ANTI-BACTERIAL WET WIPES

Product NDC: 78028-004
11-digit product format: 780280004
Labeler code: 78028
Product ID: 78028-004_d5983e19-5987-2a64-e053-2a95a90a4333
Type: HUMAN OTC DRUG
Nonproprietary name: BENZALKONIUM CHLORIDE
Dosage form: CLOTH
Route: TOPICAL
Labeler: Dalian Daxin Nonwoven Technology Co., Ltd.
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2020-07-20
Marketing end: 0000-00-00
Substance: BENZALKONIUM CHLORIDE
Active strength: 0 g/100g
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 22 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	78028-004		D	Discontinued by firm	2026-10-05
excluded product	product	78028-004		I	Inactivated by FDA	2026-10-05
excluded package	package	78028-004	78028-004-01	D	Discontinued by firm	2026-10-05
excluded package	package	78028-004	78028-004-02	D	Discontinued by firm	2026-10-05
excluded package	package	78028-004	78028-004-03	D	Discontinued by firm	2026-10-05
excluded package	package	78028-004	78028-004-04	D	Discontinued by firm	2026-10-05
excluded package	package	78028-004	78028-004-05	D	Discontinued by firm	2026-10-05
excluded package	package	78028-004	78028-004-06	D	Discontinued by firm	2026-10-05
excluded package	package	78028-004	78028-004-07	D	Discontinued by firm	2026-10-05
excluded package	package	78028-004	78028-004-08	D	Discontinued by firm	2026-10-05
excluded package	package	78028-004	78028-004-09	D	Discontinued by firm	2026-10-05
excluded package	package	78028-004	78028-004-10	D	Discontinued by firm	2026-10-05
excluded package	package	78028-004	78028-004-01	I	Inactivated by FDA	2026-10-05
excluded package	package	78028-004	78028-004-02	I	Inactivated by FDA	2026-10-05
excluded package	package	78028-004	78028-004-03	I	Inactivated by FDA	2026-10-05
excluded package	package	78028-004	78028-004-04	I	Inactivated by FDA	2026-10-05
excluded package	package	78028-004	78028-004-05	I	Inactivated by FDA	2026-10-05
excluded package	package	78028-004	78028-004-06	I	Inactivated by FDA	2026-10-05
excluded package	package	78028-004	78028-004-07	I	Inactivated by FDA	2026-10-05
excluded package	package	78028-004	78028-004-08	I	Inactivated by FDA	2026-10-05
excluded package	package	78028-004	78028-004-09	I	Inactivated by FDA	2026-10-05
excluded package	package	78028-004	78028-004-10	I	Inactivated by FDA	2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 5 · 297 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78028-004-02	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78028-004-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78028-004-08	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78028-004-02	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78028-004-01	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78028-004-09	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78028-004-07	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78028-004-04	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78028-004-03	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78028-004-08	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78028-004-10	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78028-004-06	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78028-004-01	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78028-004-07	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78028-004-06	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78028-004-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78028-004-04	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78028-004-03	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78028-004-10	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78028-004-09	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78028-004-02	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78028-004-05	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78028-004-08	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78028-004-02	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78028-004-01	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78028-004-09	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78028-004-07	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78028-004-04	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78028-004-03	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78028-004-08	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78028-004-10	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78028-004-06	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78028-004-01	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78028-004-07	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78028-004-06	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78028-004-05	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78028-004-04	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78028-004-03	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78028-004-10	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78028-004-09	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78028-004-02	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78028-004-05	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78028-004-08	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78028-004-02	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78028-004-01	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78028-004-09	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78028-004-07	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78028-004-04	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78028-004-03	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78028-004-08	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78028-004-10	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78028-004-06	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78028-004-01	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78028-004-07	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d1c9d1af-bddd-448d-86f7-69052b7d5b47	Product name	1	20220627

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
78028-004-01	78028-004 ANTI-BACTERIAL WET WIPES 0.13% BENZALKONIUM CHLORIDE
78028-004-02	78028-004 ANTI-BACTERIAL WET WIPES 0.13% BENZALKONIUM CHLORIDE
78028-004-03	78028-004 ANTI-BACTERIAL WET WIPES 0.13% BENZALKONIUM CHLORIDE
78028-004-04	78028-004 ANTI-BACTERIAL WET WIPES 0.13% BENZALKONIUM CHLORIDE
78028-004-05	78028-004 ANTI-BACTERIAL WET WIPES 0.13% BENZALKONIUM CHLORIDE
78028-004-06	78028-004 ANTI-BACTERIAL WET WIPES 0.13% BENZALKONIUM CHLORIDE
78028-004-07	78028-004 ANTI-BACTERIAL WET WIPES 0.13% BENZALKONIUM CHLORIDE
78028-004-08	78028-004 ANTI-BACTERIAL WET WIPES 0.13% BENZALKONIUM CHLORIDE
78028-004-09	78028-004 ANTI-BACTERIAL WET WIPES 0.13% BENZALKONIUM CHLORIDE
78028-004-10	78028-004 ANTI-BACTERIAL WET WIPES 0.13% BENZALKONIUM CHLORIDE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
78028-004-01	ANTI-BACTERIAL WET WIPES	6.5 g in 1 NOT APPLICABLE	CLOTH	6.5	3
78028-004-01	ANTI-BACTERIAL WET WIPES	50 in 1 PAIL	CLOTH	50	3
78028-004-02	ANTI-BACTERIAL WET WIPES	6.5 g in 1 NOT APPLICABLE	CLOTH	6.5	3
78028-004-02	ANTI-BACTERIAL WET WIPES	70 in 1 PAIL	CLOTH	70	3
78028-004-03	ANTI-BACTERIAL WET WIPES	80 in 1 PAIL	CLOTH	80	3
78028-004-03	ANTI-BACTERIAL WET WIPES	6.5 g in 1 NOT APPLICABLE	CLOTH	6.5	3
78028-004-04	ANTI-BACTERIAL WET WIPES	100 in 1 PAIL	CLOTH	100	3
78028-004-04	ANTI-BACTERIAL WET WIPES	6.5 g in 1 NOT APPLICABLE	CLOTH	6.5	3
78028-004-05	ANTI-BACTERIAL WET WIPES	6.5 g in 1 NOT APPLICABLE	CLOTH	6.5	3
78028-004-05	ANTI-BACTERIAL WET WIPES	30 in 1 BAG	CLOTH	30	3
78028-004-06	ANTI-BACTERIAL WET WIPES	6.5 g in 1 NOT APPLICABLE	CLOTH	6.5	3
78028-004-06	ANTI-BACTERIAL WET WIPES	40 in 1 BAG	CLOTH	40	3
78028-004-07	ANTI-BACTERIAL WET WIPES	6.5 g in 1 NOT APPLICABLE	CLOTH	6.5	3
78028-004-07	ANTI-BACTERIAL WET WIPES	50 in 1 BAG	CLOTH	50	3
78028-004-08	ANTI-BACTERIAL WET WIPES	6.5 g in 1 NOT APPLICABLE	CLOTH	6.5	3
78028-004-08	ANTI-BACTERIAL WET WIPES	60 in 1 BAG	CLOTH	60	3
78028-004-09	ANTI-BACTERIAL WET WIPES	80 in 1 BAG	CLOTH	80	3
78028-004-09	ANTI-BACTERIAL WET WIPES	6.5 g in 1 NOT APPLICABLE	CLOTH	6.5	3
78028-004-10	ANTI-BACTERIAL WET WIPES	150 in 1 PAIL	CLOTH	150	3
78028-004-10	ANTI-BACTERIAL WET WIPES	6.5 g in 1 NOT APPLICABLE	CLOTH	6.5	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
78028-004	ANTI-BACTERIAL WET WIPES (BENZALKONIUM CHLORIDE) CLOTH [DALIAN DAXIN NONWOVEN TECHNOLOGY CO., LTD.]	3	Legacy NDC, 20 package rows	20220115_ab2def5c-5033-902a-e053-2a95a90af986.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
F5UM2KM3W7	BENZALKONIUM CHLORIDE	8001-54-5	BENZALKONIUM CHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1038558	benzalkonium chloride 0.13 % Medicated Pad	PSN	ab2def5c-5033-902a-e053-2a95a90af986	3
1038558	benzalkonium chloride 1.3 MG/ML Medicated Pad	SCD	ab2def5c-5033-902a-e053-2a95a90af986	3
1038558	benzalkonium chloride 0.13 % Topical Cloth	SY	ab2def5c-5033-902a-e053-2a95a90af986	3
1038558	benzalkonium chloride 0.13 % Topical Swab	SY	ab2def5c-5033-902a-e053-2a95a90af986	3
1038558	benzalkonium chloride 0.13 GM per 100 GM Topical Pad	SY	ab2def5c-5033-902a-e053-2a95a90af986	3
1038558	benzalkonium chloride 0.13 GM per 100 GM Topical Swab	SY	ab2def5c-5033-902a-e053-2a95a90af986	3
1038558	benzalkonium chloride 1 ML per 750 ML Topical Swab	SY	ab2def5c-5033-902a-e053-2a95a90af986	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
78028-004-01	78028000401	50 NOT APPLICABLE in 1 PAIL (78028-004-01) > 6.5 g in 1 NOT APPLICABLE	50 not applicable	2020-07-20	0000-00-00	No	No	Current
78028-004-02	78028000402	70 NOT APPLICABLE in 1 PAIL (78028-004-02) > 6.5 g in 1 NOT APPLICABLE	70 not applicable	2020-07-20	0000-00-00	No	No	Current
78028-004-03	78028000403	80 NOT APPLICABLE in 1 PAIL (78028-004-03) > 6.5 g in 1 NOT APPLICABLE	80 not applicable	2020-07-20	0000-00-00	No	No	Current
78028-004-04	78028000404	100 NOT APPLICABLE in 1 PAIL (78028-004-04) > 6.5 g in 1 NOT APPLICABLE	100 not applicable	2020-07-20	0000-00-00	No	No	Current
78028-004-05	78028000405	30 NOT APPLICABLE in 1 BAG (78028-004-05) > 6.5 g in 1 NOT APPLICABLE	30 not applicable	2020-07-20	0000-00-00	No	No	Current
78028-004-06	78028000406	40 NOT APPLICABLE in 1 BAG (78028-004-06) > 6.5 g in 1 NOT APPLICABLE	40 not applicable	2020-07-20	0000-00-00	No	No	Current
78028-004-07	78028000407	50 NOT APPLICABLE in 1 BAG (78028-004-07) > 6.5 g in 1 NOT APPLICABLE	50 not applicable	2020-07-20	0000-00-00	No	No	Current
78028-004-08	78028000408	60 NOT APPLICABLE in 1 BAG (78028-004-08) > 6.5 g in 1 NOT APPLICABLE	60 not applicable	2020-07-20	0000-00-00	No	No	Current
78028-004-09	78028000409	80 NOT APPLICABLE in 1 BAG (78028-004-09) > 6.5 g in 1 NOT APPLICABLE	80 not applicable	2020-07-20	0000-00-00	No	No	Current
78028-004-10	78028000410	150 NOT APPLICABLE in 1 PAIL (78028-004-10) > 6.5 g in 1 NOT APPLICABLE	150 not applicable	2020-07-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
78028-004 ANTI-BACTERIAL WET WIPES 0.13% BENZALKONIUM CHLORIDE	Dalian Daxin Nonwoven Technology Co., Ltd.	2022-01-14	HUMAN OTC DRUG LABEL	3