ACP Hand sanitizer

Product NDC: 78287-160
11-digit product format: 782870160
Labeler code: 78287
Product ID: 78287-160_9af2a501-b2de-4c3e-8e70-489cc4df90dd
Type: HUMAN OTC DRUG
Nonproprietary name: Ethyl Alcohol
Dosage form: GEL
Route: TOPICAL
Labeler: Swanrose, Inc.
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2020-06-24
Marketing end: 0000-00-00
Substance: ALCOHOL
Active strength: 73 mL/100mL
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 12 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	78287-160		I	Inactivated by FDA	2026-10-05
excluded package	package	78287-160	78287-160-01	I	Inactivated by FDA	2026-10-05
excluded package	package	78287-160	78287-160-02	I	Inactivated by FDA	2026-10-05
excluded package	package	78287-160	78287-160-03	I	Inactivated by FDA	2026-10-05
excluded package	package	78287-160	78287-160-04	I	Inactivated by FDA	2026-10-05
excluded package	package	78287-160	78287-160-05	I	Inactivated by FDA	2026-10-05
excluded package	package	78287-160	78287-160-06	I	Inactivated by FDA	2026-10-05
excluded package	package	78287-160	78287-160-07	I	Inactivated by FDA	2026-10-05
excluded package	package	78287-160	78287-160-08	I	Inactivated by FDA	2026-10-05
excluded package	package	78287-160	78287-160-09	I	Inactivated by FDA	2026-10-05
excluded package	package	78287-160	78287-160-10	I	Inactivated by FDA	2026-10-05
excluded package	package	78287-160	78287-160-11	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 4 · 216 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	78287-160-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78287-160-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78287-160-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78287-160-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78287-160-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78287-160-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78287-160-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78287-160-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78287-160-11	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78287-160-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78287-160-07	`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	78287-160-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78287-160-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78287-160-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78287-160-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78287-160-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78287-160-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78287-160-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78287-160-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78287-160-11	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78287-160-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78287-160-07	`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	78287-160-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78287-160-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78287-160-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78287-160-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78287-160-09	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78287-160-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78287-160-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78287-160-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78287-160-11	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78287-160-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78287-160-07	`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	78287-160-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78287-160-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78287-160-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78287-160-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78287-160-09	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78287-160-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78287-160-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78287-160-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78287-160-11	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78287-160-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78287-160-07	`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	78287-160-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78287-160-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78287-160-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78287-160-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78287-160-09	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78287-160-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78287-160-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78287-160-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78287-160-11	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78287-160-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78287-160-07	`cfe11265f3b6…`	`090c488252e2…`

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
78287-160-01	ACP Hand Sanitizer
78287-160-02	ACP Hand Sanitizer
78287-160-03	ACP Hand Sanitizer
78287-160-04	ACP Hand Sanitizer
78287-160-05	ACP Hand Sanitizer
78287-160-06	ACP Hand Sanitizer
78287-160-07	ACP Hand Sanitizer
78287-160-08	ACP Hand Sanitizer
78287-160-09	ACP Hand Sanitizer
78287-160-10	ACP Hand Sanitizer
78287-160-11	ACP Hand Sanitizer

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
78287-160-01	ACP Hand sanitizer	29 mL in 1 BOTTLE	GEL	29	1
78287-160-02	ACP Hand sanitizer	60 mL in 1 BOTTLE	GEL	60	1
78287-160-03	ACP Hand sanitizer	80 mL in 1 BOTTLE	GEL	80	1
78287-160-04	ACP Hand sanitizer	100 mL in 1 BOTTLE	GEL	100	1
78287-160-05	ACP Hand sanitizer	250 mL in 1 BOTTLE	GEL	250	1
78287-160-06	ACP Hand sanitizer	260 mL in 1 BOTTLE	GEL	260	1
78287-160-07	ACP Hand sanitizer	300 mL in 1 BOTTLE	GEL	300	1
78287-160-08	ACP Hand sanitizer	500 mL in 1 BOTTLE	GEL	500	1
78287-160-09	ACP Hand sanitizer	980 mL in 1 BOTTLE	GEL	980	1
78287-160-10	ACP Hand sanitizer	3785 mL in 1 BOTTLE	GEL	3785	1
78287-160-11	ACP Hand sanitizer	5000 mL in 1 CAN	GEL	5000	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
78287-160	ACP HAND SANITIZER (ETHYL ALCOHOL) GEL [SWANROSE, INC.]	1	Legacy NDC, 11 package rows	20200710_38c62375-9d26-4de6-aeb4-f4177a7d662a.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3K9958V90M	ALCOHOL	64-17-5	ALCOHOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2286987	ethanol 73 % Topical Gel	PSN	38c62375-9d26-4de6-aeb4-f4177a7d662a	1
2286987	ethanol 0.73 ML/ML Topical Gel	SCD	38c62375-9d26-4de6-aeb4-f4177a7d662a	1
2286987	ethanol 73 % Topical Gel	SY	38c62375-9d26-4de6-aeb4-f4177a7d662a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
78287-160-01	78287016001	29 mL in 1 BOTTLE (78287-160-01)	29 ml	2020-06-24	0000-00-00	No	No	Current
78287-160-02	78287016002	60 mL in 1 BOTTLE (78287-160-02)	60 ml	2020-06-24	0000-00-00	No	No	Current
78287-160-03	78287016003	80 mL in 1 BOTTLE (78287-160-03)	80 ml	2020-06-24	0000-00-00	No	No	Current
78287-160-04	78287016004	100 mL in 1 BOTTLE (78287-160-04)	100 ml	2020-06-24	0000-00-00	No	No	Current
78287-160-05	78287016005	250 mL in 1 BOTTLE (78287-160-05)	250 ml	2020-06-24	0000-00-00	No	No	Current
78287-160-06	78287016006	260 mL in 1 BOTTLE (78287-160-06)	260 ml	2020-06-24	0000-00-00	No	No	Current
78287-160-07	78287016007	300 mL in 1 BOTTLE (78287-160-07)	300 ml	2020-06-24	0000-00-00	No	No	Current
78287-160-08	78287016008	500 mL in 1 BOTTLE (78287-160-08)	500 ml	2020-06-24	0000-00-00	No	No	Current
78287-160-09	78287016009	980 mL in 1 BOTTLE (78287-160-09)	980 ml	2020-06-24	0000-00-00	No	No	Current
78287-160-10	78287016010	3785 mL in 1 BOTTLE (78287-160-10)	3785 ml	2020-06-24	0000-00-00	No	No	Current
78287-160-11	78287016011	5000 mL in 1 CAN (78287-160-11)	5000 ml	2020-06-24	0000-00-00	No	No	Current