NDC 0536-1211

Dibucaine Topical Anesthetic 1% Hemorrhoidal

Dibucaine

Dibucaine Topical Anesthetic 1% Hemorrhoidal is a Topical Ointment in the Human Otc Drug category. It is labeled and distributed by Rugby Laboratories Inc.. The primary component is Dibucaine.

Product ID0536-1211_908f39d1-b115-ed4e-e053-2a95a90a4546
NDC0536-1211
Product TypeHuman Otc Drug
Proprietary NameDibucaine Topical Anesthetic 1% Hemorrhoidal
Generic NameDibucaine
Dosage FormOintment
Route of AdministrationTOPICAL
Marketing Start Date2019-08-19
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart346
Labeler NameRugby Laboratories Inc.
Substance NameDIBUCAINE
Active Ingredient Strength10 mg/g
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0536-1211-95

1 TUBE in 1 BOX (0536-1211-95) > 28 g in 1 TUBE
Marketing Start Date2019-08-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0536-1211-95 [00536121195]

Dibucaine Topical Anesthetic 1% Hemorrhoidal OINTMENT
Marketing CategoryOTC monograph final
Application Numberpart346
Product TypeHUMAN OTC DRUG
Billing UnitGM
Marketing Start Date2019-08-19

Drug Details

Active Ingredients

IngredientStrength
DIBUCAINE10 mg/g

OpenFDA Data

SPL SET ID:f23c8cd1-98f9-41cd-84d4-cf01c2ede29a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 198601

    • NDC Crossover Matching brand name "Dibucaine Topical Anesthetic 1% Hemorrhoidal" or generic name "Dibucaine"

    NDCBrand NameGeneric Name
    0536-1211Dibucaine Topical Anesthetic 1% HemorrhoidalDIBUCAINE
    59779-997CVS Hemorrhoidal Topical AnalgesicDibucaine
    0168-0046DIBUCAINEDIBUCAINE
    45802-050dibucainedibucaine
    54162-011DibucaineDibucaine
    59779-398DIBUCAINEDIBUCAINE
    71399-2829DibucaineDibucaine
    81266-920DIBUCAINEDIBUCAINE
    55741-402NupercainalDibucaine
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