Cold Therapy

Product NDC
68678-013
11-digit product format
686780013
Labeler code
68678
Product ID
68678-013_3dd5fb17-c856-952b-e063-6294a90a16b2
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
GEL
Route
TOPICAL
Labeler
AHC VENTURES CORP DBA CRYODERM
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-01-01
Substance
MENTHOL
Active strength
10 g/100mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cold Therapy
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL10 g/100mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL7T10EIP3A
Rxcui259249

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68678-013-902025-09-02C16284748780-19d75b9d0-80f2-f424-e053-dadaa90a57ceCryoderm Cold Therapy Roll On
68678-013-902024-01-30C16284748780-19d75b9d0-80f2-f424-e053-dadaa90a57ceCryoderm Cold Therapy Roll On

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68678-013-90Cold Therapy95 mL in 1 BOTTLE, DISPENSINGGEL954

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68678-013COLD THERAPY (MENTHOL) GEL [AHC VENTURES CORP DBA CRYODERM]3Current NDC, Legacy NDC, 1 package rows20220505_52fff03e-eba2-4604-a71c-2522468f627b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
259249menthol 10 % Topical GelPSN52fff03e-eba2-4604-a71c-2522468f627b4
259249menthol 0.1 MG/MG Topical GelSCD52fff03e-eba2-4604-a71c-2522468f627b4
259249menthol 10 % Topical GelSY52fff03e-eba2-4604-a71c-2522468f627b4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68678-013-906867800139095 mL in 1 BOTTLE, DISPENSING (68678-013-90) 95 ml2016-01-010000-00-00NoNoCurrent