Formula 3

Product NDC
49406-003
11-digit product format
494060003
Labeler code
49406
Product ID
49406-003_3ca9d5fc-af08-41f8-e063-6394a90aaaef
Type
HUMAN OTC DRUG
Nonproprietary name
TOLNAFTATE
Dosage form
SOLUTION
Route
TOPICAL
Labeler
The Tetra Corporation
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-10-30
Substance
TOLNAFTATE
Active strength
10 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Formula 3
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLNAFTATE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii06KB629TKV
Rxcui313423

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
49406-003-152025-08-18C16284748780-12cef2736-b4bf-d83d-e063-dadaa90ab31f0895274b-a09d-4264-a43f-852e44eb3163
49406-003-152025-01-30C16284748780-12cef2736-b4bf-d83d-e063-dadaa90ab31f0895274b-a09d-4264-a43f-852e44eb3163

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49406-003-15Formula 31 in 1 BOXSOLUTION122
49406-003-15Formula 315 mL in 1 BOTTLESOLUTION1522

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49406-003-15ML - Milliliter49406-00361ba9617-b5f8-4f1f-9d2e-32b3fe2d2d9612016-04-04

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49406-003FORMULA 3 (TOLNAFTATE) SOLUTION [THE TETRA CORPORATION]19Current NDC, Legacy NDC, 2 package rows20231013_0895274b-a09d-4264-a43f-852e44eb3163.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313423tolnaftate 1 % Topical SolutionPSN0895274b-a09d-4264-a43f-852e44eb316322
313423tolnaftate 10 MG/ML Topical SolutionSCD0895274b-a09d-4264-a43f-852e44eb316322
313423tolnaftate 1 % Topical SolutionSY0895274b-a09d-4264-a43f-852e44eb316322

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49406-003-15494060003151 BOTTLE in 1 BOX (49406-003-15) / 15 mL in 1 BOTTLE1 bottle2012-10-300000-00-00NoNoCurrent