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

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 Identifiers#

Field, Values table
FieldValues
Unii06KB629TKV
Rxcui313422

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, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11523-0011-12026-01-16C16284748780-13b156c62-2912-fb37-e063-e6dba90a4e07Lotrimin Daily Prevention Powder UI 1612510
11523-0011-22026-01-16C16284748780-13b156c62-2912-fb37-e063-e6dba90a4e07Lotrimin Daily Prevention Powder UI 1612510
11523-0011-12025-07-29C16284748780-13b156c62-2912-fb37-e063-e6dba90a4e07Lotrimin Daily Prevention Powder UI 1612510
11523-0011-22025-07-29C16284748780-13b156c62-2912-fb37-e063-e6dba90a4e07Lotrimin 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

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