Home NDC 50523-083 Antibacterial Hand Cleanse
Product NDC 50523-083
11-digit product format 505230083
Labeler code 50523
Product ID 50523-083_9a9e378d-d51f-4308-be0e-898124f38826
Type HUMAN OTC DRUG
Nonproprietary name triclosan
Dosage form SOAP
Route TOPICAL
Labeler Volume Distributors, Inc.
Application part333E
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2015-07-10
Marketing end 0000-00-00
Substance TRICLOSAN
Active strength 0 g/100g
NDC exclude flag E
Listing certified through 2017-12-31
Current FDA listing Historical FDA.report record 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 date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 50523-083-01 I Inactivated by FDA d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 50523-083-01 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 50523-083-01 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 50523-083-01 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 50523-083-01 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 50523-083-01 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 50523-083-01 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 50523-083-01 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 50523-083-01 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 50523-083-01 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 50523-083-01 I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 50523-083-01 I Inactivated by FDA 557ba5c1ecfa…9c80585c8c6e…2024-05-28 21:12 UTC · source 2024-05-28 excluded product product I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-28 21:12 UTC · source 2024-05-28 excluded package package 50523-083-01 I Inactivated by FDA 8af77b9d5b6f…d9bbb34c5368…2024-05-15 03:39 UTC · source 2024-05-14 excluded product product I Inactivated by FDA 834df4deac94…adcc014656a3…2024-05-15 03:39 UTC · source 2024-05-14 excluded package package 50523-083-01 I Inactivated by FDA 834df4deac94…adcc014656a3…2024-03-11 06:39 UTC · source 2024-03-08 excluded product product I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2024-03-11 06:39 UTC · source 2024-03-08 excluded package package 50523-083-01 I Inactivated by FDA 1332a3947898…d4bfe170f9cd…2022-08-30 03:57 UTC · source 2022-08-29 excluded product product I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 50523-083-01 I Inactivated by FDA fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 50523-083-01 I Inactivated by FDA 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product I Inactivated by FDA bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 50523-083-01 I Inactivated by FDA bd6a592717d7…303034d00443…2021-12-27 23:28 UTC · source 2021-12-27 excluded product product I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2021-12-27 23:28 UTC · source 2021-12-27 excluded package package 50523-083-01 I Inactivated by FDA 8dfbde2a14a4…c9ff85d89658…2020-12-18 03:04 UTC · source 2020-12-17 excluded product product I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-12-18 03:04 UTC · source 2020-12-17 excluded package package 50523-083-01 I Inactivated by FDA e2bbac7714bc…27bdfed8d636…2020-06-10 20:45 UTC · source 2020-06-10 excluded product product I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2020-06-10 20:45 UTC · source 2020-06-10 excluded package package 50523-083-01 I Inactivated by FDA 9bebd1f3094a…5416666fcb17…2019-12-08 06:16 UTC · source 2019-12-05 excluded product product E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 50523-083-01 E Excluded after deficient or non-compliant submission was not corrected 110d247fa046…a55b01930146…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TRICLOSAN ACTIVE INGREDIENT 4NM5039Y5X ANTIBACTERIAL HAND CLEANSE (TRICLOSAN) SOAP [VOLUME DISTRIBUTORS, INC.] 1 TRICLOSAN ACTIVE MOIETY 4NM5039Y5X ANTIBACTERIAL HAND CLEANSE (TRICLOSAN) SOAP [VOLUME DISTRIBUTORS, INC.] 1 AMMONIUM LAURYL SULFATE INACTIVE INGREDIENT Q7AO2R1M0B ANTIBACTERIAL HAND CLEANSE (TRICLOSAN) SOAP [VOLUME DISTRIBUTORS, INC.] 1 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP ANTIBACTERIAL HAND CLEANSE (TRICLOSAN) SOAP [VOLUME DISTRIBUTORS, INC.] 1 COCAMIDOPROPYL BETAINE INACTIVE INGREDIENT 5OCF3O11KX ANTIBACTERIAL HAND CLEANSE (TRICLOSAN) SOAP [VOLUME DISTRIBUTORS, INC.] 1 COCO MONOETHANOLAMIDE INACTIVE INGREDIENT C80684146D ANTIBACTERIAL HAND CLEANSE (TRICLOSAN) SOAP [VOLUME DISTRIBUTORS, INC.] 1 DECYL GLUCOSIDE INACTIVE INGREDIENT Z17H97EA6Y ANTIBACTERIAL HAND CLEANSE (TRICLOSAN) SOAP [VOLUME DISTRIBUTORS, INC.] 1 DMDM HYDANTOIN INACTIVE INGREDIENT BYR0546TOW ANTIBACTERIAL HAND CLEANSE (TRICLOSAN) SOAP [VOLUME DISTRIBUTORS, INC.] 1 EDETATE SODIUM INACTIVE INGREDIENT MP1J8420LU ANTIBACTERIAL HAND CLEANSE (TRICLOSAN) SOAP [VOLUME DISTRIBUTORS, INC.] 1 FD&C RED NO. 4 INACTIVE INGREDIENT X3W0AM1JLX ANTIBACTERIAL HAND CLEANSE (TRICLOSAN) SOAP [VOLUME DISTRIBUTORS, INC.] 1 FD&C YELLOW NO. 5 INACTIVE INGREDIENT I753WB2F1M ANTIBACTERIAL HAND CLEANSE (TRICLOSAN) SOAP [VOLUME DISTRIBUTORS, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX ANTIBACTERIAL HAND CLEANSE (TRICLOSAN) SOAP [VOLUME DISTRIBUTORS, INC.] 1 PEG-18 GLYCERYL OLEATE/COCOATE INACTIVE INGREDIENT VD2D270332 ANTIBACTERIAL HAND CLEANSE (TRICLOSAN) SOAP [VOLUME DISTRIBUTORS, INC.] 1 SODIUM CHLORIDE INACTIVE INGREDIENT 451W47IQ8X ANTIBACTERIAL HAND CLEANSE (TRICLOSAN) SOAP [VOLUME DISTRIBUTORS, INC.] 1 SODIUM LAURETH SULFATE INACTIVE INGREDIENT BPV390UAP0 ANTIBACTERIAL HAND CLEANSE (TRICLOSAN) SOAP [VOLUME DISTRIBUTORS, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R ANTIBACTERIAL HAND CLEANSE (TRICLOSAN) SOAP [VOLUME DISTRIBUTORS, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50523-083 ANTIBACTERIAL HAND CLEANSE (TRICLOSAN) SOAP [VOLUME DISTRIBUTORS, INC.] 1 Legacy NDC 20150710_3b8b15c1-4523-4b77-ba79-4bdf4458a38b.zip
DailyMed RxNorm Mappings#