FDA.reportPublic FDA data

Tolnafate

Product NDC
63868-181
11-digit product format
638680181
Labeler code
63868
Product ID
63868-181_c790a30b-025f-3cda-e053-2995a90a0a0f
Type
HUMAN OTC DRUG
Nonproprietary name
Tolnaftate Powder Spray
Dosage form
AEROSOL, SPRAY
Route
TOPICAL
Labeler
Chain Drug Marketing Association
Application
part333C
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2017-12-19
Marketing end
0000-00-00
Substance
TOLNAFTATE
Active strength
1 g/130g
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

Additional Listing Data#

Finished product
Yes
Brand name base
Tolnafate

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLNAFTATE1.3 g/130g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
06KB629TKVInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
705934Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1bd8e096-1717-4656-b52c-086d2f56f070Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-181-46Tolnafate130 g in 1 CANAEROSOL, SPRAY1306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-181TOLNAFATE (TOLNAFTATE POWDER SPRAY) AEROSOL, SPRAY [CHAIN DRUG MARKETING ASSOCIATION]6Legacy NDC, 1 package rows20241213_1bd8e096-1717-4656-b52c-086d2f56f070.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TolnafateTOLNAFTATE POWDER SPRAYChain Drug Marketing Association1bd8e096-1717-4656-b52c-086d2f56f0702026-06-09WarningsExact identifier
ndc (product): 63868-181

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
705934tolnaftate 1 % Powder SprayPSN1bd8e096-1717-4656-b52c-086d2f56f0706
705934tolnaftate 0.01 MG/MG Powder SpraySCD1bd8e096-1717-4656-b52c-086d2f56f0706
705934tolnaftate 1 % Powder SpraySY1bd8e096-1717-4656-b52c-086d2f56f0706

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63868-181-4663868018146130 g in 1 CAN (63868-181-46) 130 g2017-12-190000-00-00NoNoCurrent