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 60 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sohm Pain Away MENTHOL, CAMPHOR SOHM, Inc 86632acf-80ae-48d7-a0bb-7ec980326bae 2025-11-25 Warnings Exact identifier application number: M017 HealthWise Lidocaine Pain Relief LIDOCAINE 4% Veridian Healthcare 6f2332c0-e078-40a8-9564-f47d21bc491b 2025-11-25 Warnings Exact identifier application number: M017 JUST CBD ROLL-ON WARMING CAMPHOR Just Brands LLC 44779065-5f57-8f01-e063-6394a90a3f8e 2025-11-25 Warnings Exact identifier application number: M017 JUST CBD ROLL-ON COOLING MENTHOL Just Brands LLC 44786cb6-176e-cc6e-e063-6394a90a54ad 2025-11-25 Warnings Exact identifier application number: M017 Diphenhydramine HCl and Zinc Acetate EXTRA STRENGTH ITCH RELIEF VALU MERCHANDISERS, CO 3e9c0f5b-cb76-475b-9a2b-39afa1eeb9ff 2025-11-24 Warnings Exact identifier application number: M017 Menthol MAXIMUM STRENGTH MEDICATED FOOT POWDER VALU MERCHANDISERS, CO 89a5c4bb-442f-d3f0-e053-2a95a90a51bd 2025-11-24 Warnings Exact identifier application number: M017 Dragon Pain Relieving Balm CAMPHOR, MENTHOL AMERICANNA WELLNESS, INC. 0d11ab8e-d3ea-c7ef-e063-6294a90ae0a3 2025-11-24 Warnings Exact identifier application number: M017 Dragon Pain Relieving CAMPHOR, MENTHOL AMERICANNA WELLNESS, INC. 0d113dec-8832-d984-e063-6394a90ae7b3 2025-11-24 Warnings Exact identifier application number: M017 Dragon Pain Relieving Balm CAMPHOR, MENTHOL AMERICANNA WELLNESS, INC. 0d12f03f-dd8b-0be5-e063-6294a90a43db 2025-11-24 Warnings Exact identifier application number: M017 Thermacare Heat Therapy Max Strength Lidocaine Pain Relief Gel THERMACARE HEAT THERAPY MAX STRENGTH LIDOCAINE PAIN RELIEF GEL Clarion Brands LLC 445db02a-c8e8-6ebb-e063-6294a90a4301 2025-11-24 Warnings Exact identifier application number: M017 Dragon Pain Relieving Balm CAMPHOR, MENTHOL AMERICANNA WELLNESS, INC. 0d129641-eaea-c3ee-e063-6394a90aa58f 2025-11-24 Warnings Exact identifier application number: M017 Dragon Pain Relieving CAMPHOR, MENTHOL AMERICANNA WELLNESS, INC. 0d1059cc-1b0b-4e7b-e063-6294a90a56ea 2025-11-24 Warnings Exact identifier application number: M017 GuruNanda Pain Relief MENTHOL AND CAMPHOR GURUNANDA, LLC 3ca78342-cc6d-5f6b-e063-6294a90a3f1c 2025-11-24 Warnings Exact identifier application number: M017 Dragon Pain Relieving CAMPHOR, MENTHOL AMERICANNA WELLNESS, INC. 0d118256-90ee-28ef-e063-6394a90a21e8 2025-11-24 Warnings Exact identifier application number: M017 health beyond HYDROCORTISONE Nantong Health & Beyond Hygienic Products Inc. bdcd5b01-f5e2-4519-bf4d-25e3cc7e67af 2025-11-23 Warnings Exact identifier application number: M017 NicDuic Quit Smoking Nicotine Patches 3 Step NICOTINE PATCHES Shenzhen Paxi Trading Co., Ltd. 4429fea8-46f8-8f7f-e063-6394a90a34b4 2025-11-22 Warnings Exact identifier application number: M017 NicDuic Quit Smoking Nicotine Patches 2 Step NICOTINE PATCHES Shenzhen Paxi Trading Co., Ltd. 442a926b-d7c1-4e35-e063-6394a90ad948 2025-11-22 Warnings Exact identifier application number: M017 NicDuic Quit Smoking Nicotine Patches 1 Step NICOTINE PATCHES Shenzhen Paxi Trading Co., Ltd. 442aae32-4ac6-5dd6-e063-6294a90aad02 2025-11-22 Warnings Exact identifier application number: M017 NicDuic Quit Smoking Nicotine Patches 1-3 Step 21MG NICOTINE PATCHES Shenzhen Paxi Trading Co., Ltd. 442ae0fa-a1ed-7901-e063-6294a90ab717 2025-11-22 Warnings Exact identifier application number: M017 IceQuake Lidocaine Analgesic LIDOCAINE HYDROCHLORIDE Dextrum Laboratories, Inc 441daa6f-f273-ac09-e063-6394a90a252c 2025-11-21 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