69821-001 NDC - ANTIBACTERIAL WET WIPES (BENZALKONIUM CHLORIDE)

Drug Information

Product NDC: 69821-001

Proprietary Name: Antibacterial Wet Wipes

Non Proprietary Name: benzalkonium chloride

Active Ingredient(s):

.13 g/100g BENZALKONIUM CHLORIDE

Administration Route(s): TOPICAL

Dosage Form(s): SWAB

Labeler Information

Labeler Name:	Zhejiang Qimei Commodity Co.,Ltd.
Product Type:	HUMAN OTC DRUG
FDA Application Number:	part333A
Marketing Category:	OTC MONOGRAPH NOT FINAL
Start Marketing Date:	5/6/2015

Package Information

No.	Package Code	Package Description
1	69821-001-01	10 POUCH in 1 PACKAGE (69821-001-01) / .0042 g in 1 POUCH
2	69821-001-02	15 POUCH in 1 PACKAGE (69821-001-02) / .0042 g in 1 POUCH
3	69821-001-03	30 POUCH in 1 PACKAGE (69821-001-03) / .0042 g in 1 POUCH
4	69821-001-04	50 POUCH in 1 PACKAGE (69821-001-04) / .0042 g in 1 POUCH
5	69821-001-05	80 POUCH in 1 PACKAGE (69821-001-05) / .0042 g in 1 POUCH
6	69821-001-06	100 POUCH in 1 PACKAGE (69821-001-06) / .0042 g in 1 POUCH
7	69821-001-07	30 POUCH in 1 BOTTLE (69821-001-07) / .0042 g in 1 POUCH
8	69821-001-08	50 POUCH in 1 BOTTLE (69821-001-08) / .0042 g in 1 POUCH
9	69821-001-09	80 POUCH in 1 BOTTLE (69821-001-09) / .0042 g in 1 POUCH
10	69821-001-10	100 POUCH in 1 BOTTLE (69821-001-10) / .0042 g in 1 POUCH
11	69821-001-11	1 POUCH in 1 BAG (69821-001-11) / .0042 g in 1 POUCH
12	69821-001-12	250 POUCH in 1 CANISTER (69821-001-12) / .0042 g in 1 POUCH
13	69821-001-13	800 POUCH in 1 BAG (69821-001-13) / .0042 g in 1 POUCH
14	69821-001-14	1000 POUCH in 1 BAG (69821-001-14) / .0042 g in 1 POUCH
15	69821-001-15	1200 POUCH in 1 BAG (69821-001-15) / .0042 g in 1 POUCH
16	69821-001-16	1500 POUCH in 1 BAG (69821-001-16) / .0042 g in 1 POUCH
17	69821-001-17	16 POUCH in 1 BAG (69821-001-17) / .0042 g in 1 POUCH
18	69821-001-18	8 POUCH in 1 BAG (69821-001-18) / .36 g in 1 POUCH
19	69821-001-19	5 POUCH in 1 BAG (69821-001-19) / 225 g in 1 POUCH
20	69821-001-20	20 POUCH in 1 BAG (69821-001-20) / .9 g in 1 POUCH
21	69821-001-21	2000 POUCH in 1 BAG (69821-001-21) / 5.096 g in 1 POUCH
22	69821-001-22	1600 POUCH in 1 BAG (69821-001-22) / 4.077 g in 1 POUCH
23	69821-001-23	1800 POUCH in 1 BAG (69821-001-23) / 4.587 g in 1 POUCH
24	69821-001-24	2500 POUCH in 1 BAG (69821-001-24) / 6.37 g in 1 POUCH
25	69821-001-25	60 POUCH in 1 BAG (69821-001-25) / 6.37 g in 1 POUCH
26	69821-001-26	120 POUCH in 1 BAG (69821-001-26) / 6.37 g in 1 POUCH
27	69821-001-27	150 POUCH in 1 PAIL (69821-001-27) / 6.37 g in 1 POUCH

NDC Record

Field Name	Field Value	Definition
PRODUCT NDC	69821-001	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	Antibacterial Wet Wipes	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	SWAB	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	5/6/2015	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	Zhejiang Qimei Commodity Co.,Ltd.	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	.13
ACTIVE INGRED UNIT	g/100g

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

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