Home NDC 80861-117 Salicylic Acid
Product NDC 80861-117
11-digit product format 808610117
Labeler code 80861
Product ID 80861-117_57f48c82-691d-3e4a-e063-6294a90a9064
Type HUMAN OTC DRUG
Nonproprietary name Salicylic Acid
Dosage form CREAM
Route TOPICAL
Labeler Acne Free, LLC
Application M006
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-02-05
Substance SALICYLIC ACID
Active strength .02 g/g
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 Salicylic Acid
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SALICYLIC ACID .02 g/g
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 562600 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 80861-117-01 Salicylic Acid 1 g in 1 TUBE CREAM 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80861-117 SALICYLIC ACID CREAM [ACNE FREE, LLC] 2 Current NDC, 1 package rows 20240620_1097fc73-fa47-0f14-e063-6294a90aa499.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 14 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 Sample Exclude flag Status 80861-117-01 80861011701 1 g in 1 TUBE (80861-117-01) 1 g 2024-02-05 No No Current