BencoCaine Topical Anesthetic

Product NDC
66975-353
11-digit product format
669750353
Labeler code
66975
Product ID
66975-353_2b3a77d0-b397-3d74-e063-6294a90ae1bd
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine
Dosage form
GEL
Route
DENTAL
Labeler
Benco Dental
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-06-27
Substance
BENZOCAINE
Active strength
200 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
BencoCaine Topical Anesthetic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE200 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU3RSY48JW5
Rxcui238910, 1541816

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
66975-353-30BencoCaine Topical Anesthetic30 g in 1 JARGEL305

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZOCAINEACTIVE INGREDIENTU3RSY48JW5BENCOCAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BENCO DENTAL]1
BENZOCAINEACTIVE MOIETYU3RSY48JW5BENCOCAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BENCO DENTAL]1
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PBENCOCAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BENCO DENTAL]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQBENCOCAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BENCO DENTAL]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYBENCOCAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BENCO DENTAL]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66975-353BENCOCAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [BENCO DENTAL]5Current NDC, Legacy NDC, 1 package rows20250110_89d23b14-398e-4b3e-955a-724ff66579b9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1541816BencoCaine 20 % Oral GelPSN89d23b14-398e-4b3e-955a-724ff66579b95
238910benzocaine 20 % Oral GelPSN89d23b14-398e-4b3e-955a-724ff66579b95
1541816benzocaine 0.2 MG/MG Oral Gel [Bencocaine]SBD89d23b14-398e-4b3e-955a-724ff66579b95
238910benzocaine 0.2 MG/MG Oral GelSCD89d23b14-398e-4b3e-955a-724ff66579b95
1541816Bencocaine 20 % Oral GelSY89d23b14-398e-4b3e-955a-724ff66579b95
1541816Bencocaine 200 MG/GM Topical Oral GelSY89d23b14-398e-4b3e-955a-724ff66579b95
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSY89d23b14-398e-4b3e-955a-724ff66579b95

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66975-353-306697503533030 g in 1 JAR (66975-353-30) 30 g2018-06-010000-00-00NoNoCurrent