Thera Plus Cold Therapy Pain Relieving Menthol

Product NDC
80684-101
11-digit product format
806840101
Labeler code
80684
Product ID
80684-101_0b23e32c-9248-271c-e063-6294a90a1f5c
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
GEL
Route
TOPICAL
Labeler
Fourstar Group USA, Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-02-01
Substance
MENTHOL
Active strength
40 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
Thera Plus Cold Therapy Pain Relieving Menthol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL40 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 RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
415974Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0a462c91-5300-e282-e063-6394a90a4cc2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80684-101-00Thera Plus Cold Therapy Pain Relieving Menthol74 mL in 1 BOTTLEGEL742

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80684-101THERA PLUS COLD THERAPY PAIN RELIEVING MENTHOL (MENTHOL) GEL [FOURSTAR GROUP USA, INC.]2Current NDC, 1 package rows20240201_0a462c91-5300-e282-e063-6394a90a4cc2.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 36 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Numbsure LIDOCAINELIDOCAINE 4%Hambli Limited43a65a12-ef2a-4608-e063-6394a90a82ea2026-01-31WarningsExact identifier
application number: M017
Collajoint Lidocaine Pain Relief Gel PatchLIDOCAINE PAIN RELIEF GEL PATCHHenan Enokon Medical Instrument Co., Ltd.44e27e7f-992f-d194-e063-6294a90a94e42026-01-31WarningsExact identifier
application number: M017
CAPSAICIN HEAT PatchCAPSAICIN HEAT PATCHHenan Enokon Medical Instrument Co., Ltd.49ac2045-2c07-af9a-e063-6294a90a052a2026-01-31WarningsExact identifier
application number: M017
COLD AND HOT MEDICATED PatchCOLD AND HOT MEDICATED PATCHHenan Enokon Medical Instrument Co., Ltd.49ac6a7b-25d3-6dc4-e063-6394a90a99b62026-01-31WarningsExact identifier
application number: M017
COLD AND HOT MEDICATED PatchCOLD AND HOT MEDICATED PATCHHenan Enokon Medical Instrument Co., Ltd.49aca763-be2a-cf38-e063-6294a90a092e2026-01-31WarningsExact identifier
application number: M017
PAIN RELIEF HOT PatchPAIN RELIEF HOT PATCHHenan Enokon Medical Instrument Co., Ltd.49ad128a-0f4c-085a-e063-6294a90ac9bb2026-01-31WarningsExact identifier
application number: M017
Walgreens Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLWalgreen Company3557d2e9-714a-4066-aa73-ea9e3363e5742026-01-30WarningsExact identifier
application number: M017
Alveora HEMORRHOID MASTERLIDOCAINE 4% PHENYLEPHRINE HCL 0.25% HEMORRHOID MASTERJiangxi Yudexi Pharmaceutical Co., LTD4996f96a-898e-de01-e063-6394a90a39072026-01-30WarningsExact identifier
application number: M017
Sunburn ReliefLIDOCAINE HCL 0.5%Rite Aid Corporationb67af0c7-1ae8-4494-bb0e-d7f66ebca3522026-01-30Warnings, Adverse reactionsExact identifier
application number: M017
Drs Pharmacy PAIN RELIEF MUSCLE ARITHRITISCAPSAICINOL PHARMA TECH,LLC48fdf9dc-05df-866d-e063-6294a90ae03a2026-01-30WarningsExact identifier
application number: M017
ROCKTAPE GO Kinesiology Tape and AnalgesicMENTHOL, METHYL SALICYLATEImplus Footcare, LLCb779c7d8-dbe6-472f-9282-6cced25cfd2e2026-01-29WarningsExact identifier
application number: M017
RockSauce Warming MassageMENTHOL, METHYL SALICYLATEImplus Footcare, LLCde5f7add-1f2b-438a-ac17-753ebb53e6972026-01-29WarningsExact identifier
application number: M017
RockSauce Warming Massage Roll-OnMENTHOL, METHYL SALICYLATEImplus Footcare, LLC5a2d9c3a-67fc-4c1a-b1e8-62a93880397a2026-01-29WarningsExact identifier
application number: M017
Analgesic Dr. ColladoMENTHOL, METHYL SALICYLATELaboratorios Dr. Collado, S.Ac0dad2db-7c96-49b8-a451-bf8cfa7f798b2026-01-29WarningsExact identifier
application number: M017
RockSauce Warming MassageMENTHOL, METHYL SALICYLATEImplus Footcare, LLC3121c7f7-d7e5-4ca9-9057-03edf9c94c562026-01-29WarningsExact identifier
application number: M017
Analgesic Gel Dr. Collado Menthol 4 Methyl SalicylateMENTHOL, METHYL SALICYLATELaboratorios Dr. Collado, S.A.87c22e6f-3ab0-47c3-94ea-48b3d1a95d9d2026-01-29WarningsExact identifier
application number: M017
ProCure Hydrocortisone Cream PlusHYDROCORTISONERooftop Consumer Health, Inc.fe334cae-e019-4397-8498-df3c923ae8b52026-01-29WarningsExact identifier
application number: M017
Red Oil Pain ReliefCAMPHOR (SYNTHETIC), MENTHOL, PHENOLThe Red Oil Company Inc1e36579a-72da-46ba-ac72-5960a11c08802026-01-29WarningsExact identifier
application number: M017
Extra Strength BalmCAPSICUM, MENTHOLNATURES FORMULAE HEALTH PRODUCTS LTD.498a5e2a-4de0-561c-e063-6394a90ac05c2026-01-29WarningsExact identifier
application number: M017
MENTHOL, CAMPHORMENTHOL, CAMPHORSUNSET POTENT PAIN RELIEF45c76956-db3f-3e84-e063-6394a90adce12026-01-29WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
415974menthol 4 % Topical GelPSN0a462c91-5300-e282-e063-6394a90a4cc22
415974menthol 0.04 MG/MG Topical GelSCD0a462c91-5300-e282-e063-6394a90a4cc22
415974menthol 4 % Topical GelSY0a462c91-5300-e282-e063-6394a90a4cc22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80684-101-008068401010074 mL in 1 BOTTLE (80684-101-00) 74 ml2024-02-01NoNoCurrent