Super Bump Relief

Product NDC: 65840-100
11-digit product format: 658400100
Labeler code: 65840
Product ID: 65840-100_98963a9d-ade4-4254-ab78-64830dd0d15b
Type: HUMAN OTC DRUG
Nonproprietary name: benzoyl peroxide and salicylic acid
Dosage form: CREAM
Route: TOPICAL
Labeler: Elements Personal Care, Inc.
Application: part333D
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2011-06-08
Marketing end: 0000-00-00
Substance: BENZOYL PEROXIDE; SALICYLIC ACID
Active strength: 4 g/100g; g/100g
NDC exclude flag: E
Listing certified through: 2017-12-31
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	65840-100		D	Discontinued by firm		2026-10-05
excluded package	package	65840-100	65840-100-01	D	Discontinued by firm		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 · 44 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	65840-100-01	`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	65840-100-01	`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	65840-100-01	`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	65840-100-01	`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	65840-100-01	`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	65840-100-01	`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	65840-100-01	`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	65840-100-01	`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	65840-100-01	`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	65840-100-01	`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	65840-100-01	`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	65840-100-01	`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	65840-100-01	`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	65840-100-01	`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	65840-100-01	`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	65840-100-01	`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	65840-100-01	`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	65840-100-01	`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	65840-100-01	`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	65840-100-01	`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	65840-100-01	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	65840-100-01	`110d247fa046…`	`a55b01930146…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
65840-100-01	2019-10-29	C162847	48780-1	960f7f55-c518-8e05-e053-dbdaa90a074a	Super Bump Relief

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
BENZOYL PEROXIDE	ACTIVE INGREDIENT	W9WZN9A0GM	SUPER BUMP RELIEF (BENZOYL PEROXIDE AND SALICYLIC ACID) CREAM [ELEMENTS PERSONAL CARE, INC.]	1
SALICYLIC ACID	ACTIVE INGREDIENT	O414PZ4LPZ	SUPER BUMP RELIEF (BENZOYL PEROXIDE AND SALICYLIC ACID) CREAM [ELEMENTS PERSONAL CARE, INC.]	1
BENZOYL PEROXIDE	ACTIVE MOIETY	W9WZN9A0GM	SUPER BUMP RELIEF (BENZOYL PEROXIDE AND SALICYLIC ACID) CREAM [ELEMENTS PERSONAL CARE, INC.]	1
SALICYLIC ACID	ACTIVE MOIETY	O414PZ4LPZ	SUPER BUMP RELIEF (BENZOYL PEROXIDE AND SALICYLIC ACID) CREAM [ELEMENTS PERSONAL CARE, INC.]	1
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	SUPER BUMP RELIEF (BENZOYL PEROXIDE AND SALICYLIC ACID) CREAM [ELEMENTS PERSONAL CARE, INC.]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	SUPER BUMP RELIEF (BENZOYL PEROXIDE AND SALICYLIC ACID) CREAM [ELEMENTS PERSONAL CARE, INC.]	1
CAMPHOR OIL	INACTIVE INGREDIENT	75IZZ8Y727	SUPER BUMP RELIEF (BENZOYL PEROXIDE AND SALICYLIC ACID) CREAM [ELEMENTS PERSONAL CARE, INC.]	1
IMIDUREA	INACTIVE INGREDIENT	M629807ATL	SUPER BUMP RELIEF (BENZOYL PEROXIDE AND SALICYLIC ACID) CREAM [ELEMENTS PERSONAL CARE, INC.]	1
MAGNESIUM ALUMINUM SILICATE	INACTIVE INGREDIENT	6M3P64V0NC	SUPER BUMP RELIEF (BENZOYL PEROXIDE AND SALICYLIC ACID) CREAM [ELEMENTS PERSONAL CARE, INC.]	1
MAGNESIUM SULFATE HEPTAHYDRATE	INACTIVE INGREDIENT	SK47B8698T	SUPER BUMP RELIEF (BENZOYL PEROXIDE AND SALICYLIC ACID) CREAM [ELEMENTS PERSONAL CARE, INC.]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	SUPER BUMP RELIEF (BENZOYL PEROXIDE AND SALICYLIC ACID) CREAM [ELEMENTS PERSONAL CARE, INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	SUPER BUMP RELIEF (BENZOYL PEROXIDE AND SALICYLIC ACID) CREAM [ELEMENTS PERSONAL CARE, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SUPER BUMP RELIEF (BENZOYL PEROXIDE AND SALICYLIC ACID) CREAM [ELEMENTS PERSONAL CARE, INC.]	1
TROLAMINE	INACTIVE INGREDIENT	9O3K93S3TK	SUPER BUMP RELIEF (BENZOYL PEROXIDE AND SALICYLIC ACID) CREAM [ELEMENTS PERSONAL CARE, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	SUPER BUMP RELIEF (BENZOYL PEROXIDE AND SALICYLIC ACID) CREAM [ELEMENTS PERSONAL CARE, INC.]	1
XANTHAN GUM	INACTIVE INGREDIENT	TTV12P4NEE	SUPER BUMP RELIEF (BENZOYL PEROXIDE AND SALICYLIC ACID) CREAM [ELEMENTS PERSONAL CARE, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65840-100	SUPER BUMP RELIEF (BENZOYL PEROXIDE AND SALICYLIC ACID) CREAM [ELEMENTS PERSONAL CARE, INC.]	1	Legacy NDC	20110608_98963a9d-ade4-4254-ab78-64830dd0d15b.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
W9WZN9A0GM	BENZOYL PEROXIDE	94-36-0	BENZOYL PEROXIDE
O414PZ4LPZ	SALICYLIC ACID	69-72-7	SALICYLIC ACID

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Super Bump Relief	Elements Personal Care, Inc. \| Fragrance Manufacturing, Inc.	2011-06-06	HUMAN OTC DRUG LABEL	1