NDC 0362-3971

DycloPro

Dyclonine Hydrochloride

DycloPro is a Topical Solution in the Human Prescription Drug category. It is labeled and distributed by Septodont Inc. The primary component is Dyclonine Hydrochloride.

Product ID0362-3971_9d1148f3-0081-4574-ab81-8907cc61542b
NDC0362-3971
Product TypeHuman Prescription Drug
Proprietary NameDycloPro
Generic NameDyclonine Hydrochloride
Dosage FormSolution
Route of AdministrationTOPICAL
Marketing Start Date2019-09-01
Marketing CategoryANDA / ANDA
Application NumberANDA200480
Labeler NameSeptodont Inc
Substance NameDYCLONINE HYDROCHLORIDE
Active Ingredient Strength5 mg/mL
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0362-3971-05

1 BOTTLE in 1 BOTTLE (0362-3971-05) > 30 mL in 1 BOTTLE
Marketing Start Date2019-09-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0362-3971-05 [00362397105]

DycloPro SOLUTION
Marketing CategoryANDA
Application NumberANDA200480
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-09-01

Drug Details

Active Ingredients

IngredientStrength
DYCLONINE HYDROCHLORIDE5 mg/mL

OpenFDA Data

SPL SET ID:bfd9a2dd-7b40-40c0-b256-52f613395760
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1048281
  • 2199130
  • 2199132
  • 1048286
  • NDC Crossover Matching brand name "DycloPro" or generic name "Dyclonine Hydrochloride"

    NDCBrand NameGeneric Name
    0362-3918DycloProDyclonine Hydrochloride
    0362-3971DycloProDyclonine Hydrochloride
    63736-560Sucrets Sore Throat Wild CherryDyclonine Hydrochloride

    Trademark Results [DycloPro]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    DYCLOPRO
    DYCLOPRO
    87884637 not registered Live/Pending
    Septodont Holding SAS
    2018-04-19

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