Dentek Instant Pain Relief

Product NDC
83062-410
11-digit product format
830620410
Labeler code
83062
Product ID
83062-410_eab430c5-f8e5-1132-e053-2a95a90aee2d
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine
Dosage form
LIQUID
Route
DENTAL
Labeler
IIMED MEDICAL MEXICANA S. DE R.L. DE C.V
Application
part356
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2022-10-10
Marketing end
0000-00-00
Substance
BENZOCAINE
Active strength
200 mg/mL
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83062-410-042025-01-30C16284748780-12cef2736-8656-d83d-e063-dadaa90ab31fIIMED Dentek Instant Pain Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83062-410-03Dentek Instant Pain ReliefMaximum Strength3.5 mL in 1 VIAL, GLASSLIQUID3.52
83062-410-04Dentek Instant Pain ReliefMaximum Strength1 in 1 CARTONLIQUID12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83062-410DENTEK INSTANT PAIN RELIEF MAXIMUM STRENGTH (BENZOCAINE) LIQUID [IIMED MEDICAL MEXICANA S. DE R.L. DE C.V]2Legacy NDC, 2 package rows20231006_eab430c5-f8e4-1132-e053-2a95a90aee2d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308657benzocaine 20 % Mucous Membrane Topical SolutionPSNeab430c5-f8e4-1132-e053-2a95a90aee2d2
308657benzocaine 200 MG/ML Mucous Membrane Topical SolutionSCDeab430c5-f8e4-1132-e053-2a95a90aee2d2
308657benzocaine 20 % Mucous Membrane Topical SolutionSYeab430c5-f8e4-1132-e053-2a95a90aee2d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
83062-410-03830620410033.5 mL in 1 VIAL, GLASS3.5 mlHistorical
83062-410-04830620410041 VIAL, GLASS in 1 CARTON (83062-410-04) > 3.5 mL in 1 VIAL, GLASS (83062-410-03) 2022-10-100000-00-00NoNoCurrent