Tolnaftate

Product NDC
67510-0057
Requested package NDC
67510-0057-5
11-digit product format
675100057
Labeler code
67510
Product ID
67510-0057_a79a13f8-c5d7-8e8d-e053-2995a90af8c3
Type
HUMAN OTC DRUG
Nonproprietary name
Tolnaftate
Dosage form
CREAM
Route
TOPICAL
Labeler
Kareway Product, Inc.
Application
part333C
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-08-11
Marketing end
0000-00-00
Substance
TOLNAFTATE
Active strength
1 g/100g
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TolnaftateACTIVE INGREDIENT06KB629TKVTOLNAFTATE CREAM [KAREWAY PRODUCT, INC.]1
TolnaftateACTIVE MOIETY06KB629TKVTOLNAFTATE CREAM [KAREWAY PRODUCT, INC.]1
AlcoholINACTIVE INGREDIENT3K9958V90MTOLNAFTATE CREAM [KAREWAY PRODUCT, INC.]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXTOLNAFTATE CREAM [KAREWAY PRODUCT, INC.]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4TOLNAFTATE CREAM [KAREWAY PRODUCT, INC.]1
ParaffinINACTIVE INGREDIENTI9O0E3H2ZETOLNAFTATE CREAM [KAREWAY PRODUCT, INC.]1
Stearic acidINACTIVE INGREDIENT4ELV7Z65APTOLNAFTATE CREAM [KAREWAY PRODUCT, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RTOLNAFTATE CREAM [KAREWAY PRODUCT, INC.]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67510-0057-5675100057051 TUBE in 1 BOX (67510-0057-5) > 14 g in 1 TUBE1 tube2011-08-110000-00-00NoNoCurrent