CAREALL Miconazole Nitrate

Product NDC
51824-078
11-digit product format
518240078
Labeler code
51824
Product ID
51824-078_44ebdc80-6f2e-836c-e063-6394a90aeba7
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
CREAM
Route
TOPICAL
Labeler
New World Imports, Inc
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-12-01
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

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
CAREALL 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
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
bed775be-8bcb-44c2-9b9f-8bb25b4b2453Available 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
51824-078-01CAREALL Miconazole Nitrate28 g in 1 TUBECREAM287

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51824-078-01GM - Gram51824-0783e2179a3-5119-458d-afaa-8b9bd887439712021-08-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51824-078CAREALL MICONAZOLE NITRATE (MICONAZOLE NITRATE) CREAM [NEW WORLD IMPORTS, INC]6Current NDC, Legacy NDC, 1 package rows20231014_bed775be-8bcb-44c2-9b9f-8bb25b4b2453.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 30 of 49 · 969 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti-Fungal PowderMICONAZOLE NITRATEThe Kroger Co.209cd0ed-3029-9137-e063-6394a90aa93d2025-10-30WarningsExact identifier
application number: M005
Antifungal Miconazole Liquid ContinuousMICONAZOLE NITRATEMeijer Distribution Inc030f2a31-334b-a6d8-e063-6394a90a98fc2025-10-30WarningsExact identifier
application number: M005
Jock ItchMICONAZOLE NITRATEMeijer Distribution Inc.030f1316-ab3c-ce37-e063-6394a90a0f882025-10-30WarningsExact identifier
application number: M005
Antifungal Athletes FootMICONAZOLE NITRATEMeijer Distribution Inc030f2a31-3357-a6d8-e063-6394a90a98fc2025-10-30WarningsExact identifier
application number: M005
TolnafateTOLNAFTATE POWDER SPRAYMeijer Distribution Inc.0370c9fa-b986-3a63-e063-6294a90a76272025-10-30WarningsExact identifier
application number: M005
TolnafateTOLNAFTATE POWDER SPRAYMeijer Distribution Inc.0423c895-6841-fcd0-e063-6394a90ad7872025-10-30WarningsExact identifier
application number: M005
Miconazole NitrateANTIFUNGAL MICONAZOLE POWDER SPRAYWinco Foods, LLCcc24f4ca-a403-0dc4-e053-2a95a90a5dad2025-10-29WarningsExact identifier
application number: M005
TolnaftateANTIFUNGAL LIQUID SPRAYWinco Foods, LLCcc251fab-b66c-44f4-e053-2995a90a681a2025-10-29WarningsExact identifier
application number: M005
Remedy AntifungalMICONAZOLE NITRATEMedline Industries, LP021b4a31-d7f6-4921-b4b1-cbe832eecd932025-10-29WarningsExact identifier
application number: M005
Family Care AntifungalTOLNAFTATEUnited Exchange Corp.6301ab99-1757-144a-e053-2a91aa0adb772025-10-29WarningsExact identifier
application number: M005
Miconazole NitrateANTI-FUNGAL POWDER MICONAZOLE NITRATE TALC FREEDiscount Drug Mart, Inc37790bf8-6114-84b9-e063-6394a90ad58d2025-10-29WarningsExact identifier
application number: M005
Anti-fungal Powder Miconazole NitrateMICONAZOLE NITRATEPremier Brands of America Inc.052d8d02-2381-1e3a-e063-6394a90aa07e2025-10-29WarningsExact identifier
application number: M005
CVS Health Athletes FootTOLNAFTATECVS Pharmacy, Inc.ab746148-1111-15bc-e053-2a95a90a61f12025-10-29WarningsExact identifier
application number: M005
WinCo Foods AntifungalCLOTRIMAZOLEWinco Foods LLCc2ca0787-267a-10f4-e053-2a95a90a3a332025-10-28WarningsExact identifier
application number: M005
Miconazole NitrateJOCK ITCH SPRAY TALC FREEAmerican Sales Company4354b71e-6268-440d-b916-0403c6fc3ddb2025-10-27WarningsExact identifier
application number: M005
TolnaftateFOOT ODOR CONTROL SPRAYFoodhold USA5a8427c2-a1b2-44aa-afb3-669c12efed282025-10-27WarningsExact identifier
application number: M005
TolnaftateANTIFUNGAL SPRAY LIQUIDFSA Store Inc.fb34c5ae-2c6d-700d-e053-6394a90a909f2025-10-27WarningsExact identifier
application number: M005
Maximum Strength Antifungal LiquidTOLNAFTATEFSA Store Inc.fae36294-68b6-bf14-e053-6394a90aaacd2025-10-27WarningsExact identifier
application number: M005
EVERLIT CARE Hand SanitizerETHYL ALCOHOLNantong Health & Beyond Hygienic Products Inc.58dd955e-e68b-4fbd-90c8-a85b15c00dc72025-10-25WarningsExact identifier
application number: M005
EVERLIT CARE Hand SanitizerETHYL ALCOHOLEVERLIT GLOBAL INC.1360cdd8-b2b2-4af9-b6ff-af1101d49e182025-10-25WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998483miconazole nitrate 2 % Topical CreamPSNbed775be-8bcb-44c2-9b9f-8bb25b4b24537
998483miconazole nitrate 20 MG/ML Topical CreamSCDbed775be-8bcb-44c2-9b9f-8bb25b4b24537
998483miconazole nitrate 2 % Topical CreamSYbed775be-8bcb-44c2-9b9f-8bb25b4b24537

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51824-078-015182400780128 g in 1 TUBE (51824-078-01) 28 g2020-12-010000-00-00NoNoCurrent