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 12 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Athletes FootMICONAZOLE NITRATEPremier Brands of America Inc52d0909a-f404-0af4-e063-6394a90a3d0c2026-06-01WarningsExact identifier
application number: M005
Kopa Haiku Antifungal CreamMICONAZOLE NITRATE 2%Trovina Co. Ltd431483f6-2386-9f5c-e063-6294a90af1042026-06-01WarningsExact identifier
application number: M005
Antifungal LiquidTOLNAFTATEWalgreens Company3f8d45e1-54a2-a658-e063-6294a90a6cbb2026-06-01WarningsExact identifier
application number: M005
Remedy NailsUNDECYLENIC ACIDAdwill Labs Inc4e87b76c-c430-466a-bc30-fe1785c7c6602026-06-01WarningsExact identifier
application number: M005
Anytalk Nail Fungus Treatment 15ml (1% Tonailate)TOLNAFTATE1%Guangzhou Huixue Biotechnology Co., Ltd.52f1f654-fba3-e90e-e063-6394a90a1df42026-05-29WarningsExact identifier
application number: M005
RoyceDerm Tea Tree Oil Antifungal .spray.CLOTRIMAZOLE 1%RoyceDerm LLC52da8be4-467c-c011-e063-6294a90a166f2026-05-28WarningsExact identifier
application number: M005
Terramed Just Think Comfort Jock Itch Antifungal TreatmentMICONAZOLE NITRATERida LLC2acb9027-8f20-4b77-9b45-17fe11622c7c2026-05-27WarningsExact identifier
application number: M005
Quali Life ANTIFUNGAL TEA TREETOLNAFTATEGuangdong Aimu Biological Technology Co., Ltd52b3b0df-3f62-f9bc-e063-6394a90a52b32026-05-26WarningsExact identifier
application number: M005
ANTIFUNGAL PENUNDECYLENIC ACIDGuangzhou Mizi Biotechnology Co., Ltd.52b51877-e04c-569e-e063-6394a90a2fc92026-05-26WarningsExact identifier
application number: M005
NAIL EXTRA STRENGTH REPAIR PENUNDECYLENIC ACIDGuangzhou Mizi Biotechnology Co., Ltd.52b6208d-53e4-eaa0-e063-6394a90abe7a2026-05-26WarningsExact identifier
application number: M005
Toenail Fungus Pen PreventativeUNDECYLENIC ACIDGuangzhou Mizi Biotechnology Co., Ltd.52b6766f-948b-2602-e063-6294a90a03cf2026-05-26WarningsExact identifier
application number: M005
KDMANTOLNAFTATEDongguan Youmi Trading Co., Ltd52a4e836-2059-a49f-e063-6394a90a65562026-05-25WarningsExact identifier
application number: M005
PUTRIZENUNDECYLENIC ACID, TOLNAFTATEGuangzhou Lianbiquan Biological Technology co., Ltd52a58f24-2a11-4d34-e063-6394a90a29242026-05-25WarningsExact identifier
application number: M005
Eye CareSprayEYELID CLEANSING SPRAYShenzhen Shierjie Biological Engineering Co., LTD52aef5dd-ff33-cace-e063-6294a90a415a2026-05-25WarningsExact identifier
application number: M005
Saviland PRO Extra Strength Toenail Renewal PatchesTOLNAFTATEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD5250003a-8d3a-818b-e063-6294a90aa6592026-05-21WarningsExact identifier
application number: M005
Saviland SSPro X Series Extra Strength Toenail Renewal PatchesTOLNAFTATEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD52506297-44d7-b2a7-e063-6394a90a0a3c2026-05-21WarningsExact identifier
application number: M005
SSPROTIP X Extra Strength Nail Renewal PatchesTOLNAFTATEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD52512e7e-5e28-4383-e063-6294a90a448a2026-05-21WarningsExact identifier
application number: M005
Vrenmol Extra Strength Nail Renewal PatchesTOLNAFTATEGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD52516861-e386-d0cb-e063-6394a90a17d02026-05-21WarningsExact identifier
application number: M005
SSPROTIP X Extra Strength Toenail Renewal SolutionTOLNAFTATE,UNDECYLENIC ACIDGUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD52519110-a3c9-21da-e063-6294a90abbce2026-05-21WarningsExact identifier
application number: M005
Fungal Nail Repair PenUNDECYLENIC ACIDYunqi Cosmetics (Shenzhen) Co., Ltd523c32f7-b803-bf79-e063-6394a90aad5a2026-05-20WarningsExact 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