Hand Sanitizer Isopropyl Alcohol Antiseptic 70% Topical Gel

Product NDC: 71158-004
11-digit product format: 711580004
Labeler code: 71158
Product ID: 71158-004_ae429ff4-c97d-5cdb-e053-2995a90a944e
Type: HUMAN OTC DRUG
Nonproprietary name: ISOPROPY ALCOHOL
Dosage form: GEL
Route: TOPICAL
Labeler: Solugen, Inc.
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2020-08-31
Marketing end: 0000-00-00
Substance: ISOPROPYL ALCOHOL
Active strength: 70 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 · 7 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	71158-004		I	Inactivated by FDA	2026-10-05
excluded package	package	71158-004	71158-004-01	I	Inactivated by FDA	2026-10-05
excluded package	package	71158-004	71158-004-02	I	Inactivated by FDA	2026-10-05
excluded package	package	71158-004	71158-004-03	I	Inactivated by FDA	2026-10-05
excluded package	package	71158-004	71158-004-04	I	Inactivated by FDA	2026-10-05
excluded package	package	71158-004	71158-004-05	I	Inactivated by FDA	2026-10-05
excluded package	package	71158-004	71158-004-09	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 · 126 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	71158-004-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71158-004-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71158-004-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71158-004-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71158-004-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	71158-004-09	`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	71158-004-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71158-004-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71158-004-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71158-004-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71158-004-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	71158-004-09	`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	71158-004-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71158-004-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71158-004-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71158-004-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71158-004-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	71158-004-09	`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	71158-004-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71158-004-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71158-004-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71158-004-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71158-004-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	71158-004-09	`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	71158-004-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71158-004-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71158-004-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71158-004-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71158-004-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	71158-004-09	`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	71158-004-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71158-004-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71158-004-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71158-004-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71158-004-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	71158-004-09	`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	71158-004-03	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71158-004-05	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71158-004-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71158-004-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71158-004-04	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	71158-004-09	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71158-004-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71158-004-05	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71158-004-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71158-004-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71158-004-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	71158-004-09	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71158-004-03	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71158-004-05	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	71158-004-01	`0efc9e666f02…`	`f202fb6c5f17…`

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
71158-004-01	Hand Sanitizer Isopropyl Alcohol Antiseptic 70% Topical Gel
71158-004-02	Hand Sanitizer Isopropyl Alcohol Antiseptic 70% Topical Gel
71158-004-03	Hand Sanitizer Isopropyl Alcohol Antiseptic 70% Topical Gel
71158-004-04	Hand Sanitizer Isopropyl Alcohol Antiseptic 70% Topical Gel
71158-004-05	Hand Sanitizer Isopropyl Alcohol Antiseptic 70% Topical Gel
71158-004-09	Hand Sanitizer Isopropyl Alcohol Antiseptic 70% Topical Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71158-004-01	Hand Sanitizer Isopropyl Alcohol Antiseptic 70% Topical Gel	18927000 mL in 1 TANK	GEL	18927000	1
71158-004-02	Hand Sanitizer Isopropyl Alcohol Antiseptic 70% Topical Gel	1249000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK	GEL	1249000	1
71158-004-03	Hand Sanitizer Isopropyl Alcohol Antiseptic 70% Topical Gel	208198 mL in 1 DRUM	GEL	208198	1
71158-004-04	Hand Sanitizer Isopropyl Alcohol Antiseptic 70% Topical Gel	18927 mL in 1 DRUM	GEL	18927	1
71158-004-05	Hand Sanitizer Isopropyl Alcohol Antiseptic 70% Topical Gel	3785 mL in 1 PAIL	GEL	3785	1
71158-004-09	Hand Sanitizer Isopropyl Alcohol Antiseptic 70% Topical Gel	1000 mL in 1 BOTTLE	GEL	1000	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71158-004	HAND SANITIZER ISOPROPYL ALCOHOL ANTISEPTIC 70% TOPICAL GEL (ISOPROPY ALCOHOL) GEL [SOLUGEN, INC.]	1	Legacy NDC, 6 package rows	20200902_ae42a017-83e8-56f2-e053-2995a90aa844.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
ND2M416302	ISOPROPYL ALCOHOL	67-63-0	ISOPROPYL ALCOHOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
581698	isopropyl alcohol 70 % Topical Gel	PSN	ae42a017-83e8-56f2-e053-2995a90aa844	1
581698	isopropyl alcohol 0.7 ML/ML Topical Gel	SCD	ae42a017-83e8-56f2-e053-2995a90aa844	1
581698	isopropyl alcohol 70 % Topical Gel	SY	ae42a017-83e8-56f2-e053-2995a90aa844	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71158-004-01	71158000401	18927000 mL in 1 TANK (71158-004-01)	18927000 ml	2020-08-31	0000-00-00	No	No	Current
71158-004-02	71158000402	1249000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK (71158-004-02)	1249000 ml	2020-08-31	0000-00-00	No	No	Current
71158-004-03	71158000403	208198 mL in 1 DRUM (71158-004-03)	208198 ml	2020-08-31	0000-00-00	No	No	Current
71158-004-04	71158000404	18927 mL in 1 DRUM (71158-004-04)	18927 ml	2020-08-31	0000-00-00	No	No	Current
71158-004-05	71158000405	3785 mL in 1 PAIL (71158-004-05)	3785 ml	2020-08-31	0000-00-00	No	No	Current
71158-004-09	71158000409	1000 mL in 1 BOTTLE (71158-004-09)	1000 ml	2020-08-31	0000-00-00	Yes	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hand Sanitizer Isopropyl Alcohol Antiseptic 70% Topical Gel	Solugen, Inc.	2020-08-31	HUMAN OTC DRUG LABEL	1