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

Drug Information

Product NDC: 80948-009

Proprietary Name: PUROMA Hand Sanitizer Fragrance Free

Non Proprietary Name: Alcohol

Active Ingredient(s):

70 mL/100mL ALCOHOL

Administration Route(s): TOPICAL

Dosage Form(s): LIQUID

Labeler Information

Labeler Name:	ZENITH MICRO CONTROL
Product Type:	HUMAN OTC DRUG
FDA Application Number:	M003
Marketing Category:	OTC MONOGRAPH DRUG
Start Marketing Date:	3/11/2021

Package Information

No.	Package Code	Package Description
1	80948-009-05	6 BOTTLE in 1 PACKAGE (80948-009-05) / 60 mL in 1 BOTTLE
2	80948-009-06	12 BOTTLE in 1 PACKAGE (80948-009-06) / 60 mL in 1 BOTTLE
3	80948-009-07	24 BOTTLE in 1 PACKAGE (80948-009-07) / 60 mL in 1 BOTTLE
4	80948-009-08	48 BOTTLE in 1 PACKAGE (80948-009-08) / 60 mL in 1 BOTTLE
5	80948-009-09	4 BOTTLE in 1 PACKAGE (80948-009-09) / 89 mL in 1 BOTTLE
6	80948-009-10	6 BOTTLE in 1 PACKAGE (80948-009-10) / 89 mL in 1 BOTTLE
7	80948-009-11	12 BOTTLE in 1 PACKAGE (80948-009-11) / 89 mL in 1 BOTTLE
8	80948-009-12	24 BOTTLE in 1 PACKAGE (80948-009-12) / 89 mL in 1 BOTTLE
9	80948-009-13	48 BOTTLE in 1 PACKAGE (80948-009-13) / 89 mL in 1 BOTTLE
10	80948-009-14	4 BOTTLE in 1 PACKAGE (80948-009-14) / 178 mL in 1 BOTTLE
11	80948-009-15	6 BOTTLE in 1 PACKAGE (80948-009-15) / 178 mL in 1 BOTTLE
12	80948-009-16	12 BOTTLE in 1 PACKAGE (80948-009-16) / 178 mL in 1 BOTTLE
13	80948-009-17	24 BOTTLE in 1 PACKAGE (80948-009-17) / 178 mL in 1 BOTTLE
14	80948-009-18	48 BOTTLE in 1 PACKAGE (80948-009-18) / 178 mL in 1 BOTTLE
15	80948-009-19	4 BOTTLE in 1 PACKAGE (80948-009-19) / 237 mL in 1 BOTTLE
16	80948-009-20	6 BOTTLE in 1 PACKAGE (80948-009-20) / 237 mL in 1 BOTTLE
17	80948-009-21	12 BOTTLE in 1 PACKAGE (80948-009-21) / 237 mL in 1 BOTTLE
18	80948-009-22	24 BOTTLE in 1 PACKAGE (80948-009-22) / 237 mL in 1 BOTTLE
19	80948-009-23	48 BOTTLE in 1 PACKAGE (80948-009-23) / 237 mL in 1 BOTTLE
20	80948-009-24	2 BOTTLE in 1 PACKAGE (80948-009-24) / 326 mL in 1 BOTTLE
21	80948-009-25	4 BOTTLE in 1 PACKAGE (80948-009-25) / 326 mL in 1 BOTTLE
22	80948-009-26	6 BOTTLE in 1 PACKAGE (80948-009-26) / 326 mL in 1 BOTTLE
23	80948-009-27	2 BOTTLE in 1 PACKAGE (80948-009-27) / 488 mL in 1 BOTTLE
24	80948-009-28	2 BOTTLE in 1 PACKAGE (80948-009-28) / 947 mL in 1 BOTTLE
25	80948-009-29	5000 mL in 1 CAN (80948-009-29)
26	80948-009-30	50000 mL in 1 CAN (80948-009-30)
27	80948-009-31	200000 mL in 1 DRUM (80948-009-31)
28	80948-009-32	6 BOTTLE in 1 PACKAGE (80948-009-32) / 30 mL in 1 BOTTLE
29	80948-009-33	12 BOTTLE in 1 PACKAGE (80948-009-33) / 30 mL in 1 BOTTLE
30	80948-009-34	24 BOTTLE in 1 PACKAGE (80948-009-34) / 30 mL in 1 BOTTLE
31	80948-009-35	48 BOTTLE in 1 PACKAGE (80948-009-35) / 30 mL in 1 BOTTLE
32	80948-009-36	30 mL in 1 BOTTLE (80948-009-36)
33	80948-009-37	60 mL in 1 BOTTLE (80948-009-37)
34	80948-009-38	237 mL in 1 BOTTLE (80948-009-38)
35	80948-009-39	488 mL in 1 BOTTLE (80948-009-39)
36	80948-009-40	947 mL in 1 BOTTLE (80948-009-40)

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	80948-009	The 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 NAME	HUMAN OTC DRUG	Indicates 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 NAME	PUROMA Hand Sanitizer Fragrance Free	The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAME	Alcohol	The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAME	LIQUID	The translation of the dosage form Code submitted by the firm.
ROUTE NAME	TOPICAL	The translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE	3/11/2021	This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAME	OTC MONOGRAPH DRUG	Product 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 NUMBER	M003	This 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 NAME	ZENITH MICRO CONTROL	Name of Company corresponding to the labeler code segment of the Product NDC.
SUBSTANCE NAME	ALCOHOL	An 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 STRENGTH	70
ACTIVE INGRED UNIT	mL/100mL

Download Record

Export to text format icon Download this NDC record in Text format: Export

Export to text format icon Download this NDC record in Excel (CSV) format: Export

Export to text format icon Download this NDC record in XML format: Export

This page was last updated on: 4/12/2024

« Previous Code

Next Code »