5f7-2d47-2ad7-e063-6294a90a48482026-09-06WarningsExact identifier
application number: M005
LIFE66II ANTIFUNGAL NAILUNDECYLENIC ACID 25% ANTIFUNGAL NAILWenzhou Yuyuan Pharmaceutical Co., Ltd.5ab83796-0780-3b58-e063-6394a90a2e4e2026-09-05WarningsExact identifier
application number: M005
FGPER Topical Antifungal PenUNDECYLENIC ACIDGuangzhou ChuanMa International Trading Co.,Ltd.5abdcbff-6ab1-2f0a-e063-6294a90a57ef2026-09-05WarningsExact identifier
application number: M005
Jock Itch PowderMICONAZOLE NITRATEPremier Brands of America Inc5aaacc88-6752-ab47-e063-6394a90af7cd2026-09-04WarningsExact identifier
application number: M005
ANTIFUNGAL BODY WASHTOLNAFTATEGuangzhou ChuanMa International Trading Co.,Ltd.5a695043-f776-df5a-e063-6394a90ac2742026-09-01WarningsExact identifier
application number: M005
KetoconClear CreamKETOCONAZOLEGuangzhou Shunfei Network Technology Co., Ltd.5a54eebe-5b4a-28dd-e063-6294a90a607f2026-08-31WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEInvaDerm Corporation5a5cfed9-0587-7bef-e063-6294a90a64bf2026-08-31WarningsExact identifier
application number: M005
Gembooxt RINGWORM CreamMICONAZOLE NITRATE, HYDROCORTISONEGuangdong Quadrant Ecological Technology Co., Ltd.464a33c3-6d16-0cfd-e063-6294a90abf4b2026-08-27WarningsExact identifier
application number: M005
DrAny NAIL FUNGUS TREATMENTUNDECYLENIC ACID, TOLNAFTATEHong Kong Juxin Negosyo Kag Komersyo Co., Limited59ef412b-fc7b-0a84-e063-6394a90abf252026-08-26WarningsExact identifier
application number: M005
Miconazole NitrateMICONAZOLE NITRATESun Pharmaceutical Industries, Inc.7fd4037e-d350-47b7-a7d9-a43b8e366fa02026-08-25WarningsExact identifier
application number: M005
WISH HAND SANITIZER pink dragon blossomALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA593b3fbe-a8de-1c09-e063-6294a90adc692026-08-24WarningsExact identifier
application number: M005
Okkazhie WART REMOVER40% SALICYLIC ACIDGuangzhou Huixue Biotechnology Co., Ltd.59c2d759-d1e9-6c9d-e063-6294a90a04db2026-08-23WarningsExact identifier
application number: M005
1% ketoconazole anti dandruff1% KETOCONAZOLE ANTI DANDRUFF SHAMPOOFast Sold LLC7bb3598c-9597-4f3d-9a68-bd95657379282026-08-22WarningsExact identifier
application number: M005
JELVOXA ANTIFUNGALUNDECYLENIC ACIDWuhan Ruihengjie Technology Co., Ltd.59a2f16e-ef72-f1cb-e063-6394a90abb282026-08-22WarningsExact identifier
application number: M005
Viachs ANTIFUNGAL CreamMICONAZOLE NITRATE 2% ANTIFUNGAL CREAMWenzhou Yuyuan Pharmaceutical Co., Ltd.598b7e0c-c76d-2f56-e063-6394a90a70532026-08-21WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998461miconazole nitrate 2 % Topical PowderPSN021b4a31-d7f6-4921-b4b1-cbe832eecd937
998461miconazole nitrate 0.02 MG/MG Topical PowderSCD021b4a31-d7f6-4921-b4b1-cbe832eecd937
998461miconazole nitrate 2 % Topical PowderSY021b4a31-d7f6-4921-b4b1-cbe832eecd937

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53329-169-795332901697985 g in 1 BOTTLE (53329-169-79) 85 g2012-11-190000-00-00NoNoCurrent