FDA.reportPublic FDA data

La Roche Posay Laboratoire Dermatologique Effaclar Pore Refining Acne Treatment

Product NDC
49967-529
11-digit product format
499670529
Labeler code
49967
Product ID
49967-529_a56bbaaa-5b60-4a4b-953b-99d0abfda1c8
Type
HUMAN OTC DRUG
Nonproprietary name
Salicylic acid
Dosage form
LIQUID
Route
TOPICAL
Labeler
L'Oreal USA Products Inc
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-05-01
Substance
SALICYLIC ACID
Active strength
15 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
La Roche Posay Laboratoire Dermatologique Effaclar Pore Refining Acne Treatment
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID15 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
1244193Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
5056320e-e472-44ed-9afd-759ba55f0fd7Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-529-01La Roche Posay Laboratoire Dermatologique Effaclar Pore Refining Acne Treatment30 mL in 1 BOTTLE, DROPPERLIQUID308
49967-529-01La Roche Posay Laboratoire Dermatologique Effaclar Pore Refining Acne Treatment1 in 1 CARTONLIQUID18
49967-529-02La Roche Posay Laboratoire Dermatologique Effaclar Pore Refining Acne Treatment3 mL in 1 TUBELIQUID38
49967-529-02La Roche Posay Laboratoire Dermatologique Effaclar Pore Refining Acne Treatment1 in 1 CARTONLIQUID18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-529LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE EFFACLAR PORE REFINING ACNE TREATMENT (SALICYLIC ACID) LIQUID [L'OREAL USA PRODUCTS INC]8Current NDC, Legacy NDC, 4 package rows20231214_5056320e-e472-44ed-9afd-759ba55f0fd7.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 38 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TREAT SO DEEP ACNE-FIGHTING TREATMENTSALICYLIC ACIDASPIRE BRANDS INCd18b4f15-9ea1-4d76-a1e3-a0be1c5bb58a2024-12-06WarningsExact identifier
application number: M006
Oxy Maximum Strength Rapid Spot TreatmentOXY MAXIMUM STRENGTH RAPID SPOT TREATMENTThe Mentholatum Company28886273-a71a-46ea-e063-6394a90ac11d2024-12-05WarningsExact identifier
application number: M006
Dermaclear Spot TreatmentBENZOYL PEROXIDEAllure Labs Inc45a93c47-552f-4660-a37c-7a8cceac2d8e2024-12-05WarningsExact identifier
application number: M006
DermaClear PadsSALICYLIC ACIDAllure Labs0c6624fd-88f9-402c-8ac2-bc278242b4842024-12-05WarningsExact identifier
application number: M006
DermaClear BHA Spot TreatmentSALICYLIC ACIDAllure Labsb629cb05-548e-4d60-e053-2a95a90aeefb2024-12-05WarningsExact identifier
application number: M006
Acne Treatment Maximum StrengthSALICYLIC ACIDYoung Living Essential Oils, LC756a52ff-161d-4b6e-933b-49bce885d9982024-12-04WarningsExact identifier
application number: M006
DermaClear SerumSALICYLIC ACIDAllure Labs Inc487a7d1c-0f98-4d36-bfe9-c12bcda8d0b32024-12-04WarningsExact identifier
application number: M006
Dermaclear MaskSALICYLIC ACIDAllure Labs Inc,9429f477-a916-49c9-bf04-1cf591af5c7f2024-12-04WarningsExact identifier
application number: M006
Clear System Clarifying Gel CleanserSALICYLIC ACIDBentley Laboratories, LLC08248e40-aa71-4dfb-8a75-af8886ccb9762024-12-04WarningsExact identifier
application number: M006
DermaClear BHA CleanserSALICYLIC ACIDAllure Labs Incbfeced33-a630-4f1d-9ecf-33450bd26ae92024-12-03WarningsExact identifier
application number: M006
PCA SKIN Intensive Clarity TreatmentSALICYLIC ACIDCP Skin Health Group, Inc.7bd6edc0-941e-492d-8b3c-4e8b3425f9292024-12-03WarningsExact identifier
application number: M006
PCA SKIN BPO CleanserBENZOYL PEROXIDECP Skin Health Group, Inc.eb55cc26-cf47-4e9e-b7a8-23ef82aecce22024-12-03WarningsExact identifier
application number: M006
PCA SKIN AcneBENZOYL PEROZIDECP Skin Health Group, Inc.257bd9dd-93f9-4996-8478-8198be3ef6832024-12-03WarningsExact identifier
application number: M006
PCA GelSALICYLIC ACIDCP Skin Health Group, Inc396b4675-451f-48b2-b139-19508434e0fe2024-12-03WarningsExact identifier
application number: M006
CliniCalmHYDROCORTISONECP Skin Health Group, Inc.febcf7e8-668c-a5c9-e053-6394a90aec392024-12-03WarningsExact identifier
application number: M006
Alumier MD Acne Clarifying CleanserSALICYLIC ACIDAlumier Labs87747f82-9018-ab34-e053-2995a90a68082024-12-01WarningsExact identifier
application number: M006
Acne Control Face WashSALICYLIC ACIDBentley Laboratories, LLC068c5fef-cdc5-49f4-9372-9cfdd07508b82024-11-28WarningsExact identifier
application number: M006
Acne Control Body WashSALICYLIC ACIDBentley Laboratories, LLC3db0f885-4c08-4678-8533-ba2025bf7d482024-11-28WarningsExact identifier
application number: M006
Neutrogena Stubborn Blackheads Daily SerumSALICYLIC ACIDKenvue Brands LLCc0992ceb-5f7a-4c8f-a43f-7a300bd6bbf12024-11-26WarningsExact identifier
application number: M006
Neutrogena Stubborn Acne Spot DryingSULFURKenvue Brands LLCdffe9bf4-a8a2-4fa0-e053-2995a90abcb32024-11-26WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1244193salicylic acid 1.5 % Topical SolutionPSN5056320e-e472-44ed-9afd-759ba55f0fd78
1244193salicylic acid 15 MG/ML Topical SolutionSCD5056320e-e472-44ed-9afd-759ba55f0fd78
1244193salicylic acid 1.5 % Topical SolutionSY5056320e-e472-44ed-9afd-759ba55f0fd78

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49967-529-01499670529011 BOTTLE, DROPPER in 1 CARTON (49967-529-01) / 30 mL in 1 BOTTLE, DROPPER2022-05-010000-00-00NoNoCurrent
49967-529-02499670529021 TUBE in 1 CARTON (49967-529-02) / 3 mL in 1 TUBE1 tube2022-05-010000-00-00NoNoCurrent