NDC 0187-5466

Caladryl Clear

Pramoxine Hydrochloride And Zinc Acetate

Caladryl Clear is a Topical Lotion in the Human Otc Drug category. It is labeled and distributed by Bausch Health Us, Llc. The primary component is Pramoxine Hydrochloride; Zinc Acetate.

Product ID0187-5466_1917a021-66c3-457d-b427-82f6e9795dbd
NDC0187-5466
Product TypeHuman Otc Drug
Proprietary NameCaladryl Clear
Generic NamePramoxine Hydrochloride And Zinc Acetate
Dosage FormLotion
Route of AdministrationTOPICAL
Marketing Start Date2013-08-16
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart347
Labeler NameBausch Health US, LLC
Substance NamePRAMOXINE HYDROCHLORIDE; ZINC ACETATE
Active Ingredient Strength10 mg/mL; mg/mL
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0187-5466-06

177 mL in 1 BOTTLE, PLASTIC (0187-5466-06)
Marketing Start Date2013-08-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0187-5466-06 [00187546606]

Caladryl Clear LOTION
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart347
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2013-08-16
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
PRAMOXINE HYDROCHLORIDE10 mg/mL

OpenFDA Data

SPL SET ID:fca6f08b-7fa0-4ae6-bce3-61f3bcae4332
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1234546
  • 1234552
    • UPC Code
  • 0301875466060

    • NDC Crossover Matching brand name "Caladryl Clear" or generic name "Pramoxine Hydrochloride And Zinc Acetate"

    NDCBrand NameGeneric Name
    0187-5466Caladryl ClearPRAMOXINE HYDROCHLORIDE and ZINC ACETATE
    0395-9108CalaclearPramoxine Hydrochloride and Zinc Acetate
    49035-402CalaclearPramoxine Hydrochloride and Zinc Acetate
    82645-923CalaclearPramoxine Hydrochloride and Zinc Acetate
    24385-439Caldyphen ClearPramoxine Hydrochloride and Zinc acetate
    69842-400CVS Itch ReliefPramoxine Hydrochloride and Zinc Acetate
    0395-0400Humco CalaclearPramoxine Hydrochloride and Zinc Acetate

    Trademark Results [Caladryl Clear]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    CALADRYL CLEAR
    CALADRYL CLEAR
    74150727 1681727 Live/Registered
    BAUSCH HEALTH IRELAND LIMITED
    1991-03-22
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