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 103 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Arthritis Hot	MENTHOL AND METHYL SALICYLATE	Chattem, Inc.	cc57b9b6-8ba5-4ff3-a5df-97d8f5b1bebd	2025-01-13	Warnings	Exact identifier application number: M017
Re-Lieved Lidocaine Patch	LIDOCAINE PATCH 4%	Transfer Technology	00b40dda-53ad-0458-e063-6394a90aa835	2025-01-11	Warnings	Exact identifier application number: M017
Re-Lieved Lidocaine Patch	LIDOCAINE PATCH 4%	Transfer Technology	00b47eb7-6b43-d9e2-e063-6294a90a9a38	2025-01-11	Warnings	Exact identifier application number: M017
Re-Lieved 4% Lidocaine Fabric Tape	LIDOCAINE 4% FABRIC TAPE	Transfer Technology	e9a894b0-54f2-707e-e053-2a95a90a0f0d	2025-01-11	Warnings	Exact identifier application number: M017
Re-Lieved 3 in 1 Patch	MENTHOL, CAMPHOR, METHYL SALICYLATE PATCH	Transfer Technology	e9ab9a03-b9e3-7317-e053-2995a90a9950	2025-01-11	Warnings	Exact identifier application number: M017
ASTRAPHARM CHILLI BRAND	CAPSAICIN	Dersan Pharmaceutical Co., Ltd	b4c2d4fd-7d5d-4156-ac27-e72ebc9671ec	2025-01-10	Warnings	Exact identifier application number: M017
LABOFLEX Lidocaine Pain Relieving Patch	LIDOCAINE 4%	Laboflex, Inc.	31995f31-c272-afdb-e063-6294a90af3f9	2025-01-10	Warnings	Exact identifier application number: M017
Anti-Itch Cream	DIPHENHYDRAMINE HYDROCHLORIDE 2%, ZINC ACETATE 0.1%	Chain Drug Marketing Association Inc.	2b48cb2f-e6bf-f9de-e063-6394a90a42d4	2025-01-09	Warnings	Exact identifier application number: M017
PAIN-X	MENTHOL	OL PHARMA TECH,LLC	b22bb19a-14e5-3d32-e053-2a95a90ae520	2025-01-09	Warnings	Exact identifier application number: M017
MUSCLE RUB	MENTHOL	OL PHARMA TECH,LLC	b22c7999-52d5-25c3-e053-2a95a90a01f5	2025-01-09	Warnings	Exact identifier application number: M017
Biofreeze Professional Colorless Roll-On	MENTHOL, UNSPECIFIED FORM	A-S Medication Solutions	ce392c4f-cc43-484d-9c49-18fa25e4e5e9	2025-01-09	Warnings	Exact identifier application number: M017
NEW TEROCIN	METHYL SALICYLATE, CAPSAICIN, AND MENTHOL	A-S Medication Solutions	43e5eb27-5541-4b7b-80de-55a79a4dce55	2025-01-09	Warnings	Exact identifier application number: M017
Biofreeze Professional	MENTHOL, UNSPECIFIED FORM	A-S Medication Solutions	cbeac814-59d8-4c13-8e73-bca66f797f8d	2025-01-09	Warnings	Exact identifier application number: M017
Bactine Max	LIDOCAINE	WellSpring Pharmaceutical Corporation	acd7ae37-7c42-4ec7-a2ef-42e7f628388d	2025-01-08	Warnings	Exact identifier application number: M017
THERABLAST MAXIMUM RELIEF	LIDOCAINE, MENTHOL	Releaf Technologies LLC	09809985-3a88-9bb7-e063-6394a90a2f5f	2025-01-08	Warnings	Exact identifier application number: M017
ANTI ITCH	HYDROCORTISONE	Safeway	0bfa1653-76b7-48ed-a896-a0b5fc3bd794	2025-01-08	Warnings	Exact identifier application number: M017
Sting Relief Swab	BENZOCAINE	Epic Medical Supply Corp	259fbfe4-d67c-ea1e-e063-6294a90a0fb0	2025-01-07	Warnings	Exact identifier application number: M017
Sinsin Mulpas	CAMPHOR, MENTHOL, METHYL SALICYLATE	Sinsin Pharmaceutical Co., Ltd.	22ea8a51-fdee-4650-abf8-f996268c9303	2025-01-07	Warnings	Exact identifier application number: M017
SINSINPAP COOL	LEVOMENTHOL, THYMOL, CAMPHOR, MENTHA, EUCALYPTUS	Sinsin Pharmaceutical Co., Ltd.	9d47855f-ccb5-4557-a31a-a2b336fa9806	2025-01-07	Warnings	Exact identifier application number: M017
Burn Jel	LIDOCAINE HYDROCHLORIDE	Water-Jel Technologies	ff621b46-2342-41db-994d-851a09796d08	2025-01-06	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