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#

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 41 of 49 · 969 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Forticept Antifungal Foot GelCLOTRIMAZOLELidan, Inc.1b5851fc-ae73-4e54-bb62-3ff928628b972025-03-25WarningsExact identifier
application number: M005
MICONAZOLE Nitrate 2% Cream ANTIFUNGALMICONAZOLE NITRATEPreferred Pharmaceuticals Inc.14d2a661-a490-41ca-b84f-f2be3bc271b42025-03-24WarningsExact identifier
application number: M005
Dermatin AntifungalCLOTRIMAZOLEMelaleuca, Inc.e993fa3b-1d85-46b7-bda5-ed875be74c4e2025-03-20WarningsExact identifier
application number: M005
1% ketoconazoleKETOCONAZOLETAGRID LLC30b75584-3a1e-c125-e063-6294a90acaa72025-03-19WarningsExact identifier
application number: M005
Forticept Antifungal Foot CreamCLOTRIMAZOLELidan, Inc.17abeb4d-b211-4b8c-a9d2-4c7baba2450c2025-03-07WarningsExact identifier
application number: M005
Terramed Just Think Comfort Antifungal Medicated Body WipesTOLNAFTATERida LLC34577389-8e5d-49ab-a208-9c87b6f3cec42025-03-06WarningsExact identifier
application number: M005
Athletes FootMICONAZOLE NITRATERida LLC85e98ef8-75c3-4be1-b59f-40b5312e21372025-03-06WarningsExact identifier
application number: M005
SOUTH BEACH MULTI-PURPOSE NAIL REPAIRUNDECYLENIC ACIDSOUTH BEACH HAIR CARE PROFESIONAL INC2fb0110c-b275-2a17-e063-6394a90a2d302025-03-06WarningsExact identifier
application number: M005
DG Health Athletes FootCLOTRIMAZOLEDolgencorp, Inc.20370b32-21ad-4362-9b46-c6149c9072312025-02-28WarningsExact identifier
application number: M005
Family Wellness Clotrimazole 1 Anti Fungal CreamCLOTRIMAZOLEFamily Dollar Stores, Inc0667dd81-5633-494e-857e-45fa276fe72c2025-02-25WarningsExact identifier
application number: M005
Family Wellness Athletes Foot Tolnaftate 1 CreamTOLNAFTATEFamily Dollar Stores, Incf72b5bcd-8834-4da9-aa74-78992ec2838f2025-02-25WarningsExact identifier
application number: M005
ANTIFUNGAL MEDICATED BODY WASHTOLNAFTATERida LLCe3ebce6f-88ca-4100-ac79-d300f44e48912025-02-25WarningsExact identifier
application number: M005
FUNGINIX AFTOLNAFTATEThe Sisquoc Healthcare Corporationf6cf5315-6678-486c-85b2-d4b3f748600e2025-02-25WarningsExact identifier
application number: M005
FUNGINIX JOCK ITCH TREATMENTTOLNAFTATEThe Sisquoc Healthcare Corporationb2ce1c25-93d5-441f-9b3b-68ae46400c2c2025-02-25WarningsExact identifier
application number: M005
Miconazole NitrateMICONAZOLE NITRATEA-S Medication Solutionsbf131f33-3ab2-4f43-add5-920e78ac36a72025-02-24WarningsExact identifier
application number: M005
ClotrimazoleCLOTRIMAZOLEPreferred Pharmaceuticals Inc.0052992a-819c-4c55-bd88-201a09a3573a2025-02-21WarningsExact identifier
application number: M005
TolnaftateTOLNAFTATESheffield Pharmaceuticals LLCca52af37-c3a2-414c-a24a-a37a929251332025-02-20WarningsExact identifier
application number: M005
Dr Sheffield Athletes FootCLOTRIMAZOLESheffield Pharmaceuticals LLCb8b8e6b2-1022-4592-91ba-3cf94c7cf3182025-02-19WarningsExact identifier
application number: M005
UKVOA Toenail Fungus TreatmentTOLNAFTATE 1% FUNGI NAILJiashen International Trade Limited2e3cde7b-850e-f9d2-e063-6394a90adb182025-02-16WarningsExact identifier
application number: M005
UKOVA FOOT ODOR PROBIOTICTOLNAFTATE 1% FUNGI NAILJiashen International Trade Limited2de0225d-dd85-e2da-e063-6294a90a050b2025-02-11WarningsExact 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