Benzoyl Peroxide

Product NDC: 67405-835
11-digit product format: 674050835
Labeler code: 67405
Product ID: 67405-835_dcea9308-27e8-4a83-8fa3-deccd7e4443f
Type: HUMAN OTC DRUG
Nonproprietary name: Benzoyl Peroxide
Dosage form: LIQUID
Route: TOPICAL
Labeler: Harris Pharmaceutical, Inc.
Application: part333D
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2011-11-18
Marketing end: 0000-00-00
Substance: BENZOYL PEROXIDE
Active strength: 60 mg/mL
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	67405-835		I	Inactivated by FDA	2026-10-15
excluded package	package	67405-835	67405-835-06	I	Inactivated by FDA	2026-10-15
excluded package	package	67405-835	67405-835-12	I	Inactivated by FDA	2026-10-15

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 · 45 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	67405-835-12	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67405-835-06	`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	67405-835-12	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67405-835-06	`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	67405-835-12	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67405-835-06	`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	67405-835-12	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67405-835-06	`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	67405-835-12	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67405-835-06	`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	67405-835-12	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67405-835-06	`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	67405-835-12	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67405-835-06	`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	67405-835-12	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67405-835-06	`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	67405-835-12	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67405-835-06	`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	67405-835-12	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	67405-835-06	`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	67405-835-12	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	67405-835-06	`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	67405-835-12	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	67405-835-06	`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	67405-835-12	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	67405-835-06	`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	67405-835-12	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	67405-835-06	`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	67405-835-12	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	67405-835-06	`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
67405-835-06	2023-01-30	C162847	48780-1	f386c649-f8e1-0266-e053-dadaa90a7c1a	BENZOYL PEROXIDE TOPICAL CLEANSER 6%
67405-835-12	2023-01-30	C162847	48780-1	f386c649-f8e1-0266-e053-dadaa90a7c1a	BENZOYL PEROXIDE TOPICAL CLEANSER 6%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67405-835-06	Benzoyl Peroxide	178 mL in 1 BOTTLE	LIQUID	178		2
67405-835-12	Benzoyl Peroxide	355 mL in 1 BOTTLE	LIQUID	355		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67405-835-06	GM - Gram	67405-835	d4f0d773-c4de-46e3-9281-0a97f7f2c149	1	2012-07-24
67405-835-12	GM - Gram	67405-835	9143fca1-fd69-4e4f-a414-024a29aa19d7	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Benzoyl Peroxide	ACTIVE INGREDIENT	W9WZN9A0GM	BENZOYL PEROXIDE LIQUID [HARRIS PHARMACEUTICAL, INC.]	1
Benzoyl Peroxide	ACTIVE MOIETY	W9WZN9A0GM	BENZOYL PEROXIDE LIQUID [HARRIS PHARMACEUTICAL, INC.]	1
cetyl alcohol	INACTIVE INGREDIENT	936JST6JCN	BENZOYL PEROXIDE LIQUID [HARRIS PHARMACEUTICAL, INC.]	1
disodium oleamido MEA-sulfosuccinate	INACTIVE INGREDIENT	5M1101WGSY	BENZOYL PEROXIDE LIQUID [HARRIS PHARMACEUTICAL, INC.]	1
edetate disodium	INACTIVE INGREDIENT	7FLD91C86K	BENZOYL PEROXIDE LIQUID [HARRIS PHARMACEUTICAL, INC.]	1
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	BENZOYL PEROXIDE LIQUID [HARRIS PHARMACEUTICAL, INC.]	1
laureth-12	INACTIVE INGREDIENT	OAH19558U1	BENZOYL PEROXIDE LIQUID [HARRIS PHARMACEUTICAL, INC.]	1
magnesium aluminum silicate	INACTIVE INGREDIENT	6M3P64V0NC	BENZOYL PEROXIDE LIQUID [HARRIS PHARMACEUTICAL, INC.]	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	BENZOYL PEROXIDE LIQUID [HARRIS PHARMACEUTICAL, INC.]	1
sodium coco-sulfate	INACTIVE INGREDIENT	3599J29ANH	BENZOYL PEROXIDE LIQUID [HARRIS PHARMACEUTICAL, INC.]	1
sodium lauroamphoacetate	INACTIVE INGREDIENT	SLK428451L	BENZOYL PEROXIDE LIQUID [HARRIS PHARMACEUTICAL, INC.]	1
water	INACTIVE INGREDIENT	059QF0KO0R	BENZOYL PEROXIDE LIQUID [HARRIS PHARMACEUTICAL, INC.]	1
xanthan gum	INACTIVE INGREDIENT	TTV12P4NEE	BENZOYL PEROXIDE LIQUID [HARRIS PHARMACEUTICAL, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67405-835	BENZOYL PEROXIDE LIQUID [HARRIS PHARMACEUTICAL, INC.]	2	Legacy NDC, 2 package rows	20191228_582c1225-af19-4075-959d-b9c61842306f.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
847131	benzoyl peroxide 6 % Medicated Liquid Soap	PSN	582c1225-af19-4075-959d-b9c61842306f	2
847131	benzoyl peroxide 60 MG/ML Medicated Liquid Soap	SCD	582c1225-af19-4075-959d-b9c61842306f	2
847131	benzoyl peroxide 6 % Gel Soap	SY	582c1225-af19-4075-959d-b9c61842306f	2
847131	benzoyl peroxide 6 % Lotion Soap	SY	582c1225-af19-4075-959d-b9c61842306f	2
847131	benzoyl peroxide 6 % Topical Cleanser	SY	582c1225-af19-4075-959d-b9c61842306f	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67405-835-06	67405083506	178 mL in 1 BOTTLE (67405-835-06)	178 ml	2011-11-18	0000-00-00	No	No	Current
67405-835-12	67405083512	355 mL in 1 BOTTLE (67405-835-12)	355 ml	2011-11-18	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BENZOYL PEROXIDE TOPICAL CLEANSER 6%	Harris Pharmaceutical, Inc. \| Groupe Parima Montreal	2019-12-26	HUMAN OTC DRUG LABEL	2