FDA.reportPublic FDA data

Miconazole Nitrate

Product NDC
49035-135
11-digit product format
490350135
Labeler code
49035
Product ID
49035-135_496575e7-1fd9-0285-e063-6394a90ac8d4
Type
HUMAN OTC DRUG
Nonproprietary name
Jock Itch Spray
Dosage form
AEROSOL, SPRAY
Route
TOPICAL
Labeler
Wal-Mart Stores, Inc.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-02-28
Substance
MICONAZOLE NITRATE
Active strength
1.3 g/130g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Miconazole NitrateJOCK ITCH SPRAYWal-Mart Stores, Inc.76259769-9923-4856-a160-a738bc8a72f02026-01-27WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings For external use only. Extremely Flammable: Keep away from fire, sparks, and heated surfaces. Contents under pressure. Do not puncture or incinerate. Do not sore at temperature above 120°F. Do not use on children under 2 years of age unless directed by a doctor. When using this product avoid spraying in eyes use only as directed intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal Stop use and ask a doctor if irritation occurs there is no improvement within 2 weeks Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MICONAZOLE NITRATE1.3 g/130g

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49035-135-462023-01-31C16284748780-1f386c649-a0bb-0266-e053-dadaa90a7c1aMiconazole Jock Itch Powder Spray Talc Free
49035-135-462023-01-31C16284748780-1f386c649-a0bb-0266-e053-dadaa90a7c1aMiconazole Jock Itch Powder Spray Talc Free
49035-135-462023-01-31C16284748780-1f386c649-a0bb-0266-e053-dadaa90a7c1aAntifungal Powder Spray Jock Itch
49035-135-462023-01-30C16284748780-1f386c649-a0bb-0266-e053-dadaa90a7c1aMiconazole Jock Itch Powder Spray Talc Free
49035-135-462023-01-30C16284748780-1f386c649-a0bb-0266-e053-dadaa90a7c1aMiconazole Jock Itch Powder Spray Talc Free
49035-135-462023-01-30C16284748780-1f386c649-a0bb-0266-e053-dadaa90a7c1aAntifungal Powder Spray Jock Itch

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-135-46Miconazole Nitrate130 g in 1 PACKAGEAEROSOL, SPRAY1309

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-135MICONAZOLE NITRATE (JOCK ITCH SPRAY) AEROSOL, SPRAY [WAL-MART STORES, INC.]6Current NDC, Legacy NDC, 1 package rows20241218_76259769-9923-4856-a160-a738bc8a72f0.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-135-4649035013546130 g in 1 PACKAGE (49035-135-46) 130 g2019-02-280000-00-00NoNoCurrent