Antifungal Medicated Bar

Product NDC
85424-001
11-digit product format
854240001
Labeler code
85424
Product ID
85424-001_31305ed2-a0a1-6d4c-e063-6294a90a6ba5
Type
HUMAN OTC DRUG
Nonproprietary name
Tolnaftate
Dosage form
SOAP
Route
TOPICAL
Labeler
RoyceDerm LLC
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-04-20
Substance
TOLNAFTATE
Active strength
10 mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Antifungal Medicated Bar
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLNAFTATE10 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii06KB629TKV
Rxcui1807715

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85424-001-01Antifungal Medicated Bar232 g in 1 CARTONSOAP2321

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85424-001ANTIFUNGAL MEDICATED BAR (TOLNAFTATE) SOAP [ROYCEDERM LLC]1Current NDC, 1 package rows20250420_31305ed2-a0a0-6d4c-e063-6294a90a6ba5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1807715tolnaftate 1 % Medicated Bar SoapPSN31305ed2-a0a0-6d4c-e063-6294a90a6ba51
1807715tolnaftate 0.01 MG/MG Medicated Bar SoapSCD31305ed2-a0a0-6d4c-e063-6294a90a6ba51
1807715tolnaftate 1 % Medicated Bar SoapSY31305ed2-a0a0-6d4c-e063-6294a90a6ba51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85424-001-0185424000101232 g in 1 CARTON (85424-001-01) 232 g2025-04-20NoNoHistorical