FDA.reportPublic FDA data

FifthPulse Miconazole Nitrate Cream 4oz

Manufacturer
Front Pharmaceutical PLC
Effective date
2025-07-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:08:25

Label at a glance#

ProductFifthPulse Miconazole Nitrate Cream 4oz
Active ingredientMICONAZOLE NITRATE
Label structure7 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

DOSAGEDOSAGE

WARNINGS SECTION

warningwarning

INACTIVE INGREDIENT SECTION

inactive ingredientinactive ingredient

INDICATIONS & USAGE SECTION

IndicationIndication

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out of reach of childrenkeep out of reach of children

OTC - PURPOSE SECTION

purposepurpose

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABELPACKAGE LABEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998483miconazole nitrate 2 % Topical CreamPSN1
998483miconazole nitrate 20 MG/ML Topical CreamSCD1
998483miconazole nitrate 2 % Topical CreamSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
MICONAZOLE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

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
69571-017-01FifthPulse Miconazole Nitrate Cream 4oz113.4 g in 1 TUBECREAM113.41

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69571-01769571-017-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETOSTEARYL ALCOHOL2DMT128M1SIACT
ALCOHOL3K9958V90MIACT
DIMETHYL SULFOXIDEYOW8V9698HIACT
METHYLPARABENA2I8C7HI9TIACT
WATER059QF0KO0RIACT
STEARIC ACID4ELV7Z65APIACT
EDETATE DISODIUM7FLD91C86KIACT
MICONAZOLE NITRATEVW4H1CYW1KACTIB
MINERAL OILT5L8T28FGPIACT
PETROLATUM4T6H12BN9UIACT

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FifthPulse Miconazole Nitrate Cream 4ozMICONAZOLE NITRATEFront Pharmaceutical PLC3a382b79-dde9-dde0-e063-6294a90a53bb2025-07-18WarningsExact identifier
ndc (package): 69571-017-01
ndc (product): 69571-017
ndc11 (package): 69571001701
spl id: 3a382b79-ddea-dde0-e063-6294a90a53bb
spl set id: 3a382b79-dde9-dde0-e063-6294a90a53bb

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.