Lotrimin

Product NDC
11523-0150
11-digit product format
115230150
Labeler code
11523
Product ID
11523-0150_48850e7a-a19c-ce92-e063-6394a90afaaf
Type
HUMAN OTC DRUG
Nonproprietary name
Miconazole nitrate
Dosage form
POWDER
Route
TOPICAL
Labeler
Bayer HealthCare LLC.
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-11-06
Substance
MICONAZOLE NITRATE
Active strength
20 mg/g
Pharmacologic classes
Azole Antifungal [EPC], Azoles [CS]
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 · 4 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 packagepackage11523-0150-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage11523-0150-1f5e01cc5f278…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
Brand name suffix
AF Jock Itch
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MICONAZOLE NITRATE20 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
VW4H1CYW1KInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
998461Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1300d84f-d7ff-ec57-e063-6294a90ae0deAvailable 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
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11523-0150-12026-01-16C16284748780-13b156c62-2d29-fb37-e063-e6dba90a4e07Lotrimin ® AF Jock Itch Powder
11523-0150-12025-07-29C16284748780-13b156c62-2d29-fb37-e063-e6dba90a4e07Lotrimin ® AF Jock Itch Powder

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-0150-1LotriminAF Jock Itch177 g in 1 CANPOWDER1772

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11523-0150LOTRIMIN AF JOCK ITCH (MICONAZOLE NITRATE) POWDER [BAYER HEALTHCARE LLC.]1Current NDC, 1 package rows20240329_1300d84f-d7ff-ec57-e063-6294a90ae0de.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 40 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ELLEN HAND SANITIZER2ETHYL ALCOHOLPT. SUPER HOME PRODUCT INDONESIA334574b6-6d4a-bd37-e063-6394a90a67d62025-04-21WarningsExact identifier
application number: M005
MICONAZOLE Nitrate 2% Cream ANTIFUNGALMICONAZOLE NITRATEGERI-GENTLE CORPORATIONe6734616-c16b-430c-e053-2a95a90a18f82025-04-21WarningsExact identifier
application number: M005
Clotrimazole 1% Athletes FootCLOTRIMAZOLEGERI-GENTLE CORPORATIONe673748f-d00b-4ce8-e053-2995a90a92202025-04-21WarningsExact identifier
application number: M005
PHYTOZINE RINGWORM TREATMENT MAXIMUM STRENGTHTOLNAFTATEThe Sisquoc Healthcare Corporation5dff6ee7-f7a9-4841-8357-6b0801d253f12025-04-21WarningsExact identifier
application number: M005
HAND SANITIZERALCOHOLNINGBO TIANBO FIRST AID PRODUCT CO., LTD.88a14b15-09d6-45de-97b6-cddce7ca420b2025-04-19WarningsExact identifier
application number: M005
ELLEN HAND SANITIZERETHYL ALCOHOLPT. SUPER HOME PRODUCT INDONESIA33077eab-e686-249d-e063-6394a90a1b6d2025-04-18WarningsExact identifier
application number: M005
MEDI-FIRST First Aid AntisepticBENZALKONIUM CHLORIDEUltra Distributors Incb6efaca5-49d0-b000-e053-2995a90ab9aa2025-04-07WarningsExact identifier
application number: M005
ANTIBACTERIAL HAND SANITIZERETHYL ALCOHOLASC Marketing Ltd.b42ebe64-0cad-2d26-e053-2a95a90af3dd2025-04-07WarningsExact identifier
application number: M005
Anti-Bacterial HAND SANITIZERETHYL ALCOHOLDISNEY DESTINATIONS,LLCae739bda-edf3-634b-e053-2a95a90a73852025-04-07WarningsExact identifier
application number: M005
Hand SanitizerETHYL ALCOHOLOrazen Incaa846bb7-a64b-3358-e053-2995a90a9d092025-04-07WarningsExact identifier
application number: M005
Hand SanitizerETHYL ALCOHOLOrazen Inc9ae42862-f730-9d67-e053-2a95a90af9552025-04-07WarningsExact identifier
application number: M005
Hand SanitizerETHYL ALCOHOLOrazen Inc7e8f4517-c996-8797-e053-2991aa0a4f582025-04-07WarningsExact identifier
application number: M005
Hand SanitizerETHYL ALCOHOLRaining Rose, Inc.43ab2651-6e0a-3d48-e054-00144ff88e882025-04-07WarningsExact identifier
application number: M005
Folliculitis Treatment CreamMICONAZOLE NITRATETAGRID LLC32396be0-f74a-5483-e063-6294a90ab3ae2025-04-07WarningsExact identifier
application number: M005
Antifungal Treatment Liquid 25 undeclylenic AcidUNDECYLENIC ACIDSANSAR, LLC2ae0f300-154e-44c8-bcc3-b5c334e661ac2025-04-02WarningsExact identifier
application number: M005
BBlove ALCOHOL WIPESBBLOVE ALCOHOL WIPESShenzhen Shierjie Biological Engineering Co., LTD3126955d-8fd1-04f8-e063-6294a90a886f2025-03-31WarningsExact identifier
application number: M005
Tagrid Jock Itch Miconazole Nitrate 2%MICONAZOLE NITRATETAGRID LLC31abdc68-5027-15e7-e063-6394a90ac4e62025-03-31WarningsExact identifier
application number: M005
Tea Tree Oil Foot Soak and Body SoakZINC UNDECYLENATESANSAR, LLCc43816ac-2228-43ce-ba45-80cf3a7788f22025-03-28WarningsExact identifier
application number: M005
health beyond HAND SANITIZERALCOHOLNantong Health & Beyond Hygienic Products Inc.e5746be7-e9dc-42a6-a3d0-b386427caec52025-03-27WarningsExact identifier
application number: M005
Tagrit Antifungal Treament Ketoconazole 1%KETOCONAZOLETAGRID LLC315a8832-c42f-c07a-e063-6394a90a82182025-03-27WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998461miconazole nitrate 2 % Topical PowderPSN1300d84f-d7ff-ec57-e063-6294a90ae0de2
998461miconazole nitrate 0.02 MG/MG Topical PowderSCD1300d84f-d7ff-ec57-e063-6294a90ae0de2
998461miconazole nitrate 2 % Topical PowderSY1300d84f-d7ff-ec57-e063-6294a90ae0de2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
11523-0150-111523015001177 g in 1 CAN (11523-0150-1) 177 g2023-11-06NoNoCurrent