Thera Plus Cool and Heat Pain Relieving Gel Menthol

Product NDC
80684-097
11-digit product format
806840097
Labeler code
80684
Product ID
80684-097_0b61ea71-e589-bff5-e063-6394a90a2e50
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
LIQUID
Route
TOPICAL
Labeler
Fourstar Group USA, Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-02-01
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
Thera Plus Cool and Heat Pain Relieving Gel Menthol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL160 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL7T10EIP3A
Rxcui253056

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80684-097-00Thera Plus Cool and Heat Pain Relieving Gel Menthol74 mL in 1 BOTTLELIQUID742

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80684-097THERA PLUS COOL AND HEAT PAIN RELIEVING GEL MENTHOL (MENTHOL) LIQUID [FOURSTAR GROUP USA, INC.]2Current NDC, 1 package rows20240201_0a225714-ccb1-4676-e063-6294a90aeeb2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
253056menthol 16 % Topical GelPSN0a225714-ccb1-4676-e063-6294a90aeeb22
253056menthol 0.16 MG/MG Topical GelSCD0a225714-ccb1-4676-e063-6294a90aeeb22
253056menthol 16 % Topical GelSY0a225714-ccb1-4676-e063-6294a90aeeb22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80684-097-008068400970074 mL in 1 BOTTLE (80684-097-00) 74 ml2024-02-01NoNoHistorical