NDC 63135-581

TOPICAINE 5

Lidocaine 5%

TOPICAINE 5 is a Topical Gel in the Human Otc Drug category. It is labeled and distributed by Esba Laboratories Inc.. The primary component is Lidocaine.

Product ID63135-581_7f823d69-1b64-73d7-e053-2991aa0a262d
NDC63135-581
Product TypeHuman Otc Drug
Proprietary NameTOPICAINE 5
Generic NameLidocaine 5%
Dosage FormGel
Route of AdministrationTOPICAL
Marketing Start Date2003-04-20
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart346
Labeler NameESBA LABORATORIES INC.
Substance NameLIDOCAINE
Active Ingredient Strength5 g/100g
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 63135-581-04

113 g in 1 TUBE (63135-581-04)
Marketing Start Date2008-03-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63135-581-13 [63135058113]

TOPICAINE 5 GEL
Marketing CategoryOTC monograph final
Application Numberpart346
Product TypeHUMAN OTC DRUG
Marketing Start Date2003-04-20

NDC 63135-581-04 [63135058104]

TOPICAINE 5 GEL
Marketing CategoryOTC monograph final
Application Numberpart346
Product TypeHUMAN OTC DRUG
Billing UnitGM
Marketing Start Date2008-03-01

NDC 63135-581-30 [63135058130]

TOPICAINE 5 GEL
Marketing CategoryOTC monograph final
Application Numberpart346
Product TypeHUMAN OTC DRUG
Billing UnitGM
Marketing Start Date2003-04-20

Drug Details

Active Ingredients

IngredientStrength
LIDOCAINE5 g/100g

OpenFDA Data

SPL SET ID:15d33ff7-34ed-253d-e054-00144ff88e88
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1652108
  • 1652104
  • UPC Code
  • 0363135581302
  • NDC Crossover Matching brand name "TOPICAINE 5" or generic name "Lidocaine 5%"

    NDCBrand NameGeneric Name
    63135-581TOPICAINE 5LIDOCAINE 5%
    24357-702Anecream 5Lidocaine 5%
    70942-183Doctor Butlers Numb It All CreamLidocaine 5%
    72839-265Formula 2 Skin CareLidocaine 5%
    42291-400LidocaineLidocaine 5%
    0363-4530Lidocaine 5%Lidocaine 5%
    42858-118Lidocaine 5%Lidocaine 5%
    63629-2472Lidocaine 5%Lidocaine 5%
    68752-015Lidocaine 5%Lidocaine 5%
    70518-3522Lidocaine 5%Lidocaine 5%
    72275-716Lidovix LLidocaine 5%
    63135-811LIPOCAINE 5LIDOCAINE 5%
    63135-924LUBRICAINE 5LIDOCAINE 5%
    82429-203NUMBLidocaine 5%
    72839-141Rectal Care CreamLidocaine 5%
    69315-301RectaSmootheLidocaine 5%
    11822-0265Rite Aid Rectal CareLidocaine 5%
    57483-108XyralidLidocaine 5%

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