Home NDC 0395-9131 Hot/Cold Menthol 16% Roll-On
Product NDC 0395-9131
11-digit product format 003959131
Labeler code 0395
Product ID 0395-9131_0c93883b-eed9-0f96-e063-6394a90ae9aa
Type HUMAN OTC DRUG
Nonproprietary name Hot/Cold Menthol 16% Roll-On
Dosage form LIQUID
Route TOPICAL
Labeler Humco Holding Group, Inc
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-12-21
Substance MENTHOL
Active strength 16 mg/100mL
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings When using this product: use only as directed. Do not bandage tightly or use with a heating pad. Avoid contact with eyes and mucous membranes. Do not apply to wounds or damaged, broken or irritated skin. If you experience pain, swelling, or blistering of the skin where an OTC topical muscle and joint pain reliever was applied, stop using the product and seek professional attention immediately. These products produce local warmth or coolness.
Additional Listing Data#
Finished product Yes
Brand name base Hot/Cold Menthol 16% Roll-On
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 16 mg/100mL
Harmonized Identifiers# Field, Values table Field Values Unii L7T10EIP3A
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0395-9131-97 Hot/Cold Menthol 16% Roll-On 74 mL in 1 CONTAINER LIQUID 74 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0395-9131 HOT/COLD MENTHOL 16% ROLL-ON LIQUID [HUMCO HOLDING GROUP, INC] 3 Current NDC, Legacy NDC, 1 package rows 20231216_a8bf9744-9979-13c1-e053-2a95a90a30aa.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0395-9131-97 00395913197 74 mL in 1 CONTAINER (0395-9131-97) 74 ml 2018-12-21 0000-00-00 No No Current