Generic -Hand Sanitizer

Product NDC: 78985-001
11-digit product format: 789850001
Labeler code: 78985
Product ID: 78985-001_a7c234b3-49e2-216c-e053-2995a90a0aa0
Type: HUMAN OTC DRUG
Nonproprietary name: Generic Specialties
Dosage form: GEL
Route: TOPICAL
Labeler: Generic Specialties, Inc.
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2020-09-01
Marketing end: 0000-00-00
Substance: ALCOHOL
Active strength: 70 mL/1
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 · 9 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	78985-001		I	Inactivated by FDA	2026-08-17
excluded package	package	78985-001	78985-001-01	I	Inactivated by FDA	2026-08-17
excluded package	package	78985-001	78985-001-02	I	Inactivated by FDA	2026-08-17
excluded package	package	78985-001	78985-001-03	I	Inactivated by FDA	2026-08-17
excluded package	package	78985-001	78985-001-04	I	Inactivated by FDA	2026-08-17
excluded package	package	78985-001	78985-001-05	I	Inactivated by FDA	2026-08-17
excluded package	package	78985-001	78985-001-06	I	Inactivated by FDA	2026-08-17
excluded package	package	78985-001	78985-001-07	I	Inactivated by FDA	2026-08-17
excluded package	package	78985-001	78985-001-08	I	Inactivated by FDA	2026-08-17

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 · 162 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	78985-001-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78985-001-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78985-001-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78985-001-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78985-001-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78985-001-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78985-001-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	78985-001-02	`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	78985-001-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78985-001-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78985-001-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78985-001-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78985-001-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78985-001-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78985-001-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	78985-001-02	`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	78985-001-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78985-001-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78985-001-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78985-001-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78985-001-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78985-001-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78985-001-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	78985-001-02	`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	78985-001-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78985-001-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78985-001-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78985-001-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78985-001-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78985-001-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78985-001-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	78985-001-02	`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	78985-001-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78985-001-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78985-001-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78985-001-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78985-001-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78985-001-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78985-001-07	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	78985-001-02	`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	78985-001-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78985-001-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78985-001-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78985-001-08	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78985-001-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78985-001-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78985-001-07	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	78985-001-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	78985-001-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	78985-001-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	78985-001-06	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	78985-001-08	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	78985-001-01	`302b2466d912…`	`e7b80fea0513…`

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
78985-001-01	a7c2d766-9a59-9f61-e053-2a95a90ac4d4
78985-001-02	a7c2d766-9a59-9f61-e053-2a95a90ac4d4
78985-001-03	a7c2d766-9a59-9f61-e053-2a95a90ac4d4
78985-001-04	a7c2d766-9a59-9f61-e053-2a95a90ac4d4
78985-001-05	a7c2d766-9a59-9f61-e053-2a95a90ac4d4
78985-001-06	a7c2d766-9a59-9f61-e053-2a95a90ac4d4
78985-001-07	a7c2d766-9a59-9f61-e053-2a95a90ac4d4
78985-001-08	a7c2d766-9a59-9f61-e053-2a95a90ac4d4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
78985-001-01	Generic -Hand Sanitizer	50 in 1 BOTTLE	GEL	50	1
78985-001-02	Generic -Hand Sanitizer	89 in 1 BOTTLE	GEL	89	1
78985-001-03	Generic -Hand Sanitizer	100 in 1 BOTTLE	GEL	100	1
78985-001-04	Generic -Hand Sanitizer	200 in 1 BOTTLE	GEL	200	1
78985-001-05	Generic -Hand Sanitizer	500 in 1 BOTTLE	GEL	500	1
78985-001-06	Generic -Hand Sanitizer	1000 in 1 BOTTLE	GEL	1000	1
78985-001-07	Generic -Hand Sanitizer	5000 in 1 BOTTLE	GEL	5000	1
78985-001-08	Generic -Hand Sanitizer	350 in 1 BOTTLE	GEL	350	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
78985-001	GENERIC -HAND SANITIZER (GENERIC SPECIALTIES) GEL [GENERIC SPECIALTIES, INC.]	1	Legacy NDC, 8 package rows	20200909_a7c2d766-9a59-9f61-e053-2a95a90ac4d4.zip

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
78985-001-01	78985000101	50 GEL in 1 BOTTLE (78985-001-01)	50 gel	2020-09-01	0000-00-00	No	No	Current
78985-001-02	78985000102	89 GEL in 1 BOTTLE (78985-001-02)	89 gel	2020-09-01	0000-00-00	No	No	Current
78985-001-03	78985000103	100 GEL in 1 BOTTLE (78985-001-03)	100 gel	2020-09-01	0000-00-00	No	No	Current
78985-001-04	78985000104	200 GEL in 1 BOTTLE (78985-001-04)	200 gel	2020-09-01	0000-00-00	No	No	Current
78985-001-05	78985000105	500 GEL in 1 BOTTLE (78985-001-05)	500 gel	2020-09-01	0000-00-00	No	No	Current
78985-001-06	78985000106	1000 GEL in 1 BOTTLE (78985-001-06)	1000 gel	2020-09-01	0000-00-00	No	No	Current
78985-001-07	78985000107	5000 GEL in 1 BOTTLE (78985-001-07)	5000 gel	2020-09-01	0000-00-00	No	No	Current
78985-001-08	78985000108	350 GEL in 1 BOTTLE (78985-001-08)	350 gel	2020-09-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Generic -Hand Sanitizer - Generic Specialties, Inc. \| Generic Secialties, Inc.	Generic Specialties, Inc. \| Generic Secialties, Inc.	2020-07-25	HUMAN OTC DRUG LABEL	1