CVS Health Maximum Strength Acne Treatment

Product NDC: 69842-637
Requested package NDC: 69842-637-03
11-digit product format: 698420637
Labeler code: 69842
Product ID: 69842-637_b238bebf-2797-4cc8-bdab-e9ada225f9f7
Type: HUMAN OTC DRUG
Nonproprietary name: Benzoyl Peroxide
Dosage form: GEL
Route: TOPICAL
Labeler: CVS Health
Application: part333D
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2014-01-01
Marketing end: 0000-00-00
Substance: BENZOYL PEROXIDE
Active strength: 100 mg/mL
NDC exclude flag: No
Listing certified through: 2023-12-31
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	69842-637	69842-637-03	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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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
69842-637-03	2025-01-30	C162847	48780-1	2cef2736-6d6a-d83d-e063-dadaa90ab31f	CVS Health ™ Maximum Strength Acne Treatment Gel Acne Medication

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69842-637-01	CVS Health Maximum Strength Acne Treatment Acne Medication	28 mL in 1 TUBE	GEL	28		2
69842-637-03	CVS Health Maximum Strength Acne Treatment Acne Medication	1 in 1 CARTON	GEL	1		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69842-637	CVS HEALTH MAXIMUM STRENGTH ACNE TREATMENT ACNE MEDICATION (BENZOYL PEROXIDE) GEL [CVS HEALTH]	2	Legacy NDC, 2 package rows	20220126_b13e6c99-baa8-4e73-9572-3e0544f3b7f9.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	b13e6c99-baa8-4e73-9572-3e0544f3b7f9	2
486131	benzoyl peroxide 0.1 MG/MG Topical Gel	SCD	b13e6c99-baa8-4e73-9572-3e0544f3b7f9	2
486131	benzoyl peroxide 10 % Topical Gel	SY	b13e6c99-baa8-4e73-9572-3e0544f3b7f9	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69842-637-03	69842063703	1 TUBE in 1 CARTON (69842-637-03) > 28 mL in 1 TUBE (69842-637-01)	1 tube	2014-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
CVS Health ™ Maximum Strength Acne Treatment Gel Acne Medication	CVS Health \| Garcoa, Inc.	2022-01-24	HUMAN OTC DRUG LABEL	2