Cold Hot Medicated Patch 5% Menthol

Product NDC
71811-005
11-digit product format
718110005
Labeler code
71811
Product ID
71811-005_34779952-9daf-c107-e063-6294a90a5c8b
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
PATCH
Route
TOPICAL
Labeler
InterMed Laboratories Private Limited
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-04-29
Substance
MENTHOL
Active strength
5 g/1
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
Cold Hot Medicated Patch 5% Menthol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL5 g/1

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
420222Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
33ee0235-5a6e-0ea1-e063-6394a90a89a5Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71811-005-05Cold Hot Medicated Patch 5% Menthol1 in 1 POUCHPATCH12
71811-005-05Cold Hot Medicated Patch 5% Menthol5 in 1 BOXPATCH52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71811-005COLD HOT MEDICATED PATCH 5% MENTHOL (MENTHOL) PATCH [INTERMED LABORATORIES PRIVATE LIMITED]2Current NDC, 2 package rows20250507_33ee0235-5a6e-0ea1-e063-6394a90a89a5.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 123 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ZYLOTROL PAIN RELIEVINGLIDOCAINE HCL, MENTHOLAsclemed USA, Inc.1553351c-aee8-4c40-9548-35cce246bda92024-10-25WarningsExact identifier
application number: M017
OutgroBENZOCAINEMedtech Products Inc.d6be8a1d-aca7-42b1-86da-881d42ffe8d52024-10-25WarningsExact identifier
application number: M017
Monistat Complete Care Instant Itch ReliefHYDROCORTISONEInsight Pharmaceuticals LLCa0f40504-6183-4f32-8d17-6586b3f386a62024-10-25WarningsExact identifier
application number: M017
Boil EaseBENZOCAINEInsight Pharmaceuticals LLCbf108934-5e1a-4059-9dcf-008f52a83fab2024-10-25WarningsExact identifier
application number: M017
Dermarest Eczema MedicatedHYDROCORTISONEInsight Pharmaceuticals LLC0292ab62-5088-45fa-a056-70c2fcc19ef72024-10-25WarningsExact identifier
application number: M017
anti itchHYDROCORTISONEMeijer, Inc.2db7bcab-acb8-48ad-8cd1-842ff7765ed92024-10-23WarningsExact identifier
application number: M017
NATUREANCE MIRACLEMENTHOLEROS GLOBAL CORPec1a2a1f-a38d-9c59-e053-2a95a90ad2682024-10-23WarningsExact identifier
application number: M017
Profoot Plantar Relief StripsCAMPHOR (NATURAL), MENTHOL, METHYL SALICYLATERooftop Consumer Health, Inc.65e142d8-da21-4c55-9faf-b387cb6c2c0e2024-10-23WarningsExact identifier
application number: M017
Profoot Pain Relief PatchesCAMPHOR, MENTHOL, METHYL SALICYLATERooftop Consumer Health, Inc.cc011b79-2761-40f7-8142-88f8e30a179a2024-10-23WarningsExact identifier
application number: M017
Profoot Pain Relief PatchesCAMPHOR, MENTHOL, METHYL SALICYLATEProfoot, Inc.06f82bde-41a1-35f6-e063-6394a90a64372024-10-23WarningsExact identifier
application number: M017
Deep Cover Bug Bite ReliefBENZOCAINEMorrisons Outdoors, LLC25010dd6-fb48-8ee7-e063-6394a90aee6c2024-10-21WarningsExact identifier
application number: M017
Evel Knievels Natural Choice Pain ReliefMENTHOL, UNSPECIFIED FORMNatural Essentials, Inc.4576656c-4b6e-6965-7665-6c52756c65732024-10-21WarningsExact identifier
application number: M017
berkley and jensen anti itchHYDROCORTISONEBJWC5cc6e4f6-c62d-4923-9726-9dbc569a3f492024-10-19WarningsExact identifier
application number: M017
DG Health Hydrocortisone Maximum StrengthHYDROCORTISONEDolgencorp Inc2cc792b8-dce6-4178-bd6d-63ba268b77472024-10-19WarningsExact identifier
application number: M017
Careland Hydrogel Pain Relief PatchesLIDOCAINE, MENTHOLPlanet (Anhui) Pharmaceutical Co., Ltd.e970070c-1c3b-49f0-8298-e6c5ebbf50a02024-10-18WarningsExact identifier
application number: M017
Fruit of the Earth Cool Blue Aloe Mist ContinuousLIDOCAINE HYDROCHLORIDEFruit Of The Earth, Inc.d4caae4c-efba-2453-e053-2995a90a5e5f2024-10-18WarningsExact identifier
application number: M017
CVS Health Sunburn Relief Cooling Lidocaine 0.5 Pain-RelievingLIDOCAINE HCLCVS Pharmacyf0f1969d-10e0-76ee-e053-2995a90a73362024-10-17WarningsExact identifier
application number: M017
Wong To Yick External AnalgesicCAMPHOR MENTHOL METHYL SALICYLATEWong To Yick Wood Lock Ointment Ltd16a21af4-6bc0-4ae1-aa3b-1da84c8286e22024-10-17WarningsExact identifier
application number: M017
Wong To Yick External AnalgesicCAMPHOR MENTHOL METHYL SALICYLATEWicsun Trading Inc0b4bd444-b3c1-47aa-a7e3-f16c923261242024-10-17WarningsExact identifier
application number: M017
Fruit of the Earth Sun Town City Aloe Vera After Sun with Lidocaine HCLLIDOCAINEFruit of the Earth, Inc.c7a833bd-7457-73a3-e053-2a95a90ac53f2024-10-17WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
420222menthol 5 % Medicated PatchPSN33ee0235-5a6e-0ea1-e063-6394a90a89a52
420222menthol 0.05 MG/MG Medicated PatchSCD33ee0235-5a6e-0ea1-e063-6394a90a89a52
420222menthol 5 % Medicated PatchSY33ee0235-5a6e-0ea1-e063-6394a90a89a52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71811-005-05718110005055 POUCH in 1 BOX (71811-005-05) / 1 PATCH in 1 POUCH5 pouch2025-04-29NoNoCurrent