Anti-bacterial Lemon Drop Hand

Product NDC: 53603-2013
11-digit product format: 536032013
Labeler code: 53603
Product ID: 53603-2013_8d2085df-6ea3-42a9-85b0-5eeaa509d603
Type: HUMAN OTC DRUG
Nonproprietary name: Triclosan
Dosage form: SOAP
Route: TOPICAL
Labeler: BB17, LLC
Application: part333E
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2012-10-06
Marketing end: 0000-00-00
Substance: TRICLOSAN
Active strength: 0 g/100mL
NDC exclude flag: No
Listing certified through: 2019-12-31
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	53603-2013		I	Inactivated by FDA		2026-10-20
excluded package	package	53603-2013	53603-2013-8	I	Inactivated by FDA		2026-10-20

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 · 42 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	53603-2013-8	`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	53603-2013-8	`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	53603-2013-8	`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	53603-2013-8	`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	53603-2013-8	`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	53603-2013-8	`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	53603-2013-8	`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	53603-2013-8	`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	53603-2013-8	`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	53603-2013-8	`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	53603-2013-8	`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	53603-2013-8	`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	53603-2013-8	`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	53603-2013-8	`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	53603-2013-8	`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	53603-2013-8	`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	53603-2013-8	`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	53603-2013-8	`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	53603-2013-8	`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	53603-2013-8	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	53603-2013-8	`9bebd1f3094a…`	`5416666fcb17…`

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
53603-2013-8	2020-01-31	C162847	48780-1	9d75b9d0-9403-f424-e053-dadaa90a57ce	2d69c72e-81c4-4a83-af42-97af490fa23b

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53603-2013-8	Anti-bacterial Lemon Drop Hand	236.6 mL in 1 BOTTLE, SPRAY	SOAP	236.6		4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TRICLOSAN	ACTIVE INGREDIENT	4NM5039Y5X	ANTI-BACTERIAL LEMON DROP HAND (TRICLOSAN) SOAP [BB17, LLC]	4
TRICLOSAN	ACTIVE MOIETY	4NM5039Y5X	ANTI-BACTERIAL LEMON DROP HAND (TRICLOSAN) SOAP [BB17, LLC]	4
AMMONIUM LAURYL SULFATE	INACTIVE INGREDIENT	Q7AO2R1M0B	ANTI-BACTERIAL LEMON DROP HAND (TRICLOSAN) SOAP [BB17, LLC]	4
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	ANTI-BACTERIAL LEMON DROP HAND (TRICLOSAN) SOAP [BB17, LLC]	4
COCAMIDOPROPYL BETAINE	INACTIVE INGREDIENT	5OCF3O11KX	ANTI-BACTERIAL LEMON DROP HAND (TRICLOSAN) SOAP [BB17, LLC]	4
COCO DIETHANOLAMIDE	INACTIVE INGREDIENT	92005F972D	ANTI-BACTERIAL LEMON DROP HAND (TRICLOSAN) SOAP [BB17, LLC]	4
DISODIUM LAURETH SULFOSUCCINATE	INACTIVE INGREDIENT	D6DH1DTN7E	ANTI-BACTERIAL LEMON DROP HAND (TRICLOSAN) SOAP [BB17, LLC]	4
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	ANTI-BACTERIAL LEMON DROP HAND (TRICLOSAN) SOAP [BB17, LLC]	4
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	ANTI-BACTERIAL LEMON DROP HAND (TRICLOSAN) SOAP [BB17, LLC]	4
GLYCOL DISTEARATE	INACTIVE INGREDIENT	13W7MDN21W	ANTI-BACTERIAL LEMON DROP HAND (TRICLOSAN) SOAP [BB17, LLC]	4
METHYLCHLOROISOTHIAZOLINONE	INACTIVE INGREDIENT	DEL7T5QRPN	ANTI-BACTERIAL LEMON DROP HAND (TRICLOSAN) SOAP [BB17, LLC]	4
METHYLISOTHIAZOLINONE	INACTIVE INGREDIENT	229D0E1QFA	ANTI-BACTERIAL LEMON DROP HAND (TRICLOSAN) SOAP [BB17, LLC]	4
SODIUM C12-15 PARETH-3 SULFATE	INACTIVE INGREDIENT	19Q4RW8UWP	ANTI-BACTERIAL LEMON DROP HAND (TRICLOSAN) SOAP [BB17, LLC]	4
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	ANTI-BACTERIAL LEMON DROP HAND (TRICLOSAN) SOAP [BB17, LLC]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	ANTI-BACTERIAL LEMON DROP HAND (TRICLOSAN) SOAP [BB17, LLC]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53603-2013	ANTI-BACTERIAL LEMON DROP HAND (TRICLOSAN) SOAP [BB17, LLC]	4	Legacy NDC, 1 package rows	20130213_2d69c72e-81c4-4a83-af42-97af490fa23b.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
260054	triclosan 0.3 % Medicated Liquid Soap	PSN	2d69c72e-81c4-4a83-af42-97af490fa23b	4
260054	triclosan 3 MG/ML Medicated Liquid Soap	SCD	2d69c72e-81c4-4a83-af42-97af490fa23b	4
260054	triclosan 0.3 % Foaming Medicated Hand Soap	SY	2d69c72e-81c4-4a83-af42-97af490fa23b	4
260054	triclosan 0.3 % Medicated Liquid Soap	SY	2d69c72e-81c4-4a83-af42-97af490fa23b	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
53603-2013-8	53603201308	236.6 mL in 1 BOTTLE, SPRAY	236.6 ml	Historical