THERA RX

Product NDC: 59279-530
11-digit product format: 592790530
Labeler code: 59279
Product ID: 59279-530_c5838590-724c-40c4-8ebf-bf09a6404ca2
Type: HUMAN OTC DRUG
Nonproprietary name: triclosan
Dosage form: SOLUTION
Route: TOPICAL
Labeler: Mediceutical Laboratories, LTD
Application: part333E
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 1997-01-01
Marketing end: 0000-00-00
Substance: TRICLOSAN
Active strength: 3 mg/mL
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	59279-530		I	Inactivated by FDA	2026-11-10
excluded package	package	59279-530	59279-530-06	I	Inactivated by FDA	2026-11-10
excluded package	package	59279-530	59279-530-12	I	Inactivated by FDA	2026-11-10

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 · 63 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	59279-530-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	59279-530-12	`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	59279-530-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	59279-530-12	`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	59279-530-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	59279-530-12	`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	59279-530-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	59279-530-12	`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	59279-530-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	59279-530-12	`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	59279-530-06	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	59279-530-12	`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	59279-530-06	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	59279-530-12	`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	59279-530-06	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	59279-530-12	`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	59279-530-06	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	59279-530-12	`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	59279-530-06	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	59279-530-12	`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	59279-530-06	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	59279-530-12	`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	59279-530-06	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	59279-530-12	`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	59279-530-06	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	59279-530-12	`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	59279-530-06	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	59279-530-12	`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	59279-530-06	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	59279-530-12	`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	59279-530-06	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	59279-530-12	`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	59279-530-06	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	59279-530-12	`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	59279-530-06	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	59279-530-12	`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	59279-530-06	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	59279-530-12	`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	59279-530-06	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	59279-530-12	`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
59279-530-06	2020-01-31	C162847	48780-1	9d75b9cf-e3b1-f424-e053-dadaa90a57ce	THERA Rx
59279-530-12	2020-01-31	C162847	48780-1	9d75b9cf-e3b1-f424-e053-dadaa90a57ce	THERA Rx

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
59279-530-06	THERA RX	180 mL in 1 BOTTLE, PLASTIC	SOLUTION	180		1
59279-530-12	THERA RX	360 mL in 1 BOTTLE, PLASTIC	SOLUTION	360		1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
TRICLOSAN	ACTIVE INGREDIENT	4NM5039Y5X	THERA RX (TRICLOSAN) SOLUTION [MEDICEUTICAL LABORATORIES, LTD]	1
TRICLOSAN	ACTIVE MOIETY	4NM5039Y5X	THERA RX (TRICLOSAN) SOLUTION [MEDICEUTICAL LABORATORIES, LTD]	1
.ALPHA.-TOCOPHEROL ACETATE, D-	INACTIVE INGREDIENT	A7E6112E4N	THERA RX (TRICLOSAN) SOLUTION [MEDICEUTICAL LABORATORIES, LTD]	1
ACETIC MONOETHANOLAMIDE	INACTIVE INGREDIENT	A9O0818TWD	THERA RX (TRICLOSAN) SOLUTION [MEDICEUTICAL LABORATORIES, LTD]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	THERA RX (TRICLOSAN) SOLUTION [MEDICEUTICAL LABORATORIES, LTD]	1
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	THERA RX (TRICLOSAN) SOLUTION [MEDICEUTICAL LABORATORIES, LTD]	1
BIOTIN	INACTIVE INGREDIENT	6SO6U10H04	THERA RX (TRICLOSAN) SOLUTION [MEDICEUTICAL LABORATORIES, LTD]	1
CAMPHOR (SYNTHETIC)	INACTIVE INGREDIENT	5TJD82A1ET	THERA RX (TRICLOSAN) SOLUTION [MEDICEUTICAL LABORATORIES, LTD]	1
FD&C BLUE NO. 1	INACTIVE INGREDIENT	H3R47K3TBD	THERA RX (TRICLOSAN) SOLUTION [MEDICEUTICAL LABORATORIES, LTD]	1
JOJOBA OIL	INACTIVE INGREDIENT	724GKU717M	THERA RX (TRICLOSAN) SOLUTION [MEDICEUTICAL LABORATORIES, LTD]	1
LINOLEIC ACID	INACTIVE INGREDIENT	9KJL21T0QJ	THERA RX (TRICLOSAN) SOLUTION [MEDICEUTICAL LABORATORIES, LTD]	1
LINOLENIC ACID	INACTIVE INGREDIENT	0RBV727H71	THERA RX (TRICLOSAN) SOLUTION [MEDICEUTICAL LABORATORIES, LTD]	1
MENTHOL	INACTIVE INGREDIENT	L7T10EIP3A	THERA RX (TRICLOSAN) SOLUTION [MEDICEUTICAL LABORATORIES, LTD]	1
OCTINOXATE	INACTIVE INGREDIENT	4Y5P7MUD51	THERA RX (TRICLOSAN) SOLUTION [MEDICEUTICAL LABORATORIES, LTD]	1
PANTHENOL	INACTIVE INGREDIENT	WV9CM0O67Z	THERA RX (TRICLOSAN) SOLUTION [MEDICEUTICAL LABORATORIES, LTD]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	THERA RX (TRICLOSAN) SOLUTION [MEDICEUTICAL LABORATORIES, LTD]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	THERA RX (TRICLOSAN) SOLUTION [MEDICEUTICAL LABORATORIES, LTD]	1
SARCOSINE	INACTIVE INGREDIENT	Z711V88R5F	THERA RX (TRICLOSAN) SOLUTION [MEDICEUTICAL LABORATORIES, LTD]	1
SORBITOL	INACTIVE INGREDIENT	506T60A25R	THERA RX (TRICLOSAN) SOLUTION [MEDICEUTICAL LABORATORIES, LTD]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	THERA RX (TRICLOSAN) SOLUTION [MEDICEUTICAL LABORATORIES, LTD]	1
WHEAT GERM OIL	INACTIVE INGREDIENT	14C97E680P	THERA RX (TRICLOSAN) SOLUTION [MEDICEUTICAL LABORATORIES, LTD]	1
ZINC SULFATE	INACTIVE INGREDIENT	89DS0H96TB	THERA RX (TRICLOSAN) SOLUTION [MEDICEUTICAL LABORATORIES, LTD]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59279-530	THERA RX (TRICLOSAN) SOLUTION [MEDICEUTICAL LABORATORIES, LTD]	1	Legacy NDC, 2 package rows	20121012_f83c2901-8709-4ed6-91e7-da77e136075e.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	f83c2901-8709-4ed6-91e7-da77e136075e	1
260054	triclosan 3 MG/ML Medicated Liquid Soap	SCD	f83c2901-8709-4ed6-91e7-da77e136075e	1
260054	triclosan 0.3 % Foaming Medicated Hand Soap	SY	f83c2901-8709-4ed6-91e7-da77e136075e	1
260054	triclosan 0.3 % Medicated Liquid Soap	SY	f83c2901-8709-4ed6-91e7-da77e136075e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
59279-530-06	59279053006	180 mL in 1 BOTTLE, PLASTIC	180 ml	Historical
59279-530-12	59279053012	360 mL in 1 BOTTLE, PLASTIC	360 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
THERA Rx	Mediceutical Laboratories, LTD \| United 1 International Laboratories	2012-10-01	HUMAN OTC DRUG LABEL	1