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
IngredientStrength
CAPSAICIN.25 mg/mL
MENTHOL80 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
S07O44R1ZMInternal UNII lookup
L7T10EIP3AInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
42bf129c-5c84-4331-b6d0-78e3be71a985Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83676-435-00PURE EASE Joint Muscle lnstant Pain Relief60 mL in 1 JARCREAM601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83676-435PURE EASE JOINT MUSCLE LNSTANT PAIN RELIEF (CAPSAICIN, MENTHOL) CREAM [SERENU, INC.]1Current NDC, 1 package rows20231128_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 79 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PAIN RELIEF PATCHESLIDOCAINEAmerisource Bergen614f1e56-891f-4620-be10-0c075a1dbc3f2025-09-11WarningsExact identifier
application number: M017
Industrial Itch and Pain ReliefDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATER & R Lotion, Inc236415fc-f923-4a82-b54a-ecaf666dd2e02025-09-11WarningsExact identifier
application number: M017
Eco Lips Menthol Medicated Lip BalmMENTHOLEco Lips, Inc.fc4c25d6-6109-dfd8-e053-6394a90a4e912025-09-10WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONE 1%Encube Ethicals, Inc.d6f5c0df-6262-4704-bb24-430f66bb2ca82025-09-09WarningsExact identifier
application number: M017
Blue-Emu Lidocaine Pain Relief CreamLIDOCAINE CREAM 4%Kingsway Pharmaceuticals dba NFI, LLC592811f2-e21c-6a58-e053-2991aa0a69a92025-09-09WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEUnifirst First Aid Corporation282ed5ef-8c2a-4092-9d99-1a7eee7a39e32025-09-09WarningsExact identifier
application number: M017
LubeLife Climax Control DelayBENZOCAINECC Wellness LLCe1a98e6d-0c24-75b8-e053-2a95a90ad1362025-09-09WarningsExact identifier
application number: M017
Blue-Emu Maximum Pain ReliefTROLAMINE SALICYLATEKingsway Pharmaceuticals dba NFI, LLCc863351a-951b-4f7c-a9c0-4289d702054a2025-09-09WarningsExact identifier
application number: M017
Tiger Balm Neck and Shoulder RubCAMPHOR (SYNTHETIC) AND MENTHOLHaw Par Healthcare Ltd.02a65b25-78b2-4e29-9484-40e2228fb3842025-09-09WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEUnifirst First Aid Corporatione90df2e5-2ef4-47dd-bd74-be9cea6d9d852025-09-08WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEUnifirst First Aid Corporation69d6645e-db3c-4dc0-a9a5-e2bc963e2f282025-09-08WarningsExact identifier
application number: M017
SupreH Arnica Bruise CreamSUPREH ARNICA REMEDY PLUS BRUISE CREAMShenzhen Xinxin Yunhai Technology Co., Ltd.3e41fc0e-54c3-2622-e063-6294a90a13c92025-09-07WarningsExact identifier
application number: M017
MentholMENTHOLFlexiGo Inc3607c326-6db0-a2cd-e063-6394a90a9eb62025-09-06WarningsExact identifier
application number: M017
TIDL PAIN RELIEF CRYOTHERAPY MENTHOL CreamPAIN RELIEF CRYOTHERAPY MENTHOL CREAMShenzhen Sam Technology Co., Ltd.3e08cc87-2385-0838-e063-6394a90abf9b2025-09-05WarningsExact identifier
application number: M017
TIDL CLINICAL CRYOTHERAPY MENTHOL CreamCLINICAL CRYOTHERAPY MENTHOL CREAMShenzhen Sam Technology Co., Ltd.3e090b98-1db7-4174-e063-6394a90aa5392025-09-05WarningsExact identifier
application number: M017
ALCEMISTELIDOCAINE HCLPrice Team Ventures, LLC4383faaa-49cf-47b7-83a6-c2a94b6ff9b52025-09-05WarningsExact identifier
application number: M017
Lansinoh Pain RelievingLIDOCAINE HCLLansinoh Laboratories Incb7cf1fdb-946d-a4e8-e053-2995a90a26a82025-09-05WarningsExact identifier
application number: M017
Sumifun PLANTAR RELIEF ROLL -ON4% LIDOCAINE, 1% MENTHOLGuangzhou Zhupuyou E-commerce Co., Ltd3c9ee60b-548a-979f-e063-6394a90a70b02025-09-03WarningsExact identifier
application number: M017
Meijer Capsaicin Heat PatchCAPSAICINMeijer Distribution3c465557-0a4f-fb72-e063-6294a90a1ef22025-09-02WarningsExact identifier
application number: M017
Cold TherapyMENTHOLAHC Ventures Corp DBA Cryodermdd95c682-8ddf-43e7-a277-2fca6ec744cc2025-09-02WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83676-435-008367604350060 mL in 1 JAR (83676-435-00) 60 ml2023-11-27NoNoCurrent