FDA.reportPublic FDA data

La Roche Posay Laboratoire Dermatologique Effaclar Duo Acne Treatment

Product NDC
49967-076
11-digit product format
499670076
Labeler code
49967
Product ID
49967-076_8a40d789-adf2-4537-ad81-601c92aaa169
Type
HUMAN OTC DRUG
Nonproprietary name
Benzoyl peroxide
Dosage form
LOTION
Route
TOPICAL
Labeler
L'OREAL USA, INC.
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-07-01
Substance
BENZOYL PEROXIDE
Active strength
55 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 Duo Acne Treatment
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOYL PEROXIDE55 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
W9WZN9A0GMInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198503Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8ed6ee51-816e-4c83-a437-4ceaa339b130Available 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
49967-076-01La Roche Posay Laboratoire Dermatologique Effaclar Duo Acne Treatment40 mL in 1 TUBELOTION408
49967-076-01La Roche Posay Laboratoire Dermatologique Effaclar Duo Acne Treatment1 in 1 CARTONLOTION18
49967-076-02La Roche Posay Laboratoire Dermatologique Effaclar Duo Acne Treatment1 in 1 CARTONLOTION18
49967-076-02La Roche Posay Laboratoire Dermatologique Effaclar Duo Acne Treatment20 mL in 1 TUBELOTION208
49967-076-03La Roche Posay Laboratoire Dermatologique Effaclar Duo Acne Treatment3 mL in 1 PACKETLOTION38

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-076LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE EFFACLAR DUO ACNE TREATMENT (BENZOYL PEROXIDE) LOTION [L'OREAL USA, INC.]8Current NDC, Legacy NDC, 5 package rows20240101_8ed6ee51-816e-4c83-a437-4ceaa339b130.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 20 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dermaharmony 10% SulfurSULFURD3 Development, Inc.c78ead80-a8ee-0b52-e053-2a95a90ab8802025-12-01WarningsExact identifier
application number: M006
Dermaharmony 10% Sulfur with Tea Tree OilSULFURD3 Development, Inc.c79005d4-0c6f-75d0-e053-2995a90a83142025-12-01WarningsExact identifier
application number: M006
Resurfacing acne swipesSALICYLIC ACIDOars And Alps LLCefe14f46-c947-aea4-e053-2a95a90aad5f2025-12-01WarningsExact identifier
application number: M006
EradiKate ACNE TREATMENTSULFURRare Beauty Brands Inc44ebacf3-52c1-4896-e063-6394a90ac4472025-12-01WarningsExact identifier
application number: M006
EradiKate Daily Foaming Cleanser Acne TreatmentSULFURRare Beauty Brands Inc.44ebc725-796f-71e6-e063-6294a90a69a62025-12-01WarningsExact identifier
application number: M006
ERADIKATE ACNE MARK FADINGSALICYLIC ACIDRare Beauty Brands Inc.44ebe505-1ce8-88cf-e063-6394a90a4baf2025-12-01WarningsExact identifier
application number: M006
Jane Seymour Natural Advantage AM SPF 15 All Day Moisture with AHAsAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEGuthy-Renker,LLC76298090-e873-4307-8bdb-19cdab6d9ac22025-12-01WarningsExact identifier
application number: M006
Asepxia Baking Soda Acne BarSALICYLIC ACIDGenomma Lab USAded9fe59-9477-4425-8bbb-f9a49118f0042025-12-01WarningsExact identifier
application number: M006
Blemish Buster Solution Acne TreatmentSULFURGuthy-Renker LLCd2b9462d-7897-40a4-9022-eeb04e7d5adf2025-12-01WarningsExact identifier
application number: M006
Anna Guanche MD Miracle Cream The Pimple CreamSULFURBella Cosmeceuticals, Inc.b4562cf4-aae3-e9db-e053-2995a90a72102025-11-30WarningsExact identifier
application number: M006
Vanishing SkincareVANISHING DRY SERUM MASK, PHASE 3Vanish Skincare LLC27f19c03-1a18-6c74-e063-6394a90a6e862025-11-28WarningsExact identifier
application number: M006
OUHOE CLEARFACE Overnight AcneSALICYLIC ACIDShantou Ouhoe Technology Co., Ltd.2be1e888-e0a4-7db7-e063-6294a90a77d52025-11-27WarningsExact identifier
application number: M006
EELHOE AcneSALICYLIC ACIDShantou Eelhoe Daily Chemical Technology Co., Ltd.2a88a374-64bc-02a3-e063-6294a90a333e2025-11-27WarningsExact identifier
application number: M006
EELHOE Mole Reduce EssenceSALICYLIC ACIDShantou Eelhoe Daily Chemical Technology Co., Ltd.2f80ffc4-c945-71c9-e063-6394a90add8c2025-11-27WarningsExact identifier
application number: M006
JAYSUING ACNE PATCHESSALICYLIC ACIDShantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd.29fb7bcc-a630-1fba-e063-6294a90a65c12025-11-27WarningsExact identifier
application number: M006
ReliefCOLLOIDAL OATMEAL 1%Era Organics, Inc.0ad58a99-e41a-a830-e063-6294a90af9cb2025-11-27WarningsExact identifier
application number: M006
SuperbalmCOLLOIDAL OATMEAL 1%Era Organics, Inc.f5298e5e-583d-d74c-e053-2995a90affb52025-11-27WarningsExact identifier
application number: M006
OGEE CLEARGANICS TARGETED BLEMISH TREATMENTSALICYLIC ACID ACNE MEDICATIONOgee Inc162831d3-7e95-62f4-e063-6394a90aef7c2025-11-26WarningsExact identifier
application number: M006
EELHOE Pimple PatchesSALICYLIC ACIDShantou Ximonth Biotechnology Co., Ltd.ffd4972a-f9bd-44a4-9d29-cd57226968052025-11-26WarningsExact identifier
application number: M006
OUHOE PIMPLESALICYLIC ACIDShantou Woodsleep Biotechnology Co., Ltd.2a374e1c-0d21-e16c-e063-6394a90ab4872025-11-26WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198503benzoyl peroxide 5.5 % Topical LotionPSN8ed6ee51-816e-4c83-a437-4ceaa339b1308
198503benzoyl peroxide 55 MG/ML Topical LotionSCD8ed6ee51-816e-4c83-a437-4ceaa339b1308
198503benzoyl peroxide 5.5 % Topical LotionSY8ed6ee51-816e-4c83-a437-4ceaa339b1308

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49967-076-01499670076011 TUBE in 1 CARTON (49967-076-01) / 40 mL in 1 TUBE1 tube2012-07-010000-00-00NoNoCurrent
49967-076-02499670076021 TUBE in 1 CARTON (49967-076-02) / 20 mL in 1 TUBE1 tube2012-07-010000-00-00NoNoCurrent
49967-076-03499670076033 mL in 1 PACKET (49967-076-03) 3 ml2012-07-010000-00-00NoNoCurrent