Skintegrity Antibacterial Hand

Product NDC
53329-978
11-digit product format
533290978
Labeler code
53329
Product ID
53329-978_8c01bcd8-6beb-4940-b5b3-02c3dec43cc1
Type
HUMAN OTC DRUG
Nonproprietary name
Triclosan
Dosage form
SOAP
Route
TOPICAL
Labeler
Medline Industries, Inc.
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2011-04-08
Marketing end
0000-00-00
Substance
TRICLOSAN
Active strength
1 mL/100mL
NDC exclude flag
No
Listing certified through
2019-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct53329-978DDiscontinued by firm2026-10-20
excluded packagepackage53329-97853329-978-82DDiscontinued by firm2026-10-20
excluded packagepackage53329-97853329-978-84DDiscontinued by firm2026-10-20

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 · 36 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 packagepackage53329-978-82d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage53329-978-84d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53329-978-82f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53329-978-84f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53329-978-822ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53329-978-842ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53329-978-82a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53329-978-84a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53329-978-82cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53329-978-84cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53329-978-82cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53329-978-84cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53329-978-82302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53329-978-84302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53329-978-82ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53329-978-84ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53329-978-820efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53329-978-840efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53329-978-82ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53329-978-84ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53329-978-82367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53329-978-84367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53329-978-82557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53329-978-84557ba5c1ecfa…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
TRICLOSANACTIVE INGREDIENT4NM5039Y5XSKINTEGRITY ANTIBACTERIAL HAND FOAMING (TRICLOSAN) SOAP [MEDLINE INDUSTRIES, INC.]1
TRICLOSANACTIVE MOIETY4NM5039Y5XSKINTEGRITY ANTIBACTERIAL HAND FOAMING (TRICLOSAN) SOAP [MEDLINE INDUSTRIES, INC.]1
.ALPHA.-TOCOPHEROL ACETATE, D-INACTIVE INGREDIENTA7E6112E4NSKINTEGRITY ANTIBACTERIAL HAND FOAMING (TRICLOSAN) SOAP [MEDLINE INDUSTRIES, INC.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XSKINTEGRITY ANTIBACTERIAL HAND FOAMING (TRICLOSAN) SOAP [MEDLINE INDUSTRIES, INC.]1
AMMONIUM LAURYL SULFATEINACTIVE INGREDIENTQ7AO2R1M0BSKINTEGRITY ANTIBACTERIAL HAND FOAMING (TRICLOSAN) SOAP [MEDLINE INDUSTRIES, INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPSKINTEGRITY ANTIBACTERIAL HAND FOAMING (TRICLOSAN) SOAP [MEDLINE INDUSTRIES, INC.]1
COCO DIETHANOLAMIDEINACTIVE INGREDIENT92005F972DSKINTEGRITY ANTIBACTERIAL HAND FOAMING (TRICLOSAN) SOAP [MEDLINE INDUSTRIES, INC.]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LSKINTEGRITY ANTIBACTERIAL HAND FOAMING (TRICLOSAN) SOAP [MEDLINE INDUSTRIES, INC.]1
DMDM HYDANTOININACTIVE INGREDIENTBYR0546TOWSKINTEGRITY ANTIBACTERIAL HAND FOAMING (TRICLOSAN) SOAP [MEDLINE INDUSTRIES, INC.]1
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUSKINTEGRITY ANTIBACTERIAL HAND FOAMING (TRICLOSAN) SOAP [MEDLINE INDUSTRIES, INC.]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MSKINTEGRITY ANTIBACTERIAL HAND FOAMING (TRICLOSAN) SOAP [MEDLINE INDUSTRIES, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSKINTEGRITY ANTIBACTERIAL HAND FOAMING (TRICLOSAN) SOAP [MEDLINE INDUSTRIES, INC.]1
POLYQUATERNIUM-10 (400 CPS AT 2%)INACTIVE INGREDIENTHB1401PQFSSKINTEGRITY ANTIBACTERIAL HAND FOAMING (TRICLOSAN) SOAP [MEDLINE INDUSTRIES, INC.]1
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD)INACTIVE INGREDIENT0L414VCS5YSKINTEGRITY ANTIBACTERIAL HAND FOAMING (TRICLOSAN) SOAP [MEDLINE INDUSTRIES, INC.]1
SODIUM LAURETH SULFATEINACTIVE INGREDIENTBPV390UAP0SKINTEGRITY ANTIBACTERIAL HAND FOAMING (TRICLOSAN) SOAP [MEDLINE INDUSTRIES, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RSKINTEGRITY ANTIBACTERIAL HAND FOAMING (TRICLOSAN) SOAP [MEDLINE INDUSTRIES, INC.]1