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 54 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Artistry Studio Done With Zit Acne Treatment Clearing GelSALICYLIC ACIDAccess Business Group LLC7a9bb4a0-c463-44e8-90a3-12bd58829f9d2023-10-21WarningsExact identifier
application number: M006
PERSISTENT BODY ACNE WASH 8.5OZSALICYLIC ACIDChina Ningbo Shangge Cosmetics Technology Corp.074079cd-866d-0af0-e063-6394a90a72142023-10-09WarningsExact identifier
application number: M006
Skin Laundry. Clean Slate Exfoliating 2 Salicylic Acid Treatment Gel Cleanser Cleanse ExfoliateSALICYLIC ACIDSkin Laundry Holdings, Inc.07100fe5-3884-0948-e063-6294a90a6ec72023-10-06WarningsExact identifier
application number: M006
NAS PORE REFINING SCRUBSALICYLIC ACIDBURT'S BEES, INC.bc2c6b1e-999c-91a7-e053-2a95a90a9d1a2023-10-05WarningsExact identifier
application number: M006
NAS Targeted Spot TreatmentSALICYLIC ACIDBurt's Beesbc193e1f-c2bd-6415-e053-2995a90ae6eb2023-10-05WarningsExact identifier
application number: M006
ACNE AND LINE CORRECTING SERUMSALICYLIC ACIDCLINIQUE LABORATORIES LLCb03bdef4-a099-4543-8673-85466bd649612023-10-05WarningsExact identifier
application number: M006
SPOT ACNE TREATMENT 0.75OZBENZOYL PEROXIDERejoice International Corp.06de40a2-45bf-bf4b-e063-6294a90a586c2023-10-04WarningsExact identifier
application number: M006
PERSISTENT BODY ACNE WASH 8.5OZSALICYLIC ACIDRejoice International Corp.06df07f7-e4c5-ccef-e063-6394a90a9f3c2023-10-04WarningsExact identifier
application number: M006
SPOT ACNE TREATMENT 0.75OZBENZOYL PEROXIDEChina Ningbo Shangge Cosmetics Technology Corp.06e07266-6483-e7ef-e063-6294a90a93952023-10-04WarningsExact identifier
application number: M006
Acne ControlCREAMWalgreenfc60cccb-405b-e49e-e053-6394a90a5a122023-09-11WarningsExact identifier
application number: M006
AnubisMedAZELAIC ACID, SALICYLIC ACIDANUBIS COSMETICS SLebf3153d-30f5-54e4-e053-2995a90a74b12023-09-05WarningsExact identifier
application number: M006
AnubisMedGLYCOLIC ACID, CITRIC ACID, LACTIC ACID, KOJIC ACIDANUBIS COSMETICS SLeca95dde-cb57-2ab6-e053-2995a90af84f2023-09-05WarningsExact identifier
application number: M006
Anubis BarcelonaPEG-40 HYDROGENATED CASTOR OIL, PROPYLENE GLYCOL, ALLANTOINANUBIS COSMETICS SLeb9244ea-6102-3cbe-e053-2a95a90ab8f62023-09-01WarningsExact identifier
application number: M006
Anubis Barcelona Regul OilPROPYLENE GLYCOL, PANTHENOL, THIAMINE HCLANUBIS COSMETICS SLeb8e5beb-4452-58c2-e053-2a95a90a66e02023-09-01WarningsExact identifier
application number: M006
Anubis Barcelona Regul OilCETEARYL ETHYLHEXANOATE, PROPYLENE GLYCOL, GLYCERYL STEARATE SEANUBIS COSMETICS SLeb68c3ab-7835-1a1c-e053-2995a90a0d662023-09-01WarningsExact identifier
application number: M006
Anubis Barcelona Regul OIlPEG-40 HYDROGENATED CASTOR OIL, PROPYLENE GLYCOL, ARCTIUM MAJUS ROOT EXTRACTANUBIS COSMETICS SLeb905bd0-c600-b8b2-e053-2995a90ad2592023-09-01WarningsExact identifier
application number: M006
Anubis Barcelona Regul OilPROPYLENE GLYCOL, GLYCERYL STEARATE SE, HUMULUS LUPULUS (HOPS) CONE EXTRACTANUBIS COSMETICS SLeb7c418b-8bee-26a3-e053-2a95a90a4e962023-09-01WarningsExact identifier
application number: M006
ACNE CLEANSINGSALICYLIC ACIDCLINIQUE LABORATORIES LLC7bae5802-cf51-4b41-9d7c-d72f1eb4c4af2023-08-30WarningsExact identifier
application number: M006
Gly-Sal 2-2 PadsSALICYLIC ACIDTopiderm, Inc.a92a9ffb-5c5b-43a4-b669-04667324920b2023-02-16WarningsExact identifier
application number: M006
Derma E Acne Clarifying MaskSULFURderma e55df8fb4-abc3-43fe-b89b-6e7d638b27a62023-02-14WarningsExact 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