FDA.reportPublic FDA data

Lotrimin Daily Prevention

Product NDC
11523-0011
11-digit product format
115230011
Labeler code
11523
Product ID
11523-0011_48850bbc-9ec2-b7ee-e063-6394a90a9f0d
Type
HUMAN OTC DRUG
Nonproprietary name
tolnaftate
Dosage form
POWDER
Route
TOPICAL
Labeler
Bayer HealthCare LLC.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-02-14
Substance
TOLNAFTATE
Active strength
10 mg/g
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 · 6 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 packagepackage11523-0011-1d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage11523-0011-2d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage11523-0011-1f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage11523-0011-2f5e01cc5f278…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 Daily Prevention
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLNAFTATE10 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
06KB629TKVInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
313422Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9e8f9211-e85d-725a-e053-2995a90a09b3Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
11523-0011-12026-01-16Lotrimin Daily Prevention Powder UI 1612510
11523-0011-22026-01-16Lotrimin Daily Prevention Powder UI 1612510
11523-0011-12025-07-29Lotrimin Daily Prevention Powder UI 1612510
11523-0011-22025-07-29Lotrimin Daily Prevention Powder UI 1612510

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-0011-1Lotrimin Daily Prevention90 g in 1 BOTTLEPOWDER907
11523-0011-2Lotrimin Daily Prevention28 g in 1 BOTTLEPOWDER287

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11523-0011LOTRIMIN DAILY PREVENTION (TOLNAFTATE) POWDER [BAYER HEALTHCARE LLC.]6Current NDC, Legacy NDC, 2 package rows20241208_9e8f9211-e85d-725a-e053-2995a90a09b3.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 38 of 49 · 969 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lunavia Antifungal Foot BalmZINC UNDECYLENATE 10%XF Agencija Limited466f3285-9800-4219-902f-b78a713b952f2025-06-13WarningsExact identifier
application number: M005
Foot Cure Antifungal Foot BalmZINC UNDECYLENATESansar LLCac6075bf-cc1d-4e8a-aa13-5a85e80f34ee2025-06-13WarningsExact identifier
application number: M005
Lunavia AntifungalUNDECYLENIC ACID 25%XF Agencija Limited55891d2f-e2b8-4d9f-8140-dc258926ed902025-06-13WarningsExact identifier
application number: M005
TEGASOLVE TOENAIL FUNGUS TREATMENTUNDECYLENIC ACID 25%Zhengzhou Hangrui Network Technology Co., Ltd.375b0515-1b1f-23b8-e063-6294a90a9d682025-06-12WarningsExact identifier
application number: M005
Miconazole NitrateANTI-FUNGAL POWDER MICONAZOLE NITRATE TALC FREECVS Pharmacy979ab1d2-f184-455d-b31a-2ff2bd4592b82025-06-12WarningsExact identifier
application number: M005
Gemachlich ZuHause Fungal Nail RevitalizerGEMACHLICH ZUHAUSE FUNGAL NAIL REVITALIZERGuangdong Quadrant Ecological Technology Co., Ltd.37332cdf-7171-42cc-e063-6394a90a0fcf2025-06-10WarningsExact identifier
application number: M005
Eyelid WipesEYELID WIPESShenzhen Shierjie Biological Engineering Co., LTD36ddfa37-3913-9e48-e063-6294a90ae1be2025-06-08WarningsExact identifier
application number: M005
Everywhere Flushable WipesEVERYWHERE FLUSHABLE WIPESShenzhen Shierjie Biological Engineering Co., LTD371be299-5aaf-b9d7-e063-6294a90a87f52025-06-08WarningsExact identifier
application number: M005
Fungus MasterMICONAZOLE NITRATEClinical Resolution Laboratory, Inc.36eb334e-246b-249f-e063-6294a90ab8112025-06-06WarningsExact identifier
application number: M005
Miconazole NitrateANTI-FUNGAL POWDER MICONAZOLE NITRATE TALC FREEHudson Health LLC8d725a50-fbe4-4a48-9cbf-f8b5c12dd6472025-06-03WarningsExact identifier
application number: M005
CharmTex Lightly Scented AntibacterialBENZETHONIUM CHLORIDELiufangjing Biotechnology (Yangzhou) Co., Ltd1c9f4bff-3f6f-4498-b8a2-7d7f49d6ad2d2025-06-01WarningsExact identifier
application number: M005
DermaD ANTIFUNGAL TherapeuticSALICYLIC ACIDChen Cohen Industries Inc.b97684ae-79d0-4208-b480-67794596ece72025-05-29WarningsExact identifier
application number: M005
Fungazol Athlete FootMICONAZOLE NITRATERida LLCce60e1ec-a69b-4b98-a2b2-105e9cd37bc72025-05-28WarningsExact identifier
application number: M005
Toenail Fungus LiquidTOENAIL FUNGUS LIQUIDShenzhen Earth Surface Trading Co., Ltd.361f4c5c-7fa7-0440-e063-6294a90aad9f2025-05-27WarningsExact identifier
application number: M005
help it AntisepticBENZALKONIUM CHLORIDENantong Health & Beyond Hygienic Products Inc.0b22f423-eb11-445f-a484-9326c1fe3ad52025-05-27WarningsExact identifier
application number: M005
Seacall Hydrocortisone Ointment.SEACALL HYDROCORTISONE OINTMENTGuangdong Quadrant Ecological Technology Co., Ltd.3616980a-03dc-deba-e063-6394a90a6ce72025-05-26WarningsExact identifier
application number: M005
Terrasil Anti-Fungal Treatment MAXCLOTRIMAZOLEAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutionsdb356cc8-f473-4eb2-b8d8-72606fca9dc02025-05-23WarningsExact identifier
application number: M005
terrasil Folliculitis Cream Maximum StrengthCLOTRIMAZOLEAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions35d54756-00dd-bbe1-e063-6394a90a9e022025-05-23WarningsExact identifier
application number: M005
Paume Moisturizing Antibacterial Hand GelALCOHOLPaume Incb6fe12bf-6430-5861-e053-2a95a90a6c8f2025-05-22WarningsExact identifier
application number: M005
Tolnaftate Cream 1% ANTIFUNGALTOLNAFTATETrifecta Pharmaceuticals Usa Llc96a40ccd-17f7-4e4e-98da-207802fa2b2d2025-05-15WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313422tolnaftate 1 % Topical PowderPSN9e8f9211-e85d-725a-e053-2995a90a09b37
313422tolnaftate 0.01 MG/MG Topical PowderSCD9e8f9211-e85d-725a-e053-2995a90a09b37
313422tolnaftate 1 % Topical PowderSY9e8f9211-e85d-725a-e053-2995a90a09b37

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11523-0011-11152300110190 g in 1 BOTTLE (11523-0011-1) 90 g2020-02-140000-00-00NoNoCurrent
11523-0011-21152300110228 g in 1 BOTTLE (11523-0011-2) 28 g2022-11-010000-00-00NoNoCurrent