FDA.reportPublic FDA data

Icy Hot

Product NDC
62168-0853
11-digit product format
621680853
Labeler code
62168
Product ID
62168-0853_911ddb13-82db-4388-9693-368d35b0707c
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
2021-05-19
Substance
MENTHOL, UNSPECIFIED FORM
Active strength
428.5 mg/1
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
Icy Hot
Brand name suffix
Medicated, Back
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL, UNSPECIFIED FORM428.5 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
03d36a89-d055-4cff-aa9f-f8de25c57f77Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62168-0853-1Icy HotMedicated, Back100 in 1 CARTONPATCH1004
62168-0853-1Icy HotMedicated, Back5 in 1 POUCHPATCH54
62168-0853-2Icy HotMedicated, Back1 in 1 POUCHPATCH14
62168-0853-2Icy HotMedicated, Back240 in 1 CARTONPATCH2404

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62168-0853ICY HOT MEDICATED, BACK (MENTHOL) PATCH [LEAD CHEMICAL CO., LTD.]4Current NDC, Legacy NDC, 4 package rows20250426_03d36a89-d055-4cff-aa9f-f8de25c57f77.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 Medicated, BackMENTHOLLead Chemical Co., Ltd.03d36a89-d055-4cff-aa9f-f8de25c57f772026-06-30WarningsExact identifier
ndc (product): 62168-0853

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
420222menthol 5 % Medicated PatchPSN03d36a89-d055-4cff-aa9f-f8de25c57f774
420222menthol 0.05 MG/MG Medicated PatchSCD03d36a89-d055-4cff-aa9f-f8de25c57f774
420222menthol 5 % Medicated PatchSY03d36a89-d055-4cff-aa9f-f8de25c57f774

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62168-0853-162168085301100 POUCH in 1 CARTON (62168-0853-1) / 5 PATCH in 1 POUCH100 pouch2021-05-190000-00-00NoNoCurrent
62168-0853-262168085302240 POUCH in 1 CARTON (62168-0853-2) / 1 PATCH in 1 POUCH240 pouch2021-06-280000-00-00NoNoCurrent