FifthPulse Miconazole Nitrate Antifungal

Product NDC
87525-004
11-digit product format
875250004
Labeler code
87525
Product ID
87525-004_4e7d2ee6-0c87-7391-e063-6394a90a4ee8
Type
HUMAN OTC DRUG
Nonproprietary name
MICONAZOLE NITRATE
Dosage form
OINTMENT
Route
TOPICAL
Labeler
WeCare Products LLC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-04-30
Substance
MICONAZOLE NITRATE
Active strength
20 mg/g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
FifthPulse Miconazole Nitrate Antifungal
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MICONAZOLE NITRATE20 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVW4H1CYW1K

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
87525-004-01FifthPulse Miconazole Nitrate Antifungal1 in 1 BOXOINTMENT11
87525-004-01FifthPulse Miconazole Nitrate Antifungal28.4 g in 1 TUBEOINTMENT28.41
87525-004-02FifthPulse Miconazole Nitrate Antifungal1 in 1 BOXOINTMENT11
87525-004-02FifthPulse Miconazole Nitrate Antifungal113.4 g in 1 TUBEOINTMENT113.41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
87525-004-01875250004011 TUBE in 1 BOX (87525-004-01) / 28.4 g in 1 TUBE1 tube2026-04-30NoNoCurrent
87525-004-02875250004021 TUBE in 1 BOX (87525-004-02) / 113.4 g in 1 TUBE1 tube2026-04-30NoNoCurrent