NDC 0168-0046

DIBUCAINE

Dibucaine

DIBUCAINE is a Topical Ointment in the Human Otc Drug category. It is labeled and distributed by E. Fougera & Co. A Division Of Fougera Pharmaceuticals Inc.. The primary component is Dibucaine.

Product ID0168-0046_cc66c053-6c73-4d9b-979b-f508f7c0aa5c
NDC0168-0046
Product TypeHuman Otc Drug
Proprietary NameDIBUCAINE
Generic NameDibucaine
Dosage FormOintment
Route of AdministrationTOPICAL
Marketing Start Date1968-01-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart346
Labeler NameE. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
Substance NameDIBUCAINE
Active Ingredient Strength1 g/100g
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0168-0046-31

1 TUBE in 1 CARTON (0168-0046-31) > 28 g in 1 TUBE
Marketing Start Date1968-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0168-0046-31 [00168004631]

DIBUCAINE OINTMENT
Marketing CategoryOTC monograph final
Application Numberpart346
Product TypeHUMAN OTC DRUG
Billing UnitGM
Marketing Start Date1968-01-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
DIBUCAINE1 g/100g

OpenFDA Data

SPL SET ID:8ae5992a-c544-4fd8-93f8-0f97c653203c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198601
  • 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

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