THERAPEUTIC ICY COLD

Product NDC
69851-101
11-digit product format
698510101
Labeler code
69851
Product ID
69851-101_53b60f70-2662-486e-a5d1-a96d3c359ac0
Type
HUMAN OTC DRUG
Nonproprietary name
MENTHOL
Dosage form
GEL
Route
TOPICAL
Labeler
APEX-CAREX HEATHCARE PRODUCTS
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2015-05-15
Marketing end
0000-00-00
Substance
MENTHOL
Active strength
4 g/100mL
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69851-101-132022-01-28C16284748780-1d6a99b39-ec81-a426-e053-dadaa90af4c2219bbeb0-d2c7-4a7e-9d91-1d7c16bf54e9

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69851-101-13THERAPEUTIC ICY COLDCOOLING PAIN RELIEF ROLL-ON88.8 mL in 1 BOTTLE, WITH APPLICATORGEL88.84

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3ATHERAPEUTIC ICY COLD COOLING PAIN RELIEF ROLL-ON (MENTHOL) GEL [APEX-CAREX HEATHCARE PRODUCTS]3
MENTHOLACTIVE MOIETYL7T10EIP3ATHERAPEUTIC ICY COLD COOLING PAIN RELIEF ROLL-ON (MENTHOL) GEL [APEX-CAREX HEATHCARE PRODUCTS]3
ALCOHOLINACTIVE INGREDIENT3K9958V90MTHERAPEUTIC ICY COLD COOLING PAIN RELIEF ROLL-ON (MENTHOL) GEL [APEX-CAREX HEATHCARE PRODUCTS]3
AMINOMETHYLPROPANOLINACTIVE INGREDIENTLU49E6626QTHERAPEUTIC ICY COLD COOLING PAIN RELIEF ROLL-ON (MENTHOL) GEL [APEX-CAREX HEATHCARE PRODUCTS]3
BOSWELLIA SERRATA RESIN OILINACTIVE INGREDIENT5T1XCE6K8KTHERAPEUTIC ICY COLD COOLING PAIN RELIEF ROLL-ON (MENTHOL) GEL [APEX-CAREX HEATHCARE PRODUCTS]3
CAMPHOR OILINACTIVE INGREDIENT75IZZ8Y727THERAPEUTIC ICY COLD COOLING PAIN RELIEF ROLL-ON (MENTHOL) GEL [APEX-CAREX HEATHCARE PRODUCTS]3
CARBOMER 940INACTIVE INGREDIENT4Q93RCW27ETHERAPEUTIC ICY COLD COOLING PAIN RELIEF ROLL-ON (MENTHOL) GEL [APEX-CAREX HEATHCARE PRODUCTS]3
GLYCERININACTIVE INGREDIENTPDC6A3C0OXTHERAPEUTIC ICY COLD COOLING PAIN RELIEF ROLL-ON (MENTHOL) GEL [APEX-CAREX HEATHCARE PRODUCTS]3
HYDRATED SILICAINACTIVE INGREDIENTY6O7T4G8P9THERAPEUTIC ICY COLD COOLING PAIN RELIEF ROLL-ON (MENTHOL) GEL [APEX-CAREX HEATHCARE PRODUCTS]3
ILEX PARAGUARIENSIS LEAFINACTIVE INGREDIENT1Q953B4O4FTHERAPEUTIC ICY COLD COOLING PAIN RELIEF ROLL-ON (MENTHOL) GEL [APEX-CAREX HEATHCARE PRODUCTS]3
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TTHERAPEUTIC ICY COLD COOLING PAIN RELIEF ROLL-ON (MENTHOL) GEL [APEX-CAREX HEATHCARE PRODUCTS]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3THERAPEUTIC ICY COLD COOLING PAIN RELIEF ROLL-ON (MENTHOL) GEL [APEX-CAREX HEATHCARE PRODUCTS]3
UNCARIA TOMENTOSA LEAFINACTIVE INGREDIENT487U8M3D2PTHERAPEUTIC ICY COLD COOLING PAIN RELIEF ROLL-ON (MENTHOL) GEL [APEX-CAREX HEATHCARE PRODUCTS]3
WATERINACTIVE INGREDIENT059QF0KO0RTHERAPEUTIC ICY COLD COOLING PAIN RELIEF ROLL-ON (MENTHOL) GEL [APEX-CAREX HEATHCARE PRODUCTS]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69851-101THERAPEUTIC ICY COLD COOLING PAIN RELIEF ROLL-ON (MENTHOL) GEL [APEX-CAREX HEATHCARE PRODUCTS]4Legacy NDC, 1 package rows20191124_219bbeb0-d2c7-4a7e-9d91-1d7c16bf54e9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1486765menthol 3.9 % Topical GelPSN219bbeb0-d2c7-4a7e-9d91-1d7c16bf54e94
1486765menthol 0.039 MG/MG Topical GelSCD219bbeb0-d2c7-4a7e-9d91-1d7c16bf54e94
1486765menthol 3.9 % Topical GelSY219bbeb0-d2c7-4a7e-9d91-1d7c16bf54e94

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69851-101-136985101011388.8 mL in 1 BOTTLE, WITH APPLICATOR (69851-101-13) 88.8 ml2015-05-150000-00-00NoNoCurrent