Breakout Clearing Daytime Treatment

Product NDC: 68479-160
11-digit product format: 684790160
Labeler code: 68479
Product ID: 68479-160_d00ecad9-7ca8-4d61-a84b-3894c8f9a99e
Type: HUMAN OTC DRUG
Nonproprietary name: Benzoyl Peroxide
Dosage form: LOTION
Route: TOPICAL
Labeler: Dermalogica, Inc.
Application: part333D
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2013-06-04
Marketing end: 0000-00-00
Substance: BENZOYL PEROXIDE
Active strength: 25 mg/mL
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	68479-160		I	Inactivated by FDA	2026-10-12
excluded package	package	68479-160	68479-160-00	I	Inactivated by FDA	2026-10-12
excluded package	package	68479-160	68479-160-01	I	Inactivated by FDA	2026-10-12
excluded package	package	68479-160	68479-160-02	I	Inactivated by FDA	2026-10-12

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	68479-160-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68479-160-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68479-160-00	`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	68479-160-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68479-160-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68479-160-00	`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	68479-160-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68479-160-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68479-160-00	`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	68479-160-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68479-160-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68479-160-00	`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	68479-160-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68479-160-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68479-160-00	`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	68479-160-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68479-160-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68479-160-00	`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	68479-160-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68479-160-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68479-160-00	`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	68479-160-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68479-160-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68479-160-00	`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	68479-160-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68479-160-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68479-160-00	`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	68479-160-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68479-160-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68479-160-00	`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	68479-160-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68479-160-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68479-160-00	`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	68479-160-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68479-160-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68479-160-00	`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	68479-160-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68479-160-02	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68479-160-00	`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	68479-160-01	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68479-160-02	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68479-160-00	`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	68479-160-01	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68479-160-02	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68479-160-00	`1332a3947898…`	`d4bfe170f9cd…`

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
a46239a7-5963-4008-8cbb-6b9000f497eb	Product name	1	20250721
b382b4e1-6b48-45f6-bffc-e61b00b0ce19	Product name	3	20250317
d9d61457-6a5a-41fc-b418-e5479a2904b7	Product name	2	20230303
32012d5c-25ac-49c7-9d4c-1313177fff7c	Product name	1	20230112
13e7e7e3-e885-4c79-af6d-dad1aedbb06e	Product name	1	20220128
4a7d44fe-774d-404b-aad0-8a90fe78375a	Product name	4	20211025
3f45980c-c196-47e5-0e5e-48b7c57327c5	Product name	5	20200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27b	Product name	3	20200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992	Product name	4	20190619
ad75fcfd-a339-42a1-9c60-43ba2c654cfa	Product name	1	20170810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68479-160-00	2020-01-31	C162847	48780-1	9d75b9d0-d660-f424-e053-dadaa90a57ce	Breakout Clearing Daytime Treatment
68479-160-01	2020-01-31	C162847	48780-1	9d75b9d0-d660-f424-e053-dadaa90a57ce	Breakout Clearing Daytime Treatment
68479-160-02	2020-01-31	C162847	48780-1	9d75b9d0-d660-f424-e053-dadaa90a57ce	Breakout Clearing Daytime Treatment

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68479-160-00	Breakout Clearing Daytime Treatment	2 mL in 1 POUCH	LOTION	2	2
68479-160-01	Breakout Clearing Daytime Treatment	14 mL in 1 TUBE	LOTION	14	2
68479-160-02	Breakout Clearing Daytime Treatment	1 in 1 CARTON	LOTION	1	2
68479-160-02	Breakout Clearing Daytime Treatment	60 mL in 1 TUBE	LOTION	60	2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Benzoyl Peroxide	ACTIVE INGREDIENT	W9WZN9A0GM	BREAKOUT CLEARING DAYTIME TREATMENT (BENZOYL PEROXIDE) LOTION [DERMALOGICA, INC.]	2
Benzoyl Peroxide	ACTIVE MOIETY	W9WZN9A0GM	BREAKOUT CLEARING DAYTIME TREATMENT (BENZOYL PEROXIDE) LOTION [DERMALOGICA, INC.]	2
1,2-Hexanediol	INACTIVE INGREDIENT	TR046Y3K1G	BREAKOUT CLEARING DAYTIME TREATMENT (BENZOYL PEROXIDE) LOTION [DERMALOGICA, INC.]	2
Boerhavia Diffusa Root	INACTIVE INGREDIENT	KR0SR09KYL	BREAKOUT CLEARING DAYTIME TREATMENT (BENZOYL PEROXIDE) LOTION [DERMALOGICA, INC.]	2
Butylene Glycol	INACTIVE INGREDIENT	3XUS85K0RA	BREAKOUT CLEARING DAYTIME TREATMENT (BENZOYL PEROXIDE) LOTION [DERMALOGICA, INC.]	2
Citric Acid Monohydrate	INACTIVE INGREDIENT	2968PHW8QP	BREAKOUT CLEARING DAYTIME TREATMENT (BENZOYL PEROXIDE) LOTION [DERMALOGICA, INC.]	2
Cucumber	INACTIVE INGREDIENT	YY7C30VXJT	BREAKOUT CLEARING DAYTIME TREATMENT (BENZOYL PEROXIDE) LOTION [DERMALOGICA, INC.]	2
Dimethicone	INACTIVE INGREDIENT	92RU3N3Y1O	BREAKOUT CLEARING DAYTIME TREATMENT (BENZOYL PEROXIDE) LOTION [DERMALOGICA, INC.]	2
Edetate Disodium	INACTIVE INGREDIENT	7FLD91C86K	BREAKOUT CLEARING DAYTIME TREATMENT (BENZOYL PEROXIDE) LOTION [DERMALOGICA, INC.]	2
Egg Phospholipids	INACTIVE INGREDIENT	1Z74184RGV	BREAKOUT CLEARING DAYTIME TREATMENT (BENZOYL PEROXIDE) LOTION [DERMALOGICA, INC.]	2
Ethylhexylglycerin	INACTIVE INGREDIENT	147D247K3P	BREAKOUT CLEARING DAYTIME TREATMENT (BENZOYL PEROXIDE) LOTION [DERMALOGICA, INC.]	2
Galactoarabinan	INACTIVE INGREDIENT	SL4SX1O487	BREAKOUT CLEARING DAYTIME TREATMENT (BENZOYL PEROXIDE) LOTION [DERMALOGICA, INC.]	2
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	BREAKOUT CLEARING DAYTIME TREATMENT (BENZOYL PEROXIDE) LOTION [DERMALOGICA, INC.]	2
Glycyrrhizinate Dipotassium	INACTIVE INGREDIENT	CA2Y0FE3FX	BREAKOUT CLEARING DAYTIME TREATMENT (BENZOYL PEROXIDE) LOTION [DERMALOGICA, INC.]	2
Lavandula Angustifolia Flowering Top	INACTIVE INGREDIENT	9YT4B71U8P	BREAKOUT CLEARING DAYTIME TREATMENT (BENZOYL PEROXIDE) LOTION [DERMALOGICA, INC.]	2
Niacinamide	INACTIVE INGREDIENT	25X51I8RD4	BREAKOUT CLEARING DAYTIME TREATMENT (BENZOYL PEROXIDE) LOTION [DERMALOGICA, INC.]	2
Phenoxyethanol	INACTIVE INGREDIENT	HIE492ZZ3T	BREAKOUT CLEARING DAYTIME TREATMENT (BENZOYL PEROXIDE) LOTION [DERMALOGICA, INC.]	2
Polyisobutylene (1300 MW)	INACTIVE INGREDIENT	241BN7J12Y	BREAKOUT CLEARING DAYTIME TREATMENT (BENZOYL PEROXIDE) LOTION [DERMALOGICA, INC.]	2
Polysorbate 20	INACTIVE INGREDIENT	7T1F30V5YH	BREAKOUT CLEARING DAYTIME TREATMENT (BENZOYL PEROXIDE) LOTION [DERMALOGICA, INC.]	2
Rosemary	INACTIVE INGREDIENT	IJ67X351P9	BREAKOUT CLEARING DAYTIME TREATMENT (BENZOYL PEROXIDE) LOTION [DERMALOGICA, INC.]	2
Sunflower Oil	INACTIVE INGREDIENT	3W1JG795YI	BREAKOUT CLEARING DAYTIME TREATMENT (BENZOYL PEROXIDE) LOTION [DERMALOGICA, INC.]	2
Water	INACTIVE INGREDIENT	059QF0KO0R	BREAKOUT CLEARING DAYTIME TREATMENT (BENZOYL PEROXIDE) LOTION [DERMALOGICA, INC.]	2
Xanthan Gum	INACTIVE INGREDIENT	TTV12P4NEE	BREAKOUT CLEARING DAYTIME TREATMENT (BENZOYL PEROXIDE) LOTION [DERMALOGICA, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68479-160	BREAKOUT CLEARING DAYTIME TREATMENT (BENZOYL PEROXIDE) LOTION [DERMALOGICA, INC.]	2	Legacy NDC, 4 package rows	20151125_836ca02b-098d-456e-9a88-bdaf69656cab.zip

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
200009	benzoyl peroxide 2.5 % Topical Lotion	PSN	836ca02b-098d-456e-9a88-bdaf69656cab	2
200009	benzoyl peroxide 25 MG/ML Topical Lotion	SCD	836ca02b-098d-456e-9a88-bdaf69656cab	2
200009	benzoyl peroxide 2.5 % Topical Lotion	SY	836ca02b-098d-456e-9a88-bdaf69656cab	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
68479-160-00	68479016000	2 mL in 1 POUCH	2 ml	Historical
68479-160-01	68479016001	14 mL in 1 TUBE	14 ml	Historical
68479-160-02	68479016002	1 in 1 CARTON		Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Breakout Clearing Daytime Treatment	Dermalogica, Inc. \| PakLab \| Diamond Wipes	2015-11-24	HUMAN OTC DRUG LABEL	2