Hand Sanitizer

Product NDC: 80228-2001
Requested package NDC: 80228-2001-1
11-digit product format: 802282001
Labeler code: 80228
Product ID: 80228-2001_2eea5c8b-01b7-4fd2-e063-6294a90a2b46
Type: HUMAN OTC DRUG
Nonproprietary name: Alcohol
Dosage form: GEL
Route: TOPICAL
Labeler: Universal Synergetics, Inc
Application: M003
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2021-03-01
Marketing end: 2026-11-05
Substance: ALCOHOL
Active strength: .84 mL/1.2mL
NDC exclude flag: No
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Hand Sanitizer

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ALCOHOL	.84 mL/1.2mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3K9958V90M	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
581662	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0dd6884c-935f-4523-b19a-201b7a8666fc	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
80228-2001-1	2023-03-03	C162847	48780-1	f386c64a-1af6-0266-e053-dadaa90a7c1a	Universal Synergetics Hand Sanitizer Gel, 1.2mL (.04 fl oz)
80228-2001-1	2023-01-30	C162847	48780-1	f386c64a-1af6-0266-e053-dadaa90a7c1a	Universal Synergetics Hand Sanitizer Gel, 1.2mL (.04 fl oz)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
80228-2001-1	Hand Sanitizer	1.2 mL in 1 POUCH	GEL	1.2		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80228-2001	HAND SANITIZER (ALCOHOL) GEL [UNIVERSAL SYNERGETICS, INC]	4	Current NDC, Legacy NDC, 1 package rows	20250226_0dd6884c-935f-4523-b19a-201b7a8666fc.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 96 of 114 · 2,275 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DK12 Liquid Hand Creamy	BENZALKONIUM CHLORIDE 0.13%	Industria La Popular, S.A.	01e2e51b-212b-368e-e063-6294a90a871c	2024-12-02	Warnings	Exact identifier application number: M003
DK12 Fresh Energy Antibacterial and Moisturizing	BENZALKONIUM CHLORIDE 0.1%	Industria La Popular, S.A.	fe80635d-9594-abf3-e053-6394a90aa78b	2024-12-02	Warnings	Exact identifier application number: M003
DK12 Shower Gel Creamy	BENZALKONIUM CHLORIDE 0.13%	Industria La Popular, S.A.	05e36111-ed4e-12de-e063-6294a90af639	2024-12-02	Warnings	Exact identifier application number: M003
DK12 Creamy Antibacterial and Moisturizing	BENZALKONIUM CHLORIDE 0.1%	Industria La Popular, S.A.	fe7fde7e-82fc-c13f-e053-6394a90aff68	2024-12-02	Warnings	Exact identifier application number: M003
DK12 Oatmeal Antibacterial and Moisturizing	BENZALKONIUM CHLORIDE 0.1%	Industria La Popular, S.A.	fe16387b-1b16-1f41-e053-6294a90ae2c0	2024-12-02	Warnings	Exact identifier application number: M003
First Aid Antiseptic Isopropyl Alcohol Pad	ISOPROPYL ALCOHOL	Fourstar Group USA, Inc.	27edf5dc-3e68-bdd0-e063-6394a90ac485	2024-11-27	Warnings	Exact identifier application number: M003
MicroKlenz Antimicrobial	BENZETHONIUM CHLORIDE	Medline Industries, LP	115dda08-709c-490a-9693-419b51441960	2024-11-26	Warnings	Exact identifier application number: M003
First Aid Only Alcohol Antiseptic Pad	ALCOHOL PAD	Acme United Corporation	55421010-d806-4ca4-e054-00144ff88e88	2024-11-26	Warnings	Exact identifier application number: M003
First Aid Only Hydrogen Peroxide 3%	HYDROGEN PEROXIDE	Acme United Corporationn	f1db8929-9b95-0d6e-e053-2995a90a817f	2024-11-26	Warnings	Exact identifier application number: M003
First Aid Only Sting Relief Pad	BENZOCAINE, ISOPROPYL ALCOHOL	Acme United Corporation	d71047f6-1353-c758-e053-2995a90a962c	2024-11-26	Warnings	Exact identifier application number: M003
First Aid Only Alcohol Antiseptic Pad	ISOPROPYL ALCOHOL	Acme United Coporation	a01fec1b-1339-40b9-e053-2995a90aeda5	2024-11-23	Warnings	Exact identifier application number: M003
Med-Nap Sterile Alcohol Prep Pads	ISOPROPYL ALCOHOL	Acme United Corporation	c6eff57b-d537-69c8-e053-2a95a90adc3a	2024-11-23	Warnings	Exact identifier application number: M003
First Aid Only Alcohol Antiseptic	ISOPROPYL ALCOHOL	Acme United Corporation	a810e723-ad0c-8c71-e053-2995a90a0acc	2024-11-23	Warnings	Exact identifier application number: M003
Universal 50% Rubbing Alcohol	ISOPROPYL ALCOHOL	Universal Distribution Center LLC	0dcc9bd2-aea5-4c27-9956-47d56221726b	2024-11-22	Warnings	Exact identifier application number: M003
Universal 70% Rubbing Alcohol with Wintergreen and Glycerin	ISOPROPYL ALCOHOL	Universal Distribution Center LLC	9a9d42ad-79d5-4acc-b5d9-cb7468961d47	2024-11-22	Warnings	Exact identifier application number: M003
Universal 50% Rubbing Alcohol with Wintergreen and Glycerin	ISOPROPYL ALCOHOL	Universal Distribution Center LLC	044a6287-f568-4cfa-a813-7fc0e6ffc352	2024-11-22	Warnings	Exact identifier application number: M003
NEXXGEN 70% RUBBING ALCOHOL	ISOPROPYL ALCOHOL	A & A Nexxgen LLC	ce73ac48-c5af-4a35-950c-62ff0232aa30	2024-11-22	Warnings	Exact identifier application number: M003
Universal 70% Rubbing Alcohol	ISOPROPYL ALCOHOL	Universal Distribution Center LLC	d8b9b0e7-2cb8-4fc5-af55-790e64d6cfe8	2024-11-22	Warnings	Exact identifier application number: M003
Alcohol sterile	ISOPROPYL ALCOHOL	Cardinal Health, Inc	bb7c530f-5d80-4158-b715-09c1c837299d	2024-11-21	Warnings	Exact identifier application number: M003
Alcohol sterile	ISOPROPYL ALCOHOL	Cardinal Health 200 LLC	10135db9-f614-4511-96ac-faa6a02a1b61	2024-11-21	Warnings	Exact identifier application number: M003

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
581662	ethanol 70 % Topical Gel	PSN	0dd6884c-935f-4523-b19a-201b7a8666fc	4
581662	ethanol 0.7 ML/ML Topical Gel	SCD	0dd6884c-935f-4523-b19a-201b7a8666fc	4
581662	ethanol 70 % Topical Gel	SY	0dd6884c-935f-4523-b19a-201b7a8666fc	4
581662	ethyl alcohol 70 % Topical Gel	SY	0dd6884c-935f-4523-b19a-201b7a8666fc	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
80228-2001-1	80228200101	1.2 mL in 1 POUCH (80228-2001-1)	1.2 ml	2021-04-13	2026-11-05	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Universal Synergetics Hand Sanitizer Gel, 1.2mL (.04 fl oz)	Universal Synergetics, Inc	2025-02-24	HUMAN OTC DRUG LABEL	4