SmartPractice topical anesthetic gel

Product NDC
69521-021
11-digit product format
695210021
Labeler code
69521
Product ID
69521-021_616aa460-7858-9f4d-e053-2a91aa0a5d58
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
benzocaine
Dosage form
GEL
Route
DENTAL
Labeler
SmartHealth, Inc. (DBA SmartPractice)
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
1963-02-19
Marketing end
0000-00-00
Substance
BENZOCAINE
Active strength
220 mg/g
Pharmacologic classes
Standardized Chemical Allergen [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Allergens [CS]
NDC exclude flag
E
Listing certified through
2018-12-31
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
69521-021-342020-01-31C16284748780-19d75b9cf-ec8d-f424-e053-dadaa90a57ceSmartPractice topical anesthetic gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69521-021-34SmartPractice topical anesthetic gelCherry34 g in 1 BOTTLE, PLASTICGEL341

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69521-021SMARTPRACTICE TOPICAL ANESTHETIC GEL PINA COLADA (BENZOCAINE) GEL SMARTPRACTICE TOPICAL ANESTHETIC GEL BUBBLE GUM (BENZOCAINE) GEL SMARTPRACTICE TOPICAL ANESTHETIC GEL STRAWBERRY (BENZOCAINE) GEL SMARTPRACTICE TOPICAL ANESTHETIC GEL CHERRY (BENZOCAINE) GEL SMARTPRACTICE TOPICAL ANESTHETIC GEL MINT (BENZOCAINE) GEL SMARTPRACTICE TOPICAL ANESTHETIC GEL RASPBERRY (BENZOCAINE) GEL [SMARTHEALTH, INC. (DBA SMARTPRACTICE)]1Legacy NDC, 1 package rows20171229_616aa460-7857-9f4d-e053-2a91aa0a5d58.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
238910benzocaine 20 % Oral GelPSN616aa460-7857-9f4d-e053-2a91aa0a5d581
238910benzocaine 0.2 MG/MG Oral GelSCD616aa460-7857-9f4d-e053-2a91aa0a5d581
238910benzocaine 20 % (180-220 MG per 1 GM) Oral GelSY616aa460-7857-9f4d-e053-2a91aa0a5d581

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
69521-021-346952100213434 g in 1 BOTTLE, PLASTIC34 gHistorical