FDA.reportPublic FDA data

Rugby Benzoyl Peroxide Wash

Product NDC
0536-1351
Requested package NDC
0536-1351-42
11-digit product format
005361351
Labeler code
0536
Product ID
0536-1351_4a1682bd-ff15-4b67-83fb-c4e9fe1f78b8
Type
HUMAN OTC DRUG
Nonproprietary name
Benzoyl Peroxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Rugby Laboratories
Application
part333D
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2022-03-07
Marketing end
0000-00-00
Substance
BENZOYL PEROXIDE
Active strength
100 mg/g
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 packagepackage0536-13510536-1351-42DDiscontinued by firm2026-10-05

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
0536-1351-42Rugby Benzoyl Peroxide WashAcne Medication237 g in 1 BOTTLE, DISPENSINGLOTION2375

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1351-42GM - Gram0536-135113da9630-a524-4136-8b9b-99a4a27551c012022-05-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0536-1351RUGBY BENZOYL PEROXIDE WASH ACNE MEDICATION (BENZOYL PEROXIDE) LOTION [RUGBY LABORATORIES]2Legacy NDC, 1 package rows20240302_d0cb59bc-3c35-4861-bdff-87b27a0e1d13.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
142034benzoyl peroxide 10 % Medicated Liquid SoapPSNd0cb59bc-3c35-4861-bdff-87b27a0e1d135
142034benzoyl peroxide 100 MG/ML Medicated Liquid SoapSCDd0cb59bc-3c35-4861-bdff-87b27a0e1d135
142034benzoyl peroxide 10 % Medicated Liquid SoapSYd0cb59bc-3c35-4861-bdff-87b27a0e1d135

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0536-1351-4200536135142237 g in 1 BOTTLE, DISPENSING (0536-1351-42) 237 g2022-03-070000-00-00NoNoCurrent