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 ID: 0362-3971_9d1148f3-0081-4574-ab81-8907cc61542b
• NDC: 0362-3971
• Product Type: Human Prescription Drug
• Proprietary Name: DycloPro
• Generic Name: Dyclonine Hydrochloride
• Dosage Form: Solution
• Route of Administration: TOPICAL
• Marketing Start Date: 2019-09-01
• Marketing Category: ANDA / ANDA
• Application Number: ANDA200480
• Labeler Name: Septodont Inc
• Substance Name: DYCLONINE HYDROCHLORIDE
• Active Ingredient Strength: 5 mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 0362-3971-05

1 BOTTLE in 1 BOTTLE (0362-3971-05) > 30 mL in 1 BOTTLE

• Marketing Start Date: 2019-09-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0362-3971-05 [00362397105]

DycloPro SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA200480
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-09-01

Drug Details

Active Ingredients

Ingredient	Strength
DYCLONINE HYDROCHLORIDE	5 mg/mL

OpenFDA Data

• SPL SET ID: bfd9a2dd-7b40-40c0-b256-52f613395760
• Manufacturer:
  • Septodont Inc
• UNII:
  • ZEC193879Q
• RxNorm Concept Unique ID - RxCUI:
  • 1048281
  • 2199130
  • 2199132
  • 1048286

NDC Crossover Matching brand name "DycloPro" or generic name "Dyclonine Hydrochloride"

NDC	Brand Name	Generic Name
0362-3918	DycloPro	Dyclonine Hydrochloride
0362-3971	DycloPro	Dyclonine Hydrochloride
63736-560	Sucrets Sore Throat Wild Cherry	Dyclonine Hydrochloride