Home NDC 85808-615 PT Elite Premium Pain Relief
Product NDC 85808-615
11-digit product format 858080615
Labeler code 85808
Product ID 85808-615_3a81868c-3aa7-5e51-e063-6294a90a2952
Type HUMAN OTC DRUG
Nonproprietary name CAPSAICIN, MENTHOL
Dosage form CREAM
Route TOPICAL
Labeler PT ELITE PRODUCTS LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-05-09
Substance CAPSAICIN; MENTHOL
Active strength .35; 40 mg/mL; mg/mL
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 PT Elite Premium Pain Relief
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CAPSAICIN .35 mg/mL MENTHOL 40 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination S07O44R1ZM Internal UNII lookup L7T10EIP3A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1865193 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 85808-615-00 PT Elite Premium Pain Relief 100 mL in 1 TUBE CREAM 100 2 85808-615-00 PT Elite Premium Pain Relief 1 in 1 BOX CREAM 1 2
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 18 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 85808-615-00 85808061500 1 TUBE in 1 BOX (85808-615-00) / 100 mL in 1 TUBE 1 tube 2025-05-09 No No Current