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 36 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Phisoderm Anti-Blemish Gel CleanserSALICYLIC ACIDThe Mentholatum Company9fd851bf-1113-488b-ad16-1a3ce52a87d52024-12-17WarningsExact identifier
application number: M006
Clear Proof Clarifying Cleansing Gel Acne MedicationSALICYLIC ACIDMary Kay Inc.e06a0132-cd30-4cec-ba2e-d29a120dc17a2024-12-17WarningsExact identifier
application number: M006
NAS TonerSALICYLIC ACIDBURT'S BEES, INC.bc1d65ef-2ed9-4124-e053-2a95a90acbe32024-12-17WarningsExact identifier
application number: M006
Clear Proof Blemish Control Toner Acne MedicationSALICYLIC ACIDMary Kay Inc.22ead982-2073-4df2-bc18-a2389f9425dd2024-12-17WarningsExact identifier
application number: M006
Clear Proof Acne System The Go SetBENZOYL PEROXIDE AND SALICYLIC ACIDMary Kay Inc.3ca40242-5d92-44be-9ddc-961d569bc3302024-12-17WarningsExact identifier
application number: M006
Clear Proof Acne SystemBENZOYL PEROXIDE AND SALICYLIC ACIDMary Kay Inc.fc1b28a4-a27e-4ae5-b4ac-58927d6411682024-12-17WarningsExact identifier
application number: M006
Stridex MaximumSALICYLIC ACIDBlistex Inc.a3b16d52-76a5-438b-a120-bb59ce062cc12024-12-16WarningsExact identifier
application number: M006
Dermisa Acne TreatmentBENZOYL PEROXIDEMontani Cosmetics Incd61a6354-8194-da19-e053-2995a90a7e222024-12-15WarningsExact identifier
application number: M006
OXY ADVANCED CARE 3 in 1 RETEXTURIZING CLEANSING PADSSALICYLIC ACIDThe Mentholatum Companyc36f7012-6fc7-4141-8492-6a20d3cf48682024-12-13WarningsExact identifier
application number: M006
OXY ADVANCED CARE MAXIMUM STRENGTH 3-in-1 ACNE PADSSALICYLIC ACIDThe Mentholatum Company99874117-b1f5-48bf-a1b1-3a2af9d9ae272024-12-13WarningsExact identifier
application number: M006
OXY Advanced Care Sensitive Skin Acne CleanserBENZOYL PEROXIDEThe Mentholatum Company4967f854-d1e4-4fb6-84c7-1293f5f906302024-12-13WarningsExact identifier
application number: M006
OXY Advanced Care Soothing Cream Acne CleanserBENZOYL PEROXIDEThe Mentholatum Company4171b8a9-7ebf-4c02-a086-87038b6c68c42024-12-13WarningsExact identifier
application number: M006
Oxy Advanced Care Rapid Spot TreatmentBENZOYL PEROXIDEThe Mentholatum Companye613e8a6-ffed-49bc-bdc0-87606c51ffa32024-12-13WarningsExact identifier
application number: M006
OXY Advanced Care Soothing Cream Acne CleanserBENZOYL PEROXIDEThe Mentholatum Company76fddd7e-8323-4046-8c90-2edafc3e09372024-12-13WarningsExact identifier
application number: M006
pHisoderm Clear Confidence Face ScrubSALICYLIC ACIDThe Mentholatum Companyb3213f88-9496-4c89-ab1b-225bd81891c22024-12-13WarningsExact identifier
application number: M006
pHisoderm CLEAN ANTI-BLEMISH FACIAL CLEANSERSALICYLIC ACIDThe Mentholatum Companyd2799f22-5684-4510-9141-073acf4b15342024-12-13WarningsExact identifier
application number: M006
pHisoderm CLEAN ANTI-BLEMISH BODY WASHSALICYLIC ACIDThe Mentholatum Company6c337b14-6779-4d98-b61b-c210b0fdd9262024-12-13WarningsExact identifier
application number: M006
pHisoderm CLEAN ANTI-BLEMISH BODY WASHSALICYLIC ACIDThe Mentholatum Companyd3baf470-9528-4a6d-b354-5ebe640b77742024-12-13WarningsExact identifier
application number: M006
Oxy Total Care Clarifying MoisturizerBENZOYL PEROXIDEThe Mentholatum Company4568b5d1-efde-4b2f-b7cc-8d227d05dfa12024-12-13WarningsExact identifier
application number: M006
Oxy Total Care Vitamin C SerumSALICYLIC ACIDThe Mentholatum Company29b34faa-7c74-4e79-ad47-1660a3e701a72024-12-13WarningsExact 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