FDA.reportPublic FDA data

La Roche Posay Effaclar Medicated Cleanser

Product NDC
49967-402
11-digit product format
499670402
Labeler code
49967
Product ID
49967-402_fe1a3c1c-1220-4d46-ab61-0bb31208e78d
Type
HUMAN OTC DRUG
Nonproprietary name
Salicylic Acid
Dosage form
GEL
Route
TOPICAL
Labeler
L'Oreal USA Products Inc
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-08-01
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
La Roche Posay Effaclar Medicated Cleanser
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
562600Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4795cc87-c663-4702-b65d-ce85203f1258Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-402-01La Roche Posay Effaclar Medicated Cleanser200 mL in 1 TUBEGEL20010
49967-402-02La Roche Posay Effaclar Medicated Cleanser100 mL in 1 TUBEGEL10010
49967-402-03La Roche Posay Effaclar Medicated Cleanser15 mL in 1 TUBEGEL1510
49967-402-04La Roche Posay Effaclar Medicated Cleanser50 mL in 1 TUBEGEL5010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-402LA ROCHE POSAY EFFACLAR MEDICATED CLEANSER (SALICYLIC ACID) GEL [L'OREAL USA PRODUCTS INC]9Current NDC, 4 package rows20240103_4795cc87-c663-4702-b65d-ce85203f1258.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 12 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acne TreatmentBENZOYL PEROXIDETopco Associates LLC8d5e7e40-5e61-470a-b8ff-0b2dca3cabb02026-02-13Warnings, Adverse reactionsExact identifier
application number: M006
Daily Acne Control CleanserBENZOYL PEROXIDETopco Associates LLC8474d917-7ee4-4d1d-8499-3520f771d2fd2026-02-13Warnings, Adverse reactionsExact identifier
application number: M006
Body WashSALICYLIC ACIDTopco Associates LLC1b16b978-70e0-4bba-a8d7-a77d7e1f896a2026-02-13Warnings, Adverse reactionsExact identifier
application number: M006
Acne ScrubSALICYLIC ACIDTopco Associates LLCe98a8184-c5a8-4306-9fff-9dc77e9d2d442026-02-13Warnings, Adverse reactionsExact identifier
application number: M006
Salicylic AcidASTRINGENTTopco Associates LLC7d15560f-d8d1-4dfe-8eca-b16bb529ad872026-02-13Warnings, Adverse reactionsExact identifier
application number: M006
Oil Free Acne WashSALICYLIC ACID 2%Topco Associates LLC3149260c-b92b-43a7-8f57-897517102fa82026-02-13Warnings, Adverse reactionsExact identifier
application number: M006
Acne TreatmentBENZOYL PEROXIDEWalgreen Co.07721aa6-867a-436f-8c88-ab135f02a6b52026-02-12Warnings, Adverse reactionsExact identifier
application number: M006
Acne ScrubSALICYLIC ACIDAmazon.com Services LLC06339296-14e7-4179-aa2f-538bae921a8b2026-02-11Warnings, Adverse reactionsExact identifier
application number: M006
natouchSALICYLIC ACIDNatouch LLC3af85c98-f14d-5857-e063-6394a90aed132026-02-10WarningsExact identifier
application number: M006
ACNE TREATMENTTREATBio Clarity LLC4a7e40c1-7421-a0c7-e063-6294a90a4d6b2026-02-10WarningsExact identifier
application number: M006
HerbaGlow Baiwooxia Anti-Acne GelSALICYLIC ACID GELKungpo Health Care & Herbal Center Inc010029a3-8c1a-4f29-a162-a8ba4f9390582026-02-10WarningsExact identifier
application number: M006
Acne CleanserBENZOYL PEROXIDEWalmart, Inc.04514cbb-6041-4bd5-9ab9-31312b0d8f192026-02-06Warnings, Adverse reactionsExact identifier
application number: M006
Salicylic acidSALICYLIC ACIDTopco Associates LLC4a28800d-14ef-d841-e063-6394a90a692b2026-02-06Warnings, Adverse reactionsExact identifier
application number: M006
Medicated Apricot ScrubSALICYLIC ACIDRetail Business Services, LLC1942bd34-a152-450e-a5c5-46488da66b3d2026-02-06Warnings, Adverse reactionsExact identifier
application number: M006
Oil Free Acne WashSALICYLIC ACID 2%American Sales Company613f0a91-32d3-4a1e-9c9f-f0167481b5112026-02-06Warnings, Adverse reactionsExact identifier
application number: M006
ACNE DOTS (Skin Care Multi-Pack)SALICYLIC ACIDGanzhou Olivee Cosmetic Co., Ltd.4a0dc951-07ce-2030-e063-6294a90ab2ea2026-02-05WarningsExact identifier
application number: M006
Oil Free Acne WashSALICYLIC ACID 2%Publix Super Markets, Inc.169eaaa4-308d-44ba-ad93-3205e0dd9ae12026-02-05Warnings, Adverse reactionsExact identifier
application number: M006
SPOTLESS Daily Acne WashBENZOYL PEROXIDERodan & Fields8f7bb793-3c60-4014-954e-514ef87a44fb2026-02-04WarningsExact identifier
application number: M006
SPOTLESS Acne Clearing TreatmentBENZOYL PEROXIDERodan & Fields3d4ef4ce-9be3-436a-9f93-c01caa93d1a82026-02-04WarningsExact identifier
application number: M006
SPOTLESS REGIMEN FOR ACNE, BLEMISHES AND BREAKOUTSBENZOYL PEROXIDERodan & Fields8b2c187d-4b66-4872-8243-4365ea2e8b592026-02-04WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
562600salicylic acid 2 % Medicated Liquid SoapPSN4795cc87-c663-4702-b65d-ce85203f125810
562600salicylic acid 20 MG/ML Medicated Liquid SoapSCD4795cc87-c663-4702-b65d-ce85203f125810
562600salicylic acid 2 % Facial Cleanser TonerSY4795cc87-c663-4702-b65d-ce85203f125810
562600salicylic acid 2 % Facial ScrubSY4795cc87-c663-4702-b65d-ce85203f125810
562600salicylic acid 2 % Medicated Liquid SoapSY4795cc87-c663-4702-b65d-ce85203f125810

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
49967-402-0149967040201200 mL in 1 TUBE (49967-402-01) 200 ml2022-08-01NoNoCurrent
49967-402-0249967040202100 mL in 1 TUBE (49967-402-02) 100 ml2022-08-01NoNoCurrent
49967-402-034996704020315 mL in 1 TUBE (49967-402-03) 15 ml2022-08-01NoNoCurrent
49967-402-044996704020450 mL in 1 TUBE (49967-402-04) 50 ml2024-02-12NoNoCurrent