FifthPulse Miconazole Nitrate Cream 1oz

Product NDC
69571-016
11-digit product format
695710016
Labeler code
69571
Product ID
69571-016_3a37a3a8-9d06-926c-e063-6294a90a9ed8
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole Nitrate
Dosage form
CREAM
Route
TOPICAL
Labeler
Front Pharmaceutical PLC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-07-19
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
FifthPulse Miconazole Nitrate Cream 1oz
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
69571-016-01FifthPulse Miconazole Nitrate Cream 1oz28.4 g in 1 TUBECREAM28.41

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998483miconazole nitrate 2 % Topical CreamPSN3a37a3a8-9d05-926c-e063-6294a90a9ed81
998483miconazole nitrate 20 MG/ML Topical CreamSCD3a37a3a8-9d05-926c-e063-6294a90a9ed81
998483miconazole nitrate 2 % Topical CreamSY3a37a3a8-9d05-926c-e063-6294a90a9ed81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69571-016-016957100160128.4 g in 1 TUBE (69571-016-01) 28.4 g2025-07-19NoNoCurrent