Cold Therapy Roll on

Product NDC
69168-483
11-digit product format
691680483
Labeler code
69168
Product ID
69168-483_bb264a96-9bd7-4230-b80f-3c62c0c80cf8
Type
HUMAN OTC DRUG
Nonproprietary name
Cold Therapy Roll on
Dosage form
GEL
Route
TOPICAL
Labeler
Allegiant Health
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-07-29
Substance
MENTHOL
Active strength
.04 g/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cold Therapy Roll on
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL.04 g/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
69168-483-67Cold Therapy Roll on74 mL in 1 BOTTLEGEL742

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
415974menthol 4 % Topical GelPSN36463acb-7c28-416f-a45f-a93f0be5692b2
415974menthol 0.04 MG/MG Topical GelSCD36463acb-7c28-416f-a45f-a93f0be5692b2
415974menthol 4 % Topical GelSY36463acb-7c28-416f-a45f-a93f0be5692b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69168-483-676916804836774 mL in 1 BOTTLE (69168-483-67) 74 ml2025-07-29NoNoCurrent