FDA.reportPublic FDA data

Proactivplus Skin Smoothing Exfoliator

Product NDC
11410-011
11-digit product format
114100011
Labeler code
11410
Product ID
11410-011_47d2927b-b68b-90ff-e063-6294a90a34f6
Type
HUMAN OTC DRUG
Nonproprietary name
BENZOYL PEROXIDE
Dosage form
LOTION
Route
TOPICAL
Labeler
Alchemee, LLC
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-01-25
Substance
BENZOYL PEROXIDE
Active strength
2.5 mg/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
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
Proactivplus Skin Smoothing Exfoliator
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOYL PEROXIDE2.5 mg/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
W9WZN9A0GMInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b56b63d6-5635-4fd4-9517-8b08c3cbf9aaAvailable 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
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11410-011-68Proactivplus Skin Smoothing Exfoliator1 in 1 BOXLOTION110
11410-011-68Proactivplus Skin Smoothing Exfoliator177.4 mL in 1 TUBELOTION177.410
11410-011-82Proactivplus Skin Smoothing Exfoliator1 in 1 BOXLOTION110
11410-011-82Proactivplus Skin Smoothing Exfoliator60 mL in 1 TUBELOTION6010
11410-011-82Proactiv Plus Kit1 in 1 BOXLOTION2.5 mg in 100mL2
11410-011-82Proactiv Plus Kit60 mL in 1 TUBELOTION60 mL in 1002.5 mg in 100mL2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZOYL PEROXIDEACTIVE INGREDIENTW9WZN9A0GMPROACTIVPLUS SKIN SMOOTHING EXFOLIATOR (BENZOYL PEROXIDE) LOTION [GUTHY-RENKER LLC]1
BENZOYL PEROXIDEACTIVE MOIETYW9WZN9A0GMPROACTIVPLUS SKIN SMOOTHING EXFOLIATOR (BENZOYL PEROXIDE) LOTION [GUTHY-RENKER LLC]1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RAPROACTIVPLUS SKIN SMOOTHING EXFOLIATOR (BENZOYL PEROXIDE) LOTION [GUTHY-RENKER LLC]1
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT71DD5V995LPROACTIVPLUS SKIN SMOOTHING EXFOLIATOR (BENZOYL PEROXIDE) LOTION [GUTHY-RENKER LLC]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OPROACTIVPLUS SKIN SMOOTHING EXFOLIATOR (BENZOYL PEROXIDE) LOTION [GUTHY-RENKER LLC]1
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3PPROACTIVPLUS SKIN SMOOTHING EXFOLIATOR (BENZOYL PEROXIDE) LOTION [GUTHY-RENKER LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPROACTIVPLUS SKIN SMOOTHING EXFOLIATOR (BENZOYL PEROXIDE) LOTION [GUTHY-RENKER LLC]1
GLYCOLIC ACIDINACTIVE INGREDIENT0WT12SX38SPROACTIVPLUS SKIN SMOOTHING EXFOLIATOR (BENZOYL PEROXIDE) LOTION [GUTHY-RENKER LLC]1
HIGH DENSITY POLYETHYLENEINACTIVE INGREDIENTUG00KM4WR7PROACTIVPLUS SKIN SMOOTHING EXFOLIATOR (BENZOYL PEROXIDE) LOTION [GUTHY-RENKER LLC]1
LAURYL/MYRISTYL BENZOATEINACTIVE INGREDIENTN5RS934G6DPROACTIVPLUS SKIN SMOOTHING EXFOLIATOR (BENZOYL PEROXIDE) LOTION [GUTHY-RENKER LLC]1
LINOLEIC ACIDINACTIVE INGREDIENT9KJL21T0QJPROACTIVPLUS SKIN SMOOTHING EXFOLIATOR (BENZOYL PEROXIDE) LOTION [GUTHY-RENKER LLC]1
LINOLENIC ACIDINACTIVE INGREDIENT0RBV727H71PROACTIVPLUS SKIN SMOOTHING EXFOLIATOR (BENZOYL PEROXIDE) LOTION [GUTHY-RENKER LLC]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TPROACTIVPLUS SKIN SMOOTHING EXFOLIATOR (BENZOYL PEROXIDE) LOTION [GUTHY-RENKER LLC]1
SODIUM COCOYL ISETHIONATEINACTIVE INGREDIENT518XTE8493PROACTIVPLUS SKIN SMOOTHING EXFOLIATOR (BENZOYL PEROXIDE) LOTION [GUTHY-RENKER LLC]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IPROACTIVPLUS SKIN SMOOTHING EXFOLIATOR (BENZOYL PEROXIDE) LOTION [GUTHY-RENKER LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RPROACTIVPLUS SKIN SMOOTHING EXFOLIATOR (BENZOYL PEROXIDE) LOTION [GUTHY-RENKER LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11410-011PROACTIVPLUS SKIN SMOOTHING EXFOLIATOR (BENZOYL PEROXIDE) LOTION [ALCHEMEE, LLC]9Current NDC, Legacy NDC, 4 package rows20231130_b56b63d6-5635-4fd4-9517-8b08c3cbf9aa.zip
11410-011PROACTIV PLUS KIT (SOLUTIONS KIT) KIT [ALCHEMEE, LLC]1Current NDC, Legacy NDC20240815_1bbe19ff-0bc8-7b8b-e063-6394a90aa7f4.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 4 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SERYNTH MILIA REMOVERSALICYLIC ACID 1% MILIA REMOVERJiangxi Yudexi Pharmaceutical Co., LTD4a4c3bfa-32ec-c0dd-e063-6394a90ab15c2026-07-21WarningsExact identifier
application number: M006
OURUI ONE FACIAL BUMP REFINING ESSENCESALICYLIC ACID 0.25% FACIAL BUMP REFINING ESSENCEJiangxi Yudexi Pharmaceutical Co., LTD4959bb67-063f-ffa4-e063-6394a90aa01f2026-07-20WarningsExact identifier
application number: M006
Beilloso FACIAL BUMP REFINING ESSENCESALICYLIC ACID 1% FACIAL BUMP REFINING ESSENCEJiangxi Yudexi Pharmaceutical Co., LTD4a461a7a-f5cf-6544-e063-6294a90a00f22026-07-20WarningsExact identifier
application number: M006
Lepnuns MILIA REMOVERDIDECYL DIMETHYL AMMONIUM CHLORIDE 0.025% MILIA REMOVERJiangxi Yudexi Pharmaceutical Co., LTD497ed53c-2562-b370-e063-6294a90a5ba12026-07-20WarningsExact identifier
application number: M006
Good Molecules Acne Foaming CleanserSALICYLIC ACIDGood Molecules, LLC44fa9eda-0910-7d70-e063-6394a90af3a72026-07-20WarningsExact identifier
application number: M006
Good Molecules Acne Foaming CleanserSALICYLIC ACIDGood Moleculesdec189a2-5f93-7c3e-e053-2a95a90af9882026-07-20WarningsExact identifier
application number: M006
Clean and Clear Essentials Acne TonerSALICYLIC ACIDKenvue Brands LLC06cd03e3-6146-65d8-e063-6294a90a17012026-07-17WarningsExact identifier
application number: M006
24 Hour Acne SerumBENZOYL PEROXIDEDrmtlgy, LLC55507941-dbdf-4e5f-a74d-4da6f67b6a1f2026-07-17WarningsExact identifier
application number: M006
PCA Skin Acne Control Prebiotic CleanserSALICYLIC ACIDCP Skin Health Group, Inc.56bca675-3e59-815a-e063-6294a90a1d872026-07-16WarningsExact identifier
application number: M006
Acne patchesACNE PATCHESShenzhen Hengdasheng Technology Co., Ltd5664b9c4-6ae3-4f64-e063-6294a90a825a2026-07-14WarningsExact identifier
application number: M006
Zmztuhua Folliculitis Treatment CreamBENZOYL PEROXIDEGuangzhou Hechuang Commercial Service Co.,Ltd.567ceafc-b75a-9777-e063-6394a90ae1602026-07-13WarningsExact identifier
application number: M006
Magnilife Eczema CareSULFUR, GRAPHITE, DAPHNE MEZEREUM BARK, TOXICODENDRON PUBESCENS WHOLEThe Magni Group, Inc.8e3fc743-4c82-4a03-a963-2d5f93a1bc262026-07-13WarningsExact identifier
application number: M006
PHYLA ACNE PHAGE SERUMSALICYLIC ACIDCOSMAX USA, CORP564abe82-c983-6a98-e063-6394a90a14a02026-07-10WarningsExact identifier
application number: M006
GOOD MOLECULE MAXIMUM STRENGHT ACNESALICYLIC ACIDCOSMAX USA, CORP564aafc0-1a06-1cba-e063-6294a90ae7382026-07-10WarningsExact identifier
application number: M006
Touch Acne Treatment Benzoyl PeroxideBENZOYL PEROXIDEDiractions Capital LLC1ae4e081-b04a-407d-992d-cd398f3afc542026-07-10WarningsExact identifier
application number: M006
Drs. ACNE SPOT TREATMENTSALICYLIC ACIDOL PHARMA TECH, LLC Drs. PHARMACY161b2306-364a-e1b8-e063-6394a90a6c882026-07-09WarningsExact identifier
application number: M006
Proactiv Acne Body WashSALICYLIC ACIDAlchemee, LLC36aef223-6a4a-433f-b292-631e6068b17f2026-07-08WarningsExact identifier
application number: M006
LadovernaBENZOYL PEROXIDE CREAMGuangzhou Oupeng Cosmetics Co., Ltd.55b0f9fd-9055-6969-e063-6294a90a1a7d2026-07-07WarningsExact identifier
application number: M006
L BRI KlearawaySALICYLIC ACIDL'BRI Health & Beautyb9aa1c48-b767-47b0-bb98-efb7e860ab362026-07-06WarningsExact identifier
application number: M006
L BRI Deep Clean TonerSALICYLIC ACIDL'BRI Health & Beauty607fb6d0-ae49-472c-9224-0673af934bd22026-07-06WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308689benzoyl peroxide 2.5 % Topical GelPSN1bbe19ff-0bc8-7b8b-e063-6394a90aa7f42
248684salicylic acid 0.5 % Topical CreamPSN1bbe19ff-0bc8-7b8b-e063-6394a90aa7f42
308689benzoyl peroxide 0.025 MG/MG Topical GelSCD1bbe19ff-0bc8-7b8b-e063-6394a90aa7f42
248684salicylic acid 5 MG/ML Topical CreamSCD1bbe19ff-0bc8-7b8b-e063-6394a90aa7f42
308689benzoyl peroxide 2.5 % Topical GelSY1bbe19ff-0bc8-7b8b-e063-6394a90aa7f42
248684salicylic acid 0.5 % Topical CreamSY1bbe19ff-0bc8-7b8b-e063-6394a90aa7f42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11410-011-68114100011681 TUBE in 1 BOX (11410-011-68) / 177.4 mL in 1 TUBE1 tube2013-01-252021-05-01NoNoCurrent
11410-011-82114100011821 TUBE in 1 BOX (11410-011-82) / 60 mL in 1 TUBE1 tube2013-01-252021-05-01NoNoCurrent