Benzoyl Peroxide

Product NDC: 54162-019
11-digit product format: 541620019
Labeler code: 54162
Product ID: 54162-019_79486277-a36d-46e7-92c0-27741ad8b697
Type: HUMAN OTC DRUG
Nonproprietary name: Benzoyl Peroxide
Dosage form: GEL
Route: TOPICAL
Labeler: GERITREX LLC
Application: part333D
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2015-07-31
Marketing end: 0000-00-00
Substance: BENZOYL PEROXIDE
Active strength: 10 g/100g
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	54162-019		I	Inactivated by FDA		2026-10-05
excluded package	package	54162-019	54162-019-02	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 1 · 42 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	54162-019-02	`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	54162-019-02	`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	54162-019-02	`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	54162-019-02	`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	54162-019-02	`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	54162-019-02	`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	54162-019-02	`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	54162-019-02	`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	54162-019-02	`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	54162-019-02	`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	54162-019-02	`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	54162-019-02	`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	54162-019-02	`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	54162-019-02	`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	54162-019-02	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	54162-019-02	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	54162-019-02	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	54162-019-02	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	54162-019-02	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	54162-019-02	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	54162-019-02	`9bebd1f3094a…`	`5416666fcb17…`

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
54162-019-02	2020-01-31	C162847	48780-1	9d75b9d0-cfb5-f424-e053-dadaa90a57ce	Benzoyl Peroxide Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54162-019-02	Benzoyl Peroxide	56 g in 1 TUBE	GEL	56		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54162-019-02	GM - Gram	54162-019	6ced25e3-8f04-416f-a653-42f372258e35	1	2014-09-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BENZOYL PEROXIDE	ACTIVE INGREDIENT	W9WZN9A0GM	BENZOYL PEROXIDE GEL [GERITREX CORP]	1
BENZOYL PEROXIDE	ACTIVE MOIETY	W9WZN9A0GM	BENZOYL PEROXIDE GEL [GERITREX CORP]	1
CARBOMER 940	INACTIVE INGREDIENT	4Q93RCW27E	BENZOYL PEROXIDE GEL [GERITREX CORP]	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	BENZOYL PEROXIDE GEL [GERITREX CORP]	1
DIETHYLENE GLYCOL DISTEARATE	INACTIVE INGREDIENT	617Q4OD69O	BENZOYL PEROXIDE GEL [GERITREX CORP]	1
DISODIUM HEDTA	INACTIVE INGREDIENT	KME849MC7A	BENZOYL PEROXIDE GEL [GERITREX CORP]	1
DMDM HYDANTOIN	INACTIVE INGREDIENT	BYR0546TOW	BENZOYL PEROXIDE GEL [GERITREX CORP]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	BENZOYL PEROXIDE GEL [GERITREX CORP]	1
MAGNESIUM ALUMINUM SILICATE	INACTIVE INGREDIENT	6M3P64V0NC	BENZOYL PEROXIDE GEL [GERITREX CORP]	1
MAGNESIUM DISODIUM EDTA	INACTIVE INGREDIENT	NDT563S5VZ	BENZOYL PEROXIDE GEL [GERITREX CORP]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	BENZOYL PEROXIDE GEL [GERITREX CORP]	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	BENZOYL PEROXIDE GEL [GERITREX CORP]	1
PEG-200 DILAURATE	INACTIVE INGREDIENT	TWV5J70L88	BENZOYL PEROXIDE GEL [GERITREX CORP]	1
PEG-40 CASTOR OIL	INACTIVE INGREDIENT	4ERD2076EF	BENZOYL PEROXIDE GEL [GERITREX CORP]	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	BENZOYL PEROXIDE GEL [GERITREX CORP]	1
SILICON	INACTIVE INGREDIENT	Z4152N8IUI	BENZOYL PEROXIDE GEL [GERITREX CORP]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	BENZOYL PEROXIDE GEL [GERITREX CORP]	1
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	BENZOYL PEROXIDE GEL [GERITREX CORP]	1
TRIETHANOLAMINE LAURYL SULFATE	INACTIVE INGREDIENT	E8458C1KAA	BENZOYL PEROXIDE GEL [GERITREX CORP]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	BENZOYL PEROXIDE GEL [GERITREX CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54162-019	BENZOYL PEROXIDE GEL [GERITREX LLC]	2	Legacy NDC, 1 package rows	20160816_d117caf6-d1e7-428f-8db5-eaf101c35356.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
486131	benzoyl peroxide 10 % Topical Gel	PSN	d117caf6-d1e7-428f-8db5-eaf101c35356	2
486131	benzoyl peroxide 0.1 MG/MG Topical Gel	SCD	d117caf6-d1e7-428f-8db5-eaf101c35356	2
486131	benzoyl peroxide 10 % Topical Gel	SY	d117caf6-d1e7-428f-8db5-eaf101c35356	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
54162-019-02	54162001902	56 g in 1 TUBE	56 g	Historical