FDA.reportPublic FDA data

IT Cosmetics Bye Bye Breakout Concentrated Derma Serum Acne Treatment

Product NDC
49967-026
Requested package NDC
49967-026-01
11-digit product format
499670026
Labeler code
49967
Product ID
49967-026_2de139d9-aa09-461c-b7e5-7fb41991094f
Type
HUMAN OTC DRUG
Nonproprietary name
Salicylic Acid
Dosage form
LOTION
Route
TOPICAL
Labeler
L'Oreal USA Products Inc
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-04-01
Substance
SALICYLIC ACID
Active strength
20 mg/mL
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
IT Cosmetics Bye Bye Breakout Concentrated Derma Serum Acne Treatment
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID20 mg/mL

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
103568Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fd92c669-997e-4eea-b883-fe3486b83f31Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-026-01IT Cosmetics Bye Bye Breakout Concentrated Derma Serum Acne Treatment30 mL in 1 BOTTLE, DROPPERLOTION303
49967-026-01IT Cosmetics Bye Bye Breakout Concentrated Derma Serum Acne Treatment1 in 1 CARTONLOTION13
49967-026-02IT Cosmetics Bye Bye Breakout Concentrated Derma Serum Acne Treatment4 mL in 1 PACKETLOTION43
49967-026-03IT Cosmetics Bye Bye Breakout Concentrated Derma Serum Acne Treatment4 mL in 1 BOTTLELOTION43
49967-026-04IT Cosmetics Bye Bye Breakout Concentrated Derma Serum Acne Treatment1.5 mL in 1 PACKETLOTION1.53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-026IT COSMETICS BYE BYE BREAKOUT CONCENTRATED DERMA SERUM ACNE TREATMENT (SALICYLIC ACID) LOTION [L'OREAL USA PRODUCTS INC]2Current NDC, Legacy NDC, 5 package rows20231229_fd92c669-997e-4eea-b883-fe3486b83f31.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 31 of 54 · 1,079 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Equate Beauty Medicated Apricot Cleanser Acne MedicationSALICYLIC ACIDWALMART INC.2b94e93f-cdce-919a-e063-6294a90adc302025-01-14WarningsExact identifier
application number: M006
SUNDAY RILEY U.F.O Acne Treatment Face OilSALICYLIC ACIDSunday Riley Modern Skincare, LLC90bd3b3b-3b42-4369-8b9a-a81dd8b6a1e52025-01-14WarningsExact identifier
application number: M006
AcNe solutionSALICYLIC ACIDNoon Aesthetics M.R. Ltd04c048c6-4035-4599-a29e-ff3c7f58e58a2025-01-13WarningsExact identifier
application number: M006
SLMD Salicylic Acid Body WashSALICYLIC ACIDOwen Biosciences Inc.86b95f37-cef1-424b-87e0-9ed7eca5d2592025-01-13WarningsExact identifier
application number: M006
SLMD Silver Sulfur Acne CreamSULFUROwen Biosciences Inc.4735a6d6-bf87-404d-a46d-7f29fcff94092025-01-13WarningsExact identifier
application number: M006
Double FightSALICYLIC ACID AND BENZOYL PEROXIDENoon Aesthetics M.R. Ltd1fb83be2-6140-45e8-a95f-188f147a038d2025-01-13WarningsExact identifier
application number: M006
EradiKate ACNE TREATMENTSULFURKate Somerville Skincare, LLC713093d9-29c3-44c9-b90f-ee7448c5063e2025-01-12WarningsExact identifier
application number: M006
ERADIKATE ACNE MARK FADINGSALICYLIC ACIDKATE SOMERVILLE SKINCARE, LLC4378b359-8eb9-4095-a106-45e1107580992025-01-12WarningsExact identifier
application number: M006
EradiKate Daily Foaming Cleanser Acne TreatmentSULFURKate Somerville Skincare, LLCbebe3042-b80c-41ca-b8df-48093573c0822025-01-12WarningsExact identifier
application number: M006
Exuviance Daily Acne PeelSALICYLIC ACIDNeoStrata Company Inc.e9f7da8a-c595-4500-89f1-ec8a2a72ef592025-01-10WarningsExact identifier
application number: M006
Drs. ACNE CLEARSALICYLIC ACIDOL PHARMA TECH, LLC Drs. PHARMACYd6faa57c-d081-b57c-e053-2a95a90a79262025-01-09WarningsExact identifier
application number: M006
innisfree Gentle Retinol Salicylic Acne SerumSALICYLIC ACID GELInnisfree Corporation2b38b6f2-0de5-581b-e063-6394a90acd552025-01-08WarningsExact identifier
application number: M006
Nutricentials Here You Glow Exfoliating TonerSALICYLIC ACIDNSE Products, Inc.ecf6c01b-50e5-4cfd-8ac3-0027cdc33f902025-01-07WarningsExact identifier
application number: M006
Zitlox Salicylic AcneSALICYLIC ACIDASA Universal Inc. dba: SONAGE4b833d7a-f957-4e65-be5b-1771493149582025-01-06WarningsExact identifier
application number: M006
glo SKIN BEAUTY Clear Skin CleanserGLO SKIN BEAUTY CLEAR SKIN CLEANSERHayden Caleel LLC07f51d83-e956-442c-9afa-aa987a66ae9e2025-01-05WarningsExact identifier
application number: M006
glo SKIN BEAUTY Clear Skin Spot TreatmentGLO SKIN BEAUTY CLEAR SKIN SPOT TREATMENTHayden Caleel LLC9f33ffc7-2727-491e-a361-7f130c81d1b12025-01-05WarningsExact identifier
application number: M006
Acne Defense Face WashSALICYLIC ACIDPacifica Beauty, LLCf43590c7-84c0-6eb8-e053-2a95a90a01a72025-01-03WarningsExact identifier
application number: M006
Acne Warrior Body ScrubSALICYLIC ACIDPacifica Beauty, LLCf44a4fc5-3358-5966-e053-2995a90add562025-01-03WarningsExact identifier
application number: M006
Acne Warrior Body WashSALICYLIC ACIDPacifica Beauty, LLCf45b4c77-45a3-f480-e053-2995a90a36be2025-01-03WarningsExact identifier
application number: M006
Acne Warrior Clearing AstringentSALICYLIC ACIDPacifica Beauty, LLCf44bcd96-dbf8-5718-e053-2a95a90adc342025-01-03WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
103568salicylic acid 2 % Topical LotionPSNfd92c669-997e-4eea-b883-fe3486b83f313
103568salicylic acid 20 MG/ML Topical LotionSCDfd92c669-997e-4eea-b883-fe3486b83f313
103568salicylic acid 2 % Topical LotionSYfd92c669-997e-4eea-b883-fe3486b83f313

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
49967-026-01499670026011 BOTTLE, DROPPER in 1 CARTON (49967-026-01) / 30 mL in 1 BOTTLE, DROPPER2022-04-010000-00-00NoNoCurrent