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 24 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
A Health Itch Relief Gel	ITCH RELIEF GEL	Pharma Nobis, LLC	4f80c403-c760-31ec-e063-6394a90a61c9	2026-04-15	Warnings	Exact identifier application number: M017
Family Care Antibiotic Pain Relief 0.33oz	ANTIBIOTIC PAIN RELIEF	United Exchange Corp	4f8405fc-3e38-05d9-e063-6394a90a4cda	2026-04-15	Warnings	Exact identifier application number: M017
BiteMD	INSECT BITE RELIEF	Wisconsin Pharmacal Company	4f860c1e-a638-4923-e063-6294a90ae7e2	2026-04-15	Warnings	Exact identifier application number: M017
LavaDerm AfterSun	MENTHOL	Young Living Essential Oils, LC.	4fcddcf1-36db-2f1a-e054-00144ff8d46c	2026-04-15	Warnings	Exact identifier application number: M017
Arlun Numbing Cream	NUMBING CREAM	Guangzhou Jingliang Cosmetics Co., Ltd.	4f8b60f9-03e3-e731-e063-6294a90a3b0a	2026-04-15	Warnings	Exact identifier application number: M017
tuiwaro Numbing Cream	NUMBING CREAM	Guangzhou Jingliang Cosmetics Co., Ltd.	4f66178c-95d9-8c6a-e063-6294a90a2c09	2026-04-14	Warnings	Exact identifier application number: M017
Lidocaine Pain Relief Roll-On	LIDOCAINE 4%	Pharma Nobis, LLC	4f6d9a51-c42e-ca88-e063-6394a90a8659	2026-04-14	Warnings	Exact identifier application number: M017
Hot/Cold Menthol 16% Roll-On	HOT/COLD MENTHOL 16% ROLL-ON	Pharma Nobis, LLC	4f6f5a0b-3bfa-289e-e063-6294a90a94b3	2026-04-14	Warnings	Exact identifier application number: M017 ndc (product): 82645-014
Sting Relief Swab	BENZOCAINE	4 Visions LLC	4f76a8c5-fde6-eee0-e063-6394a90a09f8	2026-04-14	Warnings	Exact identifier application number: M017
Signature Pain Relief Cream	4% LIDOCAINE	Shengnan (Guangzhou) Cosmetics Co., LTD	4f555b8f-5193-e685-e063-6294a90a7ba2	2026-04-13	Warnings	Exact identifier application number: M017
Deep Numbing Cream	MENTHOL	YITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD	7943559b-de10-4214-96dc-f9cbac828f46	2026-04-13	Warnings	Exact identifier application number: M017
Hydrocortisone Cream 1%	HYDROCORTISONE CREAM 1% WITH ALOE	Publix Super Markets Inc.	3c45a654-7fec-55b3-e063-6294a90a184b	2026-04-13	Warnings	Exact identifier application number: M017
Hydrocortisone with Aloe	HYDROCORTISONE CREAM 1%	AMERISOURCE BERGEN	4f5aea1c-ae51-4e1a-e063-6294a90a6aa1	2026-04-13	Warnings	Exact identifier application number: M017
ActivICE	MENTHOL	Medline Industries, LP	8465b443-abe9-78fb-e053-2a91aa0ac1d8	2026-04-13	Warnings	Exact identifier application number: M017
4Jointz	MENTHOL	ARP(USA) Pty Ltd	94a5b5f5-abf7-40b3-9dd7-43e2c22f138e	2026-04-13	Warnings	Exact identifier application number: M017
Sumifun Pain Relief Creams	METHYL SALICLATE CAPSAICIN CAMPHOR	Guchutang Biotechnology (Longyan) Co., Ltd	4f3dd96a-d843-d810-e063-6394a90a188e	2026-04-12	Warnings	Exact identifier application number: M017
BonicaEaseX 24 Hour Menthol Pain Relieving	MENTHOL, UNSPECIFIED FORM	Planet (Anhui) Pharmaceutical Co., Ltd.	17fc0cd1-710d-45e6-9513-d7100e3adb42	2026-04-10	Warnings	Exact identifier application number: M017
BonicaEaseX Colorless Roll-On Menthol Pain Relieving	MENTHOL, UNSPECIFIED FORM	Planet (Anhui) Pharmaceutical Co.,Ltd	acf460b4-1b41-4b30-a74a-6c3613119d8e	2026-04-10	Warnings	Exact identifier application number: M017
BonicaEaseX Menthol Pain Relieving	MENTHOL, UNSPECIFIED FORM	Planet (Anhui) Pharmaceutical Co.,Ltd	4d84b4fb-8f55-4b2b-b261-858edb7f3144	2026-04-10	Warnings	Exact identifier application number: M017
HealthWise Pain Relief Gel Patch	CAPSAICIN, MENTHOL	Veridian Healthcare	f5484151-b6da-4f64-867f-87160a4ec2d6	2026-04-10	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