FDA.reportPublic FDA data

Lotrimin

Product NDC
11523-0136
11-digit product format
115230136
Labeler code
11523
Product ID
11523-0136_4526e2eb-ee88-3ac4-e063-6394a90a133f
Type
HUMAN OTC DRUG
Nonproprietary name
Tolnaftate
Dosage form
AEROSOL, POWDER
Route
TOPICAL
Labeler
Bayer HealthCare LLC.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-03-01
Substance
TOLNAFTATE
Active strength
10 mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
Daily Prevent Deodorant
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
705934Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1bb961cd-b6e6-3aff-e063-6394a90a432eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-0136-1LotriminDaily Prevent Deodorant160 g in 1 CANAEROSOL, POWDER1602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11523-0136LOTRIMIN DAILY PREVENT DEODORANT (TOLNAFTATE) AEROSOL, POWDER [BAYER HEALTHCARE LLC.]1Current NDC, 1 package rows20240629_1bb961cd-b6e6-3aff-e063-6394a90a432e.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 49 of 49 · 969 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Povidone Iodine ImpregnatedPOVIDONE IODINEJianerkang Medical Co., Ltd14f2a1dd-92c2-49e8-9fa0-a9d88e8c530d2023-10-23WarningsExact identifier
application number: M005
Povidone Iodine ImpregnatedPOVIDONE IODINEJianerkang Medical Co., Ltdb82cea56-b09f-411d-a6cf-c53b3ce0e3b62023-10-23WarningsExact identifier
application number: M005
Povidone Iodine ScrubPOVIDONE-IODINEJianerkang Medical Co., Ltd78131b57-1ffc-4eb8-821e-f7bb73300fe92023-10-23WarningsExact identifier
application number: M005
Povidone IodinePOVIDONE IODINEJianerkang Medical Co., Ltdeb30e5de-9074-4760-8e92-e1d1c127227d2023-10-23WarningsExact identifier
application number: M005
Povidone IodinePOVIDONE IODINEJianerkang Medical Co., Ltd0bd3de76-b726-41f1-87bc-14ab8a1eca8e2023-10-23WarningsExact identifier
application number: M005
Povidone Iodine Prep PadPOVIDONE-IODINEJianerkang Medical Co., Ltdbe85ec5b-eb49-4f1a-a87d-5c9705a20f232023-10-22WarningsExact identifier
application number: M005
EVERLIT CARE Hand SanitizerETHYL ALCOHOLNantong Health & Beyond Hygienic Products Inc.579c1ab5-50b4-4b5a-a189-c1e2827d0c3a2023-10-14WarningsExact identifier
application number: M005
Micomitin AntifungalCLOTRIMAZOLEPureTek Corporationdd05f5f9-2412-1295-e053-2995a90acb962022-02-14WarningsExact identifier
application number: M005
MicatinMICONAZOLE NITRATEWellSpring Pharmaceutical Corporation96c56ba1-c3a8-48ce-ab58-550959485e3c2016-04-07WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
705934tolnaftate 1 % Powder SprayPSN1bb961cd-b6e6-3aff-e063-6394a90a432e2
705934tolnaftate 0.01 MG/MG Powder SpraySCD1bb961cd-b6e6-3aff-e063-6394a90a432e2
705934tolnaftate 1 % Powder SpraySY1bb961cd-b6e6-3aff-e063-6394a90a432e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
11523-0136-111523013601160 g in 1 CAN (11523-0136-1) 160 g2024-03-01NoNoCurrent