Hand Sanitizer

Product NDC
11344-053
Requested package NDC
11344-053-42
11-digit product format
113440053
Labeler code
11344
Product ID
11344-053_da29f4be-daf1-4ca8-b0b3-e0576a41605a
Type
HUMAN OTC DRUG
Nonproprietary name
Ethyl Alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
Vi-Jon, LLC
Application
part333A
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2009-01-05
Marketing end
0000-00-00
Substance
ALCOHOL
Active strength
545 mg/mL
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage11344-05311344-053-42DDiscontinued by firm2026-10-05

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 dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALCOHOLACTIVE INGREDIENT3K9958V90MHAND SANITIZER (ETHYL ALCOHOL) GEL [VI-JON]4
ALCOHOLACTIVE MOIETY3K9958V90MHAND SANITIZER (ETHYL ALCOHOL) GEL [VI-JON]4
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0HAND SANITIZER (ETHYL ALCOHOL) GEL [VI-JON]4
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XHAND SANITIZER (ETHYL ALCOHOL) GEL [VI-JON]4
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)INACTIVE INGREDIENT59TL3WG5COHAND SANITIZER (ETHYL ALCOHOL) GEL [VI-JON]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDHAND SANITIZER (ETHYL ALCOHOL) GEL [VI-JON]4
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MHAND SANITIZER (ETHYL ALCOHOL) GEL [VI-JON]4
GLYCERININACTIVE INGREDIENTPDC6A3C0OXHAND SANITIZER (ETHYL ALCOHOL) GEL [VI-JON]4
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302HAND SANITIZER (ETHYL ALCOHOL) GEL [VI-JON]4
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSHAND SANITIZER (ETHYL ALCOHOL) GEL [VI-JON]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3HAND SANITIZER (ETHYL ALCOHOL) GEL [VI-JON]4
WATERINACTIVE INGREDIENT059QF0KO0RHAND SANITIZER (ETHYL ALCOHOL) GEL [VI-JON]4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11344-053-4211344005342828 mL in 1 BOTTLE, PUMP (11344-053-42) 828 ml2009-01-050000-00-00NoNoCurrent