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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
42bf129c-5c84-4331-b6d0-78e3be71a985	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8	Product name	2	20240805
473d070d-1c38-488e-b991-c4d1bf45aab8	Product name	1	20210201
d206bb34-ea65-399d-70d9-834f22dc2c18	Product name	3	20170724
1681bc73-b05f-12c3-1075-382ae39f449c	Product name	1	20140508

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 145 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AMINO ACTIVE Topical Analgesic Cream	HISTAMINE DIHYDROCHLORIDE	VIREO SYSTEMS, INC.	591b1e7e-a8c0-4640-a592-4e0f3538a40e	2023-11-11	Warnings	Exact identifier application number: M017
NERVE ACTIVE Pain Relief Cream	MENTHOL	TOP DOG DIRECT, LLC	a8b85dcb-fd3e-4340-a945-609fc741443c	2023-11-11	Warnings	Exact identifier application number: M017
GeriGentle FrostyHeat Pain Relief Patch 4 Lodocaine Back	LIDOCAINE	Geri-Gentle Corporation	e4427928-c063-9ca6-e053-2995a90a1aa1	2023-11-10	Warnings	Exact identifier application number: M017
GeriGentle FrostyHeat Pain Relief Patch Arm and Neck	MENTHOL	Geri-Gentle Corporation	e4429f70-667e-662b-e053-2a95a90a62ba	2023-11-10	Warnings	Exact identifier application number: M017
GeriGentle FrostyHeat Pain Relief Patch Back	MENTHOL	Geri-Gentle Corporation	e442b8ec-a3de-65e8-e053-2995a90af3ec	2023-11-10	Warnings	Exact identifier application number: M017
SUPER WHITE STUFF Pain Relief	MENTHOL	BLUE SPRING WELLNESS, L.L.C.	9f948fb4-4275-4a1f-83f8-cd708db4a296	2023-11-10	Warnings	Exact identifier application number: M017
SUPER WHITE STUFF PAIN RELIEF	MENTHOL	BLUE SPRING WELLNESS, L.L.C.	b4278b70-e9a6-4d1f-bbad-257fe437b86a	2023-11-10	Warnings	Exact identifier application number: M017
BLUE SPRING Foot and Leg Comfort Cream with Pain Relief	MENTHOL, CAPSAICIN	BLUE SPRING WELLNESS, L.L.C.	2f9cf514-48be-49ec-b424-0b228b4b874a	2023-11-10	Warnings	Exact identifier application number: M017
SUPER WHITE STUFF Pain Relief	MENTHOL	BLUE SPRING WELLNESS, L.L.C.	1231ddd2-7661-45b2-ab15-32f7fdc078a8	2023-11-10	Warnings	Exact identifier application number: M017
SUPER WHITE Stuff Pain Relief	MENTHOL	BLUE SPRING WELLNESS, L.L.C.	7779b26b-ae3b-4639-a6b0-826c7ab37a86	2023-11-10	Warnings	Exact identifier application number: M017
Alo Therapeutic Massage	MENTHOL, HISTAMINE DIHYDROCHLORIDE	Theraplex Solutions	a898d2ef-5fa0-4144-8bb5-f6d5fc3ff0d4	2023-11-10	Warnings	Exact identifier application number: M017
SUPER BLUE STUFF Pain Relief Cream	MENTHOL	BLUE SPRING WELLNESS, L.L.C.	066a2106-2e25-4df6-9a8d-4417ba190205	2023-11-10	Warnings	Exact identifier application number: M017
INVIGO FLEX Pain Relief Gel	MENTHOL	WYNNPHARM INC.	909e1d8c-c517-4d6a-8682-894f042c00f8	2023-11-10	Warnings	Exact identifier application number: M017
ARNIMAX Penetrating Pain Relief Gel	MENTHOL	WYNNPHARM INC.	3a31f805-19c6-4036-a663-ebef9b212007	2023-11-10	Warnings	Exact identifier application number: M017
KERA HC	HYDROCORTISONE	Clinical Therapeutic Solutions	ac215c8f-b224-480c-9295-3a34316293ba	2023-11-10	Warnings	Exact identifier application number: M017
ALO THERAPEUTIC MASSAGE PAIN RELIEVING	MENTHOL, HISTAMINE DIHYDROCHLORIDE	Theraplex Solutions	da004500-5e48-487b-b96f-520a3094096c	2023-11-10	Warnings	Exact identifier application number: M017
Osteo Bi-Flex JOINT HEALTH PAIN RELIEVING	MENTHOL, METHYL SALICYLATE	Rexall Sundown, LLC	55c55f1c-d2b3-6363-e054-00144ff88e88	2023-11-10	Warnings	Exact identifier application number: M017
NEUROFLEX Topical Pain Relieving Liquid	CAMPHOR (SYNTHETIC), MENTHOL	Almark Products Inc	6da3aa84-7a01-4041-8792-a4bbf49e6e4e	2023-11-10	Warnings	Exact identifier application number: M017
SMOOTH GATOR 60-second Pain Relief	CAMPHOR (SYNTHETIC), MENTHOL	Smooth Gator LLC	3b74b542-202f-469e-8025-4372e95e6b01	2023-11-10	Warnings	Exact identifier application number: M017
Alo Therapeutic Massage	MENTHOL, HISTAMINE DIHYDROCHLORIDE	CMI Therapy Solutions	40f8b8d1-a20b-54b0-e054-00144ff88e88	2023-11-10	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
S07O44R1ZM	CAPSAICIN	404-86-4	CAPSAICIN

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PURE EASE Joint & Muscle lnstant pain Relief Cream	SERENU, INC.	2023-11-13	HUMAN OTC DRUG LABEL	1