80948-005 NDC - PUROMA ANTIBACTERIAL FOAMING HAND WASH FRAGRANCE FREE (BENZALKONIUM CHLORIDE)

Drug Information

Product NDC: 80948-005

Proprietary Name: PUROMA Antibacterial Foaming Hand Wash FRAGRANCE FREE

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:	3/10/2021

Package Information

No.	Package Code	Package Description
1	80948-005-01	4 BOTTLE in 1 PACKAGE (80948-005-01) / 70 mL in 1 BOTTLE
2	80948-005-02	6 BOTTLE in 1 PACKAGE (80948-005-02) / 70 mL in 1 BOTTLE
3	80948-005-03	8 BOTTLE in 1 PACKAGE (80948-005-03) / 70 mL in 1 BOTTLE
4	80948-005-04	12 BOTTLE in 1 PACKAGE (80948-005-04) / 70 mL in 1 BOTTLE
5	80948-005-05	24 BOTTLE in 1 PACKAGE (80948-005-05) / 70 mL in 1 BOTTLE
6	80948-005-06	4 BOTTLE in 1 PACKAGE (80948-005-06) / 100 mL in 1 BOTTLE
7	80948-005-07	6 BOTTLE in 1 PACKAGE (80948-005-07) / 100 mL in 1 BOTTLE
8	80948-005-08	8 BOTTLE in 1 PACKAGE (80948-005-08) / 100 mL in 1 BOTTLE
9	80948-005-09	12 BOTTLE in 1 PACKAGE (80948-005-09) / 100 mL in 1 BOTTLE
10	80948-005-10	24 BOTTLE in 1 PACKAGE (80948-005-10) / 100 mL in 1 BOTTLE
11	80948-005-11	4 BOTTLE in 1 PACKAGE (80948-005-11) / 150 mL in 1 BOTTLE
12	80948-005-12	6 BOTTLE in 1 PACKAGE (80948-005-12) / 150 mL in 1 BOTTLE
13	80948-005-13	8 BOTTLE in 1 PACKAGE (80948-005-13) / 150 mL in 1 BOTTLE
14	80948-005-14	12 BOTTLE in 1 PACKAGE (80948-005-14) / 150 mL in 1 BOTTLE
15	80948-005-15	24 BOTTLE in 1 PACKAGE (80948-005-15) / 150 mL in 1 BOTTLE
16	80948-005-21	4 BOTTLE in 1 PACKAGE (80948-005-21) / 200 mL in 1 BOTTLE
17	80948-005-22	6 BOTTLE in 1 PACKAGE (80948-005-22) / 200 mL in 1 BOTTLE
18	80948-005-23	8 BOTTLE in 1 PACKAGE (80948-005-23) / 200 mL in 1 BOTTLE
19	80948-005-24	12 BOTTLE in 1 PACKAGE (80948-005-24) / 200 mL in 1 BOTTLE
20	80948-005-25	24 BOTTLE in 1 PACKAGE (80948-005-25) / 200 mL in 1 BOTTLE
21	80948-005-26	4 BOTTLE in 1 PACKAGE (80948-005-26) / 220 mL in 1 BOTTLE
22	80948-005-27	6 BOTTLE in 1 PACKAGE (80948-005-27) / 220 mL in 1 BOTTLE
23	80948-005-28	8 BOTTLE in 1 PACKAGE (80948-005-28) / 220 mL in 1 BOTTLE
24	80948-005-29	12 BOTTLE in 1 PACKAGE (80948-005-29) / 220 mL in 1 BOTTLE
25	80948-005-30	24 BOTTLE in 1 PACKAGE (80948-005-30) / 220 mL in 1 BOTTLE
26	80948-005-31	2 BOTTLE in 1 PACKAGE (80948-005-31) / 250 mL in 1 BOTTLE
27	80948-005-32	4 BOTTLE in 1 PACKAGE (80948-005-32) / 250 mL in 1 BOTTLE
28	80948-005-33	6 BOTTLE in 1 PACKAGE (80948-005-33) / 250 mL in 1 BOTTLE
29	80948-005-34	8 BOTTLE in 1 PACKAGE (80948-005-34) / 250 mL in 1 BOTTLE
30	80948-005-35	12 BOTTLE in 1 PACKAGE (80948-005-35) / 250 mL in 1 BOTTLE
31	80948-005-36	24 BOTTLE in 1 PACKAGE (80948-005-36) / 250 mL in 1 BOTTLE
32	80948-005-37	2 BOTTLE in 1 PACKAGE (80948-005-37) / 300 mL in 1 BOTTLE
33	80948-005-38	4 BOTTLE in 1 PACKAGE (80948-005-38) / 300 mL in 1 BOTTLE
34	80948-005-39	6 BOTTLE in 1 PACKAGE (80948-005-39) / 300 mL in 1 BOTTLE
35	80948-005-40	8 BOTTLE in 1 PACKAGE (80948-005-40) / 300 mL in 1 BOTTLE
36	80948-005-41	12 BOTTLE in 1 PACKAGE (80948-005-41) / 300 mL in 1 BOTTLE
37	80948-005-42	24 BOTTLE in 1 PACKAGE (80948-005-42) / 300 mL in 1 BOTTLE
38	80948-005-43	2 BOTTLE in 1 PACKAGE (80948-005-43) / 350 mL in 1 BOTTLE
39	80948-005-44	4 BOTTLE in 1 PACKAGE (80948-005-44) / 350 mL in 1 BOTTLE
40	80948-005-45	6 BOTTLE in 1 PACKAGE (80948-005-45) / 350 mL in 1 BOTTLE
41	80948-005-46	8 BOTTLE in 1 PACKAGE (80948-005-46) / 350 mL in 1 BOTTLE
42	80948-005-47	12 BOTTLE in 1 PACKAGE (80948-005-47) / 350 mL in 1 BOTTLE
43	80948-005-48	24 BOTTLE in 1 PACKAGE (80948-005-48) / 350 mL in 1 BOTTLE
44	80948-005-49	5000 mL in 1 CAN (80948-005-49)
45	80948-005-50	50000 mL in 1 CAN (80948-005-50)
46	80948-005-51	200000 mL in 1 DRUM (80948-005-51)
47	80948-005-52	250 mL in 1 BOTTLE (80948-005-52)

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	80948-005	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 Antibacterial Foaming Hand Wash 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	Benzalkonium chloride	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	3/10/2021	This is the date that the labeler indicates was the start of its marketing of the drug product.
MARKETING CATEGORY NAME	OTC MONOGRAPH NOT FINAL	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	part333A	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	BENZALKONIUM CHLORIDE	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	130
ACTIVE INGRED UNIT	mg/100mL

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

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