NDC 68788-0292

Calamine

Ferric Oxide Red

Calamine is a Topical Lotion in the Human Otc Drug category. It is labeled and distributed by Preferred Pharmaceuticals Inc.. The primary component is Ferric Oxide Red; Zinc Oxide.

Product ID68788-0292_266ac551-e64e-4ab9-9a0f-034accc3134e
NDC68788-0292
Product TypeHuman Otc Drug
Proprietary NameCalamine
Generic NameFerric Oxide Red
Dosage FormLotion
Route of AdministrationTOPICAL
Marketing Start Date2018-04-19
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart347
Labeler NamePreferred Pharmaceuticals Inc.
Substance NameFERRIC OXIDE RED; ZINC OXIDE
Active Ingredient Strength8 g/mL; mg/mL
NDC Exclude FlagN
Listing Certified Through2024-12-31

Packaging

NDC 68788-0292-1

177 mL in 1 BOTTLE, PLASTIC (68788-0292-1)
Marketing Start Date2018-04-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68788-0292-1 [68788029201]

Calamine LOTION
Marketing CategoryOTC monograph final
Application Numberpart347
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2018-04-19

Drug Details

Active Ingredients

IngredientStrength
FERRIC OXIDE RED8 g/mL

OpenFDA Data

SPL SET ID:326f3d80-c1bf-4cf0-a662-58e02ed7ee67
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
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.