FDA.reportPublic FDA data

Gelato Topical Anesthetic

Product NDC
68400-356
11-digit product format
684000356
Labeler code
68400
Product ID
68400-356_eaa59534-0d90-48bc-b1e0-5c35926cfb3c
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
part356
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2013-07-01
Marketing end
0000-00-00
Substance
BENZOCAINE
Active strength
200 mg/g
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68400-356-302023-01-30C16284748780-1f386c64a-1437-0266-e053-dadaa90a7c1aee3c488e-ebd6-4a94-a488-281fb056c0d8

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68400-356-30Gelato Topical Anesthetic30 g in 1 JARGEL304

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZOCAINEACTIVE INGREDIENTU3RSY48JW5GELATO TOPICAL ANESTHETIC (BENZOCAINE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC]3
BENZOCAINEACTIVE MOIETYU3RSY48JW5GELATO TOPICAL ANESTHETIC (BENZOCAINE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC]3
POLYETHYLENE GLYCOL 3350INACTIVE INGREDIENTG2M7P15E5PGELATO TOPICAL ANESTHETIC (BENZOCAINE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC]3
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQGELATO TOPICAL ANESTHETIC (BENZOCAINE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC]3
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYGELATO TOPICAL ANESTHETIC (BENZOCAINE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68400-356GELATO TOPICAL ANESTHETIC (BENZOCAINE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC]4Legacy NDC, 1 package rows20181229_ee3c488e-ebd6-4a94-a488-281fb056c0d8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238910benzocaine 20 % Oral GelPSNee3c488e-ebd6-4a94-a488-281fb056c0d84
727988Gelato Anesthetic 20 % Oral GelPSNee3c488e-ebd6-4a94-a488-281fb056c0d84
727988benzocaine 0.2 MG/MG Oral Gel [Gelato Anesthetic]SBDee3c488e-ebd6-4a94-a488-281fb056c0d84
238910benzocaine 0.2 MG/MG Oral GelSCDee3c488e-ebd6-4a94-a488-281fb056c0d84
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSYee3c488e-ebd6-4a94-a488-281fb056c0d84
727988Gelato Anesthetic 0.2 MG/MG Oral GelSYee3c488e-ebd6-4a94-a488-281fb056c0d84
727988Gelato Anesthetic 20 % Dental GelSYee3c488e-ebd6-4a94-a488-281fb056c0d84

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68400-356-306840003563030 g in 1 JAR (68400-356-30) 30 g2018-06-010000-00-00NoNoCurrent