FDA.reportPublic FDA data

NDC 60630-077-01 - Dentek Instant Pain Relief Maximum Strength

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
60630-077
Requested NDC
60630-077-01
Package NDCs from labels
60630-077-03, 60630-077-04, 60630-077-01, 60630-077-02
Manufacturer
IIMED MEDICAL MEXICANA S. DE R.L. DE C.V
Effective date
2023-10-05
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Benzocaine - IIMED MEDICAL MEXICANA S. DE R.L. DE C.VIIMED MEDICAL MEXICANA S. DE R.L. DE C.V2023-10-05HUMAN OTC DRUG LABEL
DenTek Instant Pain Relief Maximum Strength - Team Technologies, IncTeam Technologies, Inc2022-10-13HUMAN OTC DRUG LABEL
DENTEK INSTANT PAIN RELIEFDenTek Oral Care, Inc.2021-10-18HUMAN OTC DRUG LABEL
DenTek Instant Pain ReliefDenTek Oral Care. Inc. | DenTek Oral Care, Inc.2013-11-04HUMAN OTC DRUG LABEL

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 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 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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 5 of 35 · 698 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BencoCaine Topical AnestheticBENZOCAINEBenco Dental4d3e03ee-6e0f-c9ae-e063-6394a90a6f5b2026-03-17WarningsExact identifier
unii: U3RSY48JW5
Leader Ultra Lubricating Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCardinal Healthd7f011a2-05ba-47c3-9519-d31602e105c72026-03-12WarningsExact identifier
unii: B697894SGQ
Leader Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLCardinal Health5c5d6c13-9b51-48f0-8627-b60b0f707fd32026-03-12WarningsExact identifier
unii: B697894SGQ
BEE VENOM SKIN FIRMING CreamBEE VENOMGuangzhou Mizi Biotechnology Co., LTD.4ccf576f-b6bb-42ac-e063-6294a90a36522026-03-12WarningsExact identifier
unii: AV092KU4JH
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC043c00a6-1346-7780-e063-6294a90a3d5a2026-03-12WarningsExact identifier
unii: U3RSY48JW5
ORAL PAIN RELIEFBENZOCAINENantong Health & Beyond Hygienic Products Inc.a5f0be98-d47e-4307-8044-304a64db774b2026-03-11WarningsExact identifier
unii: U3RSY48JW5
Numstat Antiseptic and Pain-Relieving Prep PadANTISEPTIC AND PAIN-RELIEVING PREP PADSafetec of America Inc.4c9c20f2-bc17-857b-e063-6394a90a5d5c2026-03-09WarningsExact identifier
unii: U3RSY48JW5
Artificial TearsGLYCERINPreferred Pharmaceuticals Inc.dd646c72-8f47-43c6-a734-db0dcc8cd4d12026-03-06WarningsExact identifier
unii: B697894SGQ
Hug a BooBoo Medicated booboo WipesBENZOCAINELights Medical Manufacture Co., Ltd.509aaafc-2ef7-4205-818c-7ff5b146e1592026-03-04WarningsExact identifier
unii: U3RSY48JW5
DUAL ANESTHETIC NUMBINGDUAL ANESTHETIC NUMBINGLEIBOVICH EDWARD PERSOANA FIZICA AUTORIZATA4c1de25d-2586-f0cd-e063-6294a90aff362026-03-03WarningsExact identifier
unii: U3RSY48JW5
Sore Throat Logenzes Sore ThroatBENZOCAINE AND MENTHOLMajor Pharmaceuticals11416620-4892-44ba-9780-db27efff67432026-02-24WarningsExact identifier
unii: U3RSY48JW5
Everlit Care Products Sting ReliefISOPROPYL ALCOHOLEVERLIT GLOBAL INC.adfab206-b7de-4f6a-a864-edd946ea743d2026-02-09WarningsExact identifier
unii: U3RSY48JW5
Flocean ANTI-ITCHBENZOCAINE 5%ANTI-ITCHJiangxi Yudexi Pharmaceutical Co., LTD4a493911-a846-5aa0-e063-6294a90a65ac2026-02-07WarningsExact identifier
unii: U3RSY48JW5
GoodSense Eye Drops Advanced Relief MoisturizerDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLSportpharm LLC8d58dcbb-72a0-41f0-9eeb-613072a6d7ae2026-02-06WarningsExact identifier
unii: B697894SGQ
5 Elementum Delay WipesBENZOCAINE DELAY WIPESMSVenturesGroup O440539b0-612b-3b41-e063-6294a90a1ddd2026-02-05WarningsExact identifier
unii: U3RSY48JW5
Medicaine Sting and BiteBENZOCAINEDynarex Corporationb721607e-e36b-4691-a824-c8f520bd63862026-02-04WarningsExact identifier
unii: U3RSY48JW5
Cherry Sore Throat LozengesBENZOCAINE, MENTHOLMeijer Distribution Inc.2f6de590-7cad-25d7-e054-00144ff8d46c2026-02-02WarningsExact identifier
unii: U3RSY48JW5
Mixed Berry Sore Throat and Cough lozengeDEXTROMETHORPHAN HYDROBROMIDEMeijer Distribution, Inc.304ff4db-201a-60a4-e054-00144ff8d46c2026-02-02WarningsExact identifier
unii: U3RSY48JW5
Dynamo Wellness Delay MAX WipeDYNAMO WELLNESS DELAY MAX WIPEMomentum Management LLC1f95e949-8f90-4de0-9097-24eadd404e222026-01-28WarningsExact identifier
unii: U3RSY48JW5
Everlit Survival Sting Relief PadISOPROPYL ALCOHOLEVERLIT GLOBAL INC.3a0414ea-f862-aa0f-e063-6294a90aecb72026-01-23WarningsExact identifier
unii: U3RSY48JW5

Reported adverse events (FAERS/openFDA)#

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