Cold Therapy

Product NDC
68678-011
11-digit product format
686780011
Labeler code
68678
Product ID
68678-011_3dd632d6-58a1-ab21-e063-6394a90a850c
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
68678-011-052025-09-02C16284748780-19d75b9d0-d807-f424-e053-dadaa90a57ceCold Therapy Menthol Gel
68678-011-172025-09-02C16284748780-19d75b9d0-d807-f424-e053-dadaa90a57ceCold Therapy Menthol Gel
68678-011-992025-09-02C16284748780-19d75b9d0-d807-f424-e053-dadaa90a57ceCold Therapy Menthol Gel
68678-011-052024-01-30C16284748780-19d75b9d0-d807-f424-e053-dadaa90a57ceCold Therapy Menthol Gel
68678-011-172024-01-30C16284748780-19d75b9d0-d807-f424-e053-dadaa90a57ceCold Therapy Menthol Gel
68678-011-992024-01-30C16284748780-19d75b9d0-d807-f424-e053-dadaa90a57ceCold Therapy Menthol Gel
68678-011-042022-05-04C16284748780-19d75b9cf-d13c-f424-e053-dadaa90a57ceCryoderm Cold Therapy Spray
68678-011-162022-05-04C16284748780-19d75b9cf-d13c-f424-e053-dadaa90a57ceCryoderm Cold Therapy Spray
68678-011-322022-05-04C16284748780-19d75b9cf-d13c-f424-e053-dadaa90a57ceCryoderm Cold Therapy Spray
68678-011-902022-05-04C16284748780-19d75b9d0-80f2-f424-e053-dadaa90a57ceCryoderm Cold Therapy Roll On
68678-011-052022-05-03C16284748780-19d75b9d0-d807-f424-e053-dadaa90a57ceCold Therapy Menthol Gel
68678-011-172022-05-03C16284748780-19d75b9d0-d807-f424-e053-dadaa90a57ceCold Therapy Menthol Gel
68678-011-992022-05-03C16284748780-19d75b9d0-d807-f424-e053-dadaa90a57ceCold Therapy Menthol Gel
68678-011-042020-01-31C16284748780-19d75b9cf-d13c-f424-e053-dadaa90a57ceCryoderm Cold Therapy Spray
68678-011-052020-01-31C16284748780-19d75b9d0-d807-f424-e053-dadaa90a57ceCold Therapy Menthol Gel
68678-011-162020-01-31C16284748780-19d75b9cf-d13c-f424-e053-dadaa90a57ceCryoderm Cold Therapy Spray
68678-011-172020-01-31C16284748780-19d75b9d0-d807-f424-e053-dadaa90a57ceCold Therapy Menthol Gel
68678-011-322020-01-31C16284748780-19d75b9cf-d13c-f424-e053-dadaa90a57ceCryoderm Cold Therapy Spray
68678-011-902020-01-31C16284748780-19d75b9d0-80f2-f424-e053-dadaa90a57ceCryoderm Cold Therapy Roll On
68678-011-992020-01-31C16284748780-19d75b9d0-d807-f424-e053-dadaa90a57ceCold Therapy Menthol Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68678-011-05Cold Therapy126 mL in 1 BOTTLE, DISPENSINGGEL1264
68678-011-17Cold Therapy504 mL in 1 BOTTLE, DISPENSINGGEL5044
68678-011-99Cold Therapy3 mL in 1 PACKETGEL34

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68678-011COLD THERAPY (MENTHOL) GEL [AHC VENTURES CORP DBA CRYODERM]3Current NDC, Legacy NDC, 3 package rows20220504_90334420-5f81-4284-9a57-42e134ce362f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
259249menthol 10 % Topical GelPSN90334420-5f81-4284-9a57-42e134ce362f4
259249menthol 0.1 MG/MG Topical GelSCD90334420-5f81-4284-9a57-42e134ce362f4
259249menthol 10 % Topical GelSY90334420-5f81-4284-9a57-42e134ce362f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68678-011-0568678001105126 mL in 1 BOTTLE, DISPENSING (68678-011-05) 126 ml2016-01-010000-00-00NoNoCurrent
68678-011-1768678001117504 mL in 1 BOTTLE, DISPENSING (68678-011-17) 504 ml2016-01-010000-00-00NoNoCurrent
68678-011-99686780011993 mL in 1 PACKET (68678-011-99) 3 ml2016-01-010000-00-00NoNoCurrent