NDC 67516-0107

Cortibalm

Hydrocortisone Lip Balm

Cortibalm is a Topical Ointment in the Human Otc Drug category. It is labeled and distributed by Dr. Dan's Llc. The primary component is Hydrocortisone.

• Product ID: 67516-0107_4eb687fd-6368-2f13-e054-00144ff88e88
• NDC: 67516-0107
• Product Type: Human Otc Drug
• Proprietary Name: Cortibalm
• Generic Name: Hydrocortisone Lip Balm
• Dosage Form: Ointment
• Route of Administration: TOPICAL
• Marketing Start Date: 2001-01-10
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part348
• Labeler Name: Dr. Dan's LLC
• Substance Name: HYDROCORTISONE
• Active Ingredient Strength: 100 g/g
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 67516-0107-1

4.2 g in 1 PACKAGE (67516-0107-1)

• Marketing Start Date: 2001-01-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 67516-0107-1 [67516010701]

Cortibalm OINTMENT

• Marketing Category: OTC monograph not final
• Application Number: part348
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2001-01-10
• Marketing End Date: 2019-10-01

Drug Details

Active Ingredients

Ingredient	Strength
HYDROCORTISONE	100 g/g

OpenFDA Data

• SPL SET ID: 4e1390ae-644c-249c-e054-00144ff88e88
• Manufacturer:
  • Dr. Dan's LLC
• UNII:
  • WI4X0X7BPJ

NDC Crossover Matching brand name "Cortibalm" or generic name "Hydrocortisone Lip Balm"

NDC	Brand Name	Generic Name
67516-0107	Cortibalm	Hydrocortisone Lip Balm
67516-0108	Cortibalm	Hydrocortisone Lip Balm