NDC 0395-0407

Calamine Phenolated Topical Suspension

Calamine And Zinc Oxide And Phenol

Calamine Phenolated Topical Suspension is a Topical Lotion in the Human Otc Drug category. It is labeled and distributed by Humco Holding Group, Inc. The primary component is Zinc Oxide; Phenol.

Product ID0395-0407_7cc2d95c-3b8c-17d7-e053-2991aa0a2b5c
NDC0395-0407
Product TypeHuman Otc Drug
Proprietary NameCalamine Phenolated Topical Suspension
Generic NameCalamine And Zinc Oxide And Phenol
Dosage FormLotion
Route of AdministrationTOPICAL
Marketing Start Date1998-03-25
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart347
Labeler NameHumco Holding Group, Inc
Substance NameZINC OXIDE; PHENOL
Active Ingredient Strength160 mg/mL; mg/mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0395-0407-96

177 mL in 1 BOTTLE, PLASTIC (0395-0407-96)
Marketing Start Date2017-11-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0395-0407-96 [00395040796]

Calamine Phenolated Topical Suspension LOTION
Marketing CategoryOTC monograph final
Application Numberpart347
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2017-11-13

Drug Details

Active Ingredients

IngredientStrength
ZINC OXIDE160 mg/mL

OpenFDA Data

SPL SET ID:a3816729-be2b-4b4f-a609-953576cd2e3b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 991369
  • UPC Code
  • 0303950407968
  • NDC Crossover Matching brand name "Calamine Phenolated Topical Suspension" or generic name "Calamine And Zinc Oxide And Phenol"

    NDCBrand NameGeneric Name
    0395-0407Calamine Phenolated Topical SuspensionCalamine and Zinc Oxide and Phenol
    0395-9109Calamine Phenolated Topical SuspensionCalamine and Zinc Oxide and Phenol
    24385-407Calamine Phenolated Topical SuspensionCalamine and Zinc Oxide and Phenol
    82645-921Calamine Phenolated Topical SuspensionCalamine and Zinc Oxide and Phenol
    49348-802Sunmark Phenolated CalamineCalamine and Zinc Oxide and Phenol

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