FDA.reportPublic FDA data

Kanka Triple Action

Product NDC
10157-2127
11-digit product format
101572127
Labeler code
10157
Product ID
10157-2127_225703ba-c471-4c9a-9c01-4b7f075b7878
Type
HUMAN OTC DRUG
Nonproprietary name
BENZOCAINE and MENTHOL, UNSPECIFIED FORM
Dosage form
GEL
Route
ORAL
Labeler
Blistex Inc.
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-01-06
Substance
BENZOCAINE; MENTHOL, UNSPECIFIED FORM
Active strength
20; 2 g/100g; g/100g
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Kanka Triple Action
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE20 g/100g
MENTHOL, UNSPECIFIED FORM2 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU3RSY48JW5, L7T10EIP3A
Rxcui1006079

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10157-2127-1Kanka Triple Action1 in 1 CARTONGEL11
10157-2127-1Kanka Triple Action11.9 g in 1 TUBEGEL11.91

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10157-2127KANKA TRIPLE ACTION (BENZOCAINE AND MENTHOL, UNSPECIFIED FORM) GEL [BLISTEX INC.]1Current NDC, 2 package rows20250112_078fcdab-38a1-4a9a-bdd3-e17446591ea8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1006079benzocaine 20 % / menthol 2 % Oral GelPSN078fcdab-38a1-4a9a-bdd3-e17446591ea81
1006079benzocaine 0.2 MG/MG / menthol 0.02 MG/MG Oral GelSCD078fcdab-38a1-4a9a-bdd3-e17446591ea81
1006079benzocaine 20 % / menthol 2 % Mucous Membrane Topical GelSY078fcdab-38a1-4a9a-bdd3-e17446591ea81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
10157-2127-1101572127011 TUBE in 1 CARTON (10157-2127-1) / 11.9 g in 1 TUBE1 tube2025-01-06NoNoCurrent