FDA.reportPublic FDA data

Epi-Clenz Instant Hand Antiseptic

Product NDC
53329-204
11-digit product format
533290204
Labeler code
53329
Product ID
53329-204_d1000de9-822c-5f51-e053-2995a90a8070
Type
HUMAN OTC DRUG
Nonproprietary name
ethyl alcohol
Dosage form
GEL
Route
TOPICAL
Labeler
Medline Industries, LP
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2007-09-20
Marketing end
2022-01-31
Substance
ALCOHOL
Active strength
70 mL/100mL
NDC exclude flag
No
Listing certified through
0000-00-00
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct53329-204DDiscontinued by firm2026-10-05
excluded productproduct53329-204DDiscontinued by firm2026-10-05
excluded packagepackage53329-20453329-204-12DDiscontinued by firm2026-10-05
excluded packagepackage53329-20453329-204-84DDiscontinued by firm2026-10-05
excluded packagepackage53329-20453329-204-04DDiscontinued by firm2026-10-05
excluded packagepackage53329-20453329-204-06DDiscontinued by firm2026-10-05
excluded packagepackage53329-20453329-204-08DDiscontinued 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 2 · 84 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53329-204-04d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53329-204-84d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53329-204-06d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53329-204-12d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53329-204-08d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53329-204-04f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53329-204-84f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53329-204-06f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53329-204-12f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53329-204-08f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53329-204-042ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53329-204-842ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53329-204-062ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53329-204-122ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53329-204-082ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53329-204-04a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53329-204-84a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53329-204-06a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53329-204-12a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53329-204-08a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53329-204-04cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53329-204-84cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53329-204-06cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53329-204-12cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53329-204-08cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53329-204-04cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53329-204-84cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53329-204-06cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53329-204-12cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53329-204-08cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53329-204-04302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53329-204-84302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53329-204-06302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53329-204-12302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53329-204-08302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53329-204-04ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53329-204-84ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53329-204-06ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53329-204-12ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53329-204-08ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53329-204-040efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53329-204-840efc9e666f02…f202fb6c5f17…

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 INGREDIENT3K9958V90MEPI-CLENZ INSTANT HAND ANTISEPTIC (ETHYL ALCOHOL) GEL [MEDLINE INDUSTRIES, INC.]2
ALCOHOLACTIVE MOIETY3K9958V90MEPI-CLENZ INSTANT HAND ANTISEPTIC (ETHYL ALCOHOL) GEL [MEDLINE INDUSTRIES, INC.]2
.ALPHA.-TOCOPHEROL ACETATE, D-INACTIVE INGREDIENTA7E6112E4NEPI-CLENZ INSTANT HAND ANTISEPTIC (ETHYL ALCOHOL) GEL [MEDLINE INDUSTRIES, INC.]2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XEPI-CLENZ INSTANT HAND ANTISEPTIC (ETHYL ALCOHOL) GEL [MEDLINE INDUSTRIES, INC.]2
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)INACTIVE INGREDIENTZ135WT9208EPI-CLENZ INSTANT HAND ANTISEPTIC (ETHYL ALCOHOL) GEL [MEDLINE INDUSTRIES, INC.]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXEPI-CLENZ INSTANT HAND ANTISEPTIC (ETHYL ALCOHOL) GEL [MEDLINE INDUSTRIES, INC.]2
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302EPI-CLENZ INSTANT HAND ANTISEPTIC (ETHYL ALCOHOL) GEL [MEDLINE INDUSTRIES, INC.]2
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSEPI-CLENZ INSTANT HAND ANTISEPTIC (ETHYL ALCOHOL) GEL [MEDLINE INDUSTRIES, INC.]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3EPI-CLENZ INSTANT HAND ANTISEPTIC (ETHYL ALCOHOL) GEL [MEDLINE INDUSTRIES, INC.]2
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKEPI-CLENZ INSTANT HAND ANTISEPTIC (ETHYL ALCOHOL) GEL [MEDLINE INDUSTRIES, INC.]2
WATERINACTIVE INGREDIENT059QF0KO0REPI-CLENZ INSTANT HAND ANTISEPTIC (ETHYL ALCOHOL) GEL [MEDLINE INDUSTRIES, INC.]2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53329-204-0653329020406473 mL in 1 BOTTLE (53329-204-06) 473 ml2007-09-200000-00-00NoNoCurrent
53329-204-0853329020408236 mL in 1 BOTTLE (53329-204-08) 236 ml2007-09-200000-00-00NoNoCurrent