FDA.reportPublic FDA data

BRODA Acne

Product NDC
54111-112
11-digit product format
541110112
Labeler code
54111
Product ID
54111-112_d02e577d-3cb9-4906-ae3f-79f5ced8be19
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
2013-10-29
Substance
SALICYLIC ACID
Active strength
.4 g/20g
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
BRODA Acne
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID.4 g/20g

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
346298Internal RxNorm lookup
1543172Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b7e1f105-8998-46a5-b1ae-85d21790b816Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54111-112-50BRODA Acne20 g in 1 TUBEGEL205
54111-112-51BRODA Acne2 g in 1 TUBEGEL25

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZBRODA ACNE (SALICYLIC ACID) GEL [BENTLEY LABORATORIES, LLC]1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZBRODA ACNE (SALICYLIC ACID) GEL [BENTLEY LABORATORIES, LLC]1
LAURETH-4INACTIVE INGREDIENT6HQ855798JBRODA ACNE (SALICYLIC ACID) GEL [BENTLEY LABORATORIES, LLC]1
LEVOMENOLINACTIVE INGREDIENT24WE03BX2TBRODA ACNE (SALICYLIC ACID) GEL [BENTLEY LABORATORIES, LLC]1
MENTHOLINACTIVE INGREDIENTL7T10EIP3ABRODA ACNE (SALICYLIC ACID) GEL [BENTLEY LABORATORIES, LLC]1
POLOXAMER 407INACTIVE INGREDIENTTUF2IVW3M2BRODA ACNE (SALICYLIC ACID) GEL [BENTLEY LABORATORIES, LLC]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQBRODA ACNE (SALICYLIC ACID) GEL [BENTLEY LABORATORIES, LLC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3BRODA ACNE (SALICYLIC ACID) GEL [BENTLEY LABORATORIES, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RBRODA ACNE (SALICYLIC ACID) GEL [BENTLEY LABORATORIES, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54111-112BRODA ACNE (SALICYLIC ACID) GEL [BENTLEY LABORATORIES, LLC]5Current NDC, Legacy NDC, 2 package rows20241228_b7e1f105-8998-46a5-b1ae-85d21790b816.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
1543172Broda Acne Spa 2 % Topical GelPSNb7e1f105-8998-46a5-b1ae-85d21790b8165
346298salicylic acid 2 % Topical GelPSNb7e1f105-8998-46a5-b1ae-85d21790b8165
1543172salicylic acid 0.02 MG/MG Topical Gel [Broda Acne Spa]SBDb7e1f105-8998-46a5-b1ae-85d21790b8165
346298salicylic acid 0.02 MG/MG Topical GelSCDb7e1f105-8998-46a5-b1ae-85d21790b8165
1543172Broda Acne Spa 0.02 MG/MG Topical GelSYb7e1f105-8998-46a5-b1ae-85d21790b8165
1543172Broda Acne Spa 2 % Topical GelSYb7e1f105-8998-46a5-b1ae-85d21790b8165
346298salicylic acid 2 % Topical GelSYb7e1f105-8998-46a5-b1ae-85d21790b8165

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54111-112-505411101125020 g in 1 TUBE (54111-112-50) 20 g2013-10-290000-00-00NoNoCurrent
54111-112-51541110112512 g in 1 TUBE (54111-112-51) 2 g2013-10-290000-00-00NoNoCurrent