Comfortcaine Topical Anesthetic

Product NDC
68400-460
11-digit product format
684000460
Labeler code
68400
Product ID
68400-460_2b4eab7a-81a4-f87e-e063-6394a90a4107
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine
Dosage form
GEL
Route
DENTAL
Labeler
Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-11-01
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
Comfortcaine Topical Anesthetic
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE200 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiU3RSY48JW5
Rxcui238910

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
68400-460-30Comfortcaine Topical Anesthetic30 g in 1 JARGEL304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68400-460COMFORTCAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC]4Current NDC, Legacy NDC, 1 package rows20250119_e70240a8-fa9d-4005-a3a0-5cca6188bf61.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238910benzocaine 20 % Oral GelPSNe70240a8-fa9d-4005-a3a0-5cca6188bf614
238910benzocaine 0.2 MG/MG Oral GelSCDe70240a8-fa9d-4005-a3a0-5cca6188bf614
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSYe70240a8-fa9d-4005-a3a0-5cca6188bf614

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68400-460-306840004603030 g in 1 JAR (68400-460-30) 30 g2018-11-010000-00-00NoNoCurrent