Home NDC 83676-435 PURE EASE Joint Muscle lnstant Pain Relief
Product NDC 83676-435
11-digit product format 836760435
Labeler code 83676
Product ID 83676-435_0a063d7f-23a2-c949-e063-6294a90a5b57
Type HUMAN OTC DRUG
Nonproprietary name CAPSAICIN, MENTHOL
Dosage form CREAM
Route TOPICAL
Labeler SERENU, INC.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-11-27
Substance CAPSAICIN; MENTHOL
Active strength .25; 80 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 PURE EASE Joint Muscle lnstant Pain Relief
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CAPSAICIN .25 mg/mL MENTHOL 80 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 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 83676-435-00 PURE EASE Joint Muscle lnstant Pain Relief 60 mL in 1 JAR CREAM 60 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83676-435 PURE EASE JOINT MUSCLE LNSTANT PAIN RELIEF (CAPSAICIN, MENTHOL) CREAM [SERENU, INC.] 1 Current NDC, 1 package rows 20231128_42bf129c-5c84-4331-b6d0-78e3be71a985.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 18 of 153 · 3,057 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 83676-435-00 83676043500 60 mL in 1 JAR (83676-435-00) 60 ml 2023-11-27 No No Current