NDC 36800-398

Calamine Plus Pramoxine HCl

Calamine Plus Spray

Calamine Plus Pramoxine HCl is a Topical Aerosol, Spray in the Human Otc Drug category. It is labeled and distributed by Topco Associates Llc. The primary component is Ferric Oxide Red; Zinc Oxide; Pramoxine Hydrochloride.

Product ID36800-398_726cc6cb-2bc6-4de1-9b02-e18ab1ba6755
NDC36800-398
Product TypeHuman Otc Drug
Proprietary NameCalamine Plus Pramoxine HCl
Generic NameCalamine Plus Spray
Dosage FormAerosol, Spray
Route of AdministrationTOPICAL
Marketing Start Date2017-01-01
Marketing CategoryOTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL
Application Numberpart348
Labeler NameTopco Associates LLC
Substance NameFERRIC OXIDE RED; ZINC OXIDE; PRAMOXINE HYDROCHLORIDE
Active Ingredient Strength0 mg/116g; mg/116g; mg/116g
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 36800-398-41

116 g in 1 CANISTER (36800-398-41)
Marketing Start Date2017-01-01
NDC Exclude FlagN
Sample Package?N

Drug Details

Active Ingredients

IngredientStrength
FERRIC OXIDE RED.345 mg/116g

OpenFDA Data

SPL SET ID:af314adb-bd65-4233-b7e1-6cfb819615a3
Manufacturer:Topco Associates LLC
UNII
RxNorm Concept Unique ID - RxCUI
  • 1544717
  • NDC Crossover Matching brand name "Calamine Plus Pramoxine HCl" or generic name "Calamine Plus Spray"

    NDCBrand NameGeneric Name
    0363-8588Calamine Plus Pramoxine HClCalamine Plus No-Touch
    11673-635Calamine Plus Pramoxine HClCalamine Plus Spray
    30142-156Calamine Plus Pramoxine HClCalamine Plus Spray
    36800-398Calamine Plus Pramoxine HClCalamine Plus Spray
    41520-184Calamine Plus Pramoxine HClCalamine Plus Spray
    42507-147Calamine Plus Pramoxine HClCalamine Plus Spray
    56104-031Calamine Plus Pramoxine HClCalamine Plus No Touch Spray
    59779-174Calamine Plus Pramoxine HClCalamine Plus Spray

    © 2020 FDA.report
    This site is not affiliated with or endorsed by the FDA.