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 41 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Avene Cleanance Acne Medicated Clearing TreatmentBENZOYL PEROXIDEPierre Fabre USA Inc.facb99a0-f67e-80bf-e053-6294a90a23322024-11-06WarningsExact identifier
application number: M006
Rugby Benzoyl Peroxide Acne MedicationBENZOYL PEROXIDEA-S Medication Solutionsa86ae901-53d0-4bfd-808e-59d9a7bc5ef62024-11-06WarningsExact identifier
application number: M006
Meijer Acne Treatment Acne medicationBENZOYL PEROXIDEMeijer Distribution, Incf008ad20-03d0-45ae-8f75-249310eb9e702024-11-06WarningsExact identifier
application number: M006
Meijer Invisible Acne Acne medicationBENZOYL PEROXIDEMeijer Distribution, Inc2a6ec3dd-572d-4314-afbf-23aff0d1e22a2024-11-06WarningsExact identifier
application number: M006
Aveeno CLEAR COMPLEXION foaming cleanserSALICYLIC ACIDKenvue Brands LLC32425c63-7ed9-401b-a271-988b52b4f1052024-11-05WarningsExact identifier
application number: M006
Vivant Sulfur Clay MaskSULFURVivant Pharmaceuticals, LLC10cd9db0-5388-b671-e063-6394a90af50d2024-11-05WarningsExact identifier
application number: M006
Vivant BP10% Gel MedicationBENZOYL PEROXIDEVivant Pharmaceuticals, LLC10cc63b8-b4f9-6a78-e063-6294a90aade42024-11-05WarningsExact identifier
application number: M006
Vivant BP3% Exfoliating CleanserBENZOYL PEROXIDEVivant Pharmaceuticals, LLC10be3c7d-d09c-53a7-e063-6294a90a4f092024-11-05WarningsExact identifier
application number: M006
Vivant BP3% Acne WashBENZOYL PEROXIDEVivant Pharmaceuticals, LLC10bf5723-225f-67d7-e063-6394a90a72b12024-11-05WarningsExact identifier
application number: M006
Meijer oil Free Acne Wash Facial Cleanser Pink Grapefruit Acne medicationSALICYLIC ACIDMeijer Distribution, Inc3232b833-225f-429f-910c-d11874f3f1d52024-11-05WarningsExact identifier
application number: M006
Neutrogena Oil Free Acne Stress Control Triple Action TonerSALICYLIC ACIDKenvue Brands LLC817a9746-df57-4b11-b580-f57fe9940a682024-11-01WarningsExact identifier
application number: M006
SkinMedica Acne Clarifying TreatmentSALICYLIC ACIDAllergan, Inc.664d4733-e72d-410a-8ed0-a159d9dfa2362024-11-01WarningsExact identifier
application number: M006
Walgreens Acne Control Cleanser Acne MedicationBENZOYL PEROXIDEWalgreen Companyf33e4204-fed9-4f14-a00f-c81b1910254b2024-10-31WarningsExact identifier
application number: M006
Walgreens Acne Foaming Wash Acne MedicationBENZOYL PEROXIDEWalgreen Companyf34affe9-d470-48a5-b0d1-d62b9c44b3f22024-10-31WarningsExact identifier
application number: M006
Clearing Skin WashSALICYLIC ACIDDermalogica, LLC.5cd31221-d6b4-47b9-99fd-fdfc2e1b6fdf2024-10-30WarningsExact identifier
application number: M006
Walgreens Acne Foaming Cleanser Acne TreatmentBENZOYL PEROXIDEWalgreen Company5b6fab38-4a9e-4c5c-967e-e3a0ff03b6062024-10-30WarningsExact identifier
application number: M006
ZO Skin Health Acne Control Benzoyl PeroxideBENZOYL PEROXIDEZO Skin Health, Inc.252b2352-a457-4009-a62b-0ec98f018b2e2024-10-28WarningsExact identifier
application number: M006
benzoyl peroxideBENZOYL PEROXIDEPadagis Israel Pharmaceuticals Ltd9702add4-ea36-4c6b-9402-87b44f989a802024-10-23WarningsExact identifier
application number: M006
benzoyl peroxideBENZOYL PEROXIDEPadagis Israel Pharmaceuticals Ltd7441981a-654d-4f18-be21-66c863ee6d6f2024-10-23WarningsExact identifier
application number: M006
benzoyl peroxideBENZOYL PEROXIDEPadagis Israel Pharmaceuticals Ltd0ba5e88c-a4d5-4550-93fa-d3d7fee45f9f2024-10-23WarningsExact 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