Home NDC 13709-311 Cool n Heat
Product NDC 13709-311
11-digit product format 137090311
Labeler code 13709
Product ID 13709-311_0eb06bdb-c859-98c0-e063-6394a90ab3d6
Type HUMAN OTC DRUG
Nonproprietary name Cool n Heat
Dosage form SPRAY
Route TOPICAL
Labeler NeilMed Pharmaceuticals, Inc.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-11-09
Substance MENTHOL
Active strength 160 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 Cool n Heat
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 160 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 1430458 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 13709-311-01 Cool n Heat 118 mL in 1 CAN SPRAY 118 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 13709-311 COOL N HEAT SPRAY [NEILMED PHARMACEUTICALS, INC.] 6 Current NDC, Legacy NDC, 1 package rows 20240112_a24cde17-280b-8358-e053-2a95a90af67d.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.
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 13709-311-01 13709031101 118 mL in 1 CAN (13709-311-01) 118 ml 2018-11-09 0000-00-00 No No Current