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 23 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Kevo-Prophen	JUNIPER TAR	Faeve, LLC	4fe773a8-77cd-831e-e063-6294a90ae2ca	2026-04-20	Warnings	Exact identifier application number: M017
BeeVenom	METHYL SALICYLATE	Menper Distributors, Inc.	4fe7a986-336d-ad4e-e063-6294a90a0b8a	2026-04-20	Warnings	Exact identifier application number: M017
Benzodent	BENZOCAINE	Focus Consumer Healthcare, LLC	5fdcb871-d387-6352-e053-2991aa0a09da	2026-04-20	Warnings	Exact identifier application number: M017
Tecnu Calagel	DIPHENHYDRAMINE HYDROCHLORIDE	Tec Laboratories Inc.	8bc9cbfe-1dd4-18ed-e053-2a95a90a7966	2026-04-20	Warnings	Exact identifier application number: M017
Aemerry Numbing Cream	MENTHOL 5%	Da Capo Prima LLC	4fefddaf-19c8-86b4-e063-6294a90abffc	2026-04-20	Warnings	Exact identifier application number: M017
Sting Relief Swab	BENZOCAINE	4 Visions LLC	4fc7a356-2f1d-85af-e063-6394a90aec6b	2026-04-18	Warnings	Exact identifier application number: M017
Equate Lidocaine and Menthol Paraben Free	LIDOCAINE 4% PLUS MENTHOL 1%	Walmart Stores Inc	4fa917de-bc46-0b8d-e063-6294a90a218a	2026-04-17	Warnings	Exact identifier application number: M017
LidoPro	LIDOCAINE AND MENTHOL	Advanced Rx of Tennessee, LLC	4faa515f-6040-d948-e063-6294a90a187f	2026-04-17	Warnings	Exact identifier application number: M017
Coleman Bite and Sting Relief	EXTERNAL ANESTHETIC AND FIRST AID ANTISEPTIC	Wisconsin Pharmacal Company	4fadf1f1-478a-5104-e063-6294a90a10cb	2026-04-17	Warnings	Exact identifier application number: M017
Ice Gel ICE COLD ANALGESIC	MENTHOL	Universal Distribution Center LLC	4f921ced-7722-cba5-e063-6294a90a650b	2026-04-16	Warnings	Exact identifier application number: M017
Walgreens Capsaicin Hot Patch	CAPSAICIN	Walgreen Co.	41e959d8-f6ac-f5b4-e063-6294a90abd96	2026-04-16	Warnings	Exact identifier application number: M017
Walgreens Cold Therapy Pain Relieving Patch	MENTHOL	Walgreen Co.	41e7574a-348f-8eb8-e063-6294a90a6e90	2026-04-16	Warnings	Exact identifier application number: M017
Coleman Sting and Bite Relief	EXTERNAL ANALGESIC AND FIRST AID ANTISEPTIC	Wisconsin Pharmacal Company	4f94ab35-3099-716c-e063-6294a90a8bea	2026-04-16	Warnings	Exact identifier application number: M017
Kroger Witch Hazel	WITCH HAZEL	Kroger Co.	461407d0-fbf6-47e9-e063-6394a90a9a83	2026-04-16	Warnings	Exact identifier application number: M017
Stopain Extra Strength Gel	MENTHOL	Troy Manufacturing, Inc.	86fe4e8c-5279-445a-a19a-e694eac785fd	2026-04-16	Warnings	Exact identifier application number: M017
Stopain Clinical	MENTHOL, UNSPECIFIED FORM	Troy Manufacturing, Inc.	4503208f-2808-4727-8066-c431230bd70b	2026-04-16	Warnings	Exact identifier application number: M017
EXTRA STRENGTH STOPAIN COLD PAIN RELIEVING ROLL ON	MENTHOL	TROY MANUFACTURING, INC	895896dc-0762-40a7-8313-cca10ce68984	2026-04-16	Warnings	Exact identifier application number: M017
HealthWise Medicated Cold Hot 5%	MENTHOL	Veridian Healthcare	4f9b1b2d-1acc-e0a7-e063-6394a90aadbc	2026-04-16	Warnings	Exact identifier application number: M017
Lidoease 2%	LIDOCAINE HCL 2%	PureTek Corporation	3ba0c0ff-0f7a-7a29-e063-6294a90a547a	2026-04-16	Warnings	Exact identifier application number: M017
Walgreens Lidocaine Pain Relieving Patch Assorted	LIDOCAINE	Walgreen Co.	41e98f15-669f-4543-e063-6294a90a1ef7	2026-04-15	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