Rugby Benzoyl Peroxide

Product NDC
68071-4393
11-digit product format
680714393
Labeler code
68071
Product ID
68071-4393_1a8b5000-7731-1eda-e063-6394a90ae8c1
Type
HUMAN OTC DRUG
Nonproprietary name
Benzoyl Peroxide
Dosage form
GEL
Route
TOPICAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-01-20
Substance
BENZOYL PEROXIDE
Active strength
100 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage68071-4393-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage68071-4393-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage68071-4393-11332a3947898…d4bfe170f9cd…

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 PEROXIDE100 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
486131Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
69bd4f4c-017a-7422-e053-2991aa0aa655Available 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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2024-06-11Rugby ® 10% Benzoyl Peroxide Gel
2023-01-30Rugby ® 10% Benzoyl Peroxide Gel
2021-02-16Rugby ® 10% Benzoyl Peroxide Gel
2021-01-29Rugby ® 10% Benzoyl Peroxide Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4393-1Rugby Benzoyl PeroxideAcne Medication42.5 mL in 1 BOXGEL42.54

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4393RUGBY BENZOYL PEROXIDE ACNE MEDICATION (BENZOYL PEROXIDE) GEL [NUCARE PHARMACEUTICALS,INC.]4Current NDC, Legacy NDC, 1 package rows20240613_69bd4f4c-017a-7422-e053-2991aa0aa655.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 10 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SUFLUR SPOTandMASK Acne Clearing Treatment MaskSULFURCA-Botana International4d77310a-2441-a17e-e063-6394a90ae68b2026-03-20WarningsExact identifier
application number: M006
Daily Acne Control CleanserBENZOYL PEROXIDEAmazon.com Services LLC2dddc0ef-352a-4973-8402-15aecddcc43f2026-03-20Warnings, Adverse reactionsExact identifier
application number: M006
Saltair Acne BodyspraySALICYLIC ACIDSaltair Body LLC4d7c16a6-9b43-fbe3-e063-6294a90af0512026-03-20WarningsExact identifier
application number: M006
Byoma Acne Clearing Body WashSALICYLIC ACIDByoma Ltd2fffd6a2-1a0e-36d4-e063-6294a90ad1bc2026-03-19WarningsExact identifier
application number: M006
Derm Acne Solution GelSALICYLIC ACIDYantai Aien Biotechnology Co., Ltd.4d6c98ab-801d-63bc-e063-6294a90a20c32026-03-19WarningsExact identifier
application number: M006
Sofie Pavitt Face Reset Benzoyl Peroxide Acne Treatment MaskBENZOYL PEROXIDECosco International, Inc.464c0ed1-ebc4-45b1-80e3-dfe0b76312e32026-03-17WarningsExact identifier
application number: M006
Neutrogena Rapid Clear Stubborn Acne SpotBENZOYL PEROXIDEKenvue Brands LLC5b11b2de-d156-4d6a-8024-0a945661cd9a2026-03-12WarningsExact identifier
application number: M006
Clean and Clear persa-gel 10 Maximum StrengthBENZOYL PEROXIDEKenvue Brands LLCc9642441-4d3a-1128-e053-2995a90aefd12026-03-12WarningsExact identifier
application number: M006
14% Azelaic Acid AcneAZELAIC ACIDGuangdong Bisutang Biotechnology Co., Ltd.4ccaa734-83be-611b-e063-6294a90ab3bf2026-03-11WarningsExact identifier
application number: M006
Body WashSALICYLIC ACIDAmazon.com Services LLCb5d7da95-81ff-4ef9-8b80-2d046cc2a6082026-03-10Warnings, Adverse reactionsExact identifier
application number: M006
Tula Skincare Breakout Star Lightweight Acne MoisturizerSALICYLIC ACIDThe Procter & Gamble Manufacturing Company4bd1d5f5-1b3c-5e82-e063-6394a90a64542026-03-09WarningsExact identifier
application number: M006
natouchSALICYLIC ACIDNatouch LLC4cb2cc1b-1793-b0c4-e063-6294a90a430f2026-03-08WarningsExact identifier
application number: M006
BYT BANGYTONG MILIA REMOVERSALICYLIC ACID 1% MILIA REMOVER LIQUIDShenzhen Jindali Technology Co., Ltd4c5c3368-b3d2-976f-e063-6294a90a70462026-03-06WarningsExact identifier
application number: M006
RoyceDerm Rosacea Relief Cream.SULFUR 1X HPUS 10%RoyceDerm LLC4c3f6332-de46-f107-e063-6294a90ad63f2026-03-04WarningsExact identifier
application number: M006
Medicated Apricot ScrubSALICYLIC ACIDTopco Associates LLC66ccfcb7-6217-4bfb-ac11-4bcbdecb27d82026-03-03Warnings, Adverse reactionsExact identifier
application number: M006
Acne TreatmentBENZOYL PEROXIDEAmazon.com Services LLC08c28255-a223-416e-a2d9-ecb149b0f0512026-03-03Warnings, Adverse reactionsExact identifier
application number: M006
Neutrogena Evenly Clear Acne Gel MoisturizerSALICYLIC ACIDKenvue Brands LLC3f8f344d-a468-8eb3-e063-6394a90a7dd72026-03-02WarningsExact identifier
application number: M006
Acne ScrubSALICYLIC ACIDOld East Main Co.f63d4184-44a2-484f-ae51-ce37e19374a22026-03-02Warnings, Adverse reactionsExact identifier
application number: M006
Acne WashSALICYLIC ACIDOld East Main Co.7bf6f18f-a1ec-460e-afbc-51be1add05b62026-03-02Warnings, Adverse reactionsExact identifier
application number: M006
Advanced DermaClear SerumSALICYLIC ACIDAllure Labs4c10bc9a-52b0-fbf2-e063-6394a90a57802026-03-02WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
486131benzoyl peroxide 10 % Topical GelPSN69bd4f4c-017a-7422-e053-2991aa0aa6554
486131benzoyl peroxide 0.1 MG/MG Topical GelSCD69bd4f4c-017a-7422-e053-2991aa0aa6554
486131benzoyl peroxide 10 % Topical GelSY69bd4f4c-017a-7422-e053-2991aa0aa6554

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4393-16807143930142.5 mL in 1 BOX (68071-4393-1) 42.5 ml2018-04-130000-00-00NoNoCurrent