80948-009 NDC - PUROMA HAND SANITIZER FRAGRANCE FREE ()

Drug Information

  • Product NDC: 80948-009
  • Proprietary Name: PUROMA Hand Sanitizer 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: M003
Marketing Category: OTC MONOGRAPH DRUG
Start Marketing Date:3/11/2021

Package Information

No. Package Code Package Description Billing Unit
180948-009-016 PACKAGE in 1 PACKAGE (80948-009-01) / 30 mL in 1 PACKAGE
280948-009-0212 PACKAGE in 1 PACKAGE (80948-009-02) / 30 mL in 1 PACKAGE
380948-009-0324 PACKAGE in 1 PACKAGE (80948-009-03) / 30 mL in 1 PACKAGE
480948-009-0448 PACKAGE in 1 PACKAGE (80948-009-04) / 30 mL in 1 PACKAGE
580948-009-056 BOTTLE in 1 PACKAGE (80948-009-05) / 60 mL in 1 BOTTLE
680948-009-0612 BOTTLE in 1 PACKAGE (80948-009-06) / 60 mL in 1 BOTTLE
780948-009-0724 BOTTLE in 1 PACKAGE (80948-009-07) / 60 mL in 1 BOTTLE
880948-009-0848 BOTTLE in 1 PACKAGE (80948-009-08) / 60 mL in 1 BOTTLE
980948-009-094 BOTTLE in 1 PACKAGE (80948-009-09) / 89 mL in 1 BOTTLE
1080948-009-106 BOTTLE in 1 PACKAGE (80948-009-10) / 89 mL in 1 BOTTLE
1180948-009-1112 BOTTLE in 1 PACKAGE (80948-009-11) / 89 mL in 1 BOTTLE
1280948-009-1224 BOTTLE in 1 PACKAGE (80948-009-12) / 89 mL in 1 BOTTLE
1380948-009-1348 BOTTLE in 1 PACKAGE (80948-009-13) / 89 mL in 1 BOTTLE
1480948-009-144 BOTTLE in 1 PACKAGE (80948-009-14) / 178 mL in 1 BOTTLE
1580948-009-156 BOTTLE in 1 PACKAGE (80948-009-15) / 178 mL in 1 BOTTLE
1680948-009-1612 BOTTLE in 1 PACKAGE (80948-009-16) / 178 mL in 1 BOTTLE
1780948-009-1724 BOTTLE in 1 PACKAGE (80948-009-17) / 178 mL in 1 BOTTLE
1880948-009-1848 BOTTLE in 1 PACKAGE (80948-009-18) / 178 mL in 1 BOTTLE
1980948-009-194 BOTTLE in 1 PACKAGE (80948-009-19) / 237 mL in 1 BOTTLE
2080948-009-206 BOTTLE in 1 PACKAGE (80948-009-20) / 237 mL in 1 BOTTLE
2180948-009-2112 BOTTLE in 1 PACKAGE (80948-009-21) / 237 mL in 1 BOTTLE
2280948-009-2224 BOTTLE in 1 PACKAGE (80948-009-22) / 237 mL in 1 BOTTLE
2380948-009-2348 BOTTLE in 1 PACKAGE (80948-009-23) / 237 mL in 1 BOTTLE
2480948-009-242 BOTTLE in 1 PACKAGE (80948-009-24) / 326 mL in 1 BOTTLE
2580948-009-254 BOTTLE in 1 PACKAGE (80948-009-25) / 326 mL in 1 BOTTLE
2680948-009-266 BOTTLE in 1 PACKAGE (80948-009-26) / 326 mL in 1 BOTTLE
2780948-009-272 BOTTLE in 1 PACKAGE (80948-009-27) / 488 mL in 1 BOTTLE
2880948-009-282 BOTTLE in 1 PACKAGE (80948-009-28) / 947 mL in 1 BOTTLE
2980948-009-295000 mL in 1 CAN (80948-009-29)
3080948-009-3050000 mL in 1 CAN (80948-009-30)
3180948-009-31200000 mL in 1 DRUM (80948-009-31)
3280948-009-326 BOTTLE in 1 PACKAGE (80948-009-32) / 30 mL in 1 BOTTLE
3380948-009-3312 BOTTLE in 1 PACKAGE (80948-009-33) / 30 mL in 1 BOTTLE
3480948-009-3424 BOTTLE in 1 PACKAGE (80948-009-34) / 30 mL in 1 BOTTLE
3580948-009-3548 BOTTLE in 1 PACKAGE (80948-009-35) / 30 mL in 1 BOTTLE
3680948-009-3630 mL in 1 BOTTLE (80948-009-36)
3780948-009-3760 mL in 1 BOTTLE (80948-009-37)
3880948-009-38237 mL in 1 BOTTLE (80948-009-38)
3980948-009-39488 mL in 1 BOTTLE (80948-009-39)
4080948-009-40947 mL in 1 BOTTLE (80948-009-40)

NDC Record

Field Name Field Value Definition
PRODUCT NDC80948-009The 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 Hand Sanitizer 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 DATE3/11/2021This 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