BenzePrO Creamy Wash

Product NDC: 42546-017
Requested package NDC: 42546-017-18
11-digit product format: 425460017
Labeler code: 42546
Product ID: 42546-017_32ad81fd-7ae5-446a-a800-0b67ecf6e85e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: benzoyl peroxide
Dosage form: SOAP
Route: TOPICAL
Labeler: PruGen, Inc.
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2015-07-01
Marketing end: 0000-00-00
Substance: BENZOYL PEROXIDE
Active strength: 7 g/100g
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	42546-017	42546-017-18	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
42546-017-18	2022-01-28	C162847	48780-1	d6a99b39-3464-a426-e053-dadaa90af4c2	BenzePrO Creamy Wash

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
42546-017-18	BenzePrO Creamy Wash	180 g in 1 TUBE	SOAP	180		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42546-017-18	GM - Gram	42546-017	38b376bf-dacf-4b3f-b227-49ce1e537025	1	2015-09-10

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BENZOYL PEROXIDE	ACTIVE INGREDIENT	W9WZN9A0GM	BENZEPRO CREAMY WASH (BENZOYL PEROXIDE) SOAP [PRUGEN, INC.]	1
BENZOYL PEROXIDE	ACTIVE MOIETY	W9WZN9A0GM	BENZEPRO CREAMY WASH (BENZOYL PEROXIDE) SOAP [PRUGEN, INC.]	1
ALOE	INACTIVE INGREDIENT	V5VD430YW9	BENZEPRO CREAMY WASH (BENZOYL PEROXIDE) SOAP [PRUGEN, INC.]	1
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	INACTIVE INGREDIENT	4Q93RCW27E	BENZEPRO CREAMY WASH (BENZOYL PEROXIDE) SOAP [PRUGEN, INC.]	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	BENZEPRO CREAMY WASH (BENZOYL PEROXIDE) SOAP [PRUGEN, INC.]	1
DISODIUM OLEAMIDO MEA-SULFOSUCCINATE	INACTIVE INGREDIENT	5M1101WGSY	BENZEPRO CREAMY WASH (BENZOYL PEROXIDE) SOAP [PRUGEN, INC.]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	BENZEPRO CREAMY WASH (BENZOYL PEROXIDE) SOAP [PRUGEN, INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	BENZEPRO CREAMY WASH (BENZOYL PEROXIDE) SOAP [PRUGEN, INC.]	1
GREEN TEA LEAF	INACTIVE INGREDIENT	W2ZU1RY8B0	BENZEPRO CREAMY WASH (BENZOYL PEROXIDE) SOAP [PRUGEN, INC.]	1
LAURETH-12	INACTIVE INGREDIENT	OAH19558U1	BENZEPRO CREAMY WASH (BENZOYL PEROXIDE) SOAP [PRUGEN, INC.]	1
MAGNESIUM ALUMINUM SILICATE	INACTIVE INGREDIENT	6M3P64V0NC	BENZEPRO CREAMY WASH (BENZOYL PEROXIDE) SOAP [PRUGEN, INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	BENZEPRO CREAMY WASH (BENZOYL PEROXIDE) SOAP [PRUGEN, INC.]	1
SODIUM COCO-SULFATE	INACTIVE INGREDIENT	3599J29ANH	BENZEPRO CREAMY WASH (BENZOYL PEROXIDE) SOAP [PRUGEN, INC.]	1
SODIUM LAUROAMPHOACETATE	INACTIVE INGREDIENT	SLK428451L	BENZEPRO CREAMY WASH (BENZOYL PEROXIDE) SOAP [PRUGEN, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	BENZEPRO CREAMY WASH (BENZOYL PEROXIDE) SOAP [PRUGEN, INC.]	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	BENZEPRO CREAMY WASH (BENZOYL PEROXIDE) SOAP [PRUGEN, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42546-017	BENZEPRO CREAMY WASH (BENZOYL PEROXIDE) SOAP [PRUGEN, INC.]	3	Legacy NDC, 1 package rows	20180706_cb2fdb3f-24b7-481a-91c5-341c3d45842a.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
1605437	BenzePro 7 % Medicated Liquid Soap	PSN	cb2fdb3f-24b7-481a-91c5-341c3d45842a	3
845988	benzoyl peroxide 7 % Medicated Liquid Soap	PSN	cb2fdb3f-24b7-481a-91c5-341c3d45842a	3
1605437	benzoyl peroxide 70 MG/ML Medicated Liquid Soap [Benzepro]	SBD	cb2fdb3f-24b7-481a-91c5-341c3d45842a	3
845988	benzoyl peroxide 70 MG/ML Medicated Liquid Soap	SCD	cb2fdb3f-24b7-481a-91c5-341c3d45842a	3
1605437	BenzePro 7 % Medicated Cleanser	SY	cb2fdb3f-24b7-481a-91c5-341c3d45842a	3
845988	benzoyl peroxide 7 % Topical Wash	SY	cb2fdb3f-24b7-481a-91c5-341c3d45842a	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
42546-017-18	42546001718	180 g in 1 TUBE (42546-017-18)	180 g	2015-07-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BenzePrO Creamy Wash	PruGen, Inc. \| PHARMASOL CORPORATION	2018-07-05	HUMAN PRESCRIPTION DRUG LABEL	3