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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage11523-0919-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage11523-0919-1f5e01cc5f278…a2eaf40c39c3…

Reported adverse events (FAERS/openFDA)#

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

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
VW4H1CYW1KInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
998461Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
cebd222c-074f-443c-bd37-612114b27bbdAvailable on FDA.report

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#

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

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 8 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ANTIFUNGALMICONAZOLEVIVE HEALTH LLC30dca43e-e6c4-8107-e063-6394a90a2b972026-07-01WarningsExact identifier
application number: M005
Fungi Nail Everyday Antifungal PowderTOLNAFTATEKramer Laboratories8ed1a08a-3019-4564-968f-154e659c05e12026-07-01WarningsExact identifier
application number: M005
Terpenicol Antifungal SolutionMICONAZOLE NITRATEBlaine Labs Inc.f17ef2cd-5923-4df5-a7fe-aeef167e1e862026-07-01WarningsExact identifier
application number: M005
LUMUMU TOENAIL REPAIR PENUNDECYLENIC ACID 25% TOENAIL REPAIR PENWenzhou Yuyuan Pharmaceutical Co., Ltd.55763ee1-a775-731c-e063-6394a90a8f4c2026-06-30WarningsExact identifier
application number: M005
Kopa Haiku Ringworm Treatment CreamMICONAZOLE NITRATE 2%Trovina Co. Ltd52cef8ec-6578-5e80-e063-6294a90ab4232026-06-30WarningsExact identifier
application number: M005
Tinea Versicolor Treatment CreamCLOTRIMAZOLEBeautivity LLC32d71d7e-3c78-6b63-e063-6294a90adaed2026-06-29WarningsExact identifier
application number: M005
Tinea Versicolor Treatment BarCLOTRIMAZOLEBeautivity LLC33612382-2f12-e9f6-e063-6394a90aaee42026-06-29WarningsExact identifier
application number: M005
Tinea Versicolor Treatment KitCLOTRIMAZOLEBeautivity LLC3361d9a2-daf6-7749-e063-6294a90a36532026-06-29WarningsExact identifier
application number: M005
Hermon Clotrimazole antifungal treatment creamCLOTRIMAZOLE 1%Beautivity LLC3c9bd942-49c6-cada-e063-6394a90a31662026-06-29WarningsExact identifier
application number: M005
Initial Drug Listing - Hermon Athletes Foot 1% Tolnaftate CreamTOLNAFTATE 1%Beautivity LLC4141cca0-1650-6e00-e063-6394a90a13e32026-06-29WarningsExact identifier
application number: M005
Athlete Foot Treatment KitTERBINAFINE HYDROCHLORIDE, TOLNAFTATEBeautivity LLC3b3aa69f-4e73-cabc-e063-6294a90ab65b2026-06-29WarningsExact identifier
application number: M005
Athlete Foot CreamTERBINAFINE HYDROCHLORIDEBeautivity LLC3b2c1d7f-32c3-aa3b-e063-6394a90a62672026-06-29WarningsExact identifier
application number: M005
Hermon Clotrimazole antifungal soap. barCLOTRIMAZOLE 1%Beautivity LLC3cdcf8cc-510c-6115-e063-6294a90ac3ea2026-06-29WarningsExact identifier
application number: M005
Clotrimazole antifungal treatment kitCLOTRIMAZOLE 1%Beautivity LLC3ceec52e-4089-9eb0-e063-6294a90ad52a2026-06-29WarningsExact identifier
application number: M005
Ringworm Treatment CreamMICONAZOLE NITRATE 2%Beautivity LLC4805462b-aec6-78fe-e063-6394a90ae0662026-06-29WarningsExact identifier
application number: M005
Hermon Athletes foot Tolnaftate 1% kitTOLNAFTATE 1% KITBeautivity LLC4142f490-c4b5-a9f3-e063-6394a90ab75e2026-06-29WarningsExact identifier
application number: M005
Aosorw Antifungal CreamMICONAZOLE NITRATE 2%SpineStatus LLC31f4b0eb-b8aa-7ccb-e063-6394a90ad9812026-06-29WarningsExact identifier
application number: M005
VORVITA Nail HardenerPANTHENOL,HYALURONIC ACIDHK Vorvita Technology Co., Limited51d5d3c7-ca25-3ee5-e063-6294a90a3a052026-06-26WarningsExact identifier
application number: M005
natouchMICONAZOLENatouch LLC55210a9d-6c47-4fc7-e063-6294a90a36532026-06-25WarningsExact identifier
application number: M005
YEARCHOICE Fungal Nail Repair PenFUNGAL NAIL REPAIR PENGuangzhou Jingliang Cosmetics Co., Ltd.5500b582-0641-498d-e063-6394a90a3c582026-06-24WarningsExact identifier
application number: M005

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