NDC 63645-162

OraLabs Cold Sore Treatment

Benzocaine

OraLabs Cold Sore Treatment is a Topical Ointment in the Human Otc Drug category. It is labeled and distributed by Oralabs. The primary component is Benzocaine.

• Product ID: 63645-162_792873ae-b15a-408e-92d0-e8bf1e6fc8f1
• NDC: 63645-162
• Product Type: Human Otc Drug
• Proprietary Name: OraLabs Cold Sore Treatment
• Generic Name: Benzocaine
• Dosage Form: Ointment
• Route of Administration: TOPICAL
• Marketing Start Date: 2014-08-01
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part348
• Labeler Name: OraLabs
• Substance Name: BENZOCAINE
• Active Ingredient Strength: 5 mg/g
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 63645-162-04

1 g in 1 CONTAINER (63645-162-04)

• Marketing Start Date: 2014-08-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63645-162-04 [63645016204]

OraLabs Cold Sore Treatment OINTMENT

• Marketing Category: OTC monograph not final
• Application Number: part348
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2014-08-01
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
BENZOCAINE	5 mg/g

OpenFDA Data

• SPL SET ID: 792873ae-b15a-408e-92d0-e8bf1e6fc8f1
• Manufacturer:
  • OraLabs
• UNII:
  • U3RSY48JW5

NDC Crossover Matching brand name "OraLabs Cold Sore Treatment" or generic name "Benzocaine"

NDC	Brand Name	Generic Name
63645-162	OraLabs Cold Sore Treatment	OraLabs Cold Sore Treatment
0283-0220	HurriCaine	Benzocaine
0283-0293	HurriCaine	Benzocaine
0283-0520	HurriCaine	Benzocaine
0283-0569	HurriCaine	Benzocaine
0283-0679	HurriCaine	Benzocaine
0283-0871	HurriCaine	BENZOCAINE
0283-0886	HurriCaine	Benzocaine
0283-0914	HurriCaine	Benzocaine
0283-0920	HurriCaine	Benzocaine
0283-0998	HurriCaine	Benzocaine
0283-1016	HurriCaine	BENZOCAINE