Tolnaftate

Product NDC
72446-011
11-digit product format
724460011
Labeler code
72446
Product ID
72446-011_c2d7f6f5-f84e-fea4-e053-2a95a90aa513
Type
HUMAN OTC DRUG
Nonproprietary name
Anti-Fungal Liquid Maximum Strength
Dosage form
LIQUID
Route
TOPICAL
Labeler
Hudson Health LLC
Application
part333C
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2021-05-21
Marketing end
0000-00-00
Substance
TOLNAFTATE
Active strength
0 g/30mL
NDC exclude flag
No
Listing certified through
2022-12-31
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 productproduct72446-011DDiscontinued by firm2026-08-11
excluded packagepackage72446-01172446-011-01DDiscontinued by firm2026-08-11

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 · 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 packagepackage72446-011-01d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage72446-011-01f5e01cc5f278…a2eaf40c39c3…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72446-011-012023-01-31C16284748780-1f386c649-c4f7-0266-e053-dadaa90a7c1aComfortzone Antifungal Tolnaftate Liquid Solution

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72446-011TOLNAFTATE (ANTI-FUNGAL LIQUID MAXIMUM STRENGTH) LIQUID [HUDSON HEALTH LLC]5Legacy NDC20241017_c2d86409-6f98-442b-e053-2a95a90af2d3.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72446-011-017244600110130 mL in 1 BOTTLE, WITH APPLICATOR (72446-011-01) 30 ml2021-05-210000-00-00NoNoCurrent