Anti-fungal Powder Miconazole Nitrate

Product NDC
56104-500
11-digit product format
561040500
Labeler code
56104
Product ID
56104-500_42537026-f1f3-422f-e063-6394a90a07e9
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
POWDER
Route
TOPICAL
Labeler
Premier Brands of America Inc.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-09-12
Substance
MICONAZOLE NITRATE
Active strength
20 mg/g
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
Anti-fungal Powder Miconazole Nitrate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MICONAZOLE NITRATE20 mg/g

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
052d8d02-2381-1e3a-e063-6394a90aa07eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
56104-500-00Anti-fungal Powder Miconazole Nitrate71 g in 1 BOTTLE, PLASTICPOWDER714

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
56104-500ANTI-FUNGAL POWDER MICONAZOLE NITRATE (MICONAZOLE NITRATE) POWDER [PREMIER BRANDS OF AMERICA INC.]3Current NDC, 1 package rows20241016_052d8d02-2381-1e3a-e063-6394a90aa07e.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 · 1,001 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
WISH HAND SANITIZER Banana Cream SugarALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA5912d7e8-94a7-e8b9-e063-6394a90a74d62026-08-15WarningsExact identifier
application number: M005
WISH HAND SANITIZER Caramel Vanilla PopcornALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA591317be-856e-1374-e063-6394a90a7aaf2026-08-15WarningsExact identifier
application number: M005
BlissCare tea tree oil antifungalTOLNAFTATEGuangdong Aimu Biological Technology Co., Ltd58f9ff8c-d75a-ad1d-e063-6294a90af3dc2026-08-14WarningsExact identifier
application number: M005
WISH HAND SANITIZER Rose WoodsALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA58fb4491-2918-c486-e063-6394a90a621f2026-08-14WarningsExact identifier
application number: M005
VXGXO antifungal with tea tree oilTOLNAFTATEGuangdong Aimu Biological Technology Co., Ltd58fd67c5-c985-13a7-e063-6294a90a40fb2026-08-14WarningsExact identifier
application number: M005
Charmpoo ANTIFUNGAL BODY CreamMICONAZOLE NITRATE 2% ANTIFUNGAL BODY CREAMWenzhou Yuyuan Pharmaceutical Co., Ltd.58ff4779-83a7-afe2-e063-6294a90a9f9a2026-08-14WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEYYBA CORP58f1707a-579b-1e06-e063-6294a90a5a9f2026-08-13WarningsExact identifier
application number: M005
WISH HAND SANITIZER Mango Coconut CreamALCOHOL HAND SANITIZERPT SUPER HOME PRODUCT INDONESIA58faa781-520b-92fa-e063-6294a90a9ecf2026-08-13WarningsExact identifier
application number: M005
Gemachlich Zu Hause Vaginal Antifungal GelMICONAZOLE NITRATEGuangzhou Xinhongda Trading Service Co., Ltd.563cfb57-f10c-96a6-e063-6294a90a2b932026-08-12WarningsExact identifier
application number: M005
Hecila ANTIFUNGAL NAILUNDECYLENIC ACID 25% ANTIFUNGAL NAILWenzhou Yuyuan Pharmaceutical Co., Ltd.58c117cc-e039-86f6-e063-6394a90af18f2026-08-12WarningsExact identifier
application number: M005
TOTCLEAR NAIL RENEWALUNDECYLENIC ACIDGOOD BRIDGE LLC93605e22-920d-43c3-bb2b-6e3116a19f5e2026-08-12WarningsExact identifier
application number: M005
TOTCLEAR NAIL RENEWALUNDECYLENIC ACIDGOOD BRIDGE LLCfde7d6ea-1b44-4a88-820a-0f2e033727e12026-08-11WarningsExact identifier
application number: M005
XBOFPEN MULTI-PURPOSE TREATMENTTOLNAFTATE 1% MULTI-PURPOSE TREATMENTWenzhou Yuyuan Pharmaceutical Co., Ltd.58c2f50c-9c9e-4989-e063-6394a90abb212026-08-11WarningsExact identifier
application number: M005
QualiLife persimmon foot and shoeUNDECYLENIC ACIDGuangdong Aimu Biological Technology Co., Ltd584966c7-ceae-91af-e063-6294a90ac1eb2026-08-10WarningsExact identifier
application number: M005
Aiilo WART REMOVERSALICYLIC ACID 40%Guangzhou Huixue Biotechnology Co., Ltd.58ad9307-a9f9-4de8-e063-6394a90adaa62026-08-10WarningsExact identifier
application number: M005
Aiilo WART REMOVER PATCHESSALICYLIC ACID 40%Guangzhou Huixue Biotechnology Co., Ltd.58af5ac2-75a7-246d-e063-6394a90ae9662026-08-10WarningsExact identifier
application number: M005
Persiancat ANTIFUNGAL PENUNDECYLENIC ACIDGuangzhou ChuanMa International Trading Co.,Ltd.58affb96-6cfc-b1fb-e063-6294a90a340c2026-08-10WarningsExact identifier
application number: M005
Dryello Tolnaftate 1% AntifungalTOLNAFTATEProPedix, Inc.58b6820c-f601-5921-e063-6294a90aa5e92026-08-10WarningsExact identifier
application number: M005
Anti-fungalANTI-FUNGAL SOAPShenzhen Chaoxiji Technology Co.,Ltd.586ce6bf-2915-8ae7-e063-6394a90ae9be2026-08-06WarningsExact identifier
application number: M005
Anti-fungalANTI-FUNGAL SOAPShenzhen Chaoxiji Technology Co.,Ltd.586d92cb-4944-0e7b-e063-6394a90a37a22026-08-06WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998461miconazole nitrate 2 % Topical PowderPSN052d8d02-2381-1e3a-e063-6394a90aa07e4
998461miconazole nitrate 0.02 MG/MG Topical PowderSCD052d8d02-2381-1e3a-e063-6394a90aa07e4
998461miconazole nitrate 2 % Topical PowderSY052d8d02-2381-1e3a-e063-6394a90aa07e4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
56104-500-005610405000071 g in 1 BOTTLE, PLASTIC (56104-500-00) 71 g2023-09-12NoNoCurrent