Home NDC 80684-111 b pure Pressed Powder for Acne Prone Skin Tan
Product NDC 80684-111
11-digit product format 806840111
Labeler code 80684
Product ID 80684-111_1b1ad176-c025-bbdb-e063-6294a90a0764
Type HUMAN OTC DRUG
Nonproprietary name SALICYLIC ACID
Dosage form POWDER
Route TOPICAL
Labeler Fourstar Group USA, Inc.
Application M006
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-09-01
Substance SALICYLIC ACID
Active strength 5 mg/g
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 b pure Pressed Powder for Acne Prone Skin Tan
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SALICYLIC ACID 5 mg/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 1241639 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 80684-111-00 b pure Pressed Powder for Acne Prone Skin Tan 4.8 g in 1 CONTAINER POWDER 4.8 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80684-111 B PURE PRESSED POWDER FOR ACNE PRONE SKIN TAN (SALICYLIC ACID) POWDER [FOURSTAR GROUP USA, INC.] 1 Current NDC, 1 package rows 20240901_1158f6c2-2b59-4ed3-8d28-73b6da885a5d.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 Sample Exclude flag Status 80684-111-00 80684011100 4.8 g in 1 CONTAINER (80684-111-00) 4.8 g 2024-09-01 No No Current