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 46 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vichy Laboratoires Normaderm Daily Deep Cleansing Acne TreatmentSALICYLIC ACIDL'Oreal USA Products Inc74c49388-3314-47e8-80b1-19c09e6ea1f92024-07-14WarningsExact identifier
application number: M006
Vichy Laboratoires Normaderm Daily Deep Cleansing Acne TreatmentSALICYLIC ACIDCOSMETIQUE ACTIVE PRODUCTION873de079-8b8d-45cd-8c7c-4645818f5aaa2024-07-14WarningsExact identifier
application number: M006
Dr. Zenovia Clear ComplexionSALICYLIC ACIDTopiderm, Inc.4ff9b26d-3cd9-4539-b389-edd2df24a4662024-06-28WarningsExact identifier
application number: M006
LEROSETT Botanical Acne CleanserSALICYLIC ACIDGUNILLA OF SWEDEN, INC.8b31d155-c257-4452-9e22-0c69fa36173e2024-06-27WarningsExact identifier
application number: M006
SkinCeuticals Silymarin CF Acne Treatment AntioxidantSALICYLIC ACIDCosmetique Active Productionfcc3c44b-3090-45b5-91e4-e591c92a08c82024-06-24WarningsExact identifier
application number: M006
Peace Out Early Stage Acne DotSALICYLIC ACIDPeace Out LLC.0632d458-d326-ade4-e063-6294a90af3ba2024-06-20WarningsExact identifier
application number: M006
Replenix BP AcneBENZOYL PEROXIDETopiderm, Inc.f449e020-a4d8-4a1b-82eb-4dc59e99b8d42024-06-18WarningsExact identifier
application number: M006
b pure Pressed Powder for Acne Prone Skin FairSALICYLIC ACIDFourstar Group USA, Inc.ecf22bd1-4fc3-4455-ae01-13f97f53dc342024-06-17WarningsExact identifier
application number: M006
b pure Pressed Powder for Acne Prone Skin TanSALICYLIC ACIDFourstar Group USA, Inc.1158f6c2-2b59-4ed3-8d28-73b6da885a5d2024-06-17WarningsExact identifier
application number: M006
Gly-Sal 10-2SALICYLIC ACIDTopiderm, Inc.661cc58b-9360-4b96-b405-afdc2e3783972024-06-13WarningsExact identifier
application number: M006
BLAIR and JACK Anti-Bump Acne TreatmentBENZOYL PEROXIDEBlair + Jackaa8df86a-639c-4416-aadf-4b58566ed9f12024-06-11WarningsExact identifier
application number: M006
b pure Blemish Concealer for Acne Prone Skin NudeSALICYLIC ACIDFourstar Group USA, Inc.76e91277-1fb4-490b-b351-39d626bc1fc22024-06-11WarningsExact identifier
application number: M006
b pure Blemish Concealer for Acne Prone Skin FairSALICYLIC ACIDFourstar Group USA, Inc.764599e5-2ec3-4223-819e-36415fd915f72024-06-11WarningsExact identifier
application number: M006
Dr. Zenovia Acne CleanserBENZOYL PEROXIDETopiderm, Inc.00fb1ee5-6076-4980-8507-9e58a96e6a6b2024-06-11WarningsExact identifier
application number: M006
Dr. Zenovia Spot TreatmentBENZOYL PEROXIDETopiderm, Inc.dfdb3d8e-4d39-4ce4-851f-80b11972ca9e2024-06-11WarningsExact identifier
application number: M006
Rugby Benzoyl Peroxide Acne MedicationBENZOYL PEROXIDENuCare Pharmaceuticals,Inc.69bd4f4c-017a-7422-e053-2991aa0aa6552024-06-10WarningsExact identifier
application number: M006
Thayers Natural Remedies Since 1847 Rapid Acne TreatmentSULFURL'Oreal USA Products Incd7cc3c06-2f89-4c0b-b121-fdd53638b6252024-06-07WarningsExact identifier
application number: M006
Differin 10% BPO Acne TreatmentBENZOYL PEROXIDEGalderma Laboratories, L.P.05468eab-f239-42cb-9106-055a105f0fa52024-06-06WarningsExact identifier
application number: M006
2.5 Acne MedBENZOYL PEROXIDEFace Reality, Inc.58a7f677-996c-4951-8e5d-b5556244f8002024-06-05WarningsExact identifier
application number: M006
10 Acne MedBENZOYL PEROXIDEFace Reality, Inc.91791905-086f-44cf-9c1a-e9f132c6c11b2024-06-05WarningsExact 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