Hot/Cold Menthol 16% Roll-On

Product NDC: 82645-014
11-digit product format: 826450014
Labeler code: 82645
Product ID: 82645-014_4f6f50c3-79af-1aac-e063-6294a90a1a63
Type: HUMAN OTC DRUG
Nonproprietary name: Hot/Cold Menthol 16% Roll-On
Dosage form: LIQUID
Route: TOPICAL
Labeler: Pharma Nobis, LLC
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2026-04-14
Substance: MENTHOL
Active strength: 16 mg/100mL
NDC exclude flag: No
Listing certified through: 2027-12-31
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: Hot/Cold Menthol 16% Roll-On
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL	16 mg/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
4f6f5a0b-3bfa-289e-e063-6294a90a94b3	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
473d070d-1c38-488e-b991-c4d1bf45aab8	Product name	1	20210201

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
82645-014-97	Hot/Cold Menthol 16% Roll-On	1 in 1 CARTON	LIQUID	1		1
82645-014-97	Hot/Cold Menthol 16% Roll-On	74 mL in 1 BOTTLE, WITH APPLICATOR	LIQUID	74		1

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 121 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Walgreens Pain Relieving Plus Turmeric Analgesic	TROLAMINE SALICYLATE	Walgreen Company	f3a121bc-7572-49a4-9822-2b6d858c19d2	2024-10-31	Warnings	Exact identifier application number: M017
dg health hydrocortisone	HYDROCORTISONE	Dolgencorp, LLC	27dc9e09-fc4f-4b66-a303-177725f3a513	2024-10-31	Warnings	Exact identifier application number: M017
basic care hydrocortisone	HYDROCORTISONE	Amazon.com Services LLC	f5419859-3f9f-43ff-9a3f-6aa81af044f0	2024-10-31	Warnings	Exact identifier application number: M017
ARCTIC RELIEF	MENTHOL, UNSPECIFIED FORM	STRATUS PHARMACEUTICALS INC	d27fbc17-46b7-4d52-ba29-c99b6c63144a	2024-10-31	Warnings	Exact identifier application number: M017
Pain Relief Gel-Patch	LIDOCAINE, MENTHOL	R & Y Group, LLC	fe0478d8-2f06-cd56-e053-6294a90a58e5	2024-10-30	Warnings	Exact identifier application number: M017
JOINT-RITIS PAIN RELIEVING ROLL-ON	MENTHOL	Lifeline Naturals of America, Inc.	ec5d99c4-6bba-45d1-84e0-12fb7cb31495	2024-10-30	Warnings	Exact identifier application number: M017
Walgreens Pain Relieving with Turmeric Analgesic	LIDOCAINE HYDROCHLORIDE	Walgreen Company	317ec4fb-cff0-461d-9ca0-299527a3686d	2024-10-30	Warnings	Exact identifier application number: M017
Walgreens Pain Relieving Analgesic	CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATE	Walgreen Company	3215a676-104c-43c3-aa36-b30d5b67799a	2024-10-30	Warnings	Exact identifier application number: M017
Ultra-Strength Pain Relief Analgesic	CAMPHOR (SYNTHETIC) AND MENTHOL, UNSPECIFIED FORM	TARGET CORPORATION	159c5a84-bf68-41dd-a2d3-bc2402037244	2024-10-30	Warnings	Exact identifier application number: M017
DG Health Cold n Hot Pain Relieving Topical Analgesic	MENTHOL, UNSPECIFIED FORM	Dolgencorp Inc	8fe13b85-ab74-42f8-a664-d3d2959921ac	2024-10-30	Warnings	Exact identifier application number: M017
DEBACHERE Butt Balm After Care Antiseptic Pain Relief	BENZOCAINE, BENZALKONIUM CHLORIDE	DE.BACHERE USA LLC	8ba42864-69bf-455c-98d4-7f4ff94edceb	2024-10-29	Warnings	Exact identifier application number: M017
Signature Care Hydrocortisone	HYDROCORTISONE	Safeway	beefab66-b056-4bf1-b047-0780704ab87e	2024-10-29	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	H E B	15eb4676-5f6e-4c28-b5b9-4e45412dc37a	2024-10-29	Warnings	Exact identifier application number: M017
Rael PAIN RELIEF ROLL-ON Analgesic	CAMPHOR (SYNTHETIC) AND MENTHOL, UNSPECIFIED FORM	Rael, Inc.	e6c49606-7c13-4dc6-a22d-ba54173ba788	2024-10-28	Warnings	Exact identifier application number: M017
Monistat Care Instant Itch Relief	BENZOCAINE	Insight Pharmaceuticals LLC	4e9dc791-419f-4c79-aed4-760f8c17a5dd	2024-10-25	Warnings	Exact identifier application number: M017
ZYLOTROL PAIN RELIEVING	LIDOCAINE HCL, MENTHOL	Asclemed USA, Inc.	1553351c-aee8-4c40-9548-35cce246bda9	2024-10-25	Warnings	Exact identifier application number: M017
Outgro	BENZOCAINE	Medtech Products Inc.	d6be8a1d-aca7-42b1-86da-881d42ffe8d5	2024-10-25	Warnings	Exact identifier application number: M017
Monistat Complete Care Instant Itch Relief	HYDROCORTISONE	Insight Pharmaceuticals LLC	a0f40504-6183-4f32-8d17-6586b3f386a6	2024-10-25	Warnings	Exact identifier application number: M017
Boil Ease	BENZOCAINE	Insight Pharmaceuticals LLC	bf108934-5e1a-4059-9dcf-008f52a83fab	2024-10-25	Warnings	Exact identifier application number: M017
Dermarest Eczema Medicated	HYDROCORTISONE	Insight Pharmaceuticals LLC	0292ab62-5088-45fa-a056-70c2fcc19ef7	2024-10-25	Warnings	Exact identifier application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
82645-014-97	82645001497	1 BOTTLE, WITH APPLICATOR in 1 CARTON (82645-014-97) / 74 mL in 1 BOTTLE, WITH APPLICATOR	2026-04-14	No	No	Current