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 47 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreens Oil-Free Acne Wash Salicylic AcidSALICYLIC ACIDWalgreen Company9f311567-caa2-4302-9cf8-8c341917d16e2024-06-03WarningsExact identifier
application number: M006
Walgreens Maximum Strength Acne Treatment Acne medicationBENZOYL PEROXIDEWalgreen Company72ca0ddd-9292-48c9-9189-532a1768c9b72024-06-03WarningsExact identifier
application number: M006
Derma E Acne Matte MoisturizerSALICYLIC ACIDderma e48fd8477-b880-4a31-9227-095d38a7eac52024-05-31WarningsExact identifier
application number: M006
LACTO-S ACNE TREATMENTSALICYLIC ACIDNoon Aesthetics M.R. Ltdea0c7fda-30a0-48df-8a1b-4d6098c0081e2024-05-31WarningsExact identifier
application number: M006
Derma E Acne Cleansing PadsSALICYLIC ACIDderma ec749a11f-daa1-4d76-b818-cd6509efaceb2024-05-28WarningsExact identifier
application number: M006
ULTA All Clear SERUMSALICYLIC ACIDAPR BEAUTY GROUP INC199a96c1-94b8-3de6-e063-6394a90ab4782024-05-28WarningsExact identifier
application number: M006
Crystal Clear Acne Treatment PadsSALICYLIC ACIDSkin Pharm, LLC0469b1ab-5cfb-416a-b34b-7dc6fef611ff2024-05-22WarningsExact identifier
application number: M006
Anti-Aging Blemish Control Peel PadsSALICYLIC ACIDJune Jacobs Labs, LLC18fa83ab-1712-398c-e063-6394a90a6b792024-05-21WarningsExact identifier
application number: M006
Peace Out AcneSALICYLIC ACIDPeace Out LLC.efa796e8-62a8-6c20-e053-2a95a90aef6f2024-05-20WarningsExact identifier
application number: M006
Peace Out AcneSALICYLIC ACIDPeace Out LLC.eac771e2-4c1a-3808-e053-2995a90ac5fc2024-05-20WarningsExact identifier
application number: M006
Cetaphil Gentle Clear Pore Clearing Acne CleanserSALICYLIC ACIDGalderma Laboratories, L.P.fc3abc75-5d9a-4b77-9b61-e6beba8a5cfe2024-05-09WarningsExact identifier
application number: M006
Walgreens Creamy Acne Face Wash Acne MedicationBENZOYL PEROXIDEWalgreen Company13e5396b-839b-4c08-a98f-f0a36c9a0bff2024-05-09WarningsExact identifier
application number: M006
Bubble Knock Out Acne Spot TreatmentSALICYLIC ACIDBUBBLE BEAUTY17cf44cf-55f1-86a5-e063-6294a90a35d22024-05-06WarningsExact identifier
application number: M006
Bubble Super Clear Blemish Prevention SerumSALICYLIC ACIDBUBBLE BEAUTY1790ad12-c947-ddc0-e063-6394a90a85692024-05-03WarningsExact identifier
application number: M006
Walgreens Daily Acne Cleanser- Sensitive Skin FormulaBENZOYL PEROXIDEWalgreen Companyacae5006-e647-4f00-b93a-2c0bceee14cb2024-05-01WarningsExact identifier
application number: M006
Derma E Acne Blemish Control Treatment SerumSALICYLIC ACIDderma ebf5f489d-07c6-47b8-ae76-701e7ad92e8d2024-04-30WarningsExact identifier
application number: M006
Pacifica Clear Mist Facial AcneSALICYLIC ACIDPacifica Beauty, LLC16ee1a80-d523-1d02-e063-6394a90a94592024-04-25WarningsExact identifier
application number: M006
Benzoyl PeroxideBENZOYL PEROXIDEBurel Pharmaceuticals, LLC0617d42d-511d-4c1a-a919-b37abbc14efc2024-04-24WarningsExact identifier
application number: M006
Blemish DotsSALICYLIC ACID 0.5%Ganzhou Olivee Cosmetic Co., Ltd.f3cd004d-32f1-4888-8129-d355a4750b252024-03-24WarningsExact identifier
application number: M006
Lacura Blemish Dots Conceal and TreatSALICYLIC ACID 0.5%Ganzhou Olivee Cosmetic Co., Ltd.15c447b5-0e51-43e7-b697-683bc0e686c02024-03-20WarningsExact 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