FDA.reportPublic FDA data

Icy Hot

Product NDC
62168-1720
Requested package NDC
62168-1720-2
11-digit product format
621681720
Labeler code
62168
Product ID
62168-1720_2ce5d809-4f1b-45b9-93f5-3fcd41b9ed34
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine, Menthol
Dosage form
PATCH
Route
TOPICAL
Labeler
Lead Chemical Co. Ltd.
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-01-15
Substance
LIDOCAINE; MENTHOL, UNSPECIFIED FORM
Active strength
240; 60 mg/1; mg/1
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
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
Icy Hot
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE240 mg/1
MENTHOL, UNSPECIFIED FORM60 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
98PI200987Internal UNII lookup
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
1830c5ce-60e2-40e7-96cb-c5f7b9357ae5Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62168-1720-2Icy Hot1 in 1 POUCHPATCH16
62168-1720-2Icy Hot400 in 1 CARTONPATCH4006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62168-1720ICY HOT (LIDOCAINE, MENTHOL) PATCH [LEAD CHEMICAL CO. LTD.]6Current NDC, Legacy NDC, 2 package rows20240119_1830c5ce-60e2-40e7-96cb-c5f7b9357ae5.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 HotLIDOCAINE, MENTHOLLead Chemical Co. Ltd.1830c5ce-60e2-40e7-96cb-c5f7b9357ae52024-01-02WarningsExact identifier
ndc (package): 62168-1720-2
ndc (product): 62168-1720
ndc11 (package): 62168172002

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62168-1720-262168172002400 POUCH in 1 CARTON (62168-1720-2) / 1 PATCH in 1 POUCH400 pouch2021-05-100000-00-00NoNoCurrent