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 30 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SulfurCLARIFYING DETOX (ACNE TREATMENT) MASKVege Labs LLC303cea30-0502-0cb8-e063-6394a90ac9ed2025-03-13WarningsExact identifier
application number: M006
The INKEY List Salicylic Acid CleanserSALICYLIC ACIDBrand Evangelists for Beauty Ltd1ff0b8b4-f2de-477b-99f5-844ee8f6e5b22025-03-07WarningsExact identifier
application number: M006
Neutrogena Oil Free Acne Wash Pink Grapefruit Foaming ScrubSALICYLIC ACIDKenvue Brands LLC6b2e27a6-961f-4f5c-a834-fcbd23460e682025-03-05WarningsExact identifier
application number: M006
Neutrogena Body Clear Body Wash Pink GrapefruitSALICYLIC ACIDKenvue Brands LLC39a6cf99-41c8-4412-8df1-70071fd205af2025-03-05WarningsExact identifier
application number: M006
Vichy Laboratoires Normaderm Phytoaction Acne Control MoisturizerSALICYLIC ACIDCOSMETIQUE ACTIVE PRODUCTIONb5f856d6-5403-4a88-8d64-764ab9abf7d32025-02-28WarningsExact identifier
application number: M006
Pore Refining TonerSALICYLIC ACIDPrivate Label Skin Care93db4294-3422-478e-a82e-122b39cac2882025-02-27WarningsExact identifier
application number: M006
SUNDAY RILEY PEACEKEEPER ACNE TREATMENT SERUMSALICYLIC ACIDSunday Riley Modern Skincare, LLC811271e4-afe4-4dea-8137-7b1fe4397a5a2025-02-27WarningsExact identifier
application number: M006
Detoxify Facial MaskSULFURPrivate Label Skin Care4d023509-e430-4ebc-8fe7-87e638f49cbe2025-02-27WarningsExact identifier
application number: M006
Acne Correction PadsSALICYLIC ACIDPrivate Label Skin Care30103c84-bbc2-4fdf-bdbd-03e38d2c5e932025-02-26WarningsExact identifier
application number: M006
Clarifying CleanserSALICYLIC ACIDPrivate Label Skin Carecc8ffb9f-f47b-4ff0-9098-bb186f30a1032025-02-26WarningsExact identifier
application number: M006
TRSTAY LUXE Clarifying Acne Repair SerumSALICYLIC ACIDGuangdong Meizhiyuan Biotechnology Co., Ltd.2e8ae772-ba0b-efaa-e063-6294a90a24b82025-02-19WarningsExact identifier
application number: M006
Neutrogena SkinClearing Oil-Free Makeup - Classic Ivory 10SALICYLIC ACIDKenvue Brands LLC16aa0a68-b787-4f82-e063-6394a90ad38a2025-02-17WarningsExact identifier
application number: M006
Witch Hazel Pore Clarifying Toner 8 ozSALICYLIC ACID 2%Ningbo Rejoice International99748785-8321-7bbf-e053-2a95a90a16c92025-02-13WarningsExact identifier
application number: M006
YOUR Anti-Acne Body WashSALICYLIC ACIDSkin Ai, LLC2cb4d4ea-a1f2-19ef-e063-6394a90ac7502025-02-10WarningsExact identifier
application number: M006
Neutrogena Rapid Clear Treatment PadsSALICYLIC ACIDKenvue Brands LLCec139967-e448-a9cb-e053-2995a90aed6e2025-02-06WarningsExact identifier
application number: M006
Acne wash facial cleanser pink grapefruitSALICYLIC ACIDRejoice International Corp390528bf-d536-157a-e054-00144ff88e882025-02-06WarningsExact identifier
application number: M006
Acne Biotic MoisturizerSALICYLIC ACIDDermalogica, LLC.ee181358-7f51-413f-9f6b-27ce9778bd072025-02-04WarningsExact identifier
application number: M006
Belli Acne Control Spot TreatmentSULFURBODY HALO LLCda979b69-1e4c-4e2b-82c3-0f155e9786522025-01-29WarningsExact identifier
application number: M006
Basic Essentials AstringentSALICYLIC ACIDMission Series Inc. dpa Prestige Beauty Care9f7fe8e7-e238-514e-e053-2a95a90aaec12025-01-23WarningsExact identifier
application number: M006
Acne wash facial cleanser Tea tree oilSALICYLIC ACIDRejoice International Corp.39043ea1-6552-717a-e054-00144ff8d46c2025-01-23WarningsExact 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