NDC 50382-014

Tolnaftate

Tolnaftate

Tolnaftate is a Topical Cream in the Human Otc Drug category. It is labeled and distributed by Galentic Pharma (india) Private Limited. The primary component is Tolnaftate.

Product ID50382-014_1553cbe7-9b76-49f8-9801-e05eb8e3425e
NDC50382-014
Product TypeHuman Otc Drug
Proprietary NameTolnaftate
Generic NameTolnaftate
Dosage FormCream
Route of AdministrationTOPICAL
Marketing Start Date2012-06-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart333C
Labeler NameGalentic Pharma (India) Private Limited
Substance NameTOLNAFTATE
Active Ingredient Strength10 mg/g
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 50382-014-12

1 TUBE in 1 CARTON (50382-014-12) > 14 g in 1 TUBE
Marketing Start Date2012-06-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50382-014-13 [50382001413]

Tolnaftate CREAM
Marketing CategoryOTC monograph final
Application Numberpart333C
Product TypeHUMAN OTC DRUG
Marketing Start Date2019-06-15

NDC 50382-014-12 [50382001412]

Tolnaftate CREAM
Marketing CategoryOTC monograph final
Application Numberpart333C
Product TypeHUMAN OTC DRUG
Marketing Start Date2012-06-01

Drug Details

Active Ingredients

IngredientStrength
TOLNAFTATE10 mg/g

OpenFDA Data

SPL SET ID:e45cf99e-7c4c-4021-90ca-98ce441e4479
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 103951
  • NDC Crossover Matching brand name "Tolnaftate" or generic name "Tolnaftate"

    NDCBrand NameGeneric Name
    0363-0186TolnaftateAnti-Fungal Liquid Maximum Strength
    0363-0216TolnaftateOdor Control Powder Spray
    0363-1746TolnaftateTolnaftate Athletes Foot Powder Spray
    0363-8042TolnaftateAthletes Foot Liquid
    0904-0722TolnaftateTOLNAFTATE
    68016-609TolnaftateTolnaftate
    68016-586TolnaftateTolnaftate
    68016-608TolnaftateTolnaftate
    68016-536TolnaftateTolnaftate
    68071-4245TolnaftateTolnaftate
    69256-034TolnaftateTolnaftate
    69842-185TolnaftateTolnaftate
    11673-586TolnaftateTolnaftate
    11527-051TolnaftateTolnaftate
    15127-098TolnaftateTolnaftate
    15127-097TolnaftateTolnaftate
    30142-147TolnaftateTolnaftate
    36800-006TolnaftateTolnaftate
    36800-012TolnaftateTolnaftate
    36800-023TolnaftateTolnaftate
    36800-024TolnaftateTolnaftate
    36800-877TolnaftateTolnaftate
    37808-515TolnaftateTolnaftate
    37808-521TolnaftateTolnaftate
    37808-514TolnaftateTolnaftate
    41190-133TolnaftateTolnaftate
    41190-132TolnaftateTolnaftate
    41520-082TolnaftateTolnaftate
    41190-134TolnaftateTolnaftate
    41250-635TolnaftateTolnaftate
    41520-086TolnaftateTolnaftate
    42507-136TolnaftateTolnaftate
    42507-135TolnaftateTolnaftate
    42507-138TolnaftateTolnaftate
    50090-0160TolnaftateTolnaftate
    50090-0161TolnaftateTolnaftate
    50382-014TolnaftateTolnaftate
    51141-0057TolnaftateTolnaftate
    51852-102TolnaftateTolnaftate
    53210-1001TolnaftateTolnaftate
    53943-994TolnaftateTolnaftate
    54633-913TolnaftateTolnaftate
    55301-132TolnaftateTolnaftate
    55301-131TolnaftateTolnaftate
    55319-065TolnaftateTolnaftate
    55315-373TolnaftateTolnaftate
    55319-182TolnaftateTolnaftate
    56104-001TolnaftateTolnaftate
    56104-002TolnaftateTolnaftate
    56104-036TolnaftateTolnaftate

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.