FDA.reportPublic FDA data

Rugby Benzoyl Peroxide

Product NDC
0536-1058
Requested package NDC
0536-1058-75
11-digit product format
005361058
Labeler code
0536
Product ID
0536-1058_522d963d-b1df-4e6e-b3aa-582380458434
Type
HUMAN OTC DRUG
Nonproprietary name
Benzoyl Peroxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Rugby Laboratories, Inc.
Application
part333D
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-01-20
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0536-10580536-1058-75DDiscontinued by firm2026-10-05

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 · 1 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
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage0536-10580536-1058-75EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…

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 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
0536-1058-75Rugby Benzoyl PeroxideAcne Medication29.5 mL in 1 TUBELOTION29.59
0536-1058-75Rugby Benzoyl PeroxideAcne Medication1 in 1 CARTONLOTION19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1058-75ML - Milliliter0536-105829a461de-147f-492a-85c6-2991b84eec4412015-03-03

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1058RUGBY BENZOYL PEROXIDE ACNE MEDICATION (BENZOYL PEROXIDE) LOTION [RUGBY LABORATORIES, INC.]6Legacy NDC, 2 package rows20240302_460095b7-0e93-4179-877b-cc5f1b39fa0d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106310benzoyl peroxide 10 % Topical LotionPSN460095b7-0e93-4179-877b-cc5f1b39fa0d9
106310benzoyl peroxide 100 MG/ML Topical LotionSCD460095b7-0e93-4179-877b-cc5f1b39fa0d9
106310benzoyl peroxide 10 % Topical LotionSY460095b7-0e93-4179-877b-cc5f1b39fa0d9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0536-1058-75005361058751 TUBE in 1 CARTON (0536-1058-75) > 29.5 mL in 1 TUBE1 tube2015-01-200000-00-00NoNoCurrent