Avedana Cool Hot Ice

Product NDC
43749-321
11-digit product format
437490321
Labeler code
43749
Product ID
43749-321_1850af06-be68-45cd-a107-604506bef374
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
GEL
Route
TOPICAL
Labeler
Unipack, Inc.
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2017-11-04
Substance
MENTHOL
Active strength
2 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Avedana Cool Hot Ice
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL2 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL7T10EIP3A
Rxcui311502

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43749-321-08Avedana Cool Hot Ice227 g in 1 JARGEL2272

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43749-321AVEDANA COOL HOT ICE (MENTHOL) GEL [UNIPACK, INC.]2Current NDC, Legacy NDC, 1 package rows20180502_619c8e3f-0cad-4eb1-8dbb-632f3db74ba3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311502menthol 2 % Topical GelPSN619c8e3f-0cad-4eb1-8dbb-632f3db74ba32
311502menthol 0.02 MG/MG Topical GelSCD619c8e3f-0cad-4eb1-8dbb-632f3db74ba32
311502menthol 2 % Topical GelSY619c8e3f-0cad-4eb1-8dbb-632f3db74ba32
311502menthol 2 % topical stickSY619c8e3f-0cad-4eb1-8dbb-632f3db74ba32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43749-321-0843749032108227 g in 1 JAR (43749-321-08) 227 g2017-11-040000-00-00NoNoCurrent