FDA.reportPublic FDA data

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
IngredientStrength
MENTHOL20 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d4d8050e-0761-4491-8635-39c806701eb5Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84197-867-00FlexDermal Pain Relieving Roll-On90 mL in 1 BOTTLELIQUID901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84197-867FLEXDERMAL PAIN RELIEVING ROLL-ON (MENTHOL) LIQUID [SOLVADERM LLC]1Current NDC, 1 package rows20250209_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 110 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ultra Strength Muscle RubCAMPHOR, MENTHOL, METHYL SALICYLATEThe Mentholatum Company32b64985-0e2f-49ee-9840-946d7279fee72024-12-17WarningsExact identifier
application number: M017
CVS Health Cold and Hot Pain Relieving Extra StrengthMENTHOL, METHYL SALICYLATECVS Pharmacy1ca1a631-cb2c-46cd-bd41-05469b08d2082024-12-17WarningsExact identifier
application number: M017
Mentholatum Pain RelievingMENTHOL, METHYL SALICYLATEThe Mentholatum Company0056b952-9870-485a-9f35-f985472875a92024-12-17WarningsExact identifier
application number: M017
Mentholatum Lidocaine HeatLIDOCAINE HCLThe Mentholatum Companycc2ef25a-b569-4d48-a666-899f710b4b342024-12-17WarningsExact identifier
application number: M017
Rite Aid Muscle Rub Ultra StrengthCAMPHOR, MENTHOL, METHYL SALICYLATERite Aid Corporation039fff40-b5ba-42cb-932c-8a70ca92759d2024-12-17WarningsExact identifier
application number: M017
Signature Care Cold and Hot MedicatedMENTHOLSafeway88f59f95-0a7c-458c-949c-0dff16ad94e42024-12-17WarningsExact identifier
application number: M017
Equate Cool and HeatMENTHOL, METHYL SALICYLATEWal-Mart Stores Incc5ab2426-eeca-4ba4-9f00-7790d21764712024-12-17WarningsExact identifier
application number: M017
CVS Health Muscle Rub Ultra StrengthCAMPHOR, MENTHOL, METHYL SALICYLATECVS Pharmacy4fc0d6bb-efa7-40cf-a6d5-e0feaa93c80a2024-12-17WarningsExact identifier
application number: M017
DG Health Maximum Strength Pain Relieving CleansingBENZALKONIUM CL, LIDOCAINE HCLDollar General Corporation64f69315-77a3-49dc-940d-efd7a29c66452024-12-17WarningsExact identifier
application number: M017
ChiggerexBENZOCAINERANDOB LABS, LTD. DBA CROSSINGWELL CONSUMER HEALTH5e5d84ab-f57f-448d-a4c1-ced38890eec22024-12-17WarningsExact identifier
application number: M017
DerMend Moisturizing Anti-ItchPRAMOXINE HYDROCHLORIDEFerndale Laboratories, Inc.14c7fb1c-a310-4b12-ab2e-7f1c0801995c2024-12-17WarningsExact identifier
application number: M017
Hydrocortisone 1%HYDROCORTISONEGeri-Care Pharmaceuticals, Corpfd67566a-1076-019d-e053-6394a90a415c2024-12-17WarningsExact identifier
application number: M017
Extra StrengthMENTHOL AND METHYL SALICYLATENATURES FORMULAE HEALTH PRODUCTS LTD.d919b50a-5de2-1830-e053-2a95a90ab88d2024-12-17WarningsExact identifier
application number: M017
Cold and Heat Lidocaine Patch Plus MentholLIDOCAINE, MENTHOLWalgreen Company1f262473-3f3c-4f3f-b507-590d06ff69a92024-12-17WarningsExact identifier
application number: M017
Pain Relief PatchesCAMPHOR, MENTHOL, METHYL SALICYLATEWalgreen Companydb8cf218-7544-4871-b1c3-a50a3d3e59f12024-12-17WarningsExact identifier
application number: M017
Albertsons Pain Relief PatchLIDOCAINESafewaydc2823bb-8586-daca-e053-2995a90a2af02024-12-17WarningsExact identifier
application number: M017
CAPSAICIN HEAT PATCHES BACK AND LARGE AREASCAPSAICINWalgreen Companye77167ab-6cb8-4d5b-838c-b0acc05e38892024-12-17WarningsExact identifier
application number: M017
Hot and Cold Medicated PatchMENTHOLWalgreen Companyd9fc133d-ebaa-48f1-a6f9-62453970012b2024-12-17WarningsExact identifier
application number: M017
PAIN RELIEF PATCHESLIDOCAINEWalgreen Company204b96bc-af4e-4842-8b57-7b416feb4dd92024-12-17WarningsExact identifier
application number: M017
Lidocaine DryLIDOCAINECVSbb7955fe-5113-1662-e053-2a95a90a85a12024-12-16WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84197-867-008419708670090 mL in 1 BOTTLE (84197-867-00) 90 ml2025-01-24NoNoCurrent