FDA.reportPublic FDA data

IT Cosmetics Bye Bye Breakout Concentrated Derma Serum Acne Treatment

Product NDC
49967-026
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage49967-02649967-026-02DDiscontinued by firm2026-10-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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 5 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
10% Azelaic AcidAZELAIC ACID CREAMGuangzhou Ariel Medical Technology Co., Ltd.55b03daa-b6d4-9edf-e063-6394a90ac4d12026-07-03WarningsExact identifier
application number: M006
Hero Mighty CleanserSALICYLIC ACIDChurch & Dwight Co., Inc.5597df54-2e58-0d6a-e063-6394a90a16972026-07-01WarningsExact identifier
application number: M006
Hero Pore CleanserSALICYLIC ACIDChurch & Dwight Co., Inc.559987c0-7abe-13fc-e063-6294a90a9f272026-07-01WarningsExact identifier
application number: M006
Acne Treatment Cream2% SALICYLIC ACIDZytrell Skin Solutions Inc.555be487-92d8-6220-e063-6394a90a0c0a2026-06-28WarningsExact identifier
application number: M006
SKINTIFIC 3X ACID INTENSIVE ACNE TREATMENTSALICYLIC ACIDLongway Technology(Guangzhou)Co., Ltd.553957ef-cb8a-e75d-e063-6394a90a261b2026-06-27WarningsExact identifier
application number: M006
ORLASKIN ACNE TreatmentSALICYLIC ACIDGuangzhou Yapheon Health Industry Co., Ltd.552bf5df-0a3c-7c10-e063-6394a90a311f2026-06-26WarningsExact identifier
application number: M006
ORLASKIN SALICYLIC ACID ACNE TREATMENT PADSSALICYLIC ACIDGuangzhou Yapheon Health Industry Co., Ltd.552c9e72-db4b-641a-e063-6294a90a29012026-06-26WarningsExact identifier
application number: M006
CosmoClear CleanserSALICYLIC ACIDNoon Aesthetics M.R. Ltddd738dfd-676b-40fe-8b0e-3d8305e0fdcb2026-06-25WarningsExact identifier
application number: M006
Walgreens Acne Foaming CleanserBENZOYL PEROXIDEWALGREEN COMPANY549fddb8-9d42-16cb-e063-6294a90aa2a92026-06-19WarningsExact identifier
application number: M006
Walgreens Maximum Strength Acne TreatmentBENZOYL PEROXIDEWALGREEN COMPANY548e327b-1a4f-03df-e063-6294a90a39322026-06-18WarningsExact identifier
application number: M006
EpochSALICYLIC ACIDNSE Products, Inc.3084ac37-de1f-4218-9471-6a5ebf720eb92026-06-17WarningsExact identifier
application number: M006
VICHY LABORATOIRES NORMADERM ACNE CONTROL DAILY MOISTURIZERSALICYLIC ACIDLOreal USA Products Inc17b7a58b-97f2-429f-83cb-db04631d307d2026-06-16WarningsExact identifier
application number: M006
VICHY LABORATOIRES NORMADERM ACNE CONTROL DAILY MOISTURIZERSALICYLIC ACIDCosmetique Active Production17b8a58b-97f2-429f-83cb-db04631d307d2026-06-16WarningsExact identifier
application number: M006
Societe Clarity BacSALICYLIC ACIDSociete Clinical Skincare545130ce-46f9-c231-e063-6394a90a1ea82026-06-16WarningsExact identifier
application number: M006
ES Salicylic WashSALICYLIC ACIDElaine Sterling Enterprises543ab052-5aa9-6585-e063-6394a90af88f2026-06-16WarningsExact identifier
application number: M006
Societe Clear Skin PadsSALICYLIC ACIDSociete Clinical Skincare543a4347-d7d8-3050-e063-6294a90ab3a22026-06-16WarningsExact identifier
application number: M006
FHF Crisp StartACNE CLEANSERSummer Soles LLC dba Farmhouse Fresh Goods54391292-263d-253e-e063-6394a90a742f2026-06-16WarningsExact identifier
application number: M006
FHF Change Peel PadsSALICYLIC PADSSummer Soles, LLC dba Farmhouse Fresh Goods5439a9dd-786c-9140-e063-6394a90a8fa92026-06-16WarningsExact identifier
application number: M006
FHF Day BreakthruSALICYLIC SERUMSummer Doles dba Farmhouse Fresh Fresh Goods54397bb7-1845-72a7-e063-6394a90abbd12026-06-16WarningsExact identifier
application number: M006
Societe Daily ExfoliationSALICYLIC ACIDSociete Clinical Skincare54633a24-3761-14d7-e063-6294a90a89f92026-06-16WarningsExact 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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49967-026-01499670026011 BOTTLE, DROPPER in 1 CARTON (49967-026-01) / 30 mL in 1 BOTTLE, DROPPER2022-04-010000-00-00NoNoCurrent
49967-026-02499670026024 mL in 1 PACKET (49967-026-02) 4 ml2022-04-010000-00-00NoNoCurrent
49967-026-03499670026034 mL in 1 BOTTLE (49967-026-03) 4 ml2022-04-01NoNoCurrent
49967-026-04499670026041.5 mL in 1 PACKET (49967-026-04) 1.5 ml2022-12-01NoNoCurrent