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 123 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Universal PAIN RELIEF	LIDOCAINE	Universal Distribution Center LLC	b132a4f2-1b1f-4e80-a183-f9add449065f	2024-10-14	Warnings	Exact identifier application number: M017
Nervex Pain Relieving	CAPSAICIN	VITA SCIENCES, LLC	a39bba22-8c54-4252-9973-052dd2aaea36	2024-10-14	Warnings	Exact identifier application number: M017
CVS Health Lidocaine Pain-Relieving	LIDOCAINE	NATURAL ESSENTIALS, INC.	d07fdffd-bf7c-4950-9b2d-c06d54ef4c55	2024-10-14	Warnings	Exact identifier application number: M017
Walgreens Cooling	LIDOCAINE HYDROCHLORIDE	WALGREEN COMPANY	baffb272-436c-4ad8-e053-2a95a90a56fb	2024-10-14	Warnings	Exact identifier application number: M017
Walgreens Sunburn Relief	MENTHOL	WALGREEN COMPANY	c8967fba-6c28-494b-e053-2995a90acbba	2024-10-14	Warnings	Exact identifier application number: M017
Walgreens Sunburn Relief	LIDOCAINE	WALGREEN COMPANY	d5067903-c559-dc6d-e053-2995a90a8ee3	2024-10-14	Warnings	Exact identifier application number: M017
Diphenhydramine HCl and Zinc Acetate	EXTRA STRENGTH ITCH RELIEF	Meijer Distribution Inc	18998e1c-1254-4d0c-93f1-26652c5ca076	2024-10-14	Warnings	Exact identifier application number: M017
signature care itch relief	DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE	Safeway	3eedcd9f-8312-4d14-a0fe-6b00a00d3e73	2024-10-13	Warnings	Exact identifier application number: M017
itch relief	DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE	H E B	34c7bcd3-203f-4630-894d-3739a1576c8d	2024-10-13	Warnings	Exact identifier application number: M017
hydrocortisone	HYDROCORTISONE	H E B	25ec9014-64c4-44df-9e67-9f9223ffc923	2024-10-12	Warnings	Exact identifier application number: M017
PAIN RELIEF Gel-Roll On	LIDOCAINE AND MENTHOL	Shanghai Chuangshi Medical Technology (Group) Co., Ltd.	f02fa9c0-b8af-f362-e053-2a95a90ae516	2024-10-11	Warnings	Exact identifier application number: M017
Insect Sting Relief Pad	BENZOCAINE, ALCOHOL	Hubei Changjian Medical Products Co., Ltd.	6a269982-0e25-4c09-aef1-0b398bdc5ed4	2024-10-11	Warnings	Exact identifier application number: M017
HYDROCORTISONE	HYDROCORTISONE	VIVE HEALTH LLC	24221805-e5c9-5785-e063-6394a90a9d2f	2024-10-10	Warnings	Exact identifier application number: M017
De La Cruz Camphor	CAMPHOR	DLC Laboratories, Inc.	62359237-de2d-4497-bfd6-36991cfc8acf	2024-10-10	Warnings	Exact identifier application number: M017
Anti Itch	DIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATE	Meijer Distribution Inc	4f536a86-6419-4ab0-a7e8-5c37943823e2	2024-10-09	Warnings	Exact identifier application number: M017
terrasil Bruise and Pain Relief Maximum Strength	CAMPHOR, MENTHOL	Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions	240b231d-a8b2-c64c-e063-6394a90a7440	2024-10-09	Warnings	Exact identifier application number: M017
Muscle Freeze Relief	MENTHOL	NATURAL ESSENTIALS, INC.	815c534b-096d-49f2-b5f2-8c885d45a5e6	2024-10-09	Warnings	Exact identifier application number: M017
HYDROCORTISONE	HYDROCORTISONE	VIVE HEALTH LLC	2410dc2f-9332-19fa-e063-6394a90a2835	2024-10-09	Warnings	Exact identifier application number: M017
CVS Health Lidocaine Pain-Relieving	LIDOCAINE	Natural Essentials, Inc.	fc23b2e2-4abc-4119-b8bd-305b4327f1dd	2024-10-09	Warnings	Exact identifier application number: M017
KERACARE	MENTHOL 1%	Avlon Industries, Inc.	f72eec6d-1204-4e03-8aed-d5bcf8d3bbce	2024-10-09	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