NDC 55628-9109

THERASEPTIN

Zinc Oxide Menthol

THERASEPTIN is a Topical Ointment in the Human Otc Drug category. It is labeled and distributed by Cal Pharma. The primary component is Zinc Oxide; Menthol.

• Product ID: 55628-9109_2889fdb4-365d-4adb-840e-b4257c173427
• NDC: 55628-9109
• Product Type: Human Otc Drug
• Proprietary Name: THERASEPTIN
• Generic Name: Zinc Oxide Menthol
• Dosage Form: Ointment
• Route of Administration: TOPICAL
• Marketing Start Date: 2012-11-29
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part347
• Labeler Name: Cal Pharma
• Substance Name: ZINC OXIDE; MENTHOL
• Active Ingredient Strength: 21 g/100mL; g/100mL
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 55628-9109-4

120 mL in 1 TUBE (55628-9109-4)

• Marketing Start Date: 2012-11-29
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55628-9109-4 [55628910904]

THERASEPTIN OINTMENT

• Marketing Category: OTC monograph final
• Application Number: part347
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2012-11-29
• Inactivation Date: 2019-11-27

Drug Details

Active Ingredients

Ingredient	Strength
ZINC OXIDE	20.6 g/100mL

OpenFDA Data

• SPL SET ID: 0407a732-95b8-42b4-a21d-f42cfe993853
• Manufacturer:
  • Cal Pharma
• UNII:
  • SOI2LOH54Z
  • L7T10EIP3A
• RxNorm Concept Unique ID - RxCUI:
  • 1370454

NDC Crossover Matching brand name "THERASEPTIN" or generic name "Zinc Oxide Menthol"

NDC	Brand Name	Generic Name
55628-9109	THERASEPTIN	ZINC OXIDE MENTHOL
55628-9204	THERASEPTIN	ZINC OXIDE, MENTHOL