Home NDC 84680-529 BIOSAVIA External Analgesic Pain Relief
Product NDC 84680-529
11-digit product format 846800529
Labeler code 84680
Product ID 84680-529_20ba72da-a0c4-0f35-e063-6394a90af8e8
Type HUMAN OTC DRUG
Nonproprietary name CAPSAICIN
Dosage form GEL
Route TOPICAL
Labeler BIOSAVIA USA, LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-08-19
Substance CAPSAICIN
Active strength .25 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 BIOSAVIA External Analgesic Pain Relief
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CAPSAICIN .25 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination S07O44R1ZM Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 199870 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 84680-529-00 BIOSAVIA External Analgesic Pain Relief 117.5 g in 1 BOTTLE GEL 117.5 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84680-529 BIOSAVIA EXTERNAL ANALGESIC PAIN RELIEF (CAPSAICIN) GEL [BIOSAVIA USA, LLC] 1 Current NDC, 1 package rows 20240829_814aa66b-7719-4a29-a84e-18290367e9c7.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 48 of 153 · 3,057 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 84680-529-00 84680052900 117.5 g in 1 BOTTLE (84680-529-00) 117.5 g 2024-08-19 No No Current