Hand Sanitizer

Product NDC: 53329-202
11-digit product format: 533290202
Labeler code: 53329
Product ID: 53329-202_4a8e1ef2-4cd3-a9a9-e063-6394a90a3990
Type: HUMAN OTC DRUG
Nonproprietary name: ethyl alcohol
Dosage form: GEL
Route: TOPICAL
Labeler: Medline Industries, LP
Application: 505G(a)(3)
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2015-04-06
Substance: ALCOHOL
Active strength: 70 mL/100mL
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	53329-202	53329-202-70	D	Discontinued by firm		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 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ALCOHOL	70 mL/100mL

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
f84f7050-348d-4f75-ab93-e618ff8de790	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53329-202-04	Hand Sanitizer	118 mL in 1 BOTTLE	GEL	118	11
53329-202-08	Hand Sanitizer	236 mL in 1 BOTTLE	GEL	236	11
53329-202-13	Hand Sanitizer	59 mL in 1 BOTTLE	GEL	59	11
53329-202-70	Hand Sanitizer	443 mL in 1 BOTTLE	GEL	443	11
53329-202-74	Hand Sanitizer	1200 mL in 1 BOTTLE	GEL	1200	11
53329-202-84	Hand Sanitizer	1000 mL in 1 BAG	GEL	1000	11
53329-202-85	Hand Sanitizer	354 mL in 1 BOTTLE	GEL	354	11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ALCOHOL	ACTIVE INGREDIENT	3K9958V90M	HAND SANITIZER (ETHYL ALCOHOL) GEL [MEDLINE INDUSTRIES, INC.]	1
ALCOHOL	ACTIVE MOIETY	3K9958V90M	HAND SANITIZER (ETHYL ALCOHOL) GEL [MEDLINE INDUSTRIES, INC.]	1
.ALPHA.-TOCOPHEROL ACETATE, D-	INACTIVE INGREDIENT	A7E6112E4N	HAND SANITIZER (ETHYL ALCOHOL) GEL [MEDLINE INDUSTRIES, INC.]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	HAND SANITIZER (ETHYL ALCOHOL) GEL [MEDLINE INDUSTRIES, INC.]	1
CARBOMER COPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	809Y72KV36	HAND SANITIZER (ETHYL ALCOHOL) GEL [MEDLINE INDUSTRIES, INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	HAND SANITIZER (ETHYL ALCOHOL) GEL [MEDLINE INDUSTRIES, INC.]	1
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	HAND SANITIZER (ETHYL ALCOHOL) GEL [MEDLINE INDUSTRIES, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	HAND SANITIZER (ETHYL ALCOHOL) GEL [MEDLINE INDUSTRIES, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53329-202	HAND SANITIZER (ETHYL ALCOHOL) GEL [MEDLINE INDUSTRIES, LP]	9	Current NDC, Legacy NDC, 7 package rows	20240531_f84f7050-348d-4f75-ab93-e618ff8de790.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hand Sanitizer	ETHYL ALCOHOL	Medline Industries, LP	f84f7050-348d-4f75-ab93-e618ff8de790	2026-02-11	Warnings	Exact identifier ndc (product): 53329-202

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	f84f7050-348d-4f75-ab93-e618ff8de790	11
581662	ethanol 0.7 ML/ML Topical Gel	SCD	f84f7050-348d-4f75-ab93-e618ff8de790	11
581662	ethanol 70 % Topical Gel	SY	f84f7050-348d-4f75-ab93-e618ff8de790	11
581662	ethyl alcohol 70 % Topical Gel	SY	f84f7050-348d-4f75-ab93-e618ff8de790	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53329-202-04	53329020204	118 mL in 1 BOTTLE (53329-202-04)	118 ml	2015-04-06	0000-00-00	No	No	Current
53329-202-08	53329020208	236 mL in 1 BOTTLE (53329-202-08)	236 ml	2015-04-06	0000-00-00	No	No	Current
53329-202-13	53329020213	59 mL in 1 BOTTLE (53329-202-13)	59 ml	2015-04-06	0000-00-00	No	No	Current
53329-202-70	53329020270	443 mL in 1 BOTTLE (53329-202-70)	443 ml	2015-04-06	2022-03-31	No	No	Current
53329-202-74	53329020274	1200 mL in 1 BOTTLE (53329-202-74)	1200 ml	2023-08-01		No	No	Current
53329-202-84	53329020284	1000 mL in 1 BAG (53329-202-84)	1000 ml	2015-04-06	0000-00-00	No	No	Current
53329-202-85	53329020285	354 mL in 1 BOTTLE (53329-202-85)	354 ml	2021-05-01	0000-00-00	No	No	Current