Hand Sanitizer

Product NDC: 90116-435
11-digit product format: 901160435
Labeler code: 90116
Product ID: 90116-435_ac8cb5ec-91d6-4c6a-e053-2995a90abafd
Type: HUMAN OTC DRUG
Nonproprietary name: ALCOHOL
Dosage form: GEL
Route: TOPICAL
Labeler: Smart Solutions, Inc.
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2020-08-10
Marketing end: 0000-00-00
Substance: ALCOHOL
Active strength: 69 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 · 10 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	90116-435		I	Inactivated by FDA	2026-10-05
excluded package	package	90116-435	90116-435-01	I	Inactivated by FDA	2026-10-05
excluded package	package	90116-435	90116-435-02	I	Inactivated by FDA	2026-10-05
excluded package	package	90116-435	90116-435-04	I	Inactivated by FDA	2026-10-05
excluded package	package	90116-435	90116-435-05	I	Inactivated by FDA	2026-10-05
excluded package	package	90116-435	90116-435-08	I	Inactivated by FDA	2026-10-05
excluded package	package	90116-435	90116-435-16	I	Inactivated by FDA	2026-10-05
excluded package	package	90116-435	90116-435-32	I	Inactivated by FDA	2026-10-05
excluded package	package	90116-435	90116-435-33	I	Inactivated by FDA	2026-10-05
excluded package	package	90116-435	90116-435-55	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 · 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	90116-435-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	90116-435-16	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	90116-435-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	90116-435-33	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	90116-435-32	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	90116-435-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	90116-435-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	90116-435-55	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	90116-435-04	`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	90116-435-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	90116-435-16	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	90116-435-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	90116-435-33	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	90116-435-32	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	90116-435-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	90116-435-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	90116-435-55	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	90116-435-04	`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	90116-435-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	90116-435-16	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	90116-435-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	90116-435-33	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	90116-435-32	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	90116-435-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	90116-435-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	90116-435-55	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	90116-435-04	`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	90116-435-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	90116-435-16	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	90116-435-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	90116-435-33	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	90116-435-32	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	90116-435-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	90116-435-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	90116-435-55	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	90116-435-04	`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	90116-435-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	90116-435-16	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	90116-435-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	90116-435-33	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	90116-435-32	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	90116-435-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	90116-435-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	90116-435-55	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	90116-435-04	`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	90116-435-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	90116-435-16	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	90116-435-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	90116-435-33	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	90116-435-32	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	90116-435-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	90116-435-08	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	90116-435-55	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	90116-435-04	`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
90116-435-01	ac8cb499-23b6-5c44-e053-2995a90a2548
90116-435-02	ac8cb499-23b6-5c44-e053-2995a90a2548
90116-435-04	ac8cb499-23b6-5c44-e053-2995a90a2548
90116-435-05	ac8cb499-23b6-5c44-e053-2995a90a2548
90116-435-08	ac8cb499-23b6-5c44-e053-2995a90a2548
90116-435-16	ac8cb499-23b6-5c44-e053-2995a90a2548
90116-435-32	ac8cb499-23b6-5c44-e053-2995a90a2548
90116-435-33	ac8cb499-23b6-5c44-e053-2995a90a2548
90116-435-55	ac8cb499-23b6-5c44-e053-2995a90a2548

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
90116-435-01	Hand Sanitizer	3785 mL in 1 JUG	GEL	3785	1
90116-435-02	Hand Sanitizer	59 mL in 1 BOTTLE	GEL	59	1
90116-435-04	Hand Sanitizer	118 mL in 1 BOTTLE	GEL	118	1
90116-435-05	Hand Sanitizer	18927 mL in 1 PAIL	GEL	18927	1
90116-435-08	Hand Sanitizer	237 mL in 1 BOTTLE	GEL	237	1
90116-435-16	Hand Sanitizer	473 mL in 1 BOTTLE	GEL	473	1
90116-435-32	Hand Sanitizer	946 mL in 1 BOTTLE	GEL	946	1
90116-435-33	Hand Sanitizer	1249186 mL in 1 TANK	GEL	1249186	1
90116-435-55	Hand Sanitizer	208198 mL in 1 DRUM	GEL	208198	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
90116-435	HAND SANITIZER (ALCOHOL) GEL [SMART SOLUTIONS, INC.]	1	Legacy NDC, 9 package rows	20200821_ac8cb499-23b6-5c44-e053-2995a90a2548.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
90116-435-01	90116043501	3785 mL in 1 JUG (90116-435-01)	3785 ml	2020-08-10	0000-00-00	No	No	Current
90116-435-02	90116043502	59 mL in 1 BOTTLE (90116-435-02)	59 ml	2020-08-10	0000-00-00	No	No	Current
90116-435-04	90116043504	118 mL in 1 BOTTLE (90116-435-04)	118 ml	2020-08-10	0000-00-00	No	No	Current
90116-435-05	90116043505	18927 mL in 1 PAIL (90116-435-05)	18927 ml	2020-08-10	0000-00-00	No	No	Current
90116-435-08	90116043508	237 mL in 1 BOTTLE (90116-435-08)	237 ml	2020-08-10	0000-00-00	No	No	Current
90116-435-16	90116043516	473 mL in 1 BOTTLE (90116-435-16)	473 ml	2020-08-10	0000-00-00	No	No	Current
90116-435-32	90116043532	946 mL in 1 BOTTLE (90116-435-32)	946 ml	2020-08-10	0000-00-00	No	No	Current
90116-435-33	90116043533	1249186 mL in 1 TANK (90116-435-33)	1249186 ml	2020-08-10	0000-00-00	No	No	Current
90116-435-55	90116043555	208198 mL in 1 DRUM (90116-435-55)	208198 ml	2020-08-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hand Sanitizer - Smart Solutions, Inc. \| Fluid USA, Inc	Smart Solutions, Inc. \| Fluid USA, Inc	2020-08-10	HUMAN OTC DRUG LABEL	1