FDA.reportPublic FDA data

Clear System Clarifying Gel Cleanser

Product NDC
54111-189
11-digit product format
541110189
Labeler code
54111
Product ID
54111-189_5b594792-4e9d-4f6c-8307-1909759ac797
Type
HUMAN OTC DRUG
Nonproprietary name
Salicylic Acid
Dosage form
GEL
Route
TOPICAL
Labeler
Bentley Laboratories, LLC
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-12-01
Substance
SALICYLIC ACID
Active strength
2 g/100mL
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
Clear System Clarifying Gel Cleanser
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID2 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
O414PZ4LPZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
562600Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
08248e40-aa71-4dfb-8a75-af8886ccb976Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54111-189-20Clear System Clarifying Gel Cleanser20 mL in 1 TUBEGEL201
54111-189-40Clear System Clarifying Gel Cleanser40 mL in 1 TUBEGEL401
54111-189-60Clear System Clarifying Gel Cleanser60 mL in 1 TUBEGEL601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54111-189CLEAR SYSTEM CLARIFYING GEL CLEANSER (SALICYLIC ACID) GEL [BENTLEY LABORATORIES, LLC]1Current NDC, 3 package rows20241207_08248e40-aa71-4dfb-8a75-af8886ccb976.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 53 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Asepxia Charcoal Acne BarSALICYLIC ACIDGenomma Lab USAf727d947-fa91-47ae-8ea5-948afc9e5ba82023-11-06WarningsExact identifier
application number: M006
Asepxia Oil-Free Acne BarSALICYLIC ACIDGenomma Lab USA0b3a9224-f250-45e9-a1fe-a54940c6f93b2023-11-06WarningsExact identifier
application number: M006
Asepxia Softening Acne BarSALICYLIC ACIDGenomma Lab USA9cf65052-b21a-42af-b45a-6a6db36fbb452023-11-06WarningsExact identifier
application number: M006
Asepxia Scrub Acne BarSALICYLIC ACIDGenomma Lab USA361a0b50-360e-4d9b-9780-16b02a2bee3c2023-11-06WarningsExact identifier
application number: M006
Dr. C. Tuna Acne Pore Purifying TonerSALICYLIC ACIDFarmasi US LLCb8dcfaab-8c55-f23d-e053-2a95a90a8a012023-11-05WarningsExact identifier
application number: M006
Dr. C. Tuna Acne Clear Complexion CleanserSALICYLIC ACIDFarmasi US LLCb8dd3370-fe03-f0f4-e053-2a95a90ab8132023-11-05WarningsExact identifier
application number: M006
Dr. C. Tuna Acne Blemish Control SerumSALICYLIC ACIDFarmasi US LLCb8dd63d7-4ff2-60bc-e053-2a95a90ad16c2023-11-05WarningsExact identifier
application number: M006
Dr. C. Tuna Acne Clear Complexion CleanserSALICYLIC ACIDFarmasi US LLCde493e30-d10c-9def-e053-2995a90ae49a2023-11-05WarningsExact identifier
application number: M006
SERIOUS SKINCARE Continuously Clear Clearz ItBENZOYL PEROXIDEFlageoli Limitedaf4c68ef-89a8-479a-a7b1-9b005193383e2023-11-05WarningsExact identifier
application number: M006
HUMANE ACNE WASHBENZOYL PEROXIDEApprendista, LLC1d25fb25-a3d2-4c6b-a975-be7b90b702652023-11-05WarningsExact identifier
application number: M006
VIE NATURELLE ACNE BODYBENZOYL PEROXIDETNT PRO SERIES0278251d-bcf1-4177-8a57-163bd0f2df002023-11-05WarningsExact identifier
application number: M006
enfuselle Acne ClarifyingSALICYLIC ACIDShaklee Corporationdd429a9b-5c2d-4310-8506-6487b02e38802023-11-03WarningsExact identifier
application number: M006
Peach and Lily Peaches Slices Acne Exfoliating tonerSALICYLIC ACIDPeach & Lily Inc.ba70ed1c-83cb-5eaa-e053-2a95a90a92cc2023-10-28WarningsExact identifier
application number: M006
Peach and Lily Peaches Slices Acne Clarifying CleanserSALICYLIC ACIDPeach & Lily, Inc.ba70f2b9-7a34-065c-e053-2a95a90a6eb22023-10-28WarningsExact identifier
application number: M006
Peach and Lily Peaches Slices Acne Oil Acne Free MoisturizerSALICYLIC ACIDPeach & Lily, Inc.ba70e7cf-af86-6a7f-e053-2995a90af9622023-10-28WarningsExact identifier
application number: M006
Modesa Acne TreatmentBENZOYL PEROXIDEZhejiang Jingwei Pharmaceutic Al Co., Ltd.dbfe8b9e-e343-4ed5-bd81-01b27b4aa9122023-10-27WarningsExact identifier
application number: M006
Acne TreatmentBENZOYL PEROXIDEVivier Pharma, Inc.b4844539-bdd2-42a6-b946-6028de4f3cf12023-10-27WarningsExact identifier
application number: M006
Acne Treatment SystemBENZOYL PEROXIDE, SALICYLIC ACIDVivier Pharma, Inc.d39ee6a2-5d65-4198-82d9-deb83471f3122023-10-27WarningsExact identifier
application number: M006
Equate Beauty Quick Action Pads Salicylic Acid Acne TreatmentSALICYLIC ACIDBath Concept Cosmetics (Dongguan) Co., Ltdc94e85a7-b799-b70d-e053-2a95a90aaee22023-10-26WarningsExact identifier
application number: M006
ARTISTRY STUDiO Rose All Day Anti Acne Toner Pore RefresherSALICYLIC ACIDAccess Business Group LLCa9e26804-7989-41d2-8506-c4b65ca385b72023-10-21WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562600salicylic acid 2 % Medicated Liquid SoapPSN08248e40-aa71-4dfb-8a75-af8886ccb9761
562600salicylic acid 20 MG/ML Medicated Liquid SoapSCD08248e40-aa71-4dfb-8a75-af8886ccb9761
562600salicylic acid 2 % Facial Cleanser TonerSY08248e40-aa71-4dfb-8a75-af8886ccb9761
562600salicylic acid 2 % Facial ScrubSY08248e40-aa71-4dfb-8a75-af8886ccb9761
562600salicylic acid 2 % Medicated Liquid SoapSY08248e40-aa71-4dfb-8a75-af8886ccb9761

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
54111-189-205411101892020 mL in 1 TUBE (54111-189-20) 20 ml2024-12-01NoNoCurrent
54111-189-405411101894040 mL in 1 TUBE (54111-189-40) 40 ml2024-12-01NoNoCurrent
54111-189-605411101896060 mL in 1 TUBE (54111-189-60) 60 ml2024-12-01NoNoCurrent