Quala Topical Anesthetic Gel

Product NDC
43128-028
11-digit product format
431280028
Labeler code
43128
Product ID
43128-028_4d3b0c0c-5f3e-4dd2-e063-6394a90a4460
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine
Dosage form
GEL
Route
DENTAL
Labeler
National Distribution & Contracting, Inc
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-10-01
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Quala Topical Anesthetic Gel
Listing expiration
2027-12-31

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43128-028-302025-01-30C16284748780-12cef2736-a77d-d83d-e063-dadaa90ab31f9f81ffa5-05fd-4eef-e053-2995a90aac3e

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43128-028-30Quala Topical Anesthetic Gel30 g in 1 JARGEL303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43128-028QUALA TOPICAL ANESTHETIC GEL (BENZOCAINE) GEL [NATIONAL DISTRIBUTION & CONTRACTING, INC]2Current NDC, Legacy NDC, 1 package rows20220127_9f81ffa5-05fd-4eef-e053-2995a90aac3e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238910benzocaine 20 % Oral GelPSN9f81ffa5-05fd-4eef-e053-2995a90aac3e3
238910benzocaine 0.2 MG/MG Oral GelSCD9f81ffa5-05fd-4eef-e053-2995a90aac3e3
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSY9f81ffa5-05fd-4eef-e053-2995a90aac3e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43128-028-304312800283030 g in 1 JAR (43128-028-30) 30 g2019-10-010000-00-00NoNoCurrent