Home NDC 54633-414 K2 Cold Therapy
Product NDC 54633-414
11-digit product format 546330414
Labeler code 54633
Product ID 54633-414_47e35d17-8734-e55a-e063-6294a90a82ee
Type HUMAN OTC DRUG
Nonproprietary name Menthol
Dosage form LIQUID
Route TOPICAL
Labeler The Podiatree Co
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2014-05-06
Substance MENTHOL
Active strength 10 g/100mL
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 K2 Cold Therapy
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 10 g/100mL
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 259249 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 54633-414-03 K2 Cold Therapy 88.72 mL in 1 BOTTLE, WITH APPLICATOR LIQUID 88.72 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54633-414 K2 COLD THERAPY (MENTHOL) LIQUID [THE PODIATREE CO] 3 Current NDC, Legacy NDC, 1 package rows 20180110_60dce1ad-125e-396d-e053-2a91aa0a670f.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 18 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 Marketing end Sample Exclude flag Status 54633-414-03 54633041403 88.72 mL in 1 BOTTLE, WITH APPLICATOR (54633-414-03) 88.72 ml 2014-05-06 0000-00-00 No No Current