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 37 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Oxy Total Care Creamy Facial CleanserSALICYLIC ACIDThe Mentholatum Companyaed37bff-6723-4865-aa9b-10e7adcceeea2024-12-13WarningsExact identifier
application number: M006
OXY Sensitive Face Wash Maximum SoothingBENZOYL PEROXIDEThe Mentholatum Companyc02ff802-fe48-41fb-a9dd-6a74da334a522024-12-13WarningsExact identifier
application number: M006
pHisoderm Clear Confidence Daily Gel Face WashSALICYLIC ACIDThe Mentholatum Companyaccafe6b-d350-4539-a39d-a9ee9a4fee292024-12-13WarningsExact identifier
application number: M006
OXY 10 Acne CleanserBENZOYL PEROXIDEThe Mentholatum Company35dbfe37-992d-4c9c-a4be-707d32370c762024-12-13WarningsExact identifier
application number: M006
pHisoderm Clear Confidence Body WashSALICYLIC ACIDThe Mentholatum Companye4c88ea1-5311-4e1f-a9ac-facef02b9c042024-12-13WarningsExact identifier
application number: M006
Stridex XL Face and Body PadsSALICYLIC ACIDBlistex Inced459e80-22cc-40ef-862c-1adf82da23772024-12-13WarningsExact identifier
application number: M006
Stridex EssentialSALICYLIC ACIDBlistex Inc994b890a-8a82-4ce2-a4a4-bde2360cc2592024-12-13WarningsExact identifier
application number: M006
Stridex SensitiveSALICYLIC ACIDBlistex Inc843d3424-bd6c-44aa-976b-63c9da15014e2024-12-12WarningsExact identifier
application number: M006
Clean and Clear blackhead eraser scrubSALICYLIC ACIDKenvue Brands LLC20197516-ce6b-4ae9-81ee-fac7636f844a2024-12-11WarningsExact identifier
application number: M006
Neutrogena Oil Free Acne Stress Control Power Clear ScrubSALICYLIC ACIDKenvue Brands LLCa0c9c479-4fc1-43e4-97a2-e6095fc175592024-12-11WarningsExact identifier
application number: M006
Neutrogena Oil-Free Acne Wash Daily ScrubSALICYLIC ACIDKenvue Brands LLC398e39ea-5119-4094-a1be-09eb7f0d23a22024-12-11WarningsExact identifier
application number: M006
Sulfur Spot TreatmentSULFURFace Reality, Inc921e948d-a8c7-4527-9257-4b91dee8fcff2024-12-09WarningsExact identifier
application number: M006
Acne Oil Control PrimerSALICYLIC ACIDAllure Labsdb9b5de2-c07c-0b21-e053-2995a90ae9a92024-12-09WarningsExact identifier
application number: M006
Clear Cell Clarifying AcneBENZOYL PEROXIDEAllure Labsda87cbbf-12ca-3224-e053-2995a90a25e42024-12-09WarningsExact identifier
application number: M006
Daily Leave on Acne Treatment MaskBENZOYL PEROXIDEAllure Labsdbb27841-7c9e-6d00-e053-2a95a90a6ab12024-12-09WarningsExact identifier
application number: M006
Blemish Control BarSALICYLIC ACIDCP Skin Health Group, Inc.1b1ed540-4a9d-4716-95d2-6c8229a2afc92024-12-09WarningsExact identifier
application number: M006
SCRUB SO CLEAN ACNE-FIGHTING SUPER SCRUBSALICYLIC ACIDASPIRE BRANDS INCe33629fb-be88-4de2-871d-10090ca3a8f42024-12-06WarningsExact identifier
application number: M006
CLEAN GETAWAY BAGSALICYLIC ACIDASPIRE BRANDS INC16d2264b-e00b-4a3a-9b52-2bf4ca33a73a2024-12-06WarningsExact identifier
application number: M006
SO TOTALLY CLEAN DEEP PORE CLEANSERSALICYLIC ACIDASPIRE BRANDS INCdb47a78a-2694-4c21-af6e-d787a5e0fbb92024-12-06WarningsExact identifier
application number: M006
START SO FRESHSALICYLIC ACIDASPIRE BRANDS INC85f4af7d-ae9c-45cb-a7d7-5e1189f5471b2024-12-06WarningsExact 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