Quala Topical Anesthetic Gel

Product NDC
68400-509
11-digit product format
684000509
Labeler code
68400
Product ID
68400-509_d7c6b892-9e3a-347e-e053-2995a90a9800
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
2022-02-03
Marketing end
0000-00-00
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
2023-12-31
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
68400-509-302025-01-30C16284748780-12cef2736-9a7b-d83d-e063-dadaa90ab31fd7c6af67-d058-3e88-e053-2a95a90a83e0

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68400-509-30Quala Topical Anesthetic Gel30 g in 1 JARGEL301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68400-509QUALA TOPICAL ANESTHETIC GEL (BENZOCAINE) GEL [MYCONE DENTAL SUPPLY CO., INC DBA KEYSTONE INDUSTRIES AND DEEPAK PRODUCTS INC.]1Legacy NDC, 1 package rows20220212_d7c6af67-d058-3e88-e053-2a95a90a83e0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238910benzocaine 20 % Oral GelPSNd7c6af67-d058-3e88-e053-2a95a90a83e01
238910benzocaine 0.2 MG/MG Oral GelSCDd7c6af67-d058-3e88-e053-2a95a90a83e01
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSYd7c6af67-d058-3e88-e053-2a95a90a83e01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68400-509-306840005093030 g in 1 JAR (68400-509-30) 30 g2022-02-030000-00-00NoNoCurrent