Thera Plus Cold Therapy Pain Relieving Menthol

Product NDC
80684-101
11-digit product format
806840101
Labeler code
80684
Product ID
80684-101_0b23e32c-9248-271c-e063-6294a90a1f5c
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
GEL
Route
TOPICAL
Labeler
Fourstar Group USA, Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-02-01
Substance
MENTHOL
Active strength
40 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 Cold Therapy Pain Relieving Menthol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL40 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL7T10EIP3A
Rxcui415974

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80684-101-00Thera Plus Cold Therapy Pain Relieving Menthol74 mL in 1 BOTTLEGEL742

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80684-101THERA PLUS COLD THERAPY PAIN RELIEVING MENTHOL (MENTHOL) GEL [FOURSTAR GROUP USA, INC.]2Current NDC, 1 package rows20240201_0a462c91-5300-e282-e063-6394a90a4cc2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
415974menthol 4 % Topical GelPSN0a462c91-5300-e282-e063-6394a90a4cc22
415974menthol 0.04 MG/MG Topical GelSCD0a462c91-5300-e282-e063-6394a90a4cc22
415974menthol 4 % Topical GelSY0a462c91-5300-e282-e063-6394a90a4cc22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80684-101-008068401010074 mL in 1 BOTTLE (80684-101-00) 74 ml2024-02-01NoNoHistorical