BenzePrO

Product NDC: 42546-010
Requested package NDC: 42546-010-10
11-digit product format: 425460010
Labeler code: 42546
Product ID: 42546-010_42ff38ea-6810-4681-b0d4-ece33d6bd5fb
Type: HUMAN OTC DRUG
Nonproprietary name: Benzoyl Peroxide
Dosage form: AEROSOL, FOAM
Route: TOPICAL
Labeler: PruGen, Inc.
Application: part333D
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2012-07-01
Marketing end: 0000-00-00
Substance: BENZOYL PEROXIDE
Active strength: 3 g/60g
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	42546-010	42546-010-10	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 · 18 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	`bd6a592717d7…`	`303034d00443…`

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
42546-010-01	2022-01-28	C162847	48780-1	d6a99b39-ea13-a426-e053-dadaa90af4c2	BenzePro Emollient Foam
42546-010-06	2022-01-28	C162847	48780-1	d6a99b39-ea13-a426-e053-dadaa90af4c2	BenzePro Emollient Foam
42546-010-10	2022-01-28	C162847	48780-1	d6a99b39-ea13-a426-e053-dadaa90af4c2	BenzePro Emollient Foam

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
42546-010-01	BenzePrO	5 g in 1 CANISTER	AEROSOL, FOAM	5	8
42546-010-01	BenzePrO	8 in 1 CARTON	AEROSOL, FOAM	8	8
42546-010-06	BenzePrO	1 in 1 BOX	AEROSOL, FOAM	1	8
42546-010-06	BenzePrO	60 g in 1 CANISTER	AEROSOL, FOAM	60	8
42546-010-10	BenzePrO	100 g in 1 CAN	AEROSOL, FOAM	100	8
42546-010-10	BenzePrO	1 in 1 BOX	AEROSOL, FOAM	1	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42546-010-06	GM - Gram	42546-010	2b639973-3ffc-4a2f-bcd1-e71f86204354	1	2013-02-13
42546-010-10	GM - Gram	42546-010	cf81d733-17c3-45be-af9f-f701fcd3b26c	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
BENZOYL PEROXIDE	ACTIVE INGREDIENT	W9WZN9A0GM	BENZEPRO (BENZOYL PEROXIDE) AEROSOL, FOAM [PRUGEN, INC.]	4
BENZOYL PEROXIDE	ACTIVE MOIETY	W9WZN9A0GM	BENZEPRO (BENZOYL PEROXIDE) AEROSOL, FOAM [PRUGEN, INC.]	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42546-010	BENZEPRO (BENZOYL PEROXIDE) AEROSOL, FOAM [PRUGEN, INC.]	8	Legacy NDC, 6 package rows	20180621_890ed265-1217-4fa6-b7f1-a7246dbe137e.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
1302433	BenzePrO 5.3 % Topical Foam	PSN	890ed265-1217-4fa6-b7f1-a7246dbe137e	8
866054	benzoyl peroxide 5.3 % Topical Foam	PSN	890ed265-1217-4fa6-b7f1-a7246dbe137e	8
1302433	benzoyl peroxide 53 MG/ML Topical Foam [Benzepro]	SBD	890ed265-1217-4fa6-b7f1-a7246dbe137e	8
866054	benzoyl peroxide 53 MG/ML Topical Foam	SCD	890ed265-1217-4fa6-b7f1-a7246dbe137e	8
1302433	Benzepro 5.3 % Topical Foam	SY	890ed265-1217-4fa6-b7f1-a7246dbe137e	8
866054	benzoyl peroxide 5.3 % Topical Foam	SY	890ed265-1217-4fa6-b7f1-a7246dbe137e	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42546-010-10	42546001010	1 CAN in 1 BOX (42546-010-10) > 100 g in 1 CAN	1 can	2012-07-01	0000-00-00	No	No	Current