80948-012 NDC - PUROMA INSTANT FOAMING HAND SANITIZER WITHOUT FRAGRANCE ()

Drug Information

  • Product NDC: 80948-012
  • Proprietary Name: PUROMA Instant Foaming Hand Sanitizer without Fragrance
  • Non Proprietary Name:
  • Active Ingredient(s):
  • Administration Route(s):
  • Dosage Form(s):

Labeler Information

Field Name Field Value
Labeler Name: ZENITH MICRO CONTROL
Product Type:
FDA Application Number: M003
Marketing Category: OTC MONOGRAPH DRUG
Start Marketing Date:3/10/2021

Package Information

No. Package Code Package Description Billing Unit
180948-012-0160 mL in 1 BOTTLE (80948-012-01)
280948-012-0280 mL in 1 BOTTLE (80948-012-02)
380948-012-03100 mL in 1 BOTTLE (80948-012-03)
480948-012-04150 mL in 1 BOTTLE (80948-012-04)
580948-012-05220 mL in 1 PACKAGE (80948-012-05)
680948-012-06250 mL in 1 BOTTLE (80948-012-06)
780948-012-07300 mL in 1 BOTTLE (80948-012-07)
880948-012-08350 mL in 1 BOTTLE (80948-012-08)
980948-012-095000 mL in 1 CAN (80948-012-09)
1080948-012-1050000 mL in 1 CAN (80948-012-10)
1180948-012-11200000 mL in 1 CAN (80948-012-11)
1280948-012-1270 mL in 1 BOTTLE (80948-012-12)

NDC Record

Field Name Field Value Definition
PRODUCT NDC80948-012The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PROPRIETARY NAMEPUROMA Instant Foaming Hand Sanitizer without FragranceThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE3/10/2021This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEOTC MONOGRAPH DRUGProduct types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
APPLICATION NUMBERM003This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
LABELER NAMEZENITH MICRO CONTROLName of Company corresponding to the labeler code segment of the Product NDC.

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This page was last updated on: 7/4/2025

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