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 35 of 54 · 1,079 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Monat Acne TreatmentBENZOYL PEROXIDEMonat Global Corpf76eb53e-643d-52cf-e053-6394a90a6e8f2024-12-20WarningsExact identifier
application number: M006
Dermaharmony 10% Benzoyl Peroxide Cleansing BarBENZOYL PEROXIDED3 Development, Inc.c7083b69-fed4-d497-e053-2a95a90a1a8c2024-12-20WarningsExact identifier
application number: M006
Dermaharmony 5% Benzoyl Peroxide Cleansing BarBENZOYL PEROXIDED3 Development, Inc.c7ceae0d-3215-1f83-e053-2995a90a60bc2024-12-20WarningsExact identifier
application number: M006
Detox Drops 2% Salicylic Acid Acne TonerSALICYLIC ACIDCOSMAX USA, CORPORATION2999c85e-cb4b-719e-e063-6394a90a0f282024-12-19WarningsExact identifier
application number: M006
OXY 3 in 1 Acne PadsSALICYLIC ACIDThe Mentholatum Company5b1c8f11-3b5b-4c26-b4c1-0770d1dd823a2024-12-17WarningsExact identifier
application number: M006
Phisoderm Clear Confidence Spot TreatmentBENZOYL PEROXIDEThe Mentholatum Company2a51c80a-27e8-44d3-b06f-b2a9081c57962024-12-17WarningsExact identifier
application number: M006
Oxy 10 VanishingBENZOYL PEROXIDEThe Mentholatum Companyd499b69a-25aa-4e3d-a07e-a774bc0d65f12024-12-17WarningsExact identifier
application number: M006
OXY Volcanic Clay Acne WashSALICYLIC ACIDThe Mentholatum Companyeb2a0e0b-2ed5-4c14-8607-0b61ca48c4952024-12-17WarningsExact identifier
application number: M006
OXY Volcanic Ash Acne Face WashSALICYLIC ACIDThe Mentholatum Company6d768d3d-c1df-4a85-9c76-7f7a2ec90b2d2024-12-17WarningsExact identifier
application number: M006
Oxy 10 TintedBENZOYL PEROXIDEThe Mentholatum Company0ceee85d-dc8c-49b3-9b44-8fe60022c2432024-12-17WarningsExact identifier
application number: M006
Oxy 5 VanishingBENZOYL PEROXIDEThe Mentholatum Companyc4aa0fff-6e4a-47a8-9adc-ac2426f8292e2024-12-17WarningsExact identifier
application number: M006
Oxy 5 TintedBENZOYL PEROXIDEThe Mentholatum Company94c863f0-711a-4807-ba1f-a56c7e3f86702024-12-17WarningsExact identifier
application number: M006
Phisoderm Anti Blemish Body WashSALICYLIC ACIDThe Mentholatum Companybba14225-2970-4678-b5a1-78ed94c389d92024-12-17WarningsExact identifier
application number: M006
Phisoderm Anti-Blemish Gel CleanserSALICYLIC ACIDThe Mentholatum Company9fd851bf-1113-488b-ad16-1a3ce52a87d52024-12-17WarningsExact identifier
application number: M006
Clear Proof Clarifying Cleansing Gel Acne MedicationSALICYLIC ACIDMary Kay Inc.e06a0132-cd30-4cec-ba2e-d29a120dc17a2024-12-17WarningsExact identifier
application number: M006
NAS TonerSALICYLIC ACIDBURT'S BEES, INC.bc1d65ef-2ed9-4124-e053-2a95a90acbe32024-12-17WarningsExact identifier
application number: M006
Clear Proof Blemish Control Toner Acne MedicationSALICYLIC ACIDMary Kay Inc.22ead982-2073-4df2-bc18-a2389f9425dd2024-12-17WarningsExact identifier
application number: M006
Clear Proof Acne System The Go SetBENZOYL PEROXIDE AND SALICYLIC ACIDMary Kay Inc.3ca40242-5d92-44be-9ddc-961d569bc3302024-12-17WarningsExact identifier
application number: M006
Stridex MaximumSALICYLIC ACIDBlistex Inc.a3b16d52-76a5-438b-a120-bb59ce062cc12024-12-16WarningsExact identifier
application number: M006
Dermisa Acne TreatmentBENZOYL PEROXIDEMontani Cosmetics Incd61a6354-8194-da19-e053-2995a90a7e222024-12-15WarningsExact 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