NDC 54162-011

Dibucaine

Dibucaine

Dibucaine is a Topical Ointment in the Human Otc Drug category. It is labeled and distributed by Geritrex Llc. The primary component is Dibucaine.

Product ID54162-011_80c8b75b-db66-4fc2-b666-7e1aa63a3b07
NDC54162-011
Product TypeHuman Otc Drug
Proprietary NameDibucaine
Generic NameDibucaine
Dosage FormOintment
Route of AdministrationTOPICAL
Marketing Start Date2015-07-31
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart346
Labeler NameGERITREX LLC
Substance NameDIBUCAINE
Active Ingredient Strength0 g/28g
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 54162-011-01

28 g in 1 TUBE (54162-011-01)
Marketing Start Date2015-07-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54162-011-01 [54162001101]

Dibucaine OINTMENT
Marketing CategoryOTC monograph final
Application Numberpart346
Product TypeHUMAN OTC DRUG
Billing UnitGM
Marketing Start Date2015-07-31
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
DIBUCAINE.28 g/28g

OpenFDA Data

SPL SET ID:fc11a231-1d2f-42ba-8ece-34495a14ab44
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198601
    • UPC Code
  • 0354162011016

    • NDC Crossover Matching brand name "Dibucaine" or generic name "Dibucaine"

    NDCBrand NameGeneric Name
    0168-0046DIBUCAINEDIBUCAINE
    45802-050dibucainedibucaine
    54162-011DibucaineDibucaine
    57896-131DibucaineDibucaine 1%
    59779-398DIBUCAINEDIBUCAINE
    63868-911DibucaineDibucaine 1%
    69396-023DibucaineDibucaine 1%
    71399-2829DibucaineDibucaine
    81266-920DIBUCAINEDIBUCAINE
    59779-997CVS Hemorrhoidal Topical AnalgesicDibucaine
    0536-1211Dibucaine Topical Anesthetic 1% HemorrhoidalDIBUCAINE
    55741-402NupercainalDibucaine
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.