Home NDC 84443-487 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 Ingredient Strength MENTHOL 120 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L7T10EIP3A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 672559 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 84443-487-00 MedFreeze Naturally Cool Pain Relief 118 mL in 1 BOTTLE, SPRAY LIQUID 118 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 84443-487 MEDFREEZE NATURALLY COOL PAIN RELIEF (MENTHOL) LIQUID [MEDKO LLC] 1 Current NDC, 1 package rows 20240625_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 108 of 152 · 3,029 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 84443-487-00 84443048700 118 mL in 1 BOTTLE, SPRAY (84443-487-00) 118 ml 2024-05-20 No No Current