AnaDent Childrens Kanka Gel

Product NDC
27854-178
11-digit product format
278540178
Labeler code
27854
Product ID
27854-178_af2ff29f-3dd2-4fde-ad17-21bc9dddde70
Type
HUMAN OTC DRUG
Nonproprietary name
Eugenol
Dosage form
GEL
Route
DENTAL
Labeler
Belmora LLC
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-11-08
Substance
EUGENOL
Active strength
12 mg/g
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
AnaDent Childrens Kanka Gel
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
EUGENOL12 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3T8H1794QWInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1248581Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9c06211c-f05a-4ce7-89e5-63a63efb7f96Available on FDA.report

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
27854-178-01AnaDent Childrens Kanka Gel1 in 1 CARTONGEL12
27854-178-01AnaDent Childrens Kanka Gel7 g in 1 TUBEGEL72

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27854-178ANADENT CHILDRENS KANKA GEL (EUGENOL) GEL [BELMORA LLC]2Current NDC, Legacy NDC, 2 package rows20241009_9c06211c-f05a-4ce7-89e5-63a63efb7f96.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AnaDent Childrens Kanka GelEUGENOLBelmora LLC9c06211c-f05a-4ce7-89e5-63a63efb7f962024-10-04WarningsExact identifier
ndc (product): 27854-178

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1248581eugenol 1.2 % Oral GelPSN9c06211c-f05a-4ce7-89e5-63a63efb7f962
1248581eugenol 0.012 MG/MG Oral GelSCD9c06211c-f05a-4ce7-89e5-63a63efb7f962
1248581eugenol 1.2 % Oral GelSY9c06211c-f05a-4ce7-89e5-63a63efb7f962

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
27854-178-01278540178011 TUBE in 1 CARTON (27854-178-01) / 7 g in 1 TUBE1 tube2022-11-080000-00-00NoNoCurrent