Bengama Antifungal

Product NDC
69666-831
11-digit product format
696660831
Labeler code
69666
Product ID
69666-831_aa844ed9-e7b2-7eec-e053-2995a90a978b
Type
HUMAN OTC DRUG
Nonproprietary name
Tolnaftate
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Genuine Drugs
Application
part333C
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-04-20
Marketing end
0000-00-00
Substance
TOLNAFTATE
Active strength
1 mg/100mL
NDC exclude flag
No
Listing certified through
2021-12-31
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 productproduct69666-831IInactivated by FDA2026-10-05
excluded packagepackage69666-83169666-831-04IInactivated by FDA2026-10-05

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 · 20 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage69666-831-04IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage69666-831-04IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage69666-831-04IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage69666-831-04IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage69666-831-04IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage69666-831-04IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage69666-831-04UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage69666-831-04UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage69666-831-04UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage69666-831-04IInactivated by FDA9bebd1f3094a…5416666fcb17…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69666-831-042025-01-30C16284748780-19d75b9d0-425b-f424-e053-dadaa90a57ceBengama Antifungal Solution
69666-831-042020-08-05C16284748780-19d75b9d0-425b-f424-e053-dadaa90a57ceBengama Antifungal Solution
69666-831-042020-01-31C16284748780-19d75b9d0-425b-f424-e053-dadaa90a57ceBengama Antifungal Solution

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69666-831-04Bengama Antifungal118 mL in 1 BOTTLESOLUTION1184
69666-831-04Bengama Antifungal1 in 1 BOXSOLUTION14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOLNAFTATEACTIVE INGREDIENT06KB629TKVBENGAMA ANTIFUNGAL (TOLNAFTATE) SOLUTION [GENUINE DRUGS]1
TOLNAFTATEACTIVE MOIETY06KB629TKVBENGAMA ANTIFUNGAL (TOLNAFTATE) SOLUTION [GENUINE DRUGS]1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KBENGAMA ANTIFUNGAL (TOLNAFTATE) SOLUTION [GENUINE DRUGS]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ABENGAMA ANTIFUNGAL (TOLNAFTATE) SOLUTION [GENUINE DRUGS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69666-831BENGAMA ANTIFUNGAL (TOLNAFTATE) SOLUTION [GENUINE DRUGS]4Legacy NDC, 2 package rows20230219_1432381d-4f2b-4e76-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313423tolnaftate 1 % Topical SolutionPSN1432381d-4f2b-4e76-e054-00144ff8d46c4
313423tolnaftate 10 MG/ML Topical SolutionSCD1432381d-4f2b-4e76-e054-00144ff8d46c4
313423tolnaftate 1 % Topical SolutionSY1432381d-4f2b-4e76-e054-00144ff8d46c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69666-831-04696660831041 BOTTLE in 1 BOX (69666-831-04) > 118 mL in 1 BOTTLE1 bottle2015-04-200000-00-00NoNoCurrent