Home NDC 57627-201 Acne Defense Spot Treatment
Product NDC 57627-201
11-digit product format 576270201
Labeler code 57627
Product ID 57627-201_43e5977e-e84f-e303-e063-6394a90aca85
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 2026-12-31
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 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SALICYLIC ACID 2 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination O414PZ4LPZ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 346298 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 57627-201-01 Acne Defense Spot TreatmentMerle Norman 14 g in 1 TUBE GEL 14 5 57627-201-02 Acne Defense Spot TreatmentMerle Norman 1 in 1 CARTON GEL 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 57627-201 ACNE DEFENSE SPOT TREATMENT MERLE NORMAN (SALICYLIC ACID) GEL [MERLE NORMAN COSMETICS, INC] 4 Current NDC, Legacy NDC, 2 package rows 20241010_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 8 of 55 · 1,088 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 57627-201-01 57627020101 14 g in 1 TUBE 14 g Historical 57627-201-02 57627020102 1 TUBE in 1 CARTON (57627-201-02) / 14 g in 1 TUBE (57627-201-01) 1 tube 2017-07-14 0000-00-00 No No Current