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 ID54859-120_7a7884d7-7b51-4101-ac96-d61c47346a59
NDC54859-120
Product TypeHuman Otc Drug
Proprietary NameDermagesic
Generic NamePramoxine Hcl, Zinc Oxide, Calamine
Dosage FormLiquid
Route of AdministrationTOPICAL
Marketing Start Date2014-01-01
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart347
Labeler NameLlorens Pharmaceuticals International Division
Substance NamePRAMOXINE HYDROCHLORIDE; ZINC OXIDE; FERRIC OXIDE RED
Active Ingredient Strength1 mg/100mL; mg/100mL; mg/100mL
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 54859-120-04

118 mL in 1 BOTTLE (54859-120-04)
Marketing Start Date2014-01-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54859-120-04 [54859012004]

Dermagesic LIQUID
Marketing CategoryOTC monograph not final
Application Numberpart347
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2014-01-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
PRAMOXINE HYDROCHLORIDE1 mg/100mL

OpenFDA Data

SPL SET ID:8b3f8894-1ed7-4888-a42c-8510d6161edd
Manufacturer
UNII

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

NDCBrand NameGeneric Name
54859-120DermagesicPramoxine HCl, Zinc Oxide, Calamine
54859-202DermagesicPramoxine HCl, Zinc Oxide, Calamine

Trademark Results [Dermagesic]

Mark Image

Registration | Serial
Company
Trademark
Application Date
DERMAGESIC
DERMAGESIC
87837492 5600474 Live/Registered
LLORENS PHARMACEUTICAL INTERNATIONAL DIVISION, INC.
2018-03-16

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