FDA.reportPublic FDA data

Remedy Antifungal

Product NDC
53329-169
Requested package NDC
53329-169-79
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

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 50 · 984 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gemachlich Zu Hause Vaginal Antifungal GelMICONAZOLE NITRATEGuangzhou Xinhongda Trading Service Co., Ltd.563cfb57-f10c-96a6-e063-6294a90a2b932026-08-06WarningsExact identifier
application number: M005
Miconazole NitrateMICONAZOLE NITRATESun Pharmaceutical Industries, Inc.7fd4037e-d350-47b7-a7d9-a43b8e366fa02026-08-05WarningsExact identifier
application number: M005
Antifungal LiquidTOLNAFTATEFamily Dollar Services, Inc57c20748-fdad-b73b-e063-6294a90a1c172026-08-04WarningsExact identifier
application number: M005
Gembooxt RINGWORM CreamMICONAZOLE NITRATE, HYDROCORTISONEGuangdong Quadrant Ecological Technology Co., Ltd.464a33c3-6d16-0cfd-e063-6294a90abf4b2026-08-04WarningsExact identifier
application number: M005
YAMANGU FUNGAL NAIL RENEWALUNDECYLENIC ACID 25% FUNGAL NAIL RENEWALWenzhou Yuyuan Pharmaceutical Co., Ltd.5843cc12-de66-ca47-e063-6294a90ae55b2026-08-04WarningsExact identifier
application number: M005
Maximum Strength Antifungal LiquidTOLNAFTATEMeijer Distribution Inc0b3eb169-b309-8c1a-e063-6294a90a726e2026-08-03WarningsExact identifier
application number: M005
ProCure Antifungal CreamMICONAZOLE NITRATE 2%Twin Med LLC39d55df5-8a8e-3a9b-e063-6294a90af20b2026-08-03WarningsExact identifier
application number: M005
MiratiFul Nail Fungus TreatmentTOLNAFTATETexas MiratiFul Enterprises Inc.35eb20e3-86d4-4bec-b572-3d5fe86ac74d2026-08-03WarningsExact identifier
application number: M005
LUCKSKY Fungal Nail RenewalUNDECYLENIC ACID 25% TOLNAFTATE1% FUNGAL NAIL RENEWALWenzhou Yuyuan Pharmaceutical Co., Ltd.57a73b60-bbac-97e6-e063-6294a90ab9a92026-07-28WarningsExact identifier
application number: M005
Ponamfo ANTIFUNGAL TREATMENT PENUNDECYLENICGuangzhou Bixiaoyu Trading Co., Ltd.57a9ccff-270b-9769-e063-6394a90a5e0c2026-07-28WarningsExact identifier
application number: M005
FUNGAL NAIL PATCHESUNDECYLENIC ACIDGuangzhou Hechuang Commercial Service Co.,Ltd.5240412c-4257-8e9d-e063-6394a90a0a122026-07-28WarningsExact identifier
application number: M005
FFPMAM Antifungal CreamFFPMAM ANTIFUNGAL CREAMGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd57b7cf61-d4cd-53f7-e063-6394a90afc542026-07-28WarningsExact identifier
application number: M005
Youggle WART REMOVERSALICYLIC ACIDGuangzhou Huixue Biotechnology Co., Ltd.57a3744e-316c-8a3d-e063-6294a90a15d12026-07-27WarningsExact identifier
application number: M005
antifungal penANTIFUNGAL PENGUANGZHOU YUSONG FINE CHEMICLS Co., Ltd5756256e-ed2b-4e13-e063-6294a90a1e0f2026-07-24WarningsExact identifier
application number: M005
SERYNTH ANTIFUNGAL NAIL TREATMENT PENUNDECYLENIC ACID 25% ANTIFUNGAL NAIL TREATMENT PENJiangxi Yudexi Pharmaceutical Co., LTD4d59116a-bcd0-9ed4-e063-6394a90a6dbd2026-07-24WarningsExact identifier
application number: M005
SERYNTH MULTI-PURPOSE FUNCUSTOLNAFTATE 1% MULTI-PURPOSE FUNCUSJiangxi Yudexi Pharmaceutical Co., LTD4a6ea0c9-1495-8ede-e063-6294a90ad0932026-07-23WarningsExact identifier
application number: M005
HELPS WITH NAGELPILZTOLNAFTATE 1% HELPS WITH NAGELPILZ LIQUIDShanghai Honghui Chuang Intelligent Technology Co., Ltd55753a4a-a4d0-a183-e063-6394a90acf112026-07-22WarningsExact identifier
application number: M005
FUNGAL NAIL TREATMENT kit .liquid.PSEUDOLARIX AMABILIS BARK 1%GETHSEMANE BRANCH CORPORATION5719942d-6b10-612e-e063-6294a90a4fe92026-07-21WarningsExact identifier
application number: M005
BeamBalm ANTIFUNGAL CARE ESSENTIAL OilUNDECYLENIC ACID 10% ANTIFUNGAL CARE ESSENTIAL OILJiangxi Yudexi Pharmaceutical Co., LTD4ff57d2d-5e74-a995-e063-6394a90a3f9a2026-07-21WarningsExact identifier
application number: M005
WERPEKA FUNGAL NAIL RENEWALUNDECYLENIC ACID 25% FUNGAL NAIL RENEWALJiangxi Yudexi Pharmaceutical Co., LTD4f7a8273-b7af-d532-e063-6394a90aa63a2026-07-21WarningsExact 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