FDA.reportPublic FDA data

KINKAN COOL

Product NDC
51027-0330
11-digit product format
510270330
Labeler code
51027
Product ID
51027-0330_3734da7d-dfb4-cae0-e063-6294a90ad6a8
Type
HUMAN OTC DRUG
Nonproprietary name
diphenhydramine hydrochloride, menthol
Dosage form
LINIMENT
Route
TOPICAL
Labeler
KINKANDO CO., LTD .
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2000-04-26
Substance
DIPHENHYDRAMINE HYDROCHLORIDE; MENTHOL
Active strength
1; .5 g/50mL; g/50mL
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
KINKAN COOL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE1 g/50mL
MENTHOL.5 g/50mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiTC2D6JAD40, L7T10EIP3A
Rxcui1298287

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51027-0330-2KINKAN COOL1 in 1 BOXLINIMENT18
51027-0330-2KINKAN COOL96 in 1 CARTONLINIMENT968

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
diphenhydramine hydrochlorideACTIVE INGREDIENTTC2D6JAD40KINKAN COOL (DIPHENHYDRAMINE HYDROCHLORIDE, MENTHOL) LINIMENT [KINKANDO CO., LTD.]1
mentholACTIVE INGREDIENTL7T10EIP3AKINKAN COOL (DIPHENHYDRAMINE HYDROCHLORIDE, MENTHOL) LINIMENT [KINKANDO CO., LTD.]1
diphenhydramineACTIVE MOIETY8GTS82S83MKINKAN COOL (DIPHENHYDRAMINE HYDROCHLORIDE, MENTHOL) LINIMENT [KINKANDO CO., LTD.]1
mentholACTIVE MOIETYL7T10EIP3AKINKAN COOL (DIPHENHYDRAMINE HYDROCHLORIDE, MENTHOL) LINIMENT [KINKANDO CO., LTD.]1
alcoholINACTIVE INGREDIENT3K9958V90MKINKAN COOL (DIPHENHYDRAMINE HYDROCHLORIDE, MENTHOL) LINIMENT [KINKANDO CO., LTD.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXKINKAN COOL (DIPHENHYDRAMINE HYDROCHLORIDE, MENTHOL) LINIMENT [KINKANDO CO., LTD.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51027-0330KINKAN COOL (DIPHENHYDRAMINE HYDROCHLORIDE, MENTHOL) LINIMENT [KINKANDO CO., LTD .]7Current NDC, Legacy NDC, 2 package rows20241116_82011efe-825c-4102-b6f1-59eff4c8040a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1298287diphenhydrAMINE HCl 2 % / menthol 1 % Topical SolutionPSN82011efe-825c-4102-b6f1-59eff4c8040a8
1298287diphenhydramine hydrochloride 20 MG/ML / menthol 10 MG/ML Topical SolutionSCD82011efe-825c-4102-b6f1-59eff4c8040a8
1298287diphenhydramine hydrochloride 2 % / menthol 1 % Topical SolutionSY82011efe-825c-4102-b6f1-59eff4c8040a8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51027-0330-25102703300296 BOX in 1 CARTON (51027-0330-2) / 1 BOTTLE in 1 BOX / 50 mL in 1 BOTTLE96 box2000-04-260000-00-00NoNoCurrent