NDC 0316-0100

Ulcerease

Phenol 0.6% Anesthetic Oral Rinse

Ulcerease is a Oral Rinse in the Human Otc Drug category. It is labeled and distributed by Crown Laboratories. The primary component is Phenol.

• Product ID: 0316-0100_89689542-1741-466c-e053-2995a90a7d2b
• NDC: 0316-0100
• Product Type: Human Otc Drug
• Proprietary Name: Ulcerease
• Generic Name: Phenol 0.6% Anesthetic Oral Rinse
• Dosage Form: Rinse
• Route of Administration: ORAL
• Marketing Start Date: 1977-03-28
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part356
• Labeler Name: Crown Laboratories
• Substance Name: PHENOL
• Active Ingredient Strength: 6 mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 0316-0100-06

178 mL in 1 BOTTLE (0316-0100-06)

• Marketing Start Date: 1977-03-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0316-0100-06 [00316010006]

Ulcerease RINSE

• Marketing Category: OTC monograph not final
• Application Number: part356
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 1977-03-28

Drug Details

Active Ingredients

Ingredient	Strength
PHENOL	6 mg/mL

OpenFDA Data

• SPL SET ID: 89689542-1741-466c-e053-2995a90a7d2b
• Manufacturer:
  • Crown Laboratories
• UNII:
  • 339NCG44TV
• UPC Code:
  • 0303160100062