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 29 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TINGL EXFOLIATING PADSSALICYLIC ACIDDrmtlgy, LLCd81da185-69e0-41cf-850f-46a207aad0d62025-04-08WarningsExact identifier
application number: M006
Neutrogena All in 1 Acne Control Daily ScrubSALICYLIC ACIDKenvue Brands LLCae0fa680-6012-44c3-a1e8-a4d8d870a7212025-04-08WarningsExact identifier
application number: M006
Neutrogena Stubborn Body Acne TreatmentSALICYLIC ACIDKenvue Brands LLCdd1436c0-aa9e-259c-e053-2a95a90a0b4c2025-04-08WarningsExact identifier
application number: M006
TreeActiv Cystic Acne Spot TreatmentSULFURLeiluna LLCd1b81650-ccc4-49ed-9378-726b3a3a04c72025-04-08WarningsExact identifier
application number: M006
AHA BHA Blemish Control and Exfoliating SerumSALICYLIC ACID SERUMBanuskin, Inc.31e47495-a9fa-a9e8-e063-6294a90a6b672025-04-03WarningsExact identifier
application number: M006
Sulfur Spot TreatmentSULFUR ACNE TREATMENTBanuskin, Inc.31e527e0-ce37-e920-e063-6394a90ac8272025-04-03WarningsExact identifier
application number: M006
Shea MoistureNOURISHED AND RADIANT ACNE TREATMENT SERUM WITH 2% SALICYLIC ACIDConopco d/b/a/ Unilever31815039-5685-6b05-e063-6294a90a2a5e2025-03-29WarningsExact identifier
application number: M006
Clarifying CleanserSALICYLIC ACIDMurad, LLC9c9e66fb-9212-4e61-b7ba-c31cfa91d3c92025-03-28WarningsExact identifier
application number: M006
CeraVe Developed with Dermatologists Acne Control Cleanser Oil Absorbing TechnologySALICYLIC ACIDL'Oreal USA Products Inc7b622b57-21be-4870-a2fe-11447a9e321a2025-03-28WarningsExact identifier
application number: M006
Clarifying CleanserSALICYLIC ACIDMurad, LLC8297fbbe-ea3f-40bc-8dd8-319de45b30242025-03-28WarningsExact identifier
application number: M006
Kiehls Gently Effective Acne Treating CleansingSALICYLIC ACIDL'Oreal USA Products Incb6894aae-c131-4e4a-a035-f7c20f6bc5052025-03-28WarningsExact identifier
application number: M006
TKTXTKTXCOMMERCE OPERATIONS LLC2f867e2b-df7d-c34a-e063-6294a90a17242025-03-25WarningsExact identifier
application number: M006
Neutrogena Body Clear Body ScrubSALICYLIC ACIDKenvue Brands LLC8dbd1942-f644-446b-9292-8fc44fb165a22025-03-20WarningsExact identifier
application number: M006
clenziderm m.d. system acne therapeutic systemSALICYLIC ACID AND BENZOYL PEROXIDEObagi Cosmeceuticals LLC7710e51a-dd3a-4f44-8c97-c089c6817cb02025-03-19WarningsExact identifier
application number: M006
Dissolvable Microneedle Blemish PatchesSALICYLIC ACIDAdvaccine Biopharmaceuticals Suzhou Co., Ltd27b3b2cf-83f6-78fb-e063-6394a90a41f42025-03-18WarningsExact identifier
application number: M006
Neutrogena Oil-Free Acne Wash Sensitive Skin Facial Cleanser Fragrance FreeSALICYLIC ACIDKenvue Brands LLC1a439f48-22f1-73fa-e063-6294a90a3f8e2025-03-18WarningsExact identifier
application number: M006
SOS Rituals Pore Pop Fizz Mask Blackhead TreatmentSALICYLIC ACIDI World LLC692a7c40-7b55-4e53-9e06-60052d96f4cb2025-03-17WarningsExact identifier
application number: M006
GOODBYE ACNE THERAPEUTIC SULFUR MASKSULFURPETER THOMAS ROTH, LLC308ec305-dbf3-c6f9-e063-6294a90a14ec2025-03-17WarningsExact identifier
application number: M006
SOS Rituals Bacne AwaySALICYLIC ACIDI World LLCd79c491f-6123-49fb-a92e-dab684f6eef42025-03-14WarningsExact identifier
application number: M006
SOS Rituals Glow Away Blemish Spot TreatmentSALICYLIC ACIDI World LLC621ecd53-275b-4530-8b34-7cbc5817f77b2025-03-14WarningsExact 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