NDC 55319-063

Calamine

Ferric Oxide Red

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

Product ID55319-063_2bcc63b0-ea47-464c-80cf-0d2e61ef3729
NDC55319-063
Product TypeHuman Otc Drug
Proprietary NameCalamine
Generic NameFerric Oxide Red
Dosage FormLotion
Route of AdministrationTOPICAL
Marketing Start Date1989-07-15
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart347
Labeler NameFamily Dollar
Substance NameFERRIC OXIDE RED; ZINC OXIDE
Active Ingredient Strength80 mg/mL; mg/mL
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 55319-063-30

177 mL in 1 BOTTLE, PLASTIC (55319-063-30)
Marketing Start Date1989-07-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55319-063-30 [55319006330]

Calamine LOTION
Marketing CategoryOTC monograph final
Application Numberpart347
Product TypeHUMAN OTC DRUG
Marketing Start Date1989-07-15

Drug Details

Active Ingredients

IngredientStrength
FERRIC OXIDE RED8 g/mL

OpenFDA Data

SPL SET ID:1a03331e-3676-451c-be22-9a547e8ae6e2
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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.