FDA.reportPublic FDA data

TheraCare Pain Relieving Menthol Gel

Product NDC
71101-015
11-digit product format
711010015
Labeler code
71101
Product ID
71101-015_40ab4ec2-5e0b-2406-e063-6394a90a83ab
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol 2%
Dosage form
GEL
Route
TOPICAL
Labeler
Veridian Healthcare
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-10-01
Substance
MENTHOL
Active strength
2 g/mL
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
TheraCare Pain Relieving Menthol Gel
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL2 g/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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
311502Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9d2ccb02-746c-4cb9-905d-280987778f4dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71101-015-01TheraCare Pain Relieving Menthol Gel1 in 1 BOXGEL11
71101-015-01TheraCare Pain Relieving Menthol Gel226.8 mL in 1 BOTTLEGEL226.81

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 95 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MUSCLEMENTHOLWATER-JEL TECHNOLOGIES1af399af-07b0-4899-9bcc-1e244b63b1cf2025-04-08WarningsExact identifier
application number: M017
Lidocaine with MentholLIDOCAINE HCL AND MENTHOLKareway Product, Inc.9ee46a5b-d00c-4254-e053-2995a90aeb3a2025-04-08WarningsExact identifier
application number: M017
Foster and Thrive Lidocaine Pain Relief PatchLIDOCAINE 4%Strategic Sourcing Services LLC324802c9-e2c2-bf74-e063-6394a90a86972025-04-08WarningsExact identifier
application number: M017
OARS AND ALPS MUSCLE RECOVERY BALMMENTHOL, METHYL SALICYLATECosco International, Inc8745802f-018d-4cf8-bbf3-3b04c8f545382025-04-08WarningsExact identifier
application number: M017
NOVUM APRMENTHOLNOVUM SOLUTIONS INC1b869a1f-5787-4d03-a546-43a8217b2b2c2025-04-07WarningsExact identifier
application number: M017
MAG 5 PT ROLL-ON PAIN RELIEF COOLINGMENTHOLRENU LABORATORIES, LLC31e4fa2c-3a98-d618-e063-6394a90aec1c2025-04-07WarningsExact identifier
application number: M017
RockSauce FIERY HOT PAIN RELIEFMETHYL SALICYLATE, MENTHOL, CAPSAICINImplus Footcare, LLCcc7cbf4a-8274-e463-e053-2995a90a51e02025-04-07WarningsExact identifier
application number: M017
RockSauce FIERY HOT PAIN RELIEFMETHYL SALICYLATE, MENTHOL, CAPSAICINImplus Footcare, LLCbdee018a-2c3c-3116-e053-2a95a90ac8d82025-04-07WarningsExact identifier
application number: M017
RockSauce FIERY HOT PAIN RELIEFMETHYL SALICYLATE, MENTHOL, CAPSAICINImplus Footcare, LLCbdee2b65-2759-0e62-e053-2a95a90a03782025-04-07WarningsExact identifier
application number: M017
RockSauce ICY COLD PAIN RELIEFMENTHOLImplus Footcare, LLCbdc7c7f3-ac98-8fe9-e053-2a95a90a26632025-04-07WarningsExact identifier
application number: M017
RockSauce ICY COLD PAIN RELIEFMENTHOLImplus Footcare, LLCbd4fdff1-9174-31c2-e053-2a95a90a749f2025-04-07WarningsExact identifier
application number: M017
GREEN GUARD Topical Pain ReliefLIDOCAINE HCIUltra Distributors Incb6f0041c-47fc-0bcd-e053-2a95a90ab1f92025-04-07WarningsExact identifier
application number: M017
CBD Clinic Pain Relief - Level 5MENTHOL, CAMPHORABACUS HEALTH PRODUCTS, INC.f0ebc1c6-93fb-efd6-e053-2995a90a25bb2025-04-07WarningsExact identifier
application number: M017
CBD Clinic Pain Relief - Level 4MENTHOL, CAMPHORABACUS HEALTH PRODUCTS, INC.f0e9ac7c-a840-2e05-e053-2a95a90a33f12025-04-07WarningsExact identifier
application number: M017
CBDMEDIC Active Sport Pain ReliefCAMPHOR AND MENTHOLABACUS HEALTH PRODUCTS, INC.f0ec5f47-2f8e-0558-e053-2a95a90aa7ca2025-04-07WarningsExact identifier
application number: M017
Hot Cold Medicated PatchesHOT COLD MEDICATED PATCHESHenan Enokon Medical Instrument Co., Ltd.159266a8-94fa-e2ff-e063-6394a90a9a772025-04-02WarningsExact identifier
application number: M017
Pain Relief PatchPAIN RELIEF PATCHHenan Enokon Medical Instrument Co., Ltd.1592d29d-e275-a44d-e063-6294a90ab17d2025-04-02WarningsExact identifier
application number: M017
JointflexCAMPHORStrides Consumer LLC766b73f2-67bd-4d5c-805c-1057b3981ebf2025-04-02WarningsExact identifier
application number: M017
Olu Pain ManagementLIDOCAINE AND CAMPHORAsclemed USA, Inc.d4d556c1-b64b-4b8e-8e4b-4f40eda242502025-04-01WarningsExact identifier
application number: M017
Hempvana Maximum Strength Pain Relief Cream 10% Trolamine SalicylateTROLAMINE SALICYLATETELEBRANDS CORP31ce185e-07b7-d837-e063-6394a90a1fb02025-04-01WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311502menthol 2 % Topical GelPSN9d2ccb02-746c-4cb9-905d-280987778f4d1
311502menthol 0.02 MG/MG Topical GelSCD9d2ccb02-746c-4cb9-905d-280987778f4d1
311502menthol 2 % Topical GelSY9d2ccb02-746c-4cb9-905d-280987778f4d1
311502menthol 2 % topical stickSY9d2ccb02-746c-4cb9-905d-280987778f4d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71101-015-01711010015011 BOTTLE in 1 BOX (71101-015-01) / 226.8 mL in 1 BOTTLE1 bottle2025-10-01NoNoCurrent