Medline

Product NDC
53329-218
11-digit product format
533290218
Labeler code
53329
Product ID
53329-218_42f3af59-a020-421e-e063-6294a90a6eab
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole nitrate
Dosage form
CREAM
Route
TOPICAL
Labeler
Medline Industries, LP
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-10-01
Substance
MICONAZOLE NITRATE
Active strength
20 mg/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
Medline
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MICONAZOLE NITRATE20 mg/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVW4H1CYW1K

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53329-218-44Medline113 g in 1 TUBECREAM1133

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-218MEDLINE (MICONAZOLE NITRATE) CREAM [MEDLINE INDUSTRIES, LP]2Current NDC, 1 package rows20241010_1ea444eb-f2f5-8c63-e063-6294a90acac8.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53329-218-4453329021844113 g in 1 TUBE (53329-218-44) 113 g2024-10-01NoNoHistorical