Acne Defense Spot Treatment

Product NDC
57627-201
11-digit product format
576270201
Labeler code
57627
Product ID
57627-201_5dac29e0-e332-6994-e063-6394a90a8a92
Type
HUMAN OTC DRUG
Nonproprietary name
Salicylic Acid
Dosage form
GEL
Route
TOPICAL
Labeler
Merle Norman Cosmetics, Inc
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-07-14
Substance
SALICYLIC ACID
Active strength
2 g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
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
Acne Defense Spot Treatment
Brand name suffix
Merle Norman
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALICYLIC ACID2 g/100g

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57627-201-01Acne Defense Spot TreatmentMerle Norman14 g in 1 TUBEGEL145
57627-201-02Acne Defense Spot TreatmentMerle Norman1 in 1 CARTONGEL15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57627-201ACNE DEFENSE SPOT TREATMENT MERLE NORMAN (SALICYLIC ACID) GEL [MERLE NORMAN COSMETICS, INC]4Current NDC, Legacy NDC, 2 package rows20241010_c6296d3a-fabe-4a8f-91e8-cac2ae6ff926.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 17 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SHISEIDO WASO KOSHIRICE ACNE CALMING TREATMENTSALICYLIC ACIDSHISEIDO AMERICAS CORPORATION3b584705-21a8-4e37-96cc-f9c8058db5c42026-01-05WarningsExact identifier
application number: M006
I DEW CARE CLEAN ZIT AWAY ACNE FOAMING CLEANSERSALICYLIC ACIDMemebox Corporation297bbe36-23be-0995-e063-6294a90a98df2026-01-01WarningsExact identifier
application number: M006
Sofie Pavitt Face Reset Benzoyl Peroxide Acne Treatment MaskBENZOYL PEROXIDECosco International, Inc.6d7fd1ce-2155-4aa4-87c6-c6fc0c0d3f422026-01-01WarningsExact identifier
application number: M006
Acne Treatment GelSALICYLIC ACIDS+688783fd-574e-40dd-a4cb-c59afdebcddc2025-12-31WarningsExact identifier
application number: M006
Sei Bella Clarity Clear Acne All-Over Clearing Serum Cleansing SerumSALICYLIC ACIDMelaleuca, Inc.19266ab3-54cd-225d-e063-6294a90aa5122025-12-31WarningsExact identifier
application number: M006
Clarity Clear Skin Solutions Acne Spot TreatmentBENZOYL PEROXIDEMelaleuca, Inc.193667e8-3a4d-9270-e063-6294a90a1c262025-12-31WarningsExact identifier
application number: M006
Sei Bella Clarity Clear Refining Foaming Cleanser Acne treatmentSALICYLIC ACIDMelaleuca, Inc.19370e9a-4907-2ddc-e063-6294a90a97112025-12-31WarningsExact identifier
application number: M006
CLEAR MED 10%BENZOYL PEROXIDECONTROL CORRECTIVE SKINCARE INC7acd1404-2af7-4ec4-b1e9-a905c9f823b82025-12-31WarningsExact identifier
application number: M006
CLEAR MED 5%BENZOYL PEROXIDECONTROL CORRECTIVE SKINCARE INC03799b2c-cab1-4672-9004-29e4873d022f2025-12-31WarningsExact identifier
application number: M006
SALICYLIC WASHSALICYLIC ACIDCONTROL CORRECTIVE SKINCARE INC3c6fee91-6f02-40b6-b71f-495b4f235d172025-12-31WarningsExact identifier
application number: M006
SULFUR CALMING MASKSULFURCONTROL CORRECTIVE SKINCARE INC446bd2ea-da88-422a-b086-e61b2d5b62692025-12-31WarningsExact identifier
application number: M006
ACNE SPOT TREATMENTSALICYLIC ACIDCONTROL CORRECTIVE SKINCARE INC11d47f80-02ae-44a6-acf1-3babb762967b2025-12-31WarningsExact identifier
application number: M006
EXFO TONIC ACNE TREATMENTSALICYLIC ACIDCONTROL CORRECTIVE SKINCARE INC782867ee-8e38-42fc-bd31-c16e618b01d22025-12-31WarningsExact identifier
application number: M006
THYLOXSULFURBradford Soap Works, Inc.5f52b769-9893-4391-b98f-3765e7b494852025-12-31WarningsExact identifier
application number: M006
AVEDA OUTER PEACE ACNE RELIEF PADSSALICYLIC ACIDAveda Corporationc37052cc-6705-48ff-adf1-0dec7d7360072025-12-31WarningsExact identifier
application number: M006
Acne Care Charcoal CleanserACNE CARE CHARCOAL CLEANSERWhole Foods Market891c09a1-116b-3afd-e053-2995a90a856c2025-12-30WarningsExact identifier
application number: M006
Acne Care MoisturizerACNE CARE MOISTURIZERWhole Foods Market8957fab8-ec9c-2494-e053-2995a90a6c292025-12-30WarningsExact identifier
application number: M006
Body Acne TreatmentBODY SPRAYSkin PS Brands099ddba5-8e34-1e11-e063-6294a90af4c02025-12-30WarningsExact identifier
application number: M006
Salicylic Acid CleanserEXFOLIATING AND CLARIFYING FACE WASHSkin PS Brandsfb230cde-b225-6df6-e053-6294a90aa6532025-12-30WarningsExact identifier
application number: M006
BP Acne Spot TreatmentACNE SPOT TREATMENTSkin PS Brandsfeb0ed89-878b-2497-e053-6394a90ad1c12025-12-30WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
346298salicylic acid 2 % Topical GelPSNc6296d3a-fabe-4a8f-91e8-cac2ae6ff9265
346298salicylic acid 0.02 MG/MG Topical GelSCDc6296d3a-fabe-4a8f-91e8-cac2ae6ff9265
346298salicylic acid 2 % Topical GelSYc6296d3a-fabe-4a8f-91e8-cac2ae6ff9265

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
57627-201-015762702010114 g in 1 TUBE14 gHistorical
57627-201-02576270201021 TUBE in 1 CARTON (57627-201-02) / 14 g in 1 TUBE (57627-201-01) 1 tube2017-07-140000-00-00NoNoCurrent