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

Additional Listing Data#

Finished product
Yes
Brand name base
Cool n Heat
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL160 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL7T10EIP3A
Rxcui1430458

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13709-311-01Cool n Heat118 mL in 1 CANSPRAY1186

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13709-311COOL N HEAT SPRAY [NEILMED PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 1 package rows20240112_a24cde17-280b-8358-e053-2a95a90af67d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1430458menthol 16 % Topical SprayPSNa24cde17-280b-8358-e053-2a95a90af67d6
1430458menthol 160 MG/ML Topical SpraySCDa24cde17-280b-8358-e053-2a95a90af67d6
1430458menthol 16 % Topical SpraySYa24cde17-280b-8358-e053-2a95a90af67d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13709-311-0113709031101118 mL in 1 CAN (13709-311-01) 118 ml2018-11-090000-00-00NoNoCurrent