FDA.reportPublic FDA data

Lotrimin

Product NDC
11523-0919
11-digit product format
115230919
Labeler code
11523
Product ID
11523-0919_4884f594-2fb8-4a34-e063-6294a90a96fb
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole nitrate
Dosage form
POWDER
Route
TOPICAL
Labeler
Bayer HealthCare LLC.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1993-09-01
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
Lotrimin
Brand name suffix
Antifungal
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MICONAZOLE NITRATE20 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVW4H1CYW1K
Rxcui998461

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
11523-0919-12026-01-16C16284748780-13b156c62-30e9-fb37-e063-e6dba90a4e07Lotrimin ® Antifungal
11523-0919-12025-07-29C16284748780-13b156c62-30e9-fb37-e063-e6dba90a4e07Lotrimin ® Antifungal

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-0919-1LotriminAntifungal90 g in 1 CANPOWDER9010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11523-0919-1GM - Gram11523-0919adee5f01-32f1-4a72-a5cb-3f8fd361a70612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Miconazole nitrateACTIVE INGREDIENTVW4H1CYW1KLOTRIMIN ANTIFUNGAL (MICONAZOLE NITRATE) POWDER [MSD CONSUMER CARE, INC.]2
MiconazoleACTIVE MOIETY7NNO0D7S5MLOTRIMIN ANTIFUNGAL (MICONAZOLE NITRATE) POWDER [MSD CONSUMER CARE, INC.]2
benzethonium chlorideINACTIVE INGREDIENTPH41D05744LOTRIMIN ANTIFUNGAL (MICONAZOLE NITRATE) POWDER [MSD CONSUMER CARE, INC.]2
kaolinINACTIVE INGREDIENT24H4NWX5COLOTRIMIN ANTIFUNGAL (MICONAZOLE NITRATE) POWDER [MSD CONSUMER CARE, INC.]2
sodium bicarbonateINACTIVE INGREDIENT8MDF5V39QOLOTRIMIN ANTIFUNGAL (MICONAZOLE NITRATE) POWDER [MSD CONSUMER CARE, INC.]2
starch, cornINACTIVE INGREDIENTO8232NY3SJLOTRIMIN ANTIFUNGAL (MICONAZOLE NITRATE) POWDER [MSD CONSUMER CARE, INC.]2
zinc oxideINACTIVE INGREDIENTSOI2LOH54ZLOTRIMIN ANTIFUNGAL (MICONAZOLE NITRATE) POWDER [MSD CONSUMER CARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11523-0919LOTRIMIN ANTIFUNGAL (MICONAZOLE NITRATE) POWDER [BAYER HEALTHCARE LLC.]8Current NDC, Legacy NDC, 1 package rows20241208_cebd222c-074f-443c-bd37-612114b27bbd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998461miconazole nitrate 2 % Topical PowderPSNcebd222c-074f-443c-bd37-612114b27bbd10
998461miconazole nitrate 0.02 MG/MG Topical PowderSCDcebd222c-074f-443c-bd37-612114b27bbd10
998461miconazole nitrate 2 % Topical PowderSYcebd222c-074f-443c-bd37-612114b27bbd10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11523-0919-11152309190190 g in 1 CAN (11523-0919-1) 90 g1993-09-010000-00-00NoNoCurrent