FDA.reportPublic FDA data

DenTek Instant Pain Relief

Product NDC
60630-077
Requested package NDC
60630-077-04
11-digit product format
606300077
Labeler code
60630
Product ID
60630-077_bd751b9a-a6c1-47ca-8c3d-32d3ad657c2c
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine
Dosage form
LIQUID
Route
DENTAL; TOPICAL
Labeler
DenTek Oral Care, Inc.
Application
part356
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2015-07-31
Marketing end
0000-00-00
Substance
BENZOCAINE
Active strength
200 mg/mL
NDC exclude flag
No
Listing certified through
2022-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage60630-07760630-077-04IInactivated by FDA2026-10-05

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 · 9 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded 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
60630-077-042025-01-30C16284748780-12cef2736-60a3-d83d-e063-dadaa90ab31fDENTEK INSTANT PAIN RELIEF
60630-077-022023-12-05C16284748780-19855e2a2-45c9-60a7-e053-dbdaa90a05bdDenTek Instant Pain Relief
60630-077-022019-11-27C16284748780-19855e2a2-45c9-60a7-e053-dbdaa90a05bdDenTek Instant Pain Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60630-077-03DenTek Instant Pain ReliefMaximum Strength3.5 mL in 1 VIAL, GLASSLIQUID3.56
60630-077-04DenTek Instant Pain ReliefMaximum Strength1 in 1 CARTONLIQUID16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZOCAINEACTIVE INGREDIENTU3RSY48JW5DENTEK INSTANT PAIN RELIEF MAXIMUM STRENGTH (BENZOCAINE) LIQUID [DENTEK ORAL CARE. INC.]1
BENZOCAINEACTIVE MOIETYU3RSY48JW5DENTEK INSTANT PAIN RELIEF MAXIMUM STRENGTH (BENZOCAINE) LIQUID [DENTEK ORAL CARE. INC.]1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQDENTEK INSTANT PAIN RELIEF MAXIMUM STRENGTH (BENZOCAINE) LIQUID [DENTEK ORAL CARE. INC.]1
SUCRALOSEINACTIVE INGREDIENT96K6UQ3ZD4DENTEK INSTANT PAIN RELIEF MAXIMUM STRENGTH (BENZOCAINE) LIQUID [DENTEK ORAL CARE. INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60630-077DENTEK INSTANT PAIN RELIEF MAXIMUM STRENGTH (BENZOCAINE) LIQUID [DENTEK ORAL CARE, INC.]6Legacy NDC, 2 package rows20211014_3a3468b4-0625-71cd-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308657benzocaine 20 % Mucous Membrane Topical SolutionPSN3a3468b4-0625-71cd-e054-00144ff8d46c6
308657benzocaine 20 % Mucous Membrane Topical SolutionPSN3afd5a15-02db-27d3-e054-00144ff88e886
308657benzocaine 200 MG/ML Mucous Membrane Topical SolutionSCD3a3468b4-0625-71cd-e054-00144ff8d46c6
308657benzocaine 200 MG/ML Mucous Membrane Topical SolutionSCD3afd5a15-02db-27d3-e054-00144ff88e886
308657benzocaine 20 % Mucous Membrane Topical SolutionSY3a3468b4-0625-71cd-e054-00144ff8d46c6
308657benzocaine 20 % Mucous Membrane Topical SolutionSY3afd5a15-02db-27d3-e054-00144ff88e886
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 formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60630-077-04606300077041 VIAL, GLASS in 1 CARTON (60630-077-04) > 3.5 mL in 1 VIAL, GLASS (60630-077-03) 2015-07-310000-00-00NoNoCurrent