PCMX with Emollient

Product NDC: 52380-9957
11-digit product format: 523809957
Labeler code: 52380
Product ID: 52380-9957_65a8bec7-b3b1-1919-e053-2991aa0a6540
Type: HUMAN OTC DRUG
Nonproprietary name: Chloroxylenol
Dosage form: SOLUTION
Route: TOPICAL
Labeler: Aplicare Products, LLC.
Application: part333A
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2004-05-01
Marketing end: 0000-00-00
Substance: CHLOROXYLENOL
Active strength: 3 mg/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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	52380-9957		I	Inactivated by FDA	2026-10-05
excluded package	package	52380-9957	52380-9957-3	I	Inactivated by FDA	2026-10-05
excluded package	package	52380-9957	52380-9957-4	I	Inactivated by FDA	2026-10-05
excluded package	package	52380-9957	52380-9957-9	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 2 · 84 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	52380-9957-3	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52380-9957-4	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	52380-9957-9	`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	52380-9957-3	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52380-9957-4	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	52380-9957-9	`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	52380-9957-3	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52380-9957-4	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	52380-9957-9	`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	52380-9957-3	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52380-9957-4	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	52380-9957-9	`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	52380-9957-3	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52380-9957-4	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	52380-9957-9	`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	52380-9957-3	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52380-9957-4	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	52380-9957-9	`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	52380-9957-3	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52380-9957-4	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	52380-9957-9	`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	52380-9957-3	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52380-9957-4	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	52380-9957-9	`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	52380-9957-3	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52380-9957-4	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	52380-9957-9	`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	52380-9957-3	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52380-9957-4	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	52380-9957-9	`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	52380-9957-3	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	52380-9957-4	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	52380-9957-9	`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	52380-9957-3	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	52380-9957-4	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	52380-9957-9	`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	52380-9957-3	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	52380-9957-4	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	52380-9957-9	`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	52380-9957-3	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	52380-9957-4	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	52380-9957-9	`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	52380-9957-3	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	52380-9957-4	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	52380-9957-9	`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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
52380-9957-3	2020-01-31	C162847	48780-1	9d75b9d0-3c70-f424-e053-dadaa90a57ce	PCMX with Emollient
52380-9957-4	2020-01-31	C162847	48780-1	9d75b9d0-3c70-f424-e053-dadaa90a57ce	PCMX with Emollient
52380-9957-9	2020-01-31	C162847	48780-1	9d75b9d0-3c70-f424-e053-dadaa90a57ce	PCMX with Emollient

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
52380-9957-3	PCMX with Emollient	946 mL in 1 BOTTLE	SOLUTION	946	5
52380-9957-4	PCMX with Emollient	118 mL in 1 BOTTLE	SOLUTION	118	5
52380-9957-9	PCMX with Emollient	208198 mL in 1 DRUM	SOLUTION	208198	5

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Chloroxylenol	ACTIVE INGREDIENT	0F32U78V2Q	PCMX WITH EMOLLIENT (CHLOROXYLENOL) SOLUTION [APLICARE, INC.]	3
Chloroxylenol	ACTIVE MOIETY	0F32U78V2Q	PCMX WITH EMOLLIENT (CHLOROXYLENOL) SOLUTION [APLICARE, INC.]	3
Anhydrous Citric Acid	INACTIVE INGREDIENT	XF417D3PSL	PCMX WITH EMOLLIENT (CHLOROXYLENOL) SOLUTION [APLICARE, INC.]	3
PEG-120 Methyl Glucose Dioleate	INACTIVE INGREDIENT	YM0K64F20V	PCMX WITH EMOLLIENT (CHLOROXYLENOL) SOLUTION [APLICARE, INC.]	3
Phenoxyethanol	INACTIVE INGREDIENT	HIE492ZZ3T	PCMX WITH EMOLLIENT (CHLOROXYLENOL) SOLUTION [APLICARE, INC.]	3
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	PCMX WITH EMOLLIENT (CHLOROXYLENOL) SOLUTION [APLICARE, INC.]	3
Sodium Hydroxide	INACTIVE INGREDIENT	55X04QC32I	PCMX WITH EMOLLIENT (CHLOROXYLENOL) SOLUTION [APLICARE, INC.]	3
Sodium Lauroyl Sarcosinate	INACTIVE INGREDIENT	632GS99618	PCMX WITH EMOLLIENT (CHLOROXYLENOL) SOLUTION [APLICARE, INC.]	3
Sodium Lauryl Sulfate	INACTIVE INGREDIENT	368GB5141J	PCMX WITH EMOLLIENT (CHLOROXYLENOL) SOLUTION [APLICARE, INC.]	3
Water	INACTIVE INGREDIENT	059QF0KO0R	PCMX WITH EMOLLIENT (CHLOROXYLENOL) SOLUTION [APLICARE, INC.]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52380-9957	PCMX WITH EMOLLIENT (CHLOROXYLENOL) SOLUTION [APLICARE PRODUCTS, LLC.]	5	Legacy NDC, 3 package rows	20180220_9fc5ad9e-66cd-42e9-8bc8-43f44eee27a2.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
1045621	chloroxylenol 3.3 % Medicated Liquid Soap	PSN	9fc5ad9e-66cd-42e9-8bc8-43f44eee27a2	5
1045621	chloroxylenol 33 MG/ML Medicated Liquid Soap	SCD	9fc5ad9e-66cd-42e9-8bc8-43f44eee27a2	5
1045621	chloroxylenol 3.3 % Medicated Liquid Soap	SY	9fc5ad9e-66cd-42e9-8bc8-43f44eee27a2	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
52380-9957-3	52380995703	946 mL in 1 BOTTLE	946 ml	Historical
52380-9957-4	52380995704	118 mL in 1 BOTTLE	118 ml	Historical
52380-9957-9	52380995709	208198 mL in 1 DRUM	208198 ml	Historical