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 48 of 55 · 1,088 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
My Beauty Spot Acne BusterSALICYLIC ACID 0.5%Ganzhou Olivee Cosmetic Co., Ltd.c61e100b-a141-45b3-842b-855be28b02262024-03-20WarningsExact identifier
application number: M006
My Beauty Spot Acne BusterSALICYLIC ACID 0.5%Ganzhou Olivee Cosmetic Co., Ltd.f5c5a2df-11c5-4134-bf1f-b505642164492024-03-20WarningsExact identifier
application number: M006
Blemish Control Dots aloe veraSALICYLIC ACID 0.5%Ganzhou Olivee Cosmetic Co., Ltd.4722ff71-7d9f-4ef2-9f8b-3614e80b864f2024-03-20WarningsExact identifier
application number: M006
Blemish Control DotsSALICYLIC ACID 0.5%Ganzhou Olivee Cosmetic Co., Ltd.dc5410d0-d9f0-4ea4-b587-8bdfc39ac92b2024-03-20WarningsExact identifier
application number: M006
Blemish DotsSALICYLIC ACID 0.5%Ganzhou Olivee Cosmetic Co., Ltd.ca0e6b50-2995-41f8-b944-9f166aac05112024-03-13WarningsExact identifier
application number: M006
Maximum Sterngth Cleansing Pads EquateSALICYLIC ACIDWalmart7db929b6-6470-4840-b016-7e19688548dd2024-03-11WarningsExact identifier
application number: M006
Acne Body WashSALICYLIC ACIDRejoice International97369cca-735a-425f-a0bc-00bc076914652024-02-28WarningsExact identifier
application number: M006
Oil-Free Foaming Acne Wash Facial Cleanser GrapefruitSALICYLIC ACIDRejoice Internationala31baa57-1dfd-44d6-87a5-1b06377cb8b92024-02-28WarningsExact identifier
application number: M006
Oil-Free Foaming Acne Wash Facial Cleanser Tea Tree OilSALICYLIC ACIDRejoice International7ae434d1-8b07-4121-9163-df07598d41562024-02-28WarningsExact identifier
application number: M006
XtraCare Deep Cleaning AstringentSALICYLIC ACIDRejoice International20cb8584-8a31-40a8-8a47-d9fa8ec8abcf2024-02-28WarningsExact identifier
application number: M006
The INKEY List Beta Hydroxy Acid SerumSALICYLIC ACIDBrand Evangelists for Beauty Ltdd554920f-e33a-484b-bbd8-5137156163842024-02-26WarningsExact identifier
application number: M006
LBRI PURE n NATURAL KlearAwaySALICYLIC ACIDL'BRI Health & Beauty561d17fc-0bbf-4112-9820-7d151cce00982024-02-22WarningsExact identifier
application number: M006
Benzo JelBENZOCAINEHenry Schein Inc.2cd571fc-30ee-40da-a2c7-25adb7d4b5c32024-02-15WarningsExact identifier
application number: M006
Rugby Benzoyl Peroxide Acne MedicationBENZOYL PEROXIDERugby Laboratories5cf3da87-ed50-4791-8f71-1b572f3b8f432024-02-09WarningsExact identifier
application number: M006
Rugby Benzoyl Peroxide Acne MedicationBENZOYL PEROXIDERugby Laboratoriesde9ac9fe-b6af-45b7-bbf2-70c47f45885b2024-02-09WarningsExact identifier
application number: M006
Clear Acne Face CleanserACNE FACE CLEANSERKamedis354e2f5b-021b-4683-abe3-7517faf6f7342024-02-07WarningsExact identifier
application number: M006
Clear Acne Spot TreatmentACNE SPOT TREATMENTKamedis00764a10-f1fe-45f5-89b4-9e891a2210042024-02-07WarningsExact identifier
application number: M006
Clear Acne Face MoisturizerACNE FACE MOISTURIZERKamedisb9304cde-1778-40c7-889f-f7647820f44f2024-02-07WarningsExact identifier
application number: M006
Oxy Advanced Care Rapid Spot TreatmentBENZOYL PEROXIDEThe Mentholatum Company0a608bd9-029a-4194-9173-acdcc32056b72024-02-06WarningsExact identifier
application number: M006
CLEAR IMPROVEMENT ACNE CLEARING HYDRATING LTNSALICYLIC ACIDORIGINS NATURAL RESOURCES INC.10a4bae1-bbbb-0bf3-e063-6294a90a4af62024-02-05WarningsExact 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