Hand Cleanse

Product NDC: 58503-008
11-digit product format: 585030008
Labeler code: 58503
Product ID: 58503-008_edb1695d-1c92-157f-e053-2a95a90a020e
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: 2013-05-24
Marketing end: 0000-00-00
Substance: TRICLOSAN
Active strength: 8 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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	58503-008		I	Inactivated by FDA		2026-08-17
excluded package	package	58503-008	58503-008-01	I	Inactivated by FDA		2026-08-17

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 · 18 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	58503-008-01	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	58503-008-01	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	58503-008-01	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	58503-008-01	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	58503-008-01	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	58503-008-01	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	58503-008-01	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	58503-008-01	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	58503-008-01	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
58503-008-01	2025-01-30	C162847	48780-1	2cef2736-82bc-d83d-e063-dadaa90ab31f	Hand Cleanse

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58503-008-01	Hand CleanseRefill	500 mg in 1 BOTTLE	GEL	500		4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TRICLOSAN	ACTIVE INGREDIENT	4NM5039Y5X	HAND CLEANSE REFILL (TRICLOSAN) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]	2
TRICLOSAN	ACTIVE MOIETY	4NM5039Y5X	HAND CLEANSE REFILL (TRICLOSAN) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]	2
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	HAND CLEANSE REFILL (TRICLOSAN) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]	2
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	HAND CLEANSE REFILL (TRICLOSAN) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]	2
COCO DIETHANOLAMIDE	INACTIVE INGREDIENT	92005F972D	HAND CLEANSE REFILL (TRICLOSAN) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	HAND CLEANSE REFILL (TRICLOSAN) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]	2
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	HAND CLEANSE REFILL (TRICLOSAN) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	HAND CLEANSE REFILL (TRICLOSAN) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]	2
METHYLCHLOROISOTHIAZOLINONE	INACTIVE INGREDIENT	DEL7T5QRPN	HAND CLEANSE REFILL (TRICLOSAN) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]	2
METHYLISOTHIAZOLINONE	INACTIVE INGREDIENT	229D0E1QFA	HAND CLEANSE REFILL (TRICLOSAN) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]	2
PEG-150 DISTEARATE	INACTIVE INGREDIENT	6F36Q0I0AC	HAND CLEANSE REFILL (TRICLOSAN) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]	2
SODIUM C14-16 OLEFIN SULFONATE	INACTIVE INGREDIENT	O9W3D3YF5U	HAND CLEANSE REFILL (TRICLOSAN) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]	2
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	HAND CLEANSE REFILL (TRICLOSAN) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]	2
SODIUM LAURETH SULFATE	INACTIVE INGREDIENT	BPV390UAP0	HAND CLEANSE REFILL (TRICLOSAN) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	HAND CLEANSE REFILL (TRICLOSAN) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58503-008	HAND CLEANSE REFILL (TRICLOSAN) GEL [CHINA NINGBO SHANGGE COSMETIC TECHNOLOGY CORP.]	4	Legacy NDC, 1 package rows	20221118_2818fc19-d7c8-4253-80d5-c61a277b1a12.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4NM5039Y5X	TRICLOSAN	3380-34-5	TRICLOSAN

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
58503-008-01	58503000801	500 mg in 1 BOTTLE (58503-008-01)	500 mg	2013-05-24	0000-00-00	No	No	Current