FDA.reportPublic FDA data

Clear Proof Acne Treatment

Product NDC
51531-9071
11-digit product format
515319071
Labeler code
51531
Product ID
51531-9071_5d1ae085-93cf-6664-e063-6394a90a60c6
Type
HUMAN OTC DRUG
Nonproprietary name
Benzoyl Peroxide
Dosage form
GEL
Route
TOPICAL
Labeler
Mary Kay Inc.
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-06-15
Marketing end
2028-07-14
Substance
BENZOYL PEROXIDE
Active strength
5 g/100g
NDC exclude flag
No
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
Clear Proof Acne Treatment
Brand name suffix
Acne Medication

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOYL PEROXIDE5 g/100g

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
51531-9071-0Clear Proof Acne TreatmentAcne Medication3 g in 1 TUBEGEL37
51531-9071-1Clear Proof Acne TreatmentAcne Medication28 g in 1 TUBEGEL287
51531-9071-1Clear Proof Acne TreatmentAcne Medication1 in 1 CARTONGEL17

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Benzoyl PeroxideACTIVE INGREDIENTW9WZN9A0GMCLEAR PROOF ACNE TREATMENT ACNE MEDICATION (BENZOYL PEROXIDE) GEL [MARY KAY INC.]1
Benzoyl PeroxideACTIVE MOIETYW9WZN9A0GMCLEAR PROOF ACNE TREATMENT ACNE MEDICATION (BENZOYL PEROXIDE) GEL [MARY KAY INC.]1
1,3-BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RACLEAR PROOF ACNE TREATMENT ACNE MEDICATION (BENZOYL PEROXIDE) GEL [MARY KAY INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MCLEAR PROOF ACNE TREATMENT ACNE MEDICATION (BENZOYL PEROXIDE) GEL [MARY KAY INC.]1
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)INACTIVE INGREDIENT59TL3WG5COCLEAR PROOF ACNE TREATMENT ACNE MEDICATION (BENZOYL PEROXIDE) GEL [MARY KAY INC.]1
CucumberINACTIVE INGREDIENTYY7C30VXJTCLEAR PROOF ACNE TREATMENT ACNE MEDICATION (BENZOYL PEROXIDE) GEL [MARY KAY INC.]1
DENATONIUM BENZOATEINACTIVE INGREDIENT4YK5Z54AT2CLEAR PROOF ACNE TREATMENT ACNE MEDICATION (BENZOYL PEROXIDE) GEL [MARY KAY INC.]1
Docusate SodiumINACTIVE INGREDIENTF05Q2T2JA0CLEAR PROOF ACNE TREATMENT ACNE MEDICATION (BENZOYL PEROXIDE) GEL [MARY KAY INC.]1
Echinacea PurpureaINACTIVE INGREDIENTQI7G114Y98CLEAR PROOF ACNE TREATMENT ACNE MEDICATION (BENZOYL PEROXIDE) GEL [MARY KAY INC.]1
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86KCLEAR PROOF ACNE TREATMENT ACNE MEDICATION (BENZOYL PEROXIDE) GEL [MARY KAY INC.]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXCLEAR PROOF ACNE TREATMENT ACNE MEDICATION (BENZOYL PEROXIDE) GEL [MARY KAY INC.]1
Horse ChestnutINACTIVE INGREDIENT3C18L6RJAZCLEAR PROOF ACNE TREATMENT ACNE MEDICATION (BENZOYL PEROXIDE) GEL [MARY KAY INC.]1
Poloxamer 182INACTIVE INGREDIENTJX0HIX6OAGCLEAR PROOF ACNE TREATMENT ACNE MEDICATION (BENZOYL PEROXIDE) GEL [MARY KAY INC.]1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3CLEAR PROOF ACNE TREATMENT ACNE MEDICATION (BENZOYL PEROXIDE) GEL [MARY KAY INC.]1
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4CLEAR PROOF ACNE TREATMENT ACNE MEDICATION (BENZOYL PEROXIDE) GEL [MARY KAY INC.]1
Sodium HydroxideINACTIVE INGREDIENT55X04QC32ICLEAR PROOF ACNE TREATMENT ACNE MEDICATION (BENZOYL PEROXIDE) GEL [MARY KAY INC.]1
TERT-BUTYL ALCOHOLINACTIVE INGREDIENTMD83SFE959CLEAR PROOF ACNE TREATMENT ACNE MEDICATION (BENZOYL PEROXIDE) GEL [MARY KAY INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RCLEAR PROOF ACNE TREATMENT ACNE MEDICATION (BENZOYL PEROXIDE) GEL [MARY KAY INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51531-9071CLEAR PROOF ACNE TREATMENT ACNE MEDICATION (BENZOYL PEROXIDE) GEL [MARY KAY INC.]7Current NDC, Legacy NDC, 3 package rows20241222_e01859b1-057e-4b01-8b37-2df378aae212.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 45 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
amazon basics step 1 cleanser Acne treatmentBENZOYL PEROXIDEAMAZON.COM SERVICES LLC23a060f0-d379-4370-9a79-ca6e854419b42024-08-26WarningsExact identifier
application number: M006
SEYTU SpotSALICYLIC ACIDOmnilife USA, Inc.68252aa0-36cd-4380-8898-16a5e47318662024-08-23WarningsExact identifier
application number: M006
Peach Slices 3 Step Acne Starter KitSALICYLIC ACIDPeach & Lily, Inc0c8860ca-5376-4e98-a7a9-4668dff4f0aa2024-08-14WarningsExact identifier
application number: M006
PHARMA CLEAR CLEANSERSALICYLIC ACIDPHARMAGEL INTERNATIONAL INCd2c39d80-5ccd-43a8-a8bf-eba502bfdbf12024-08-13WarningsExact identifier
application number: M006
PHARMA CLEAR MOISTURIZERSALICYLIC ACIDPHARMAGEL INTERNATIONAL INCc4c08475-bafa-4bb1-92a5-e94e600862642024-08-13WarningsExact identifier
application number: M006
PHARMA CLEAR ACNE TREATMENTSALICYLIC ACIDPHARMAGEL INTERNATIONAL INC6d94f911-d751-45e4-b24d-8d85c6a3cefb2024-08-13WarningsExact identifier
application number: M006
Anti-Everything Face SerumSALICYLIC ACID SERUMBentley laboratories, llC8330e61c-50ec-44a5-91d9-a97e5a9d03882024-08-05WarningsExact identifier
application number: M006
Anti-Everything Face MoisturizerSALICYLIC ACID CREAMBentley Laboratories, LLC36cb28f2-2620-4b88-811f-a2d6c1e22e792024-08-05WarningsExact identifier
application number: M006
Tucks Medicated Cooling PadsWITCH HAZELBlistex Inc1eb3c742-7104-7b47-e063-6394a90a84ba2024-08-02WarningsExact identifier
application number: M006
Replenix Gly-Sal 10-2 cleanserSALICYLIC ACIDTopiderm, Inc.00d1f8af-88de-4a14-80ec-5ee9fd38b1912024-08-02WarningsExact identifier
application number: M006
AL0076001 Alba Botanica Acnedote Deep Pore WashSALICYLIC ACIDThe Hain Celestial Group, Inc.6157c9c6-f252-5b49-e053-2991aa0ad8ed2024-07-31WarningsExact identifier
application number: M006
AL00761 Alba Botanica Acnedote Face and Body ScrubSALICYLIC ACIDThe Hain Celestial Group, Inc.c55efca6-5a5b-134b-e053-2a95a90a82452024-07-31WarningsExact identifier
application number: M006
Gly-Sal 5-2SALICYLIC ACIDTopiderm, Inc.a75e4cee-678f-4e44-9e5e-bafae1c23f9b2024-07-31WarningsExact identifier
application number: M006
Face Reality Advanced Acne MedBENZOYL PEROXIDEFace Realitye1eb8496-0611-4dbc-befb-fb43ec1644332024-07-26WarningsExact identifier
application number: M006
Face Reality 5% Advanced Acne MedBENZOYL PEROXIDEFace Reality0e52972d-b4d9-43f8-8dbb-2eec0782e0f72024-07-26WarningsExact identifier
application number: M006
Face Reality 10% Advanced Acne MedBENZOYL PEROXIDEFace Realitya214ea15-6346-4729-ba84-fbc842faf92a2024-07-26WarningsExact identifier
application number: M006
Replenix Gly-Sal 2-2SALICYLIC ACIDTopiderm, Inc.6c6bbedc-e2ee-46a0-8800-e356bdd262b02024-07-25WarningsExact identifier
application number: M006
Thayers Since 1847 Natural Remedies Double Action Acne SerumSALICYLIC ACIDL'Oreal USA Products Incf9daadf9-a9d3-4f2d-af07-5f0b70f7803f2024-07-17WarningsExact identifier
application number: M006
BLEMISH DOTS - RETINOL (10 PATCHES)SALICYLIC ACID 0.5%Ganzhou Olivee Cosmetic Co., Ltd.c7164d75-75e7-494a-9595-028ecbf262762024-07-14WarningsExact identifier
application number: M006
BLEMISH DOTS - CHARCOAL (10 PATCHES)SALICYLIC ACID 0.5%Ganzhou Olivee Cosmetic Co., Ltd.286f642f-7359-41b9-9daf-e866a87fbefa2024-07-14WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308694benzoyl peroxide 5 % Topical GelPSNe01859b1-057e-4b01-8b37-2df378aae2127
1489132clearproof Acne Treatment 5 % Topical GelPSNe01859b1-057e-4b01-8b37-2df378aae2127
1489132benzoyl peroxide 0.05 MG/MG Topical Gel [Clear Proof Acne Treatment]SBDe01859b1-057e-4b01-8b37-2df378aae2127
308694benzoyl peroxide 0.05 MG/MG Topical GelSCDe01859b1-057e-4b01-8b37-2df378aae2127
308694benzoyl peroxide 5 % Topical GelSYe01859b1-057e-4b01-8b37-2df378aae2127
1489132Clear Proof Acne Treatment 0.05 MG/MG Topical GelSYe01859b1-057e-4b01-8b37-2df378aae2127
1489132Clear Proof Acne Treatment 5 % Topical GelSYe01859b1-057e-4b01-8b37-2df378aae2127

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51531-9071-0515319071003 g in 1 TUBE (51531-9071-0) 3 g2016-08-162028-07-14NoNoCurrent
51531-9071-1515319071011 TUBE in 1 CARTON (51531-9071-1) / 28 g in 1 TUBE1 tube2016-08-162028-07-14NoNoCurrent