FDA.reportPublic FDA data

Acne Treatment

Product NDC
67226-2050
11-digit product format
672262050
Labeler code
67226
Product ID
67226-2050_08bf29ff-1c59-1547-e063-6294a90ac7ee
Type
HUMAN OTC DRUG
Nonproprietary name
BENZOYL PEROXIDE
Dosage form
LOTION
Route
TOPICAL
Labeler
Vivier Pharma, Inc.
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-11-01
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
Acne Treatment
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
106309Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b4844539-bdd2-42a6-b946-6028de4f3cf1Available 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
67226-2050-3Acne Treatment30 mL in 1 TUBELOTION3014
67226-2050-3Acne Treatment1 in 1 BOXLOTION114
67226-2050-3Acne Treatment System1 in 1 BOXLOTION50 mg in 1mL8
67226-2050-3Acne Treatment System30 mL in 1 TUBELOTION30 mL50 mg in 1mL8

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZOYL PEROXIDEACTIVE INGREDIENTW9WZN9A0GMSKINTX ACNE TREATMENT (BENZOYL PEROXIDE) LOTION [VIVIER PHARMA, INC.]4
BENZOYL PEROXIDEACTIVE MOIETYW9WZN9A0GMSKINTX ACNE TREATMENT (BENZOYL PEROXIDE) LOTION [VIVIER PHARMA, INC.]4
C13-14 ISOPARAFFININACTIVE INGREDIENTE4F12ROE70SKINTX ACNE TREATMENT (BENZOYL PEROXIDE) LOTION [VIVIER PHARMA, INC.]4
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PSKINTX ACNE TREATMENT (BENZOYL PEROXIDE) LOTION [VIVIER PHARMA, INC.]4
LANOLIN OILINACTIVE INGREDIENTOVV5IIJ58FSKINTX ACNE TREATMENT (BENZOYL PEROXIDE) LOTION [VIVIER PHARMA, INC.]4
LAURETH-4INACTIVE INGREDIENT6HQ855798JSKINTX ACNE TREATMENT (BENZOYL PEROXIDE) LOTION [VIVIER PHARMA, INC.]4
LAURETH-7INACTIVE INGREDIENTZ95S6G8201SKINTX ACNE TREATMENT (BENZOYL PEROXIDE) LOTION [VIVIER PHARMA, INC.]4
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCSKINTX ACNE TREATMENT (BENZOYL PEROXIDE) LOTION [VIVIER PHARMA, INC.]4
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TSKINTX ACNE TREATMENT (BENZOYL PEROXIDE) LOTION [VIVIER PHARMA, INC.]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3SKINTX ACNE TREATMENT (BENZOYL PEROXIDE) LOTION [VIVIER PHARMA, INC.]4
WATERINACTIVE INGREDIENT059QF0KO0RSKINTX ACNE TREATMENT (BENZOYL PEROXIDE) LOTION [VIVIER PHARMA, INC.]4
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEESKINTX ACNE TREATMENT (BENZOYL PEROXIDE) LOTION [VIVIER PHARMA, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67226-2050ACNE TREATMENT (BENZOYL PEROXIDE) LOTION [VIVIER PHARMA, INC.]14Current NDC, Legacy NDC, 2 package rows20231030_b4844539-bdd2-42a6-b946-6028de4f3cf1.zip
67226-2050ACNE TREATMENT SYSTEM (BENZOYL PEROXIDE, SALICYLIC ACID) KIT [VIVIER PHARMA, INC.]8Current NDC, Legacy NDC20231030_d39ee6a2-5d65-4198-82d9-deb83471f312.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 3 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acne Free Free 24 HR Acne Clearing SystemBENZOYL PEROXIDEAcneFree, LLCc939847a-72eb-96fa-e053-2a95a90a4f9c2026-07-31WarningsExact identifier
application number: M006
Terminator 10BENZOYL PEROXIDEAcneFree, LLCc06778b6-0ed6-7d82-e053-2a95a90a2ef82026-07-31WarningsExact identifier
application number: M006
Acne Free Oil Free Acne Cleanser 2.5 Benzoyl PeroxideBENZOYL PEROXIDEAcneFree LLCc939847a-72cc-96fa-e053-2a95a90a4f9c2026-07-31WarningsExact identifier
application number: M006
Benzoyl Peroxide Deep Cleansing Foaming WashBENZOYL PEROXIDEAcneFree, LLCfe2d0e24-8c68-b2ea-e053-6294a90ad72c2026-07-31WarningsExact identifier
application number: M006
Salicylic AcidSALICYLIC ACIDAcne Free, LLC1097fc73-fa47-0f14-e063-6294a90aa4992026-07-31WarningsExact identifier
application number: M006
Even and Clear CleanserSALICYLIC ACIDAmbi Enterprises LLCbff537cf-aa79-5250-e053-2995a90a388a2026-07-31WarningsExact identifier
application number: M006
Oil Free Deep Cleansing Duo Cleansing Brush Oil Free Acne CleanserBENZOYL PEROXIDEAcneFree, LLCc7a675fa-b6c0-6237-e053-2a95a90a04062026-07-31WarningsExact identifier
application number: M006
Acne Free SEVERE ACNE 24 HR Acne Clearing SystemBENZOYL PEROXIDEAcneFree, LLCc939681e-ea93-31ce-e053-2a95a90a8c702026-07-31WarningsExact identifier
application number: M006
Acne Free SENSITIVE SKIN 24 HR Acne Clearing SystemSALICYLIC ACID, BENZOYL PEROXIDEAcneFree LLCc9397a25-8fed-48d0-e053-2a95a90ab4952026-07-31WarningsExact identifier
application number: M006
sulfur acne treatmentSULFURAcne Free105545d8-974c-5a9a-e063-6294a90aecc42026-07-31WarningsExact identifier
application number: M006
24 Hour Sensitive Skin Acne Clearing SystemSALICYLIC ACIDAcne Free LLC39ea674d-ff6e-a8c6-e063-6394a90a06562026-07-31WarningsExact identifier
application number: M006
cardae FOLLICULITIS CreamMICONAZOLE NITRATE 2% FOLLICULITIS CREAMWenzhou Yuyuan Pharmaceutical Co., Ltd.57e0be6a-3141-f3b6-e063-6394a90a15202026-07-30WarningsExact identifier
application number: M006
SKINTIFIC 3X ACID INTENSIVE ACNE TREATMENTSALICYLIC ACIDGold Inti Trade Corporation57a7c929-31f5-ef82-e063-6394a90ab9af2026-07-28WarningsExact identifier
application number: M006
Acne Treatment with SulfurSULFURDLC Laboratories, Inc.4a1591e8-6135-4b22-b54c-5553c2dc05402026-07-28WarningsExact identifier
application number: M006
amberglow BLEMISH PATCHESSALICYLIC ACIDPearl World Inc.12054430-25ff-4b72-8f64-822b27abb4432026-07-27WarningsExact identifier
application number: M006
RFA BPO Acne Treatment 2.5%BENZOYL PEROXIDETopiderm, Inc.c5053e9e-7608-45d9-9b9b-9b93210eb9172026-07-27WarningsExact identifier
application number: M006
ACNO Solution ACNE TREATMENTSALICYLIC ACIDNoon Aesthetics M.R. Ltd4a267e44-03d9-471f-9708-a5c60ff690972026-07-24WarningsExact identifier
application number: M006
DERMFREE MILIA REMOVERSALICYLIC ACID 1% MILIA REMOVERJiangxi Yudexi Pharmaceutical Co., LTD4a5c8a6e-b02d-3a87-e063-6294a90a14ff2026-07-23WarningsExact identifier
application number: M006
salicylic acidSALICYLIC ACIDChain Drug Marketing Association4dc96074-50a1-baa8-e063-6294a90a5aab2026-07-22Warnings, Adverse reactionsExact identifier
application number: M006
SYLVIRENE MILIA REMOVERSALICYLIC ACID 1% MILIA REMOVERJiangxi Yudexi Pharmaceutical Co., LTD4a3751f8-2365-1b34-e063-6394a90acf742026-07-21WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106309benzoyl peroxide 5 % Topical LotionPSNb4844539-bdd2-42a6-b946-6028de4f3cf114
106309benzoyl peroxide 50 MG/ML Topical LotionSCDb4844539-bdd2-42a6-b946-6028de4f3cf114
106309benzoyl peroxide 5 % Topical LotionSYb4844539-bdd2-42a6-b946-6028de4f3cf114
1092658{1 (30 ML) (benzoyl peroxide 50 MG/ML Topical Lotion) / 1 (150 ML) (salicylic acid 20 MG/ML Medicated Liquid Soap) } PackGPCKd39ee6a2-5d65-4198-82d9-deb83471f3128
106309benzoyl peroxide 5 % Topical LotionPSNd39ee6a2-5d65-4198-82d9-deb83471f3128
1092658benzoyl peroxide 5 % Topical Lotion (30 ML) / salicylic acid 2 % Medicated Liquid Soap (150 ML) PackPSNd39ee6a2-5d65-4198-82d9-deb83471f3128
562600salicylic acid 2 % Medicated Liquid SoapPSNd39ee6a2-5d65-4198-82d9-deb83471f3128
106309benzoyl peroxide 50 MG/ML Topical LotionSCDd39ee6a2-5d65-4198-82d9-deb83471f3128
562600salicylic acid 20 MG/ML Medicated Liquid SoapSCDd39ee6a2-5d65-4198-82d9-deb83471f3128
1092658{1 (150 ML salicylic acid 2 % Medicated Liquid Soap) / 1 (30 ML benzoyl peroxide 5 % Topical Lotion) } PackSYd39ee6a2-5d65-4198-82d9-deb83471f3128
106309benzoyl peroxide 5 % Topical LotionSYd39ee6a2-5d65-4198-82d9-deb83471f3128
562600salicylic acid 2 % Facial Cleanser TonerSYd39ee6a2-5d65-4198-82d9-deb83471f3128
562600salicylic acid 2 % Facial ScrubSYd39ee6a2-5d65-4198-82d9-deb83471f3128
562600salicylic acid 2 % Medicated Liquid SoapSYd39ee6a2-5d65-4198-82d9-deb83471f3128

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67226-2050-3672262050031 TUBE in 1 BOX (67226-2050-3) / 30 mL in 1 TUBE1 tube2011-11-010000-00-00NoNoCurrent