TRICLOTREX-B

Product NDC: 66854-016
11-digit product format: 668540016
Labeler code: 66854
Product ID: 66854-016_7d5b0d07-c818-43eb-991e-9f8db5a36101
Type: HUMAN OTC DRUG
Nonproprietary name: TRICLOSAN
Dosage form: GEL
Route: TOPICAL
Labeler: SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS
Application: part333E
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2012-04-16
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	66854-016		I	Inactivated by FDA	2026-10-12
excluded package	package	66854-016	66854-016-01	I	Inactivated by FDA	2026-10-12
excluded package	package	66854-016	66854-016-02	I	Inactivated by FDA	2026-10-12

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 2 · 66 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	66854-016-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	66854-016-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	66854-016-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	66854-016-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	66854-016-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	66854-016-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	66854-016-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	66854-016-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	66854-016-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	66854-016-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	66854-016-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	66854-016-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	66854-016-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	66854-016-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	66854-016-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	66854-016-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	66854-016-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	66854-016-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	66854-016-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	66854-016-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	66854-016-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	66854-016-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	66854-016-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	66854-016-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	66854-016-02	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	66854-016-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	66854-016-02	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	66854-016-01	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	66854-016-02	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	66854-016-01	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	66854-016-02	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	66854-016-01	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	66854-016-02	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	66854-016-01	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	66854-016-02	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	66854-016-01	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	66854-016-02	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	66854-016-01	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	66854-016-02	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	66854-016-01	`e2bbac7714bc…`	`27bdfed8d636…`

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
NDC	Effective	Action	Document	Indexing SPL	Related label
66854-016-01	2019-11-13	C162847	48780-1	97449f38-c401-f6ea-e053-dbdaa90aa703	TRICLOTREX-B ANTIBACTERIAL GEL
66854-016-02	2019-11-13	C162847	48780-1	97449f38-c401-f6ea-e053-dbdaa90aa703	TRICLOTREX-B ANTIBACTERIAL GEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
66854-016-01	TRICLOTREX-BANTIBACTERIAL (NEUTRAL)	110 g in 1 JAR	GEL	110		1
66854-016-02	TRICLOTREX-BANTIBACTERIAL (NEUTRAL)	430 g in 1 JAR	GEL	430		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TRICLOSAN	ACTIVE INGREDIENT	4NM5039Y5X	TRICLOTREX-B ANTIBACTERIAL (NEUTRAL) (TRICLOSAN) GEL [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
TRICLOSAN	ACTIVE MOIETY	4NM5039Y5X	TRICLOTREX-B ANTIBACTERIAL (NEUTRAL) (TRICLOSAN) GEL [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	TRICLOTREX-B ANTIBACTERIAL (NEUTRAL) (TRICLOSAN) GEL [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	TRICLOTREX-B ANTIBACTERIAL (NEUTRAL) (TRICLOSAN) GEL [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	4Q93RCW27E	TRICLOTREX-B ANTIBACTERIAL (NEUTRAL) (TRICLOSAN) GEL [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
D&C BLUE NO. 4	INACTIVE INGREDIENT	0KSY80VYS3	TRICLOTREX-B ANTIBACTERIAL (NEUTRAL) (TRICLOSAN) GEL [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
EXT. D&C VIOLET NO. 2	INACTIVE INGREDIENT	G5UX3K0728	TRICLOTREX-B ANTIBACTERIAL (NEUTRAL) (TRICLOSAN) GEL [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
FD&C RED NO. 40	INACTIVE INGREDIENT	WZB9127XOA	TRICLOTREX-B ANTIBACTERIAL (NEUTRAL) (TRICLOSAN) GEL [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	TRICLOTREX-B ANTIBACTERIAL (NEUTRAL) (TRICLOSAN) GEL [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
PEG-7 GLYCERYL COCOATE	INACTIVE INGREDIENT	VNX7251543	TRICLOTREX-B ANTIBACTERIAL (NEUTRAL) (TRICLOSAN) GEL [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	TRICLOTREX-B ANTIBACTERIAL (NEUTRAL) (TRICLOSAN) GEL [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	TRICLOTREX-B ANTIBACTERIAL (NEUTRAL) (TRICLOSAN) GEL [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	TRICLOTREX-B ANTIBACTERIAL (NEUTRAL) (TRICLOSAN) GEL [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66854-016	TRICLOTREX-B ANTIBACTERIAL (NEUTRAL) (TRICLOSAN) GEL [SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS]	1	Legacy NDC, 2 package rows	20120531_40698562-70b4-43f7-bae0-b8bc679ebc29.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	Status
66854-016-01	66854001601	110 g in 1 JAR	110 g	Historical
66854-016-02	66854001602	430 g in 1 JAR	430 g	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TRICLOTREX-B ANTIBACTERIAL GEL	SPAI-SONS PHARMACEUTICAL INTERNATIONAL COSMETICS	2012-05-31	HUMAN OTC DRUG LABEL	1