Hand Sanitizer

Product NDC: 75383-101
11-digit product format: 753830101
Labeler code: 75383
Product ID: 75383-101_d6a8e68e-48ee-ee85-e053-2995a90ad415
Type: HUMAN OTC DRUG
Nonproprietary name: Isopropyl Alcohol
Dosage form: GEL
Route: TOPICAL
Labeler: PHARMEDICA USA LLC
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2020-12-01
Marketing end: 0000-00-00
Substance: ISOPROPYL ALCOHOL
Active strength: 75 mL/100mL
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 11 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	75383-101		I	Inactivated by FDA	2026-10-05
excluded product	product	75383-101		I	Inactivated by FDA	2026-10-05
excluded package	package	75383-101	75383-101-98	I	Inactivated by FDA	2026-10-05
excluded package	package	75383-101	75383-101-99	I	Inactivated by FDA	2026-10-05
excluded package	package	75383-101	75383-101-00	I	Inactivated by FDA	2026-10-05
excluded package	package	75383-101	75383-101-01	I	Inactivated by FDA	2026-10-05
excluded package	package	75383-101	75383-101-02	I	Inactivated by FDA	2026-10-05
excluded package	package	75383-101	75383-101-03	I	Inactivated by FDA	2026-10-05
excluded package	package	75383-101	75383-101-04	I	Inactivated by FDA	2026-10-05
excluded package	package	75383-101	75383-101-05	I	Inactivated by FDA	2026-10-05
excluded package	package	75383-101	75383-101-06	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 · 165 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 product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	75383-101-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	75383-101-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	75383-101-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	75383-101-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	75383-101-00	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	75383-101-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	75383-101-99	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	75383-101-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	75383-101-98	`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 product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	75383-101-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	75383-101-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	75383-101-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	75383-101-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	75383-101-00	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	75383-101-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	75383-101-99	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	75383-101-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	75383-101-98	`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 product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	75383-101-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	75383-101-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	75383-101-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	75383-101-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	75383-101-00	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	75383-101-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	75383-101-99	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	75383-101-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	75383-101-98	`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 product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	75383-101-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	75383-101-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	75383-101-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	75383-101-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	75383-101-00	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	75383-101-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	75383-101-99	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	75383-101-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	75383-101-98	`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 product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	75383-101-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	75383-101-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	75383-101-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	75383-101-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	75383-101-00	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	75383-101-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	75383-101-99	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	75383-101-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	75383-101-98	`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 product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	75383-101-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	75383-101-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	75383-101-03	`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
60c52429-fcef-eb54-2387-43bc9e4f296b	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Indexing SPL table
NDC	Effective	Indexing SPL	Related label
75383-101-00	2023-07-28	d6a99b39-796e-a426-e053-dadaa90af4c2	acc634bb-4d4a-c6b2-e053-2995a90a89dd
75383-101-01	2023-07-28	d6a99b39-796e-a426-e053-dadaa90af4c2	acc634bb-4d4a-c6b2-e053-2995a90a89dd
75383-101-02	2023-07-28	d6a99b39-796e-a426-e053-dadaa90af4c2	acc634bb-4d4a-c6b2-e053-2995a90a89dd
75383-101-03	2023-07-28	d6a99b39-796e-a426-e053-dadaa90af4c2	acc634bb-4d4a-c6b2-e053-2995a90a89dd
75383-101-04	2023-07-28	d6a99b39-796e-a426-e053-dadaa90af4c2	acc634bb-4d4a-c6b2-e053-2995a90a89dd
75383-101-05	2023-07-28	d6a99b39-796e-a426-e053-dadaa90af4c2	acc634bb-4d4a-c6b2-e053-2995a90a89dd
75383-101-06	2023-07-28	d6a99b39-796e-a426-e053-dadaa90af4c2	acc634bb-4d4a-c6b2-e053-2995a90a89dd
75383-101-98	2023-07-28	d6a99b39-4b71-a426-e053-dadaa90af4c2	Hand Sanitizer Lotion Product
75383-101-99	2023-07-28	d6a99b39-4b71-a426-e053-dadaa90af4c2	Hand Sanitizer Lotion Product
75383-101-00	2022-01-30	d6a99b39-796e-a426-e053-dadaa90af4c2	acc634bb-4d4a-c6b2-e053-2995a90a89dd
75383-101-01	2022-01-30	d6a99b39-796e-a426-e053-dadaa90af4c2	acc634bb-4d4a-c6b2-e053-2995a90a89dd
75383-101-02	2022-01-30	d6a99b39-796e-a426-e053-dadaa90af4c2	acc634bb-4d4a-c6b2-e053-2995a90a89dd
75383-101-03	2022-01-30	d6a99b39-796e-a426-e053-dadaa90af4c2	acc634bb-4d4a-c6b2-e053-2995a90a89dd
75383-101-04	2022-01-30	d6a99b39-796e-a426-e053-dadaa90af4c2	acc634bb-4d4a-c6b2-e053-2995a90a89dd
75383-101-05	2022-01-30	d6a99b39-796e-a426-e053-dadaa90af4c2	acc634bb-4d4a-c6b2-e053-2995a90a89dd
75383-101-06	2022-01-30	d6a99b39-796e-a426-e053-dadaa90af4c2	acc634bb-4d4a-c6b2-e053-2995a90a89dd
75383-101-98	2022-01-30	d6a99b39-4b71-a426-e053-dadaa90af4c2	Hand Sanitizer Lotion Product
75383-101-99	2022-01-30	d6a99b39-4b71-a426-e053-dadaa90af4c2	Hand Sanitizer Lotion Product
75383-101-00	2022-01-28	d6a99b39-796e-a426-e053-dadaa90af4c2	acc634bb-4d4a-c6b2-e053-2995a90a89dd
75383-101-01	2022-01-28	d6a99b39-796e-a426-e053-dadaa90af4c2	acc634bb-4d4a-c6b2-e053-2995a90a89dd
75383-101-02	2022-01-28	d6a99b39-796e-a426-e053-dadaa90af4c2	acc634bb-4d4a-c6b2-e053-2995a90a89dd
75383-101-03	2022-01-28	d6a99b39-796e-a426-e053-dadaa90af4c2	acc634bb-4d4a-c6b2-e053-2995a90a89dd
75383-101-04	2022-01-28	d6a99b39-796e-a426-e053-dadaa90af4c2	acc634bb-4d4a-c6b2-e053-2995a90a89dd
75383-101-05	2022-01-28	d6a99b39-796e-a426-e053-dadaa90af4c2	acc634bb-4d4a-c6b2-e053-2995a90a89dd
75383-101-06	2022-01-28	d6a99b39-796e-a426-e053-dadaa90af4c2	acc634bb-4d4a-c6b2-e053-2995a90a89dd
75383-101-98	2022-01-28	d6a99b39-4b71-a426-e053-dadaa90af4c2	Hand Sanitizer Lotion Product
75383-101-99	2022-01-28	d6a99b39-4b71-a426-e053-dadaa90af4c2	Hand Sanitizer Lotion Product

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
75383-101-00	Hand Sanitizer	1040988.24 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK	GEL	1040988.24	3
75383-101-01	Hand Sanitizer	60 mL in 1 BOTTLE	GEL	60	3
75383-101-02	Hand Sanitizer	118 mL in 1 BOTTLE	GEL	118	3
75383-101-03	Hand Sanitizer	237 mL in 1 BOTTLE	GEL	237	3
75383-101-04	Hand Sanitizer	500 mL in 1 BOTTLE	GEL	500	3
75383-101-05	Hand Sanitizer	946 mL in 1 BOTTLE	GEL	946	3
75383-101-06	Hand Sanitizer	3785 mL in 1 BOTTLE	GEL	3785	3
75383-101-98	Hand Sanitizer	100 mL in 1 TUBE	GEL	100	3
75383-101-99	Hand Sanitizer	60 mL in 1 TUBE	GEL	60	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
75383-101	HAND SANITIZER (ISOPROPYL ALCOHOL) GEL [PHARMEDICA USA LLC]	3	Legacy NDC, 2 package rows	20220129_b57ff22c-0144-6186-e053-2995a90a1cbb.zip
75383-101	HAND SANITIZER (ISOPROPYL ALCOHOL) GEL [PHARMEDICA USA LLC]	3	Legacy NDC, 7 package rows	20220129_acc634bb-4d4a-c6b2-e053-2995a90a89dd.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
2285607	isopropyl alcohol 75 % Topical Gel	PSN	acc634bb-4d4a-c6b2-e053-2995a90a89dd	3
2285607	isopropyl alcohol 75 % Topical Gel	PSN	b57ff22c-0144-6186-e053-2995a90a1cbb	3
2285607	isopropyl alcohol 0.75 ML/ML Topical Gel	SCD	acc634bb-4d4a-c6b2-e053-2995a90a89dd	3
2285607	isopropyl alcohol 0.75 ML/ML Topical Gel	SCD	b57ff22c-0144-6186-e053-2995a90a1cbb	3
2285607	isopropyl alcohol 75 % Topical Gel	SY	acc634bb-4d4a-c6b2-e053-2995a90a89dd	3
2285607	isopropyl alcohol 75 % Topical Gel	SY	b57ff22c-0144-6186-e053-2995a90a1cbb	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
75383-101-00	75383010100	1040988.24 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK (75383-101-00)	1040988.24 ml	2020-08-13	0000-00-00	No	No	Current
75383-101-01	75383010101	60 mL in 1 BOTTLE (75383-101-01)	60 ml	2020-08-13	0000-00-00	No	No	Current
75383-101-02	75383010102	118 mL in 1 BOTTLE (75383-101-02)	118 ml	2020-08-13	0000-00-00	No	No	Current
75383-101-03	75383010103	237 mL in 1 BOTTLE (75383-101-03)	237 ml	2020-08-13	0000-00-00	No	No	Current
75383-101-04	75383010104	500 mL in 1 BOTTLE (75383-101-04)	500 ml	2020-08-13	0000-00-00	No	No	Current
75383-101-05	75383010105	946 mL in 1 BOTTLE (75383-101-05)	946 ml	2020-08-13	0000-00-00	No	No	Current
75383-101-06	75383010106	3785 mL in 1 BOTTLE (75383-101-06)	3785 ml	2020-08-13	0000-00-00	No	No	Current
75383-101-98	75383010198	100 mL in 1 TUBE (75383-101-98)	100 ml	2020-12-01	0000-00-00	No	No	Current
75383-101-99	75383010199	60 mL in 1 TUBE (75383-101-99)	60 ml	2020-12-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hand Sanitizer - PHARMEDICA USA LLC	PHARMEDICA USA LLC	2022-01-28	HUMAN OTC DRUG LABEL	3
Hand Sanitizer Lotion Product	PHARMEDICA USA LLC	2022-01-28	HUMAN OTC DRUG LABEL	3