Skintegrity Antibacterial Hand

Product NDC
53329-043
11-digit product format
533290043
Labeler code
53329
Product ID
53329-043_f8366a24-06ac-4417-a1fc-ea7338a0781d
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
E
Listing certified through
2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct53329-043IInactivated by FDA2026-10-12
excluded packagepackage53329-04353329-043-20IInactivated by FDA2026-10-12

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 · 44 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 packagepackage53329-043-20d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage53329-043-20f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage53329-043-202ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage53329-043-20a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage53329-043-20cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage53329-043-20cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage53329-043-20302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage53329-043-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53329-043-200efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage53329-043-20ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage53329-043-20367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage53329-043-20557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage53329-043-208af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage53329-043-20834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage53329-043-201332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage53329-043-20fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage53329-043-2086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage53329-043-20bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage53329-043-208dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage53329-043-20e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage53329-043-209bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage53329-043-20110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53329-043-202019-10-29C16284748780-1960f7f55-cfc2-8e05-e053-dbdaa90a074aDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53329-043-20Skintegrity Antibacterial HandBlue1 in 1 BOXSOAP13
53329-043-20Skintegrity Antibacterial HandBlue800 mL in 1 BAGSOAP8003

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRICLOSANACTIVE INGREDIENT4NM5039Y5XSKINTEGRITY ANTIBACTERIAL HAND BLUE (TRICLOSAN) SOAP [MEDLINE INDUSTRIES, INC.]3
TRICLOSANACTIVE MOIETY4NM5039Y5XSKINTEGRITY ANTIBACTERIAL HAND BLUE (TRICLOSAN) SOAP [MEDLINE INDUSTRIES, INC.]3
AMMONIUM LAURYL SULFATEINACTIVE INGREDIENTQ7AO2R1M0BSKINTEGRITY ANTIBACTERIAL HAND BLUE (TRICLOSAN) SOAP [MEDLINE INDUSTRIES, INC.]3
ARGININEINACTIVE INGREDIENT94ZLA3W45FSKINTEGRITY ANTIBACTERIAL HAND BLUE (TRICLOSAN) SOAP [MEDLINE INDUSTRIES, INC.]3
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171KSKINTEGRITY ANTIBACTERIAL HAND BLUE (TRICLOSAN) SOAP [MEDLINE INDUSTRIES, INC.]3
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPSKINTEGRITY ANTIBACTERIAL HAND BLUE (TRICLOSAN) SOAP [MEDLINE INDUSTRIES, INC.]3
COCO DIETHANOLAMIDEINACTIVE INGREDIENT92005F972DSKINTEGRITY ANTIBACTERIAL HAND BLUE (TRICLOSAN) SOAP [MEDLINE INDUSTRIES, INC.]3
DMDM HYDANTOININACTIVE INGREDIENTBYR0546TOWSKINTEGRITY ANTIBACTERIAL HAND BLUE (TRICLOSAN) SOAP [MEDLINE INDUSTRIES, INC.]3
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUSKINTEGRITY ANTIBACTERIAL HAND BLUE (TRICLOSAN) SOAP [MEDLINE INDUSTRIES, INC.]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDSKINTEGRITY ANTIBACTERIAL HAND BLUE (TRICLOSAN) SOAP [MEDLINE INDUSTRIES, INC.]3
GLUTAMIC ACIDINACTIVE INGREDIENT3KX376GY7LSKINTEGRITY ANTIBACTERIAL HAND BLUE (TRICLOSAN) SOAP [MEDLINE INDUSTRIES, INC.]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXSKINTEGRITY ANTIBACTERIAL HAND BLUE (TRICLOSAN) SOAP [MEDLINE INDUSTRIES, INC.]3
GLYCINEINACTIVE INGREDIENTTE7660XO1CSKINTEGRITY ANTIBACTERIAL HAND BLUE (TRICLOSAN) SOAP [MEDLINE INDUSTRIES, INC.]3
ISOLEUCINEINACTIVE INGREDIENT04Y7590D77SKINTEGRITY ANTIBACTERIAL HAND BLUE (TRICLOSAN) SOAP [MEDLINE INDUSTRIES, INC.]3
LEUCINEINACTIVE INGREDIENTGMW67QNF9CSKINTEGRITY ANTIBACTERIAL HAND BLUE (TRICLOSAN) SOAP [MEDLINE INDUSTRIES, INC.]3
PHENYLALANINEINACTIVE INGREDIENT47E5O17Y3RSKINTEGRITY ANTIBACTERIAL HAND BLUE (TRICLOSAN) SOAP [MEDLINE INDUSTRIES, INC.]3
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD)INACTIVE INGREDIENT0L414VCS5YSKINTEGRITY ANTIBACTERIAL HAND BLUE (TRICLOSAN) SOAP [MEDLINE INDUSTRIES, INC.]3
PROLINEINACTIVE INGREDIENT9DLQ4CIU6VSKINTEGRITY ANTIBACTERIAL HAND BLUE (TRICLOSAN) SOAP [MEDLINE INDUSTRIES, INC.]3
SERINEINACTIVE INGREDIENT452VLY9402SKINTEGRITY ANTIBACTERIAL HAND BLUE (TRICLOSAN) SOAP [MEDLINE INDUSTRIES, INC.]3
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XSKINTEGRITY ANTIBACTERIAL HAND BLUE (TRICLOSAN) SOAP [MEDLINE INDUSTRIES, INC.]3
SODIUM LAURETH SULFATEINACTIVE INGREDIENTBPV390UAP0SKINTEGRITY ANTIBACTERIAL HAND BLUE (TRICLOSAN) SOAP [MEDLINE INDUSTRIES, INC.]3
VALINEINACTIVE INGREDIENTHG18B9YRS7SKINTEGRITY ANTIBACTERIAL HAND BLUE (TRICLOSAN) SOAP [MEDLINE INDUSTRIES, INC.]3
WATERINACTIVE INGREDIENT059QF0KO0RSKINTEGRITY ANTIBACTERIAL HAND BLUE (TRICLOSAN) SOAP [MEDLINE INDUSTRIES, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-043SKINTEGRITY ANTIBACTERIAL HAND BLUE (TRICLOSAN) SOAP [MEDLINE INDUSTRIES, INC.]3Legacy NDC, 2 package rows20110714_f8366a24-06ac-4417-a1fc-ea7338a0781d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
413247triclosan 0.5 % Medicated Liquid SoapPSNf8366a24-06ac-4417-a1fc-ea7338a0781d3
413247triclosan 5 MG/ML Medicated Liquid SoapSCDf8366a24-06ac-4417-a1fc-ea7338a0781d3
413247triclosan 0.5 % Foaming Medicated Hand SoapSYf8366a24-06ac-4417-a1fc-ea7338a0781d3
413247triclosan 0.5 % Medicated Liquid SoapSYf8366a24-06ac-4417-a1fc-ea7338a0781d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53329-043-20533290043201 in 1 BOXHistorical