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 124 of 152 · 3,029 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Eagle Medicated MENTHOL METHYL SALICYLATE Eagle Indo Pharma, PT da338796-de9c-be51-e053-2a95a90a2509 2024-10-07 Warnings Exact identifier application number: M017 Eagle Medicated MENTHOL METHYL SALICYLATE Eagle Indo Pharma e2c5f821-cdd5-190d-e053-2a95a90a9159 2024-10-07 Warnings Exact identifier application number: M017 NanoXtreme Pain Relieving MENTHOL, METHYL SALICYLATE MG Science Technologies LLC c1490c30-a9db-4120-adaf-9e8000169e46 2024-10-07 Warnings Exact identifier application number: M017 CAREALL Hydrocortisone Maximum Strength HYDROCORTISONE New World Imports, Inc ea656cf8-cad5-4fa5-82e7-daec77a0bb04 2024-10-07 Warnings Exact identifier application number: M017 Eagle Medicated Oil Refreshing MENTHOL, METHYL SALICYLATE Eagle Indo Pharma, PT e2729023-d689-7ae2-e053-2a95a90a78dc 2024-10-06 Warnings Exact identifier application number: M017 Flanax Back Pain Relief LIDOCAINE Belmora LLC 46d33346-e582-4af1-b81a-feca7033dceb 2024-10-04 Warnings Exact identifier application number: M017 Muscle Balm MENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC) Natural Essentials, Inc. 16918ba3-2e07-4232-9ed3-4c7751796cd2 2024-10-04 Warnings Exact identifier application number: M017 Fast Freeze Pain Relieving Continuous MENTHOL, UNSPECIFIED FORM Natural Essentials, Inc. 998a4824-9ed9-4fe0-b45b-72e52861fcd3 2024-10-04 Warnings Exact identifier application number: M017 Fast Freeze Lidocaine Roll-On LIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOL Natural Essentials, Inc. 74b06366-5eb4-4eba-aa2b-2b672828294d 2024-10-04 Warnings Exact identifier application number: M017 Fast Freeze Lidocaine LIDOCAINE Natural Essentials, Inc. 029bd3fb-1b5b-48e0-b9af-d91d548b5b0f 2024-10-04 Warnings Exact identifier application number: M017 Fast Freeze MENTHOL Natural Essentials Inc. a96e3e41-871c-4cf3-93b6-af2a6246ded8 2024-10-04 Warnings Exact identifier application number: M017 CVS Pain Relief MENTHOL 4% CVS 20234356-5e80-b79e-e063-6294a90a2ee3 2024-10-04 Warnings Exact identifier application number: M017 FLANAX BACK PAIN RELIEF LIDOCAINE Belmora Llc af4bf57c-f250-4506-83eb-e0f253e96062 2024-10-04 Warnings Exact identifier application number: M017 topcare hydrocortisone HYDROCORTISONE Topco Associates LLC 11a30ec9-ebc2-4a00-8a8d-431d0d973b37 2024-10-03 Warnings Exact identifier application number: M017 pain relief patch LIDOCAINE 4% Bionpharma Inc. 19c69983-4e78-8ec5-e063-6394a90a84be 2024-10-03 Warnings Exact identifier application number: M017 Good Sense Anti Itch HYDROCORTISONE L. Perrigo Company ecd6d841-40b9-42c9-825d-d172cd04824d 2024-10-03 Warnings Exact identifier application number: M017 Gold Bond Medicated Original Strength Body MENTHOL Navajo Manufacturing Company Inc. f71d598c-92c3-d6fd-e053-6394a90a97d7 2024-10-03 Warnings Exact identifier application number: M017 Signature Care Hydrocortisone HYDROCORTISONE Safeway 9e663535-4acc-4b37-acae-8c17517c5a3d 2024-10-03 Warnings Exact identifier application number: M017 Topcare Hydrocortisone HYDROCORTISONE Topco Associates LLC 849c60fc-e455-4c50-8adf-ac59c0ee785b 2024-10-03 Warnings Exact identifier application number: M017 rexall anti itch maximum strength relief HYDROCORTISONE Dolgencorp, LLC 894cf9ab-693a-4210-96df-605947f51b63 2024-10-03 Warnings Exact identifier application number: M017
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