FDA.reportPublic FDA data

CAREALL Tolnaftate

Product NDC
51824-001
11-digit product format
518240001
Labeler code
51824
Product ID
51824-001_44ec1209-557e-ac0f-e063-6394a90a4274
Type
HUMAN OTC DRUG
Nonproprietary name
Tolnaftate
Dosage form
CREAM
Route
TOPICAL
Labeler
New World Imports, Inc
Application
M005
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-06-01
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
CAREALL Tolnaftate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TOLNAFTATE10 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii06KB629TKV
Rxcui103951

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51824-001-01CAREALL Tolnaftate28 g in 1 TUBECREAM2814
51824-001-05CAREALL Tolnaftate14 g in 1 TUBECREAM1414

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51824-001-01GM - Gram51824-001f647e118-dc13-4ba8-a36f-7a6c807c5bce12020-03-10
51824-001-05GM - Gram51824-00105105d17-2bba-49de-b472-eed92cad36c512020-03-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TolnaftateACTIVE INGREDIENT06KB629TKVCAREALL TOLNAFTATE (TOLNAFTATE) CREAM [NEW WORLD IMPORTS, INC]6
TolnaftateACTIVE MOIETY06KB629TKVCAREALL TOLNAFTATE (TOLNAFTATE) CREAM [NEW WORLD IMPORTS, INC]6
Ceteth-20INACTIVE INGREDIENTI835H2IHHXCAREALL TOLNAFTATE (TOLNAFTATE) CREAM [NEW WORLD IMPORTS, INC]6
Cetyl AlcoholINACTIVE INGREDIENT936JST6JCNCAREALL TOLNAFTATE (TOLNAFTATE) CREAM [NEW WORLD IMPORTS, INC]6
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TCAREALL TOLNAFTATE (TOLNAFTATE) CREAM [NEW WORLD IMPORTS, INC]6
Mineral OilINACTIVE INGREDIENTT5L8T28FGPCAREALL TOLNAFTATE (TOLNAFTATE) CREAM [NEW WORLD IMPORTS, INC]6
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3CAREALL TOLNAFTATE (TOLNAFTATE) CREAM [NEW WORLD IMPORTS, INC]6
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHCAREALL TOLNAFTATE (TOLNAFTATE) CREAM [NEW WORLD IMPORTS, INC]6
Sorbitan MonostearateINACTIVE INGREDIENTNVZ4I0H58XCAREALL TOLNAFTATE (TOLNAFTATE) CREAM [NEW WORLD IMPORTS, INC]6
Stearyl AlcoholINACTIVE INGREDIENT2KR89I4H1YCAREALL TOLNAFTATE (TOLNAFTATE) CREAM [NEW WORLD IMPORTS, INC]6
WaterINACTIVE INGREDIENT059QF0KO0RCAREALL TOLNAFTATE (TOLNAFTATE) CREAM [NEW WORLD IMPORTS, INC]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51824-001CAREALL TOLNAFTATE (TOLNAFTATE) CREAM [NEW WORLD IMPORTS, INC]13Current NDC, Legacy NDC, 2 package rows20240119_cabf84c1-1500-46fe-b226-b16d4a0666c7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
103951tolnaftate 1 % Topical CreamPSNcabf84c1-1500-46fe-b226-b16d4a0666c714
103951tolnaftate 10 MG/ML Topical CreamSCDcabf84c1-1500-46fe-b226-b16d4a0666c714
103951tolnaftate 1 % Topical CreamSYcabf84c1-1500-46fe-b226-b16d4a0666c714

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51824-001-015182400010128 g in 1 TUBE (51824-001-01) 28 g2018-06-150000-00-00NoNoCurrent
51824-001-055182400010514 g in 1 TUBE (51824-001-05) 14 g2012-06-010000-00-00NoNoCurrent