HAND SANITIZER

Product NDC: 78678-003
11-digit product format: 786780003
Labeler code: 78678
Product ID: 78678-003_244a535d-e343-45b9-bbcc-2c1d55bb40ff
Type: HUMAN OTC DRUG
Nonproprietary name: Alcohol
Dosage form: SOLUTION
Route: TOPICAL
Labeler: Volunteer Plastics
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2020-05-22
Marketing end: 0000-00-00
Substance: ALCOHOL
Active strength: 80 L/100L
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 · 10 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	78678-003		I	Inactivated by FDA	2026-10-15
excluded package	package	78678-003	78678-003-03	I	Inactivated by FDA	2026-10-15
excluded package	package	78678-003	78678-003-04	I	Inactivated by FDA	2026-10-15
excluded package	package	78678-003	78678-003-05	I	Inactivated by FDA	2026-10-15
excluded package	package	78678-003	78678-003-06	I	Inactivated by FDA	2026-10-15
excluded package	package	78678-003	78678-003-07	I	Inactivated by FDA	2026-10-15
excluded package	package	78678-003	78678-003-08	I	Inactivated by FDA	2026-10-15
excluded package	package	78678-003	78678-003-09	I	Inactivated by FDA	2026-10-15
excluded package	package	78678-003	78678-003-10	I	Inactivated by FDA	2026-10-15
excluded package	package	78678-003	78678-003-11	I	Inactivated by FDA	2026-10-15

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 · 180 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	78678-003-11	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78678-003-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78678-003-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78678-003-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78678-003-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78678-003-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78678-003-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78678-003-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78678-003-07	`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	78678-003-11	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78678-003-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78678-003-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78678-003-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78678-003-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78678-003-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78678-003-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78678-003-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78678-003-07	`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	78678-003-11	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78678-003-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78678-003-09	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78678-003-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78678-003-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78678-003-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78678-003-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78678-003-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78678-003-07	`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	78678-003-11	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78678-003-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78678-003-09	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78678-003-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78678-003-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78678-003-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78678-003-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78678-003-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78678-003-07	`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	78678-003-11	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78678-003-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78678-003-09	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78678-003-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78678-003-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78678-003-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78678-003-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78678-003-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78678-003-07	`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	78678-003-11	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78678-003-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78678-003-09	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78678-003-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78678-003-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78678-003-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78678-003-08	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78678-003-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78678-003-07	`cdf11ea48f46…`	`ba0047e9e063…`

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
5eb9f24b-9328-475e-af0a-18021935eb6a	Product name	1	20180220

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
78678-003-03	261e001f-e7f9-4324-8853-63374e628b16
78678-003-04	261e001f-e7f9-4324-8853-63374e628b16
78678-003-05	261e001f-e7f9-4324-8853-63374e628b16
78678-003-06	261e001f-e7f9-4324-8853-63374e628b16
78678-003-07	261e001f-e7f9-4324-8853-63374e628b16
78678-003-08	261e001f-e7f9-4324-8853-63374e628b16
78678-003-09	261e001f-e7f9-4324-8853-63374e628b16
78678-003-10	261e001f-e7f9-4324-8853-63374e628b16
78678-003-11	261e001f-e7f9-4324-8853-63374e628b16

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
78678-003-03	HAND SANITIZER	0.887 L in 1 BOTTLE	SOLUTION	0.887	2
78678-003-04	HAND SANITIZER	0.148 L in 1 BOTTLE	SOLUTION	0.148	2
78678-003-05	HAND SANITIZER	0.236 L in 1 BOTTLE	SOLUTION	0.236	2
78678-003-06	HAND SANITIZER	3.875 L in 1 BOTTLE, PUMP	SOLUTION	3.875	2
78678-003-07	HAND SANITIZER	3.875 L in 1 BOTTLE	SOLUTION	3.875	2
78678-003-08	HAND SANITIZER	1.89 L in 1 BOTTLE, PUMP	SOLUTION	1.89	2
78678-003-09	HAND SANITIZER	1.89 L in 1 BOTTLE	SOLUTION	1.89	2
78678-003-10	HAND SANITIZER	.355 L in 1 BOTTLE, DISPENSING	SOLUTION	.355	2
78678-003-11	HAND SANITIZER	.355 L in 1 PACKAGE	SOLUTION	.355	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
78678-003	HAND SANITIZER (ALCOHOL) SOLUTION [VOLUNTEER PLASTICS]	2	Legacy NDC, 9 package rows	20200806_261e001f-e7f9-4324-8853-63374e628b16.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
1039339	ethanol 80 % Topical Solution	PSN	261e001f-e7f9-4324-8853-63374e628b16	2
1039339	ethanol 0.8 ML/ML Topical Solution	SCD	261e001f-e7f9-4324-8853-63374e628b16	2
1039339	ethanol 80 % Topical Solution	SY	261e001f-e7f9-4324-8853-63374e628b16	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
78678-003-03	78678000303	.887 L in 1 BOTTLE (78678-003-03)		2020-05-22	0000-00-00	No	No	Current
78678-003-04	78678000304	.148 L in 1 BOTTLE (78678-003-04)		2020-05-22	0000-00-00	No	No	Current
78678-003-05	78678000305	.236 L in 1 BOTTLE (78678-003-05)		2020-07-22	0000-00-00	No	No	Current
78678-003-06	78678000306	3.875 L in 1 BOTTLE, PUMP (78678-003-06)	3.875 l	2020-07-22	0000-00-00	No	No	Current
78678-003-07	78678000307	3.875 L in 1 BOTTLE (78678-003-07)	3.875 l	2020-07-22	0000-00-00	No	No	Current
78678-003-08	78678000308	1.89 L in 1 BOTTLE, PUMP (78678-003-08)	1.89 l	2020-07-22	0000-00-00	No	No	Current
78678-003-09	78678000309	1.89 L in 1 BOTTLE (78678-003-09)	1.89 l	2020-07-22	0000-00-00	No	No	Current
78678-003-10	78678000310	.355 L in 1 BOTTLE, DISPENSING (78678-003-10)		2020-07-22	0000-00-00	No	No	Current
78678-003-11	78678000311	.355 L in 1 PACKAGE (78678-003-11)		2020-07-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
HAND SANITIZER - Volunteer Plastics \| JATKO LLC	Volunteer Plastics \| JATKO LLC	2020-07-22	HUMAN OTC DRUG LABEL	2