Flexitol Anti Fungal

Product NDC
43251-3351
11-digit product format
432513351
Labeler code
43251
Product ID
43251-3351_7a47e254-5846-47c7-8a7e-aad2484846ff
Type
HUMAN OTC DRUG
Nonproprietary name
Undecylenic acid
Dosage form
LIQUID
Route
TOPICAL
Labeler
LaCorium Health International Pty Ltd
Application
part333C
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2009-01-03
Marketing end
0000-00-00
Substance
UNDECYLENIC ACID
Active strength
250 mg/mL
NDC exclude flag
E
Listing certified through
2017-12-31
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 productproduct43251-3351IInactivated by FDA2026-08-11
excluded packagepackage43251-335143251-3351-1IInactivated by FDA2026-08-11

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 · 44 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 packagepackage43251-3351-1d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage43251-3351-1f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage43251-3351-12ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage43251-3351-1a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage43251-3351-1cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage43251-3351-1cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage43251-3351-1302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage43251-3351-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage43251-3351-10efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage43251-3351-1ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage43251-3351-1367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage43251-3351-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage43251-3351-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage43251-3351-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage43251-3351-11332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage43251-3351-1fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage43251-3351-186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage43251-3351-1bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage43251-3351-18dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage43251-3351-1e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage43251-3351-19bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage43251-3351-1110d247fa046…a55b01930146…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43251-3351-12019-11-27C16284748780-19855d018-ddc6-cd31-e053-dbdaa90ab51aFlexitol ® Anti-Fungal Liquid

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43251-3351-1Flexitol Anti Fungal1 in 1 CARTONLIQUID13
43251-3351-1Flexitol Anti Fungal30 mL in 1 BOTTLELIQUID303

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Undecylenic acidACTIVE INGREDIENTK3D86KJ24NFLEXITOL ANTI FUNGAL (UNDECYLENIC ACID) LIQUID [LACORIUM HEALTH INTERNATIONAL PTY LTD]3
Undecylenic acidACTIVE MOIETYK3D86KJ24NFLEXITOL ANTI FUNGAL (UNDECYLENIC ACID) LIQUID [LACORIUM HEALTH INTERNATIONAL PTY LTD]3
.Alpha.-Tocopherol Acetate, DL-INACTIVE INGREDIENTWR1WPI7EW8FLEXITOL ANTI FUNGAL (UNDECYLENIC ACID) LIQUID [LACORIUM HEALTH INTERNATIONAL PTY LTD]3
Aloe Vera LeafINACTIVE INGREDIENTZY81Z83H0XFLEXITOL ANTI FUNGAL (UNDECYLENIC ACID) LIQUID [LACORIUM HEALTH INTERNATIONAL PTY LTD]3
Butylated HydroxytolueneINACTIVE INGREDIENT1P9D0Z171KFLEXITOL ANTI FUNGAL (UNDECYLENIC ACID) LIQUID [LACORIUM HEALTH INTERNATIONAL PTY LTD]3
Eucalyptus OilINACTIVE INGREDIENT2R04ONI662FLEXITOL ANTI FUNGAL (UNDECYLENIC ACID) LIQUID [LACORIUM HEALTH INTERNATIONAL PTY LTD]3
Hypromellose 2906 (4000 MPA.S)INACTIVE INGREDIENT5EYA69XGATFLEXITOL ANTI FUNGAL (UNDECYLENIC ACID) LIQUID [LACORIUM HEALTH INTERNATIONAL PTY LTD]3
Isopropyl AlcoholINACTIVE INGREDIENTND2M416302FLEXITOL ANTI FUNGAL (UNDECYLENIC ACID) LIQUID [LACORIUM HEALTH INTERNATIONAL PTY LTD]3
Tea Tree OilINACTIVE INGREDIENTVIF565UC2GFLEXITOL ANTI FUNGAL (UNDECYLENIC ACID) LIQUID [LACORIUM HEALTH INTERNATIONAL PTY LTD]3
UreaINACTIVE INGREDIENT8W8T17847WFLEXITOL ANTI FUNGAL (UNDECYLENIC ACID) LIQUID [LACORIUM HEALTH INTERNATIONAL PTY LTD]3
WaterINACTIVE INGREDIENT059QF0KO0RFLEXITOL ANTI FUNGAL (UNDECYLENIC ACID) LIQUID [LACORIUM HEALTH INTERNATIONAL PTY LTD]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43251-3351FLEXITOL ANTI FUNGAL (UNDECYLENIC ACID) LIQUID [LACORIUM HEALTH INTERNATIONAL PTY LTD]3Legacy NDC, 2 package rows20121222_39f54d88-4e35-4f26-a988-42807d7e010e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
998329undecylenic acid 25 % Topical SolutionPSN39f54d88-4e35-4f26-a988-42807d7e010e3
998329undecylenic acid 250 MG/ML Topical SolutionSCD39f54d88-4e35-4f26-a988-42807d7e010e3
998329undecylenic acid 25 % Topical SolutionSY39f54d88-4e35-4f26-a988-42807d7e010e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
43251-3351-1432513351011 in 1 CARTONHistorical