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80948-016 NDC - PUROMA FOAMING HAND SANITIZER ALCOHOL FREE WITH FRAGRANCE FLORAL (BENZALKONIUM CHLORIDE)

Drug Information

Product NDC: 80948-016

Proprietary Name: PUROMA Foaming Hand Sanitizer Alcohol Free With Fragrance Floral

Non Proprietary Name: Benzalkonium chloride

Active Ingredient(s):
  • 130 mg/100mL BENZALKONIUM CHLORIDE


Administration Route(s): TOPICAL

Dosage Form(s): LIQUID

Labeler Information

Labeler Name: ZENITH MICRO CONTROL
Product Type: HUMAN OTC DRUG
FDA Application Number: part333A
Marketing Category: OTC MONOGRAPH NOT FINAL
Start Marketing Date:4/27/2021

Package Information

No. Package Code Package Description Billing Unit
180948-016-016 BOTTLE in 1 PACKAGE (80948-016-01) / 60 mL in 1 BOTTLE
280948-016-028 BOTTLE in 1 PACKAGE (80948-016-02) / 60 mL in 1 BOTTLE
380948-016-0312 BOTTLE in 1 PACKAGE (80948-016-03) / 60 mL in 1 BOTTLE
480948-016-0424 BOTTLE in 1 PACKAGE (80948-016-04) / 60 mL in 1 BOTTLE
580948-016-0548 BOTTLE in 1 PACKAGE (80948-016-05) / 60 mL in 1 BOTTLE
680948-016-064 BOTTLE in 1 PACKAGE (80948-016-06) / 70 mL in 1 BOTTLE
780948-016-076 BOTTLE in 1 PACKAGE (80948-016-07) / 70 mL in 1 BOTTLE
880948-016-088 BOTTLE in 1 PACKAGE (80948-016-08) / 70 mL in 1 BOTTLE
980948-016-0912 BOTTLE in 1 PACKAGE (80948-016-09) / 70 mL in 1 BOTTLE
1080948-016-1024 BOTTLE in 1 PACKAGE (80948-016-10) / 70 mL in 1 BOTTLE
1180948-016-1148 BOTTLE in 1 PACKAGE (80948-016-11) / 70 mL in 1 BOTTLE
1280948-016-124 BOTTLE in 1 PACKAGE (80948-016-12) / 80 mL in 1 BOTTLE
1380948-016-136 BOTTLE in 1 PACKAGE (80948-016-13) / 80 mL in 1 BOTTLE
1480948-016-148 BOTTLE in 1 PACKAGE (80948-016-14) / 80 mL in 1 BOTTLE
1580948-016-1512 BOTTLE in 1 PACKAGE (80948-016-15) / 80 mL in 1 BOTTLE
1680948-016-1624 BOTTLE in 1 PACKAGE (80948-016-16) / 80 mL in 1 BOTTLE
1780948-016-1748 BOTTLE in 1 PACKAGE (80948-016-17) / 80 mL in 1 BOTTLE
1880948-016-184 BOTTLE in 1 PACKAGE (80948-016-18) / 100 mL in 1 BOTTLE
1980948-016-196 BOTTLE in 1 PACKAGE (80948-016-19) / 100 mL in 1 BOTTLE
2080948-016-208 BOTTLE in 1 PACKAGE (80948-016-20) / 100 mL in 1 BOTTLE
2180948-016-2112 BOTTLE in 1 PACKAGE (80948-016-21) / 100 mL in 1 BOTTLE
2280948-016-2224 BOTTLE in 1 PACKAGE (80948-016-22) / 100 mL in 1 BOTTLE
2380948-016-2348 BOTTLE in 1 PACKAGE (80948-016-23) / 100 mL in 1 BOTTLE
2480948-016-242 BOTTLE in 1 PACKAGE (80948-016-24) / 150 mL in 1 BOTTLE
2580948-016-254 BOTTLE in 1 PACKAGE (80948-016-25) / 150 mL in 1 BOTTLE
2680948-016-266 BOTTLE in 1 PACKAGE (80948-016-26) / 150 mL in 1 BOTTLE
2780948-016-278 BOTTLE in 1 PACKAGE (80948-016-27) / 150 mL in 1 BOTTLE
2880948-016-2812 BOTTLE in 1 PACKAGE (80948-016-28) / 150 mL in 1 BOTTLE
2980948-016-302 BOTTLE in 1 PACKAGE (80948-016-30) / 200 mL in 1 BOTTLE
3080948-016-314 BOTTLE in 1 PACKAGE (80948-016-31) / 200 mL in 1 BOTTLE
3180948-016-326 BOTTLE in 1 PACKAGE (80948-016-32) / 200 mL in 1 BOTTLE
3280948-016-338 BOTTLE in 1 PACKAGE (80948-016-33) / 200 mL in 1 BOTTLE
3380948-016-3412 BOTTLE in 1 PACKAGE (80948-016-34) / 200 mL in 1 BOTTLE
3480948-016-3524 BOTTLE in 1 PACKAGE (80948-016-35) / 200 mL in 1 BOTTLE
3580948-016-362 BOTTLE in 1 PACKAGE (80948-016-36) / 220 mL in 1 BOTTLE
3680948-016-374 BOTTLE in 1 PACKAGE (80948-016-37) / 220 mL in 1 BOTTLE
3780948-016-446 BOTTLE in 1 PACKAGE (80948-016-44) / 250 mL in 1 BOTTLE
3880948-016-458 BOTTLE in 1 PACKAGE (80948-016-45) / 250 mL in 1 BOTTLE
3980948-016-4612 BOTTLE in 1 PACKAGE (80948-016-46) / 250 mL in 1 BOTTLE
4080948-016-4724 BOTTLE in 1 PACKAGE (80948-016-47) / 250 mL in 1 BOTTLE
4180948-016-494 BOTTLE in 1 PACKAGE (80948-016-49) / 300 mL in 1 BOTTLE
4280948-016-506 BOTTLE in 1 PACKAGE (80948-016-50) / 300 mL in 1 BOTTLE
4380948-016-518 BOTTLE in 1 PACKAGE (80948-016-51) / 300 mL in 1 BOTTLE
4480948-016-5212 BOTTLE in 1 PACKAGE (80948-016-52) / 300 mL in 1 BOTTLE
4580948-016-5812 BOTTLE in 1 PACKAGE (80948-016-58) / 350 mL in 1 BOTTLE
4680948-016-5924 BOTTLE in 1 PACKAGE (80948-016-59) / 350 mL in 1 BOTTLE
4780948-016-605000 mL in 1 CAN (80948-016-60)
4880948-016-6150000 mL in 1 CAN (80948-016-61)
4980948-016-62200000 mL in 1 DRUM (80948-016-62)
5080948-016-6370 mL in 1 BOTTLE (80948-016-63)
5180948-016-64150 mL in 1 BOTTLE (80948-016-64)
5280948-016-6524 BOTTLE in 1 PACKAGE (80948-016-65) / 150 mL in 1 BOTTLE
5380948-016-666 BOTTLE in 1 PACKAGE (80948-016-66) / 220 mL in 1 BOTTLE
5480948-016-678 BOTTLE in 1 PACKAGE (80948-016-67) / 220 mL in 1 BOTTLE
5580948-016-6812 BOTTLE in 1 PACKAGE (80948-016-68) / 220 mL in 1 BOTTLE
5680948-016-6924 BOTTLE in 1 PACKAGE (80948-016-69) / 220 mL in 1 BOTTLE
5780948-016-702 BOTTLE in 1 PACKAGE (80948-016-70) / 250 mL in 1 BOTTLE
5880948-016-714 BOTTLE in 1 PACKAGE (80948-016-71) / 250 mL in 1 BOTTLE
5980948-016-722 BOTTLE in 1 PACKAGE (80948-016-72) / 300 mL in 1 BOTTLE
6080948-016-7324 BOTTLE in 1 PACKAGE (80948-016-73) / 300 mL in 1 BOTTLE
6180948-016-742 BOTTLE in 1 PACKAGE (80948-016-74) / 350 mL in 1 BOTTLE
6280948-016-754 BOTTLE in 1 PACKAGE (80948-016-75) / 350 mL in 1 BOTTLE
6380948-016-766 BOTTLE in 1 PACKAGE (80948-016-76) / 350 mL in 1 BOTTLE
6480948-016-778 BOTTLE in 1 PACKAGE (80948-016-77) / 350 mL in 1 BOTTLE

NDC Record

Field Name Field Value Definition
PRODUCT NDC80948-016The 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.
PRODUCT TYPE NAMEHUMAN OTC DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMEPUROMA Foaming Hand Sanitizer Alcohol Free With Fragrance FloralThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEBenzalkonium chlorideThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMELIQUIDThe translation of the dosage form Code submitted by the firm.
ROUTE NAMETOPICALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE4/27/2021This 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.
SUBSTANCE NAMEBENZALKONIUM CHLORIDEAn active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
ACTIVE NUMERATOR STRENGTH130 
ACTIVE INGRED UNITmg/100mL 

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This page was last updated on: 2/1/2023
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