NDC 54859-202

Dermagesic

Pramoxine Hcl, Zinc Oxide, Calamine

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

• Product ID: 54859-202_1c7321fa-9ba7-46a9-911a-45160c44acb4
• NDC: 54859-202
• Product Type: Human Otc Drug
• Proprietary Name: Dermagesic
• Generic Name: Pramoxine Hcl, Zinc Oxide, Calamine
• Dosage Form: Cream
• Route of Administration: TOPICAL
• Marketing Start Date: 2016-04-01
• Marketing Category: OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
• Application Number: part347
• Labeler Name: Llorens Pharmaceutical International Division
• Substance Name: PRAMOXINE HYDROCHLORIDE; ZINC OXIDE; FERRIC OXIDE RED
• Active Ingredient Strength: 10 mg/g; mg/g; mg/g
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 54859-202-04

113 g in 1 JAR (54859-202-04)

• Marketing Start Date: 2016-04-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 54859-202-04 [54859020204]

Dermagesic CREAM

• Marketing Category: OTC monograph not final
• Application Number: part347
• Product Type: HUMAN OTC DRUG
• Billing Unit: GM
• Marketing Start Date: 2016-04-01
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
PRAMOXINE HYDROCHLORIDE	10 mg/g

OpenFDA Data

• SPL SET ID: bbff6b53-29da-45c1-8ccd-3e9df7f250e0
• Manufacturer:
  • Llorens Pharmaceutical International Division
• UNII:
  • SOI2LOH54Z
  • 88AYB867L5
  • 1K09F3G675
• RxNorm Concept Unique ID - RxCUI:
  • 1798481

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