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 128 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AVON footworks Maximum Strength Cracked Heel	BENZALKONIUM CHLORIDE, LIDOCAINE	The Avon Company	1f45752e-4a55-431e-e063-6294a90aa57a	2024-08-01	Warnings	Exact identifier application number: M017
Relief	MENTHOL	La Mend, Inc.	1f92de3a-7180-5884-e063-6294a90aebf5	2024-08-01	Warnings	Exact identifier application number: M017
Meijer Medicated Foot Powder	MENTHOL	Meijer Distribution	07ec6c20-73c4-e5e4-e063-6294a90a7e55	2024-07-29	Warnings	Exact identifier application number: M017
Ralli Rapid Pain Relief	MENTHOL	Troy Manufacturing, Inc.	e05ec3b7-e9ab-4eaa-8518-86304336697c	2024-07-29	Warnings	Exact identifier application number: M017
Walgreens Roll-On	CAPSAISIN 0.1%	Walgreens Co	1e65bf31-15c7-5e6a-e063-6394a90ac956	2024-07-29	Warnings	Exact identifier application number: M017
Camphotrex	CAMPHOR, MENTHOL	PureTek Corporation	3b6c6eef-e92d-497d-afe8-82356637c2b8	2024-07-26	Warnings	Exact identifier application number: M017
Camphotrol	CAMPHOR, MENTHOL	PureTek Corporation	ccac9f37-a374-4765-e053-2a95a90ad2f7	2024-07-26	Warnings	Exact identifier application number: M017
Real Time Pain Relief Foot	MENTHOL	Real Time Products Inc.	29c8e06d-9b29-44f9-ac21-9160d06475cb	2024-07-24	Warnings	Exact identifier application number: M017
Capsaicin 0.075 Percent	CAPSAICIN	Alexso, Inc	33d2a9cd-0ca1-4e19-8b7a-f899f1205cbd	2024-07-22	Warnings	Exact identifier application number: M017
TIDL Pain Relief CRYO Therapy Limited Edition	PAIN RELIEF CRYO THERAPY LIMITED EDITION	Shenzhen Sam Technology Co., Ltd.	1d966b67-fd9c-eab6-e063-6294a90aa75e	2024-07-19	Warnings	Exact identifier application number: M017
Fruit of the Earth Aloe Vera Cool Blue	LIDOCAINE HYDROCHLORIDE	Fruit of the Earth, Inc.	1d65bc34-2bc2-4f52-a9b3-1cb08324eb79	2024-07-19	Warnings	Exact identifier application number: M017
Ultra Balm	MENTHOL AND METHYL SALICYLATE	Ling Nam Medicine Factory (H.K.) Ltd.	de997baf-aa04-474e-b912-3fc67e720d0b	2024-07-19	Warnings	Exact identifier application number: M017
Ling Nam Hak Kwai Oil	TURPENTINE OIL	Ling Nam Medicine Factory (H.K.) Ltd.	3f16cce3-366f-41f3-8829-6de4082a8c19	2024-07-19	Warnings	Exact identifier application number: M017
Koong Yick Hak Kwai Oil	TURPENTINE OIL	Ling Nam Medicine Factory (H.K.) Ltd.	bc33e185-3b42-98b5-e053-2995a90a6308	2024-07-18	Warnings	Exact identifier application number: M017
Koong Yick Hung Fa	METHYL SALICYLATE	Ling Nam Medicine Factory (H.K.) Ltd.	9c8a121d-6da2-4435-a2d7-a0b71d10740d	2024-07-18	Warnings	Exact identifier application number: M017
Ling Nam Hung Far	METHYL SALICYLATE	Ling Nam Medicine Factory (H.K.) Ltd.	b6916b6e-b7eb-1eb7-e053-2995a90ae6fb	2024-07-18	Warnings	Exact identifier application number: M017
itch relief	DIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE	Bionpharma Inc.	178ed513-4f22-8f11-e063-6294a90a109b	2024-07-16	Warnings	Exact identifier application number: M017
POWERECT Benzocaine Male Delay Gel	BENZOCAINE	SKINS SEXUAL HEALTH LIMITED	2fafe1f2-a31e-4b2a-bc51-81e16b319c3a	2024-07-16	Warnings	Exact identifier application number: M017
SKINS DELAY Climax Control Benzocaine Gel	BENZOCAINE	SKINS SEXUAL HEALTH LIMITED	53730576-2609-4f28-8bfa-a1ceea698b83	2024-07-16	Warnings	Exact identifier application number: M017
TIDL PAIN RELIEF CRYO THERAPY Unscented formula Spray.	PAIN RELIEF CRYO THERAPY UNSCENTED FORMULA SPRAY	Shenzhen Sam Technology Co., Ltd.	1d1a0346-3b00-4803-e063-6294a90aec6d	2024-07-13	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