80948-004 NDC - PUROMA ALCOHOL HAND SANITIZER WIPES FRAGRANCE FREE ()

Drug Information

  • Product NDC: 80948-004
  • Proprietary Name: PUROMA Alcohol Hand Sanitizer Wipes Fragrance Free
  • 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: part333A
Marketing Category: OTC MONOGRAPH NOT FINAL
Start Marketing Date:3/1/2021
End Marketing Date:3/29/2021

Package Information

No. Package Code Package Description Billing Unit
180948-004-0110 PACKAGE in 1 PACKAGE (80948-004-01) / 66 mL in 1 PACKAGE
280948-004-0110 PACKAGE in 1 PACKAGE (80948-004-01) / 66 mL in 1 PACKAGE
380948-004-0220 PACKAGE in 1 PACKAGE (80948-004-02) / 132 mL in 1 PACKAGE
480948-004-0220 PACKAGE in 1 PACKAGE (80948-004-02) / 132 mL in 1 PACKAGE
580948-004-0340 PACKAGE in 1 PACKAGE (80948-004-03) / 264 mL in 1 PACKAGE
680948-004-0340 PACKAGE in 1 PACKAGE (80948-004-03) / 264 mL in 1 PACKAGE
780948-004-0480 PACKAGE in 1 PACKAGE (80948-004-04) / 528 mL in 1 PACKAGE
880948-004-0480 PACKAGE in 1 PACKAGE (80948-004-04) / 528 mL in 1 PACKAGE
980948-004-05120 PACKAGE in 1 PACKAGE (80948-004-05) / 792 mL in 1 PACKAGE
1080948-004-05120 PACKAGE in 1 PACKAGE (80948-004-05) / 792 mL in 1 PACKAGE
1180948-004-0650 PACKAGE in 1 CANISTER (80948-004-06) / 350 mL in 1 PACKAGE
1280948-004-0650 PACKAGE in 1 CANISTER (80948-004-06) / 350 mL in 1 PACKAGE
1380948-004-07100 CANISTER in 1 CANISTER (80948-004-07) / 700 mL in 1 CANISTER
1480948-004-07100 CANISTER in 1 CANISTER (80948-004-07) / 700 mL in 1 CANISTER

NDC Record

Field Name Field Value Definition
PRODUCT NDC80948-004The 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 Alcohol Hand Sanitizer Wipes Fragrance FreeThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE3/1/2021This 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.
PRODUCT NDC80948-004The 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 Alcohol Hand Sanitizer Wipes Fragrance FreeThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
START MARKETING DATE3/1/2021This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAMEOTC MONOGRAPH NOT FINALProduct 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 NUMBERpart333AThis 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: 8/8/2025

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