NDC 55316-063

Calamine

Ferric Oxide Red

Calamine is a Topical Lotion in the Human Otc Drug category. It is labeled and distributed by Dzb Brands, Llc. The primary component is Ferric Oxide Red; Zinc Oxide.

Product ID55316-063_2b2dc4bf-3865-4fc8-a290-0c6bb0c10c4e
NDC55316-063
Product TypeHuman Otc Drug
Proprietary NameCalamine
Generic NameFerric Oxide Red
Dosage FormLotion
Route of AdministrationTOPICAL
Marketing Start Date2008-02-05
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart347
Labeler NameDZB Brands, LLC
Substance NameFERRIC OXIDE RED; ZINC OXIDE
Active Ingredient Strength80 mg/mL; mg/mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 55316-063-26

177 mL in 1 BOTTLE, PLASTIC (55316-063-26)
Marketing Start Date2008-02-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55316-063-26 [55316006326]

Calamine LOTION
Marketing CategoryOTC monograph final
Application Numberpart347
Product TypeHUMAN OTC DRUG
Marketing Start Date2008-02-05

Drug Details

Active Ingredients

IngredientStrength
FERRIC OXIDE RED.8 kg/100L

OpenFDA Data

SPL SET ID:8c1b0675-bbe9-42a4-80f1-3efff1d6346c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 617954

    • NDC Crossover Matching brand name "Calamine" or generic name "Ferric Oxide Red"

    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
    30142-063CalamineFERRIC OXIDE RED
    36800-063CalamineFERRIC OXIDE RED
    68071-4322CalamineCalamine
    68788-0292CalamineCalamine
    75981-063CalamineCalamine
    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

    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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