FDA.reportPublic FDA data

Lotrimin AF

Product NDC
11523-4327
Requested package NDC
11523-4327-1
11-digit product format
115234327
Labeler code
11523
Product ID
11523-4327_eb02e0b2-f23a-384c-e053-2a95a90a0cd1
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole nitrate
Dosage form
SPRAY
Route
TOPICAL
Labeler
Bayer Healthcare LLC.
Application
part333C
Marketing category
OTC MONOGRAPH FINAL
Marketing start
1993-09-01
Marketing end
0000-00-00
Substance
MICONAZOLE NITRATE
Active strength
20 mg/g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage11523-432711523-4327-1IInactivated by FDA2026-10-16

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 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage11523-432711523-4327-1IInactivated by FDAexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage11523-432711523-4327-1IInactivated by FDAexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11523-4327-12025-07-29C16284748780-13b156c62-2954-fb37-e063-e6dba90a4e07Lotrimin ® AF Antifungal Liquid

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-4327-1Lotrimin AFAntifungal133 g in 1 CANSPRAY1339

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
11523-4327-1GM - Gram11523-43275746ffda-6ca7-446e-a6b8-9105d7b39c1c12015-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Miconazole nitrateACTIVE INGREDIENTVW4H1CYW1KLOTRIMIN AF ANTIFUNGAL (MICONAZOLE NITRATE) SPRAY [MSD CONSUMER CARE, INC.]1
MiconazoleACTIVE MOIETY7NNO0D7S5MLOTRIMIN AF ANTIFUNGAL (MICONAZOLE NITRATE) SPRAY [MSD CONSUMER CARE, INC.]1
dimethyl etherINACTIVE INGREDIENTAM13FS69BXLOTRIMIN AF ANTIFUNGAL (MICONAZOLE NITRATE) SPRAY [MSD CONSUMER CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11523-4327LOTRIMIN AF ANTIFUNGAL (MICONAZOLE NITRATE) SPRAY [BAYER HEALTHCARE LLC.]9Legacy NDC, 1 package rows20241208_d6eb3b78-405b-43e5-9db5-da671465eda1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998533miconazole nitrate 2 % Topical SprayPSNd6eb3b78-405b-43e5-9db5-da671465eda19
998533miconazole nitrate 20 MG/ML Topical SpraySCDd6eb3b78-405b-43e5-9db5-da671465eda19
998533miconazole nitrate 2 % Topical SpraySYd6eb3b78-405b-43e5-9db5-da671465eda19
998533miconazole nitrate 3 GM in 150 GM Topical SpraySYd6eb3b78-405b-43e5-9db5-da671465eda19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11523-4327-111523432701133 g in 1 CAN (11523-4327-1) 133 g1993-09-010000-00-00NoNoCurrent