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 43 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TARGET UP AND UP ACNE MEDICATIONBENZOYL PEROXIDETARGET CORPORATIONbadbe092-eaff-1163-e053-2a95a90abb6e2024-10-14WarningsExact identifier
application number: M006
Target Up and Up Acne Spot TreatmentBENZOYL PEROXIDETARGET CORPORATIONf12eface-bf9c-33fd-e053-2a95a90a7b352024-10-14WarningsExact identifier
application number: M006
Target Up and Up 3 Step Acne SystemBENZOYL PEROXIDETARGET CORPORATIONf784bd99-0b8a-2521-e053-6294a90a25192024-10-14WarningsExact identifier
application number: M006
Up and Up Blemish Controlling Apricot ScrubSALICYLIC ACIDTARGET CORPORATION92d44bd6-bea8-6134-e053-2995a90ad1202024-10-14WarningsExact identifier
application number: M006
Up and Up Deep Clean TonerSALICYLIC ACIDTARGET CORPORATION945b0588-6864-27bc-e053-2995a90a73e32024-10-14WarningsExact identifier
application number: M006
SIGNATURE CARE BLEMISH AND BLACKHEAD CONTROLSALICYLIC ACIDSAFEWAY, INC.a573c428-870d-0bf7-e053-2995a90a595a2024-10-14WarningsExact identifier
application number: M006
SIGNATURE CARE ACNE MEDICATIONBENZOYL PEROXIDESAFEWAY, INC.a62af431-b033-3603-e053-2995a90a961e2024-10-14WarningsExact identifier
application number: M006
Signature Care Oil Free Acne Wash Pink Grapefruit Foaming ScrubSALICYLIC ACIDSafeway, Inc.baee746b-cb5d-3621-e053-2a95a90a302f2024-10-14WarningsExact identifier
application number: M006
Walgreens Acne Spot TreatmentBENZOYL PEROXIDEWALGREEN COMPANYf12d432e-3115-47ec-e053-2a95a90a69d32024-10-11WarningsExact identifier
application number: M006
Walgreens 3 Step Acne SystemBENZOYL PEROXIDEWALGREEN COMPANYf7933ecd-4fc7-8526-e053-6394a90a15c52024-10-11WarningsExact identifier
application number: M006
ClearSynergySALICYLIC ACIDSRL Enterprises, LLCb0ad3d4c-7afa-4503-b5d6-c88bf898155e2024-10-08WarningsExact identifier
application number: M006
Asepxia Acne TreatmentSALICYLIC ACIDGenomma Lab USA910d4320-bf89-436a-a8d4-54d001281dee2024-10-08WarningsExact identifier
application number: M006
Asepxia AcneSALICYLIC ACIDGenomma Lab USA9e8de726-480c-44c7-82c8-ce66412d881e2024-10-07WarningsExact identifier
application number: M006
benzoyl peroxideBENZOYL PEROXIDEBryant Ranch Prepackd3f16759-1ddf-4cfc-8b93-f60e680ba2f82024-10-03WarningsExact identifier
application number: M006
Atrix Clarifying TonerSALICYLIC ACIDPureTek Corporation191a2f96-eb97-4b45-b6a8-0d5835e7e7572024-10-02WarningsExact identifier
application number: M006
ZO Skin Health Retinol Plus Acne ComplexSALICYLIC ACIDZO Skin Health, Inc.1d65e4d2-0856-9135-e063-6294a90a5c662024-10-01WarningsExact identifier
application number: M006
Atrix Acne TreatmentSALICYLIC ACIDPureTek Corporationba106b20-32aa-df90-e053-2995a90adaef2024-10-01WarningsExact identifier
application number: M006
Atrix Antibacterial WashSALICYLIC ACIDPURETEK CORPORATIONbd5b6f29-5b97-0853-e053-2a95a90aed592024-10-01WarningsExact identifier
application number: M006
Target Up and Up Salicylic Acid Acne WashSALICYLIC ACIDTARGET CORPORATION235aa04e-746f-d66a-e063-6394a90a11442024-09-30WarningsExact identifier
application number: M006
Target Up and Up Benzoyl Peroxide Acne WashBENZOYL PEROXIDETARGET CORPORATION235b9df0-41dd-5476-e063-6394a90ae6682024-09-30WarningsExact 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