Home NDC 53329-169 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 Ingredient Strength MICONAZOLE NITRATE 2 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination VW4H1CYW1K Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 998461 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53329-169-79 Remedy Antifungal 85 g in 1 BOTTLE POWDER 85 7
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded MICONAZOLE NITRATE ACTIVE INGREDIENT VW4H1CYW1K REMEDY ANTIFUNGAL (MICONAZOLE NITRATE) POWDER [MEDLINE INDUSTRIES, INC.] 1 MICONAZOLE ACTIVE MOIETY 7NNO0D7S5M REMEDY ANTIFUNGAL (MICONAZOLE NITRATE) POWDER [MEDLINE INDUSTRIES, INC.] 1 .ALPHA.-TOCOPHEROL ACETATE INACTIVE INGREDIENT 9E8X80D2L0 REMEDY ANTIFUNGAL (MICONAZOLE NITRATE) POWDER [MEDLINE INDUSTRIES, INC.] 1 7-DEHYDROCHOLESTEROL INACTIVE INGREDIENT BK1IU07GKF REMEDY ANTIFUNGAL (MICONAZOLE NITRATE) POWDER [MEDLINE INDUSTRIES, INC.] 1 APHANIZOMENON FLOS-AQUAE INACTIVE INGREDIENT 49VG1X560X REMEDY ANTIFUNGAL (MICONAZOLE NITRATE) POWDER [MEDLINE INDUSTRIES, INC.] 1 CAPRYLIC/CAPRIC/LINOLEIC TRIGLYCERIDE INACTIVE INGREDIENT U73D397055 REMEDY ANTIFUNGAL (MICONAZOLE NITRATE) POWDER [MEDLINE INDUSTRIES, INC.] 1 CLOVE INACTIVE INGREDIENT K48IKT5321 REMEDY ANTIFUNGAL (MICONAZOLE NITRATE) POWDER [MEDLINE INDUSTRIES, INC.] 1 CORN OIL INACTIVE INGREDIENT 8470G57WFM REMEDY ANTIFUNGAL (MICONAZOLE NITRATE) POWDER [MEDLINE INDUSTRIES, INC.] 1 EGG PHOSPHOLIPIDS INACTIVE INGREDIENT 1Z74184RGV REMEDY ANTIFUNGAL (MICONAZOLE NITRATE) POWDER [MEDLINE INDUSTRIES, INC.] 1 ETHYLENE BRASSYLATE INACTIVE INGREDIENT 9A87HC7ROD REMEDY ANTIFUNGAL (MICONAZOLE NITRATE) POWDER [MEDLINE INDUSTRIES, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX REMEDY ANTIFUNGAL (MICONAZOLE NITRATE) POWDER [MEDLINE INDUSTRIES, INC.] 1 GLYCYRRHIZINATE DIPOTASSIUM INACTIVE INGREDIENT CA2Y0FE3FX REMEDY ANTIFUNGAL (MICONAZOLE NITRATE) POWDER [MEDLINE INDUSTRIES, INC.] 1 GREEN TEA LEAF INACTIVE INGREDIENT W2ZU1RY8B0 REMEDY ANTIFUNGAL (MICONAZOLE NITRATE) POWDER [MEDLINE INDUSTRIES, INC.] 1 HYDRATED SILICA INACTIVE INGREDIENT Y6O7T4G8P9 REMEDY ANTIFUNGAL (MICONAZOLE NITRATE) POWDER [MEDLINE INDUSTRIES, INC.] 1 ISOPROPYL MYRISTATE INACTIVE INGREDIENT 0RE8K4LNJS REMEDY ANTIFUNGAL (MICONAZOLE NITRATE) POWDER [MEDLINE INDUSTRIES, INC.] 1 METHYL DIHYDROJASMONATE (SYNTHETIC) INACTIVE INGREDIENT 3GW44CIE3Y REMEDY ANTIFUNGAL (MICONAZOLE NITRATE) POWDER [MEDLINE INDUSTRIES, INC.] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU REMEDY ANTIFUNGAL (MICONAZOLE NITRATE) POWDER [MEDLINE INDUSTRIES, INC.] 1 SOY PROTEIN INACTIVE INGREDIENT R44IWB3RN5 REMEDY ANTIFUNGAL (MICONAZOLE NITRATE) POWDER [MEDLINE INDUSTRIES, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ REMEDY ANTIFUNGAL (MICONAZOLE NITRATE) POWDER [MEDLINE INDUSTRIES, INC.] 1 STARCH, TAPIOCA INACTIVE INGREDIENT 24SC3U704I REMEDY ANTIFUNGAL (MICONAZOLE NITRATE) POWDER [MEDLINE INDUSTRIES, INC.] 1 VANILLA INACTIVE INGREDIENT Q74T35078H REMEDY ANTIFUNGAL (MICONAZOLE NITRATE) POWDER [MEDLINE INDUSTRIES, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R REMEDY ANTIFUNGAL (MICONAZOLE NITRATE) POWDER [MEDLINE INDUSTRIES, INC.] 1 YEAST INACTIVE INGREDIENT 3NY3SM6B8U REMEDY ANTIFUNGAL (MICONAZOLE NITRATE) POWDER [MEDLINE INDUSTRIES, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53329-169 REMEDY ANTIFUNGAL (MICONAZOLE NITRATE) POWDER [MEDLINE INDUSTRIES, LP] 6 Current NDC, Legacy NDC, 1 package rows 20241011_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 24 of 49 · 973 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Fortinia CLOTRIMAZOLE The Podiatree Company 60ba6f8a-8617-d4f6-e053-2991aa0a4a71 2026-01-08 Warnings Exact identifier application number: M005 RoyceDerm Anti fungal RELIEF cream SALICYLIC ACID 2% RoyceDerm LLC 47ec6277-e40f-af82-e063-6294a90ac8c1 2026-01-08 Warnings Exact identifier application number: M005 BBlove ALCOHOL WIPES BBLOVE ALCOHOL WIPES Shenzhen Shierjie Biological Engineering Co., LTD 1a451616-b16e-8aa7-e063-6294a90a26a1 2026-01-07 Warnings Exact identifier application number: M005 Wet wipes WET WIPES Shenzhen Shierjie Biological Engineering Co., LTD 273b3ae2-6dec-31a4-e063-6294a90aca89 2026-01-07 Warnings Exact identifier application number: M005 Bee Venom Fungal Nail Treatment Liquid BEE VENOM FUNGAL NAIL TREATMENT Shenzhen Earth Surface Trading Co., Ltd. 47c37468-ba5c-0d11-e063-6294a90ac554 2026-01-06 Warnings Exact identifier application number: M005 ProBliva Anti Fungal Shampoo. ANTIFUNGAL CAVTECH HOLDING LLC 47af9ff8-5d5c-4524-e063-6394a90ac91f 2026-01-05 Warnings Exact identifier application number: M005 Beauty Creations Pink Halo Hand Sanitizer Mist ETHYL ALCOHOL Nantong Health & Beyond Hygienic Products Inc. dda9f4cb-e431-4164-be61-0daf1a86d10f 2026-01-04 Warnings Exact identifier application number: M005 FUNGAL NAIL PATCHES UNDECYLENIC ACID Guangzhou Hechuang Commercial Service Co.,Ltd. 477c971d-829f-5040-e063-6394a90a41e4 2026-01-03 Warnings Exact identifier application number: M005 Nail Renovar Plus TOLNAFTATE SOHM, Inc 2c09925c-e63e-4d9b-8d76-b06bd2cba26c 2026-01-02 Warnings Exact identifier application number: M005 Natural Sense Full Body Cleansing Towel CLEANSING TOWEL Dr. Natural LLC 4742eec4-b7a3-2c89-e063-6294a90a19fc 2025-12-31 Warnings Exact identifier application number: M005 Lasolex AG MICONAZOLE NITRATE Puretek Corporation 4411142f-a8ec-c8c2-e063-6394a90aa25c 2025-12-31 Warnings Exact identifier application number: M005 Hermon Antifungal Stick 1% CLOTRIMAZOLE Beautivity LLC 474a5783-4488-034e-e063-6294a90a5de3 2025-12-31 Warnings Exact identifier application number: M005 SnugZ Hand Sanitizing Wipes HAND SANITIZING WIPES SnugZ/USA, LLC c5d9122a-2c67-2387-e053-2a95a90a2c3a 2025-12-29 Warnings Exact identifier application number: M005 Clotrimazole (Topical Solution), 1% CLOTRIMAZOLE Puro Pharma Inc. cb424fa8-3ed5-45cd-b03f-64675584b34e 2025-12-27 Warnings Exact identifier application number: M005 CLOTRIMAZOLE CLOTRIMAZOLE GRAXCELL PHARMACEUTICAL, LLC. 5f8ca6ad-cb25-1abf-e053-2a91aa0aca99 2025-12-25 Warnings Exact identifier application number: M005 CuraNails Antifungal Pen UNDECYLENIC ACID 25% Quality Discount Inc. 3e641d36-72f6-4682-bd31-f7cd04d857f2 2025-12-25 Warnings Exact identifier application number: M005 Opti-Nail 2-in-1 TOLNAFTATE Kramer Laboratories bc8a5492-8bd0-4c80-a270-e4958aeb5ed6 2025-12-23 Warnings Exact identifier application number: M005 ProBliva Medicated Anti Fungal ANTIFUNGAL CAVTECH HOLDING LLC 46852aea-028c-71c2-e063-6394a90a8055 2025-12-22 Warnings Exact identifier application number: M005 Terthon Clotrimazole 1% Antifungal Cream CLOTRIMAZOLE 1% SOLALIA LLC 468f1b1b-f67d-8b98-e063-6294a90a7f45 2025-12-22 Warnings Exact identifier application number: M005 Clotrimazole CLOTRIMAZOLE Granules USA, Inc. 6e63e29a-eb50-1790-e053-2a91aa0a3616 2025-12-22 Warnings Exact identifier application number: M005
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 53329-169-79 53329016979 85 g in 1 BOTTLE (53329-169-79) 85 g 2012-11-19 0000-00-00 No No Current