FDA.reportPublic FDA data

Liquid Hand Cleanse

Product NDC
58503-016
Requested package NDC
58503-016-01
11-digit product format
585030016
Labeler code
58503
Product ID
58503-016_edb1a506-428b-81ae-e053-2a95a90a7532
Type
HUMAN OTC DRUG
Nonproprietary name
Triclosan
Dosage form
GEL
Route
TOPICAL
Labeler
China Ningbo Shangge Cosmetic Technology Corp.
Application
part333E
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2013-07-05
Marketing end
0000-00-00
Substance
TRICLOSAN
Active strength
10 mg/500mg
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage58503-01658503-016-01IInactivated by FDA2026-10-15

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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58503-016-012025-01-30C16284748780-12cef2736-abc9-d83d-e063-dadaa90ab31fLiquid Hand Cleanse

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58503-016-01Liquid Hand Cleanse500 mg in 1 BOTTLEGEL5003

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRICLOSANACTIVE INGREDIENT4NM5039Y5XLIQUID HAND CLEANSE (TRICLOSAN) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
TRICLOSANACTIVE MOIETY4NM5039Y5XLIQUID HAND CLEANSE (TRICLOSAN) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
CETETH-7INACTIVE INGREDIENT4ST6952Q67LIQUID HAND CLEANSE (TRICLOSAN) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPLIQUID HAND CLEANSE (TRICLOSAN) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
COCONUT OILINACTIVE INGREDIENTQ9L0O73W7LLIQUID HAND CLEANSE (TRICLOSAN) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
DIETHANOLAMINEINACTIVE INGREDIENTAZE05TDV2VLIQUID HAND CLEANSE (TRICLOSAN) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KLIQUID HAND CLEANSE (TRICLOSAN) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
ETHYL SULFATEINACTIVE INGREDIENTP3LK0HF3B7LIQUID HAND CLEANSE (TRICLOSAN) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOALIQUID HAND CLEANSE (TRICLOSAN) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MLIQUID HAND CLEANSE (TRICLOSAN) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
OCTHILINONEINACTIVE INGREDIENT4LFS24GD0VLIQUID HAND CLEANSE (TRICLOSAN) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XLIQUID HAND CLEANSE (TRICLOSAN) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1
WATERINACTIVE INGREDIENT059QF0KO0RLIQUID HAND CLEANSE (TRICLOSAN) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58503-016LIQUID HAND CLEANSE (TRICLOSAN) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]3Legacy NDC, 1 package rows20221118_2143884b-08d5-46ae-bd99-6d04a7165d89.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
413246triclosan 0.2 % Medicated Liquid SoapPSN2143884b-08d5-46ae-bd99-6d04a7165d893
413246triclosan 2 MG/ML Medicated Liquid SoapSCD2143884b-08d5-46ae-bd99-6d04a7165d893
413246triclosan 0.2 % Medicated Liquid SoapSY2143884b-08d5-46ae-bd99-6d04a7165d893

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58503-016-0158503001601500 mg in 1 BOTTLE (58503-016-01) 500 mg2013-07-050000-00-00NoNoCurrent