Cold Therapy

Product NDC
68678-012
11-digit product format
686780012
Labeler code
68678
Product ID
68678-012_3dd5f406-2bb4-a4f9-e063-6294a90a16b2
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
SPRAY
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
Rxcui1371206

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68678-012-04Cold Therapy126 mL in 1 BOTTLE, SPRAYSPRAY1265
68678-012-16Cold Therapy504 mL in 1 BOTTLE, SPRAYSPRAY5045
68678-012-32Cold Therapy1008 mL in 1 BOTTLE, SPRAYSPRAY10085

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68678-012COLD THERAPY (MENTHOL) SPRAY [AHC VENTURES CORP DBA CRYODERM]4Current NDC, Legacy NDC, 3 package rows20220513_dd95c682-8ddf-43e7-a277-2fca6ec744cc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1371206menthol 1 % Topical SprayPSNdd95c682-8ddf-43e7-a277-2fca6ec744cc5
1371206menthol 10 MG/ML Topical SpraySCDdd95c682-8ddf-43e7-a277-2fca6ec744cc5
1371206menthol 1 % Topical SpraySYdd95c682-8ddf-43e7-a277-2fca6ec744cc5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68678-012-0468678001204126 mL in 1 BOTTLE, SPRAY (68678-012-04) 126 ml2016-01-010000-00-00NoNoCurrent
68678-012-1668678001216504 mL in 1 BOTTLE, SPRAY (68678-012-16) 504 ml2016-01-010000-00-00NoNoCurrent
68678-012-32686780012321008 mL in 1 BOTTLE, SPRAY (68678-012-32) 1008 ml2016-01-010000-00-00NoNoCurrent