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 Identifiers#

Field, Values table
FieldValues
Unii3T8H1794QW
Rxcui1248581

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

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