NDC 49035-413

Calamine

Calamine And Zinc Oxide

Calamine is a Topical Lotion in the Human Otc Drug category. It is labeled and distributed by Wal-mart Stores, Inc.. The primary component is Zinc Oxide.

Product ID49035-413_0a25d97b-1d95-49c6-9352-e3b4ef2c3979
NDC49035-413
Product TypeHuman Otc Drug
Proprietary NameCalamine
Generic NameCalamine And Zinc Oxide
Dosage FormLotion
Route of AdministrationTOPICAL
Marketing Start Date2017-12-30
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart347
Labeler NameWal-mart Stores, Inc.
Substance NameZINC OXIDE
Active Ingredient Strength160 mg/mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 49035-413-96

177 mL in 1 BOTTLE, PLASTIC (49035-413-96)
Marketing Start Date2017-12-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 49035-413-96 [49035041396]

Calamine LOTION
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart347
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-12-30

Drug Details

Active Ingredients

IngredientStrength
ZINC OXIDE160 mg/mL

OpenFDA Data

SPL SET ID:61929c97-bd6b-0d7c-e053-2991aa0aa571
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 617954

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

    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.