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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct83062-410IInactivated by FDA2026-10-02
excluded packagepackage83062-41083062-410-04IInactivated by FDA2026-10-02

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage83062-410-04IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage83062-410-04IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage83062-410-04IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage83062-410-04IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage83062-410-04IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage83062-410-04IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage83062-410-04UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage83062-410-04UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage83062-410-04UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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