FDA.reportPublic FDA data

KANKA

Product NDC
10157-2106
11-digit product format
101572106
Labeler code
10157
Product ID
10157-2106_bbba35d9-5dd7-4471-ad62-63061a9128a1
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine and ZINC CHLORIDE
Dosage form
GEL
Route
ORAL
Labeler
Blistex Inc
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-09-25
Substance
BENZOCAINE; ZINC CHLORIDE
Active strength
20; .1 mg/100g; g/100g
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [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
Brand name suffix
SoftBrush
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE20 mg/100g
ZINC CHLORIDE.1 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU3RSY48JW5, 86Q357L16B
Rxcui1249105

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10157-2106-1KANKA SoftBrush2 g in 1 APPLICATORGEL22
10157-2106-1KANKA SoftBrush1 in 1 BLISTER PACKGEL12
10157-2106-2KANKA SoftBrush2 g in 1 APPLICATORGEL22
10157-2106-2KANKA SoftBrush2 in 1 BLISTER PACKGEL22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10157-2106KANKA SOFTBRUSH (BENZOCAINE AND ZINC CHLORIDE) GEL [BLISTEX INC]2Current NDC, Legacy NDC, 4 package rows20241215_093f3545-1d8e-48a3-a533-e9c3ae6d740b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1249105benzocaine 20 % / zinc chloride 0.1 % Oral GelPSN093f3545-1d8e-48a3-a533-e9c3ae6d740b2
1249105benzocaine 0.2 MG/MG / zinc chloride 0.001 MG/MG Oral GelSCD093f3545-1d8e-48a3-a533-e9c3ae6d740b2
1249105benzocaine 20 % / zinc chloride 0.1 % Oral GelSY093f3545-1d8e-48a3-a533-e9c3ae6d740b2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10157-2106-1101572106011 APPLICATOR in 1 BLISTER PACK (10157-2106-1) / 2 g in 1 APPLICATOR1 applicator2019-09-250000-00-00NoNoCurrent
10157-2106-2101572106022 APPLICATOR in 1 BLISTER PACK (10157-2106-2) / 2 g in 1 APPLICATOR2 applicator2019-09-250000-00-00NoNoCurrent