FDA.reportPublic FDA data

Tolnaftate

Product NDC
50090-0160
Requested package NDC
50090-0160-0
11-digit product format
500900160
Labeler code
50090
Product ID
50090-0160_a4e10c96-1b23-4d39-ace9-c265ccedc340
Type
HUMAN OTC DRUG
Nonproprietary name
TOLNAFTATE
Dosage form
CREAM
Route
TOPICAL
Labeler
A-S Medication Solutions
Application
part333C
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2010-02-11
Marketing end
0000-00-00
Substance
TOLNAFTATE
Active strength
10 mg/g
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50090-016050090-0160-0DDiscontinued 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 · 11 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…

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
50090-0160-02023-02-07C16284748780-1f386c649-f3aa-0266-e053-dadaa90a7c1a98d95cd0-e7f6-4354-8374-ea5555e5acaa
50090-0160-02023-01-30C16284748780-1f386c649-f3aa-0266-e053-dadaa90a7c1a98d95cd0-e7f6-4354-8374-ea5555e5acaa

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0160-0GM - Gram50090-01607a3531f3-2fee-45ee-96da-19e2def8c31012018-08-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TOLNAFTATEACTIVE INGREDIENT06KB629TKVTOLNAFTATE CREAM [A-S MEDICATION SOLUTIONS LLC]1
TOLNAFTATEACTIVE MOIETY06KB629TKVTOLNAFTATE CREAM [A-S MEDICATION SOLUTIONS LLC]1
CETETH-20INACTIVE INGREDIENTI835H2IHHXTOLNAFTATE CREAM [A-S MEDICATION SOLUTIONS LLC]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1STOLNAFTATE CREAM [A-S MEDICATION SOLUTIONS LLC]1
CHLOROCRESOLINACTIVE INGREDIENT36W53O7109TOLNAFTATE CREAM [A-S MEDICATION SOLUTIONS LLC]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPTOLNAFTATE CREAM [A-S MEDICATION SOLUTIONS LLC]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UTOLNAFTATE CREAM [A-S MEDICATION SOLUTIONS LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TOLNAFTATE CREAM [A-S MEDICATION SOLUTIONS LLC]1
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUSINACTIVE INGREDIENTKH7I04HPUUTOLNAFTATE CREAM [A-S MEDICATION SOLUTIONS LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RTOLNAFTATE CREAM [A-S MEDICATION SOLUTIONS LLC]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0160-0500900160001 TUBE in 1 CARTON (50090-0160-0) > 14.18 g in 1 TUBE1 tube2014-11-280000-00-00NoNoCurrent