ANTI-BACTERIAL DOUGH

Product NDC: 78048-016
11-digit product format: 780480016
Labeler code: 78048
Product ID: 78048-016_d3ccdeb4-5152-0c2e-e053-2a95a90ae8d4
Type: HUMAN OTC DRUG
Nonproprietary name: ANTI-BACTERIAL DOUGH
Dosage form: GEL
Route: TOPICAL
Labeler: Dongguan City Dexu Toys Co., Ltd.
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2021-03-23
Marketing end: 0000-00-00
Substance: BENZALKONIUM CHLORIDE
Active strength: 0 g/100g
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 11 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	78048-016		I	Inactivated by FDA	2026-10-05
excluded package	package	78048-016	78048-016-01	I	Inactivated by FDA	2026-10-05
excluded package	package	78048-016	78048-016-02	I	Inactivated by FDA	2026-10-05
excluded package	package	78048-016	78048-016-03	I	Inactivated by FDA	2026-10-05
excluded package	package	78048-016	78048-016-04	I	Inactivated by FDA	2026-10-05
excluded package	package	78048-016	78048-016-05	I	Inactivated by FDA	2026-10-05
excluded package	package	78048-016	78048-016-06	I	Inactivated by FDA	2026-10-05
excluded package	package	78048-016	78048-016-07	I	Inactivated by FDA	2026-10-05
excluded package	package	78048-016	78048-016-08	I	Inactivated by FDA	2026-10-05
excluded package	package	78048-016	78048-016-09	I	Inactivated by FDA	2026-10-05
excluded package	package	78048-016	78048-016-10	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 3 · 165 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78048-016-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78048-016-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78048-016-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78048-016-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78048-016-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78048-016-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78048-016-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78048-016-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78048-016-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78048-016-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78048-016-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78048-016-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78048-016-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78048-016-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78048-016-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78048-016-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78048-016-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78048-016-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78048-016-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78048-016-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78048-016-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78048-016-09	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78048-016-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78048-016-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78048-016-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78048-016-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78048-016-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78048-016-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78048-016-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78048-016-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78048-016-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78048-016-09	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78048-016-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78048-016-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78048-016-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78048-016-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78048-016-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78048-016-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78048-016-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78048-016-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78048-016-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78048-016-09	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78048-016-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78048-016-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78048-016-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78048-016-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78048-016-07	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78048-016-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78048-016-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78048-016-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78048-016-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78048-016-09	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78048-016-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78048-016-06	`cdf11ea48f46…`	`ba0047e9e063…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
78048-016-01	78048-016 ANTI-BACTERIAL DOUGH
78048-016-02	78048-016 ANTI-BACTERIAL DOUGH
78048-016-03	78048-016 ANTI-BACTERIAL DOUGH
78048-016-04	78048-016 ANTI-BACTERIAL DOUGH
78048-016-05	78048-016 ANTI-BACTERIAL DOUGH
78048-016-06	78048-016 ANTI-BACTERIAL DOUGH
78048-016-07	78048-016 ANTI-BACTERIAL DOUGH
78048-016-08	78048-016 ANTI-BACTERIAL DOUGH
78048-016-09	78048-016 ANTI-BACTERIAL DOUGH
78048-016-10	78048-016 ANTI-BACTERIAL DOUGH

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
78048-016-01	ANTI-BACTERIAL DOUGH	29 g in 1 BOX	GEL	29	1
78048-016-02	ANTI-BACTERIAL DOUGH	57 g in 1 BOX	GEL	57	1
78048-016-03	ANTI-BACTERIAL DOUGH	85 g in 1 BOX	GEL	85	1
78048-016-04	ANTI-BACTERIAL DOUGH	114 g in 1 BOX	GEL	114	1
78048-016-05	ANTI-BACTERIAL DOUGH	142 g in 1 BOX	GEL	142	1
78048-016-06	ANTI-BACTERIAL DOUGH	170 g in 1 BOX	GEL	170	1
78048-016-07	ANTI-BACTERIAL DOUGH	199 g in 1 BOX	GEL	199	1
78048-016-08	ANTI-BACTERIAL DOUGH	227 g in 1 BOX	GEL	227	1
78048-016-09	ANTI-BACTERIAL DOUGH	255 g in 1 BOX	GEL	255	1
78048-016-10	ANTI-BACTERIAL DOUGH	284 g in 1 BOX	GEL	284	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
78048-016	ANTI-BACTERIAL DOUGH GEL [DONGGUAN CITY DEXU TOYS CO., LTD.]	1	Legacy NDC, 10 package rows	20211225_d3ccdea4-daf0-d30f-e053-2995a90a0048.zip

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
78048-016-01	78048001601	29 g in 1 BOX (78048-016-01)	29 g	2021-12-25	0000-00-00	No	No	Current
78048-016-02	78048001602	57 g in 1 BOX (78048-016-02)	57 g	2021-03-30	0000-00-00	No	No	Current
78048-016-03	78048001603	85 g in 1 BOX (78048-016-03)	85 g	2021-03-30	0000-00-00	No	No	Current
78048-016-04	78048001604	114 g in 1 BOX (78048-016-04)	114 g	2021-03-30	0000-00-00	No	No	Current
78048-016-05	78048001605	142 g in 1 BOX (78048-016-05)	142 g	2021-03-30	0000-00-00	No	No	Current
78048-016-06	78048001606	170 g in 1 BOX (78048-016-06)	170 g	2021-03-30	0000-00-00	No	No	Current
78048-016-07	78048001607	199 g in 1 BOX (78048-016-07)	199 g	2021-03-30	0000-00-00	No	No	Current
78048-016-08	78048001608	227 g in 1 BOX (78048-016-08)	227 g	2021-03-30	0000-00-00	No	No	Current
78048-016-09	78048001609	255 g in 1 BOX (78048-016-09)	255 g	2021-03-30	0000-00-00	No	No	Current
78048-016-10	78048001610	284 g in 1 BOX (78048-016-10)	284 g	2021-03-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
78048-016 ANTI-BACTERIAL DOUGH	Dongguan City Dexu Toys Co., Ltd.	2021-12-23	HUMAN OTC DRUG LABEL	1