NDC 54859-120

Dermagesic

Pramoxine Hcl, Zinc Oxide, Calamine

Dermagesic is a Topical Liquid in the Human Otc Drug category. It is labeled and distributed by Llorens Pharmaceuticals International Division. The primary component is Pramoxine Hydrochloride; Zinc Oxide; Ferric Oxide Red.

• Product ID: 54859-120_7a7884d7-7b51-4101-ac96-d61c47346a59
• NDC: 54859-120
• Product Type: Human Otc Drug
• Proprietary Name: Dermagesic
• Generic Name: Pramoxine Hcl, Zinc Oxide, Calamine
• Dosage Form: Liquid
• Route of Administration: TOPICAL
• Marketing Start Date: 2014-01-01
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part347
• Labeler Name: Llorens Pharmaceuticals International Division
• Substance Name: PRAMOXINE HYDROCHLORIDE; ZINC OXIDE; FERRIC OXIDE RED
• Active Ingredient Strength: 1 mg/100mL; mg/100mL; mg/100mL
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 54859-120-04

118 mL in 1 BOTTLE (54859-120-04)

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

NDC SPL Data Element Entries

NDC 54859-120-04 [54859012004]

Dermagesic LIQUID

• Marketing Category: OTC monograph not final
• Application Number: part347
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2014-01-01
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
PRAMOXINE HYDROCHLORIDE	1 mg/100mL

OpenFDA Data

• SPL SET ID: 8b3f8894-1ed7-4888-a42c-8510d6161edd
• Manufacturer:
  • Llorens Pharmaceuticals International Division
• UNII:
  • SOI2LOH54Z
  • 88AYB867L5
  • 1K09F3G675

NDC Crossover Matching brand name "Dermagesic" or generic name "Pramoxine Hcl, Zinc Oxide, Calamine"

NDC	Brand Name	Generic Name
54859-120	Dermagesic	Pramoxine HCl, Zinc Oxide, Calamine
54859-202	Dermagesic	Pramoxine HCl, Zinc Oxide, Calamine