Benzoyl Peroxide

Product NDC: 68071-2307
11-digit product format: 680712307
Labeler code: 68071
Product ID: 68071-2307_1d78819d-c76c-7ba4-e063-6394a90a404d
Type: HUMAN OTC DRUG
Nonproprietary name: Benzoyl Peroxide
Dosage form: GEL
Route: TOPICAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: M014
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2015-01-20
Substance: BENZOYL PEROXIDE
Active strength: 50 mg/mL
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Benzoyl Peroxide
Brand name suffix: Acne Medication
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
BENZOYL PEROXIDE	50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
W9WZN9A0GM	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
308694	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
b55acec6-5a4d-08b7-e053-2995a90a0f74	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-2307-5	Benzoyl PeroxideAcne Medication	42.5 mL in 1 TUBE	GEL	42.5		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2307	BENZOYL PEROXIDE ACNE MEDICATION (BENZOYL PEROXIDE) GEL [NUCARE PHARMACEUTICALS,INC.]	3	Current NDC, Legacy NDC, 1 package rows	20240726_b55acec6-5a4d-08b7-e053-2995a90a0f74.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 7 of 7 · 129 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
EAR WAX RMVL Rite Aid	CARBAMIDE PEROXIDE 6.5%	Rite Aid	9e3cedcc-e523-2653-e053-2a95a90ad143	2023-12-15	Warnings	Exact identifier application number: M014
EarWax Removal Kit Rite Aid	CARBAMIDE PEROXIDE 6.5%	Rite Aid	da78ac58-6c1c-4fa9-baac-e9dec0241385	2023-12-15	Warnings	Exact identifier application number: M014
Otix Ear wax Removal System Ear wax and Bulb	CARBAMIDE PEROXIDE	Bell Pharmaceuticals, Inc.	15868798-28cd-4495-9baf-711e81ad8bdd	2023-12-14	Warnings	Exact identifier application number: M014
Otix Ear wax Removal Drops	CARBAMIDE PEROXIDE	Bell Pharmaceuticals, Inc.	0e70ab09-9360-4ab6-a1fe-6f82af392581	2023-12-14	Warnings	Exact identifier application number: M014
TopCare Earwax Removal Drops	CARBAMIDE PEROXIDE	Topco Associates LLC	c5b1ad0e-3712-40fd-afbe-54c0b5f1160b	2023-12-14	Warnings	Exact identifier application number: M014
DG Health Earwax Removal kit	CARBAMIDE PEROXIDE 6.5%	DOLLAR GENERAL CORPORATION	4b6fc00f-72d7-4675-9881-b763f27c06e3	2023-12-07	Warnings	Exact identifier application number: M014
Ear Wax Removal Drops Equate	CARBAMIDE PEROXIDE - 6.5%	WALMART STORES INC	33065ba2-5ce2-4db7-9d7a-d8aa2f38a90d	2023-12-04	Warnings	Exact identifier application number: M014
Good Neighbor Pharmacy Earwax Removal Drops	CARBAMIDE PEROXIDE	Proficient Rx LP	a131447b-a5a0-45cd-a59c-a9f719275baa	2023-12-01	Warnings	Exact identifier application number: M014
Ear Wax Removal Drops	CARBAMIDE PEROXIDE - 6.5%	Sheffield Pharmaceuticals LLC	aad7e2cd-cb28-423c-a441-eabe6516d40f	2022-12-06	Warnings	Exact identifier application number: M014

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
308694	benzoyl peroxide 5 % Topical Gel	PSN	b55acec6-5a4d-08b7-e053-2995a90a0f74	3
308694	benzoyl peroxide 0.05 MG/MG Topical Gel	SCD	b55acec6-5a4d-08b7-e053-2995a90a0f74	3
308694	benzoyl peroxide 5 % Topical Gel	SY	b55acec6-5a4d-08b7-e053-2995a90a0f74	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-2307-5	68071230705	42.5 mL in 1 TUBE (68071-2307-5)	42.5 ml	2020-11-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Rugby ® 5% Benzoyl Peroxide Gel Acne Medication	NuCare Pharmaceuticals,Inc.	2024-07-17	HUMAN OTC DRUG LABEL	3