Benzoyl Peroxide

Product NDC: 67405-825
11-digit product format: 674050825
Labeler code: 67405
Product ID: 67405-825_60741417-ceee-404a-9b85-ba38566855dc
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: 2023-09-30
Substance: BENZOYL PEROXIDE
Active strength: 50 mg/mL
NDC exclude flag: No
Listing certified through: 0000-00-00
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	67405-825		D	Discontinued by firm	2026-10-15
excluded package	package	67405-825	67405-825-05	D	Discontinued by firm	2026-10-15
excluded package	package	67405-825	67405-825-08	D	Discontinued by firm	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 · 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
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	67405-825-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	67405-825-05	`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	67405-825-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	67405-825-05	`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	67405-825-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	67405-825-05	`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	67405-825-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	67405-825-05	`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	67405-825-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	67405-825-05	`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	67405-825-08	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	67405-825-05	`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	67405-825-08	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	67405-825-05	`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	67405-825-08	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	67405-825-05	`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	67405-825-08	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	67405-825-05	`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	67405-825-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	67405-825-05	`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	67405-825-08	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	67405-825-05	`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	67405-825-08	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	67405-825-05	`557ba5c1ecfa…`	`9c80585c8c6e…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
67405-825-05	GM - Gram	67405-825	ec707618-edc7-44af-b2de-0c79da7f53d9	1	2012-07-24
67405-825-08	GM - Gram	67405-825	18ef64b3-a01c-48e8-87c6-7a49978ca5d9	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

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
67405-825-05	67405082505	148 mL in 1 BOTTLE (67405-825-05)	148 ml	2011-11-18	2023-08-31	No	No	Current
67405-825-08	67405082508	237 mL in 1 BOTTLE (67405-825-08)	237 ml	2011-11-18	2023-09-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BENZOYL PEROXIDE TOPICAL WASH 5%	HARRIS PHARMACEUTICAL, INC. \| Groupe PARIMA Inc.	2022-07-07	HUMAN OTC DRUG LABEL	3