FlexDermal Pain Relieving Roll-On

Product NDC: 84197-867
11-digit product format: 841970867
Labeler code: 84197
Product ID: 84197-867_2d76e34f-c583-4eae-e063-6294a90a5de5
Type: HUMAN OTC DRUG
Nonproprietary name: MENTHOL
Dosage form: LIQUID
Route: TOPICAL
Labeler: SOLVADERM LLC
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2025-01-24
Substance: MENTHOL
Active strength: 20 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: FlexDermal Pain Relieving Roll-On
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL	20 mg/mL

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
d4d8050e-0761-4491-8635-39c806701eb5	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
84197-867-00	FlexDermal Pain Relieving Roll-On	90 mL in 1 BOTTLE	LIQUID	90		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
84197-867	FLEXDERMAL PAIN RELIEVING ROLL-ON (MENTHOL) LIQUID [SOLVADERM LLC]	1	Current NDC, 1 package rows	20250209_d4d8050e-0761-4491-8635-39c806701eb5.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 133 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dermachange Cold Therapy	MENTHOL	Private Label Beauty and Wellness	12ef7dd8-3da3-9c87-e063-6394a90ac924	2024-03-05	Warnings	Exact identifier application number: M017
Dermachange Arthritis Relief	TROLAMIN SALICYLATE	Private Beauty Label and Wellness	12dbfa50-1b97-f988-e063-6394a90a662c	2024-03-04	Warnings	Exact identifier application number: M017
Analgesic	MENTHOL	Safetec of America, Inc.	b0f4010c-995f-40e1-aa40-92760e697a61	2024-03-02	Warnings	Exact identifier application number: M017
Icy Hot Advanced Relief	CAMPHOR AND MENTHOL	Chattem, Inc.	9979ff36-415b-44e4-bb10-6bf682cd00f9	2024-03-01	Warnings	Exact identifier application number: M017
Amish Origins Pain Relieving Menthol 8%	MENTHOL	Amish Origins Management, LLC	5051b650-18a4-481e-a8d7-d41d4ae51efd	2024-02-29	Warnings	Exact identifier application number: M017
Hydrocortisone	HYDROCORTISONE	TRIFECTA PHARMACEUTICALS USA LLC	2999fecb-cb15-4023-ade4-ab5822b094d5	2024-02-29	Warnings	Exact identifier application number: M017
Amish Origins Pain Relieving Menthol 8	MENTHOL	Amish Origins Management, LLC	aaad56d5-6737-4edc-af0e-8e207695c0ec	2024-02-29	Warnings	Exact identifier application number: M017
Amish Origins Pain Relieving Menthol 8%	MENTHOL	Amish Origins Management, LLC	b120404f-5a07-4182-bb50-d943418622da	2024-02-29	Warnings	Exact identifier application number: M017
Amish Origins Topical Analgesic Camphor 2%	CAMPHOR (SYNTHETIC)	Amish Origins Management, LLC	437491ca-60ff-4508-b408-f97e7152f638	2024-02-29	Warnings	Exact identifier application number: M017
Amish Origins Topical Analgesic Camphor 2%	CAMPHOR (SYNTHETIC)	Amish Origins Management, LLC	ffe15aed-ea90-4db8-aace-d691a81c05ae	2024-02-29	Warnings	Exact identifier application number: M017
LidoPro Patch	LIDOCAINE, MENTHOL, AND METHYL SALICYLATE	Advanced Rx Pharmacy of Tennessee, LLC	128d0ba9-bc9d-af16-e063-6394a90af5ef	2024-02-29	Warnings	Exact identifier application number: M017
Leader Roll-On Cooling Pain Relief Topical Analgesic	MENTHOL, UNSPECIFIED FORM	Cardinal Health, 110 dba LEADER	e86cba40-6b10-454d-98b3-6b547456eaad	2024-02-29	Warnings	Exact identifier application number: M017
Maximum Strength Scalp Itch Relief Anti-itch	HYDROCORTISONE	Rite Aid	55569563-fc38-4f97-8e74-9f96e3173384	2024-02-28	Warnings	Exact identifier application number: M017
Walgreens Eczema Relief	HYDROCORTISONE ACETATE	Walgreen Co.	4a65a1bf-aa24-4452-9ec3-a28c8bf0e47c	2024-02-28	Warnings	Exact identifier application number: M017
meijer Cold Therapy Pain Relieving analgesic	MENTHOL, UNSPECIFIED FORM	Meijer Distribution, Inc	fb163112-d84d-418d-a410-3214c0ee4b5a	2024-02-28	Warnings	Exact identifier application number: M017
SunBurnt PLUS	LIDOCAINE HYDROCHLORIDE	Quest Products, LLC.	12128c75-015d-8a72-e063-6394a90ae00a	2024-02-23	Warnings	Exact identifier application number: M017
Kroger Analgesic Analgesic	LIDOCAINE HYDROCHLORIDE	THE KROGER CO	e6c5ead3-87d0-48ed-a4dc-86cf89ebb285	2024-02-22	Warnings	Exact identifier application number: M017
Rugby Pain Relieving Analgesic	MENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATE	Bryant Ranch Prepack	fcf48536-224e-4a3d-9124-770031823972	2024-02-22	Warnings	Exact identifier application number: M017
meijer ROLL-ON Cold Therapy Pain Relieving Topical analgesic	MENTHOL, UNSPECIFIED FORM	Meijer Distribution, Inc	8bc3956b-b82d-4ed3-8bc3-db0078466bbc	2024-02-22	Warnings	Exact identifier application number: M017
Promescent Delay Wipes	BENZOCAINE	Absorption	f0a5b6be-acc5-473c-9054-b9534e769db1	2024-02-20	Warnings	Exact identifier application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
84197-867-00	84197086700	90 mL in 1 BOTTLE (84197-867-00)	90 ml	2025-01-24	No	No	Current