Home NDC 82645-014 Hot/Cold Menthol 16% Roll-On
Product NDC 82645-014
11-digit product format 826450014
Labeler code 82645
Product ID 82645-014_4f6f50c3-79af-1aac-e063-6294a90a1a63
Type HUMAN OTC DRUG
Nonproprietary name Hot/Cold Menthol 16% Roll-On
Dosage form LIQUID
Route TOPICAL
Labeler Pharma Nobis, LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-04-14
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 82645-014-97 Hot/Cold Menthol 16% Roll-On 1 in 1 CARTON LIQUID 1 1 82645-014-97 Hot/Cold Menthol 16% Roll-On 74 mL in 1 BOTTLE, WITH APPLICATOR LIQUID 74 1
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 111 of 152 · 3,029 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 82645-014-97 82645001497 1 BOTTLE, WITH APPLICATOR in 1 CARTON (82645-014-97) / 74 mL in 1 BOTTLE, WITH APPLICATOR 2026-04-14 No No Current