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 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 Hot/Cold Menthol 16% Roll-On
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 16 mg/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 SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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
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 153 · 3,057 matching rows.
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