FDA.reportPublic FDA data

TopCare

Product NDC
36800-052
11-digit product format
368000052
Labeler code
36800
Product ID
36800-052_cbbdbcd1-b4ad-4e7c-a90e-f71d56cade04
Type
HUMAN OTC DRUG
Nonproprietary name
Tolnaftate
Dosage form
CREAM
Route
TOPICAL
Labeler
Topco Associates LLC
Application
part333C
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2006-02-17
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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
36800-052-602025-01-30C16284748780-12cef2736-b285-d83d-e063-dadaa90ab31fTopCare ® Tolnaftate Antifungal Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-052-60TopCare Tolnaftate Antifungal1 in 1 CARTONCREAM14
36800-052-60TopCare Tolnaftate Antifungal14.2 g in 1 TUBECREAM14.24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TolnaftateACTIVE INGREDIENT06KB629TKVTOPCARE TOLNAFTATE ANTIFUNGAL (TOLNAFTATE) CREAM [TOPCO ASSOCIATES LLC]1
TolnaftateACTIVE MOIETY06KB629TKVTOPCARE TOLNAFTATE ANTIFUNGAL (TOLNAFTATE) CREAM [TOPCO ASSOCIATES LLC]1
Butylated HydroxytolueneINACTIVE INGREDIENT1P9D0Z171KTOPCARE TOLNAFTATE ANTIFUNGAL (TOLNAFTATE) CREAM [TOPCO ASSOCIATES LLC]1
petrolatumINACTIVE INGREDIENT4T6H12BN9UTOPCARE TOLNAFTATE ANTIFUNGAL (TOLNAFTATE) CREAM [TOPCO ASSOCIATES LLC]1
Polyethylene glycol 3350INACTIVE INGREDIENTG2M7P15E5PTOPCARE TOLNAFTATE ANTIFUNGAL (TOLNAFTATE) CREAM [TOPCO ASSOCIATES LLC]1
Polyethylene glycol 400INACTIVE INGREDIENTB697894SGQTOPCARE TOLNAFTATE ANTIFUNGAL (TOLNAFTATE) CREAM [TOPCO ASSOCIATES LLC]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPTOPCARE TOLNAFTATE ANTIFUNGAL (TOLNAFTATE) CREAM [TOPCO ASSOCIATES LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-052TOPCARE TOLNAFTATE ANTIFUNGAL (TOLNAFTATE) CREAM [TOPCO ASSOCIATES LLC]4Legacy NDC, 2 package rows20201203_aba4ce9a-ae88-4223-b20f-d7897f7c2232.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
103951tolnaftate 1 % Topical CreamPSNaba4ce9a-ae88-4223-b20f-d7897f7c22324
103951tolnaftate 10 MG/ML Topical CreamSCDaba4ce9a-ae88-4223-b20f-d7897f7c22324
103951tolnaftate 1 % Topical CreamSYaba4ce9a-ae88-4223-b20f-d7897f7c22324

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-052-60368000052601 TUBE in 1 CARTON (36800-052-60) > 14.2 g in 1 TUBE1 tube2006-02-170000-00-00NoNoCurrent