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

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
U3RSY48JW5Internal UNII lookup
86Q357L16BInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1249105Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
093f3545-1d8e-48a3-a533-e9c3ae6d740bAvailable on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 13 of 40 · 782 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Orajel 4X Medicated For Toothache and GumBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.999851ac-925c-7d1f-e053-2a95a90a240b2025-12-12WarningsExact identifier
application number: M022
Orajel 3X Medicated For Toothache and GumBENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.99a2b061-0875-59a4-e053-2995a90ab3732025-12-12WarningsExact identifier
application number: M022
Orajel Antiseptic Rinse For All Mouth SoresHYDROGEN PEROXIDE AND MENTHOLChurch & Dwight Co., Inc.06188d36-0d60-6ae6-e054-00144ff8d46c2025-12-12WarningsExact identifier
application number: M022
Orajel 3X Medicated For All Mouth SoresBENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.99b589ac-9833-fb60-e053-2995a90a09352025-12-12WarningsExact identifier
application number: M022
Orajel 4X Medicated For Toothache and Gum, CreamBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.999aa7b9-bf9e-9285-e053-2a95a90a345b2025-12-12WarningsExact identifier
application number: M022
Orajel 4X Medicated PM For Toothache and GumBENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.999cff2b-c23e-5abe-e053-2a95a90a75692025-12-12WarningsExact identifier
application number: M022
Benzoin Compound TinctureBENZOIN RESINHumco Holding Group, Inc.a893a232-2ea8-4e0d-8cbf-7f5040b3be2e2025-12-11WarningsExact identifier
application number: M022
Listerine Original Intense Antiseptic Antigingivitis/ Antiplaque MouthwashEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLKenvue Brands LLC456d45e8-bf6d-31c4-e063-6394a90a5c002025-12-10WarningsExact identifier
application number: M022
Oral pain reliefBENZOCAINEALAINA HEALTHCARE PRIVATE LIMITEDd98c1b2f-fe75-4d52-b082-1abb7628c59e2025-12-09WarningsExact identifier
application number: M022
HEB Sensitive Extra Whitening TwinSODIUM FLUORIDEHEB41d5ae3e-51c1-263b-e063-6394a90a33122025-12-08WarningsExact identifier
application number: M022
CankerMeltsBENZOCAINEQuest Products, LLC070dae82-14c2-66d2-e063-6394a90ab2592025-12-04WarningsExact identifier
application number: M022
Sore Throat ReadyInCasePHENOLP & L Development, LLC2fb3d17e-8ca3-4edb-8b82-4b484f42616e2025-12-03WarningsExact identifier
application number: M022
Listerine Cool Mint Intense Antiseptic Antigingivitis/ Antiplaque MouthwashEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLKenvue Brands LLC44f2b66a-26ae-1044-e063-6394a90a9ab62025-12-02WarningsExact identifier
application number: M022
Sensodyne Fresh CleanSTANNOUS FLUORIDEHaleon US Holdings LLC2d433ac1-3ddf-a2f4-e063-6394a90a91f82025-12-01WarningsExact identifier
application number: M022
Walgreens SalineNASALWALGREEN COMPANY147e45c8-1e71-4c06-89f1-42e9f96833662025-12-01WarningsExact identifier
application number: M022
EELHOE Probiotic Bright White FreshGLYCERINShantou Eelhoe Daily Chemical Technology Co., Ltd.425cec0e-aa74-5341-e063-6294a90ac86b2025-11-27WarningsExact identifier
application number: M022
EELHOE 5 Days Tooth PowderGLYCERINShantou Eelhoe Daily Chemical Technology Co., Ltd.42f98b14-d1d5-4af8-e063-6294a90a8f672025-11-27WarningsExact identifier
application number: M022
JAYSUING Colour CorrectorGLYCERINShantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd.425d9c23-a692-3c62-e063-6294a90a94042025-11-27WarningsExact identifier
application number: M022
Walgreen SalineNASALWALGREENS CO.ee264d8b-0bb2-472a-907c-6a6291f154cd2025-11-26WarningsExact identifier
application number: M022
Walgreens Sore Throat Cherry FlavorPHENOLWALGREEN COMPANYfe092017-1f3e-41f1-b718-e24de53cf2762025-11-26WarningsExact identifier
application number: M022

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