FDA.reportPublic FDA data

Rugby Benzoyl Peroxide

Product NDC
0536-1055
11-digit product format
005361055
Labeler code
0536
Product ID
0536-1055_bfe57b5b-90ae-4643-aa53-ce8dff70a6c3
Type
HUMAN OTC DRUG
Nonproprietary name
Benzoyl Peroxide
Dosage form
GEL
Route
TOPICAL
Labeler
Rugby Laboratories
Application
M006
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

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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0536-10550536-1055-57DDiscontinued by firm2026-10-15

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0536-10550536-1055-57DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0536-10550536-1055-57DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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
Rugby Benzoyl Peroxide
Brand name suffix
Acne Medication
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOYL PEROXIDE50 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
W9WZN9A0GMInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
de9ac9fe-b6af-45b7-bbf2-70c47f45885bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
b382b4e1-6b48-45f6-bffc-e61b00b0ce19Product name320250317
d9d61457-6a5a-41fc-b418-e5479a2904b7Product name220230303
32012d5c-25ac-49c7-9d4c-1313177fff7cProduct name120230112
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
4a7d44fe-774d-404b-aad0-8a90fe78375aProduct name420211025
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0536-1055-25Rugby Benzoyl PeroxideAcne Medication60 mL in 1 TUBEGEL608
0536-1055-25Rugby Benzoyl PeroxideAcne Medication1 in 1 CARTONGEL18
0536-1055-56Rugby Benzoyl PeroxideAcne Medication42.5 mL in 1 TUBEGEL42.58
0536-1055-56Rugby Benzoyl PeroxideAcne Medication1 in 1 CARTONGEL18
0536-1055-57Rugby Benzoyl PeroxideAcne Medication90 mL in 1 TUBEGEL908
0536-1055-57Rugby Benzoyl PeroxideAcne Medication1 in 1 CARTONGEL18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1055-25GM - Gram0536-1055f4c29262-6ad3-410a-b5be-9502dcc50fe412020-05-08
0536-1055-56GM - Gram0536-1055363f9952-a5d1-4875-80bf-9625fb034d8412017-05-03
0536-1055-57GM - Gram0536-105542bf1054-7b01-419a-bd06-67ee3fceb1d112020-07-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Benzoyl PeroxideACTIVE INGREDIENTW9WZN9A0GMRUGBY BENZOYL PEROXIDE ACNE MEDICATION (BENZOYL PEROXIDE) GEL [RUGBY LABORATORIES, INC.]1
Benzoyl PeroxideACTIVE MOIETYW9WZN9A0GMRUGBY BENZOYL PEROXIDE ACNE MEDICATION (BENZOYL PEROXIDE) GEL [RUGBY LABORATORIES, INC.]1
Carboxymethylcellulose SodiumINACTIVE INGREDIENTK679OBS311RUGBY BENZOYL PEROXIDE ACNE MEDICATION (BENZOYL PEROXIDE) GEL [RUGBY LABORATORIES, INC.]1
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86KRUGBY BENZOYL PEROXIDE ACNE MEDICATION (BENZOYL PEROXIDE) GEL [RUGBY LABORATORIES, INC.]1
Laureth-4INACTIVE INGREDIENT6HQ855798JRUGBY BENZOYL PEROXIDE ACNE MEDICATION (BENZOYL PEROXIDE) GEL [RUGBY LABORATORIES, INC.]1
Sodium HydroxideINACTIVE INGREDIENT55X04QC32IRUGBY BENZOYL PEROXIDE ACNE MEDICATION (BENZOYL PEROXIDE) GEL [RUGBY LABORATORIES, INC.]1
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPRUGBY BENZOYL PEROXIDE ACNE MEDICATION (BENZOYL PEROXIDE) GEL [RUGBY LABORATORIES, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RRUGBY BENZOYL PEROXIDE ACNE MEDICATION (BENZOYL PEROXIDE) GEL [RUGBY LABORATORIES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1055RUGBY BENZOYL PEROXIDE ACNE MEDICATION (BENZOYL PEROXIDE) GEL [RUGBY LABORATORIES, INC.]6Current NDC, Legacy NDC, 6 package rows20240210_de9ac9fe-b6af-45b7-bbf2-70c47f45885b.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 13 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oil Free Acne WashSALICYLIC ACID 2%CVS Pharmacy, Inc.7a8225ab-b60a-4978-bdfe-db0b00307ef12026-02-03WarningsExact identifier
application number: M006
Acne TreatmentBENZOYL PEROXIDECVS Pharmacy, Inc.d9fbaeba-cebf-4d02-aa7d-3ee1d2fdc50c2026-02-02Warnings, Adverse reactionsExact identifier
application number: M006
Even and Clear Exfoliating WashSALICYLIC ACIDAmbi Enterprises, LLC499d7616-4677-f6a7-e063-6294a90aeaa22026-01-30WarningsExact identifier
application number: M006
Medicated Apricot ScrubSALICYLIC ACIDRite Aid Corporationfb90b880-07e5-4bda-b907-228a669505552026-01-30Warnings, Adverse reactionsExact identifier
application number: M006
Acne TreatmentBENZOYL PEROXIDERite Aid Corporationa51b7668-1ba1-42cb-b804-4fdf766106952026-01-30Warnings, Adverse reactionsExact identifier
application number: M006
Acne TreatmentSALICYLIC ACIDNatureplex, LLC31b50718-cc60-460d-aad7-b9620970d4112026-01-29WarningsExact identifier
application number: M006
Peace Out Acne CleanserSALICYLIC ACIDPeace Out LLC0a8897b0-cb8f-ba50-e063-6394a90a7f342026-01-29WarningsExact identifier
application number: M006
Peace Out Acne MoisturizerSALICYLIC ACIDPeace Out LLC.18bb4314-0b18-b3bc-e063-6294a90a18542026-01-29WarningsExact identifier
application number: M006
ZITFREE ACNE TREATMENTBENZOYL PEROXIDENatureplex, LLC70c2e3fb-e643-467b-80fd-c40e3c3e95132026-01-29WarningsExact identifier
application number: M006
ProBliva Antibacterial and Acne Body WashANTIBACTERIAL AND ACNE BODY WASHCAVTECH HOLDING LLC496f7a1e-05b6-d434-e063-6394a90afe542026-01-28WarningsExact identifier
application number: M006
Sunscreen SPF50NON NANO ZINC OXIDESBS BILIMSEL BIO COZUMLER SANAYI VE TICARET ANONIM SIRKETI PINAR SUBESIc5d52f13-a649-9579-e053-2a95a90a062c2026-01-27WarningsExact identifier
application number: M006
Viaderma Calm Anti-ItchHYDROCORTISONEVIADERMA DISTRIBUTION INCea281bde-a7a2-47b6-895a-5dc2924972de2026-01-27WarningsExact identifier
application number: M006
Viaderma Clear Acne TreatmentSALICYLIC ACIDVIADERMA DISTRIBUTION INCace405bd-6fe6-4db1-ba1f-9b9861abe6632026-01-27WarningsExact identifier
application number: M006
DHC Acne Spot TherapySULFURDHC USA Incorporated84d49048-95cf-4f14-9698-c746237fec9d2026-01-24WarningsExact identifier
application number: M006
MEDPURA Benzoyl Peroxide Aqueous Base, Acne Treatment GelBENZOYL PEROXIDEAkron Pharma Inc.b7d335d1-3022-4b28-913c-477152a7dad22026-01-23WarningsExact identifier
application number: M006
Skinkure Acne Eraser Spot TreatmentSALICYLIC ACIDSKINKURE, LLC0fc85727-4321-7750-e063-6294a90ad3fe2026-01-23WarningsExact identifier
application number: M006
EmuaidSALICYLIC ACIDSpeer Laboratories, LLCa1486276-30f7-4245-815b-d57edf411cda2026-01-23WarningsExact identifier
application number: M006
Neutrogena Evenly Clear Acne CleanserSALICYLIC ACIDKenvue Brands LLC3e985a61-2aa7-963b-e063-6294a90a7c122026-01-22WarningsExact identifier
application number: M006
Resurfacing acne swipesSALICYLIC ACIDSKIN PS Brands9629fdcb-f3b5-9685-e053-2a95a90a02302026-01-22WarningsExact identifier
application number: M006
PanOxylSALICYLIC ACIDCrown Laboratories48fd0106-4db4-f33a-e063-6294a90a5a0b2026-01-22WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308694benzoyl peroxide 5 % Topical GelPSNa86ae901-53d0-4bfd-808e-59d9a7bc5ef617
308694benzoyl peroxide 0.05 MG/MG Topical GelSCDa86ae901-53d0-4bfd-808e-59d9a7bc5ef617
308694benzoyl peroxide 5 % Topical GelSYa86ae901-53d0-4bfd-808e-59d9a7bc5ef617
308694benzoyl peroxide 5 % Topical GelPSNde9ac9fe-b6af-45b7-bbf2-70c47f45885b8
308694benzoyl peroxide 0.05 MG/MG Topical GelSCDde9ac9fe-b6af-45b7-bbf2-70c47f45885b8
308694benzoyl peroxide 5 % Topical GelSYde9ac9fe-b6af-45b7-bbf2-70c47f45885b8
308694benzoyl peroxide 5 % Topical GelPSNb55acec6-5a4d-08b7-e053-2995a90a0f743
308694benzoyl peroxide 0.05 MG/MG Topical GelSCDb55acec6-5a4d-08b7-e053-2995a90a0f743
308694benzoyl peroxide 5 % Topical GelSYb55acec6-5a4d-08b7-e053-2995a90a0f743

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0536-1055-25005361055251 TUBE in 1 CARTON (0536-1055-25) / 60 mL in 1 TUBE1 tube2019-10-312027-02-01NoNoCurrent
0536-1055-56005361055561 TUBE in 1 CARTON (0536-1055-56) / 42.5 mL in 1 TUBE1 tube2015-01-200000-00-00NoNoCurrent
0536-1055-57005361055571 TUBE in 1 CARTON (0536-1055-57) > 90 mL in 1 TUBE1 tube2019-10-310000-00-00NoNoCurrent