FDA.reportPublic FDA data

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 14 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dermatouch Acnecare Facial ScrubSALICYLIC ACIDSpa de Soleil025d4242-9e7d-9ba1-e063-6294a90af7522026-01-21WarningsExact identifier
application number: M006
Dermatouch Acnecare PadsSALICYLIC ACIDSpa de Soleil025d79e9-3aeb-40b9-e063-6394a90a48a42026-01-21WarningsExact identifier
application number: M006
Dermatouch Acnecare MoisturizerSALICYLIC ACIDSpa de Soleilf81834b7-672d-4411-e053-6394a90aeada2026-01-21WarningsExact identifier
application number: M006
Dermatouch Acnecare CleanserSALICYLIC ACIDSpa de Soleile3514af1-f9b9-c251-e053-2a95a90ac80e2026-01-21WarningsExact identifier
application number: M006
BioMicroneedle PDRN CreamSILICON DIOXIDEGuangzhou Shengyanghui Industrial Trading Co., Ltd48e2edae-94ea-c42e-e063-6394a90a907b2026-01-21WarningsExact identifier
application number: M006
Oil Free Daily Face EQBSALICYLIC ACID 2%Walmart039d3187-b8d6-3613-e063-6294a90a9b152026-01-20WarningsExact identifier
application number: M006
All Day Moisturizing SPF 15 EQBOCTINOXATE 6% ZINC OXIDE 3%Walmartc09a59ca-97d0-4a74-9c10-31a939472fc62026-01-20WarningsExact identifier
application number: M006
Acne ScrubSALICYLIC ACIDSpa de Soleil0a9067f7-2a9d-abae-e063-6394a90a35332026-01-20WarningsExact identifier
application number: M006
Acne CleanserSALICYLIC ACIDSpa de Soleil0a90a5e9-65e7-f885-e063-6394a90a8bf82026-01-20WarningsExact identifier
application number: M006
Acne MoisturizerSALICYLIC ACIDSpa de Soleil0a9047c8-2038-7c92-e063-6294a90a59982026-01-20WarningsExact identifier
application number: M006
Acne Care LotnSALICYLIC ACIDSpa de Soleil0a90dd85-06d1-13e0-e063-6394a90af2b62026-01-20WarningsExact identifier
application number: M006
Equate 2% Salicylic acid Acne treatment pad2% SALICYLIC ACIDWalmart, Inc.c83c9a42-796a-f322-e053-2995a90a4be92026-01-19WarningsExact identifier
application number: M006
SCANTILY PADACNE TREATMENTDermala Incc5145f1d-78f7-22b4-e053-2a95a90a5c592026-01-19WarningsExact identifier
application number: M006
ACNE TREATMENT PADSACNE TREATMENT PADSShenzhen Hengdasheng Technology Co., Ltd47b6edd6-180f-a62f-e063-6294a90aad352026-01-17WarningsExact identifier
application number: M006
Retexturizing Body PadsSALICYLIC ACIDMurad, LLCe0bb5a87-6bf7-4273-b7dc-2b59270829772026-01-16WarningsExact identifier
application number: M006
BenzoAzeline 5BENZOYL PEROXIDENoon Aesthetics M.R. Ltd0db88619-a1be-46d0-b1e7-26253a8c50e52026-01-16WarningsExact identifier
application number: M006
Zapzyt Acne Wash CleanserSALICYLIC ACIDFocus Consumer Healthcare, LLC6078c812-947f-3be0-e053-2a91aa0aafb02026-01-16WarningsExact identifier
application number: M006
Benzoazeline ForteBENZOYL PEROXIDENoon Aesthetics M.R. Ltdeb8c6984-2531-44c0-9a5d-5d64070f04ae2026-01-15WarningsExact identifier
application number: M006
MAX COMPLEXION CORRECTION PADSSALICYLIC ACIDPETER THOMAS ROTH LABS LLC4870f872-0802-7f08-e063-6394a90a19e92026-01-15WarningsExact identifier
application number: M006
Therapeutic HydrogelSALICYLIC ACIDNoon Aesthetics M.R. Ltdcfe76456-0a4c-4dd8-b060-af9d109fb9b92026-01-15WarningsExact 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