Hand Cleanse

Product NDC
58503-084
11-digit product format
585030084
Labeler code
58503
Product ID
58503-084_4abb3ce0-ea45-4d61-b064-b0b9d1da3bf7
Type
HUMAN OTC DRUG
Nonproprietary name
triclosan
Dosage form
SOAP
Route
TOPICAL
Labeler
China Ningbo Shangge Cosmetic Technology Corp.
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

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 productproduct58503-084IInactivated by FDA2026-10-12
excluded packagepackage58503-08458503-084-01IInactivated 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 NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage58503-084-01IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage58503-084-01IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage58503-084-01IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage58503-084-01IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage58503-084-01IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage58503-084-01IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage58503-084-01IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage58503-084-01IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage58503-084-01IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage58503-084-01IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage58503-084-01IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage58503-084-01IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage58503-084-01IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage58503-084-01IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage58503-084-01IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage58503-084-01IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage58503-084-01IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage58503-084-01IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage58503-084-01IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage58503-084-01IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage58503-084-01IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage58503-084-01EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58503-084-012020-01-31C16284748780-19d75b9d0-45dc-f424-e053-dadaa90a57cecb4530de-3701-4a98-972d-2a86b8c0dd36

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRICLOSANACTIVE INGREDIENT4NM5039Y5XHAND CLEANSE CITRUS BLAST SCENT (TRICLOSAN) SOAP [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
TRICLOSANACTIVE MOIETY4NM5039Y5XHAND CLEANSE CITRUS BLAST SCENT (TRICLOSAN) SOAP [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPHAND CLEANSE CITRUS BLAST SCENT (TRICLOSAN) SOAP [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
COCO MONOETHANOLAMIDEINACTIVE INGREDIENTC80684146DHAND CLEANSE CITRUS BLAST SCENT (TRICLOSAN) SOAP [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KHAND CLEANSE CITRUS BLAST SCENT (TRICLOSAN) SOAP [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MHAND CLEANSE CITRUS BLAST SCENT (TRICLOSAN) SOAP [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXHAND CLEANSE CITRUS BLAST SCENT (TRICLOSAN) SOAP [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
METHYLCHLOROISOTHIAZOLINONEINACTIVE INGREDIENTDEL7T5QRPNHAND CLEANSE CITRUS BLAST SCENT (TRICLOSAN) SOAP [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFAHAND CLEANSE CITRUS BLAST SCENT (TRICLOSAN) SOAP [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
PEG-150 DISTEARATEINACTIVE INGREDIENT6F36Q0I0ACHAND CLEANSE CITRUS BLAST SCENT (TRICLOSAN) SOAP [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
SODIUM C14-16 OLEFIN SULFONATEINACTIVE INGREDIENTO9W3D3YF5UHAND CLEANSE CITRUS BLAST SCENT (TRICLOSAN) SOAP [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XHAND CLEANSE CITRUS BLAST SCENT (TRICLOSAN) SOAP [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
SODIUM LAURETH SULFATEINACTIVE INGREDIENTBPV390UAP0HAND CLEANSE CITRUS BLAST SCENT (TRICLOSAN) SOAP [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
WATERINACTIVE INGREDIENT059QF0KO0RHAND CLEANSE CITRUS BLAST SCENT (TRICLOSAN) SOAP [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58503-084HAND CLEANSE CITRUS BLAST SCENT (TRICLOSAN) SOAP [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1Legacy NDC20150710_cb4530de-3701-4a98-972d-2a86b8c0dd36.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
413246triclosan 0.2 % Medicated Liquid SoapPSNcb4530de-3701-4a98-972d-2a86b8c0dd361
413246triclosan 2 MG/ML Medicated Liquid SoapSCDcb4530de-3701-4a98-972d-2a86b8c0dd361
413246triclosan 0.2 % Medicated Liquid SoapSYcb4530de-3701-4a98-972d-2a86b8c0dd361