La Roche Posay Laboratoire Dermatologique Effaclar AZ Acne Treatment

Product NDC
69625-735
11-digit product format
696250735
Labeler code
69625
Product ID
69625-735_3a5dff13-b7a0-43b8-bc36-f22ced147147
Type
HUMAN OTC DRUG
Nonproprietary name
Salicylic acid
Dosage form
CREAM
Route
TOPICAL
Labeler
COSMETIQUE ACTIVE PRODUCTION
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-06-12
Substance
SALICYLIC ACID
Active strength
12 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 AZ Acne Treatment
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID12 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 SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
75e15ed6-e871-4dde-b7fc-145054626fa9Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c6fc281-9445-2e9e-1c29-a09ddbc4299cProduct name220200213
2a856070-cbe7-4f85-be0f-09885ff91196Product name120150806

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69625-735-01La Roche Posay Laboratoire Dermatologique Effaclar AZ Acne Treatment1 in 1 CARTONCREAM11
69625-735-01La Roche Posay Laboratoire Dermatologique Effaclar AZ Acne Treatment40 mL in 1 BOTTLE, PUMPCREAM401
69625-735-02La Roche Posay Laboratoire Dermatologique Effaclar AZ Acne Treatment3 mL in 1 TUBECREAM31
69625-735-02La Roche Posay Laboratoire Dermatologique Effaclar AZ Acne Treatment1 in 1 CARTONCREAM11

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 55 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Replenix Acne Gly-Sal 2-2 Foaming CleanserSALICYLIC ACIDTopiderm, Inc.811dbf95-2b39-45c5-99a2-33c3c9d195702019-12-19WarningsExact identifier
application number: M006
REPLENIX ACNE SOLUTIONS WASHBENZOYL PEROXIDETopiderm, Inc.8dc2d27d-3cc4-4874-b4c2-32607849b2052019-12-17WarningsExact identifier
application number: M006
REPLENIX ACNE Solution BENZOYL PEROXIDE WASHBENZOYL PEROXIDETopiderm, Inc.235e9dd5-13f2-4078-9807-1d87fd9e6cba2019-12-17WarningsExact identifier
application number: M006
Replenix AcneBENZOYL PEROXIDETopiderm, Inc03d4c298-8f44-41f7-b086-96ae836152bb2019-10-31WarningsExact identifier
application number: M006
Replenix AcneBENZOYL PEROXIDETopiderm, Inc.c12f9005-a549-4447-9beb-df7126f77df12019-10-31WarningsExact identifier
application number: M006
Gly-Sal 10-2 PadsSALICYLIC ACIDTopiderm, Inc.b39e845d-4c40-4f9e-9cb5-a8386f3266522019-10-23WarningsExact identifier
application number: M006
Gly-Sal 5-2 PadsSALICYLIC ACIDTopiderm, Inc.e73bd26c-cdc2-47ab-94e8-3bc49a9b19e82019-10-22WarningsExact identifier
application number: M006
SKIN MEDICA Purifying Foaming WashSALICYLIC ACIDAllergan, Inc.064d9e2b-077f-4229-b653-666fc5479ae22013-03-01WarningsExact identifier
application number: M006

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69625-735-01696250735011 BOTTLE, PUMP in 1 CARTON (69625-735-01) / 40 mL in 1 BOTTLE, PUMP2025-06-12NoNoCurrent
69625-735-02696250735021 TUBE in 1 CARTON (69625-735-02) / 3 mL in 1 TUBE1 tube2025-06-12NoNoCurrent