MedFreeze Naturally Cool Pain Relief

Product NDC
84443-487
11-digit product format
844430487
Labeler code
84443
Product ID
84443-487_3ed51aab-0364-d97f-e063-6294a90aacd1
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
LIQUID
Route
TOPICAL
Labeler
MEDKO LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-05-20
Substance
MENTHOL
Active strength
120 mg/mL
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
MedFreeze Naturally Cool Pain Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL120 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
672559Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
240f2346-c585-4334-997c-45db6268d7c4Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84443-487-00MedFreeze Naturally Cool Pain Relief118 mL in 1 BOTTLE, SPRAYLIQUID1182

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84443-487MEDFREEZE NATURALLY COOL PAIN RELIEF (MENTHOL) LIQUID [MEDKO LLC]1Current NDC, 1 package rows20240625_240f2346-c585-4334-997c-45db6268d7c4.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 72 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Coralite Muscle and Joint Pain ReliefCAPSACINUnited Exchange Corp.ba9a3d72-db7a-4dd0-9220-f43c9ed871142025-10-21WarningsExact identifier
application number: M017
Coralite Extra Strength Pain Relief Sleeve WristMENTHOLUnited Exchange Corp.ae314478-b8ab-4e90-bd0a-7a882d5c1b2e2025-10-21WarningsExact identifier
application number: M017
Coralite Cold and HotMENTHOLUnited Exchange Corp.85bd7658-e951-7daf-e053-2a91aa0a9f542025-10-21WarningsExact identifier
application number: M017
Family Care Maximum Strength Medicated Anti ItchMENTHOLUnited Exchange Corp.430b5753-3087-4cb1-bf54-0eedc3f4b1d52025-10-21WarningsExact identifier
application number: M017
Family Care Anti-ItchHYDROCORTISONEUnited Exchange Corp.8e4d46d8-7084-0666-e053-2995a90ad5202025-10-21WarningsExact identifier
application number: M017
Coralite Pain ReliefCAMPHOR, MENTHOL, METHYL SALICYLATEUnited Exchange Corp.69aec845-3d4c-d226-e053-2991aa0afd122025-10-21WarningsExact identifier
application number: M017
WHITE FLOWER ANALGESIC BALMCAMPHOR, MENTHOL AND METHYL SALICYLATEHOE HIN PAK FAH YEOW MANUFACTORY LTDf3e3b8b5-b12b-49ac-9318-b0c358b136e92025-10-21WarningsExact identifier
application number: M017
Mountain Ice Sports RecoveryMENTHOLMountainside Medical Equipment, Inc.98638529-3c17-436e-901f-c8aea52bdab62025-10-20WarningsExact identifier
application number: M017
Lip Clear Lysine PlusMENTHOL, UNSPECIFIED FORMQuantum, Inc.21a5b4fb-baed-4766-9820-5c6051c147202025-10-20WarningsExact identifier
application number: M017
Buzz Away Sting SootheMENTHOLQuantum, Inc.419e34ea-17b2-ec32-e063-6394a90a603d2025-10-20WarningsExact identifier
application number: M017
Family Care Anti-ItchHYDROCORTISONEUnited Exchange Corp.deb09e89-9794-89a7-e053-2a95a90abdf82025-10-20WarningsExact identifier
application number: M017
Numbing CreamMENTHOLFlexiGo Inc41571c8f-332b-f423-e063-6394a90a88972025-10-20WarningsExact identifier
application number: M017
Soothing Nerve TherapyMENTHOLWise Consumer Products40829d6b-5005-7ec9-e063-6294a90a970e2025-10-20WarningsExact identifier
application number: M017
Numbing CreamMENTHOLFlexiGo Inc4146fd51-b18c-393d-e063-6294a90a4d9a2025-10-20WarningsExact identifier
application number: M017
Lidocaine 4% Maximum OTC StrengthLIDOCAINECardinal Health 107, LLC975031df-d46d-4098-b1c0-1c0c92b419952025-10-20WarningsExact identifier
application number: M017
Cortizone 10 Intensive HealingHYDROCORTISONEChattem, Inc.bb3d1a3e-4c0c-4694-9c05-80152dd9bd1c2025-10-20WarningsExact identifier
application number: M017
Sting relief padBENZOCAINE, ALCOHOLGuangdong Comfort Medical Products Co., Ltd.6e905065-10a9-1ded-e053-2a91aa0a46a12025-10-19WarningsExact identifier
application number: M017
Elgin Pain ReliefMENTHOLEco-Logics, Inc.375bfe83-c895-3ea7-e054-00144ff88e882025-10-18WarningsExact identifier
application number: M017
Advanced Healing Diabetic Skin CareDIMETHICONEEco-Logics, Inc.c6704d06-0311-406e-98a7-b8c8881aefd52025-10-18WarningsExact identifier
application number: M017
Elgin Pain ReliefMENTHOLEco-Logics, Inc.378d1109-6511-1f63-e054-00144ff88e882025-10-18WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
672559menthol 12 % Topical SprayPSN240f2346-c585-4334-997c-45db6268d7c42
672559menthol 120 MG/ML Topical SpraySCD240f2346-c585-4334-997c-45db6268d7c42
672559menthol 12 % Topical SpraySY240f2346-c585-4334-997c-45db6268d7c42

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84443-487-0084443048700118 mL in 1 BOTTLE, SPRAY (84443-487-00) 118 ml2024-05-20NoNoCurrent