FDA.reportPublic FDA data

AKIN ANTI-FUNGAL

Product NDC
69822-254
11-digit product format
698220254
Labeler code
69822
Product ID
69822-254_e452c7f3-d08c-15e0-e053-2a95a90afb10
Type
HUMAN OTC DRUG
Nonproprietary name
CLOTRIMAZOLE
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Southern Sales & Service, Inc.
Application
M005
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2017-01-01
Marketing end
0000-00-00
Substance
CLOTRIMAZOLE
Active strength
10 mg/mL
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct69822-254DDiscontinued by firm2026-10-15
excluded packagepackage69822-25469822-254-05DDiscontinued by firm2026-10-15

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
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage69822-254-0586f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage69822-254-05bd6a592717d7…303034d00443…

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
b64d2752-34ef-378a-1f4f-8bff32b0d1aeProduct name420250626
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9Product name220250121
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2022-07-22AKIN Anti-Fungal Treatment
2022-01-28AKIN Anti-Fungal Treatment
2020-02-11AKIN Anti-Fungal Treatment
2020-01-31AKIN Anti-Fungal Treatment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69822-254-05AKIN ANTI-FUNGAL15 mL in 1 BOTTLESOLUTION155
69822-254-05AKIN ANTI-FUNGAL1 in 1 CARTONSOLUTION15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69822-254AKIN ANTI-FUNGAL (CLOTRIMAZOLE) SOLUTION [SOUTHERN SALES & SERVICE, INC.]5Legacy NDC, 2 package rows20231201_7836127f-d472-4aac-9443-10f56d735d1f.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 29 of 49 · 973 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anti-Fungal PowderMICONAZOLE NITRATETopCo Associates19c3fbc5-abde-57df-e063-6394a90a125c2025-11-06WarningsExact identifier
application number: M005
TolnaftateFOOT ODOR CONTROL SPRAYTopco Associates LLC17993a9f-0d44-43a1-8608-94ee8a08b5392025-11-06WarningsExact identifier
application number: M005
DVO Estriol creamESTRIOL0.2%Guangzhou Huixue Biotechnology Co., Ltd.42e4cc84-7c00-6937-e063-6294a90a0c092025-11-05WarningsExact identifier
application number: M005
MedlineMICONAZOL NITRATEMedline Industries, LPdad58efb-cc20-577a-e053-2a95a90abd9d2025-11-03WarningsExact identifier
application number: M005
TolnafateTOLNAFTATE POWDER SPRAYHEBc6af941a-0b85-4611-a6f3-b13fcf3c4a872025-11-03WarningsExact identifier
application number: M005
TolnaftateFOOT ODOR CONTROL SPRAYHEBc585605b-ecb8-4dd8-9205-a9be02d751fa2025-11-03WarningsExact identifier
application number: M005
Premier Solutions Antifungal Tolnaftate LiquidTOLNAFTATEPremier Brands of America, Inc.e1971c1c-5687-577b-e053-2a95a90ad95f2025-11-03WarningsExact identifier
application number: M005
Miconazole nitrateANTIFUNGAL MICONAZOLE LIQUID CONTINUOUS SPRAYPremier Brands of America Inc.3803c643-35d1-06d4-e063-6294a90ac6f62025-11-03WarningsExact identifier
application number: M005
Anti-fungal Powder Miconazole NitrateMICONAZOLE NITRATEMeijer Distribution Inc03fd069d-685d-b8ac-e063-6394a90a31f82025-10-31WarningsExact identifier
application number: M005
TolnaftateANTIFUNGAL LIQUID SPRAYPremier Brands of America Inc.7a6a63cd-e87d-4229-8acf-b65d63909eb62025-10-31WarningsExact identifier
application number: M005
AzolenMICONAZOLE NITRATEStratus Pharmaceuticals, Inc.9c2574f3-3be4-405a-9c87-943dc6ef87772025-10-30WarningsExact identifier
application number: M005
Family Care AntifungalCLOTRIMAZOLEUnited Exchange Corp.63255079-ecf1-1e77-e053-2a91aa0a7b6c2025-10-30WarningsExact identifier
application number: M005
Miconazorb AFMICONAZOLE NITRATEAmerisourceBergen Drug Corporation13a20d21-42d5-fe56-e063-6394a90aaf572025-10-30WarningsExact identifier
application number: M005
Antifungal Liquid ContinuousMICONAZOLE NITRATEFamily Dollar Services, Inc17cc4601-f946-df8b-e063-6394a90a38972025-10-30WarningsExact identifier
application number: M005
TolnaftateANTIFUNGAL LIQUID SPRAYARMY & AIR FORCE EXCHANGE SERVICE932b1be8-3dbb-49ae-822a-c44a24fbe36a2025-10-30WarningsExact identifier
application number: M005
Miconazole nitrateANTIFUNGAL MICONAZOLE LIQUID CONTINUOUS SPRAYGEISS, DESTIN AND DUNN, INC.c367c2e8-5423-bf01-e053-2a95a90ab8e92025-10-30WarningsExact identifier
application number: M005
Miconazole NitrateJOCK ITCH SPRAYHarris Teeter, LLC636b0d6f-4e36-4c96-9e71-7bfdebb7f3cb2025-10-30WarningsExact identifier
application number: M005
TolnaftateANTIFUNGAL LIQUID SPRAYHarris Teeter, LLCf140e9bb-507b-4048-8b7b-8cc51b6a497d2025-10-30WarningsExact identifier
application number: M005
HEB Athlete Foot AntifungalMICONAZOLE NITRATEHEB2e204111-b5d3-0220-e063-6294a90a67bb2025-10-30WarningsExact identifier
application number: M005
TolnaftateANTIFUNGAL SPRAY LIQUIDKroger Co.0cfebac3-684d-4599-b75f-9a82708db7172025-10-30WarningsExact identifier
application number: M005

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309370clotrimazole 1 % Topical SolutionPSN7836127f-d472-4aac-9443-10f56d735d1f5
309370clotrimazole 10 MG/ML Topical SolutionSCD7836127f-d472-4aac-9443-10f56d735d1f5
309370clotrimazole 1 % Topical SolutionSY7836127f-d472-4aac-9443-10f56d735d1f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69822-254-05698220254051 BOTTLE in 1 CARTON (69822-254-05) > 15 mL in 1 BOTTLE1 bottle2017-01-010000-00-00NoNoCurrent