Tolnaftate

Product NDC
37808-521
11-digit product format
378080521
Labeler code
37808
Product ID
37808-521_c7927383-e9f0-6b0e-e053-2a95a90a28df
Type
HUMAN OTC DRUG
Nonproprietary name
Antifungal Continuous Liquid Spray
Dosage form
AEROSOL, SPRAY
Route
TOPICAL
Labeler
HEB
Application
part333C
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2017-12-22
Marketing end
0000-00-00
Substance
TOLNAFTATE
Active strength
2 g/150g
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 productproduct37808-521DDiscontinued by firm2026-10-05
excluded packagepackage37808-52137808-521-53DDiscontinued by firm2026-10-05

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 · 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 packagepackage37808-521-53d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage37808-521-53f5e01cc5f278…a2eaf40c39c3…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-521TOLNAFTATE (ANTIFUNGAL CONTINUOUS LIQUID SPRAY) AEROSOL, SPRAY [HEB]6Legacy NDC20241212_169391cb-298c-428b-b1c4-1139bc24a46a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-521-5337808052153150 g in 1 CAN (37808-521-53) 150 g2017-12-220000-00-00NoNoCurrent