Icy Hot

Product NDC
62168-0847
11-digit product format
621680847
Labeler code
62168
Product ID
62168-0847_62c6f235-4861-4faf-8273-dbd8a8b23ecc
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
PATCH
Route
TOPICAL
Labeler
Lead Chemical Co., Ltd.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2007-12-01
Substance
MENTHOL, UNSPECIFIED FORM
Active strength
750 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage62168-084762168-0847-5DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 14 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-04-01 02:39 UTC · source 2025-03-3162168-0847-42ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3162168-0847-62ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2862168-0847-4a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2862168-0847-6a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2162168-0847-4cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2162168-0847-6cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1062168-0847-4cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1062168-0847-6cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3162168-0847-4302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2062168-0847-4ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1062168-0847-40efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0862168-0847-4ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0362168-0847-4367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0962168-0847-4557ba5c1ecfa…9c80585c8c6e…

Additional Listing Data#

Finished product
Yes
Brand name base
Icy Hot
Brand name suffix
Medicated, XL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL, UNSPECIFIED FORM750 mg/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
d4e13689-8973-4041-9f33-e710547dcdeeAvailable on FDA.report

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62168-0847-5Icy HotMedicated, XL3 in 1 POUCHPATCH313
62168-0847-5Icy HotMedicated, XL120 in 1 CARTONPATCH12013
62168-0847-7Icy HotMedicated, XL100 in 1 CARTONPATCH10013
62168-0847-7Icy HotMedicated, XL3 in 1 POUCHPATCH313

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3AICY HOT MEDICATED (MENTHOL) PATCH ICY HOT MEDICATED, BACK (MENTHOL) PATCH ICY HOT MEDICATED, XL (MENTHOL) PATCH ICY HOT MEDICATED, ADVANCED RELIEF (MENTHOL) PATCH [LEAD CHEMICAL CO. LTD.]3
MENTHOLACTIVE MOIETYL7T10EIP3AICY HOT MEDICATED (MENTHOL) PATCH ICY HOT MEDICATED, BACK (MENTHOL) PATCH ICY HOT MEDICATED, XL (MENTHOL) PATCH ICY HOT MEDICATED, ADVANCED RELIEF (MENTHOL) PATCH [LEAD CHEMICAL CO. LTD.]3
ALUMINUM HYDROXIDEINACTIVE INGREDIENT5QB0T2IUN0ICY HOT MEDICATED (MENTHOL) PATCH ICY HOT MEDICATED, BACK (MENTHOL) PATCH ICY HOT MEDICATED, XL (MENTHOL) PATCH ICY HOT MEDICATED, ADVANCED RELIEF (MENTHOL) PATCH [LEAD CHEMICAL CO. LTD.]3
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311ICY HOT MEDICATED (MENTHOL) PATCH ICY HOT MEDICATED, BACK (MENTHOL) PATCH ICY HOT MEDICATED, XL (MENTHOL) PATCH ICY HOT MEDICATED, ADVANCED RELIEF (MENTHOL) PATCH [LEAD CHEMICAL CO. LTD.]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXICY HOT MEDICATED (MENTHOL) PATCH ICY HOT MEDICATED, BACK (MENTHOL) PATCH ICY HOT MEDICATED, XL (MENTHOL) PATCH ICY HOT MEDICATED, ADVANCED RELIEF (MENTHOL) PATCH [LEAD CHEMICAL CO. LTD.]3
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9ICY HOT MEDICATED (MENTHOL) PATCH ICY HOT MEDICATED, BACK (MENTHOL) PATCH ICY HOT MEDICATED, XL (MENTHOL) PATCH ICY HOT MEDICATED, ADVANCED RELIEF (MENTHOL) PATCH [LEAD CHEMICAL CO. LTD.]3
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSICY HOT MEDICATED (MENTHOL) PATCH ICY HOT MEDICATED, BACK (MENTHOL) PATCH ICY HOT MEDICATED, XL (MENTHOL) PATCH ICY HOT MEDICATED, ADVANCED RELIEF (MENTHOL) PATCH [LEAD CHEMICAL CO. LTD.]3
METHYL ACRYLATEINACTIVE INGREDIENTWC487PR91HICY HOT MEDICATED (MENTHOL) PATCH ICY HOT MEDICATED, BACK (MENTHOL) PATCH ICY HOT MEDICATED, XL (MENTHOL) PATCH ICY HOT MEDICATED, ADVANCED RELIEF (MENTHOL) PATCH [LEAD CHEMICAL CO. LTD.]3
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPICY HOT MEDICATED (MENTHOL) PATCH ICY HOT MEDICATED, BACK (MENTHOL) PATCH ICY HOT MEDICATED, XL (MENTHOL) PATCH ICY HOT MEDICATED, ADVANCED RELIEF (MENTHOL) PATCH [LEAD CHEMICAL CO. LTD.]3
NONOXYNOL-30INACTIVE INGREDIENTJJX07DG188ICY HOT MEDICATED (MENTHOL) PATCH ICY HOT MEDICATED, BACK (MENTHOL) PATCH ICY HOT MEDICATED, XL (MENTHOL) PATCH ICY HOT MEDICATED, ADVANCED RELIEF (MENTHOL) PATCH [LEAD CHEMICAL CO. LTD.]3
POLYACRYLIC ACID (250000 MW)INACTIVE INGREDIENT9G2MAD7J6WICY HOT MEDICATED (MENTHOL) PATCH ICY HOT MEDICATED, BACK (MENTHOL) PATCH ICY HOT MEDICATED, XL (MENTHOL) PATCH ICY HOT MEDICATED, ADVANCED RELIEF (MENTHOL) PATCH [LEAD CHEMICAL CO. LTD.]3
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQICY HOT MEDICATED (MENTHOL) PATCH ICY HOT MEDICATED, BACK (MENTHOL) PATCH ICY HOT MEDICATED, XL (MENTHOL) PATCH ICY HOT MEDICATED, ADVANCED RELIEF (MENTHOL) PATCH [LEAD CHEMICAL CO. LTD.]3
POLYISOBUTYLENE (1000 MW)INACTIVE INGREDIENT5XB3A63Y52ICY HOT MEDICATED (MENTHOL) PATCH ICY HOT MEDICATED, BACK (MENTHOL) PATCH ICY HOT MEDICATED, XL (MENTHOL) PATCH ICY HOT MEDICATED, ADVANCED RELIEF (MENTHOL) PATCH [LEAD CHEMICAL CO. LTD.]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HICY HOT MEDICATED (MENTHOL) PATCH ICY HOT MEDICATED, BACK (MENTHOL) PATCH ICY HOT MEDICATED, XL (MENTHOL) PATCH ICY HOT MEDICATED, ADVANCED RELIEF (MENTHOL) PATCH [LEAD CHEMICAL CO. LTD.]3
SODIUM POLYACRYLATE (2500000 MW)INACTIVE INGREDIENT05I15JNI2JICY HOT MEDICATED (MENTHOL) PATCH ICY HOT MEDICATED, BACK (MENTHOL) PATCH ICY HOT MEDICATED, XL (MENTHOL) PATCH ICY HOT MEDICATED, ADVANCED RELIEF (MENTHOL) PATCH [LEAD CHEMICAL CO. LTD.]3
SORBITAN SESQUIOLEATEINACTIVE INGREDIENT0W8RRI5W5AICY HOT MEDICATED (MENTHOL) PATCH ICY HOT MEDICATED, BACK (MENTHOL) PATCH ICY HOT MEDICATED, XL (MENTHOL) PATCH ICY HOT MEDICATED, ADVANCED RELIEF (MENTHOL) PATCH [LEAD CHEMICAL CO. LTD.]3
TALCINACTIVE INGREDIENT7SEV7J4R1UICY HOT MEDICATED (MENTHOL) PATCH ICY HOT MEDICATED, BACK (MENTHOL) PATCH ICY HOT MEDICATED, XL (MENTHOL) PATCH ICY HOT MEDICATED, ADVANCED RELIEF (MENTHOL) PATCH [LEAD CHEMICAL CO. LTD.]3
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HICY HOT MEDICATED (MENTHOL) PATCH ICY HOT MEDICATED, BACK (MENTHOL) PATCH ICY HOT MEDICATED, XL (MENTHOL) PATCH ICY HOT MEDICATED, ADVANCED RELIEF (MENTHOL) PATCH [LEAD CHEMICAL CO. LTD.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPICY HOT MEDICATED (MENTHOL) PATCH ICY HOT MEDICATED, BACK (MENTHOL) PATCH ICY HOT MEDICATED, XL (MENTHOL) PATCH ICY HOT MEDICATED, ADVANCED RELIEF (MENTHOL) PATCH [LEAD CHEMICAL CO. LTD.]3
WATERINACTIVE INGREDIENT059QF0KO0RICY HOT MEDICATED (MENTHOL) PATCH ICY HOT MEDICATED, BACK (MENTHOL) PATCH ICY HOT MEDICATED, XL (MENTHOL) PATCH ICY HOT MEDICATED, ADVANCED RELIEF (MENTHOL) PATCH [LEAD CHEMICAL CO. LTD.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62168-0847ICY HOT MEDICATED (MENTHOL) PATCH ICY HOT MEDICATED, XL (MENTHOL) PATCH [LEAD CHEMICAL CO., LTD.]13Current NDC, Legacy NDC, 4 package rows20250425_d4e13689-8973-4041-9f33-e710547dcdee.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Icy Hot MedicatedMENTHOLLead Chemical Co., Ltd.d4e13689-8973-4041-9f33-e710547dcdee2025-04-21WarningsExact identifier
ndc (product): 62168-0847

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
420222menthol 5 % Medicated PatchPSNd4e13689-8973-4041-9f33-e710547dcdee13
420222menthol 0.05 MG/MG Medicated PatchSCDd4e13689-8973-4041-9f33-e710547dcdee13
420222menthol 5 % Medicated PatchSYd4e13689-8973-4041-9f33-e710547dcdee13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62168-0847-262168084702120 POUCH in 1 BOX (62168-0847-2) > 3 PATCH in 1 POUCH (62168-0847-1) 120 pouch2007-12-010000-00-00NoNoCurrent
62168-0847-462168084704100 POUCH in 1 BOX (62168-0847-4) > 4 PATCH in 1 POUCH (62168-0847-3) 100 pouch2011-06-012024-03-31NoNoCurrent
62168-0847-562168084705120 POUCH in 1 CARTON (62168-0847-5) / 3 PATCH in 1 POUCH120 pouch2021-05-172026-07-31NoNoCurrent
62168-0847-762168084707100 POUCH in 1 CARTON (62168-0847-7) / 3 PATCH in 1 POUCH100 pouch2023-09-19NoNoCurrent