Home NDC 84285-101 DermaSolve Medicated
Product NDC 84285-101
11-digit product format 842850101
Labeler code 84285
Product ID 84285-101_24fea3b2-1f0b-e289-e063-6394a90a5641
Type HUMAN OTC DRUG
Nonproprietary name Salicylic Acid
Dosage form LOTION/SHAMPOO
Route TOPICAL
Labeler Fortitude Health, LLC
Application M032
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-10-21
Substance SALICYLIC ACID
Active strength 3 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 DermaSolve Medicated
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SALICYLIC ACID 3 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 205023 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 84285-101-08 DermaSolve Medicated 226 g in 1 BOTTLE LOTION/SHAMPOO 226 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84285-101 DERMASOLVE MEDICATED (SALICYLIC ACID) LOTION/SHAMPOO [FORTITUDE HEALTH, LLC] 1 Current NDC, 1 package rows 20241023_24fea3b2-1f0a-e289-e063-6394a90a5641.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 17 of 32 · 630 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 84285-101-08 84285010108 226 g in 1 BOTTLE (84285-101-08) 226 g 2024-10-21 No No Current