AcneFree Clear Skin Treatments

Product NDC: 0187-1611
11-digit product format: 001871611
Labeler code: 0187
Product ID: 0187-1611_ab40ff51-090a-4839-a3ee-ff05738fd358
Type: HUMAN OTC DRUG
Nonproprietary name: benzoyl peroxide
Dosage form: KIT
Labeler: Valeant Pharmaceuticals North America LLC
Application: part333D
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2014-06-25
Marketing end: 0000-00-00
Active strength: 0
NDC exclude flag: E
Listing certified through: 2018-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	0187-1611		D	Discontinued by firm		2026-08-17
excluded package	package	0187-1611	0187-1611-04	D	Discontinued by firm		2026-08-17

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 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0187-1611-04	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0187-1611-04	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0187-1611-04	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0187-1611-04	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0187-1611-04	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0187-1611-04	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0187-1611-04	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0187-1611-04	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0187-1611-04	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0187-1611-04	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0187-1611-04	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0187-1611-04	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	0187-1611-04	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	0187-1611-04	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	0187-1611-04	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0187-1611-04	2021-08-05	C162847	48780-1	9d75b9d0-5551-f424-e053-dadaa90a57ce	AcneFree ® Severe 24 hour Severe Acne Clearing System
0187-1611-04	2020-01-31	C162847	48780-1	9d75b9d0-5551-f424-e053-dadaa90a57ce	AcneFree ® Severe 24 hour Severe Acne Clearing System

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0187-1611-04	EA - Each	0187-1611	778373e2-1efa-454a-96ea-0cc6e34e4d54	1	2020-01-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BENZOYL PEROXIDE	ACTIVE INGREDIENT	W9WZN9A0GM	ACNEFREE CLEAR SKIN TREATMENTS 24 HOUR SEVERE ACNE CLEARING SYSTEM (BENZOYL PEROXIDE) KIT [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	4
BENZOYL PEROXIDE	ACTIVE MOIETY	W9WZN9A0GM	ACNEFREE CLEAR SKIN TREATMENTS 24 HOUR SEVERE ACNE CLEARING SYSTEM (BENZOYL PEROXIDE) KIT [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	4
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	ACNEFREE CLEAR SKIN TREATMENTS 24 HOUR SEVERE ACNE CLEARING SYSTEM (BENZOYL PEROXIDE) KIT [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	4
ALKYL (C12-15) BENZOATE	INACTIVE INGREDIENT	A9EJ3J61HQ	ACNEFREE CLEAR SKIN TREATMENTS 24 HOUR SEVERE ACNE CLEARING SYSTEM (BENZOYL PEROXIDE) KIT [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	4
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	ACNEFREE CLEAR SKIN TREATMENTS 24 HOUR SEVERE ACNE CLEARING SYSTEM (BENZOYL PEROXIDE) KIT [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	4
BUTYLENE GLYCOL	INACTIVE INGREDIENT	3XUS85K0RA	ACNEFREE CLEAR SKIN TREATMENTS 24 HOUR SEVERE ACNE CLEARING SYSTEM (BENZOYL PEROXIDE) KIT [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	4
CERAMIDE 3	INACTIVE INGREDIENT	4370DF050B	ACNEFREE CLEAR SKIN TREATMENTS 24 HOUR SEVERE ACNE CLEARING SYSTEM (BENZOYL PEROXIDE) KIT [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	4
CERAMIDE 6 II	INACTIVE INGREDIENT	F1X8L2B00J	ACNEFREE CLEAR SKIN TREATMENTS 24 HOUR SEVERE ACNE CLEARING SYSTEM (BENZOYL PEROXIDE) KIT [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	4
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	ACNEFREE CLEAR SKIN TREATMENTS 24 HOUR SEVERE ACNE CLEARING SYSTEM (BENZOYL PEROXIDE) KIT [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	4
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	ACNEFREE CLEAR SKIN TREATMENTS 24 HOUR SEVERE ACNE CLEARING SYSTEM (BENZOYL PEROXIDE) KIT [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	4
CHAMOMILE	INACTIVE INGREDIENT	FGL3685T2X	ACNEFREE CLEAR SKIN TREATMENTS 24 HOUR SEVERE ACNE CLEARING SYSTEM (BENZOYL PEROXIDE) KIT [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	4
CHOLESTEROL	INACTIVE INGREDIENT	97C5T2UQ7J	ACNEFREE CLEAR SKIN TREATMENTS 24 HOUR SEVERE ACNE CLEARING SYSTEM (BENZOYL PEROXIDE) KIT [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	4
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	ACNEFREE CLEAR SKIN TREATMENTS 24 HOUR SEVERE ACNE CLEARING SYSTEM (BENZOYL PEROXIDE) KIT [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	4
COCAMIDOPROPYL HYDROXYSULTAINE	INACTIVE INGREDIENT	62V75NI93W	ACNEFREE CLEAR SKIN TREATMENTS 24 HOUR SEVERE ACNE CLEARING SYSTEM (BENZOYL PEROXIDE) KIT [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	4
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	ACNEFREE CLEAR SKIN TREATMENTS 24 HOUR SEVERE ACNE CLEARING SYSTEM (BENZOYL PEROXIDE) KIT [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	4
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	ACNEFREE CLEAR SKIN TREATMENTS 24 HOUR SEVERE ACNE CLEARING SYSTEM (BENZOYL PEROXIDE) KIT [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	4
EDETATE SODIUM	INACTIVE INGREDIENT	MP1J8420LU	ACNEFREE CLEAR SKIN TREATMENTS 24 HOUR SEVERE ACNE CLEARING SYSTEM (BENZOYL PEROXIDE) KIT [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	4
ETHYLHEXYLGLYCERIN	INACTIVE INGREDIENT	147D247K3P	ACNEFREE CLEAR SKIN TREATMENTS 24 HOUR SEVERE ACNE CLEARING SYSTEM (BENZOYL PEROXIDE) KIT [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	4
ETHYLPARABEN	INACTIVE INGREDIENT	14255EXE39	ACNEFREE CLEAR SKIN TREATMENTS 24 HOUR SEVERE ACNE CLEARING SYSTEM (BENZOYL PEROXIDE) KIT [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	4
GINGER	INACTIVE INGREDIENT	C5529G5JPQ	ACNEFREE CLEAR SKIN TREATMENTS 24 HOUR SEVERE ACNE CLEARING SYSTEM (BENZOYL PEROXIDE) KIT [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	4
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ACNEFREE CLEAR SKIN TREATMENTS 24 HOUR SEVERE ACNE CLEARING SYSTEM (BENZOYL PEROXIDE) KIT [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	4
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	ACNEFREE CLEAR SKIN TREATMENTS 24 HOUR SEVERE ACNE CLEARING SYSTEM (BENZOYL PEROXIDE) KIT [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	4
GLYCOLIC ACID	INACTIVE INGREDIENT	0WT12SX38S	ACNEFREE CLEAR SKIN TREATMENTS 24 HOUR SEVERE ACNE CLEARING SYSTEM (BENZOYL PEROXIDE) KIT [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	4
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE	INACTIVE INGREDIENT	D2QHA03458	ACNEFREE CLEAR SKIN TREATMENTS 24 HOUR SEVERE ACNE CLEARING SYSTEM (BENZOYL PEROXIDE) KIT [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	4
LEVOMENOL	INACTIVE INGREDIENT	24WE03BX2T	ACNEFREE CLEAR SKIN TREATMENTS 24 HOUR SEVERE ACNE CLEARING SYSTEM (BENZOYL PEROXIDE) KIT [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	4
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER	INACTIVE INGREDIENT	EG97988M5Q	ACNEFREE CLEAR SKIN TREATMENTS 24 HOUR SEVERE ACNE CLEARING SYSTEM (BENZOYL PEROXIDE) KIT [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	4
METHYLISOTHIAZOLINONE	INACTIVE INGREDIENT	229D0E1QFA	ACNEFREE CLEAR SKIN TREATMENTS 24 HOUR SEVERE ACNE CLEARING SYSTEM (BENZOYL PEROXIDE) KIT [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	4
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	ACNEFREE CLEAR SKIN TREATMENTS 24 HOUR SEVERE ACNE CLEARING SYSTEM (BENZOYL PEROXIDE) KIT [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	4
PEG-100 STEARATE	INACTIVE INGREDIENT	YD01N1999R	ACNEFREE CLEAR SKIN TREATMENTS 24 HOUR SEVERE ACNE CLEARING SYSTEM (BENZOYL PEROXIDE) KIT [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	4
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	ACNEFREE CLEAR SKIN TREATMENTS 24 HOUR SEVERE ACNE CLEARING SYSTEM (BENZOYL PEROXIDE) KIT [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	4
PHYTOSPHINGOSINE	INACTIVE INGREDIENT	GIN46U9Q2Q	ACNEFREE CLEAR SKIN TREATMENTS 24 HOUR SEVERE ACNE CLEARING SYSTEM (BENZOYL PEROXIDE) KIT [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	4
POLYSORBATE 60	INACTIVE INGREDIENT	CAL22UVI4M	ACNEFREE CLEAR SKIN TREATMENTS 24 HOUR SEVERE ACNE CLEARING SYSTEM (BENZOYL PEROXIDE) KIT [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	4
POTASSIUM HYDROXIDE	INACTIVE INGREDIENT	WZH3C48M4T	ACNEFREE CLEAR SKIN TREATMENTS 24 HOUR SEVERE ACNE CLEARING SYSTEM (BENZOYL PEROXIDE) KIT [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	4
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ACNEFREE CLEAR SKIN TREATMENTS 24 HOUR SEVERE ACNE CLEARING SYSTEM (BENZOYL PEROXIDE) KIT [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	4
PSEUDOPTEROGORGIA ELISABETHAE	INACTIVE INGREDIENT	UDY3H1OUX5	ACNEFREE CLEAR SKIN TREATMENTS 24 HOUR SEVERE ACNE CLEARING SYSTEM (BENZOYL PEROXIDE) KIT [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	4
SODIUM C14-16 OLEFIN SULFONATE	INACTIVE INGREDIENT	O9W3D3YF5U	ACNEFREE CLEAR SKIN TREATMENTS 24 HOUR SEVERE ACNE CLEARING SYSTEM (BENZOYL PEROXIDE) KIT [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	4
SODIUM LAUROYL LACTYLATE	INACTIVE INGREDIENT	7243K85WFO	ACNEFREE CLEAR SKIN TREATMENTS 24 HOUR SEVERE ACNE CLEARING SYSTEM (BENZOYL PEROXIDE) KIT [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	4
WATER	INACTIVE INGREDIENT	059QF0KO0R	ACNEFREE CLEAR SKIN TREATMENTS 24 HOUR SEVERE ACNE CLEARING SYSTEM (BENZOYL PEROXIDE) KIT [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	4
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	ACNEFREE CLEAR SKIN TREATMENTS 24 HOUR SEVERE ACNE CLEARING SYSTEM (BENZOYL PEROXIDE) KIT [VALEANT PHARMACEUTICALS NORTH AMERICA LLC]	4

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
W9WZN9A0GM	BENZOYL PEROXIDE	94-36-0	benzoyl peroxide

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
AcneFree ® Severe 24 hour Severe Acne Clearing System	Valeant Pharmaceuticals North America LLC \| Universal Packaging Systems, Inc. \| Ei LLC	2017-02-21	HUMAN OTC DRUG LABEL	5

AcneFree Clear Skin Treatments

NDC auxiliary status#

Observed NDC auxiliary status history#

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

Related Records#

Related UNII Ingredients#

Related DailyMed Labels#