Home NDC 61328-404-05 ACNE SPOT TREATMENT
Product NDC 61328-404
Requested package NDC 61328-404-05
11-digit product format 613280404
Labeler code 61328
Product ID 61328-404_483368a7-95f2-5d8d-e063-6394a90a232e
Type HUMAN OTC DRUG
Nonproprietary name SALICYLIC ACID
Dosage form CREAM
Route TOPICAL
Labeler Skinfix, Inc.
Application M006
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-03-16
Substance SALICYLIC ACID
Active strength 2 g/100mL
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 SPOT TREATMENT
Brand name suffix 2% BHA
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SALICYLIC ACID 2 g/100mL
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 317152 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 61328-404-05 ACNE SPOT TREATMENT2% BHA 15 mL in 1 TUBE CREAM 15 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61328-404 ACNE SPOT TREATMENT 2% BHA (SALICYLIC ACID) CREAM [SKINFIX, INC.] 3 Current NDC, Legacy NDC, 1 package rows 20241228_ceccea68-07d8-0903-e053-2995a90ab2b7.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 54 · 1,079 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 61328-404-05 61328040405 15 mL in 1 TUBE (61328-404-05) 15 ml 2021-03-16 0000-00-00 No No Current