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

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 Identifiers#

Field, Values table
FieldValues
UniiVW4H1CYW1K
Rxcui998483

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

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