NDC 45591-041

Calamine

Calamine 8% And Zinc Oxide 8%

Calamine is a Topical Lotion in the Human Otc Drug category. It is labeled and distributed by Pierson Laboratories. The primary component is Zinc Oxide.

Product ID45591-041_6050b319-9903-333d-e053-2a91aa0ad1f3
NDC45591-041
Product TypeHuman Otc Drug
Proprietary NameCalamine
Generic NameCalamine 8% And Zinc Oxide 8%
Dosage FormLotion
Route of AdministrationTOPICAL
Marketing Start Date2017-12-14
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart347
Labeler NamePierson Laboratories
Substance NameZINC OXIDE
Active Ingredient Strength160 mg/mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 45591-041-96

177 mL in 1 BOTTLE, PLASTIC (45591-041-96)
Marketing Start Date2017-12-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 45591-041-96 [45591004196]

Calamine LOTION
Marketing CategoryOTC monograph final
Application Numberpart347
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-12-14

Drug Details

Active Ingredients

IngredientStrength
ZINC OXIDE160 mg/mL

OpenFDA Data

SPL SET ID:6050b319-9902-333d-e053-2a91aa0ad1f3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 199109
    • UPC Code
  • 0045591041964

    • NDC Crossover Matching brand name "Calamine" or generic name "Calamine 8% And Zinc Oxide 8%"

    NDCBrand NameGeneric Name
    0363-0224CalamineFERRIC OXIDE RED
    0363-9114CalamineCalamine, Pramoxind HCl
    0363-9336CalamineCalamine, Pramoxine HCl
    0395-9110CalamineCalamine 8% and Zinc Oxide 8%
    0869-0063CalamineFERRIC OXIDE RED
    0869-0336CalamineCalamine, Pramoxine HCl
    0904-2533CalamineFERRIC OXIDE RED
    11344-336CalamineCalamine, Pramoxind HCl
    11673-063CalamineFERRIC OXIDE RED
    21130-941CalamineFERRIC OXIDE RED
    68071-4322CalamineCalamine
    68788-0292CalamineCalamine
    75981-063CalamineCalamine
    30142-063CalamineCalamine
    36800-063CalamineCalamine
    36800-336CalamineCalamine
    41163-009CalamineCalamine
    41190-063CalamineCalamine
    41250-034CalamineCalamine
    41520-063CalamineCalamine
    41250-888CalamineCalamine
    42507-063CalamineCalamine
    45591-041CalamineCalamine
    49035-413CalamineCalamine
    55301-063CalamineCalamine
    55316-063CalamineCalamine
    55319-063CalamineCalamine
    55910-063CalamineCalamine
    59970-075CalamineCalamine
    63940-336CalamineCalamine
    50804-063CalamineCalamine
    0395-0413Humco CalamineCalamine 8% and Zinc Oxide 8%
    11822-4352Rite Aid CalamineCalamine 8% and Zinc Oxide 8%
    15127-413Select Brand CalamineCalamine 8% and Zinc Oxide 8%

    Trademark Results [Calamine]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    CALAMINE
    CALAMINE
    86788723 4972728 Live/Registered
    Stepanek, Julie
    2015-10-15
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