VistaCaine Topical Anesthetic

Product NDC
64522-004
11-digit product format
645220004
Labeler code
64522
Product ID
64522-004_d658d6c6-e004-5083-e053-2a95a90a1a1f
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine
Dosage form
GEL
Route
DENTAL
Labeler
Inter-Med, INC.
Application
part356
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2018-02-01
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
64522-004-302025-01-30C16284748780-12cef2736-6e75-d83d-e063-dadaa90ab31f632c9ed0-3b9b-4fa8-817e-c4ac7e21ad59

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64522-004-30VistaCaine Topical Anesthetic30 g in 1 JARGEL302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64522-004VISTACAINE TOPICAL ANESTHETIC (BENZOCAINE) GEL [INTER-MED, INC.]2Legacy NDC, 1 package rows20220125_632c9ed0-3b9b-4fa8-817e-c4ac7e21ad59.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238910benzocaine 20 % Oral GelPSN632c9ed0-3b9b-4fa8-817e-c4ac7e21ad592
2002727VistaCaine 200 MG/GM Oral GelPSN632c9ed0-3b9b-4fa8-817e-c4ac7e21ad592
2002727benzocaine 0.2 MG/MG Oral Gel [Vistacaine]SBD632c9ed0-3b9b-4fa8-817e-c4ac7e21ad592
238910benzocaine 0.2 MG/MG Oral GelSCD632c9ed0-3b9b-4fa8-817e-c4ac7e21ad592
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSY632c9ed0-3b9b-4fa8-817e-c4ac7e21ad592
2002727Vistacaine 0.2 MG/MG Oral GelSY632c9ed0-3b9b-4fa8-817e-c4ac7e21ad592
2002727Vistacaine 200 MG/GM Oral GelSY632c9ed0-3b9b-4fa8-817e-c4ac7e21ad592

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64522-004-306452200043030 g in 1 JAR (64522-004-30) 30 g2018-02-010000-00-00NoNoCurrent