FDA.reportPublic FDA data

ICY FREEZE

Product NDC
66902-168
Requested package NDC
66902-168-40
11-digit product format
669020168
Labeler code
66902
Product ID
66902-168_3b4fa787-26ca-8c7a-e063-6294a90ad49e
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol, unspecified form
Dosage form
SPRAY
Route
TOPICAL
Labeler
Natural Essentials, Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-05-14
Substance
MENTHOL, UNSPECIFIED FORM
Active strength
100 mg/mL
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 FREEZE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL, UNSPECIFIED FORM100 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
667889Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
28fdb049-b297-4358-9447-7d69ba879702Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66902-168-40ICY FREEZE120 mL in 1 CANSPRAY1203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66902-168ICY FREEZE (MENTHOL, UNSPECIFIED FORM) SPRAY [NATURAL ESSENTIALS, INC.]2Current NDC, Legacy NDC, 1 package rows20241006_28fdb049-b297-4358-9447-7d69ba879702.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 52 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Blue-Emu THRIVE CoolingTRIPELENNAMINE 0.5%Kingsway Pharmaceuticals dba NFI, LLC7ac6456a-42c5-4ac8-aae6-db4abfda9df02025-12-22WarningsExact identifier
application number: M017
MENTHOLMENTHOLSUNSET PAIN RELIEF45c5ca6f-d425-6cfb-e063-6394a90a1b662025-12-20WarningsExact identifier
application number: M017
HERSTAT GST Genital Sore TreatmentCAMPHOR, MENTHOLHerstat (USA) Inc.e8d27684-fb15-2e6a-e053-2a95a90a248f2025-12-19WarningsExact identifier
application number: M017
Kroger Anti ItchHYDROCORTISONEThe Kroger Co46547277-f11a-b9e7-e063-6294a90a2ccd2025-12-19WarningsExact identifier
application number: M017
Kroger Cool and Heat Roll-OnMENTHOLKroger46551d07-3006-c3ec-e063-6294a90aa3f22025-12-19WarningsExact identifier
application number: M017
Naughty Kitty KatNO GAG DEEP THROAT SPRAYINKED SUGAR, INC170eb644-c72c-5744-e063-6394a90a767d2025-12-19WarningsExact identifier
application number: M017
Tiger Balm Red Extra StrengthCAMPHOR (SYNTHETIC) AND MENTHOLHaw Par Healthcare Ltd.ce703715-4c11-472c-9270-daac87b7be052025-12-19WarningsExact identifier
application number: M017
Aspercreme with Lidocaine Foot Pain CremeLIDOCAINE HYDROCHLORIDEChattem, Inc.da82cc0e-cc39-408e-87e1-c35bb6f9f51e2025-12-19WarningsExact identifier
application number: M017
Health Trak Plus Menthol-Infused Pain Relief SocksMENTHOLRailroad Sock LLC43413e55-1db2-fc1a-e063-6394a90a71672025-12-18WarningsExact identifier
application number: M017
BIO-ICEMENTHOL, CAMPHORElectrostim Medical Services Inc. d/b/a EMSI1bfd1468-9139-43b1-9709-d47b63d17cfb2025-12-18WarningsExact identifier
application number: M017
LidotrodeLIDOCAINEStrand Health Group1fd20b9a-b8bc-c94f-e063-6394a90a2b692025-12-18WarningsExact identifier
application number: M017
A Health Itch Relief GelITCH RELIEF GELBionpharma, Inc.ecf5decb-c98b-7739-e053-2995a90a55412025-12-18WarningsExact identifier
application number: M017
After Burn2.5% LIDOCAINE HCLTender Corporation d/b/a Adventure Ready Brands4640395f-a76c-d022-e063-6294a90adde62025-12-18WarningsExact identifier
application number: M017
SPARTAN WIPESENDURANCE WIPESTIV PRIME SRL26d02431-2c95-001c-e063-6394a90a29c72025-12-18WarningsExact identifier
application number: M017
Stopain Extra Strength ContinuousMENTHOLTroy Manufacturing, Inc.a0f76968-d22c-4b1c-a9e6-8d0179a2e98e2025-12-18WarningsExact identifier
application number: M017
ZIMS MAX FREEZELIDOCAINE HYDROCHLORIDE AND MENTHOL,KOBAYASHI Healthcare International, Inc.e364ff83-4aaf-4897-a7da-06581bc321f22025-12-18WarningsExact identifier
application number: M017
Tiger Balm White Regular StrengthCAMPHOR (SYNTHETIC) AND MENTHOLHaw Par Healthcare Ltd.f406161e-a9c4-47d1-8b21-93b1b79380632025-12-17WarningsExact identifier
application number: M017
ResinolPETROLATUM AND RESORCINOLResiCal, Inc.03f57a4a-f94b-4ba6-b709-41cfb6e162612025-12-17WarningsExact identifier
application number: M017
HealthWise Maximum Pain ReliefLIDOCAINEVeridian Healthcareafc3c16d-0076-44b2-ae7e-5f36d4d8088e2025-12-17WarningsExact identifier
application number: M017
HealthWise Max Lidocaine plus MentholLIDOCAINE, MENTHOLVeridian Healthcaref39a27da-6799-4fc6-97ca-101eac4a93602025-12-17WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
667889menthol 10 % Topical SprayPSN28fdb049-b297-4358-9447-7d69ba8797023
667889menthol 100 MG/ML Topical SpraySCD28fdb049-b297-4358-9447-7d69ba8797023
667889menthol 10 % Topical SpraySY28fdb049-b297-4358-9447-7d69ba8797023

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66902-168-4066902016840120 mL in 1 CAN (66902-168-40) 120 ml2020-05-140000-00-00NoNoCurrent