FDA.reportPublic FDA data

La Roche Posay Effaclar Dermatological Acne System 3 Step Acne Routine

Product NDC
49967-282
11-digit product format
499670282
Labeler code
49967
Product ID
49967-282_194cac19-b8d9-4fec-bfb8-ee59fec0a301
Type
HUMAN OTC DRUG
Nonproprietary name
Benzoyl Peroxide and Salicylic Acid
Dosage form
KIT
Labeler
L'Oreal USA Products Inc
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-01-01
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
La Roche Posay Effaclar Dermatological Acne System 3 Step Acne Routine
Listing expiration
2026-12-31

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198503Internal RxNorm lookup
199308Internal RxNorm lookup
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
fa21d384-6867-442f-8537-290a691e2520Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
b382b4e1-6b48-45f6-bffc-e61b00b0ce19Product name320250317
d9d61457-6a5a-41fc-b418-e5479a2904b7Product name220230303
32012d5c-25ac-49c7-9d4c-1313177fff7cProduct name120230112
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
4a7d44fe-774d-404b-aad0-8a90fe78375aProduct name420211025
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-282-01La Roche Posay Effaclar Dermatological Acne System 3 Step Acne Routine1 in 1 CARTONKIT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-282LA ROCHE POSAY EFFACLAR DERMATOLOGICAL ACNE SYSTEM 3 STEP ACNE ROUTINE (BENZOYL PEROXIDE AND SALICYLIC ACID) KIT [L'OREAL USA PRODUCTS INC]2Current NDC, 1 package rows20241023_fa21d384-6867-442f-8537-290a691e2520.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 1 of 55 · 1,083 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PIMPLE PATCHESPIMPLE PATCHESShenzhen Hengdasheng Technology Co., Ltd584d3833-4593-94db-e063-6294a90ad3ff2026-08-05WarningsExact identifier
application number: M006
Acne Clearing Sulfur MaskSULFURAcneFree, LLCc0675282-ff00-edba-e053-2995a90ace682026-07-31WarningsExact identifier
application number: M006
Sulfur Acne Foaming CleanserSULFURAcne Free, LLCfeb82a3d-cda3-c62a-e053-6394a90ad9bb2026-07-31WarningsExact identifier
application number: M006
Acne Free BLACKHEAD REMOVING SCRUB 2 Salicylic Acid with CharcoalSALICYLIC ACIDAcneFree LLCc9393340-8a5f-6b7c-e053-2995a90afcd92026-07-31WarningsExact identifier
application number: M006
AMBI Even and Clear Exfoliating Wash Acne TreatmentSALICYLIC ACIDAMBI ENTERPRISES, LLC43a4712d-9a6d-4bfc-abe4-f6e81dca35492026-07-31WarningsExact identifier
application number: M006
Acne Free Free 24 HR Acne Clearing SystemBENZOYL PEROXIDEAcneFree, LLCc939847a-72eb-96fa-e053-2a95a90a4f9c2026-07-31WarningsExact identifier
application number: M006
Terminator 10BENZOYL PEROXIDEAcneFree, LLCc06778b6-0ed6-7d82-e053-2a95a90a2ef82026-07-31WarningsExact identifier
application number: M006
Acne Free Oil Free Acne Cleanser 2.5 Benzoyl PeroxideBENZOYL PEROXIDEAcneFree LLCc939847a-72cc-96fa-e053-2a95a90a4f9c2026-07-31WarningsExact identifier
application number: M006
Benzoyl Peroxide Deep Cleansing Foaming WashBENZOYL PEROXIDEAcneFree, LLCfe2d0e24-8c68-b2ea-e053-6294a90ad72c2026-07-31WarningsExact identifier
application number: M006
Salicylic AcidSALICYLIC ACIDAcne Free, LLC1097fc73-fa47-0f14-e063-6294a90aa4992026-07-31WarningsExact identifier
application number: M006
Even and Clear CleanserSALICYLIC ACIDAmbi Enterprises LLCbff537cf-aa79-5250-e053-2995a90a388a2026-07-31WarningsExact identifier
application number: M006
Oil Free Deep Cleansing Duo Cleansing Brush Oil Free Acne CleanserBENZOYL PEROXIDEAcneFree, LLCc7a675fa-b6c0-6237-e053-2a95a90a04062026-07-31WarningsExact identifier
application number: M006
Acne Free SEVERE ACNE 24 HR Acne Clearing SystemBENZOYL PEROXIDEAcneFree, LLCc939681e-ea93-31ce-e053-2a95a90a8c702026-07-31WarningsExact identifier
application number: M006
Acne Free SENSITIVE SKIN 24 HR Acne Clearing SystemSALICYLIC ACID, BENZOYL PEROXIDEAcneFree LLCc9397a25-8fed-48d0-e053-2a95a90ab4952026-07-31WarningsExact identifier
application number: M006
sulfur acne treatmentSULFURAcne Free105545d8-974c-5a9a-e063-6294a90aecc42026-07-31WarningsExact identifier
application number: M006
24 Hour Sensitive Skin Acne Clearing SystemSALICYLIC ACIDAcne Free LLC39ea674d-ff6e-a8c6-e063-6394a90a06562026-07-31WarningsExact identifier
application number: M006
cardae FOLLICULITIS CreamMICONAZOLE NITRATE 2% FOLLICULITIS CREAMWenzhou Yuyuan Pharmaceutical Co., Ltd.57e0be6a-3141-f3b6-e063-6394a90a15202026-07-30WarningsExact identifier
application number: M006
SKINTIFIC 3X ACID INTENSIVE ACNE TREATMENTSALICYLIC ACIDGold Inti Trade Corporation57a7c929-31f5-ef82-e063-6394a90ab9af2026-07-28WarningsExact identifier
application number: M006
BellamiLuxx Butt Acne Treatment CreamSALICYLIC ACID 2%BellamiLuxx LLC42f3367f-40a2-5d97-e063-6294a90a6e332026-07-28WarningsExact identifier
application number: M006
Acne Treatment with SulfurSULFURDLC Laboratories, Inc.4a1591e8-6135-4b22-b54c-5553c2dc05402026-07-28WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198503benzoyl peroxide 5.5 % Topical LotionPSNfa21d384-6867-442f-8537-290a691e25202
199308salicylic acid 0.5 % Topical SolutionPSNfa21d384-6867-442f-8537-290a691e25202
562600salicylic acid 2 % Medicated Liquid SoapPSNfa21d384-6867-442f-8537-290a691e25202
198503benzoyl peroxide 55 MG/ML Topical LotionSCDfa21d384-6867-442f-8537-290a691e25202
562600salicylic acid 20 MG/ML Medicated Liquid SoapSCDfa21d384-6867-442f-8537-290a691e25202
199308salicylic acid 5 MG/ML Topical SolutionSCDfa21d384-6867-442f-8537-290a691e25202
198503benzoyl peroxide 5.5 % Topical LotionSYfa21d384-6867-442f-8537-290a691e25202
199308salicylic acid 0.5 % Topical SolutionSYfa21d384-6867-442f-8537-290a691e25202
562600salicylic acid 2 % Facial Cleanser TonerSYfa21d384-6867-442f-8537-290a691e25202
562600salicylic acid 2 % Facial ScrubSYfa21d384-6867-442f-8537-290a691e25202
562600salicylic acid 2 % Medicated Liquid SoapSYfa21d384-6867-442f-8537-290a691e25202

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
49967-282-01499670282011 KIT in 1 CARTON (49967-282-01) * 100 mL in 1 BOTTLE * 20 mL in 1 TUBE * 100 mL in 1 TUBE1 kit2015-01-01NoNoCurrent