Highmark Professional Gold and Clean Antimicrobial Ltn Sp

Product NDC: 61139-421
11-digit product format: 611390421
Labeler code: 61139
Product ID: 61139-421_d36346f0-be43-4775-a538-8692d01aa6a8
Type: HUMAN OTC DRUG
Nonproprietary name: Chloroxylenol
Dosage form: LIQUID
Route: TOPICAL
Labeler: Office Max, Inc.
Application: part333E
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2013-11-22
Marketing end: 0000-00-00
Substance: CHLOROXYLENOL
Active strength: 0 mg/mL
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 · 6 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	61139-421		I	Inactivated by FDA	2026-10-16
excluded package	package	61139-421	61139-421-10	I	Inactivated by FDA	2026-10-16
excluded package	package	61139-421	61139-421-20	I	Inactivated by FDA	2026-10-16
excluded package	package	61139-421	61139-421-80	I	Inactivated by FDA	2026-10-16
excluded package	package	61139-421	61139-421-89	I	Inactivated by FDA	2026-10-16
excluded package	package	61139-421	61139-421-90	I	Inactivated by FDA	2026-10-16

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 2 of 3 · 132 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
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	61139-421-89	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61139-421-20	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61139-421-90	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61139-421-80	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61139-421-10	`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	61139-421-89	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61139-421-20	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61139-421-90	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61139-421-80	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61139-421-10	`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	61139-421-89	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	61139-421-20	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	61139-421-90	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	61139-421-80	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	61139-421-10	`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	61139-421-89	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	61139-421-20	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	61139-421-90	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	61139-421-80	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	61139-421-10	`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	61139-421-89	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	61139-421-20	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	61139-421-90	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	61139-421-80	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	61139-421-10	`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	61139-421-89	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	61139-421-20	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	61139-421-90	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	61139-421-80	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	61139-421-10	`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	61139-421-89	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	61139-421-20	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	61139-421-90	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	61139-421-80	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	61139-421-10	`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	61139-421-89	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	61139-421-20	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	61139-421-90	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	61139-421-80	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	61139-421-10	`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	61139-421-89	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	61139-421-20	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	61139-421-90	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	61139-421-80	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	61139-421-10	`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	61139-421-89	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	61139-421-20	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	61139-421-90	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	61139-421-80	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	61139-421-10	`e2bbac7714bc…`	`27bdfed8d636…`

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 concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
424daadb-95de-8ece-97f5-235e3f7f0001	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
61139-421-10	Highmark Professional Gold and Clean Antimicrobial Lotion Soap
61139-421-20	Highmark Professional Gold and Clean Antimicrobial Lotion Soap
61139-421-80	Highmark Professional Gold and Clean Antimicrobial Lotion Soap
61139-421-89	Highmark Professional Gold and Clean Antimicrobial Lotion Soap
61139-421-90	Highmark Professional Gold and Clean Antimicrobial Lotion Soap

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61139-421-10	Highmark Professional Gold and Clean Antimicrobial Ltn Sp	1000 mL in 1 BOTTLE	LIQUID	1000	1
61139-421-20	Highmark Professional Gold and Clean Antimicrobial Ltn Sp	2000 mL in 1 BOTTLE	LIQUID	2000	1
61139-421-80	Highmark Professional Gold and Clean Antimicrobial Ltn Sp	800 mL in 1 BAG	LIQUID	800	1
61139-421-89	Highmark Professional Gold and Clean Antimicrobial Ltn Sp	1200 mL in 1 BOTTLE	LIQUID	1200	1
61139-421-90	Highmark Professional Gold and Clean Antimicrobial Ltn Sp	1250 mL in 1 BOTTLE	LIQUID	1250	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CHLOROXYLENOL	ACTIVE INGREDIENT	0F32U78V2Q	HIGHMARK PROFESSIONAL GOLD AND CLEAN ANTIMICROBIAL LTN SP (CHLOROXYLENOL) LIQUID [OFFICE MAX, INC.]	1
CHLOROXYLENOL	ACTIVE MOIETY	0F32U78V2Q	HIGHMARK PROFESSIONAL GOLD AND CLEAN ANTIMICROBIAL LTN SP (CHLOROXYLENOL) LIQUID [OFFICE MAX, INC.]	1
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	HIGHMARK PROFESSIONAL GOLD AND CLEAN ANTIMICROBIAL LTN SP (CHLOROXYLENOL) LIQUID [OFFICE MAX, INC.]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	HIGHMARK PROFESSIONAL GOLD AND CLEAN ANTIMICROBIAL LTN SP (CHLOROXYLENOL) LIQUID [OFFICE MAX, INC.]	1
COCO MONOETHANOLAMIDE	INACTIVE INGREDIENT	C80684146D	HIGHMARK PROFESSIONAL GOLD AND CLEAN ANTIMICROBIAL LTN SP (CHLOROXYLENOL) LIQUID [OFFICE MAX, INC.]	1
COCO-BETAINE	INACTIVE INGREDIENT	03DH2IZ3FY	HIGHMARK PROFESSIONAL GOLD AND CLEAN ANTIMICROBIAL LTN SP (CHLOROXYLENOL) LIQUID [OFFICE MAX, INC.]	1
COCONUT ACID	INACTIVE INGREDIENT	40U37V505D	HIGHMARK PROFESSIONAL GOLD AND CLEAN ANTIMICROBIAL LTN SP (CHLOROXYLENOL) LIQUID [OFFICE MAX, INC.]	1
CORN OIL	INACTIVE INGREDIENT	8470G57WFM	HIGHMARK PROFESSIONAL GOLD AND CLEAN ANTIMICROBIAL LTN SP (CHLOROXYLENOL) LIQUID [OFFICE MAX, INC.]	1
EDETATE SODIUM	INACTIVE INGREDIENT	MP1J8420LU	HIGHMARK PROFESSIONAL GOLD AND CLEAN ANTIMICROBIAL LTN SP (CHLOROXYLENOL) LIQUID [OFFICE MAX, INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	HIGHMARK PROFESSIONAL GOLD AND CLEAN ANTIMICROBIAL LTN SP (CHLOROXYLENOL) LIQUID [OFFICE MAX, INC.]	1
MONOETHANOLAMINE	INACTIVE INGREDIENT	5KV86114PT	HIGHMARK PROFESSIONAL GOLD AND CLEAN ANTIMICROBIAL LTN SP (CHLOROXYLENOL) LIQUID [OFFICE MAX, INC.]	1
OLEIC ACID	INACTIVE INGREDIENT	2UMI9U37CP	HIGHMARK PROFESSIONAL GOLD AND CLEAN ANTIMICROBIAL LTN SP (CHLOROXYLENOL) LIQUID [OFFICE MAX, INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	HIGHMARK PROFESSIONAL GOLD AND CLEAN ANTIMICROBIAL LTN SP (CHLOROXYLENOL) LIQUID [OFFICE MAX, INC.]	1
SODIUM SULFATE	INACTIVE INGREDIENT	0YPR65R21J	HIGHMARK PROFESSIONAL GOLD AND CLEAN ANTIMICROBIAL LTN SP (CHLOROXYLENOL) LIQUID [OFFICE MAX, INC.]	1
VITAMIN A PALMITATE	INACTIVE INGREDIENT	1D1K0N0VVC	HIGHMARK PROFESSIONAL GOLD AND CLEAN ANTIMICROBIAL LTN SP (CHLOROXYLENOL) LIQUID [OFFICE MAX, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	HIGHMARK PROFESSIONAL GOLD AND CLEAN ANTIMICROBIAL LTN SP (CHLOROXYLENOL) LIQUID [OFFICE MAX, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61139-421	HIGHMARK PROFESSIONAL GOLD AND CLEAN ANTIMICROBIAL LTN SP (CHLOROXYLENOL) LIQUID [OFFICE MAX, INC.]	1	Legacy NDC, 5 package rows	20140103_d36346f0-be43-4775-a538-8692d01aa6a8.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0F32U78V2Q	CHLOROXYLENOL	88-04-0	CHLOROXYLENOL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
61139-421-10	61139042110	1000 mL in 1 BOTTLE	1000 ml	Historical
61139-421-20	61139042120	2000 mL in 1 BOTTLE	2000 ml	Historical
61139-421-80	61139042180	800 mL in 1 BAG	800 ml	Historical
61139-421-89	61139042189	1200 mL in 1 BOTTLE	1200 ml	Historical
61139-421-90	61139042190	1250 mL in 1 BOTTLE	1250 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Highmark Professional Gold and Clean Antimicrobial Lotion Soap	Office Max, Inc.	2013-11-22	HUMAN OTC DRUG LABEL	1