DERMAKLEEN

Product NDC: 61924-092
11-digit product format: 619240092
Labeler code: 61924
Product ID: 61924-092_d57e4b6c-0b21-7ab2-e053-2995a90a77e4
Type: HUMAN OTC DRUG
Nonproprietary name: ANTIMICROBIAL DRUG PRODUCT
Dosage form: SOAP
Route: TOPICAL
Labeler: Dermarite Industries LLC
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2012-05-15
Marketing end: 0000-00-00
Substance: CHLOROXYLENOL
Active strength: 0 g/mL
NDC exclude flag: No
Listing certified through: 2023-12-31
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	61924-092		I	Inactivated by FDA	2026-10-05
excluded package	package	61924-092	61924-092-01	I	Inactivated by FDA	2026-10-05
excluded package	package	61924-092	61924-092-08	I	Inactivated by FDA	2026-10-05
excluded package	package	61924-092	61924-092-11	I	Inactivated by FDA	2026-10-05
excluded package	package	61924-092	61924-092-27	I	Inactivated by FDA	2026-10-05
excluded package	package	61924-092	61924-092-34	I	Inactivated by FDA	2026-10-05

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 · 36 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
2024-11-09 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	61924-092-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61924-092-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61924-092-34	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61924-092-27	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61924-092-16	`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	61924-092-08	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61924-092-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61924-092-34	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61924-092-27	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61924-092-16	`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	61924-092-08	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61924-092-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61924-092-34	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61924-092-27	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61924-092-16	`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	61924-092-08	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	61924-092-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	61924-092-34	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	61924-092-27	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	61924-092-16	`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	61924-092-08	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	61924-092-01	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	61924-092-34	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	61924-092-27	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	61924-092-16	`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	61924-092-08	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	61924-092-01	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	61924-092-34	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	61924-092-27	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	61924-092-16	`1332a3947898…`	`d4bfe170f9cd…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
61924-092-01	2024-12-06	DRUG LISTING: DERMAKLEEN
61924-092-08	2024-12-06	DRUG LISTING: DERMAKLEEN
61924-092-16	2024-12-06	DRUG LISTING: DERMAKLEEN
61924-092-27	2024-12-06	DRUG LISTING: DERMAKLEEN
61924-092-34	2024-12-06	DRUG LISTING: DERMAKLEEN
61924-092-01	2024-01-30	DRUG LISTING: DERMAKLEEN
61924-092-08	2024-01-30	DRUG LISTING: DERMAKLEEN
61924-092-16	2024-01-30	DRUG LISTING: DERMAKLEEN
61924-092-27	2024-01-30	DRUG LISTING: DERMAKLEEN
61924-092-34	2024-01-30	DRUG LISTING: DERMAKLEEN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
61924-092-01	DERMAKLEEN	3800 mL in 1 JUG	SOAP	3800	11
61924-092-08	DERMAKLEEN	222 mL in 1 BOTTLE, PUMP	SOAP	222	11
61924-092-11	DERMAKLEEN	1000 mL in 1 BOTTLE	SOAP	1000	11
61924-092-27	DERMAKLEEN	800 mL in 1 BAG	SOAP	800	11
61924-092-34	DERMAKLEEN	1000 mL in 1 BAG	SOAP	1000	11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Chloroxylenol	ACTIVE INGREDIENT	0F32U78V2Q	DERMAKLEEN (ANTIMICROBIAL DRUG PRODUCT) SOAP [DERMARITE INDUSTRIES LLC]	3
CHLOROXYLENOL	ACTIVE MOIETY	0F32U78V2Q	DERMAKLEEN (ANTIMICROBIAL DRUG PRODUCT) SOAP [DERMARITE INDUSTRIES LLC]	3
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	DERMAKLEEN (ANTIMICROBIAL DRUG PRODUCT) SOAP [DERMARITE INDUSTRIES LLC]	3
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	DERMAKLEEN (ANTIMICROBIAL DRUG PRODUCT) SOAP [DERMARITE INDUSTRIES LLC]	3
Cocamidopropyl Betaine	INACTIVE INGREDIENT	5OCF3O11KX	DERMAKLEEN (ANTIMICROBIAL DRUG PRODUCT) SOAP [DERMARITE INDUSTRIES LLC]	3
COCO MONOETHANOLAMIDE	INACTIVE INGREDIENT	C80684146D	DERMAKLEEN (ANTIMICROBIAL DRUG PRODUCT) SOAP [DERMARITE INDUSTRIES LLC]	3
D&C GREEN NO. 6	INACTIVE INGREDIENT	4QP5U84YF7	DERMAKLEEN (ANTIMICROBIAL DRUG PRODUCT) SOAP [DERMARITE INDUSTRIES LLC]	3
DMDM Hydantoin	INACTIVE INGREDIENT	BYR0546TOW	DERMAKLEEN (ANTIMICROBIAL DRUG PRODUCT) SOAP [DERMARITE INDUSTRIES LLC]	3
EDETATE SODIUM	INACTIVE INGREDIENT	MP1J8420LU	DERMAKLEEN (ANTIMICROBIAL DRUG PRODUCT) SOAP [DERMARITE INDUSTRIES LLC]	3
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	DERMAKLEEN (ANTIMICROBIAL DRUG PRODUCT) SOAP [DERMARITE INDUSTRIES LLC]	3
Methylchloroisothiazolinone	INACTIVE INGREDIENT	DEL7T5QRPN	DERMAKLEEN (ANTIMICROBIAL DRUG PRODUCT) SOAP [DERMARITE INDUSTRIES LLC]	3
Methylisothiazolinone	INACTIVE INGREDIENT	229D0E1QFA	DERMAKLEEN (ANTIMICROBIAL DRUG PRODUCT) SOAP [DERMARITE INDUSTRIES LLC]	3
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	DERMAKLEEN (ANTIMICROBIAL DRUG PRODUCT) SOAP [DERMARITE INDUSTRIES LLC]	3
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	DERMAKLEEN (ANTIMICROBIAL DRUG PRODUCT) SOAP [DERMARITE INDUSTRIES LLC]	3
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	DERMAKLEEN (ANTIMICROBIAL DRUG PRODUCT) SOAP [DERMARITE INDUSTRIES LLC]	3
Sodium Chloride	INACTIVE INGREDIENT	451W47IQ8X	DERMAKLEEN (ANTIMICROBIAL DRUG PRODUCT) SOAP [DERMARITE INDUSTRIES LLC]	3
Sodium Hydroxide	INACTIVE INGREDIENT	55X04QC32I	DERMAKLEEN (ANTIMICROBIAL DRUG PRODUCT) SOAP [DERMARITE INDUSTRIES LLC]	3
Sodium Laureth Sulfate	INACTIVE INGREDIENT	BPV390UAP0	DERMAKLEEN (ANTIMICROBIAL DRUG PRODUCT) SOAP [DERMARITE INDUSTRIES LLC]	3
Sodium Lauryl Sulfate	INACTIVE INGREDIENT	368GB5141J	DERMAKLEEN (ANTIMICROBIAL DRUG PRODUCT) SOAP [DERMARITE INDUSTRIES LLC]	3
Water	INACTIVE INGREDIENT	059QF0KO0R	DERMAKLEEN (ANTIMICROBIAL DRUG PRODUCT) SOAP [DERMARITE INDUSTRIES LLC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61924-092	DERMAKLEEN (ANTIMICROBIAL DRUG PRODUCT) SOAP [DERMARITE INDUSTRIES LLC]	11	Legacy NDC, 5 package rows	20241208_ff28985e-d941-4350-971f-fdc2dbbb93bb.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1549613	chloroxylenol 0.2 % Medicated Liquid Soap	PSN	ff28985e-d941-4350-971f-fdc2dbbb93bb	11
1549618	Dermakleen 0.2 % Medicated Liquid Soap	PSN	ff28985e-d941-4350-971f-fdc2dbbb93bb	11
1549618	chloroxylenol 2 MG/ML Medicated Liquid Soap [Dermakleen]	SBD	ff28985e-d941-4350-971f-fdc2dbbb93bb	11
1549613	chloroxylenol 2 MG/ML Medicated Liquid Soap	SCD	ff28985e-d941-4350-971f-fdc2dbbb93bb	11
1549618	Dermakleen 2 MG/ML Medicated Liquid Soap	SY	ff28985e-d941-4350-971f-fdc2dbbb93bb	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
61924-092-01	61924009201	3800 mL in 1 JUG (61924-092-01)	3800 ml	2012-06-01	0000-00-00	No	No	Current
61924-092-08	61924009208	222 mL in 1 BOTTLE, PUMP (61924-092-08)	222 ml	2012-05-15	0000-00-00	No	No	Current
61924-092-11	61924009211	1000 mL in 1 BOTTLE	1000 ml					Historical
61924-092-16	61924009216	473 mL in 1 BOTTLE, PUMP (61924-092-16)	473 ml	2020-09-09	0000-00-00	No	No	Current
61924-092-27	61924009227	800 mL in 1 BAG (61924-092-27)	800 ml	2012-06-01	0000-00-00	No	No	Current
61924-092-34	61924009234	1000 mL in 1 BAG (61924-092-34)	1000 ml	2012-06-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
DRUG LISTING: DERMAKLEEN	Dermarite Industries LLC \| DermaRite Industries, LLC	2024-12-05	HUMAN OTC DRUG LABEL	11