NDC 59970-075

Calamine

Zinc Oxide, Ferric Oxide Red, Pramozine Hcl

Calamine is a Topical Lotion in the Human Otc Drug category. It is labeled and distributed by Navarro Discount Pharmacies, Llc. The primary component is Zinc Oxide; Ferric Oxide Red; Pramoxine Hydrochloride.

Product ID59970-075_31cda82e-11b2-4537-9f32-f54b01141bb8
NDC59970-075
Product TypeHuman Otc Drug
Proprietary NameCalamine
Generic NameZinc Oxide, Ferric Oxide Red, Pramozine Hcl
Dosage FormLotion
Route of AdministrationTOPICAL
Marketing Start Date2013-06-03
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart347
Labeler NameNavarro Discount Pharmacies, LLC
Substance NameZINC OXIDE; FERRIC OXIDE RED; PRAMOXINE HYDROCHLORIDE
Active Ingredient Strength80 mg/mL; mg/mL; mg/mL
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 59970-075-01

177 mL in 1 BOTTLE (59970-075-01)
Marketing Start Date2013-06-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 59970-075-01 [59970007501]

Calamine LOTION
Marketing CategoryOTC monograph final
Application Numberpart347
Product TypeHUMAN OTC DRUG
Marketing Start Date2013-06-03
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
ZINC OXIDE80 mg/mL

OpenFDA Data

SPL SET ID:7f2c5adf-92ca-4257-b71b-f7578a481c92
Manufacturer
UNII
UPC Code
  • 0847717030582

    • NDC Crossover Matching brand name "Calamine" or generic name "Zinc Oxide, Ferric Oxide Red, Pramozine Hcl"

    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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