Pure Kleen

Product NDC: 76016-544
11-digit product format: 760160544
Labeler code: 76016
Product ID: 76016-544_f6d5caf2-a745-4ac2-9c6b-6185578e7ee7
Type: HUMAN OTC DRUG
Nonproprietary name: CHLOROXYLENOL
Dosage form: SOAP
Route: TOPICAL
Labeler: Arrow-Magnolia International, Inc,
Application: part333E
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2011-01-01
Marketing end: 0000-00-00
Substance: CHLOROXYLENOL
Active strength: 3 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 · 24 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	76016-544		D	Discontinued by firm	2026-09-14
excluded package	package	76016-544	76016-544-01	D	Discontinued by firm	2026-09-14
excluded package	package	76016-544	76016-544-03	D	Discontinued by firm	2026-09-14
excluded package	package	76016-544	76016-544-05	D	Discontinued by firm	2026-09-14
excluded package	package	76016-544	76016-544-06	D	Discontinued by firm	2026-09-14
excluded package	package	76016-544	76016-544-07	D	Discontinued by firm	2026-09-14
excluded package	package	76016-544	76016-544-08	D	Discontinued by firm	2026-09-14
excluded package	package	76016-544	76016-544-09	D	Discontinued by firm	2026-09-14
excluded package	package	76016-544	76016-544-10	D	Discontinued by firm	2026-09-14
excluded package	package	76016-544	76016-544-11	D	Discontinued by firm	2026-09-14
excluded package	package	76016-544	76016-544-12	D	Discontinued by firm	2026-09-14
excluded package	package	76016-544	76016-544-13	D	Discontinued by firm	2026-09-14
excluded package	package	76016-544	76016-544-14	D	Discontinued by firm	2026-09-14
excluded package	package	76016-544	76016-544-15	D	Discontinued by firm	2026-09-14
excluded package	package	76016-544	76016-544-16	D	Discontinued by firm	2026-09-14
excluded package	package	76016-544	76016-544-17	D	Discontinued by firm	2026-09-14
excluded package	package	76016-544	76016-544-18	D	Discontinued by firm	2026-09-14
excluded package	package	76016-544	76016-544-19	D	Discontinued by firm	2026-09-14
excluded package	package	76016-544	76016-544-20	D	Discontinued by firm	2026-09-14
excluded package	package	76016-544	76016-544-24	D	Discontinued by firm	2026-09-14
excluded package	package	76016-544	76016-544-27	D	Discontinued by firm	2026-09-14
excluded package	package	76016-544	76016-544-28	D	Discontinued by firm	2026-09-14
excluded package	package	76016-544	76016-544-35	D	Discontinued by firm	2026-09-14
excluded package	package	76016-544	76016-544-55	D	Discontinued by firm	2026-09-14

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 8 · 456 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	76016-544-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76016-544-24	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76016-544-14	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76016-544-16	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76016-544-28	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76016-544-55	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76016-544-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76016-544-19	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76016-544-17	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76016-544-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76016-544-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76016-544-27	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76016-544-13	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76016-544-11	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76016-544-15	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76016-544-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76016-544-18	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76016-544-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76016-544-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76016-544-35	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76016-544-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76016-544-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	76016-544-09	`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	76016-544-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76016-544-24	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76016-544-14	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76016-544-16	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76016-544-28	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76016-544-55	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76016-544-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76016-544-19	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76016-544-17	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76016-544-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76016-544-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76016-544-27	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76016-544-13	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76016-544-11	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76016-544-15	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76016-544-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76016-544-18	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76016-544-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76016-544-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76016-544-35	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76016-544-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76016-544-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	76016-544-09	`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	76016-544-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	76016-544-24	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	76016-544-14	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	76016-544-16	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	76016-544-28	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	76016-544-55	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	76016-544-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	76016-544-19	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	76016-544-17	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	76016-544-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	76016-544-20	`2ef7874e63bc…`	`57b86245f4fa…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
76016-544-01	2023-06-29	Pure Kleen 6544 Drug Facts and Label
76016-544-03	2023-06-29	Pure Kleen 6544 Drug Facts and Label
76016-544-05	2023-06-29	Pure Kleen 6544 Drug Facts and Label
76016-544-06	2023-06-29	Pure Kleen 6544 Drug Facts and Label
76016-544-07	2023-06-29	Pure Kleen 6544 Drug Facts and Label
76016-544-08	2023-06-29	Pure Kleen 6544 Drug Facts and Label
76016-544-09	2023-06-29	Pure Kleen 6544 Drug Facts and Label
76016-544-10	2023-06-29	Pure Kleen 6544 Drug Facts and Label
76016-544-11	2023-06-29	Pure Kleen 6544 Drug Facts and Label
76016-544-12	2023-06-29	Pure Kleen 6544 Drug Facts and Label
76016-544-13	2023-06-29	Pure Kleen 6544 Drug Facts and Label
76016-544-14	2023-06-29	Pure Kleen 6544 Drug Facts and Label
76016-544-15	2023-06-29	Pure Kleen 6544 Drug Facts and Label
76016-544-16	2023-06-29	Pure Kleen 6544 Drug Facts and Label
76016-544-17	2023-06-29	Pure Kleen 6544 Drug Facts and Label
76016-544-18	2023-06-29	Pure Kleen 6544 Drug Facts and Label
76016-544-19	2023-06-29	Pure Kleen 6544 Drug Facts and Label
76016-544-20	2023-06-29	Pure Kleen 6544 Drug Facts and Label
76016-544-24	2023-06-29	Pure Kleen 6544 Drug Facts and Label
76016-544-27	2023-06-29	Pure Kleen 6544 Drug Facts and Label
76016-544-28	2023-06-29	Pure Kleen 6544 Drug Facts and Label
76016-544-35	2023-06-29	Pure Kleen 6544 Drug Facts and Label
76016-544-55	2023-06-29	Pure Kleen 6544 Drug Facts and Label
76016-544-01	2020-01-31	Pure Kleen 6544 Drug Facts and Label
76016-544-03	2020-01-31	Pure Kleen 6544 Drug Facts and Label
76016-544-05	2020-01-31	Pure Kleen 6544 Drug Facts and Label
76016-544-06	2020-01-31	Pure Kleen 6544 Drug Facts and Label
76016-544-07	2020-01-31	Pure Kleen 6544 Drug Facts and Label
76016-544-08	2020-01-31	Pure Kleen 6544 Drug Facts and Label
76016-544-09	2020-01-31	Pure Kleen 6544 Drug Facts and Label
76016-544-10	2020-01-31	Pure Kleen 6544 Drug Facts and Label
76016-544-11	2020-01-31	Pure Kleen 6544 Drug Facts and Label
76016-544-12	2020-01-31	Pure Kleen 6544 Drug Facts and Label
76016-544-13	2020-01-31	Pure Kleen 6544 Drug Facts and Label
76016-544-14	2020-01-31	Pure Kleen 6544 Drug Facts and Label
76016-544-15	2020-01-31	Pure Kleen 6544 Drug Facts and Label
76016-544-16	2020-01-31	Pure Kleen 6544 Drug Facts and Label
76016-544-17	2020-01-31	Pure Kleen 6544 Drug Facts and Label
76016-544-18	2020-01-31	Pure Kleen 6544 Drug Facts and Label
76016-544-19	2020-01-31	Pure Kleen 6544 Drug Facts and Label
76016-544-20	2020-01-31	Pure Kleen 6544 Drug Facts and Label
76016-544-24	2020-01-31	Pure Kleen 6544 Drug Facts and Label
76016-544-27	2020-01-31	Pure Kleen 6544 Drug Facts and Label
76016-544-28	2020-01-31	Pure Kleen 6544 Drug Facts and Label
76016-544-35	2020-01-31	Pure Kleen 6544 Drug Facts and Label
76016-544-55	2020-01-31	Pure Kleen 6544 Drug Facts and Label

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
CHLOROXYLENOL	ACTIVE INGREDIENT	0F32U78V2Q	PURE KLEEN (CHLOROXYLENOL) SOAP [ARROW-MAGNOLIA INTERNATIONAL, INC.]	1
CHLOROXYLENOL	ACTIVE MOIETY	0F32U78V2Q	PURE KLEEN (CHLOROXYLENOL) SOAP [ARROW-MAGNOLIA INTERNATIONAL, INC.]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	PURE KLEEN (CHLOROXYLENOL) SOAP [ARROW-MAGNOLIA INTERNATIONAL, INC.]	1
METANIL YELLOW	INACTIVE INGREDIENT	7SPF5O5BW8	PURE KLEEN (CHLOROXYLENOL) SOAP [ARROW-MAGNOLIA INTERNATIONAL, INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PURE KLEEN (CHLOROXYLENOL) SOAP [ARROW-MAGNOLIA INTERNATIONAL, INC.]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	PURE KLEEN (CHLOROXYLENOL) SOAP [ARROW-MAGNOLIA INTERNATIONAL, INC.]	1
SODIUM LAURETH SULFATE	INACTIVE INGREDIENT	BPV390UAP0	PURE KLEEN (CHLOROXYLENOL) SOAP [ARROW-MAGNOLIA INTERNATIONAL, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	PURE KLEEN (CHLOROXYLENOL) SOAP [ARROW-MAGNOLIA INTERNATIONAL, INC.]	1

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pure Kleen 6544 Drug Facts and Label	Arrow-Magnolia International, Inc, \| ABC Compounding Co., Inc.	2015-04-15	HUMAN OTC DRUG LABEL	2

Pure Kleen

NDC auxiliary status#

Observed NDC auxiliary status history#

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Related Records#

Related UNII Ingredients#

Related DailyMed Labels#