NDC 55315-413

Freds Calamine

Calamine 8% And Zinc Oxide 8%

Freds Calamine is a Topical Lotion in the Human Otc Drug category. It is labeled and distributed by Fred's, Inc.. The primary component is Zinc Oxide.

Product ID55315-413_5df489e4-d619-66fa-e053-2991aa0a88cc
NDC55315-413
Product TypeHuman Otc Drug
Proprietary NameFreds Calamine
Generic NameCalamine 8% And Zinc Oxide 8%
Dosage FormLotion
Route of AdministrationTOPICAL
Marketing Start Date1998-03-25
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart347
Labeler NameFred's, Inc.
Substance NameZINC OXIDE
Active Ingredient Strength160 mg/mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 55315-413-96

177 mL in 1 BOTTLE, PLASTIC (55315-413-96)
Marketing Start Date2017-11-13
Marketing End Date2024-03-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55315-413-96 [55315041396]

Freds Calamine LOTION
Marketing CategoryOTC monograph final
Application Numberpart347
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-11-13

Drug Details

Active Ingredients

IngredientStrength
ZINC OXIDE160 mg/mL

OpenFDA Data

SPL SET ID:5df48f74-ea90-9a01-e053-2a91aa0a7d3b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 199109
  • UPC Code
  • 0084579118762
  • NDC Crossover Matching brand name "Freds Calamine" or generic name "Calamine 8% And Zinc Oxide 8%"

    NDCBrand NameGeneric Name
    55315-413Freds CalamineCalamine 8% and Zinc Oxide 8%
    33992-4130Assured CalamineCalamine 8% and Zinc Oxide 8%
    0395-9110CalamineCalamine 8% and Zinc Oxide 8%
    45591-041CalamineCalamine 8% and Zinc Oxide 8%
    82645-900CalamineCalamine 8% and Zinc Oxide 8%
    53943-413DDM CalamineCalamine 8% and Zinc Oxide 8%
    24385-413GNP Calamine Topical SuspensionCalamine 8% and Zinc Oxide 8%
    64092-413Health Care CalamineCalamine 8% and Zinc Oxide 8%
    62011-0114Health Mart CalamineCalamine 8% and Zinc Oxide 8%
    0395-0413Humco CalamineCalamine 8% and Zinc Oxide 8%
    68016-413Premiere Value CalamineCalamine 8% and Zinc Oxide 8%
    63868-317Quality Choice CalamineCalamine 8% and Zinc Oxide 8%
    11822-4352Rite Aid CalamineCalamine 8% and Zinc Oxide 8%
    15127-413Select Brand CalamineCalamine 8% and Zinc Oxide 8%
    49348-011Sunmark CalamineCalamine 8% and Zinc Oxide 8%

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